Justia Drugs & Biotech Opinion Summaries

Articles Posted in US Court of Appeals for the Federal Circuit

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Indivior markets and holds the New Drug Application (NDA) for Suboxone® sublingual film, an opioid addiction treatment that combines two active ingredients: the opioid buprenorphine and the opioid antagonist naloxone. Suboxone Film is applied below a patient’s tongue, where it then rapidly dissolves to release the active ingredients. In 2010, the FDA approved Indivior’s film product, the first such product to gain FDA approval. Previously, Indivior sold buprenorphine/naloxone only in a tablet form. These appeals involve issues of infringement and invalidity of four patents covering pharmaceutical films and methods of making them, particularly two patents that claim pharmaceutical films and are listed in the Orange Book2 as covering Suboxone Film. The district court concluded that the asserted claims of three patents are not invalid as obvious; that one patent is not invalid as indefinite and that Watson infringes that patent; and that DRL and Alvogen do not infringe either of two patents. The court found certain claims in a fourth patent invalid. The Federal Circuit vacated, as moot, the holding that those claims were invalid as obvious but otherwise affirmed. In a parallel inter partes review proceeding, the Patent Trial and Appeal Board had held the claims unpatentable as anticipated and obvious, and the Federal Circuit affirmed. View "Indivior Inc. v. Dr. Reddy's Laboratories, S.A." on Justia Law

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UCB’s 434 patent, entitled “Transdermal therapeutic system which contains a d2 agonist and which is provided for treating Parkinsonism, and a method for the production thereof,” claims a polymorph of rotigotine. UCB’s 414 patent is entitled “Polymorphic form of rotigotine and process for production.” UCB has been selling the FDA-approved product, Neupro, since 2007. The district court concluded that Actavis’s generic products infringed the patent under the doctrine of equivalents and upheld the 434 patent's validity over obviousness and anticipation challenges. The court invalidated the 414 patent under 35 U.S.C. 102(a) as known and used by others in the U.S. before the date of invention. The Federal Circuit affirmed. There is not enough evidence to conclude that UCB surrendered polyisobutylene as a possible equivalent; UCB’s claiming of acrylates and silicates does not bar treating polyisobutylenes as an equivalent for infringement purposes and vitiation does not bar application of the doctrine of equivalents here. Actavis offers no examples of prior art that would be ensnared by the addition of polyisobutylene to the claim, in contrast to the claim as is. The court upheld fact findings as to polyisobutylene’s characteristics as compared to silicates and acrylates and as to what a skilled artisan would have known about the interchangeability of polyisobutylene-based adhesives and silicone-based adhesives and the conclusion that the accused products infringe the claims under the doctrine of equivalents. View "UCB, Inc. v. Watson Laboratories Inc." on Justia Law

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Mayne’s 745 patent discloses and claims pharmaceutical compositions of azole antifungal drugs that are practically insoluble in aqueous media. The patent explains that insoluble drugs are difficult to formulate into dosage forms because of their low absorption and poor bioavailability and purports to provide a pharmaceutical composition addressing these shortcomings. On MSD’s petition, the Patent Trial and Appeal Board initiated inter partes review and found several claims unpatentable as anticipated or obvious, 35 U.S.C. 103 The Federal Circuit affirmed, upholding the Board’s decision to permit MSD’s amendment, finding no indication of intentional concealment, no bad faith on MSD’s part, no attempt to circumvent the estoppel rules, or any other material benefit to it in its delay in naming MCI as a real party in interest. The Board did not err in its constructions of either “pharmaceutical composition” or the “wherein” clauses; under the Board’s constructions, the claims are obvious or anticipated View "Mayne Pharma International Pty. Ltd. v. Merck Sharp & Dohme Corp." on Justia Law

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Non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin and naproxen, control pain but have undesirable side effects, including gastrointestinal problem. Some practitioners began prescribing acid inhibitors, including PPIs, to reduce the acidity in the gastrointestinal tract. The combination therapy had complications. Stomach acid degraded the PPI before it could reach the small intestine. To address those complications, Dr. Plachetka invented a drug (Vimovo®.) that coordinated the release of an acid inhibitor and an NSAID in a single tablet with a core of an NSAID, an enteric coating around the NSAID that prevents its release before the pH increases to a certain desired level, and an acid inhibitor like PPI around the outside of the enteric coating that actively works to increase the pH to the desired level. Plachetka’s invention contemplates using some uncoated PPI for immediate release. Manufacturers, wanting to market a generic version of Vimovo®, submitted Abbreviated New Drug Applications to the FDA. They stipulated to infringement, except with respect to one ANDA product and alleged that the Vimovo® patents were invalid as obvious over prior art, 35 U.S.C. 103 and for lack of enablement and adequate written description, 35 U.S.C. 112. The Federal Circuit reversed a holding that the Vimovo® patents were valid. The specification provides nothing more than a claim that uncoated PPI might work, even though persons of ordinary skill in the art would not have thought so, and does not satisfy the written description requirement. View "Nuvo Pharmaceuticals, Inc. v. Dr. Reddy's Laboratories Inc." on Justia Law

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BTG’s 438 Patent, entitled “Methods and Compositions for Treating Cancer,” discloses the administration of a therapeutically effective amount of a CYP17 inhibitor, such as abiraterone acetate, in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid. The patent defines an “anti-cancer agent” as “any therapeutic agent that directly or indirectly kills cancer cells or directly or indirectly prohibits[,] stops[,] or reduces the proliferation of cancer cells.” BTG sued Amneal, asserting that its Abbreviated New Drug Applications (ANDA) for the generic version of BTG’s abiraterone product ZYTIGA® infringed the patent. On inter partes review, the Patent Trial and Appeal Board found that the patent’s claims would have been obvious under 35 U.S.C. 103. The district court affirmed, accepting the Board’s claim construction and the same combination of prior art. The Federal Circuit affirmed. The Board correctly concluded that the claims cover a therapy in which abiraterone has an anticancer effect, while prednisone either has its own anti-cancer effect or has a palliative/side-effect reduction effect, and that the “prior art provides a reasonable expectation that prednisone could be used as a therapeutic agent in the treatment of prostate cancer.” View "BTG International Ltd. v. Amneal Pharmaceuticals LLC" on Justia Law

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The Novartis 131 patent claims methods of using the compound everolimus to treat advanced renal cell carcinoma (RCC). Advanced RCC is a cancer of the kidneys that has spread to other parts of the body. Everolimus is the active ingredient in Novartis’s Afinitor product. West-Ward’s predecessor filed an Abbreviated New Drug Application (ANDA) seeking to manufacture and sell generic versions of Afinitor. Novartis filed an infringement suit in response. The district court ruled that West-Ward failed to prove by clear and convincing evidence that claims 1–3 of the 131 patent are invalid as obvious in light of prior art, 35 U.S.C. 103(a). The Federal Circuit affirmed. While the district court erred in its analysis of whether there was a motivation to combine, a person of ordinary skill would not have reasonably expected success in using everolimus to treat advanced RCC as of February 2001. View "Novartis Pharmaceuticals Corp v. West-Ward Pharmaceuticals International, Ltd." on Justia Law

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Amgen created and commercialized two related biologic products, filgrastim (Neupogen®) and pegfilgrastim (Neulasta®), indicated for treating neutropenia, a deficiency of white blood cells. Neutropenia often results from exposure to certain chemotherapeutic regimens or radiation therapy during cancer treatment. In 2014, Sandoz submitted to the FDA an abbreviated Biologics License Application (aBLA) to market a biosimilar filgrastim product. While Sandoz’s aBLA referenced Neupogen®, Sandoz elected not to provide Amgen with its aBLA or manufacturing information. Amgen sought a declaratory judgment that Sandoz’s proposed biosimilar would infringe its patent, Biologics Price Competition and Innovation Act, 35 U.S.C. 271(e)(2)(C); 42 U.S.C. 262(l)(9)(C) Sandoz received FDA approval for its filgrastim biosimilar, Zarxio®. After Sandoz launched Zarxio®, Amgen amended its complaint to plead infringement under 35 U.S.C. 271(e)(2)(C)(ii), (g). In 2015, Sandoz submitted an aBLA to market a biosimilar pegfilgrastim product referencing Neulasta®. Amgen filed a complaint, alleging infringement of that patent. Sandoz has not yet received approval for its proposed pegfilgrastim biosimilar. The Federal Circuit affirmed summary judgment of noninfringement, upholding the district court’s construction of “disease treating-effective amount of at least one chemotherapeutic agent” as limited to “[a]n amount sufficient to treat a disease for which at least one chemotherapeutic agent is prescribed.” View "Amgen Inc. v. Sandoz Inc." on Justia Law

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The 779 Patent, entitled “Process for Preparing Morphinan-6-One Products with Low Levels of α,β-Unsaturated Ketone Compounds,” generally relates to compounds known as “morphinan alkaloids,” such as “oxymorphone,” which have “great medical importance” and “are used extensively for pain relief.” Endo, which licenses the patent, sued, alleging that two Abbreviated New Drug Applications filed by Actavis infringed claims in the patent. The Federal Circuit affirmed an infringement finding, concluding that Actavis failed to prove by clear and convincing evidence that any of the asserted claims were invalid as obvious or anticipated. The district court correctly construed 14-hydroxymorphinone as 14-hydroxymorphinone hydrochloride. The claims were not obvious under 35 U.S.C. 103(a); a person of ordinary skill in the art would not have a reasonable expectation of success in combining the prior art. View "Endo Pharmaceuticals Inc. v. Actavis, LLC" on Justia Law

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Amarin markets Vascepa®, a prescription drug consisting of eicosapentaenoic acid in ethyl ester form, synthetically produced from fish oil, intended to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Vascepa® is the only FDA-approved purified ethyl ester E-EPA product sold in the U.S. Amarin filed a complaint with the International Trade Commission (ITC) under 19 U.S.C. 1337 (Tariff Act), alleging that certain companies were falsely labeling and deceptively advertising their imported synthetically produced omega-3 products as “dietary supplements,” where the products are actually “new drugs” under the Food, Drug, and Cosmetic Act (FDCA) that have not been approved for use in the U.S. Amarin claimed that their importation and sale was an unfair act or unfair method of competition because it violates the Lanham Act, 15 U.S.C. 1125(a), and the Tariff Act “based upon" FDCA standards. The FDA urged the Commission not to institute an investigation and to dismiss Amarin’s complaint, arguing that the FDCA prohibits private enforcement actions and precludes any claim that would “require[] the Commission to directly apply, enforce, or interpret the FDCA.” The ITC and Federal Circuit agreed.Amarin’s allegations are based entirely on FDCA violations; such claims are precluded by the FDCA, where the FDA has not yet provided guidance as to whether violations have occurred. Although Amarin claimed violations of the Tariff Act, its claims constituted an attempt to enforce the FDCA. View "Amarin Pharma, Inc. v. International Trade Commission" on Justia Law

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Eli Lilly’s patent relates to administering folic acid and a methylmalonic acid (MMA) lowering agent, such as vitamin B12, before administering pemetrexed disodium, a chemotherapy agent, in order to reduce the toxic effects of pemetrexed, an antifolate. In inter partes review, the Patent Trial and Appeals Board rejected arguments that certain claims were unpatentable as obvious, 36 U.S.C. 101. The Federal Circuit affirmed. Substantial evidence supports the Board’s finding that the prior art did not provide a motivation for a skilled artisan to administer an MMA lowering agent, such as vitamin B12, in addition to folic acid. View "Neptune Generics, LLC v. Eli Lilly & Co." on Justia Law