Justia Drugs & Biotech Opinion Summaries

AstraZeneca, a drug manufacturer that owns the patents covering Nexium, a prescription heartburn medication, sued Ranbaxy for patent infringement after Ranbaxy announced that it sought to market a generic version of Nexium. The two companies reached a settlement agreement under which Ranbaxy agreed to delay the launch of its generic until a certain date in return for various promises from AstraZeneca. Plaintiffs - pharmaceutical retail outlets and certified classes of direct purchasers and end payers - filed suit, arguing that the terms of the settlement agreements violated federal antitrust laws and state analogues. The jury found that although Plaintiffs had proved an antitrust violation, Plaintiffs had not shown that they suffered an antitrust injury that entitled them to damages. The First Circuit affirmed, holding (1) the district court did not commit reversible error in its evidentiary rulings, the formulation of the special verdict form and jury instructions, or its judgment as a matter of law on overarching conspiracy; and (2) the jury verdict rendered harmless any error that may have occurred during the summary judgment proceedings. View "In re Nexium Antitrust Litigation" on Justia Law

In the 1990s, Stryker purchased a Pfizer subsidiary that made orthopedic products, including the “Uni-knee” artificial joint. It was later discovered that those devices were sterilized using gamma rays, which caused polyethylene to degrade. If implanted past their five-year shelf-life, the knees could fail. Expired Uni-Knees were implanted in patients. Stryker, facing individual product-liability claims and potentially liable to Pfizer, sought defense and indemnification under a $15 million XL “commercial umbrella” policy, and a TIG “excess liability” policy that kicked in after the umbrella policy was fully “exhausted.” XL denied coverage, arguing that the Uni-Knee claims were “known or suspected” before the inception of the policy. Stryker filed lawsuits against the insurers, then unilaterally settled its individual product-liability claims for $7.6 million. Stryker was adjudicated liable to Pfizer for $17.7 million. About 10 years later, the Sixth Circuit held that XL was obliged to provide coverage. XL paid out the Pfizer judgment first, exhausting coverage limits. TIG declined to pay the remaining $7.6 million, arguing that Stryker failed to obtain “written consent” at the time the settlements were made. Stryker claimed that the policy was latently ambiguous because XL satisfied the Pfizer judgment first, Stryker was forced to present its settlements to TIG years after they were made. The district court granted Stryker summary judgment. The Sixth Circuit reversed, finding the contract unambiguous in requiring consent. View "Stryker Corp. v. National Union Fire Insurance Co." on Justia Law

The Alfred E. Mann Foundation owns two patents that cover implantable cochlear stimulators and formed Advanced Bionics to manufacture implants. The patents are directed to an ear implant with telemetry functionality for testing purposes, and generally describe a two-part system comprising an external wearable system with a wearable processor (WP) and headpiece, and an internal implantable cochlear stimulator (ICS). Sound is transmitted from the headpiece to the WP, which processes the transmissions before sending them to the ICS. The ICS processes the sound to stimulate the cochlea––the organ that converts sound to nerve impulses––via implanted electrodes, thereby allowing the user to hear. The system allows testers, usually physicians, to measure and adjust various parameters of the implant to assess whether the device is functioning properly. The Foundation sued Cochlear Corporation for infringement. The court found certain claims invalid for indefiniteness, entered judgment as a matter of law of no willful infringement, and granted a new trial on damages. The Federal Circuit affirmed in part, upholding the infringement determination with respect to some claims, but vacated and remanded with respect to willfulness in light of the Supreme Court’s 2016 decision, Halo Electronics, Inc. v. Pulse Electronics, Inc. View "Alfred E. Mann Foundation for Scientific Research v. Cochlear Corp." on Justia Law

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