Justia Drugs & Biotech Opinion Summaries

The Fifth Circuit affirmed the district court's grant of summary judgment on plaintiff's failure-to-warn claim asserted against the manufacturers of Taxotere, a chemotherapy medication. Plaintiff argues that Taxotere's manufacturers failed to provide an adequate warning of potentially permanent hair loss, which caused her injuries.The court concluded that, under Louisiana law, plaintiff cannot establish causation where, on this record, it is beyond any genuine dispute that a warning of the risk of permanent hair loss—as opposed to temporary hair loss—would not have affected the prescribing physician's decision to prescribe Taxotere. Therefore, plaintiff's claim fails as a matter of law. View "Phillips v. Sanofi U.S. Services, Inc." on Justia Law

The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301, sets forth separate and detailed regimes for the regulation of medical products classified as drugs or devices. Since 2017, the U.S. Food and Drug Administration (FDA) has exercised its claimed discretion to classify Genus’s “Vanilla SilQ” line of diagnostic contrast agents as drugs, notwithstanding the FDA’s recognition that the products “appear” to satisfy the statutory definition for devices. Contrast agents are used in medical imaging to improve the visualization of tissues, organs and physiological processes. The FDA claims that, if a medical product satisfies the statutory definitions of both a “drug” and a “device,” the Act’s overlapping definitions grant by implication the FDA broad discretion to regulate the product under either regime. Genus challenged the FDA’s classification decision as inconsistent with the Administrative Procedure Act (APA), 5 U.S.C. 706(2), and the FDCA.The D.C. Circuit affirmed summary judgment in favor of Genus. The FDCA unambiguously forecloses the FDA’s interpretation. “It would make little sense, then, for the Congress to have constructed such elaborate regulatory regimes—carefully calibrated to products’ relative risk levels—only for the FDA to possess the authority to upend the statutory scheme by reclassifying any device as a drug, no matter its relative risk level.” View "Genus Medical Technologies LLC v. United States Food and Drug Administration" on Justia Law

Plaintiffs filed an antitrust class action against Actelion, alleging that Actelion extended its patent monopoly for its branded drug Tracleer — a drug to treat pulmonary artery hypertension — beyond the patent's expiration date. Plaintiffs claimed that Actelion did so "through illegitimate means" with the intent of precluding competition from generic drug manufacturers and charging supracompetitive prices for Tracleer, in violation of federal and state antitrust laws. Plaintiffs further claimed that, as a result of Actelion's illegal monopolization, they were injured by having to pay supracompetitive prices for Tracleer for some three years after Actelion's patent for Tracleer expired.The Fourth Circuit vacated the district court's limitations ruling and concluded that plaintiffs' antitrust claims did not accrue until they were injured by paying supracompetitive prices for Tracleer after the patent expired in November 2015. Therefore, plaintiffs action commenced in November 2018 was timely. The court also concluded that, even if the February 2014 date, when Actelion entered into agreements settling the generic manufacturers' antitrust claims, marked the last anticompetitive act, damages could not then have been recovered by plaintiffs because their claims would not have been ripe for judicial resolution in view of the speculative nature of future conduct that might have thereafter occurred. Therefore, limitations would not begin to run until the claims became ripe. In any event, the court explained that because plaintiffs alleged that Actelion continued with anticompetitive acts after November 2015 in selling Tracleer at supracompetitive prices, new limitations periods began to run from each sale that caused plaintiffs damages. The court largely agreed with the district court's standing, but concluded that the allegations asserting violations of the laws in states where plaintiffs did not purchase Tracleer may yet be considered when determining whether plaintiffs can, based on a Rule 23 analysis, represent class members who purchased Tracleer in those States, and if they can, then whether plaintiffs can include those claims. View "Mayor and City Council of Baltimore v. Actelion Pharmaceuticals Ltd." on Justia Law

The Commission charged Impax Laboratories with antitrust violations for accepting payments ultimately worth more than $100 million to delay the entry of its generic drug for more than two years. The Commission conducted a rule-of-reason analysis and unanimously concluded that Impax violated antitrust law.The Fifth Circuit denied the petition for review, concluding that substantial evidence supports the Commission's finding that the reverse payment settlement threatened competition. In this case, Endo agreed to make large payments to the company that was allegedly infringing its patents; in exchange, Impax agreed to delay entry of its generic drug until two-and-a-half years after the FDA approved the drug; and neither the saved costs of forgoing a trial nor any services Endo received justified these payments. Furthermore, substantial evidence supports the Commission's conclusion that a less restrictive, no-payment settlement, alternative was feasible. Therefore, Impax agreed to an unreasonable restraint of trade because the reverse payment settlement was an agreement to preserve and split monopoly profits that was not necessary to allow generic competition before the expiration of Endo's patent. View "Impax Laboratories, Inc. v. Federal Trade Commission" on Justia Law

The First Circuit affirmed the judgment of the district court granting summary judgment in favor of CVS Pharmacy, Inc. and dismissing this complaint involving a pharmacist's dispensation of a prescription that triggered the pharmacy's internal warning system, holding that the district court did not err.Plaintiff brought this action alleging that he sustained permanent ocular damages as a result of a medication dispensed by CVS. Plaintiff brought a claim for negligence, a claim under Mass. Gen. Laws ch. 93A, and a claim for product liability. The district court granted summary judgment for CVS. The First Circuit affirmed, holding that Plaintiff did not provide any adequate basis for reversing the district court's decisions. View "Carrozza v. CVS Pharmacy, Inc." on Justia Law

Stanford’s 925 application is directed to methods and computing systems for determining haplotype phase--an indication of the parent from whom a gene has been inherited. Improved haplotype phasing techniques “promise[] to revolutionize personalized health care by tailoring risk modification, medications, and health surveillance to patients’ individual genetic backgrounds.” Achieving the understanding necessary to accomplish those goals requires “interpretation of massive amounts of genetic data produced with each genome sequence.” The 925 application describes a method for receiving genotype and pedigree data and processing the data by performing mathematical calculations and statistical modeling to arrive at a haplotype phase determination.The Federal Circuit affirmed the Patent Trial and Appeal Board in rejecting the claims as patent-ineligible under 35 U.S.C. 101 because they are drawn to abstract mathematical calculations and statistical modeling, and similar subject matter that is not patent-eligible. Claim 1 recites no steps that practically apply the claimed mathematical algorithm; instead, claim 1 ends at storing the haplotype phase and “providing” it “in response to a request.” Simply storing information and providing it upon request does not alone transform the abstract idea into patent-eligible subject matter. View "In Re Board of Trustees of the Leland Stanford Junior University" on Justia Law

The Supreme Court granted in part and denied in part a petition for a writ of mandamus stemming from lawsuits brought against generic drug manufacturers for selling vials of propofol to ambulatory surgical centers despite an allegedly foreseeable risk that they would be used on multiple patients, holding that some of the claims were preempted.Plaintiffs alleged that Petitioners knew or should have known that selling 50 mL vials of propofol, as opposed to 20 mL vials, to ambulatory surgical centers with high patient turnover was unsafe due to the risk of contamination from multi-dosing. Petitioners filed a motion to dismiss, alleging that Plaintiff's claims conflicted with federal law. The district courts summarily denied the motions to dismiss. Petitioners then filed the instant writ petition. The Supreme Court granted the writ in part, holding (1) Plaintiffs' negligence cause of action and request for punitive damages survived; but (2) the remainder of Plaintiffs' causes of action were preempted. View "Teva Parenteral Medicines, Inc. v. Eighth Judicial District Court" on Justia Law

Bayer’s patent is directed to recombinant forms of human factor VIII (FVIII), a protein that is produced, and released into the bloodstream, by the liver. In Bayer’s suit, alleging that Baxalta’s biologic product Adynovate® infringes certain claims of the patent, a jury found that the asserted claims were enabled and infringed, and that Bayer was entitled to reasonable-royalty damages. The district court did not send the question of willful infringement to the jury, holding as a matter of law that Baxalta’s conduct did not meet the requirements for willfulness.The Federal Circuit affirmed, rejecting Baxalta’s challenges to the district court’s construction of the claim term “at the B-domain” and its interpretation of the word “random” in its construction of the claim term “an isolated polypeptide conjugate.” The court upheld the district court’s judgments of infringement and enablement as supported by substantial evidence, along with the court’s awards of damages and pre-verdict supplemental damages. Even accepting Bayer’s evidence as true and weighing all inferences in Bayer’s favor, the record is insufficient to establish that Baxalta’s “conduct rose to the level of wanton, malicious, and bad-faith behavior required for willful infringement.” View "Bayer HealthCare LLC v. Baxalta Inc." on Justia Law

Elevated LDL cholesterol is linked to heart disease. LDL receptors remove LDL cholesterol from the bloodstream; the PCSK9 enzyme regulates LDL receptor degradation. Amgen’s 165 and 741 patents describe antibodies that purportedly bind to the PCSK9 protein and lower LDL levels by blocking PCSK9 from binding to LDL receptors. Amgen sued Sanofi, alleging infringement of multiple patents, including the 165 and 741 patents. Amgen and Sanofi stipulated to infringement of selected claims and tried issues of validity to a jury.The court granted judgment as a matter of law (JMOL) of nonobviousness and of no willful infringement. Following remand, a jury again found that Sanofi failed to prove that the asserted claims were invalid for lack of written description and enablement. The district court granted Sanofi’s Motion for JMOL for lack of enablement and denied the motion for lack of written description. The Federal Circuit affirmed. Undue experimentation would be required to practice the full scope of these claims, which encompasses millions of candidates claimed with respect to multiple specific functions. It would be necessary to first generate and then screen each candidate antibody to determine whether it meets the double-function claim limitations. View "Amgen Inc. v. Sanofi, Aventisub LLC" on Justia Law

In this case involving claims of personal injury and product liability against the manufacturer of a medical device the Supreme Judicial Court reversed the decision of the superior court judge denying the manufacturer's motion to dismiss, holding that plaintiffs asserting parallel state law claims may do so with no greater degree of specificity than otherwise required under Iannacchino v. Ford Motor Co., 451 Mass. 623, 636 (2008).Plaintiff sued Genzyme Corporation, asserting that Synvisc-One, a class III medical device subject to premarket approval under the Medical Device Amendments (MDA), 21 U.S.C. 360c et seq., was negligently manufactured, designed, distributed, and sold by Genzyme. Genzyme filed a motion to dismiss on the grounds that the allegations were preempted by federal regulation. The trial judge denied the motion to dismiss. The Supreme Judicial Court reversed, holding that while all of Plaintiff's state law claims properly paralleled the federal requirements, none of them was sufficiently pleaded under Iannacchino to survive Genzyme's motion to dismiss. View "Dunn v. Genzyme Corp." on Justia Law