Justia Drugs & Biotech Opinion Summaries

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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

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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

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The Ninth Circuit affirmed the district court's grant of summary judgment to Allergan in an action under state law alleging that plaintiff suffered injuries when her breast implants bled silicone into her body. Through the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act (FDCA), Congress permitted FDA oversight of medical devices; the MDA expressly preempts state law regulation of medical devices; and for a state law claim regarding a Class III medical device to survive express preemption by the MDA, a plaintiff must establish that the defendant violated an FDA requirement. In this case, the panel held that plaintiff failed to show that Allergan violated a federal requirement for its Style 20 breast implant. The panel held that plaintiff failed to raise a genuine dispute of material fact that Allergan violated the FDA's pre-market approval and Current Good Manufacturing Practices. Therefore, plaintiff has now shown a violation of an FDA requirement, which she must for her state law claims to fit through the narrow exception to MDA preemption. View "Weber v. Allergan, Inc." on Justia Law

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Horizon’s patents generally relate to methods and compositions for treating osteoarthritis and share a substantially similar specification; there are method-of-use patents and formulation patents. Both groups of patents are listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for Horizon’s PENNSAID® 2% product, a nonsteroidal anti-inflammatory drug (NSAID) and the first FDA-approved twice-daily topical diclofenac sodium formulation for the treatment of pain of osteoarthritis of the knees. Prior art, PENNSAID® 1.5%, also treats osteoarthritis knee pain but differs from PENNSAID® 2% both in the formulation and recommended dosage. Actavis sought to market a generic version of PENNSAID 2% and filed an Abbreviated New Drug Application (ANDA) with certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV), stating that the patents-at-issue were invalid or would not be infringed by Actavis’s generic product. Horizon filed an infringement suit under 35 U.S.C. 271(e)(2)(A). The Federal Circuit affirmed findings of invalidity and noninfringement, upholding claim construction that the terms “impurity A”; “degrades at less than 1% over 6 months”; and “consisting essentially of” are indefinite. Actavis’s ANDA label did not induce infringement of the method-of-use patent. View "HZNP Medicines LLC v. Actavis Laboratories UT, Inc." on Justia Law

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After plaintiff filed suit against Mentor and Mentor Corporation for compensatory and punitive damages for injuries she suffered as a result of the surgical implantation of a polypropylene mesh sling manufactured by Mentor to treat her stress urinary incontinence, a jury found Mentor liable and awarded $400,000 in compensatory and $4 million in punitive damages. The district court upheld the jury's verdict with respect to liability and compensatory damages, but concluded that the punitive damages award exceeded Florida's statutory cap, reducing the punitive damages award to $2 million. The Eleventh Circuit affirmed, holding that the trial court acted well within the bounds of its discretion in allowing the jury to consider an expert's testimony relating to specific causation and Mentor was not entitled to judgment as a matter of law. The court also held that, in this case, which was focused on the physiological response to a design defect in a medical device, the dose-response relation was not implicated and there was no abuse of discretion in admitting the testimony. The court considered Mentor's remaining evidentiary challenges and held that the district court at no point exceeded the bounds of its discretion. Therefore, Mentor was not entitled to a new trial. Finally, the court affirmed the district court's reduction of the punitive damages award where evidence that Mentor knew of a high incidence of injury was not sufficient for finding a specific intent to harm. View "Taylor v. Mentor Worldwide, LLC" on Justia Law

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Non-small cell lung cancer (NSCLC) was the leading cause of cancer deaths in 2000. The standard for treating NSCLC was chemotherapy, which ameliorated some lung cancer-related symptoms, but was limited in use due to toxicity. In response to a need for a therapy that would effective and well-tolerated, investigators pursued targeted therapies as alternatives to chemotherapy. A great majority of alternative therapies for NSCLC failed in clinical trials. One compound that ultimately gained FDA approval was erlotinib. OSI markets erlotinib under the name Tarceva®, which is covered by the 221 patent, which issued in 2005. On inter partes review, the Patent Board found certain claims unpatentable under 35 U.S.C. 103, in light of prior art and the 10-K disclosure filed by OSI with the Securities and Exchange Commission. The Federal Circuit reversed. Substantial evidence did not support the Board’s finding that the asserted combinations of prior art or prior art and the 10-K disclosures each would have provided a person of ordinary skill with a reasonable expectation of success in using erlotinib to treat NSCLC in a mammal. View "OSI Pharmaceuticals, LLC v. Apotex Inc" on Justia Law

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In July 2012, Dr. William Sullivan prescribed Remicade, a medication manufactured by Janssen Biotech, Inc. ("JBI"), to Tim McKenzie as a treatment for Tim's psoriatic arthritis. Tim thereafter received Remicade intravenously every two weeks until November 2014, when he developed severe neuropathy causing significant weakness, the inability to walk without assistance, and the loss of feeling in, and use of, his hands and arms. Although Tim stopped receiving Remicade at that time, he and his wife, Sherrie, alleged they were not told that Remicade was responsible for his injuries. In December 2015, Tim traveled to the Mayo Clinic in Rochester, Minnesota, to receive treatment for his neuropathy. The McKenzies stated that while at the Mayo Clinic, Tim was eventually diagnosed with demyelinating polyneuropathy, and doctors told them that it was likely caused by the Remicade. In 2016, the McKenzies sued JBI and Dr. Sullivan in Alabama Circuit Court, asserting failure-to-warn, negligence, breach-of-warranty, fraud, and loss-of-consortium claims. The complaint filed by the McKenzies was not signed, but it indicated it had been prepared by Sherrie, who was not only a named plaintiff, but also an attorney and active member of the Alabama State Bar. Keith Altman, an attorney from California admitted pro hac vice in November 2017, assisted with the preparation of the complaint. The Alabama Supreme Court found it apparent from even a cursory review of the complaint, that it was copied from a complaint filed in another action. The complaint included numerous factual and legal errors, including an assertion that Tim was dead even though he was alive, and claims invoking the laws of Indiana even though that state had no apparent connection to this litigation. The trial court struck the McKenzies' initial complaint because it was not signed as required by Rule 11(a) and because it contained substantial errors and misstatements of fact and law. The trial court later dismissed the failure-to-warn and negligence claims asserted by the McKenzies in a subsequent amended complaint because that amended complaint was not filed until after the expiration of the two-year statute of limitations applicable to those claims. Because the trial court acted within the discretion granted it by Rule 11(a) when it struck the McKenzies' initial complaint and because the McKenzies did not establish that the applicable statute of limitations should have been tolled, the trial court's order dismissing the McKenzies' claims as untimely was properly entered. View "McKenzie v. Janssen Biotech, Inc." on Justia Law

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Plaintiff Robert Kenney was a former employee of Defendant Helix TCS, Inc. (“Helix”), which provided security services for businesses in Colorado’s state-sanctioned marijuana industry. Kenney filed this lawsuit against Helix under the Fair Labor Standards Act (“FLSA”), alleging that Helix misclassified him and similarly situated workers as exempt from the FLSA’s overtime obligations. Helix moved to dismiss Kenney’s claim based on the Controlled Substance Act (“CSA”), arguing that Kenney’s employment activities were in violation of the CSA and are thus not entitled to FLSA protections. The Tenth Circuit concluded Helix wanted it to interpret the CSA in a manner implicitly repealing the FLSA’s overtime mandate for employers in the marijuana industry. The Tenth Circuit determined the “case law is clear that employers are not excused from complying with federal laws” because of their other federal violations. “Moreover, the purposes of the FLSA do not conflict with the CSA quite as directly as Helix implies. Helix cherry-picks among the enumerated purposes of the FLSA, citing only those most favorable to its arguments.” The Tenth Circuit did not draw conclusions about the merits of Kenney’s FLSA claims. Rather, the Court held only that Kenney and similarly situated individuals were not categorically excluded from FLSA protections. It therefore affirmed the denial of Helix’s motion to dismiss. View "Kenney v. Helix TCS" on Justia Law

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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