Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

Articles Posted in Drugs & Biotech

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Nalpropion markets Contrave® for weight management in overweight or obese adults, with three Orange Book-listed patents. The 626 patent is drawn to a method for treating overweight or obesity comprising diagnosing an individual as suffering from overweight or obesity by body mass index, administering bupropion in an amount effective to induce weight loss, and administering naltrexone in an amount effective to enhance the weight loss activity of bupropion. The 195 patent is also directed to methods of treating overweight or obesity, but the claims are drawn to specific dosages of sustained-release naltrexone and bupropion that achieve a specific dissolution profile. The 111 patent is directed to a composition of sustained-release bupropion and naltrexone for affecting weight loss. Actavis filed an abbreviated new drug application seeking to enter the market with a generic version of Contrave® before the expiration of those patents. Nalpropion alleged infringement; Actavis brought invalidity counterclaims. The district court held each claim not invalid and infringed. The Federal Circuit affirmed in part, rejecting Actavis’s argument that a claim of the 195 patent lacked adequate written description support because its claimed dissolution profile was achieved using one method but the specification discloses data obtained using another method. The court reversed with respect to the 626 patent; it would have been obvious for a person of skill to combine bupropion and naltrexone for treating overweight and obesity because both drugs were known to cause weight loss. View "Nalpropian Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc." on Justia Law

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Sanofi’s 170 and 592 patents respectively claim the compound cabazitaxel and methods of using it. Sanofi markets cabazitaxel under the trade name Jevtana® to treat certain drug-resistant prostate cancers. Both patents are listed in the Orange Book as covering cabazitaxel. Cabazitaxel belongs to a family of compounds called taxanes and is the third and most recent taxane drug to gain FDA approval. The others are paclitaxel, approved in 1992, and docetaxel, approved in 1996. Defendants filed Abbreviated New Drug Applications to market generic versions of cabazitaxel before the expiration of the patents, prompting Sanofi to sue for infringement. Defendants sought a declaration of invalidity. The district court found claims 7, 11, 14–16, and 26 of the 592 patent invalid as obvious and claims 1 and 2 of the 170 patent not invalid as obvious. The Federal Circuit vacated as to claims 7, 11, 14–16, and 26 of the 592 patent because there was no case or controversy with respect to those claims when the district court issued its decision. Sanofi’s disclaimer of the disclaimed claims mooted any controversy over them. The court affirmed that the 170 patent is not invalid as obvious over docetaxel. View "Sanofi-Aventis U.S., LLC v. Fresenius Kabi USA, LLC" on Justia Law

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Lilly markets the compound pemetrexed in the form of a disodium salt as Alimta®, which is indicated, both alone and in combination with other active agents, for treating certain types of non-small cell lung cancer and mesothelioma. Patent disputes about Alimta® reach back more than a decade. DRL, Hospira, and Actavis submitted New Drug Applications (NDA) under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(b)(2), relying on Lilly’s clinical data for pemetrexed disodium but each seeks to market different pemetrexed salts. The district court concluded that the NDA submission infringed the 209 patent under 35 U.S.C. 271(e)(2) and prohibited FDA approval of the products at issue until the expiration of that patent. The Federal Circuit reversed in part. The finding of literal infringement in the Hospira Decision was clearly erroneous in light of the court’s claim construction of “administration of pemetrexed disodium.” The court otherwise affirmed the infringement holding; the district court did not err in its application of the doctrine of equivalents in either decision. View "Eli Lilly and Co. v. Hospira, Inc." on Justia Law

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Anjinomoto’s 655 patent claims E. coli bacteria that have been genetically engineered to increase their production of aromatic L-amino acids, such as L-tryptophan, during fermentation, as well as methods of producing aromatic L-amino acids using such bacteria. Ajinomoto filed a complaint against CJ with the International Trade Commission, alleging that CJ was importing certain products that infringed the patent. CJ used several strains of E. coli to produce L-tryptophan products, which it then imported into the United States. The Commission determined that CJ’s earlier strains did not infringe but that CJ’s two later strains did, and that the relevant claim of the 655 patent is not invalid for lack of an adequate written description. The Federal Circuit affirmed, upholding the Commission’s construction of “replacing the native promoter . . . with a more potent promoter.” The court rejected CJ’s claim of prosecution history estoppel and held that the 655 patent expressly provides four examples of “more potent promoters,” so that the Commission supportably found that a skilled artisan could make relatively predictable changes to the native promoter to arrive at a more potent promoter. View "Ajinomoto Co., Inc. v. International Trade Commission" on Justia Law

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A teratogen is an agent known to disturb the development of an embryo or fetus. Teratogenic drugs, such as thalidomide, can cause birth defects or other abnormalities following fetal exposure during pregnancy. Celgene’s 501 and 720 patents are generally directed to methods for safely distributing teratogenic or other potentially hazardous drugs while avoiding exposure to a fetus to avoid adverse side effects of the drug. The patents describe the System for Thalidomide Education and Prescription Safety that compiles information about patients and prescribers to prevent the prescription from being filled before appropriate counseling. The Coalition for Affordable Drugs (CFAD) sought inter partes review. The Patent Trial and Appeal Board determined that all of the claims of the 501 patent and multiple claims of the 720 patent were obvious. The Federal Circuit affirmed and held that the retroactive application of IPR proceedings to pre-Leahy-Smith America Invents Act, 125 Stat. 284-341, patents is not an unconstitutional taking under the Fifth Amendment. IPRs do not differ sufficiently from the PTO reconsideration avenues available when the patents here were issued to constitute a taking. View "Celgene Corp. v. Peter" on Justia Law

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Recombinant therapeutic proteins are a class of biologic medicines that are manufactured inside living cells. Before a protein can be therapeutically useful, it must first be purified from contaminants. Amgen’s patent claims methods of purifying proteins using hydrophobic interaction chromatography. Amgen sued Coherus for infringing the patent under the doctrine of equivalents because the salt combination used in Coherus’s process did not match any of the three expressly claimed salt combinations in the Amgen patent. The Federal Circuit affirmed the dismissal of the suit, reasoning that prosecution history estoppel bars Amgen from succeeding on its infringement claim under the doctrine of equivalents. During prosecution of the patent, Amgen clearly and unmistakably surrendered salt combinations other than the particular combinations recited in the claims. View "Amgen Inc. v. Coherus Biosciences Inc." on Justia Law

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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