Justia Drugs & Biotech Opinion Summaries

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RDC is a direct purchaser and wholesaler of Remicade, the brand name of infliximab, a “biologic infusion drug” manufactured by J&J and used to treat inflammatory conditions such as rheumatoid arthritis and Crohn’s disease. For many years, Remicade was the only infliximab drug available. That position was threatened when the FDA began approving “biosimilars,” produced by other companies and deemed by the FDA to have no clinically meaningful differences from Remicade. RDC alleged that J&J sought to maintain Remicade’s monopoly by engaging in an anticompetitive “Biosimilar Readiness Plan,” which consisted of imposing biosimilar-exclusion contracts on insurers that either require insurers to deny coverage for biosimilars altogether or impose unreasonable preconditions governing coverage; multi-product bundling of J&J’s Remicade with other J&J drugs, biologics, and medical devices; and exclusionary agreements and bundling arrangements with healthcare providers. RDC’s own contractual relationship with J&J is limited to a 2015 Distribution Agreement, which is not alleged to be part of J&J’s Plan. The Agreement contains an arbitration clause, applicable to any claim “arising out of or relating to the Agreement. Reversing the district court, the Third Circuit held that RDC’s antitrust claims do “arise out of or relate to” the Agreement and must be referred to arbitration. View "In re: Remicade (Direct Purchaser) Antitrust Litigation" on Justia Law

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This case arose from the FDA's seizure from Hi-Tech a substantial quantity of products containing 1,3-dimethylamylamine or DMAA, which is used in fitness products aimed at bodybuilders and other athletes. The district court granted the FDA's motion for summary judgment, holding that the seizure of DMAA was both substantively and procedurally proper. The Eleventh Circuit affirmed and held that DMAA is not an "herb or other botanical" and is not a "constituent" of an herb or other botanical under the Dietary Supplement Health and Education Act of 1994. Furthermore, the court held that DMAA is not generally recognized by qualified experts, as adequately shown through scientific procedures, to be safe under the conditions of its intended use. The court also held that the district court did not abuse its discretion when it declined to reopen discovery, and Hi-Tech was afforded the full range of procedural due process available in federal court. View "United States v. Hi-Tech Pharmaceuticals, Inc." on Justia Law

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Quidel Corporation (Quidel) petitioned for a writ of mandate and/or prohibition to direct the trial court to vacate its order granting summary judgment. Quidel contended the trial court incorrectly concluded a provision in its contract with Beckman Coulter, Inc. (Beckman) was an invalid restraint on trade in violation of Business and Professions Code section 16600. In 1996, Biosite Inc. (Biosite; Quidel is the successor in interest to Biosite) licensed patent rights and know-how related to a B-type natriuretic peptide (BNP), which can be measured in a person's blood. The semi-exclusive licensing agreement allowed Biosite to develop an immunoassay to determine the level of BNP in a person's blood sample, to help diagnose congestive heart failure. After acquiring the intellectual property rights and know-how, Biosite developed and created a BNP assay for use with its point-of-care analyzer device, and it obtained regulatory approval. By 2003, Beckman had developed a laboratory analyzer, but it did not have a license for a BNP assay compatible with its analyzer. Around this same time, other companies were also pursuing BNP assays for use with their larger analyzers, which could run multiple, different immunoassays at higher volumes than the point-of-care analyzer Biosite had. Collaborating would mean Biosite could expand its customer base to those who wanted to use the larger capacity laboratory analyzers and Beckman could include the BNP assay in its menu of immunoassay offerings. Biosite and Beckman negotiated the Agreement over several months, and they exchanged numerous drafts before executing it. The Agreement prohibited Biosite from engaging other manufacturers to provide the BNP assay for their competing lab analyzers. The term of the Agreement was negotiated to coincide with the term of a related licensing agreement Biosite had with another company, Scios. Section 5.2.3 of the Agreement prohibited Beckman from researching or developing an assay that detected the presence or absence of the BNP or NT-proBNP proteins or markers for use in diagnosing cardiac disease until two years before the Agreement's expiration. Beckman sued Quidel for declaratory relief for violation of section 16600 and violation of the Cartwright Act, asking the Court to declare section 5.2.3 of the Agreement was void and unenforceable and to issue a permanent injunction preventing the enforcement of section 5.2.3 of the Agreement. Quidel argued the trial court improperly extended the holding from Edwards v. Arthur Andersen LLP, 44 Cal.4th 937 (2008) beyond the employment context to section 5.2.3 of the Agreement. The Court of Appeal determined the trial court's per se application of section 16600 to section 5.2.3 of the Agreement between Quidel and Beckman was not correct, granted Quidel’s petition and issued a writ instructing the trial court to vacate the December 7, 2018 order granting summary adjudication on the first cause of action. View "Quidel Corporation v. Super. Ct." on Justia Law

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Allergan’s patents, entitled “Combination of Brimonidine and Timolol for Topical Ophthalmic Use,” the Patents-in-Suit share a common specification that relates “to the topical ophthalmic use of brimonidine in combination with timolol . . . for treatment of glaucoma or ocular hypertension.” Allergan sued Sandoz, asserting that Sandoz’s Abbreviated New Drug Application (ANDA) for a generic version of Allergan’s ophthalmic drug Combigan® infringed those patents. The district court granted Allergan a preliminary injunction. The Federal Circuit affirmed, limiting a number of “wherein” clauses in the patents. Both Allergan and the Examiner explicitly relied on the “wherein” clauses to distinguish the claimed methods over the prior art during prosecution. The “wherein” clauses were neither unnecessary nor irrelevant. View "Allergan Sales, LLC v. Sandoz, Inc." on Justia Law

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Arthrex’s 541 patent describes a surgical suture anchor used to reattach soft tissue to bone. The disclosed “fully threaded suture anchor” includes “an eyelet shield that is molded into the distal part of the biodegradable suture anchor.” In an inter partes review, the Patent Trial and Appeal Board ruled two claims invalid. In doing so, the Board employed different language than Smith & Nephew, Inc.’s petition to explain why a person of ordinary skill in the art would have been motivated to combine the teachings of the prior art. The Federal Circuit affirmed. The Board’s minor variation in wording does not violate the safeguards of the Administrative Procedure Act and did not deprive Arthrex of an opportunity to be heard. The Board’s findings have substantial evidence support, its claim constructions are correct, and Arthrex has not articulated a cognizable constitutional challenge to inter partes review for its patent. View "Arthrex, Inc. v. Smith & Nephew, Inc." on Justia Law

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Plaintiffs own cats with health problems. Their veterinarians prescribed Hill’s cat food. They purchased this higher-priced cat food from PetSmart stores using their veterinarian’s prescriptions before learning that the Prescription Diet cat food is not materially different from non-prescription cat food and no prescription is necessary. Plaintiffs filed a class-action lawsuit under the Illinois Consumer Fraud and Deceptive Business Practices Act. The district judge dismissed the claim as lacking the specificity required for a fraud claim and barred by a statutory safe harbor for conduct specifically authorized by a regulatory body (the FDA). The Seventh Circuit reversed. The safe-harbor provision does not apply. Under the Food, Drug, and Cosmetic Act, 21 U.S.C. 301, pet food intended to treat or prevent disease and marketed as such is considered a drug and requires FDA approval. Without FDA approval, the manufacturer may not sell it in interstate commerce and the product is deemed adulterated and misbranded. FDA guidance recognizes that most pet-food products in this category do not have the required approval and states that it is less likely to initiate an enforcement action if consumers purchase the food through or under the direction of a veterinarian (among other factors). The guidance does not specifically authorize the conduct alleged here, so the safe harbor does not apply. Plaintiffs pleaded the fraud claim with the particularity required by FRCP 9(b). View "Vanzant v. Hill's Pet Nutrition, Inc." on Justia Law

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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