Understanding the Patent Term Extension Statute

The Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, is responsible for allowing patent owners to extend the patent term due to the need to undergo a premarket review. The relevant provisions of Hatch-Waxman were intended to remove two distortions to the normal “patent term” arising from the requirement that certain products obtain regulatory approval before marketing..” Eli Lilly & Co. v. Medtronic Inc., 496, US 661, 669 (1990).

The first disruption occurred after the end of the patent term, as competitors could not immediately enter the market after patent expiration because they were not allowed to begin testing and other activities necessary to obtain approval from the Food and Drug Administration (FDA). ) before the patent expired. This initial disruption is addressed at 35 USC 271(e)(1), which provides a safe harbor for otherwise infringing conduct intended solely for a use reasonably related to the development and submission of information under a federal law that prohibits the manufacture, the use or sale of medicines or veterinary biological products.

The second distortion was that the patent holder loses the patent term during the early years of the patent because the product cannot be commercially marketed without FDA approval. The portion of the law dealing with extensions of patent terms (PTE) due to delays in agencies other than the United States Patent and Trademark Office (USPTO) is codified at 35 USC 156which is designed to create new incentives for research and development of certain products that require regulatory approval before marketing.

What the statute says about PTE

35 USC 156 allows the owners of patents on certain human drugs, food or color additives, medical devices, veterinary drugs, and veterinary biological products to recover from the FDA some of the time lost pending FDA approval before bringing it back to the market to the terms of those patents. The rights arising from the patent term extension under 35 USC 156(a) are defined by 35 USC 156(b) and are not strictly limited to claims by claim, but are instead limited to claims relating to the product, a method of using a product, or a method of manufacturing a product, which 35 USC 156(a) says “shall be extended.” See also Genetics Institute LLC v. Novartis Vaccines and Diagnostics Inc., 655 F.3d 1291 (Fed. Cir. 2011). Notwithstanding, pursuant to 35 USC 156(b), if the patent claims additional products in addition to the approved product, the exclusive patent rights to the additional products expire with the original patent expiration date. To see Biogen Int’l GmbH v Banner Life Scis. LLC, 956 F.3d 1351 (Fed. Cir. 2020) (stating that the scope of rights during the extended period included only the active ingredient of an approved product, or an ester or salt thereof, and not a deesterified version (metabolite ) of the approved product, even if the claim stated the non-esterified version).

In general, for a patent owner to take advantage of the extension available under 35 USC 156, an application for an extension of the term of a patent must be filed by the registered owner of the patent within the 60 day period beginning on the date on which the product has been authorized for commercial marketing or use. See 35 USC 156(d)(1). When the regulatory review concerns a drug for which the Secretary of Health and Human Services intends to recommend controls under the Controlled Substances Act, the 60-day period begins on the “Covered Date,” where the “Covered Date” is defined as the last of:

• (A) the date on which an application is approved:
  • (i) pursuant to section 351(a)(2)(C) of the Public Health Act; or
  • (ii) under section 505(b) or 512(c) of the Federal Food, Drug, and Cosmetic Act;
• (B) the date on which an application is conditionally approved under section 571(b) of the Federal Food, Drug, and Cosmetic Act;
• (C) the date on which an indexation request is granted under section 572(d) of the Federal Food, Drug, and Cosmetic Act; or
• (D) the date of issuance of the interim final rule controlling the drug under section 201(j) of the Controlled Substances Act.

Clarity type Double patenting and PTE

Non-statutory obvious double patenting (ODP) does not invalidate any PTE granted under 35 USC 156 if the claims are otherwise valid under the expiration date before the PTE. To see Novartis AG v Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir. 2018). “For example, if a patent, under the original expiration date without PTE, should have been definitively rejected (but not) due to dual patents of the obvious type, then this court’s case law on dual patents of the obvious type would apply, and the patent could be declared invalid. However, if a patent, under the expiration date before the PTE, is valid under all other provisions of law, then it is entitled to the full term of its PTE.” Identity card in 1374, 128 USPQ2d in 1757. The Novartis The court affirmed the validity of a PTE even where the PTE created a potential non-statutory double patenting issue due to the later date of enforceability of applicable claims of the patent as a result of the PTE’s finding that it expired earlier, patentable unclear patent “was not a double patent”. patent reference” to extended patent. Identity card at 1375. Specifically, the court held that “(b)y statutory principles of construction were applied, following this court’s precedent in (Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317, 82 USPQ2d 1203 (Fed. Cir. 2007)), and addressing the traditional, obvious dual patenting principles, we hold that a PTE under § 156 is valid so long as the extended patent is otherwise valid is without the extension.” Identity card Therefore, the court refused to allow that “a court-established doctrine” regarding double patenting would “cut off a statutory extension of time.” Identity card in 1375.

Thus, a patent can be extended under 35 USC 156 even though the claim has been definitively rejected. A patent term extension under 35 USC 156 is a limited extension of patent rights related to the approved product that is tied to the original term of the patent. See 35 USC 156(b). Only one patent for each product can be extended for a statutory review period, and 35 USC 156 establishes the expiration date of a patent term extension. Although 35 USC 154(b)(2) (June 8, 1995) prohibits a patent from being extended under 35 USC 154(b) if the patent has been definitively rejected due to an obvious double patent rejection, there is no exclusion in 35 USC 156. In addition, 35 USC 154(b)(2)(B)) provides that a patent cannot be amended after the date set forth in the disclaimer, but there is no similar provision in 35 USC 156. Patents may receive a patent term extension under 35 USC 156 after an expiration date set forth in a terminal disclaimer. To see Merck & Co., Inc. v. Hi-Tech Pharmacal, Co., Inc., 482 F.3d 1317 (Fed. Cir. 2007).

To be entitled to a patent term extension, 35 USC 156(a)(1) through (5) requires the applicant to demonstrate that:

• the patent has not expired prior to the filing of an application under 35 USC 156(d) (which may be an application for extension of patent term under subsection (d)(1) or an application for interim extension under subsection (d) )(5)) ;
• the patent was never extended under 35 USC 156(e)(1);
• the application for renewal shall be filed with the Office by the registered owner of the patent or his agent within 60 days of regulatory approval of the commercial marketing application and the application shall include details relating to the patent, the approved product and the regulatory review the time spent obtaining regulatory approval;
• the product is subject to a statutory review period within the meaning of 35 USC 156(g) before its commercial marketing or use;
• the approval is the first authorized commercial marketing or use of the product (35 USC 156(a)(5)(A)), except in the case of human medicinal products manufactured using recombinant DNA technology where the provisions of 35 USC 156(a) )(5)(B) apply, or in the case of a new veterinary medicinal product or a veterinary biological product where the provisions of 35 USC 156(a)(5)(C) apply are.

35 USC 156(c)(4) also requires that no other patent term has been extended for the same regulatory review period for the product.

The USPTO initially determines whether the application is formally complete and whether the patent is eligible for renewal. The statute requires the Director of the USPTO to notify the Secretary of Agriculture or the Secretary of Health and Human Services within sixty days of the filing of a patent term extension application complying with 35 USC 156 and provide a copy to the secretary submits. of the application. Not later than 30 days after receipt of the Director’s application, the Secretary will determine the length of the applicable statutory review period and notify the Director of this determination. If the Director determines that the patent is eligible for renewal, the Director will calculate the period of extension for which the patent is eligible under the relevant statutory provision and issue an appropriate renewal certificate.

Learn more about IPWatchdog’s Life Sciences Masters program this week, where panelists will discuss “Repairing PTE to make the ‘product’ suitable for biologics’, among many other topics. Register here to attend.

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