Life Sciences

  • July 30, 2015

    No New Trial For Drug Buyers In Nexium Pay-For-Delay Suit

    A Massachusetts federal judge refused Thursday to let Nexium buyers get a second crack at their pay-for-delay suit against AstraZeneca PLC and Ranbaxy Inc., saying the plaintiffs' claim for how new evidence would let them prove their case at trial was "at least a couple of bridges too far."

  • July 30, 2015

    Rise Of Crossover Rounds: More Biotechs Eye Late-Stage Cash

    A growing number of life sciences companies are locking down crossover financing rounds shortly before kicking off their initial public offering plans, a move that’s helping to fuel strong listings in the space, experts say.

  • July 30, 2015

    Bayer, Merck Hit With More Suits Over Avelox Nerve Damage

    At least two new plaintiffs filed complaints Wednesday in Pennsylvania federal court accusing Bayer Corp. and Merck & Co. Inc. of downplaying the risk of permanent nerve damage posed by the antibiotic Avelox and promoting the drug for minor conditions that can be treated with safer medications.

  • July 30, 2015

    USPTO Posts Update On Alice, Mayo, Myriad Rules

    The U.S. Patent and Trademark Office issued interim guidance Thursday to its 2014 memo to examiners concerning how to determine subject matter eligibility under federal patent law, in light of the recent Alice, Mayo and Myriad Supreme Court decisions.

  • July 30, 2015

    Novartis Looks To Kill Gleevec Antitrust Suit

    Novartis Pharmaceuticals Corp. told a Massachusetts federal judge to dismiss a proposed class action that claims the company illegally withheld generic versions of a leukemia drug from consumers, saying the plaintiffs lack standing to sue and have failed to state a claim.

  • July 30, 2015

    AbbVie Says Chancery Rightly Axed Suit Over Failed Inversion

    AbbVie Inc. told the Delaware Supreme Court late Wednesday that the Chancery Court was right to toss shareholders' records demands investigating the failed $55 billion merger with Shire PLC, which fell apart amid an Obama administration crackdown on tax-driven inversions, arguing there was no proper purpose for the probe.

  • July 30, 2015

    NuVasive Inks $14M FCA Deal Over Kickbacks, Off-Label Uses

    Medical device maker NuVasive Inc. will pay $13.5 million to resolve whistleblower allegations that it violated the False Claims Act by promoting off-label uses of spinal fusion products for Medicare patients and dispensing kickbacks through a supposedly independent medical society, the U.S. Department of Justice said Thursday.

  • July 30, 2015

    Bio-Rad Says Former GC Was Fired For 'Abusive' Conduct

    Bio-Rad Laboratories Inc. told a California federal court Tuesday that its general counsel was fired because of “abusive and damaging conduct,” not because he reported his suspicion that company brass were bribing Chinese officials as alleged in the legal officer’s retaliation lawsuit.

  • July 30, 2015

    Corporate Tax Code Needs Reform, Senate Panel Hears

    A host of business leaders on Thursday lobbied a U.S. Senate committee for relief from high corporate tax rates, saying the current system pressures them to relocate overseas and makes their companies vulnerable to buyouts by foreign rivals.

  • July 30, 2015

    Utah High Court Sends Amnesiac Atty’s Fee Dispute To Jury

    An attorney who was forced to bow out of litigation over the diet drug Fen-Phen when he developed amnesia can present to a jury his claim that his former firm underpaid him for his work, the Utah Supreme Court ruled Tuesday, reversing a trial court’s decision.

  • July 29, 2015

    Final Thalidomide Claim Is Time-Barred, GSK Tells 3rd. Circ.

    GlaxoSmithKline LLC asked the Third Circuit on Wednesday to uphold a Pennsylvania court's finding that Hagens Berman Sobol Shapiro LLP's last client standing in litigation over the 1950s morning sickness drug Thalidomide was too late in bringing her suit, after the firm was previously sanctioned over obviously time-barred claims.

  • July 29, 2015

    Actavis Blasts USPTO Decision In Opana Row

    Actavis Inc. on Tuesday asked a New York federal judge overseeing Endo Pharmaceuticals Inc.’s case accusing it and several other generics manufacturers of infringing its patent for painkiller Opana ER to disregard a U.S. Patent and Trademark Office decision upholding Endo’s patent, arguing the administrative ruling has no bearing on the pending civil case.

  • July 29, 2015

    Medicare Contractors Overpaid $36M For Drugs, Audit Finds

    Over three years, Medicare contractors overpaid providers at least $35.8 million for outpatient drugs, according to a U.S. Department of Health and Human Services’ Office of the Inspector General report released Wednesday.

  • July 29, 2015

    PTAB To Scrutinize Xyrem Patents In Inter Partes Review

    The Patent Trial and Appeal Board instituted inter partes review Tuesday of four Jazz Pharmaceuticals Inc. patents for the narcolepsy drug Xyrem, the same patents it previously refused to review under a different America Invents Act program.

  • July 29, 2015

    Novartis Spins Off 3 Drugs To New UK Biopharma Company

    Novartis AG has sold three midstage clinical drugs to a newly formed U.K.-based pharmaceutical company in exchange for equity, the pharmaceutical giant announced on Wednesday.

  • July 29, 2015

    US Seeks Criminal Contempt Over Herbal Supplement Store

    The U.S. Department of Justice on Wednesday sought a criminal contempt finding against the operator of an online herbal supplement store in Montana federal court, alleging he’s continued to sell products falsely professing to cure serious diseases despite two court orders to shut his business down.

  • July 29, 2015

    European Commission OKs Mylan's Hostile Perrigo Takeover

    The European Commission has cleared drugmaker Mylan NV to acquire Irish pharmaceutical company Perrigo Co. PLC, Mylan announced Wednesday, bringing it a step closer to closing the $35.6 billion hostile bid, which Perrigo rejected earlier this year.

  • July 29, 2015

    Celgene Wants Sanctions For 'Abusive' AIA Review Petition

    Celgene Corp. filed on Tuesday a motion for sanctions against an organization tied to hedge fund manager Kyle Bass, arguing the group’s challenge to Celgene’s drug patents is an abuse of the American Invents Act review program.

  • July 29, 2015

    J&J, Janssen Face Risperdal Suit From Cherokee Nation

    Johnson & Johnson Inc. and subsidiary Janssen Pharmaceuticals Inc. removed a suit to Oklahoma federal court in which the Cherokee Nation claims that the companies misbranded its anti-psychotic Risperdal and failed to disclose the drug's risk to the elderly.

  • July 29, 2015

    The Top Product Liability Cases Of 2015: Midyear Report

    A New Jersey judge departed from his predecessor in dismissing hundreds of suits in the consolidated Accutane litigation, General Motors Co. secured a Chapter 11 shield from certain ignition switch liability suits, and asbestos plaintiffs in New York City won a decision that will aid their fight for punitive damages. Here, Law360 looks at the year's most significant product liability cases so far.

Expert Analysis

  • Prosecution Of Off-Label Speech In A Post-Caronia World

    Emily L. Pincow

    At the heart of the dispute in Amarin Pharma Inc. v. U.S. Food and Drug Administration before the Southern District of New York is the complaint that the federal government cannot prosecute the simple promotion of a drug’s off-label use because such an interpretation raises First Amendment concerns, says Emily Pincow of Weil Gotshal & Manges LLP.

  • Why UK Backed Off From Loyalty Rebate Abuse Probe

    Diarmuid Ryan

    While the U.K. Competition and Markets Authority's decision to close its investigation into loyalty-inducing discounts offered by a pharmaceutical firm suggests a continuing reluctance to devote resources to complex abuse of dominance probes, the fact that the CMA investigated this for a year, together with the more active enforcement by other European competition authorities, shows that firms that may be dominant cannot afford to ... (continued)

  • The Contentious Biosimilar Nonproprietary Naming Debate

    Joanne Hawana

    The U.S. Food and Drug Administration should be releasing initial policy positions soon on nonproprietary naming for biological products. Joanne Hawana of Mintz Levin Cohn Ferris Glovsky and Popeo PC examines both sides of the debate.

  • REBUTTAL: The Problem With 3rd-Party Litigation Financing

    Lisa Rickard

    Manipulating gender disparity in the service of hawking a flawed investment product does nothing but trivialize a serious and important issue. The tortured logic in Burford Capital LLC’s recent plug for third-party litigation financing is nothing more than a marketing ploy to boost revenues, says Lisa Rickard, president of the U.S. Chamber Institute for Legal Reform.

  • Recent Lessons In D&O Fee Advancement And Indemnification

    David L. Goldberg

    A Third Circuit decision in IP theft case Aleynikov v. Goldman Sachs Group Inc. and the Delaware Chancery Court’s ruling in insider trading suit Holley v. Nipro Diagnostics Inc. have raised important issues regarding fee advancement bylaws. For one, a litigant will not be considered an “officer” simply based on his or her title, say attorneys with Katten Muchin Rosenman LLP.

  • Informing The Artisan: Reasonable Certainty In Patent Claims

    Neil Steinkamp

    By clarifying the standard against which patent definiteness is evaluated, the U.S. Supreme Court in Nautilus has articulated the role of reasonable certainty in patent claim construction. While there is no bright-line test to define reasonable certainty, the concept of reasonableness itself is well accepted as the basis of the common law system, say Neil Steinkamp and Robert Levine of Stout Risius Ross Inc.

  • Ex Ante Vs. Ex Post: Janis Joplin’s Yearbook Revisited

    Paul E. Godek

    Fisher and Romaine’s well-known article, “Janis Joplin’s Yearbook and the Theory of Damages,” argues that commercial damages should be measured as of the time the challenged act occurred, an approach that has generally been favored. However, their argument is somewhat contrived, says Paul Godek, principal at MiCRA and a former economic adviser at the Federal Trade Commission.

  • Amgen, Sandoz Both Winners And Losers At Federal Circuit

    Paul A. Calvo, Ph.D.

    The lack of unanimity, combined with the exceptional importance of this decision to the biopharmaceutical industry suggests that one or both litigants may seek en banc rehearing, say Dr. Paul Calvo and Timothy Shea Jr. of Sterne Kessler Goldstein & Fox PLLC.

  • Procuring Personalized Medicine Patents In US Vs. Europe

    Gabriela Coman

    In the United States, many patent claims related to personalized medicine are being challenged based on patentable subject matter, whereas in Europe, most claims are questioned based on novelty and inventive step, says Gabriela Coman of Dickstein Shapiro LLP.

  • Inside FDA Regulation Of Antibody Drug Conjugates

    Charles E. Lyon

    Understanding how the U.S. Federal Drug Administration regulates antibody drug conjugates and how regulatory data exclusivity will likely be awarded for different types of ADCs is of critical importance to life science companies that are developing these new types of innovative and targeted biopharmaceuticals, say Charles Lyon and Robert Sahr at Choate Hall & Stewart LLP.