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Plaintiff filed suit on behalf of his mother's estate against WellDyne and Exactus, asserting claims for negligence, negligence per se and breach of the implied warranty of fitness for a particular purpose against both defendants. Plaintiff also alleged Exactus was vicariously liable for the actions of WellDyne under agency and joint venture theories. In this case, plaintiff's mother died shortly after a hospital stay stemming from her ingestion of prescription medications that were erroneously mailed to her by WellDyne. The district court granted summary judgment in favor of WellDyne and Exactus as to all counts, finding that plaintiff's mother was contributorily negligent as a matter of law which completely barred her recovery in North Carolina. The court reversed the district court's judgment insofar as it granted summary judgment on the basis of contributory negligence and causation, remanding for the district judge to conduct a Daubert analysis of the expert opinions proffered by plaintiff to determine whether taking some of the misdirected medications was the cause of the mother's injuries and death. The court affirmed summary judgment to Exactus; affirmed summary judgment to WellDyne as to the claim for implied warranty of a particular purpose; and remanded. View "Small v. Welldyne, Inc." on Justia Law

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Merck’s drug Fosamax treats and prevents osteoporosis in postmenopausal women. When the FDA approved Fosamax in 1995 (21 U.S.C. 355(d)), its label did not warn of the then-speculative risk of atypical femoral fractures associated with the drug. Stronger evidence connecting Fosamax to such fractures developed later. The FDA ordered Merck to add a warning to the Fosamax label in 2011. Individuals who took Fosamax and suffered atypical femoral fractures sued, claiming that state law imposed upon Merck a legal duty to warn. Merck asserted that the FDA would have rejected any attempt to change the label. The district court agreed with Merck’s pre-emption argument and granted Merck summary judgment. The Third Circuit vacated. The Supreme Court remanded. The Third Circuit incorrectly treated the pre-emption question as one of fact. A state-law failure-to-warn claim is pre-empted where there is “clear evidence” that the FDA would not have approved a change to the label. “Clear evidence” shows the court that the manufacturer fully informed the FDA of the justifications for the warning and that the FDA would not approve a label change to include that warning. FDA regulations permit drug manufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association.” The pre-emption question can only be determined by agency actions taken pursuant to the FDA’s congressionally delegated authority. The question of agency disapproval is primarily one of law for a judge to decide. Judges, rather than juries, are better equipped to evaluate an agency’s determination and to understand and interpret agency decisions in the statutory and regulatory context. While contested facts will sometimes prove relevant, they are subsumed within a tightly-circumscribed legal analysis and do not warrant submission to a jury. View "Merck Sharp & Dohme Corp. v. Albrecht" 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

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The patents at issue are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for NUCYNTA® ER (extended release), a tapentadol hydrochloride tablet. The 364 patent is directed to the Form A polymorph of the chemical compound tapentadol hydrochloride and a method of treating pain and/or urinary incontinence and states that Form A “is very stable at ambient conditions and therefore useful for producing a pharmaceutical composition.” The 130 patent describes a method of using tapentadol and tapentadol hydrochloride for the treatment of polyneuropathic pain, which is caused by damage to multiple nerves. In an infringement suit, stemming from Abbreviated New Drug Application (ANDA) filings seeking to market generic versions of immediate and extended release tapentadol hydrochloride tablets, the Federal Circuit affirmed the district court in finding that the 364 patent is not invalid for obviousness or lack of utility (the defendants had stipulated to infringement) and that the ANDA filings do not infringe the 130 patent, which is not invalid as anticipated. View "Grunenthal GMBH v. Alkem Laboratories Limited" on Justia Law