The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President...

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The Leahy-Smith America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana

Transcript of The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President...

Page 1: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

The Leahy-Smith America Invents Act

Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana

Page 2: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

A Brief Overview of

Key Changes

The Leahy-Smith America Invents Act

Page 3: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

May be copied or otherwise used for educational purposes. 3

Required Studies, Provisions Urged by Special

Constituencies – Mostly of Little Practical Consequence

or Sustained Impact

Broadly Supported USPTO Provisions

Page 4: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

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1. Patent validity confined to transparent, objective, predictable and simple concepts. 2. Assured patent enforceability; broad remedial provisions for errors and omissions. 3. Ability to challenge any patent on any issue in the 9-month post-grant “window.” 4. USPTO financing/fee setting assured – to enable long-range strategic planning. 5. Patent formalities simplified – assignee filing, no separate inventor’s oath required. 6. Broad “prior user” defense based on pre-existing commercial uses of inventions. 7. Defect in Federal Circuit jurisdiction over patent counterclaims removed. 8. “False marking” qui tam suits barred; competitive harm required in private suits. 9. Opportunity for public submissions of prior art before the USPTO can grant a patent. 10. Joinder (except for HW suits) of multiple parties limited to common factual basis.

Page 5: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

AIA leaves only a 4-prong set of requirements for patentability—

• Sufficient differentiation from prior public disclosures and earlier patent filings of others.

• Sufficient disclosure to identify the claimed embodiments and to enable them to be put to a specific, practical, and substantial use.

• Sufficient definiteness to differentiate subject matter claimed from subject matter that is not.

• Sufficient concreteness to avoid excessively conceptual or otherwise abstract subject matter.

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§112(a)

§102

§103

§112(b)

§101

§112(f)

Page 6: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Collectively, the patentability changes have profound implications—

• Highly transparent patentability standards.

• Solely objective criteria for patentability.

• More predictable assessments of patentability.

• Greatly simplified tests for patentability.

• Repeal of the following as prior art – loss of right: §102(b) “in public use or on sale” forfeiture.

§102(c) “abandonment.”

§102(d) premature foreign patenting.

§102(f) personal knowledge of another.*

§102(g) prior inventions.

• §112(a)“best mode” – gone for invalidity/unenforceability. * -OddzOn Prods., Inc. v. Just Toys, Inc., 122 F.3d 1396 (Fed. Cir. 1997). 6 May be copied or otherwise used for educational purposes.

AIA §3

AIA §15

Page 7: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

A single “prior art” definition for both novelty and non-obviousness

• §102(a)(1) public disclosures – subject matter made available to the public by any means.

• §102(a)(2) earlier U.S. patent filings later published – information available to the public.

• Inventor- and collaboration-friendly features: – 1-year inventor’s grace period is not changed. – Co-workers’ and collaborators’ earlier patent filings

not prior art – including for novelty purposes. – The “grace period” perfected for an inventor who

makes the first public disclosure of an invention.

7 May be copied or otherwise used for educational purposes.

AIA §3

Page 8: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

All “deceptive intent” limitations on remedial provisions removed

• For the first time since 1836, the words “deceptive intent” will not appear in the patent statute.

• Access to remedial provisions will no longer be limited; more defective patents can be rendered both valid and enforceable.

• Greatest importance may lie in reissuing patents and correcting inventorship naming.

8 May be copied or otherwise used for educational purposes.

AIA §20

Page 9: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

AIA creates no-fault “inventorship” naming; no “mal-joinder” invalidity

• Filing permitted by the assignee as the patent applicant, not merely the inventor.

• Inventor’s oath required, but with “savings clause” and can include in the assignment.

• Inventorship correction irrespective of an original naming involving “deceptive intent.”

• Collection of changes on inventor naming can remove misjoinder/non-joinder as validity issue – will merely determine ownership.

9 May be copied or otherwise used for educational purposes.

AIA §4

AIA §20

AIA §§3/4/20

Page 10: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

AIA allows USPTO to consider additional/corrected information—

• Patent owner can ask for “supplemental examination” to consider new or corrected information; if a validity issue is raised, the USPTO will reexamine the patent.

• Prompt elimination of invalid patent claims. • No inequitable conduct allegations can be based

upon the information considered, reconsidered, or corrected during a supplemental examination.

• Provides an alternative to having a court consider misconduct and validity issues in a later patent infringement litigation.

10 May be copied or otherwise used for educational purposes.

AIA §12

Page 11: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

AIA post-grant review and inter partes review: new patent quality initiatives

• PGR = all issues of patent validity. • IPR = patents/publications; nonobviousness. • Administrative patent judges render final

decision within 1 year from institution. • Requires a t-o-p-s patent law substrate.

– Limits discovery needed for full/fair adjudication. – Provides administrative feasibility.

• Will greatly accelerate development of patent law in areas of technology new to patenting.

11 May be copied or otherwise used for educational purposes.

AIA §6

Page 12: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Positives for patent owners

• Simplifies (harmonizes) global patenting strategies and procurement practices.

• Virtually eliminates the prospect of irremediable unenforceability of a patent.

• Profound improvement in the certainty of patentability assessments.

• Discovery obtained from patent owner should be of little or no relevance to a patent’s validity in much (most?) patent litigation.

12 May be copied or otherwise used for educational purposes.

Page 13: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

§102 Novelty, Prior Art §103 Obviousness

Transparent, Objective,

Predictable and Simple

Page 14: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

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§102 Conditions for patentability; novelty and loss of right to patent A person shall be entitled to a patent unless – (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, [35 USC 102(a)] or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or (c) he has abandoned the invention, or (d) the invention was first patented or caused to be patented, or was the subject of an inventor's certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor's certificate filed more than twelve months before the filing of the application in the United States, or (e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or (f) he did not himself invent the subject matter sought to be patented, or (g) (1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person's invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

§103. Conditions for patentability; non-obvious subject matter (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. (b)(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if – (A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and (B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person. (2) A patent issued on a process under paragraph (1) – (A) shall also contain the claims to the composition of matter used in or made by that process, or (B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154. (3) For purposes of paragraph (1), the term “biotechnological process” means – (A) a process of genetically altering or otherwise inducing a single– or multi-celled organism to – (i) express an exogenous nucleotide sequence, (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or (iii) express a specific physiological characteristic not naturally associated with said organism; (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and (C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B). (c)(1) Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person. (2) For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if— (A) the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made; (B) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and C) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement. (3) For purposes of paragraph (2), the term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention. Pre-AIA §§ 102/103

Page 15: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

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§102 Conditions for patentability; novelty and loss of right to patent A person shall be entitled to a patent unless – (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, [35 USC 102(a)] or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or (c) he has abandoned the invention, or (d) the invention was first patented or caused to be patented, or was the subject of an inventor's certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor's certificate filed more than twelve months before the filing of the application in the United States, or (e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or (f) he did not himself invent the subject matter sought to be patented, or (g) (1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person's invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

§103. Conditions for patentability; non-obvious subject matter (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. (b)(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if – (A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and (B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person. (2) A patent issued on a process under paragraph (1) – (A) shall also contain the claims to the composition of matter used in or made by that process, or (B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154. (3) For purposes of paragraph (1), the term “biotechnological process” means – (A) a process of genetically altering or otherwise inducing a single– or multi-celled organism to – (i) express an exogenous nucleotide sequence, (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or (iii) express a specific physiological characteristic not naturally associated with said organism; (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and (C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B). (c)(1) Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person. (2) For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if— (A) the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made; (B) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and C) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement. (3) For purposes of paragraph (2), the term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention. Post-AIA §§ 102/103

Most provisions have no counterpart

under the new law.

Page 16: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

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Sec. 103. Conditions for patentability; non-obvious subject matter (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. (b)(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if – (A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and (B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person. (2) A patent issued on a process under paragraph (1) – (A) shall also contain the claims to the composition of matter used in or made by that process, or (B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154. (3) For purposes of paragraph (1), the term “biotechnological process” means – (A) a process of genetically altering or otherwise inducing a single– or multi-celled organism to – (i) express an exogenous nucleotide sequence, (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or (iii) express a specific physiological characteristic not naturally associated with said organism; (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and (C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B). (c)(1) Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person. (2) For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if— (A) the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made; (B) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and C) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement. (3) For purposes of paragraph (2), the term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.

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Sec. 103. Conditions for patentability; non-obvious subject matter (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. (b)(1) Notwithstanding subsection (a), and upon timely election by the applicant for patent to proceed under this subsection, a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under subsection (a) of this section shall be considered nonobvious if – (A) claims to the process and the composition of matter are contained in either the same application for patent or in separate applications having the same effective filing date; and (B) the composition of matter, and the process at the time it was invented, were owned by the same person or subject to an obligation of assignment to the same person. (2) A patent issued on a process under paragraph (1) – (A) shall also contain the claims to the composition of matter used in or made by that process, or (B) shall, if such composition of matter is claimed in another patent, be set to expire on the same date as such other patent, notwithstanding section 154. (3) For purposes of paragraph (1), the term “biotechnological process” means – (A) a process of genetically altering or otherwise inducing a single– or multi-celled organism to – (i) express an exogenous nucleotide sequence, (ii) inhibit, eliminate, augment, or alter expression of an endogenous nucleotide sequence, or (iii) express a specific physiological characteristic not naturally associated with said organism; (B) cell fusion procedures yielding a cell line that expresses a specific protein, such as a monoclonal antibody; and (C) a method of using a product produced by a process defined by subparagraph (A) or (B), or a combination of subparagraphs (A) and (B). (c)(1) Subject matter developed by another person, which qualifies as prior art only under one or more of subsections (e), (f), and (g) of section 102 of this title, shall not preclude patentability under this section where the subject matter and the claimed invention were, at the time the invention was made, owned by the same person or subject to an obligation of assignment to the same person. (2) For purposes of this subsection, subject matter developed by another person and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person if— (A) the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date the claimed invention was made; (B) the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; and C) the application for patent for the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement. (3) For purposes of paragraph (2), the term “joint research agreement” means a written contract, grant, or cooperative agreement entered into by two or more persons or entities for the performance of experimental, developmental, or research work in the field of the claimed invention.

Page 18: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. (a) A patent may not be obtained notwithstanding that though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the claimed invention subject matter sought to be patented and the prior art are such that the claimed invention subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. A patent may not be obtained notwithstanding that though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the claimed invention subject matter sought to be patented and the prior art are such that the claimed invention subject matter as a whole would have been obvious before the effective filing date of the claimed invention at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.

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Simplify, Clarify

Language

Add the Effective

Filing Date

Pre-AIA §103(a)

Post-AIA §103

The terms “claimed invention” and “effective filing date” are now defined in §100;

“disclosed” is now explicitly used in §102 as a generic term inclusive of “described.”

Page 19: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

New §102(a) defines all of what can possibly be prior art under the AIA

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Under new §102(a), prior art is confined to disclosures made

available to the public prior to the inventor’s

patent filing and earlier patent filings of others

that subsequently became public (published

or issued). The result is a prior art

definition with unprecedented

transparency under U.S. patent law.

A patent for a claimed invention may not be obtained if—*

*-Preamble should be construed as in §103.

May be copied or otherwise used for educational purposes.

Page 20: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

New §102 and amended §103 use a common definition for prior art

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A patent for a claimed invention may not be obtained if—*

May be copied or otherwise used for educational purposes.

The brevity of the 1952 Patent Act has been restored; the language

has been refined.

Page 21: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Two §102(a) Categories: (1) Public and (2) Patent-Filing Disclosures

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Under new §102(a), prior art is confined to disclosures made

available to the public prior to the inventor’s

patent filing and earlier patent filings of others

that subsequently became public (published

or issued). The result is a prior art

definition with unprecedented

transparency under U.S. patent law.

A patent for a claimed invention may not be obtained if—*

*-Preamble should be construed as in §103.

May be copied or otherwise used for educational purposes.

§102(a)(2) Patent-Filing Disclosures

[U.S. & U.S. PCT]

§102(a)(1): Public

Disclosures

Page 22: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Understanding new §102 prior art requires starting with §100/§102(d)

• New §100 definitions provide better clarity in the patent statute – greater readability, less ambiguity.

• New statute takes on definitions for– – “inventor” and “joint inventor”

– “effective filing date” and “effectively filed” [§102(d)]

– “claimed invention”

• “Inventor” = inventive entity.

• “Effectively filed” = a prior-filed patent is prior art for what the earlier patent filing describes, irrespective of whether the earlier patent filing itself enables.

22 May be copied or otherwise used for educational purposes.

Page 23: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

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New provisions of the patent statute

make extensive use of these defined terms, rendering

them important for interpreting the patent statute consistent with

legislative intent.

May be copied or otherwise used for educational purposes.

Page 24: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

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Pre-AIA patent law treats all documentary prior art

identically in that what is documented becomes prior art for whatever it teaches –

or in the words of pre-AIA §102, what is “described.” The first-inventor-to-file

principle accordingly requires the recognition of earlier-

filed patent filings that later become public as prior art for

whatever is described therein, but without requiring

enablement as of the date they are to be considered as effectively filed for what is

described; enablement of all prior art is assessed later, as

of the effective filing date for the claimed invention. See In

re Samour, 571 F.2d 559 (CCPA 1978). §102(d)

May be copied or otherwise used for educational purposes.

Page 25: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

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In re Wertheim is gone; earlier patent filings not subject to “enablement”

May be copied or otherwise used for educational purposes.

Filing/Publication Dates (Roman Numerals)

A + C + D

Provisional Filings

Nonprovisional Publishes

IV

A + B + C

III

A + B

II

A

I V

A effectively filed on I. C effectively filed on III. D effectively filed on IV. B becomes prior art when published (V). Cong. Rec. S1369 (March 8, 2011).

A, B, C, and D = separate

embodiments

Page 26: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

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§102 Conditions for patentability; novelty and loss of right to patent A person shall be entitled to a patent unless – (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, [35 USC 102(a)] or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or (c) he has abandoned the invention, or (d) the invention was first patented or caused to be patented, or was the subject of an inventor's certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor's certificate filed more than twelve months before the filing of the application in the United States, or (e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or (f) he did not himself invent the subject matter sought to be patented, or (g) (1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person's invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

Page 27: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

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§102 Conditions for patentability; novelty and loss of right to patent A person shall be entitled to a patent unless – (a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, [35 USC 102(a)] or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or (c) he has abandoned the invention, or (d) the invention was first patented or caused to be patented, or was the subject of an inventor's certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor's certificate filed more than twelve months before the filing of the application in the United States, or (e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or (f) he did not himself invent the subject matter sought to be patented, or (g) (1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person's invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

Page 28: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

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§102 Conditions for patentability; novelty A person shall be entitled to a patent unless – (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or (e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent,

Page 29: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

§102 Conditions for patentability; novelty A person shall be entitled to a patent unless – (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or (e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent,

May be copied or otherwise used for educational purposes. 29

Pre-AIA §102(b)

Pre-AIA §102(e)

Page 30: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States, or (b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, or otherwise available to the public more than one year prior to the date of the application for patent in the United States, or (b) (a)(1) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, or otherwise available to the public more than one year prior to the date of the application for patent in the United States before the effective fling date of the claimed invention, or

May be copied or otherwise used for educational purposes. 30

Geographic Limitations Removed

Public Accessibility

Required

Effective Filing Date

Added

Pre-AIA §102(b)

Post-AIA §102(a)(1)

Page 31: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

New §102(a)(1) conserves key language from existing §102(b) –

(a) A person shall be entitled to a patent unless –

(b1) the claimed invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, or otherwise available to the public [more than one year prior to the date of the application for patent in the United States] before the effective filing date of the claimed invention, or ….

31 May be copied or otherwise used for educational purposes.

“Effective filing date”

and “claimed invention” are defined

terms in §100.

The new requirement “or otherwise available to the public” takes all of existing §102(b) prior art, and (1)

limits what would have been prior art through a public accessibility

limitation and (2) expands what was formerly prior art by removing the

“in this country” limitation.

New §102(a)(1) differs from

existing §102(b) by using “effective

filing” date in lieu of “one year” date.

Page 32: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

May be copied or otherwise used for educational purposes. 32

(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, (e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, in which the patent or application, as the case may be, names another inventor (e) (a)(2) the invention was described in (1) an application for patent, published or deemed published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent issued under section 151 granted on an application for patent by another filed in the United States before the invention by the applicant for patent, in which the patent or application, as the case may be, names another inventor

“By Another” Limitation

Rearranged

Redrafted Internal

References

Effective Filing Date And Effectively Filed Are

Added

Next Slide

Pre-AIA §102(e)

Post-AIA §102(a)(2)

Page 33: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

New §102(a)(2) conserves key language from existing §102(e) –

(a) A person shall be entitled to a patent unless – ….

(e2) the invention was described in (1) an application for patent, published or deemed published under section 122(b), by another filed in the United States [before the invention by the applicant for patent] or (2) a patent [granted] issued under section 151 on an application for patent by another filed in the United States [before the invention by the applicant for patent,] in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.

33 May be copied or otherwise used for educational purposes.

“Deemed published” incorporates §374 PCT filings.

“Issued under §151” references

U.S. patent filings.

“Names another inventor” is synonym for

“application … by another.”

New §102(a)(2) references

patents first.

Page 34: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Deemed published” accounts for U.S.-designating PCT patent applications

§374. Publication of international application

The publication under the treaty defined in section 351(a) of this title, of an international application designating the United States shall be deemed a publication under section 122(b), except as provided in sections 102(e) and 154(d) of this title.*

*- Amended under Sections 3(g)(4) and 20(j)(1) of the AIA.

34 May be copied or otherwise used for educational purposes.

Page 35: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

§102(a)(1) and §102(a)(2) use identical language for all published prior art

35 May be copied or otherwise used for educational purposes.

• §102(a)(1): “described in a printed publication…” • §102(a)(2): “described in a patent … or in an

application for patent published or deemed published … .”

• Both linguistic formulations in new §102(a) are unchanged from the pre-AIA patent statute – scope and content of what is considered “published” prior art will be unchanged by the AIA, except for the further clarification of the Wertheim issue of “same day” patent issuance.

Page 36: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

AIA §102(a): 100% transparency in what will constitute prior art

• The 1952 Patent Act: §102 “codified” the law as it had existed, dating back to 1836.

• The Leahy-Smith America Invents Act: §102 is fundamentally reformed with overarching requirement for “public accessibility” for subject matter to be prior art. – disclosures available to the public or – earlier U.S. patent filings subsequently made

available to the public through publication.

36 May be copied or otherwise used for educational purposes.

Page 37: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

What is needed to make a disclosure “otherwise available to the public”?

• New term of art in U.S. patent law. • Definitive legislative history: • “in section 102 the ‘in this country’ limitation as

applied to ‘public use’ and ‘on sale’ is removed, and the phrase ‘available to the public’ is added to clarify the broad scope of relevant prior art, as well as to emphasize the fact that it must be publicly accessible.” *

*- pp. 42-43, House Report to Accompany H.R. 1249 (June 1, 2011).

37 May be copied or otherwise used for educational purposes.

Page 38: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

38

The House Report (footnote 20, p. 43 references the Kyl

statement at S1368-S1371

(March 8, 2011) exhaustively sets

forth the rationale for the “public accessibility”

criteria to be used to determine §102

prior art. Uses an existing

body of well-developed law in

preference to adopting a new legal standard.

May be copied or otherwise used for educational purposes.

Page 39: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

• Public accessibility is the “touchstone in determining whether a reference constitutes a ‘printed publication’ bar… .” In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986).

• Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1379 (Fed. Cir. 2006), finding a foreign patent, like a U.S. patent, “publicly accessible” because “one skilled in the art exercising reasonable diligence” could find it and it was “classified and indexed” in the foreign patent office.

39

Public accessibility is long ensconced in Federal Circuit jurisprudence

May be copied or otherwise used for educational purposes.

Page 40: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

In re Lister, 583 F.3d 1225 (Fed. Cir. 2009)

“In order to qualify as a printed publication within the meaning of §102, a reference “must have been sufficiently accessible to the public interested in the art.” Cronyn, 890 F.2d at 1160 … . Whether a reference is publicly accessible is determined on a case-by-case basis based on the “facts and circumstances surrounding the reference’s disclosure to members of the public.” Klopfenstein, 380 F.3d at 1350. A reference is considered publicly accessible if it was “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Kyocera Wireless Corp. v. Int'l Trade Comm'n, 545 F.3d 1340, 1350 [89 USPQ2d 1057] (2008) (quotation marks omitted).

40 May be copied or otherwise used for educational purposes.

Page 41: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Will legislative history play a role in construing the new patent act?

41

• If history is a guide, it will be decisive. • 1952 Patent Act stated any subject matter

“known or used” qualified as §102(a) prior art, but the Revision Notes* indicated: – “The interpretation by the courts of paragraph (a) as

being more restricted than the actual language would suggest (for example, known has been held to mean publicly known) is recognized but no change in the language is made at this time.”

*-Senate Report No. 1979, 82d Cong., 2d Sess. (1952)

May be copied or otherwise used for educational purposes.

Page 42: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Will legislative history play a role in construing the new patent act?

42

• If history is a guide, it will be decisive.

• In the Patent Law Amendments Act of 1984, Congress gave specific direction to the USPTO through legislative history,* indicating: – “The Committee expects that the Patent and Trademark Office will

reinstitute in appropriate circumstances the practice of rejecting claims in commonly owned applications of different inventive entities on the ground of double patenting. This will be necessary in order to prevent an organization from obtaining two or more patents with different expiration dates covering nearly identical subject matter.”

*- Section-By-Section Analysis of H.R. 6286, Patent Law Amendments Act of 1984 inserted in the Congressional Record of October 1, 1984 at H1525 to H10529.

May be copied or otherwise used for educational purposes.

Page 43: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Will foreign patent laws play a role in construing the new patent act?

43

• Perhaps not, but they offer a neat comparison.

• Article 54(2) EPC* on “Novelty”: – “The state of the art shall be held to comprise everything made

available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.”

• Article 55(1) EPC on “Non-prejudicial disclosures” (“Grace Period” Provisions): – “For the application of Article 54 a disclosure of the invention shall

not be taken into consideration if it occurred no earlier than six months preceding the filing of the European patent application and if it was due to, or in consequence of … .”

*- Convention of the Grant of European Patents (5 October 1973, Munich). May be copied or otherwise used for educational purposes.

Page 44: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Will foreign patent laws play a role in construing the new patent act?

44

• No, but they offer an interesting comparison.

• Article 54(2) EPC on “Novelty”: – “The state of the art shall be held to comprise everything made

available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.”

• Article 55(1) EPC on “Non-prejudicial disclosures”: – “For the application of Article 54 a disclosure of the invention shall

not be taken into consideration if it occurred no earlier than six months preceding the filing of the European patent application and if it was due to, or in consequence of … .”

The EPC “Grace Period” Worded More Broadly to Encompass Any “Disclosures”

The EPC “Prior Art” Whatever Is “Available to

the Public”

May be copied or otherwise used for educational purposes.

Page 45: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

A simple “prior art” definition with both defined and unneeded terms

Prior art exists if a disclosure establishes that: (1) “the claimed invention was patented, described in

a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date. . .” or (2) “the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date . . .”

45 May be copied or otherwise used for educational purposes.

Page 46: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Prior art exists if a disclosure establishes that: (1) “the claimed invention was patented, described in

a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date. . .” or (2) “the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date . . .”

46

A simple “prior art” definition with both defined and unneeded terms

May be copied or otherwise used for educational purposes.

A disclosure of the claimed invention was publicly accessible before the effective

filing date, e.g., described in a document. §102(a)(1)

Page 47: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Prior art exists if a disclosure establishes that: (1) “the claimed invention was patented, described in

a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date. . .” or (2) “the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date . . .”

47

The claimed invention was described in a later-published U.S./U.S. PCT patent application or

patent of another inventor, effectively filed before the inventor’s effective filing date.

A disclosure of the claimed invention was publicly accessible before the effective

filing date, e.g., described in a document.

§102(a)(2)

A simple “prior art” definition with both defined and unneeded terms

May be copied or otherwise used for educational purposes.

§102(a)(1)

Page 48: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Prior art exists if a disclosure establishes that: (1) “the claimed invention was patented, described in

a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date. . .” or (2) “the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date . . .”

48

A simple “prior art” definition with both defined and unneeded terms

May be copied or otherwise used for educational purposes.

A disclosure of the claimed invention was publicly accessible before the effective

filing date, e.g., described in a document. §102(a)(1)

The claimed invention was described in a later-published U.S./U.S. PCT patent application or

patent of another inventor, effectively filed before the inventor’s effective filing date.

§102(a)(2)

Public Disclosures

Page 49: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Prior art exists if a disclosure establishes that: (1) “the claimed invention was patented, described in

a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date. . .” or (2) “the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date . . .”

49

A simple “prior art” definition with both defined and unneeded terms

May be copied or otherwise used for educational purposes.

The claimed invention was described in a later-published U.S./U.S. PCT patent application or

patent of another inventor, effectively filed before the inventor’s effective filing date.

§102(a)(2)

Patent-Filing Disclosures That

Later Become Public

A disclosure of the claimed invention was publicly accessible before the effective

filing date, e.g., described in a document. §102(a)(1)

Public Disclosures

Page 50: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

50 May be copied or otherwise used for educational purposes.

Page 51: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

51

The “Exceptions” relate to “disclosures” and, where applicable, to the “subject matter

disclosed,” and some are triggered only if the subject matter is “publicly disclosed.”

§102(b)

May be copied or otherwise used for educational purposes.

Page 52: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Disclosures,” “subject matter disclosed” and “publicly disclosed”

• §103 has been amended so that prior art is now defined as the subject matter that has been “disclosed” under §102. – The pre-AIA §103 used “disclosed or described.”

– The AIA amends §103 so that “identically disclosed as set out in section 102” now defines what is “prior art” for §103 purposes.

• A “disclosure” (as in Europe and elsewhere) is the broadest possible term to describe the divulgation of subject matter.

• The “subject matter disclosed” is the subject matter content revealed by the disclosure.

• Something “publicly disclosed” is a “publicly accessible” disclosure encompassed by §102(a)(1), as contrasted to a (non-public) patent-filing disclosure under §102(a)(2).

May be copied or otherwise used for educational purposes. 52

Page 53: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Both the House Report and Leahy-Hatch colloquy provide total clarity…

May be copied or otherwise used for educational purposes. 53

Congressional Record S1496 (March 9, 2011), provides unequivocal language that assure the AIA cannot diminish in any way the inventor’s “grace period”

as it exists under pre-AIA law. See also Cong. Rec. H4429 (June 22, 2011)

to the identical effect.

Page 54: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

54

Inventor-friendly and collaboration-friendly features of U.S. law codified as “exceptions” to prior art – one set for public disclosures and a second for prior-filed patent filings of others.

Prior Public

Disclosures are subject to two separate “Exceptions.”

May be copied or otherwise used for educational purposes.

Page 55: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

55

Inventor-friendly and collaboration-friendly features of U.S. law codified as “exceptions” to

prior art – one set for prior disclosures and a second for prior-filed patent filings of others.

Prior-filed, later-published U.S./U.S. PCT patent filings are subject to three separate “Exceptions.”

Prior Public

Disclosures are subject to two separate “Exceptions.”

May be copied or otherwise used for educational purposes.

Page 56: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

56

Prior-disclosures as prior art are

subject to two separate

“Exceptions.”

Inventor-friendly and collaboration-friendly features of U.S. law codified as “exceptions” to

prior art – one set for prior disclosures and a second for prior-filed patent filings of others.

Prior-filed, later-published U.S./U.S. PCT patent filings are subject to three separate “Exceptions.”

§102(b)(1) exceptions deal only

with §102(a)(1) prior art.

§102(b)(2) exceptions deal only

with §102(a)(2) prior art.

May be copied or otherwise used for educational purposes.

Page 57: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

57

The CREATE Act from 2004 remains substantively unchanged,

except that statute is now clarified that parties to the joint research agreement must have

made both the claimed invention and the prior-filed subject matter

that is excluded as prior art.

Additionally, the test for applicability is that the joint

research agreement be in effect as of the effective filing for the

claimed invention with respect to which the exclusion from prior art

applies.

§102(c)

May be copied or otherwise used for educational purposes.

Page 58: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

58

The CREATE Act from 2004 remains substantively unchanged,

except that statute is now clarified that parties to the joint research agreement must have

made both the claimed invention and the prior-filed subject matter

that is excluded as prior art.

Additionally, the test for applicability is that the joint

research agreement be in effect as of the effective filing for the

claimed invention with respect to which the exclusion from prior art

applies.

§102(c)

May be copied or otherwise used for educational purposes.

Application must name parties to JRA.

Claimed invention must be made pursuant to activities under the JRA.

JRA must be executed before the effective filing date and claimed

invention and subject matter excluded from prior art must be made (or

developed) by parties to the JRA.

Page 59: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Public disclosures not more than 1-year before “effective filing date” –

A disclosure under §102(a)(1) is excepted if: (A) “the disclosure was made by the inventor or

joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor” or

(B) “the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor”

59 May be copied or otherwise used for educational purposes.

Page 60: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

A disclosure under §102(a)(1) is excepted if: (A) “the disclosure was made by the inventor or

joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor“ or

(B) “the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor”

60

The public disclosure represents the inventor’s own work – the

existing U.S. grace period. §102(b)(1)(A)

Public disclosures not more than 1-year before “effective filing date” –

May be copied or otherwise used for educational purposes.

Page 61: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

A disclosure under §102(a)(1) is excepted if: (A) “the disclosure was made by the inventor or

joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor“ or

(B) “the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor”

61

A subsequent disclosure by anyone else is not prior art with respect to subject matter in an inventor’s earlier public disclosure.

§102(b)(1)(B)

Public disclosures not more than 1-year before “effective filing date” –

The public disclosure represents the inventor’s own work – the

existing U.S. grace period. §102(b)(1)(A)

May be copied or otherwise used for educational purposes.

Page 62: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

A disclosure under §102(a)(1) is excepted if: (A) “the disclosure was made by the inventor or

joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor“ or

(B) “the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor”

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A subsequent disclosure by anyone else is not prior art with respect to subject matter in an inventor’s earlier public disclosure.

The disclosure represents the inventor’s own work – the existing

U.S. grace period.

§102(b)(1)(B)

§102(b)(1)(A)

Public disclosures not more than 1-year before “effective filing date” –

§102(a)(2)(B) Exception is one of two exceptions (the other being §102(b)(2)(B)) that produces aspects of a so-called “first-

to-disclose,” rather than a strict first-inventor-to-file system, because any public

disclosure by the inventor initiating the one-year “grace period” before the

inventor’s patent filing suffices to preserve the right to seek and obtain a valid patent on the subject matter publicly disclosed

notwithstanding subsequent disclosures of the same subject matter.

The §102((b)(2)(B) Exception operates to

require that such subsequent disclosures of the same subject matter made by others be

disregarded as prior art.

May be copied or otherwise used for educational purposes.

Page 63: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

An earlier patent filing under §102(a)(2) is excepted if: (A) “the subject matter disclosed was obtained directly or

indirectly from the inventor or a joint inventor” or (B) “the subject matter disclosed had, before such subject

matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor” or

(C) “the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.”

63

*

Earlier (not-yet-public) patent filings as prior art as of when effectively filed…

May be copied or otherwise used for educational purposes.

Page 64: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

An earlier patent filing under §102(a)(2) is excepted if: (A) “the subject matter disclosed was obtained directly or

indirectly from the inventor or a joint inventor“ or (B) “the subject matter disclosed had, before such subject

matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor” or

(C) “the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.”

64

The inventor’s own work. §102(b)(2)(A)

Earlier (not-yet-public) patent filings as prior art as of when effectively filed…

May be copied or otherwise used for educational purposes.

Page 65: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

An earlier patent filing under §102(a)(2) is excepted if: (A) “the subject matter disclosed was obtained directly or

indirectly from the inventor or a joint inventor“ or (B) “the subject matter disclosed had, before such subject

matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor” or

(C) “the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.”

65

The inventor’s co-workers and research collaborators patent filings.

§102(b)(2)(A)

§102(b)(2)(C)

The inventor’s own work.

Earlier (not-yet-public) patent filings as prior art as of when effectively filed…

May be copied or otherwise used for educational purposes.

Page 66: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Earlier (not-yet-public) patent filings as prior art as of when effectively filed…

An earlier patent filing under §102(a)(2) is excepted if: (A) “the subject matter disclosed was obtained directly or

indirectly from the inventor or a joint inventor“ or (B) “the subject matter disclosed had, before such subject

matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor” or

(C) “the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.”

66

Earlier patent filings of others to the extent of inventor’s public disclosures

that precede those patent filings.

The inventor’s co-workers and research collaborators patent filings.

§102(b)(2)(B)

§102(b)(2)(A)

§102(b)(2)(C)

The inventor’s own work.

May be copied or otherwise used for educational purposes.

Page 67: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

An earlier patent filing under §102(a)(2) is excepted if: (A) “the subject matter disclosed was obtained directly or

indirectly from the inventor or a joint inventor“ or (B) “the subject matter disclosed had, before such subject

matter was effectively filed under subsection (a)(2), been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor” or

(C) “the subject matter disclosed and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person.”

67

Earlier patent filings of others to the extent of inventor’s public disclosures

that precede those patent filings.

The inventor’s co-workers and research collaborators patent filings.

§102(b)(2)(B)

§102(b)(2)(A)

§102(b)(2)(C)

The inventor’s own work.

Earlier (not-yet-public) patent filings as prior art as of when effectively filed…

§102(b)(2)(B) Exception can produce a first-inventor-to-publish result because

any subsequent patent filing on behalf of an unrelated inventor can be excluded as

prior art, permitting the publishing inventor to later file for a patent and to

secure a valid U.S. patent over the earlier patent filing of the unrelated inventor.

The Exception applies where the

inventor’s disclosure precedes the filing, but still falls within the 1-year public

disclosure “grace period” under §102(b)(1), excepting the inventor’s own disclosure as prior art under §102(a)(1).

May be copied or otherwise used for educational purposes.

Page 68: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Principles for applying the exception for “publicly disclosed” subject matter

• The core principle: making an earlier public disclosure of subject matter will provide the inventor no greater “prior art” exclusion relative to subsequent public disclosures and patent filings of others than had the same subject matter been contained in a patent filing made by the inventor as of the earlier disclosure date.

• In addition, the inventor making the earlier disclosure will not actually establish an effective filing date for what is disclosed, even if an enabling disclosure.

• Thus, the protection afforded will be significant in many situations, but will fall far short of being a perfect substitute for making a patent filing.

68 May be copied or otherwise used for educational purposes.

Page 69: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

The “first disclosure” exception can insulate against “obviousness”

• A university or like-situated inventor may be the first to publish the core outline of a new enabling technology that will open up an entire new field of invention.

• Rivals in the same field of research may then quickly publish on their own contributions to this new field of invention, offering independent disclosures of the same core enabling technology.

• The first inventor to publish, when thereafter seeking patents on embodiments of the new technology, can overcome an obviousness challenge based upon the intervening publications – subject matter earlier publicly disclosed will be excluded from prior art.

69 May be copied or otherwise used for educational purposes.

Page 70: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

The “first disclosure” exception is not the basis of a viable patenting strategy • Only the actual subject matter prior publicly disclosed

[§102(a)(1)] is subject to the exception with respect to a subsequent disclosure by a person, not obtaining the information subsequently disclosed directly or indirectly from the inventor, that would otherwise be prior art.

• If an inventor is the first to publish embodiment X and an independent creator/developer subsequently publicly discloses (or seeks a patent) on embodiments X and Y, then embodiment X is excepted from the prior art, but embodiment Y is not subject to the exception and remains prior art—and may render embodiment X obvious and unpatentable.

• Seeking a patent and establishing an effective filing date is preferable to publishing as a patenting strategy.

70 May be copied or otherwise used for educational purposes.

Page 71: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

The “first disclosure” exception is not the basis of a viable patenting strategy • Independent, intervening work may also impact

the non-obviousness of prior publicly disclosed invention under §102(b)(1)(B)/§102(b)(2)(B) – Inventor provides first public disclosure of X, for which

patentability is premised on lack of any known or obvious methodology for making X. *

– Subsequent, pre-filing disclosure of unrelated work providing an alternative method that could be used for making X.

– As of the effective filing date for X, the pre-filing disclosure is §102(a)(1) is prior art and X can be made by a known method, impairing non-obviousness.

71 May be copied or otherwise used for educational purposes.

*-In re Hoeksema, 399 F.2d 209 (1968)

Page 72: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

What are the new legal concepts and potential uncertainties in new §102?

• New terminology and potentially new legal concepts created in new §102: – For the definition of prior art there should be none;

§102(a) uses only precedented, well-developed legal concepts to define prior art: available to the public = “publicly accessible.”

– For the exclusions from prior art, “disclosure,” “publicly disclosed” and “subject matter disclosed” are new terms of art that must be construed in light of the amendment to §103: prior art = what is disclosed.

• The new §102 terminology is highly precedented, with an unambiguous import.

72 May be copied or otherwise used for educational purposes.

Page 73: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

What patent strategies can address potential uncertainties in new §102?

• Inventors should refrain from considering pre-filing publication as a patenting strategy.

• If an inventor has published before seeking a patent, the patent filing should proceed forthwith if an intervening disclosure or patent filing is a concern.

• This represents no change from the optimal patenting strategies under pre-AIA patent law, given the dismal prospect of a pre-AIA inventor who is not the first inventor to file for a patent eventually securing the right to a patent.

73 May be copied or otherwise used for educational purposes.

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74 May be copied or otherwise used for educational purposes.

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75

The “Effective Date” provisions on first-inventor-to-file are determined on the effective filing dates for each of the claims in a patent application and require

patenting strategies that take careful account of the 18-month transition period. May be copied or otherwise used for educational purposes.

The March 16, 2013 Effective

Date Is Measured by

Any Claim Having an

Effective Filing Date on or after

That Date.

A Companion Provision Continues

§102(g) Prior Art Liability for any Post-Transition Application that Ever Contained a Claim Subject to

Pre-AIA §102.

Page 76: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

18-Month Transition to New System Based upon “Filing Date” Prior Art

• Date of enactment is September 16, 2011, placing the “first-inventor-to-file” date as March 16, 2013.

• An application is subject to first-inventor-to-file if the application at any time: – Contained a claim with an effective filing date on

or after March 16, 2013.

– A claim for benefit of any application that at any time contained such a claim.

76 May be copied or otherwise used for educational purposes.

Page 77: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

First-inventor-to-file patents can still be subject to existing §102(g)

• An application, although fully subject to all first-inventor-to-file provisions of new §102, is subject to existing §102(g) if the application at any time: – Contained a claim with an effective filing date before

March 16, 2013. – A claim for benefit of any application that at any time

contained such a claim.

• Effect: Inventor is subject to §102(g) prior inventions and cannot rely on a date of invention to overcome §102(a) and §102(e) prior art.

77 May be copied or otherwise used for educational purposes.

Page 78: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Inventors can “flip into” the benefits of new §102 or maintain pre-AIA §102

78 May be copied or otherwise used for educational purposes.

Congress protected use of “continuing” applications in which inventors may retain

first-to-invent priority

Transition provisions

foresaw and forestalled a “bubble” of

filings. Cong. Rec. S1373 (March 8, 2011)

Page 79: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Patent Filing Strategies: Number, Content, and Timing

• Pre-transition patent filing strategies based on: – Practical need to be the first-inventor-to-file. – Legal need for an adequate patent disclosure.

• Transitional patenting strategies will account for: – Huge advantage by avoiding “mixed” priorities. – Waiting for post-transition will shed all “loss of right

to patent” issues and any prior inventions as prior art.

• Post-transition patent filing strategies: – Same as pre-transition patent filing strategies; key

drivers for patent filing are largely unchanged.

79 May be copied or otherwise used for educational purposes.

Page 80: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Patent Filing Strategies: Publication vs. Patent Filing

• Current law – publication before patent filing is never a sound patenting strategy. – Interloper problem – seeing a publication spurs a

prompt patent filing by a competitor who becomes the first inventor to file for the patent.

• New law – publication before patent filing is never a preferred patenting strategy. – Interloper problem solved, but loses potential for

18-month secrecy; inventor’s own published patent application becomes statutory bar sooner.

80 May be copied or otherwise used for educational purposes.

Page 81: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Rational patent filing strategies would mean no pre-transition “bubble”

• Unwise to accelerate filing to retain first-to-invent, if a C-I-P might be needed—lose most of the benefit of using invention date proofs.

• Hurried filing will forfeit the benefit of repeal of forfeiture and other “loss of right” provisions.

• Both regimes effectively require being first inventor to file to have any reasonable likelihood of securing patent.

• Conclusion: Should be no (rational) filing bubble.

81 May be copied or otherwise used for educational purposes.

Page 82: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Double filing” preferable to delayed filing for first-inventor-to-file rule?

• For applications filed in the normal course before the transition, a duplicate filing immediately after transition might be a viable strategy to garner the new law’s advantages. – If pre-transition filing date were not needed for filing

priority or prior art reasons, then post-transition filing affords advantages that prior inventions of others and secret uses are irrelevant to patent validity.

• Conclusion: Rather than delay filing for first-inventor-to-file advantages, duplicate filing may be more prudent. Near duplicate patents can issue given improved §102(b)(2)(c) exceptions.

82 May be copied or otherwise used for educational purposes.

Page 83: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Novelty, non-obviousness, and prior art under the AIA

• “Prior art” is now transparent, objective, and simple. Should lead to more predictability.

• Inventor/collaboration-friendly aspects of U.S. patent law retained and improved.

• Transition should not (rationally) impact any aspect of patenting strategies, except for the need to avoid “mixed” priorities and the potential for post-transition “double filing.”

• Truly a 21st century approach to patenting.

83 May be copied or otherwise used for educational purposes.

Page 84: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Handling the “Best Mode” Disclosure Issue

The Leahy-Smith America Invents Act

Page 85: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Best mode” requirement is wholly finished as an invalidity defense.

85

Applies to all patent litigation

commenced after the

enactment of the AIA.

May be copied or otherwise used for educational purposes.

Page 86: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

BM disclosure not required for prov. priority or §120 benefit of prior filing

• 35 U.S.C. §111, both in paragraph (a)(2)(A) and in (b)(1)(A) continues to require a §112 BM specification.

• However, benefit can be had without a BM for priority of provisional filings (§119) and non-provisional filings (§120).

86

Nothing in the new statute addresses foreign priority claims specifically or disturbs the Transco* decision that

priority/parent disclosure of “best mode” suffices without the need to update.

*-See Transco Prods. Inc. v. Performance Contracting, Inc., 38 F.3d 551 (Fed. Cir. 1994).

May be copied or otherwise used for educational purposes.

Page 87: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Best mode” disclosure does impact the ability to fully protect an invention

• The “best mode” requirement is dead; long live the “best mode” requirement. – Not consequential in any patentability, patent

validity or patent enforceability context.

– The practical necessity to continue making a “best mode” disclosure as a patent filing strategy.

• Written description needed to claim specifically.

• Also may be necessary to enable fully.

• May prove to be the only novel/nonobvious mode.

87 May be copied or otherwise used for educational purposes.

Page 88: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Future of §112 “best mode” – “technical fix” to repeal outright

• As a compliance matter, if it remains in the statute, it must be complied with… … inventors cannot pick the parts of title 35 to observe

or ignore. … “honest inventors” will meet compliance burden and

their patenting processes must so reflect.

• As a practical matter, many inventors may elect to forego making it part of their patenting processes – especially if they are effectively beyond the reach of discovery in U.S. patent litigation.

88 May be copied or otherwise used for educational purposes.

Page 89: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Deceptive Intent” Repeal, Inventor-Related

Issues, Reissue and Supplemental

Examination

The Leahy-Smith America Invents Act

Page 90: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Deceptive intention” first appeared in 1836 and expanded in 1870 and …

Reissue

Reissue

Disclaimer

90 May be copied or otherwise used for educational purposes.

Page 91: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

… and deceptive intent will now be vanquished from the patent statute

91

§116

§256

§251

§253

§288

§§184/185

Reissue

Disclaimer

Invalid Claim

Foreign Filing Licenses

Inventor Correction

May be copied or otherwise used for educational purposes.

Page 92: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

… and deceptive intent will now be vanquished from the patent statute

92

§116

§256

§251

§253

§288

§§184/185

Reissue

Disclaimer

Invalid Claim

Foreign Filing Licenses

Inventor Correction

May be copied or otherwise used for educational purposes.

Page 93: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Removal of “deceptive intent” from title 35 has multiple implications

• Conforms U.S. patent statute to global norms, where “deceptive intent” inquiries are absent.

• Eliminates arbitrary nature of having a “deceptive intent” standard in some statutory provisions, but not others.

• Narrows the areas where unenforceability issues can arise in litigation.

• Expands remedial actions available.

93 May be copied or otherwise used for educational purposes.

Page 94: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Oath,” inventor correction, and “deceptive intent” repeal synergy

94

Patent applications must name the “inventor” and an “oath or declaration” is required, but the sole required statements are (1) application filing was authorized and named individual believes

himself/herself to be an “original” inventor.

May be copied or otherwise used for educational purposes.

Page 95: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

95

Where the inventor or a joint inventor fails to execute an

oath/declaration, then a substitute statement may be filed in lieu of

the oath/declaration.

May be copied or otherwise used for educational purposes.

Page 96: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

96

The “required statements” can be incorporated into the inventor’s

assignment document – the oath/declaration or assignment

need only be filed before the notice of allowance is provided.

No further or supplemental oath needed in §120 applications.

96 May be copied or otherwise used for educational purposes.

Page 97: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

A categorical right is created to withdraw, correct or replace any statement under

§115. No further oath/statement required after initial oath/statement filed.

No invalidity or unenforceability based upon the oath/declaration requirements if

corrected. These provisions operate in tandem with

provisions that permit changes to the named inventors irrespective of

“deceptive intent.”

97 May be copied or otherwise used for educational purposes.

Page 98: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“No-Fault” Changes to Inventorship

• 35 U.S.C. §116: – “Whenever through error a person is named in an application

for patent as the inventor, or through error an inventor is not named in an application, and such error arose without any deceptive intention on his part, the Director may permit the application to be amended accordingly, under such terms as he prescribes.”

• 35 U.S.C. §256: – “Whenever through error a person is named in an issued patent

as the inventor, or through error an inventor is not named in an issued patent and such error arose without any deceptive intention on his part, the Director may, on application of all the parties and assignees, with proof of the facts and such other requirements as may be imposed, issue a certificate correcting such error.”

98 May be copied or otherwise used for educational purposes.

Page 99: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Combined impact of “deceptive intent” and “oath” changes

• Oath/declaration a pure formality – one-time statement by inventor in which the inventor authorizes the patent filing.

• If incorrect naming of inventors exists, correction always possible.

• Correction of inventor-naming will obviate invalidity and cannot give rise to unenforceability.

• Most oath/declaration “statements” will be made in assignments – merely as added boilerplate.

• Sole legal significance of inventor naming is to determine proper ownership of the application.

99 May be copied or otherwise used for educational purposes.

Page 100: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Filing patent applications by the assignee represents a further synergy.

The patent statute has been amended to

accommodate “assignee filing.”

“Applicant” no longer is synonymous with

“inventor.” Applications must

“name” the “inventor.” U.S. patenting practices

will, thus, conform to the global norm.

The inventor’s required statements should be

simply part of the assignment.

100 May be copied or otherwise used for educational purposes.

Page 101: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

AIA patent procurement implications

• Use of PCT will be simplified – starting in September 2012 – because the PCT applicant in all PCT countries will be the assignee.

• Assignments should be updated immediately to reflect the “required statements” – done right once assures no subsequent issues. – CAUTION: Until USPTO rulemaking appears, it is

unclear what additional information or statements might be required.

101 May be copied or otherwise used for educational purposes.

Page 102: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Reissue” will be more broadly available to correct defective patents

• Biggest implication – no pre-filing “due diligence” is needed to assess whether any “deceptive intent” was involved in the “error” on which the reissue is based.

– “Whenever any patent is, through error without any deceptive intention, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent”

• If any “defect” in the patent may have been the product of some “deceptive intent,” “supplemental examination” may represent another (or concurrent) alternative for addressing.

102 May be copied or otherwise used for educational purposes.

Page 103: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Disclaimers” can be more readily made under §253

• Biggest implication – no pre-filing “due diligence” is needed to assess whether any “deceptive intent” was involved in a claim being disclaimed under §253. – “Whenever, without any deceptive intention, a claim of a

patent is invalid the remaining claims shall not thereby be rendered invalid.”

• Although not invalid, the remaining patent claims may nonetheless be unenforceable based upon the inequitable conduct of an “unclean litigant.” Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806, 814-15 (1945).

103 May be copied or otherwise used for educational purposes.

Page 104: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Foreign Filing Licenses” can be more readily sought under §§184/185

• Biggest implication – no pre-filing “due diligence” is needed to assess whether any “deceptive intent” in the error and resulting failure to seek a license under §184. – “The license may be granted retroactively where an

application has been filed abroad through error and without deceptive intent and the application does not disclose an invention within the scope of section 181 of this title.” 35 U.S.C. §184.

– “A United States patent issued to such person, his successors, assigns, or legal representatives shall be invalid, unless the failure to procure such license was through error and without deceptive intent, and the patent does not disclose subject matter within the scope of section 181 of this title.” 35 U.S.C. §185.

104 May be copied or otherwise used for educational purposes.

Page 105: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Infringement action can be maintained, even with an invalid claim. • Biggest implication – no statutory basis for

invalidating remaining claims where the patent contains an invalid claim and “deceptive intent” was shown. – “Whenever, without deceptive intention, a claim of a

patent is invalid, an action may be maintained for the infringement of a claim of the patent which may be valid.”

• Does not trump Precision Instruments and the possible unenforceability of the remaining claims.

105 May be copied or otherwise used for educational purposes.

Page 106: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

“Supplemental examination” will be an advantageous alternative to reissue

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Supplemental Examination (SE) can be based on any “relevant” information,

irrespective of materiality.

SE has a 3-month statutory pendency—and the

concludes.

SE concludes with the Director determining if a

“substantial new question” of patentability (ex parte reexamination standard) was found during the SE.

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SNQ results in Director-ordered reexamination under Chapter 30, but

open to any substantial question of

patentability.

Director immediately commences substantive examination of the SNQ,

without patent owner statement

(35 U.S.C. §304).

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Subject to certain exceptions, the

information that was considered,

reconsidered, or corrected in the Supplemental

Examination cannot be cited as a basis for

unenforceability of the patent.

“Inequitable conduct” defense is barred as to

such information.

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Bar to unenforceability defense does not apply to “prior

allegations” (Hatch-Waxman ¶IV certification or D.J.

pleadings) and to “patent enforcement actions” brought prior to the conclusion of the

Supplemental Examination and any reexamination ordered.

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Page 110: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Aggregate impact of “deceptive intent,” oath “safe harbor,” and SE

• United States has a more internationally normal patent law—not obsessed with possible misconduct, but on patentability/validity.

• Limits the oxymoronic element of U.S. patent law that declared valid patents to be nonetheless fraudulent patents.

• Appropriate policy for a transparent patent system—publication of pending applications, pre-grant submissions by the public, comprehensive post-grant review on all validity issues allowed.

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AIA patent procurement implications

• The new system provides a greater incentive for candor, not a lesser one.

• Applicants’ more complete and candid disclosures help cement patent against later post-grant review and inter partes reviews.

• Can safely disclose most pertinent and relevant prior art and characterize its significance—given the “safety valve” of SE.

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Page 112: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Derivation proceedings will be all that remains of “interferences”

• Patent interferences have always permitted derivation claims and the same derivation claims will be all that will remain of patent interferences. – Likely to continue to be a specialized area of

patent practice.

– Likely to be very few in number.

– Many may end with corrected inventorship and, thus, ownership of the involved applications.

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Page 113: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Broadening of remedial provisions and simplifying formalities

• U.S. patent law will now follow international norms on a broad swath of ancillary patenting practices. – Assignee filing, naming of inventor, absence of any

requirement for a separate oath, absence of limitations on remedial actions based on “deceptive intent.”

• Inventorship will now determine ownership, correction option will eliminate as an invalidity ground.

• Supplemental examination will encourage prompt correction of incorrect or missing information in the examination of a patent, partially superseding reissue.

• The collection of ancillary changes complements and produces synergies with the TOPS patentability law.

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Page 114: The Leahy-Smith America Invents Act · America Invents Act Robert A. Armitage Senior Vice President and General Counsel Eli Lilly and Company Indianapolis, Indiana . A Brief Overview

Final takeaway comments

• The AIA, by any measure, is a singularly remarkable legislative achievement.

• In all respects, U.S. patent law should become a model and the mold for patent laws globally.

• Valid patents become more secure and securely enforceable; invalid patents can be more readily exposed and quickly canceled.

• A truly 21st century approach to patenting.

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