Justia Drugs & Biotech Opinion Summaries

Syngenta sued Willowood, a Hong Kong company that sells fungicide to its Oregon-based affiliate, for infringement of patents directed to a fungicide compound and its manufacturing processes and infringement of copyrights for detailed product labels that provide directions for use, storage, and disposal, plus first-aid instructions and environmental, physical, and chemical hazard warnings. The district court dismissed the copyright claims as precluded by the Federal Insecticide Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. 135 and granted-in-part Syngenta’s summary judgment motion with respect to patent infringement. After a jury trial, the court entered a defense judgment on the patent claims. The Federal Circuit affirmed-in-part, reversed-in-part, and vacated in part. The district court did not provide an adequate analysis of the potential conflict between FIFRA and the Copyright Act. Because FIFRA does not, on its face, require a “me-too” registrant to copy the label of a registered product, FIFRA only conflicts with the Copyright Act to the extent that some particular element of Syngenta’s label is both protected under copyright doctrines and necessary for the expedited approval of Willowood’s generic pesticide. The court erred by imposing a single-entity requirement on the performance of a patented process under 35 U.S.C. 271(g); practicing a patented process abroad does not trigger liability under section 271(g) in the same manner that practicing a patented process domestically does under section 271(a). View "Syngenta Crop Protection, LLC v. Willowood, LLC" on Justia Law

Health benefit plans sued GSK, the manufacturer of the prescription drug Avandia, under state consumer-protection laws and the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. ch. 96 (RICO), based on GSK’s marketing of Avandia as having benefits to justify its price, which was higher than the price of other drugs used to treat type-2 diabetes. The district court granted GSK summary judgment, finding that the state-law consumer-protection claims were preempted by the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. ch. 9; the Plans had failed to identify a sufficient “enterprise” for purposes of RICO; and the Plans’ arguments related to GSK’s alleged attempts to market Avandia as providing cardiovascular “benefits” were “belated.” The Third Circuit reversed, applying the Supreme Court’s 2019 "Merck" decision. The state-law consumer-protection claims are not preempted by the FDCA. The Plans should have been given the opportunity to seek discovery before summary judgment on the RICO claims. Further, from the inception of this litigation, the Plans’ claims have centered on GSK’s marketing of Avandia as providing cardiovascular benefits as compared to other forms of treatment, so the district court’s refusal to consider the Plans’ “benefits” arguments was in error because those arguments were timely raised. View "In re: Avandia Marketing, Sales and Products Liability Litigation" on Justia Law

Amgen’s patents relate to erythropoietin (EPO) isoforms and aspects of their production. EPO is a glycoprotein hormone that regulates red blood cell maturation and production. Recombinant human EPO is an important therapeutic protein for the treatment of anemia. Amgen manufactures and markets recombinant human EPO as Epogen. Hospira submitted its Biologics License Application (BLA) to the FDA, seeking approval for a biosimilar to Amgen’s Epogen product. Amgen sued Hospira for infringement under 35 U.S.C. 271(a) and 271(e)(2)(C). A jury found the asserted claims not invalid and infringed. Of the 21 accused drug substance batches, the jury found seven batches entitled to the Safe Harbor defense. The jury awarded Amgen $70 million in damages. The Federal Circuit affirmed, upholding the district court’s claim construction and finding substantial evidence of infringement. Section 271(e)(1) carves out a "Safe Harbor” exception to patent infringement liability when otherwise-infringing activities are solely for uses reasonably related to obtaining FDA approval. Substantial evidence supports the jury’s finding that the 14 batches at issue were not manufactured “solely for uses reasonably related to the development and submission of information” to the FDA. View "Amgen Inc. v. Hospira, Inc." on Justia Law

The DC Circuit affirmed the district court's judgment sustaining the Tobacco Control Act and its application to e-cigarettes. The court held that e-cigarettes are indisputably highly addictive and pose health risks, especially to youth, that are not well understood. Therefore, the court held that it is entirely rational and nonarbitrary to apply to e-cigarettes the Act's baseline requirement that, before any new tobacco product may be marketed, its manufacturer show the FDA that selling it is consistent with the public health.Furthermore, the First Amendment does not bar the FDA from preventing the sale of e-cigarettes as safer than existing tobacco products until their manufacturers have shown that they actually are safer as claimed. The court explained that this conclusion was amply supported by nicotine's addictiveness, the complex health risks tobacco products pose, and a history of the public being misled by claims that certain tobacco products are safer, despite disclaimers and disclosures. Finally, the court held that nothing about the Act's ban on distributing free e-cigarette samples runs afoul of the First Amendment where free samples are not expressive conduct and, in any event, the government's interest in preventing their distribution is unrelated to the suppression of expression. View "Nicopure Labs, LLC v. FDA" on Justia Law

The Ninth Circuit reversed the district court's dismissal of civil Racketeer Influenced and Corrupt Organizations Act (RICO) claims based on lack of RICO standing in a putative class action brought against pharmaceutical companies. Plaintiffs filed suit alleging that the companies refused to change the warning label of their drug Actos or otherwise inform the public after they learned that the drug increased a patient’s risk of developing bladder cancer.The panel held that patients and health insurance companies who reimbursed patients adequately alleged the required element of proximate cause where they alleged that, but for defendant's omitted mention of a drug's known safety risk, they would not have paid for the drug. The panel agreed with the First and Third Circuits that plaintiffs' damages were not too far removed from defendants' alleged omissions and misrepresentations to satisfy RICO's proximate cause requirement. In this case, plaintiffs sufficiently alleged a direct relationship, and the Holmes factors weighed in favor of permitting their RICO claims to proceed. The panel explained that, although prescribing physicians served as intermediaries between defendants' fraudulent omission of Actos's risk of causing bladder cancer and plaintiffs' payments for the drug, prescribing physicians did not constitute an intervening cause to cut off the chain of proximate causation. The panel also held that plaintiffs have adequately alleged the reliance necessary to satisfy RICO's proximate cause requirement. View "Painters and Allied Trades District Council 82 Health Care Fund v. Takeda Pharmaceuticals Co." on Justia Law

Pharma Tech sued LifeScan for infringement of two patents that concern blood glucose monitoring systems for home use by individuals with diabetes. The shared specification of Pharma Tech’s patents states that the claimed inventions improve on prior art blood glucose monitoring systems by “eliminat[ing] several of the critical operator depend[e]nt variables that adversely affect the accuracy and reliability” of these systems. The specification explains that the invention accomplishes this objective by performing multiple Cottrell current measurements and comparing the results. “In a system that is operating correctly, the results should agree within reasonable limits.” The Federal Circuit affirmed summary judgment of noninfringement. Pharma Tech agreed that the accused products do not literally infringe the claim. Prosecution history estoppel bars the claims for infringement under the doctrine of equivalents; the accused system falls within the claim scope surrendered by the inventors during prosecution of the patent. View "Pharma Tech Solutions, Inc. v. LifeScan, Inc." on Justia Law

Appellants Jonathan Saksek and Joshua Winter challenged a superior court decision to affirm summary judgment in favor of Appellees Janssen Pharmaceuticals, Inc., Johnson & Johnson Company, and Janssen Research and Development, LLC (collectively, “Janssen”). Saksek and Winter were two of a large number of men who filed suit against Janssen, alleging that they developed gynecomastia as a result of their ingestion of Risperdal, an antipsychotic drug manufactured by Janssen. In 2014, Janssen filed two motions for summary judgment, which were nominally directed at Saksek’s and Winter’s cases, but had language affecting all Risperdal plaintiffs: the companies sought a global ruling that all claims accrued for statute of limitations purposes no later than October 31, 2006, when Janssen changed the Risperdal label to reflect a greater association between gynecomastia and Risperdal. The trial court ruled that all Risperdal-gynecomastia claims accrued no later June 31, 2009. The superior court disagreed, ruling that all such claims accrued no later than Janssen’s preferred date (October 31, 2006). Concluding that the superior court erred in granting summary judgment at all in Saksek’s and Winter’s cases, the Pennsylvania Supreme Court vacated its decision and remanded to the trial court for further proceedings. View "In Re: Risperdal Litig." on Justia Law

The Eleventh Circuit vacated the district court's dismissal of plaintiffs' claims against defendants based on lack of standing. The court held that plaintiffs plausibly alleged that they suffered an economic loss when they purchased supplements that were worthless because the Federal Food, Drug, and Cosmetic Act (FDCA) prohibited sale of the supplements. The court explained that Congress, through the FDCA and the Dietary Supplement Health and Education Act (DSHEA), banned adulterated supplements to protect consumers from ingesting products that Congress judged to be insufficiently safe.In this case, the complaint's allegations establish that plaintiffs purchased adulterated dietary supplements that they would not have purchased had they known that sale of the supplements was banned. The court also held that plaintiffs sufficiently alleged sufficient facts to show that their injuries were fairly traceable to defendants. Accordingly, plaintiffs had Article III standing to pursue their claims. View "Debernardis v. IQ Formulations, LLC" on Justia Law

Index and Gilead were developing drugs for treating the hepatitis C virus (HCV). Idenix alleged that the imminent FDA approval, and launch, of Gilead’s HCV treatment drug sofosbuvir would infringe Idenix’s 597 patent. After a jury trial, Gilead stipulated to infringement under the district court’s claim construction but argued that the patent was invalid for failure to meet the written description and enablement requirements. The jury found for Idenix, upheld the patent and awarded damages. The district court denied Gilead’s motion with respect to written description but granted judgment as a matter of law on enablement, holding the 597 patent invalid. The Federal Circuit affirmed as to non-enablement and held that the patent is also invalid for lack of written description. Although the level of skill in the art is high, the patent does not provide enough meaningful guidance or working examples, across the full scope of the claim, to allow a person of ordinary skill in the art to determine which nucleosides would be effective against HCV without extensive screening. The immense breadth of screening required amounts to "undue experimentation." Given the conspicuous absence of that compound, a person of ordinary skill in the art would not “visualize or recognize the members of the genus” as including 2'-fluoro-down, and the specification could not demonstrate that the inventor had possession of that embodiment at the time of filing. View "Idenix Pharmaceuticals LLC v. Gilead Sciences Inc." on Justia Law

Forest Laboratories, LLC ("Forest"), filed a permissive appeal pursuant to Rule 5, Ala. R. App. P., of an Alabama circuit court's order denying it summary judgment. Forest manufactured and marketed Lexapro, a drug prescribed for depression, and Forest Pharmaceuticals, Inc. ("FPI") sold and distributed Lexapro. In 2015, Elias Joubran's physician prescribed Lexapro for Elias's depression. Elias's prescription was filled with generic escitalopram that was manufactured and sold by a company other than Forest. On December 30, 2015, Elias entered the house belonging to him and his wife, Sheila Joubran; he shot and killed Sheila, then shot and killed himself. Kevin Feheley, Sr., serving as personal representative of Shiela's estate, sued Mary Jourbran in her capacity as the personal representative of Elias's estate. Forest, FPI and several fictitiously named defendants were included in the suit. The complaint alleged that, at the time of the murder/suicide, Elias was under prescription for pharmaceuticals manufactured by defendants, including Forest and FPI, and that "Forest's Lexapro[] enhanced, enabled and aggravated [Elias's] depression and violent behaviors." The Alabama Legislature enacted section 6-5-530, Ala. Code 1975, "on the heels" of the Alabama Supreme Court's decision in Wyeth, Inc. v. Weeks, 159 So. 3d 649 (2014). In addressing the Weeks decision, section 6-5-530 specifically provided that a plaintiff who is suing based on personal injury, death, or property damage caused by a product "must prove ... that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based" regardless of the type of claims or theory of liability the plaintiff asserts. Because this case was a permissive appeal, the questions before the Supreme Court were limited to whether 6-5-530 effectively overruled Weeks, and whether a manufacturer could be held liable for an injury caused by a product it did not manufacture. The Court determined Section 6-5-530 abrogated Weeks: a pharmaceutical manufacturer cannot be held liable for injury caused by a product it did not manufacture. Based on the Court's answer to the trial court's certified question in the permissive appeal, it reversed the trial court's order denying Forest's motion for a summary judgment and remanded this case for further proceedings. View "Forest Laboratories, LLC v. Feheley, Sr." on Justia Law