Cross-Border Patent Issues in the Life Sciences · PDF fileCross-Border Patent Issues in the...

Cross-Border Patent Issues in the Life Sciences

April 5, 2017

IP Perspectives – US and China

Gwilym Attwell

Principal

Fish & Richardson

Wilmington, DE

Rui Luo

Counsel

Han Kun Law Office

Beijing, China

Overview

• Topics?...

• Will focus on IP related issues

affecting transnational portfolios

with both US and Chinese assets

• Housekeeping

• CLE (U.S. attendees only)

• Questions

• Materials

• http://fr.com/webinars

http://fr.com/webinars

Agenda

• Current trends in post-grant proceedings in the

life sciences

• Recent developments & decisions

• What to watch in 2017?

3

4

Invalidation Procedures–United States

USPTO Proceedings

5

Proceeding When Does It Apply? Legal standard Grounds (Prior Art)

Supplemental

Examination

-Available starting on Sept. 16, 2012

-Applies to all patents

Substantial new question

of patentability would

result in ex parte reexam

by PTO

Any information

Ex parte

reexam

(unchanged*)

Available now Substantial new question

of patentability

Patents

Published patent apps

Printed publications

Inter partes

review (IPR)


-Applies to all patents

-PTO can initially limit (e.g., 250/year)

Reasonable likelihood

that petitioner would

prevail on at least 1 claim

Patents

Published patent apps

Printed publications

Post-grant

review (PGR)

(9 month

window)


-Applies only to patents having a claim

with a priority date on or after March 16,

2013

-PTO can initially limit (e.g., 250/year)

More likely than not that

at least 1 claim is

unpatentable

Any invalidity ground

Derivation

Proceedings

(DER)

Applies to all claims with priority dates

on/after March 16, 2013 (Interference

remains available for others)

Claimed invention

derived from another

N/A

IPR Overview

6

IPR Essential Features

• Claim construction: Broadest reasonable interpretation (“BRI”)

• Grounds for unpatentability limited to patents and printed publications

• Must file within one year of service of complaint for infringement

• Barred if DJ action regarding validity was filed before IPR petition

• Burden of proof: Preponderance of the evidence

• Limited discovery

• Very limited ability to amend claims

• Fast relative to reexamination and district court litigation

• Estoppel (any ground raised or that reasonably could have been raised)

• Can be settled

PGR - What is it?

• Additional grounds not available in IPR/CBM

• §102 and §103 on printed publications -- but also

• §101

• §112 (written description, enablement, indefiniteness -- but no best mode);

• Double patenting;

• Inventorship; and

• Prior use

• More severe estoppel – any ground that petitioner raised or reasonably could have raised – applied to all grounds, above.

7

IPR/PGR Overview

8

9

Current Trends – United States

PTAB – Most Active Forum

In 2014 and 2016, the PTAB was the most active forum for US patent

validity challenges, and in 2015 the PTAB had a record year for filings.

Source: DocketNavigator Analytics

Most active

courts by

number of

cases

2011 2012 2013 2014 2015 2016

PTAB - 112 792 1,677 1,800 1,758

TXED 580 1,252 1,498 1,428 2,548 1,678

DED 486 1,001 1,335 942 544 458

CACD 329 506 411 320 277 287

AIA Petitions Have Exceeded Expectations . .

11

6510 AIA

Petitions Filed

Since

Source: US PTO, data current as of 2/28/2017

BioPharma IPR Filings Holding Steady

12

44

125

186179

0

20

40

60

80

100

120

140

160

180

200

2013 2014 2015 2016

IPRs Filed in TC1600

Source: LexMachina, data current as of 12/31/2016

Technology Breakdown by USPTO Tech Center (2013-Present)

13

Source: US PTO; data current through 2/28/2017

BioPharma IPR Status

• 621 total biopharma IPR petitions filed since 2013*

14

117, 19%

100, 16%

269, 43%

134, 22%

Settled/Dismissed (pre-institution)

Open (pre-institution)

Instituted

Denied Institution

65, 24%

56, 21%

35, 13%

14, 5%

98, 37%

Open (post-institution)

Joined to Other Trial

Settled (post-institution)

Patent Owner Disclaimed

FWD


*1 petition in which patent owner disclaimed pre-institution

Institution Rates by Technology

• Institution rate is lower in life sciences than other technologies

15

Source: US PTO (2/28/2017)

Outcomes [Final Written Decisions]– BioPharmaIPRs (2013-2016)

• 99 petitions filed since 2013 have reached a Final Written Decision

16

All Claims Unpatentable,

44, 45%

Mixed Claim Findings, 6, 6%

All Claims Upheld, 45,

46%

All Claims Amended, 3,

3%


Filers in the Life Sciences

17

Source: Professsor Jacob Sherkow, New York Law School; presentation at BIO IPCC Meeting

67%

16%

16%1%

Who is Filing IPRs in the Life Sciences?

Generics

Brand

Investment firms

Public interest groups

Top Participants in Life Sciences IPRs

18

Source: LexMachina, data current as of 10/25/2016;

Top 10 Petitioners in TC 1600 Top 10 Patent Owners in TC 1600

PGR – Statistics – Compared to IPR/CBM

19

Source: US PTO (2/28/2017)

20

Recent Developments & Decisions – United States

PTAB Decisions—Objective Evidence – Patent Owner Wins

21

Innopharma Licensing, Inc., et al., Mylan Pharmaceuticals, Inc. and Mylan, Inc. v. Senju Pharm. Co.,

Ltd., Bausch & Lomb, Inc., and Bausch & Lomb Pharma Holdings, IPR2015-00902, Paper No. 90

(PTAB July 28, 2016)

• Claims covered a liquid preparation for ophthalmic use comprising: (1) bromfenac (type of NSAID) and (2) tyloxapol in an amount “sufficient to stabilize” bromfenac

• Petitioner challenged claims as obvious over the combination of two references (Ogawa and Sallman)

• Ogawa disclosed ophthalmic compositions containing bromfenac and polysorbate 80. Both tyloxapol and polysorbate 80 were non-ionic surfactants.

• Sallman disclosed the use of tyloxapol as a solubilizer for a different NSAID in an ophthalmic composition.

• Final written decision: Petitioner failed to prove that any of the claims were unpatentable

• Objective evidence of nonobviousness was key to decision!


22




• Unexpected results evidence: experimental results showing tyloxapol increased bromfenac stability significantly better than polysorbate 80. Expert witness explained test results and significance.

• Commercial success evidence: showed that success of commercial product (Prolensa) falling within claims was due to stabilizing effect of tyloxapol and ability to eliminate burning and stinging associated with other eye drops. PTAB: “The fact that Prolensa replaced such prescriptions suggests commercial success.” Paper 90, p. 20.

• Industry acclaim evidence: Expert testimony “supported by objective evidence” describing benefits of Prolensa, praise by leading doctors, and praise in peer-reviewed medical journals.


23




• PTAB credited objective evidence of nonobviousness in concluding

that claims would not have been obvious:

“Taking account of the objective indicia of non-obviousness, including

Patent Owner’s significant evidence of unexpected results, we are not

persuaded that Petitioner demonstrates sufficiently that the combined

disclosures of Ogawa and Sallmann, when considered in light of the

asserted background prior art references, establish the obviousness of

the claimed invention. Petitioner’s proposed substitution of

tyloxapol for polysorbate 80 produced a surprising and

unexpected stabilizing effect on bromfenac. The other objective

indicia of non-obviousness flow from that surprising results.”

Paper 90, p. 72 (emphasis added).

PTAB Decisions—Objective Evidence – Petitioner Wins

24

Coalition for Affordable Drugs II LLC v. NPS Pharmaceuticals, Inc., IPR2015-01093, Paper No. 67 (PTAB October 21, 2016)

• Kyle Bass hedge fund filing

• Claims covered L-histidine stabilized drug formulations of glucagon-

like peptide-2 (“GLP-2”) and GLP-2 analogs (sold by Shire as

GATTEX®).

• Claims set forth several combinations of GLP-2 peptides and

peptide concentrations, pH levels, L-histidine concentrations, and

different bulking agents and concentrations.

• Claims challenged as obvious on 4 related grounds. Issue was

whether it would have been obvious to formulate GLP-2 analogs

with histidine and mannitol (bulking agent/excipient).

• PTAB found all claims unpatentable under § 103.


25


• Patent owner presented objective evidence of nonobviousness:

unexpected results, commercial success, and satisfaction of long-felt

need.

• PTAB was not persuaded.


26


• Unexpected results: Patent Owner presented bar graphs

illustrating heat stress stability studies. PTAB concluded that

results were NOT unexpected:

“[W]e determine that a preponderance of the evidence demonstrates

that an ordinary artisan would have expected the addition of

histidine to improve the stability of a protein formulation, at least

to some degree, based on the disclosures [of the prior art].”

Paper 67, p. 29.

• PTAB further held that even if results were unexpected, they were

not probative of nonobviousness because any differences in stability

improvement were “a difference in degree, not kind.” Id., p. 30.


27


• Commercial success: Patent Owner presented evidence of large

market share, high price, sales and sale growth, and large economic

returns for GATTEX®.

• PTAB held that Patent Owner failed to establish a nexus

between GATTEX® sales and patent claims:

“[I]t is unclear if the sales are due to the stability of the product,

or to the active agent, which is disclosed [by the prior art].”

Paper 67, p. 32.


28


• Long-felt need: Patent Owner presented evidence that GATTEX®

was the first approved GLP-2 product for short bowel syndrome.

• PTAB held that Patent Owner failed to establish a nexus

between the alleged long-felt need and the patent claims:

“Patent Owner does not provide evidence sufficient to permit a

determination as to whether the long-felt need was met by the

discovery of GLP-2 analogs having the necessary activity

(disclosed in the prior art), or the use of L-histidine and mannitol

or sucrose in a stabilized GLP-2 analog formulation.” Paper 67, p.

33.

PTAB Decisions—Printed Publications

29

Teva Pharm. USA, Inc. v. Indivior UK Ltd., IPR2016-00280, Paper No. 23 (PTAB June 10, 2016)

• Claims directed towards an orally dissolvable film that included

buprenorphine, naloxone, a buffer, and a polymer carrier matrix.

Film had a bioequivalent release profile and drug absorption as a

Suboxone® tablet.

• Petitioner raised four grounds of unpatentability based on §103.

Each ground included the “Suboxone® 2002 label” and the

“Suboxone® Table Summary Basis of Approval” (“SBOA”) as

secondary references.

• PTAB declined to grant the petition.

• PTAB held that Petitioner failed to establish that either the

Suboxone® 2002 label or the SBOA was a printed publication.

PTAB Decisions—Printed Publications

30

Teva Pharm. USA, Inc. v. Indivior UK Ltd., IPR2016-00280, Paper No. 23 (PTAB June 10, 2016)

• Petitioner argued that in co-pending litigation, Patent Owner stipulated that both the Suboxone® 2002 label and the SBOA were prior art to the patent at issue. Petitioner offered no further evidence that either was a printed publication.

• PTAB held Petitioner failed to meet its threshold burden of demonstrating that either was a printed publication:

(a) Petitioner filed no exhibits, such as a court document, from the district court case relating to the stipulation;

(b) The stipulation alone is insufficient to meet the threshold requirement because parties may have had others reason to stipulate to the issue;

(c) The petition lacked any information “directly related” to whether either the label or the SBOA were actually publicly accessible in the relevant timeframe. Paper 23, p. 10.

PGR – Institution Denied – Pharma

Dr. Reddy’s Laboratories v. Helsinn Healthcare S.A., PGR2016-00008; U.S. Patent 9,173,942; §102 and §112

• Petitioner – asserted grounds including lack of w/d and violation of on-sale bar provision of §102

• PTAB – denied institution:

• §112 -- “it is undisputed that the specification describes formulations comprising the same ingredients, in the same amounts, concentrations, and combinations required by the challenged claims. Given this disclosure, one of ordinary skill in the art could hardly fail to recognize a description of the claimed formulations in the specification, whether or not the claims recite that the formulations are stable.”

• §102 – “Petitioner has established that MGI’s Form 8-K SEC filings and Helsinn’s press releases made public the existence of the Supply and Licensing Agreements, but Petitioner has not shown that the heavily redacted SEC filings or the press releases, devoid of detail, made the claimed invention available to the public. Thus, we determine that the Supply and Licensing Agreements did not make the claimed invention available to the public one year prior to the critical date at issue here.”

• §103 – no expectation that prior art reference [Tang] would have been effective at treating emesis; “If anything, Tang would have suggested amounts and concentrations still higher than the highest dose and concentration evaluated by Tang.”

31

PGR – Final Written Decision – Medical Device

US Endodontics, LLC v. Gold Standard Instruments, LLC, PGR2015-00019, U.S.

Patent 8,876,991; §102, §103 and §112

• PGR instituted on §102, §103 and §112 grounds.

• PTAB:

• All instituted claims unpatentable

• As claims were not supported by adequate §112 support in priority applications,

the claims only entitled to actual filing date [January 29, 2014]

• Lack of adequate enablement – guidance in the specification [500oC for 75

minutes] is very limited compared to the broad scope of the claims [from 25oC to

1300oC with no duration]; even inventor expressed questions about the specific

temperatures required --- would therefore require undue experimentation

• Lack of adequate written description – the claimed genus is not supported by the

species disclosed [in Example 4]

• §102 – asserted reference was prior art as claims were not entitled to priority claim

[see above]

32

33

What To Watch For In 2017 –United States

What to Watch For in 2017?

• Continued increase in number of filings in life sciences field?

• Will institution rates / claim survival rates change?

• Will there be more pioneer v. pioneer filings or will we continue to

see a majority of the life sciences filings being made by generics?

• More filings in the biosimilars space?

• Will we continue to see an increase in PGR filings?

34

35

Invalidation Procedures– China

China Invalidation Proceeding Overview

36

Basics

• Forum – Patent Reexamination Board (“PRB”) of SIPO

• Filing Time – Any time after grant of patent

• Petitioner – Any entity or individual, including the patentee

• Applicable Law – Patent Law and related regulations effective at

the time of patent application


37

Noteworthy Features

• Period for evidence production is strictly restricted

• Options for claim amendment is limited, but relaxed recently

• Estoppel won’t become effective if rejected by invalidation decision

• Invalidation decision can issue despite of settlement by parties

• Invalidation proceeding may trigger stay of infringement action

• PRB usually issues invalidation decision within one year after initial filing


38

Judicial Review

• Exclusive Jurisdiction

Trial Court - Beijing IP Court since November 6, 2014 / Beijing

No.1 Intermediate Court prior to November 6, 2014

Appellate Court - Beijing High Court

• Plaintiff – Patentee or/and Petitioner unsatisfied with invalidation

decision

• Defendant – Patent Examination Board

• Judgment – Uphold the invalidation decision, or revoke the decision

and remand the case to the PRB


39

Petition Filed

Deadline to Supplement Invalidation

Grounds and

Evidence

(1 month)

Oral Hearing

(4~6 months)

Invalidation Decision

(6~12 months)

Deadline to Request

Judicial Review

(3 months after service of

invalidation decision)

Timeline

40

Current Trends - China

Invalidation Petitions Increases Steadily in China

27492941 2930

3422

37243969

0

500

1000

1500

2000

2500

3000

3500

4000

4500

2011 2012 2013 2014 2015 2016

Source: Annual Reports of State Intellectual Property Office 2011~2016

Technology Breakdown of Invalidation Petitions

Machinery42%

Optoelectronics15%

Biology&Pharmacy&Chemisty

19%

Design13%

Source: Internal Work Report of SIPO 2014

Hard to Overturn PRB Decisions in Judicial Review

Uphold PRB Decision

83%

Revoke PRB Decision

10%

Withdrew7%

Source: Internal Work Report of Beijing IP Court 2015

44

Recent Developments & Decisions - China

PRB Decisions—Limitation on Drug Using

45

Zhang v. Gene Technology Co., Ltd

Invalidation Decision No.23948 (PRB September 22, 2014); (2015) Jing Zhi Xing Chu No. 33 (Beijing

IP Court ); (2016) Jing Xing Zhong No. 1762 (Beijing High Court, July 20, 2016)

• Claims covered a product and method for treating breast cancer with composition of anti-ErbB2 antibody, wherein the composition was contained in a package with a label on it to instruct the patient to avoid using anthracycline antibiotics-type chemotherapeutics in combination with the composition.

• Petitioner challenged claims as obvious over a reference Jose Baselga, which disclosed an animal experiment on nude mice wherein the composition of rhuMoAb HER2 antibody (anti-ErbB2 antibody) was used for treating xenografted human breast cancer tumors.

• PRB decision: all claims were deemed obvious as the PRB found the instruction on the package label does not constitute effective limitation


46




• The main distinguishing elements between the patent and Jose

Baselga were:

• The patented composition was contained in a package with a

label on it to instruct the patient to avoid using anthracycline

antibiotics-type chemotherapeutics in combination with the

composition;

• Jose Baselga only disclosed an experiment on nude mice rather

than a treatment on a human.


47




• Patentee argued that the patent was non-obvious:

• Jose Baselga did not explicitly break the routine method of using

the anthracycline-type chemotherapeutics to treat breast cancer;

and

• Jose Baselga did not provide any clue on the side effect of using

the anti-ErbB2 antibody in combination with the anthracycline

antibiotics-type chemotherapeutics.


48




• PRB found in its invalidation decision that the patent “lacked

prominent substantive features and significant progress”:

• The essential objective of the patent was to provide a packaged

drug convenient for patients to take;

• The distinguishing element regarding a label providing drug

using instruction was common practice in the filed;

• The prior art provided sufficient inspiration for persons with

ordinary skills in the art to achieve the patent in light of Jose

Baselga; and

• The patent did not disclose any unexpected technical results of

the patent compared with Jose Baselga.


49




• Beijing High Court sustained the invalidation decision and further

emphasized in its final judgment that:

• The instruction on the label was purely about how to use the

drug, which would not change the physical structure or

composition of the drug;

• The limitation about how to use the drug should not be

considered when construing the scope of a claim regarding the

manufacturing of the drug; and

• The use of a package to contain the anti-ErbB2 antibody and

putting a label on the package to specify drug indication and

using instruction was common practice in the art and it was

obvious to persons with ordinary skills in the art.


50

Take-Aways

• Limitation on the using of a drug shall be excluded when

construing the scope of a claim regarding the manufacturing of

the drug.

PRB Decisions—Amendment of Claim

51

FU lei v. Beida Pharmaceutical Co., Ltd. Invalidation Decision No. 27258

(October 9, 2015)

• Claims covered a fused quinazoline derivative as a tyrosine kinase inhibitor, as well as their synthesis and use in the treatment of tyrosine kinase-modulating diseases.

• Petitioner challenged, among other invalidation grounds, that the claims were amended beyond the scope of initial disclosure during the prosecution process, as the added elements regarding non-aromatic ring and heteroatom were not explicitly disclosed in the original application documents.

• PRB decision: the amendment of the claims did not go beyond the initial disclosure, as the added elements were indirectly disclosed by the original application documents and the specific elements can be deduced based on the guidance of the embodiments.


52


(October 9, 2015)

• During the prosecution process, the Patentee added three elements

to the “A” ring in Claim 1:

• The “A” ring is a 9-membered to 15-membered ring;

• The “A” ring is a non-aromatic monocyclic ring; and

• The “A” ring comprises at least two oxygen atoms and 0 to 3

heteroatoms selected from oxygen, sulfur or nitrogen.

• The element regarding the 9-membered to 15-membered ring was

disclosed explicitly in the text of the original application documents,

while the elements related to the non-aromatic monocyclic ring and

heteroatoms were not clearly disclosed.


53


(October 9, 2015)

• Petitioner alleged that the amendment related to the non-aromatic monocyclic ring and heteroatoms were beyond the initial disclosure as none of them were explicitly recorded in the text of the original application documents.

• Patentee argued that:

• The embodiments in the specification listed a large number of compositions wherein the A rings were non-aromatic monocyclic rings; and

• The persons with ordinary skills in the art could deduce the number of the heteroatoms based on the type of A ring and the content of Claim 12, wherein the heteroatom were 2-5 atoms selected from oxygen, sulfur and nitrogen.


54


(October 9, 2015)

• The PRB found the amendment did not go beyond the scope of

initial disclosure:

• Claim 12 already disclosed the A ring could have 2~5

heteroatoms selected from oxygen, sulfur and nitrogen, which

was an upper concept of the element “2 oxygen atoms and 0~3

atoms selected from oxygen, sulfur and nitrogen”;

• Most compositions disclosed by the embodiments were non-

aromatic monocyclic rings; and

• The added elements, though not explicitly recorded in the initial

disclosure, were actually a small part of the larger concept

disclosed by the original application documents.


55

Take-Aways

• Adding an element not explicitly recorded in the original

application document will not necessarily go beyond the initial

disclosure scope.

• Such addition can be accepted as long as the added element

can be ascertained as part of the invention completed prior to

the application date.

PRB Decisions—Settlement by Parties

56

Anonymous v. Li Xiaoxiang Invalidation Decision No. 16429 (April 28, 2011)

• Claims covered a hetastarch injection and the method to

manufacture it.

• Petitioner filed a invalidation petition for invalidating the patent-at-

issue in its entirety based on non-obviousness ground.

• Due to the settlement with Patentee, Petitioner decided to withdraw

the invalidation petition after the oral hearing.

• PRB decision: based on the facts identified and examined

during the oral hearing, it was clear that the patent-at-issue was

obvious in light of the prior art, and thus it should be

invalidated to protect the public interests.


57

Anonymous v. Li Xiaoxiang Invalidation Decision No. 16429 (April 28, 2011)

• Section 72.2 of the Implementation Rules of Patent Law (2010)

proscribed that:

• If the petitioner withdraw the invalidation petition or the petition is

seen as to be withdrawn before the PRB issues the invalidation

decision, the invalidation proceeding shall be terminated.

However, if the PRB deems that it can make a decision to

invalidate the patent-at-issue in its entirety or partially, the

invalidation proceeding shall not be terminated.

• The PRB practiced Section 72.2 to protect the public interests.


58

Take-Aways

• Settlement does not necessarily mean the end of invalidation

proceeding.

• Time window for settlement should be carefully selected.

59

What To Watch For In 2017 -China


60

Fourth Amendment of Patent Law in China

• Draft amendment released for public comment in December 3, 2015, final text to be promulgated in 2017

• License of course: established by patentee’s declaration with SIPO, granted to any intended licensee, no injunction allowed

• Implied license for SEP: automatically granted for undisclosed SEP

• Statutory damages: increased to RMB 5 million (UDS 700,000+)

• Punitive damages: 1 to 3 times of normal royalties for deliberate infringers


61

Update to Guidelines for Patent Examination in China

• Became effective since April 1, 2017

• Business model claim: newly allowed in the form of method claim,

must contain technical element(s)

• Admission for experiment data loosened: experiment data for

chemistry related patents submitted after application date may be

admitted

• New option to amend claim during invalidation proceeding: adding

element(s) from other claim(s) to further limit claim scope


62

SEP in Pharma Industry: Sihuan v. Qilu

• Sihuan accused Qilu for patent infringement on two patents regarding

a drug for cardiovascular and cerebrovascular dilatation

• Two patents at issue were incorporated in the National Mandatory

Drug Standard issued by CFDA

• Qilu filed an anti-trust complaint against Sihuan at Beijing IP Court,

accusing Sihuan for failing to comply with FRAND principle and

requesting a ban on any injunction regarding the standard essential

patents at issue (still pending)

• Court decision (if any) will establish rules for SEP in pharma industry

Overview of Upcoming Topics

• Antitrust Issues When Engaged in Transnational Litigation

• Life Sciences IP in the US and China

• ITC Practice for Transnational Companies

• Damages Law in the US and China

63

Thank You!

64

Please send your NY CLE forms or questions about the webinar to

Lauren McGovern at [email protected]

A replay of the webinar will be available for viewing at


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Gwilym Attwell

Principal

Fish & Richardson

Wilmington, DE

[email protected]

Rui Luo

Counsel

Han Kun Law Office

Beijing, China

[email protected]

mailto:[email protected]


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