That’s when I know something is amiss. The most recent occurrence of the “Rule of Three” happened when three different attorneys from different firms asked essentially the same question: “Kurt, is the Patent and Trademark Office’s November 2009 decision denying multiple interim patent term extensions, and that you blogged on in December 2009, still the Office’s position?”By way of background, there are two types of interim patent extensions under the Patent Term Extension (“PTE”) statute (35 U.S.C. § 156): (1) interim patent extensions granted during the “review phase” of the statutory “regulatory review period” (35 U.S.C. § 156(d)(5)); and (2) interim patent extensions granted during the PTO’s review of an application for a PTE (35 U.S.C. § 156(e)(2)). The PTE statute also states at 35 U.S.C. § 156(c)(4) that “in no event shall more than one patent be extended under subsection (e)(1) for the same regulatory review period for any product.”

The product received FDA permission for commercial marketing or use, and the permission for the commercial marketing or use of the product is the first such permission received under the provision of law under which the applicable regulatory review period occurred (e.g., Federal Food, Drug and Cosmetic Act).No other patent term has been extended for the same regulatory review period for the product.To apply for PTE, the owner of the patent or its agent (“the applicant”), has to submit an application under 35 U.S.C. § 156 to the United States Patent and Trademark Office (“USPTO”) within the sixty-day period beginning on the same date the product received permission for commercial marketing or use from the FDA. The sixty-day deadline is non-extendable, and a patent holder may lose its right to PTE if the deadline is missed.

For example, from 2008-17, 12.4% of all new drugs approved by the FDA were prodrugs.These include: Emend®(2008), Toviaz®(2008), Romidepsin®(2009), Pradaxa®(2010), Edarbi®(2011), Zytiga®(2011), Tecfidera®(2013), Sovaldi®(2013), Sivextio®(2014), Entresto®(2015) and Emflaza®(2017).Recently, the Federal Circuit inBiogen International GmbH v. Banner Life Sciences LLCdecided the scope of protection for claims to a prodrug during the extension (“PTE”) granted under 35 U.S. C. section 156(a). Since many pharmaceutical patents are extended under this provision, understanding the metes and bounds of protection applied in theBiogencase, is important for pharmaceutical companies.B. Overview of Patent Term ExtensionTo compensate patentees for the loss of patent term for patents covering pharmaceutical products due to the prolonged regulatory approval process, Congress enacted 35 U.S.C. section 156 as part of the Hatch-Waxman Act.

Heeding Judge Hilton’s order to “take such actions as necessary to ensure that the ‘404 patent does not expire pending further resolution of these proceedings,” and at the same recognizing the Federal Circuit’s 2007 ruling in Somerset Pharmaceuticals v. Dudas that an interim PTE is not available when the PTO has already denied a PTE application, however, the PTO’s March 19th denial was preceded by a March 18, 2010 decision(here and here)granting MDCO an interim PTE until May 23, 2010 for the '404 patent.As we previously reported, Judge Hilton’s March 16, 2010 decision stems from a January 2010 Complaint and Motion for Summary Judgment following the PTO’s January 8, 2010 denial of MDCO’s December 2009 Request for Reconsideration asking the PTO to employ a “rule of construction” under which the Office would consider the 60-day PTE application submission period at 35 U.S.C. § 156(d)(1) to commence on the first business day after the day the FDA transmits notice of NDA approval of the drug product if that transmittal occurs after normal business hours (i.e., after 4:30 PM east coast time in some cases). In the case of the PTE application for the ‘404 patent covering ANGIOMAX, that would mean the 60-day period would have begun on Monday, December 18, 2000 and the PTE application would have been timely filed within 35 U.S.C. § 156(d)(1), rather than on Friday, December 15, 2000 when FDA issued its approval letter for the ANGIOMAX NDA (NDA No. 20-873) – albeit at 5:18 PM on that day.

By Kurt R. Karst – In a March 16, 2010 opinion and order, Judge Claude M. Hilton of the U.S. District Court for the Eastern District of Virginia (Alexandria Division) vacated the Patent and Trademark Office’s (“PTO’s”) denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,196,404 (“the ‘404 patent”) covering The Medicines Company’s (“MDCO’s”) ANGIOMAX (bivalirudin), and remanded the case to the PTO “for reconsideration as to the date of approval under [35 U.S.C. § 156] and to take such actions as necessary to ensure that the ‘404 patent does not expire pending further resolution of these proceedings.” The question of the availability of a PTE for the ‘404 patent has been going on for many years, and has involved all three branches of government.

263-1. Federal Circuit Finds Patent Term Extension Under 35 U.S.C. § 156 Does Not Apply to De-Esterified Forms of an Active IngredientThe United States Court of Appeals for the Federal Circuit recently affirmed a judgment of the United States District Court for the District of Delaware (District Court) that Banner Life Sciences LLC (Banner) does not infringe the extended portion of U.S. Patent 7,619,001 (’001 Patent), extended under the patent term restoration provisions of the Hatch-Waxman Act. See Biogen Int’l GmbH v. Banner Life Scis.

By Kurt R. Karst –Late last week, the U.S. District Court for the Eastern District of Virginia granted the U.S. Patent and Trademark Office’s (“PTO’s”) Motion for Summary Judgment in a challenge mounted by the Genetics & IVF Institute (“GIVF”) to the PTO’s August 2010 denial of a Patent Term Extension (“PTE”) for U.S. Patent No. 5,135,759 (“the ‘759 patent”), which covers a method to preselect the sex of offspring and is owned by the U.S. Department of Agriculture (“USDA”). As we previously reported, GIVF, as the exclusive licensee of the (now-expired) ‘759 patent, sued the PTO under the Administrative Procedure Act, and asked the court to, among other things, vacate and set aside the PTO’s August 2010 decision and to declare that the PTO has the discretion to extend the term of the ‘759 patent for the full period required under 35 U.S.C. § 156.The case involves the interim PTE provisions at 35 U.S.C. § 156(d)(5), under which the PTO may grant an interim patent extension while a Premarket Approval application (“PMA”) is undergoing FDA review if the patent owner (or his agent) “reasonably expects that the applicable regulatory review period . . . that began for a product that is the subject of such patent may extend beyond the expiration of the patent term in effect.” To request an initial interim PTE, the owner (or his agent) submits an application to the PTO “during the period beginning 6 months, and ending 15 days before such term is due to expire.”

The patent is for a medical device for sperm sorting apparatus that is the subject of a Premarket Approval application (“PMA”) undergoing FDA review. The ‘759 patent is owned by the U.S. Department of Agriculture (“USDA”) and is exclusively licensed to GIVF.Under the PTE statute at 35 U.S.C. § 156(d)(5)(A), the PTO may grant an interim patent extension while a PMA is undergoing FDA review if the patent owner (or his agent) “reasonably expects that the applicable regulatory review period . . . that began for a product that is the subject of such patent may extend beyond the expiration of the patent term in effect.” To request an initial interim PTE, the owner (or his agent) submits an application to the PTO “during the period beginning 6 months, and ending 15 days before such term is due to expire.”

No MMF is present in Tecfidera® DMF capsules, but the DMF in Tecfidera® is converted into MMF in the body and MMF produces a therapeutic effect. Biogen obtained 811 days of PTE under 35 U.S.C. § 156, thereby extending the expiration date of the patent from April 1, 2018, to June 20, 2020.In January 2018, Banner Life Sciences LLC submitted a new drug application (NDA) for an MMF-based drug called Bafiertam, relying on Biogen’s clinical data for Tecfidera® to demonstrate safety and efficacy. In December 2018, Biogen sued Banner for patent infringement.

The ‘404 patent expires on March 23, 2010, but is subject to a 6-month period of pediatric exclusivity.We recently reported that TMC has been lobbying Congress to pass legislation that would amend the PTE statute at 35 U.S.C. § 156 to permit the PTO to accept the late filing of a PTE application, and in particular, TMC’s PTE application for the ‘404 patent – but for a $65 million fee. Thus far, TMC’s lobbying efforts have not been fruitful.