Hatch Waxman 20jul1020
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Transcript of Hatch Waxman 20jul1020
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Hatch-Waxman Boot Camp
July 19-20, 2010
Mary C. TillLegal Advisor
Office of Patent Legal Administration
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
-Patent Term Adjustment-35 U.S.C. 154(b)-PTA
-Office Deductions and Applicant Deductions
-Wyeth v. Kappos
-Patent Term Extension-35 U.S.C. 156-PTE
-Eligibility and Regulatory Requirements
-Wyeth v. Sebelius et al.
-Ortho-McNeil v Lupin
-Photocure v. Kappos
-The Medicines Company v. Kappos
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Adjustment
-Congress changed the law in 1994 to amend 35 U.S.C. 154 to
provide that the term of patent protection begins on the date
of patent grant and ends on the date twenty years from thefiling date of the application, or the earliest U.S. filing date for
which a benefit is claimed.
-American Inventors Protection Act in 1999, amended 35 U.S.C.
154 to provide day-by-day patent term adjustment if theOffice fails, within specified time periods, to issue a patent.
The Offices failure to meet certain time periods is offset by the
applicant failing to engage in reasonable efforts to conclude
prosecution.
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Adjustment
USPTO time period objectives:
-Issue an office action within 14 months after the application was filed.
-Respond to a reply from the applicant within 4 months of the replyfiling date.
-Respond to an appeal brief from the applicant within 4 months of the
appeal brief being filed.
-Issue a patent within 3 years of the actual filing date of theapplication.
-Issue a patent within four months after the date on which the issue fee
was paid and all outstanding formal requirements were met.
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Adjustment
Applicant Adjustment Reductions:
-Reductions can occur when the applicant failed to
engage in reasonable efforts to conclude processing or
examination of an application for the cumulative total of
any periods of time in excess of 3 months that are take not
respond to a notice from the Office beyond three months
making any rejection, objection, argument or otherrequest. (35 U.S.C. 154(b)(2)(C)).
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Adjustment
Applicant Adjustment Reductions:
-Congress provided that USPTO can prescribe
circumstances that constitute the failure of an applicant toengage in reasonable efforts to conclude processing or
examination of an application.
-37 C.F.R. 1.704(c)(1)-(11) were promulgated.
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Adjustment
Applicant Adjustment Reductions:
-37 C.F.R. 1.704(c)(1)-(11) provides for a reduction in
the PTA accumulated because of Office delays, e.g.,suspension of action or deferral of issuance of a patent an
applicants request; (2) abandonment of an application or
delay in filing a petition to withdraw abandonment
holding; (3) converting a provisional to a non-provisionaland (4) submission of papers after notice of allowance.
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Adjustment
-In 2000, the USPTO promulgated rules which implement the
statutes from Congress with respect to patent term adjustment.
-Rule 1.703(f) provided an interpretation of a specific statutory
provision which relates to overlapping days in the periods of
delay before the USPTO. The rule provided that to the extent
that periods of adjustment overlap, the period of adjustment
will not exceed the actual number of days the issuance of thepatent was delayed.
-Wyeth, dissatisfied with their PTA determination, sued the
USPTO under the APA.
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Adjustment
-On January 7th, 2010,Federal Circuit decided Wyeth v.
Kappos.
-Federal Circuit determined the statutory construction of 35USC 154(b)(2)(A).
-Federal Circuit determined that the phrase to the extent that
periods of delay attributable to grounds specified in
paragraph (1) overlap means same calendar days.-Accordingly, A delays and B delays overlap only if such
delays occur on the same calendar day.
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Adjustment
-Federal Circuit decision means that some patentees may be
receiving more patent term adjustment under the CAFC
interpretation than under the previous USPTOinterpretation of 35 USC 154(b)(2)(A).
-USPTO has modified the computer program to be consistent
with the Wyeth decision.
-USPTO is deciding petitions consistent with the interpretationof Wyeth v. Kappos.
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
35 U.S.C. 156-titled patent term extension, as part
of the Hatch-Waxman Act, restores patent term to a
patent that was effectively lost due to pre-market
approval requirements before a regulating agency
(the agencies involved are the Food and Drug
Administration and the United States Department of
Agriculture).
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
Statutory Requirements:
- The patent claims the product, or a method of using the
product or a method of manufacturing the product (35 U.S.C. 156(a)).
-The term of the patent has not expired before the application
for PTE has been submitted (35 U.S.C. 156(a)(1)).
-The term has never been extended under 156 before (35U.S.C. 156(a)(2)).
-The product has been subject to a regulatory review period
before its commercial marketing or use (35 U.S.C. 156(a)(4)).
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
Statutory Requirements (contd):
-The permission for the commercial marketing or use ofthe product after the regulatory review period is the
first permitted commercial marketing or use of the
product under the provisions of law under which such
regulatory review period occurred (35 U.S.C. 156(a)(5)).
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
Statutory Requirements (contd):
-An application for patent term extension must be
submitted by the owner or record or its agent to theUSPTO (35 U.S.C. 156(a)(3)) within the sixty dayperiod beginning on the date the product receivedpermission under the provision of law under which the
applicable regulatory review period occurred forcommercial marketing or use (35 U.S.C. 156(d)(1)).
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
PTE Application:
Who: submitted by patent owner or his agent (35 U.S.C.
156(d)(1)).
When: filed with the USPTO within the sixty-day period beginning
on the date the product received permission. . . for commercial
marketing or use (35 U.S.C. 156(d)(1)).
What: contents of the application contain information as per 35U.S.C. 156(d)(1)(A)-(E).
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
Eligible Products:
-Drug Products (New drugs, antibiotic drugs, human biological
products, new animal drugs, or veterinary biologicalproducts).
-Medical Device
-Food Additive
-Color Additive
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
Relevant Regulatory Review Periods:
-Section 505 of Federal Food Drug and Cosmetic Act (new drugs).
-Section 351 of the Public Health Services Act (human biological products).-Section 515 of the Federal Food Drug and Cosmetic Act (medical devices).
-Section 512 of the Federal Food Drug and Cosmetic Act (new animal drugs).
-The Virus-Serum Toxin Act, 21 U.S.C. 151-159 (veterinary biological
product).
- Section the 409 of the Federal Food Drug and Cosmetic Act (food additivesand color additives).
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
Limitations on amount of term extension:
-Includes only time after the date the patent is issued (35 U.S.C.
156(c)).-Time where applicant failed to exercise due diligence is
subtracted (35 U.S.C. 156(c)(1)).
-Only one-half of the testing phase is counted (35 U.S.C. 156(c)(2)).
-The total market exclusivity time of a drug cannot exceed 14years, regardless of how much time was lost to clinical testingand regulatory review. (35 U.S.C. 156(c)(3)).
-The total time of extension is limited to no more than 5 years
(35 U.S.C. 156(g)(6)).
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
Wyeth v. Sebelius (603 F.3d 1291 (Fed. Cir. 2010))
-When does the approval phase begin for a new animal
drug application when the parts of the application aresubmitted on a rolling basis?
The approval phase begins when the Administrative
New Animal Drug Application is submitted to FDA
referencing all the previously submitted and approvedapplication components.
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
Ortho-McNeil v. Lupin (603 F.3d 1377 (Fed. Cir. 2010))
-Is a patent claiming a specific enantiomer eligible for
patent term extension when a racemate of the enantiomerwas previously approved?
Yes, a patent claiming the specific enantiomer may be
extended under 35 U.S.C. 156 even though the racemate
of the enantiomer was previously approved and a patentclaiming the racemate received extension.
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
Photocure v. Kappos (603 F.3d 1372 (Fed. Cir. 2010))
-Is a patent claiming an ester of a previously approved
active ingredient eligible for patent term extension?
Yes, the statutory language recites, active ingredient
including any salt or ester of the active ingredient, not
active moiety. Glaxo II (894 F.2d 392 (Fed. Cir. 1990) is
controlling in that the term product in 156(a)(5)(A) meansactive ingredient, that is, the substance physically present
in the final dosage form.
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Patent Term Extension
The Medicines Company v. Kappos (E.D. Va. 1:10CV286)
-Does the term date as used in section 156(d)(1)
(beginning on the date. . . .) refer to a business day orcalendar day?
Medicines Company argues business day. Government
argues calendar date. Case is pending.
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Examining Pharmaceutical Patent Extensions: Patent
Term Adjustment and Patent Term Restoration
Thank you!Contact Information:Mary C. Till
Legal Advisor, Office of Patent Legal Administration
USPTO