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

    [email protected]