Justia Drugs & Biotech Opinion Summaries

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

Hartig filed a putative class action, alleging antitrust violations involving medicated eyedrops manufactured by the Defendants. Hartig claimed that the Defendants’ wrongful suppression of generic competition resulted in supracompetitive pricing of those eyedrops. Although not a direct purchaser of the medications, Hartig claimed it had standing to sue because of an assignment of rights from Amerisource, a direct purchaser. The district court dismissed for lack of subject matter jurisdiction, finding that an anti-assignment clause in a distribution agreement between Allergan (the assignee of the named inventors) and Amerisource barred any assignment of antitrust claims from Amerisource to Hartig. The Third Circuit vacated; the district court erred in treating antitrust standing as an issue of subject-matter jurisdiction. The court distinguished between Article III standing and antitrust standing and stated that, when the correct procedures are followed, the court may consider the impact of the anti-assignment clause. View "Hartig Drug Co., Inc v. Senju Pharma. Co., Ltd" on Justia Law

Eight separate complaints were filed in San Francisco Superior Court by or on behalf of 678 individuals. Eighty-six of those individuals were California residents and the remainder were nonresidents. All of the plaintiffs were allegedly prescribed Plavix, a drug created and marketed by Bristol-Myers Squibb Company (BMS), and allegedly suffered adverse consequences. BMS, which conducts significant business and research activities in California but is neither incorporated nor headquartered in the state, moved to quash service of summons on the ground that the court lacked personal jurisdiction over it to adjudicate the claims of the nonresident plaintiffs. The superior court denied BMS’s motion. BMS petitioned the Court of Appeal for a writ of mandate, naming the nonresident plaintiffs as real parties in interest. The Court of Appeal denied the writ, concluding that BMS was subject to the personal jurisdiction of the California courts on the basis of specific jurisdiction. The Supreme Court affirmed, holding that, in light of BMS’s extensive contacts with California, courts may exercise specific personal jurisdiction over the nonresident plaintiffs’ claims in this action, which arise from the same course of conduct that gave rise to the California plaintiffs’ claims. View "Bristol-Myers Squibb Co. v. Superior Court of San Francisco County" on Justia Law

The 997 patent relates to spinal surgery that “insert[s] an artificial implant between two adjacent vertebrae” from a patient’s side and discloses “instrumentation and methods of performing surgical procedures on the human thoracic and lumbar spine along the lateral aspect [(i.e., side)] of the spine” to correct “thoracic and lumbar disc disease and spinal deformities where concomitant fusion is desired.” The lateral approach to spinal surgery seeks to avoid complications that may arise when the surgery is performed from the patient’s front or back. Based on petitions filed by NuVasive, the Patent Trial and Appeal Board instituted inter partes review and found claims 1–8 and 17–23 obvious and therefore invalid. The Federal Circuit affirmed in part. Substantial evidence supported findings of obviousness in light of prior art and concerning motivation to combine prior art. The court vacated with respect to a limitation in one specific claim. View "In re: Warsaw Orthopedic, Inc." on Justia Law