The Life Sciences Lawyer’s Guide to PTA and PTE PTE Best Practices The Life Sciences Lawyer’s Guide to PTA and PTE Mary C. Till Senior Legal Advisor Office of Patent Legal Administration January 27, 2011 BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Eligibility requirements (patents, claim language) Eligibility Requirements Application Requirements Multiple Applications Combination Products Interim Extensions Calculating the restored term Regulatory review period Statutory caps Examples Reissue during PTE processing time Frequently asked questions BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Eligible Patents 156(a)-”the term of a patent which claims a product, a method of using a product, or a method of manufacturing a product, shall be extended. . .” How must the product be recited in the claim? BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Patent Claim Language Product Patents: claim the small molecule (genus and/or species), antibody, sequence, device, pharmaceutical composition, etc. Use Patents: method of treating disease X in a patient in need thereof, by administering an effective amount of substance Y. Method of Manufacturing Patents: a process for preparing the substance Y comprising steps 1, 2, 3, etc. BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Eligibility Requirements Patent has not expired. Patent has never been extended before under (e)(1). An application is submitted by patent owner or his agent. The product was subject to a regulatory review period before its commercial marketing or use. The permission for the commercial marketing or use is the first permitted commercial marketing or use under the provision of law under which the regulatory review period occurred. BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration 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 products). Section 409 of the Federal Food Drug and Cosmetic Act (food additives and color additives). BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Section 156(d)(1) sets forth the application requirements: Identify the product and identify the statutory provision under which regulatory review occurred. Identify the patent and the claims of the patent that cover the product. Information to enable USPTO to determine eligibility and rights under the grant. Dates and activities during regulatory review. Any additional information. BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Timely filed section 156(d)(1) application Section 156(d)(1) defines the period within which to file an application for term extension as, “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.” BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Two situations can give rise to multiple applications for PTE First, when multiple patents claim the approved product, or a method of using or manufacturing the approved product, patent owners may file multiple applications and choose the one to receive the extension at the end of the PTE process (see 37 C.F.R. § 1.785). Second, multiple approvals for the same product on the same day (35 U.S.C. § 156(c)(4)). BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Combination Products Multiple active ingredients drug products Arnold Partnership v. Dudas, 362 F.3d 1338 (Fed. Cir. 2004). Synergy? Drug/device combination products BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Interim Extension under 35 U.S.C. § 156(d)(5) Section 156(d)(5) interim extension Product is not yet approved. Patent is expiring while product is undergoing continued review by the regulating agency. Clinical work is done, agency is conducting approval review. Statutorily set time frame for application submission. BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Timely filed section 156(d)(5) and subsequent section 156(d)(5) interim extensions § 156(d)(5)(A) defines the period within which to file an application for interim extension as, “beginning 6 months, and ending 15 days before such term is due to expire.” § 156(d)(5)(C) defines the period within which to file a subsequent application for interim extension as, “the period beginning 60 days before, and ending 30 days before, the expiration of the preceding interim extension.” BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration Interim Extension under 35 U.S.C. § 156(e)(2) Section 156(e)(2) interim extension Product has been approved. Patent is expiring before certificate of extension can be granted. No statutorily set time frame for application submission.

PTE: Laying the Groundwork for Patent Term Restoration Timely filed section 156(e)(2) interim extension Section 156(e)(2) does not contain a statutory time period for application submission. 37 C.F.R. § 1.760 indicates that any request for interim extension under 156(e)(2) should be filed at least 3 months before the patent expires.

PTE: Laying the Groundwork for Patent Term Restoration Calculating the restored term (35 U.S.C. § 156(c)) Extended term is equal to the regulatory review period (RRP) for the approved product; Which period occurs after the date the patent is issued (PG-patent pre-grant periods of regulatory review); RRP is reduced by the period during which the applicant for the extension did not act with due diligence (DD); RRP which is the “testing phase” as defined in 156(g) includes only one-half of the days (TP).

PTE: Laying the Groundwork for Patent Term Restoration Calculating the restored term (35 U.S.C. § 156(c)) The extended term is one of three values: Calculated = RRP - PGRRP - DD - ½ (TP - PGTP); Days equal to 14 years of total exclusivity; or Maximum of 5 years at the end of the 35 U.S.C. § 154 patent term.

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Calculated extension example 156 Term = RRP - PGRRP - DD - ½ (TP - PGTP) RRP = 1,941 days DD = 0 days Testing Phase (TP) = 1,256 days (8/25/1999 thru 1/31/2003) Patent grant date = 9/3/2002 PGRRP (pre-grant RRP days-all in TP) = 1,106 days = PGTP Approval Date: 12/15/04, so 14 year limit is 12/15/18 (2525 days). Original Expiration Date: 1/16/12 156 Term (calculated) = 1,941 - 1,106 - 0 - ½ (1,256-1,106) = 760 days Extension is always least number of days, so it is limited to 760 days. Lunesta BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration 14 year limit example 156 Term (calculated) = RRP - PGRRP - DD - ½ (TP - PGTP) RRP = 2,224 days DD = 0 days Testing Phase (TP) = 1,920 days (6/22/1999 thru 9/22/2004) Patent grant date = 3/7/2000 PGRRP (pre-grant RRP days-all in TP) = 260 days = PGTP Approval Date: 7/22/2005, 14 year limit is 7/22/2019 Original Expiration Date: 3/6/2017 156 Term (calculated) = 2,224 - 260 - 0 – ½ (1,920-260) = 1,134 days But extension is always least number of days, so it is limited to 868 days based on 14 year limit. Rozerem BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration 5 year limit example 156 Term (calculated) = RRP - PGRRP - DD - ½ (TP - PGTP) RRP = 4,781 days DD = 0 Testing Phase (TP) = 3,786 days (7/4/1991 thru 11/13/2001) Patent grant date = 6/11/1991 PGRRP (pre-grant RRP days) = 0 days Approval Date: 8/3/2004, 14 year limit is 8/3/2018 (extension would be more than 10 years) Original Expiration Date: 6/11/2008 156 Term (calculated) = 4,781-0-0- ½ (3,786-0) = 2,888 days (7.9 years) Extension is always least number of days, so it is limited to 5 years based on section 156(g)(6)(A). Cymbalta BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Seeking or Pending Reissue during PTE Processing Once a product receives approval, the patent owner has a 60 day window within which to submit an application for term extension (35 U.S.C. § 156(d)(1)). Sometimes a reissue of the patent for which extension has been sought is undergoing prosecution. Sometimes during the processing of the patent for which extension has been sought, a reissue application is filed for the patent. BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration PTE Best Practices PTE: Laying the Groundwork for Patent Term Restoration Effect of Reissue On PTE Section 251 states (in part), “on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent.” Section 252 states (in part), “[t]he surrender of the original patent shall take effect upon the issue of the reissued patent, and every reissued patent shall have the same effect and operation in law, on the trial of actions for causes thereafter arising, as if the same had been originally granted in such amended form. . . .” BCP Meeting 9-8-2010

PTE: Laying the Groundwork for Patent Term Restoration Frequent PTE Questions (1) Has U.S. Patent No. X,XXX,XXX been extended? (2) The patent owner and the marketing applicant before the agency are not the same entity, do we need to submit anything extra with our application? (3) Can a third party participate in the PTE process? (4) The FDA’s Orange Book lists lots of patents for product X, why is only one patent listed on the USPTO’s list of extended patents? (5) Our drug product has not received approval yet, but a medical device incorporating the drug product has been approved, can we extend one patent based on the medical device review and another patent based on the drug product review?

PTE: Laying the Groundwork for Patent Term Restoration Answers to Frequent PTE Questions (1) Most PTE applications and grants are available for viewing in Public PAIR, check there first. (2) An authorization letter from the marketing applicant that the patent owner can rely on his activities before the regulating agency should be submitted with the application. (3) No. (4) Because of 35 U.S.C. § 156(c)(4), only one patent may be extended per regulatory review period. (5) Yes, language of §§ 156(a)(5)(A) and (c)(4) would permit this. Each was reviewed under a different regulatory provision.

PTE: Laying the Groundwork for Patent Term Restoration Additional Frequent PTE Questions (6) Section 156(c)(1) indicates that any period of time that the patent owner did not act with due diligence during the regulatory review period is subtracted. Does the PTE applicant have to allege diligence? (7) During patent prosecution, there is a duty of disclosure under 37 C.F.R. § 1.56. Is there a similar duty during PTE processing? How does the USPTO handle processing of a PTE application if the expiration date of the patent changes? If there is no challenge under section 156(d)(2)(B)(i) to the determination of the regulatory review period by FDA following the Federal Register publication of the determination of the length, can the length of the extension granted be challenged later? What is the scope of the rights under section 156(b)?

PTE: Laying the Groundwork for Patent Term Restoration Answers to Additional Frequent PTE Questions (6) No. (7) Yes, see 37 C.F.R. § 1.765. “All such individuals who are aware, or become aware, of material information adverse to a determination of entitlement to the extension sought. . .must bring such information to the attention of the Office” (8) If a terminal disclaimer is filed post grant and post PTE filing, but prior to certificate of extension grant, USPTO will calculate term based on that earlier expiration date. If there is additional PTA due, USPTO will calculate term based on that later expiration date. (9) No, see 35 U.S.C. § 282. “A due diligence determination under section 156(d)(2) is not subject to review in such an action.” (10) The USPTO is not involved with enforcement of rights. However, the language in section 156(b) is dependent upon the identity of the approved product as well as the type of claim which was extended.

PTE: Laying the Groundwork for Patent Term Restoration Thank you! Contact Information: Mary C. Till Senior Legal Advisor Office of Patent Legal Administration USPTO mary.till@uspto.gov 571-272-7755