1 Hatch-Waxman Boot Camp July 19-20, 2010 Mary C. Till Legal Advisor Office of Patent Legal Administration

2 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

3 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 the filing 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 the Office fails, within specified time periods, to issue a patent. The Office’s failure to meet certain time periods is offset by the applicant failing to engage in reasonable efforts to conclude prosecution.

4 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 reply filing 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 the application. -Issue a patent within four months after the date on which the issue fee was paid and all outstanding formal requirements were met.

5 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 other request.” (35 U.S.C. § 154(b)(2)(C)).

6 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 to engage in reasonable efforts to conclude processing or examination of an application.” -37 C.F.R. § 1.704(c)(1)-(11) were promulgated.

7 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 applicant’s request; (2) abandonment of an application or delay in filing a petition to withdraw abandonment holding; (3) converting a provisional to a non-provisional and (4) submission of papers after notice of allowance.

8 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 the patent was delayed. -Wyeth, dissatisfied with their PTA determination, sued the USPTO under the APA.

9 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Adjustment -On January 7 th, 2010,Federal Circuit decided Wyeth v. Kappos. -Federal Circuit determined the statutory construction of 35 USC 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.

10 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 USPTO interpretation 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 interpretation of Wyeth v. Kappos.

11 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).

12 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 (35 U.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)).

13 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension Statutory Requirements (cont’d): -The permission for the commercial marketing or use of the 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)).

14 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension Statutory Requirements (cont’d): -An application for patent term extension must be submitted by the owner or record or its agent to the USPTO (35 U.S.C. § 156(a)(3)) within the sixty day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use (35 U.S.C. § 156(d)(1)).

15 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 35 U.S.C. § 156(d)(1)(A)-(E).

16 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 biological products). -Medical Device -Food Additive -Color Additive

17 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. § § (veterinary biological product). - Section the 409 of the Federal Food Drug and Cosmetic Act (food additives and color additives).

18 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 14 years, regardless of how much time was lost to clinical testing and 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)).

19 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 are submitted 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 approved application components.

20 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 enantiomer was 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 patent claiming the racemate received extension.

21 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) means “active ingredient,” that is, the substance physically present in the final dosage form.

22 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 or calendar day? Medicines Company argues business day. Government argues calendar date. Case is pending.

23 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