Justia Drugs & Biotech Opinion Summaries

NuVasive’s patent describes and claims implants for spinal fusion surgery. On inter partes review, the Patent Trial and Appeal Board cancelled all but one challenged claim under 35 U.S.C. 103, finding in one prior-art reference (Michelson), a spinal fusion implant that meets two of the claim requirements of the NuVasive patent—having a length both greater than 40 mm and at least 2.5 times its width. NuVasive argued that it did not receive adequate notice of or opportunity to address that reading of Michelson and its consequences for the overall obviousness analysis. The Federal Circuit vacated in part and remanded Medtronic’s petition put NuVasive on notice that Medtronic was relying on particular portions of Michelson to teach the NuVasive patent’s claimed long-and-narrow implants. Medtronic’s petition did not, however, notify NuVasive of the assertions about the pertinent portions of Michelson that later became critical; the Board’s ultimate reliance on that material, together with its refusal to allow NuVasive to respond fully once that material was called out, violated NuVasive’s rights under the Administrative Procedure Act. View "In re: NuVasive, Inc.." on Justia Law

Plaintiff filed a putative securities class action against defendants in connection with public statements made about Arena’s weight-loss drug, lorcaserin. When Arena filed its application with the FDA, the FDA’s advisory panel published a briefing document that disclosed, for the first time, that Arena had been in a “highly unusual” back-and-forth with the FDA regarding the results of cancer studies on rats (the “Rat Study”). Plaintiff filed suit after news of the Rat Study broke. The district court dismissed the First, Second, and Proposed Third Amended Complaints. The court agreed that once defendants touted the safety and likely approval of the drug based on animal studies, defendants were obligated to disclose the Rat Study's existence to the market. The court concluded that plaintiff has alleged scienter with sufficient particularity to survive a motion to dismiss. In this case, there is no question that plaintiff has alleged that defendants knew that the Rat Study existed, that defendants knew that the FDA’s request for bi-monthly reports and follow-up studies was highly unusual and out-of-process, and defendants went ahead and told investors about their confidence in lorcaserin’s approval based on preclinical animal studies. Therefore, the court concluded that plaintiff has properly pleaded scienter under Federal Rule of Civil Procedure 9(b) and the Private Securities Litigation Reform Act (PSLRA), 15 U.S.C. 78u-4. The court reversed and remanded. View "Schwartz v. Arena Pharmaceuticals, Inc." on Justia Law

Wagner, a licensed attorney proceeding pro se, took both brand‐name and generic hormone therapy drugs as prescribed by her gynecologist to treat her post‐menopausal endometrial hyperplasia. After taking the drugs, Wagner developed breast cancer. Wagner sued multiple pharmaceutical companies that designed, manufactured, promoted and distributed the drugs she took, asserting Wisconsin state law tort claims, all based upon allegations that the defendants sold dangerous products and failed to adequately warn of their risks. Defendants moved for Rule 12(c) judgment on the pleadings, arguing that federal law preempted Wagner’s claims. In response, Wagner asserted, for the first time, that the defendants delayed updating their generic brand labels to match the updated, stricter labels on the brand‐name drug. The district judge granted the motion, finding that the Food, Drug, and Cosmetics Act, 21 U.S.C. 301, preempted the state law claims. The Seventh Circuit affirmed: Wagner’s complaint lacked the requisite factual allegations to support a failure to update theory and federal law preempts her Wisconsin state‐law claims. View "Wagner v. Teva Pharmaceuticals USA, Inc." on Justia Law

The 141 application relates to methods of treating or preventing influenza by administering the drug zanamivir by oral inhalation. The examiner rejected the pending claims as obvious over Australian Patent No. AU-A1-27242/92 (Von Itzstein I), in view of WIPO Publication WO 91/16320 (Von Itzstein II) and other references. The Patent Trial and Appeal Board agreed, finding that Von Itzstein II’s disclosure of “inhalation” for treating influenza with its compounds “is reasonably understood to disclose inhalation by either the nose alone, mouth alone, or both” and concluded that Von Itzstein II ,in view of Von Itzstein I’s disclosure of zanamivir, rendered the claims obvious. The Board also considered the applicant’s evidence of secondary considerations—namely of unexpected results—but found it to be unpersuasive. The Federal Circuit affirmed the rejection as supported by substantial evidence. View "In re: Efthymiopoulos" on Justia Law

Massachusetts Institute of Technology sued Shire Pharmaceuticals, for infringement of patents that are directed to three-dimensional scaffolding for growing cells in vitro to produce organ tissue in vivo. Following the district court’s construction of the terms “vascularized organ tissue” and “cells derived from a vascularized tissue” and its determination that the term “three-dimensional scaffold” was not indefinite, the parties stipulated to a final judgment of validity and infringement. The Federal Circuit affirmed, finding no error in the district court’s claim construction. View "Mass. Inst. of Tech. v. Shire Pharma., Inc." on Justia Law

Generic drug manufacturers (plaintiffs) originally sued name-brand drug companies (defendants) that manufacture and sell “Doryx,” the delayed-release doxycycline hyclate, an oral antibiotic of the tetracycline class used to treat severe acne. Tetracyclines are a broad category of antibiotics, the most common being doxycycline monohydrate and minocycline, which vary in their use and efficacy. Plaintiffs claimed that defendants conspired to protect their position in the market through “product hopping,” by making four critical changes to Doryx, all of which required generics to go through a cumbersome regulatory approval process if they wanted to continue to benefit from state substitution laws. Several plaintiffs settled their cases and the district court rejected, on summary judgment, remaining claims of unlawful monopoly and attempted monopolization under section 2 of the Sherman Act; agreement in restraint of trade under section 1 of the Sherman Act; and tortious interference with prospective contractual relationships under Pennsylvania law. The Third Circuit affirmed, finding that defendants’ conduct was not anticompetitive, and that, even if it was, it was not established that defendants had the requisite market power in the relevant product market. Adoption of plaintiffs’ theory of “anticompetitive product redesign” could have adverse, unintended consequences, including slowing innovation. View "Mylan Pharma. Inc v. Warner Chilcott Pub. Ltd. Co." on Justia Law

Abbott’s 915 patent discloses a protein, TBP-II, which binds to and neutralizes a protein called Tumor Necrosis Factor α (TNFα), which is associated with various immunological diseases. Following a 2008 remand by the district court, the Board of Patent Appeals rejected claims by Yeda that the patent was invalid as anticipated. In 2015, the district court affirmed. The issue of invalidity turned on whether the patent benefits from the filing dates from either of two German patent applications. If it did, then the field of prior art narrows to exclude the claimed anticipating reference. Whether the 915 patent was entitled to benefit from the German application’s filing date depends on whether the German application provided adequate written description support for the invention claimed in the 915 patent. The Federal Circuit affirmed the district court’s 2015 decision that Abbott’s 915 patent is supported by the written description of one of the German applications, rendering moot Yeda’s appeal concerning the 2008 decision. View "Yeda Research & Dev. Co., Ltd. v. Abbott GMBH & Co. KG" on Justia Law

LifeNet’s 200 patent claims plasticized soft tissue grafts suitable for transplantation into humans. The patent explains that tissue grafts are typically preserved and provided in a dehydrated state, such as through freeze-drying, then rehydrated before implantation. The freeze-drying process is not optimal: it can cause the tissue to become brittle with a tendency to fracture; it requires time in the operating room to rehydrate the tissue; and even after rehydration the tissue’s properties do not approximate that of normal tissue, and the graft can fail. The 200 patent’s “plasticized” tissue grafts avoid these problems. The tissue is preserved not by freeze-drying but by replacing the tissue’s water with biocompatible plasticizers, such as glycerol, that provide the hydrating functions of water. These plasticized grafts exhibit properties similar to that of normal tissue and avoid the rehydration process required for freeze-dried tissue. A jury found that the patent was not invalid and was infringed. The Federal Circuit affirmed, upholding the district court’s conclusion that construction of the entire term “not removed” was “unnecessary,” because that two-word phrase is easily understood by a person of ordinary skill in the art to have its plain meaning that no plasticizers are removed prior to transplantation.” View "LifeNet Health v. Lifecell Corp." on Justia Law

Cephalon’s patent, issued in 1997, claimed a specific distribution of modafinil, used to treat sleep disorders. Cephalon obtained Reissue Patent 516 in 2002. Cephaolon’s use of modafinil was patent-protected until April 2015. In 1998, the FDA approved Cephalon’s New Drug Application (NDA) for the brand-name drug Provigil and granted New Chemical Entity exclusivity until December 2005, as an orphan drug. Cephalon later obtained six months of pediatric exclusivity, 21 U.S.C. 355a(c). Without the patent, Cephalon’s exclusivity would have ended in June 2006. In December 2002, four generic drug each independently filed an Abbreviated NDA seeking to sell generic modafinil. All four were treated as the first filer. Each application certification “automatically counts as patent infringement,” 35 U.S.C. 271(e)(2)(A)), so Cephalon sued all four, then entered into “reverse-payment settlements” to keep each out of the market. A putative class of wholesalers who purchased Provigil directly from Cephalon filed suit, alleging a global conspiracy involving Cephalon and the generic manufacturers, 15 U.S.C. 1; four separate conspiracies; and monopolization, 15 U.S.C. 2. A motion for class certification was filed after eight years of litigation. One month later the court granted defendants summary judgment on the antitrust conspiracy claim. The court certified the class after three defendants settled for $512 million. The Third Circuit vacated the class certification order and remanded for further consideration of whether joinder of all class members is impracticable. Plaintiffs have not met their burden of showing that the numerosity requirement of Rule 23(a)(1) was satisfied. View "In Re: Modafinil AntiTrust Litig." on Justia Law

UCB sought a declaration that its Cimzia® brand antibody does not infringe Yeda’s 923 Patent and that the 923 Patent was invalid. Yeda counterclaimed for infringement. The district court granted summary judgment of non-infringement, holding that, based on the specification and prosecution history, the monoclonal antibodies claimed in the 923 patent are not infringed by the chimeric or humanized antibodies of the Cimzia® product. The Federal Circuit affirmed, finding that the district court correctly applied the law and that Yeda is estopped from including chimeric and humanized antibodies within the scope of the monoclonal antibodies claimed in the 923 Patent. View "UCB, Inc. v. Yeda Research & Dev. Co., Ltd." on Justia Law