Justia Drugs & Biotech Opinion Summaries

SkinMedica owns the 494 and 746 patents, which relate to methods for producing pharmaceutical compositions containing “novel conditioned cell culture medium compositions ... [and] uses for the[m].” Skinmedica filed a patent infringement suit against Histogen for producing dermatological products according to methods covered by the claims of those patents. The district court entered summary judgment of noninfringement after construing the phrase “culturing ... cells in three-dimensions” as “growing ... cells in three dimensions (excluding growing in monolayers or on microcarrier beads).” The Federal Circuit affirmed. View "SkinMedica Inc v. Histogen Inc" on Justia Law

Carrera sued Bayer, claiming that Bayer falsely advertised its product One-A-Day WeightSmart as a multivitamin and dietary supplement that had metabolism-enhancing effects due to its ingredient, epigallocatechin gallate, a green tea extract. The daily dose was one tablet and the price was about $8.99 for 50 tablets. Bayer sold WeightSmart through retail stores until 2007 and did not sell directly to consumers. Carrera initially sought to certify a nationwide class under Fed. R. Civ. P. 23(b)(3), bringing a claim under the New Jersey Consumer Fraud Act. The court denied certification because New Jersey law did not apply to out-of-state customers. Carrera then moved to certify a Rule 23(b)(3) class of Florida consumers under the Florida Deceptive and Unfair Trade Practices Act. Bayer challenged certification, reasoning that class members are unlikely to have documentary proof of purchase and Bayer has no list of purchasers. The Third Circuit vacated class certification. If class members are impossible to identify without extensive and individualized fact-finding or mini-trials, a class action is inappropriate. If class members cannot be ascertained from a defendant’s records, there must be “a reliable, administratively feasible alternative,” not a method that would amount to no more than ascertaining by potential class members‟ say so.”View "Carrera v. Bayer Corp." on Justia Law

Baxter’s Colleague Infusion Pump, an electronic device used to deliver intravenous fluids to patients, was known to have a range of defects. The FDA sent Baxter warning letters. Baxter’s response was not satisfactory. In 2005 the FDA sought forfeiture of all Baxter‐owned Pumps. In 2006, Baxter entered into a Consent Decree to stop manufacturing and distributing all models of the Pump within the U.S., and committed to bringing the approximately 200,000 Pumps in the hands of health care professionals into compliance with the FDA Act. Baxter devoted significant resources to fixing the Pumps, but the FDA was not satisfied and ordered a product recall. In a derivative suit, plaintiffs alleged that that Baxter’s directors and officers breached fiduciary duties by consciously disregarding their responsibility to bring about compliance with the Consent Decree, causing Baxter to lose more than $550 million. Plaintiffs did not first ask Baxter’s board of directors to pursue those claims, but alleged futility. The district court dismissed, finding that Westmoreland failed adequately to plead demand futility, as required by FRCP 23.1(b)(3) and Delaware substantive law. The Seventh Circuit reversed, stating that particularized facts furnished by plaintiffs cast a reasonable doubt that the defendants’ conduct was the product of a valid exercise of business judgment. View "Westmoreland Cnty. Emps. Retirement Sys. v. Parkinson" on Justia Law

Prior art concerning treatment of the skin disease, psoriasis, discloses a combination treatment of a vitamin D analog and a corticosteroid. Leo’s patent calls for simultaneous treatment with vitamin D and corticosteroids to heal psoriasis faster and more effectively; a storage-stable combination of vitamin D and corticosteroids in a single formulation did not exist in prior art because vitamin D and corticosteroids have different pH requirements for optimum stability. Because of the storage-stability problem, doctors had to prescribe a regimen that required patients to apply one drug in the morning and another at night, which caused patient compliance issues. Leo discovered that a new set of solvents, including polyoxypropylene 15 stearyl ether, solved the storage stability problem by allowing the vitamin D analog and corticosteroid to coexist in a single pharmaceutical product. The Board of Patent Appeals rejected several claims. The Federal Circuit reversed. The Board incorrectly construed the term “storage stable,” incorrectly found the claimed invention would have been obvious in view of prior art, and incorrectly weighed the objective indicia of nonobviousness. View "Leo Pharm. Prods., Ltd. v. Kappos" on Justia Law

Conventional tests for prenatal abnormalities caused by genetic abnormalities have relied on invasive and potentially risky techniques like amniocentesis to obtain fetal cells. As an alternative, scientists developed methods of analyzing DNA extracted from fetal cells floating in maternal blood to determine fetal abnormalities and other fetal traits. These methods require separating fluids from the cells and then discarding the fluids, either plasma or serum, and then separating fetal cells from the much more common maternal cells. The 540 patent discloses methods to identify fetal genetic defects by analyzing the fluid that had commonly been discarded as medical waste: maternal plasma or serum. The new tests presented fewer risks and a better rate of abnormality detection. Ariosa sought a declaratory judgment that it could use its Harmony test without infringing the 540 patent. The district court denied the patent holder’s motion for summary judgment. The Federal Circuit vacated and remanded, finding that the district court incorrectly interpreted the asserted claim terms “amplifying” and “paternally inherited nucleic acid” and improperly balanced factors regarding issuance of a preliminary injunction. View "Aria Diagnostics, Inc. v. Sequenom, Inc." on Justia Law

Rembrandt’s patent relates to contact lenses that have a highly wettable surface and are permeable to oxygen. The patent discloses a soft gas permeable lens with an acrylic layer on the surface of the lens body that increases the wettability and comfort of the contact lens. The district court held that Johnson & Johnson did not infringe the patent. The Federal Circuit affirmed. View "Rembrandt Vision Techs., L.P. v. Johnson & Johnson Vision Care, Inc." on Justia Law

Generic manufacturers submitted Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market generic versions of Copaxone®, a drug used in treating multiple sclerosis. Teva, which markets Copaxone®, sued the generic manufacturers for patent infringement under 35 U.S.C. 271(e)(2)(A). The patents at issue share a common specification and are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Copaxone®. The patents include claims reciting a product called copolymer-1 and recite two methods of making copolymer-1: one using statistical average measures and the other describing how many molecules in a polymer sample have molecular weights that fall within an arbitrarily set range. The district court found that various claims of the nine patents by Teva are infringed, based on holdings regarding indefiniteness, nonenablement, and obviousness. The Federal Circuit affirmed in part and reversed in part, holding that Group I claims are invalid for indefiniteness, but that Group II claims were not proven indefinite. The district court did not err in finding that the claims are infringed, and that the generic manufacturers failed to prove that the claims would have been obvious and are not enabled. View "Teva Pharm. USA, Inc. v. Sandoz, Inc." on Justia Law

The patent at issue concerns methods for preventing bovine mastitis, the inflammation of udder tissue in cows, and is entitled “Antiinfective free intramammary veterinary composition.” The summary of the invention describes how the composition employs a physical barrier within the teat canal to block introduction of mastitis-causing organisms without requiring use of antiinfectives such as antibiotics. A patent examiner rejected certain claims introduced in the context of ex parte reexamination. The Patent Trial and Appeal Board and Federal Circuit affirmed, finding that substantial evidence supported the Board’s finding that one claim failed the written description requirement because the disclosure did not “describe[] a formulation excluding a specific species of the anti-infective genus, while permitting others to be present.” View "In re: Bimeda Research & Dev. Ltd." on Justia Law

Plaintiffs, a group of prisoners, filed suit against the FDA for allowing state correctional departments to import sodium thiopental (thiopental), a misbranded and misapproved new drug used in lethal injection protocols, in violation of the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 381(a), and the Administrative Procedure Act (APA), 5 U.S.C. 706(2)(A). The court concluded that, because there were clear statutory guidelines for the agency to follow in exercising its enforcement powers, the FDA's compliance with section 381(a) was subject to judicial review under the standards of the APA. The court also concluded that the FDA's policy of admitting foreign manufactured thiopental destined for state correctional facilities were not in accordance with law because section 381(a) required the agency to sample and examine for violations of any drug offered for import that had been prepared in an unregistered facility. The court concluded, however, that the district court erred by failing to seek the joinder of the state governments whose possession and use of the thiopental at issue the court declared illegal. Accordingly, the order of the district court pertaining to the thiopental already in the possession of the states was vacated, but the underlying judgment of the district court was affirmed. View "Cook, et al. v. FDA, et al." on Justia Law

GSK holds patent and FDA rights to market and sell the pharmaceutical (paroxetine hydrochloride) controlled release tablets for treatment of depression, under the brand name Paxil. Under a 2007 settlement agreement, GSK granted Mylan certain rights to produce, market, and sell generic paroxetine. In 2010, GSK agreed, in an unrelated settlement, to begin supplying Apotex with GSK-produced generic paroxetine for marketing and sale. Mylan sued GSK and Apotex, claiming the 2010 agreement violated its licensing agreement, which did not permit GSK to provide its own form of generic paroxetine to another generic drug company to be marketed and sold in direct competition with Mylan. The district court found that the terms of the agreement were unambiguous and did not limit to whom GSK was permitted to market and sell its own version of generic paroxetine. The Third Circuit reversed the order of summary judgment on the breach-of-contract cause of action against GSK, but affirmed summary judgment on other claims. View "Mylan Inc. v. SmithKline Beecham Corp." on Justia Law