Justia Drugs & Biotech Opinion Summaries

The Fifth Circuit affirmed the district court's grant of summary judgment to Solvay on relators' False Claims Act (FCA) claims. The court held that relators failed to produce sufficient evidence to survive summary judgment on any of their briefed claims where the public disclosure bar applied to relators' AndroGel claims; at bottom, the probative value of relators' off-label marketing causation evidence was primarily based on conjecture and speculation and was insufficient to create a genuine issue of material fact for trial; and summary judgment was appropriate as to relators' claim that Solvay unduly influenced P&T committees to place Solvay's drugs on preferred drug lists and as to relators' FCA retaliation claims. Finally, the court affirmed the district court's ruling that partly granted court costs to Solvay. View "King v. Solvay Pharmaceuticals, Inc." on Justia Law

This appeal involved two antipsychotic drugs primarily used to treat schizophrenia and bipolar disorder: Abilify Maitena, manufactured by Otsuka; and Aristada, manufactured by Alkermes. Otsuka sought judicial review, contending that the FDA's same-moiety limitation on the scope of a drug's marketing exclusivity conflicted with the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355(a). The DC Circuit affirmed the district court's grant of summary judgment for the FDA and Alkermes, holding that the FDA's same-moiety test was a reasonable construction of the statute and was consistent with the agency’s regulations. View "Otsuka Pharmaceutical Co. v. Price" on Justia Law

The First Circuit affirmed the district court’s finding, in this securities fraud class action against Sarepta Therapeutics, Inc. and former and current Sarepta executives, that Plaintiffs, several shareholders, failed to allege facts creating a strong inference that Defendants intentionally or recklessly deceived the investing public in the months before the Food and Drug Administration deemed premature Sarepta’s application for approval of a novel gene therapy. The price of the publicly traded securities issued by Sarepta dropped sixty-four percent after the FDA judged Sarepta’s filing premature. Plaintiffs allegedly that Defendants overstated the significance of certain data and exaggerated the likelihood that the FDA would accept a new drug application for filing, thereby deceiving the investing public and causing the purchase of Sarepta securities at inflated prices. The First Circuit affirmed the district court’s dismissal of this action, holding that Plaintiffs failed to satisfy the requisite pleadings standards. View "Corban v. Sarepta Therapeutics, Inc." on Justia Law

Consolidated appeals involve allegations that the patent-holders for Lipitor and Effexor XR delayed entry into the market by generic versions of those drugs by engaging in a monopolistic scheme that involved fraudulently procuring and enforcing the underlying patents, then entering into a reverse-payment settlement agreement with a generic manufacturer. In 2013, the Supreme Court recognized that reverse payment schemes can violate antitrust laws and that it is normally not necessary to litigate patent validity to answer the antitrust question. The district judge dismissed several claims. The Third Circuit remanded after rejecting an argument that plaintiffs’ allegations required transfer of the appeals to the Federal Circuit, which has exclusive jurisdiction over appeals from civil actions “arising under” patent law, 28 U.S.C. 1295(a)(1). Not all cases presenting questions of patent law necessarily arise under patent law; here, patent law neither creates plaintiffs’ cause of action nor is a necessary element to any of plaintiffs’ claims. Plaintiffs plausibly allege the existence of agreements between the patent holders and the generic manufacturers. The court remanded one of the Lipitor appeals, brought by California pharmacists, and involving claims solely under California law, for determination of whether remand to state court was appropriate. The Lipitor plaintiffs made plausible allegations of fraudulent patent procurement and enforcement, and other related misconduct. View "In re: Lipitor Antitrust Litigation" on Justia Law

Direct purchasers of Wellbutrin XL, a drug for treating depression, sued, alleging that GSK violated the Sherman Antitrust Act by entering into an unlawful conspiracy with Biovail, GSK’s partner in the development of Wellbutrin XL, to delay the launch of generic versions of the drug. Indirect-purchasers asserted similar theories under state law. The purchasers claim that GSK delayed the launch of generic versions by supporting baseless patent infringement suits and a baseless FDA Citizen Petition aimed at generic drug companies and by entering into an unlawful reverse payment settlement agreement with potential competitors. The district court granted GSK summary judgment, finding insufficient evidence that GSK’s patent litigation was a sham or that the settlement delayed the launch of generic Wellbutrin XL. The court granted GSK’s Daubert motion to exclude the testimony of the purchasers’ economic expert; decertified the indirect-purchaser class for lack of ascertainability; dismissed the indirect-purchaser claims brought under the laws of states that were not the home of a named class representative; and denied Aetna’s motion to intervene. The Third Circuit affirmed. After considering the Supreme Court’s 2013 decision, FTC v. Actavis, the court concluded that the purchasers failed to establish a genuine dispute of fact either as to whether GSK engaged in sham litigation or whether GSK’s actions delayed the launch of generic Wellbutrin XL. View "In re: Wellbutrin XL Antitrust Litigation" on Justia Law

The Biologics Price Competition and Innovation Act, 42 U.S.C. 262, establishes a scheme for adjudicating claims of patent infringement in the FDA's approval of “biological products.” To obtain FDA approval, the sponsor of a new biological product must demonstrate that it is “safe, pure, and potent.” For a “biosimilar” product based on an approved “reference” product, a party may submit an abbreviated “subsection (k)” application that “piggybacks” on the showing made for an approved reference product but must provide the reference product's sponsor with its subsection (k) application and information that describes the manufacturing process. The parties then collaborate to identify patents for immediate litigation. The second phase is triggered by the applicant’s notice of commercial marketing and involves any patents that were included on the lists but not previously litigated. Hospira's subsection (k) application sought approval of a biosimilar of EPOGEN®, Amgen’s FDA-approved product, Although Amgen asserted that Hospira failed to disclose the composition of the cell-culture medium used during manufacturing, the parties began identifying patents. Amgen claimed that it could not assess the reasonableness of asserting infringement claims concerning other patents for culturing cells and moved to compel discovery on the composition of Hospira’s cell-culture medium in its suit on listed patents. The court denied Amgen’s motion, stating that the information had no relevance to the asserted patents. Amgen appealed that interlocutory order. The Federal Circuit dismissed, holding that it lacked jurisdiction under the collateral order doctrine and that Amgen failed to satisfy the prerequisites for mandamus. View "Amgen, Inc.. v. Hospira, Inc.." on Justia Law

In this action brought by two individuals (Relators) under the False Claims Act (FCA) and various state analogues, the First Circuit affirmed in part and reversed in part the district court’s dismissal of the complaint. The district court concluded that Relators failed to plead false claims under either the FCA or the state-law versions of the FCA with the particularity required by Fed. R. Civ. P. 9(b). The First Circuit held (1) the complaint was correctly dismissed to the extent it relied on the alleged falsity of statements made by the product manufacturer in securing approval from the FDA to market a hip-replacement device; but (2) the district court erred in dismissing the complaint to the extent to rested on allegations that the manufacturer sold latently defective versions of its FDA-approved product on unsuspecting doctors who sought government reimbursement for defective products, as Relators’ complaint was sufficient to survive a Rule 9(b) motion to dismiss. View "Nargol v. DePuy Orthopaedics, Inc." on Justia Law

The specifications of the three Soft Gel patents describe a method for dissolving CoQ10. The patented inventions include a composition, a soft gelatin capsule, and a method of making such a soft gelatin capsule, each involving a solution of CoQ10 dissolved in a monoterpene. CoQ10, also called ubiquinone, is a coenzyme, i.e., a chemical compound that is required for the biological activity of certain proteins and is necessary for certain metabolic processes and for the production of cellular energy; it has a secondary role as an antioxidant. In clinical trials, CoQ10 has been shown to be effective in regulating blood pressure and cholesterol levels, improving cardiovascular health, and “thwarting various diseases such as certain types of cancers.” It is “sparingly soluble in hydrophilic solvents such as water.” According to the patents, at the time of the inventions, most solvents that were used to administer CoQ10 in liquid form could dissolve, at most, only about 5 to 10 percent of the CoQ10. Jarrow requested inter partes reexaminations of the three Soft Gel patents. The Patent Board invalidated several claims. The Federal Circuit affirmed, finding the claims invalid as obvious in light of prior references, 35 U.S.C. 103(a). View "Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc." on Justia Law

Millennium developed the patented product for the treatment of oncology diseases, particularly multiple myeloma and mantle cell lymphoma. The product has the brand name Velcade®. Sandoz and others filed abbreviated new drug applications (ANDAs), admitting infringement and seeking to invalidate various claims of the 446 Patent. The district courts held that certain claims were invalid as obvious, 35 U.S.C. 103. In consolidated appeals, the Federal Circuit concluded that the district court erred and that invalidity was not established. Sandoz identified no reference or combination of references that show or suggest a reason to make the claimed compound. The district court clearly erred in its examination of the objective indicia of unexpected results and long-felt need. View "Millenium Pharmaceuticals, Inc. v. Sandoz, Inc." on Justia Law

Plaintiff filed a products liability suit against McNeil and its corporate parent, Johnson & Johnson, after he suffered a severe reaction after taking Motrin. The Court of Appeal held that the jury's verdict finding McNeil liable for negligent failure to warn must be reversed because it was fatally inconsistent with the verdict finding McNeil not liable for strict liability failure to warn; the negligent failure to warn special verdict was also defective because of the failure to include the necessary question whether a reasonable manufacturer under the same or similar circumstances would have warned of the danger; the verdicts against McNeil for negligent and strict liability design defect, as well as against Johnson & Johnson for strict liability design defect, must be reversed, because the design defect claims were based on a theory—failure to sell dexibuprofen—that was impliedly preempted; the strict liability design defect verdicts must also be reversed because the jury found McNeil and Johnson & Johnson liable solely under the consumer expectation test, but that test did not apply when, as here, the question of design defect involved complex questions of feasibility, practicality, risk, and benefit beyond the common knowledge of jurors; and none of plaintiffs' design defect claims could be retried. View "Trejo v. Johnson & Johnson" on Justia Law