Justia Drugs & Biotech Opinion Summaries

Arla, a Denmark-based global dairy conglomerate, launched a $30 million advertising campaign aimed at expanding its U.S. cheese sales, branded “Live Unprocessed.” The ads assure consumers that Arla cheese contains no “weird stuff” or “ingredients that you can’t pronounce,” particularly, no milk from cows treated with recombinant bovine somatotropin (“rbST”), an artificial growth hormone. The flagship ad implies that milk from rbST-treated cows is unwholesome. Narrated by a seven-year-old girl, the ad depicts rbST as a cartoon monster with razor-sharp horns. Elanco makes the only FDA-approved rbST supplement. Elanco sued, alleging that the ads contain false and misleading statements in violation of the Lanham Act. Elanco provided scientific literature documenting rbST’s safety, and evidence that a major cheese producer had decreased its demand for rbST in response to the ads. The Seventh Circuit affirmed the issuance of a preliminary injunction, rejecting arguments that Elanco failed to produce consumer surveys or other reliable evidence of actual consumer confusion and did not submit adequate evidence linking the ad campaign to decreased demand for its rbST. Consumer surveys or other “hard” evidence of actual consumer confusion are unnecessary at the preliminary-injunction stage. The evidence of causation is sufficient at this stage: the harm is easily traced because Elanco manufactures the only FDA-approved rbST. The injunction is sufficiently definite and adequately supported by the record and the judge’s findings. View "Eli Lilly and Co. v. Arla Foods USA, Inc." on Justia Law

Monsanto developed a genetic modification in soybean seeds (Roundup Ready® (RR)), known as the 40-3-2 event (RR trait), which enables soybean plants to tolerate application of glyphosate herbicide to kill weeds. Monsanto owns the patent for the RR trait and granted Pioneer a license to produce and sell seeds containing the traits. After Pioneer became a subsidiary of DuPont, Monsanto and Pioneer entered into an amended license, under which DuPont produced and sold RR trait seed. In 2006, DuPont announced that it had developed a glyphosate-tolerant trait, OGAT, expected to confer tolerance to both glyphosate and acetolactate synthase inhibitor herbicide. Testing indicated that OGAT alone did not provide sufficient glyphosate-tolerance for commercial use. DuPont then combined OGAT with the RR trait; the OGAT/RR stack provided increased yields in field trials. DuPont did not sell any OGAT/RR product, however, and discontinued development. Monsanto sued DuPont for breach of the license and patent infringement. The district court granted partial judgment to Monsanto, holding that the license was unambiguous and did not grant the right to stack non-RR technologies with the licensed” trait, but allowed DuPont to amend its answer to assert reformation counterclaims and defenses. The court ultimately told DuPont to “either voluntarily dismiss these reformation claims or produce … all documents … previously withheld.” DuPont continued litigating its reformation counterclaims and produced previously withheld internal e-mails that showed its awareness that it did not have the right to commercialize the OGAT/RR stack. The court found that DuPont’s position was not rooted in fact, that DuPont made misrepresentations and had perpetrated a fraud on the court, struck DuPont’s reformation defense and counterclaims, and awarded limited attorney fees to Monsanto. The Federal Circuit affirmed. View "Monsanto Co. v. E.I. du Pont de Nemours & Co." on Justia Law

Bayer’s patent concerns genetically modifying plants to confer resistance to a common herbicide (2,4-D) by inserting a particular DNA segment into plant cells, which reproduce to create new cells that contain that gene. Those cells produce an enzyme that catalyzes a biochemical reaction with 2,4-D in which the herbicide is broken down into something harmless to the plant. A plant with the gene survives 2,4-D application while surrounding weeds do not. At the time of the patent application, the inventors had sequenced one gene coding for one enzyme, using a test supposedly capable of finding other, similar genes. In writing the application, they claimed a broad category based on the function of the particular enzyme, defining the category by using a term with established scientific meaning. Years before the patent issued, experiments showed that the term did not apply to the particular enzyme whose gene was sequenced, but Bayer did not change its claim language. When Bayer sued Dow for infringement, Bayer recognized that the term’s established scientific meaning, did not cover the accused product, which was, itself, different from the enzyme whose gene Bayer’s inventors had sequenced. Bayer argued for broad functional claim construction. The district court entered summary judgment of noninfringement, citing particularly the great breadth of the asserted functional construction. The Federal Circuit affirmed. View "Bayer CropScience AG v. Dow AgroSciences, LLC" 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, groups of investors who purchased the securities of KV, brought this class action lawsuit alleging that KV and some of its individual officers committed securities fraud. Plaintiffs alleged that KV made false or misleading statements about its compliance with Food and Drug Administration (FDA) regulations governing the manufacture of pharmaceutical products, and made false or misleading statements about earnings resulting from pharmaceutical products allegedly manufactured in violation of FDA regulations. The court concluded plaintiffs' complaint adequately set forth the reasons why KV's statements about is compliance were false, or at least misleading, at the time they were made; the district court did not err when it determined the investors' complaint did not sufficiently plead that KV made false or misleading statements about earnings tied to the manufacture of generic Metoprolol; the district court correctly dismissed the scheme liability claims against the two individual KV officers; but the district court erred in denying the motion to amend the complaint. Accordingly the court affirmed in part, reversed in part, and remanded for further proceedings. View "Public Pension Fund Group, et al. v. KV Pharmaceutical Co., et al." on Justia Law