Life Sciences

  • September 19, 2014

    Full Fed. Circ. Won't Eye 'Mandate Rule' In Becton IP Case

    The full Federal Circuit decided Friday not to review the so-called mandate rule requiring lower courts to strictly comply with appeals court decisions, rejecting Becton Dickinson and Co.'s argument that the rule was misapplied when the court refused to reduce a $5 million patent verdict against it.

  • September 19, 2014

    Biotechs Brave Market As Historic IPO Grabs Spotlight

    Three biotechs and a health care provider quietly kicked off trading this week, braving the market as all eyes were fixed on e-commerce giant Alibaba Group Holding Ltd.’s public debut on the New York Stock Exchange, after it raised a startling $21.8 billion.

  • September 19, 2014

    Merck, BMS Circling Deal With Cipla Over Sustiva Generic

    Merck Sharp & Dohme Corp. and Bristol-Myers Squibb Co. may be nearing the end of a patent row with Cipla USA Inc. over Cipla’s plans to make a generic version of the antiretroviral drug Sustiva, according to a letter filed on Thursday in New Jersey federal court.

  • September 19, 2014

    HHS Watchdog Warns Of Coupon Kickbacks In Part D

    Brand-name drugmakers have imperfect systems for preventing use of copay coupons in Medicare Part D and may be letting millions of seniors access discounts that constitute illicit kickbacks, the Office of Inspector General at the U.S. Department of Health and Human Services reported Friday.

  • September 19, 2014

    FDA Chides Cipher Over Drug Ad's Superiority Claims

    Canada-based Cipher Pharmaceuticals Inc. improperly advertised that its distinctive formulation of cholesterol drug fenofibrate makes the product more effective than versions sold by rival companies, according to a Thursday disciplinary letter from the U.S. Food and Drug Administration.

  • September 19, 2014

    Citing Lexmark, Drug Co. Says Bayer Couldn't Cancel Mark

    A small U.S. drugmaker wants a federal judge to overturn a trademark office ruling that said its registration for “Flanax” was an attempt to free-ride on Bayer AG's international brand name for Aleve, arguing that the recent Lexmark ruling means Bayer didn't have standing to bring the case.

  • September 19, 2014

    Allergan Defends Redactions In Valeant Insider Trading Suit

    Allergan Inc. on Thursday asked a California federal court to reject Valeant Pharmaceuticals International Inc.'s attempts to bar it from redacting documents in its insider trading suit against Valeant, saying its rival only wants the documents to help a $53 billion hostile takeover bid. 

  • September 19, 2014

    Bill Exposes Drug Cos. To Suits For Abusing Safety Controls

    New legislation in the U.S. House of Representatives would let generic-drug makers sue for heavy damages if brand-name manufacturers, under the guise of drug-safety restrictions, refuse to supply products needed for the testing and approval of copycat medications.

  • September 19, 2014

    FCA Free Speech Defense Tested In DOJ-PhRMA Fight

    A fiery feud in California federal court between the U.S. Department of Justice and Pharmaceutical Research and Manufacturers of America shows the gloves are finally off in a fight that will shape the future of False Claims Act litigation, experts say, with opposing sides clashing over whether the First Amendment always shields honest off-label promotion.

  • September 19, 2014

    GSK Fined Record $489M For Bribery In China

    GlaxoSmithKline PLC was fined a record 3 billion yuan ($488.5 million) on Friday for bribing doctors in a verdict handed down by a Chinese court, which also sentenced several of the drugmaker’s executives to up to four years in prison, according to Chinese media reports.

  • September 19, 2014

    Dealmakers Q&A: Crowell & Moring's Bryan Brewer

    Big data and information technology are poised to play prominent roles in upcoming transactions. The companies and investors that seem to be placing a high value on these dynamics appear to have an influence on results in pricing and the overall success of the transaction after it closes, says Bryan Brewer, co-chairman of Crowell & Moring LLP's corporate group.

  • September 19, 2014

    Dealmakers Q&A: Nelson Mullins' Brian Moore

    The potential risks for successor liability even after exhaustive due diligence, coupled with the costs in terms of corporate resources and time to conduct such due diligence, have in recent years had a chilling effect on mergers and acquisitions involving companies with significant overseas operations, says Brian Moore of Nelson Mullins Riley & Scarborough LLP.

  • September 18, 2014

    ProQR Prices IPO At $102M Despite Other Biotech Flops

    Dutch biopharmaceutical company ProQR Therapeutics BV is going through with plans to raise up to $102 million in an initial public offering despite two biotech IPOs flopping earlier this month.

  • September 18, 2014

    Takeda Hid Actos Bladder Cancer Risks, Philly Jury Hears

    An expert witness testifying on behalf of a woman who claims she developed bladder cancer after taking the diabetes drug Actos told a Philadelphia jury on Thursday that Takeda Pharmaceuticals Co. Ltd. had worked to suppress information about the cancer risks associated with the medication.

  • September 18, 2014

    Testosterone Booster False-Ad Row Survives Dismissal Bid

    A California federal judge ruled Wednesday that a proposed consumer class can’t seek to bar Infinitelabs LLC from making misleading claims that its supplement aids testosterone production, since the plaintiff won’t buy the product again, but allowed the remaining claims to move forward.

  • September 18, 2014

    White House Gears Up To Combat Drug-Resistant Bacteria

    The White House on Thursday announced a five-year plan to fight the rise of antibiotic-resistant bacteria, including the establishment of a new $20 million prize for diagnostic testing to help health care providers quickly identify highly resistant bacterial infections.

  • September 18, 2014

    Medtronic Pays States To Settle Defibrillator FCA Claims

    Medtronic Inc. reached an agreement with 46 states and the District of Columbia to settle a whistleblower's False Claims Act allegations that the company offered illegal kickbacks to physicians to implant its pacemakers and defibrillators, in a deal that follows a $10 million federal settlement, New York’s attorney general said on Thursday.

  • September 18, 2014

    FDA Panel Targets Testosterone Therapy Risks

    A U.S. Food and Drug Administration advisory panel on Wednesday urged the agency to direct testosterone therapy drug manufacturers to further assess the cardiovascular risks associated with their treatments and recommended the agency revise the therapy’s current indication.

  • September 18, 2014

    Eli Lilly Slams NY Cymbalta Suit As Possible MDL Looms

    Eli Lilly & Co. on Wednesday sought early dismissal of a suit alleging it failed to warn a New York man he would suffer negative withdrawal effects when he stopped taking the antidepressant Cymbalta, hoping to moot more than two dozen similar cases in proposed multidistrict litigation.

  • September 18, 2014

    Bayer To Spin Off $10B Polymer Biz In Public Listing

    German pharmaceutical powerhouse Bayer AG said Thursday it will spin off its $10 billion plastics unit into a separate publicly traded business to free up resources for its more profitable health-related operations, falling in step with other life sciences giants who are refining their portfolios.

Expert Analysis

  • Criminal Division Wants In On FCA Whistleblower Complaints

    Christopher Wray

    Now that an early criminal review by the U.S. Department of Justice will be standard operating procedure in every whistleblower matter — in addition to potentially concurrent review by criminal assistant U.S. attorneys in the district where the qui tam action is filed — False Claims Act defendants may face a greater threat of prosecution, say attorneys with King & Spalding LLP.

  • New, Final DEA Drug Disposal Rules Are Shady On Details

    Ronald J. Friedman

    The lack of accountability over the Drug Enforcement Administration's drug diversion mail back and collection receptacle programs runs counter to current regulations for existing “reverse distributors,” who are required to maintain very detailed records on drugs they receive prior to disposal, says Ronald Friedman of Lane Powell PC.

  • TAA Case Is Study On Contractors' FCA Vulnerability

    Donna Lee Yesner

    Cox v. Smith & Nephew Inc. highlights the vulnerability of medical device manufacturers that source products from nondesignated countries under the Trade Agreements Act to potential False Claims Act liability and the need for diligence in ascertaining the country of origin for goods under government contract, say Donna Yesner and Stephen Ruscus of Morgan Lewis & Bockius LLP.

  • Generics Need Sword, Shield For 'Exceptional' Patent Case

    Jeffrey Hovden

    Following the U.S. Supreme Court decisions in Octane Fitness and Highmark, brands may find it easier to get exceptional-case fees and costs from generics. Generics — already struggling at the margin to maximize their litigation budgets — need to get a firm grip on this development so that they can avoid paying these fees, and maybe even turn the tables on their adversaries, says Jeffrey Hovden of Robins Kaplan Miller & Ciresi LLP.

  • AIA Section 102 — Simplified

    Paul Morgan

    Section 102 is perhaps the most important provision of the America Invents Act — but, not surprisingly, it is not a model of plain English. I attempted to rewrite it in simpler, shorter language for easier understanding, says Paul Morgan, former assistant chief patent counsel at Xerox Corp.

  • Post-Nautilus Most Indefinite Patent Challenges Fail

    John T. Gutkoski

    Since the U.S. Supreme Court issued Nautilus Inc. v. Biosig Instruments Inc. and adopted the new “reasonable certainty” standard for finding patent claim terms indefinite, courts have found the vast majority of claim terms to be sufficiently definite — whether viewed on a case-by-case or term-by-term basis, the vast majority of indefiniteness challenges have failed, say attorneys at Hiscock & Barclay LLP.

  • Takeaways For Generics After Octane And Highmark

    Charles J. Andres Jr.

    The U.S. Supreme Court’s replacement of a “rigid” circuit court rule in Highmark Inc. v. Allcare Health Management System Inc. and Octane Fitness LLC v. Icon Health & Fitness Inc. with a more flexible standard has ample precedent, thus although fee-shifting awards as an equitable remedy should still be the exception we anticipate their frequency to increase, say attorneys at Wilson Sonsini Goodrich & Rosati PC.

  • OPINION: Why Didn’t McDonnell Plead Guilty?

    Daniel Suleiman

    Given the price of defeat and the strength of the government’s evidence, why didn’t former Virginia Governor Robert McDonnell plead guilty when he had the chance? There are three common reasons why white collar criminal defendants choose to fight instead of admit guilt, says Daniel Suleiman, special counsel at Covington & Burling LLP and a former senior official in the U.S. Department of Justice Criminal Division.

  • OPINION: Pro Bono May Help Diversity Recruiting Efforts

    David A. Lash

    A recent Law360 article about the perennial BigLaw concern over how to recruit and retain female and ethnically diverse attorneys addressed a new approach being taken by some law firms — going beyond traditional mentoring programs by creating a sponsorship relationship. Pro bono can also play a part, say David Lash and Merle Vaughn of the Association of Pro Bono Counsel.

  • 2nd Circ. Limits Monopolist Duty To Deal With Competitors

    John Elliott

    In the recent Adderall XR case, a Second Circuit panel ruled that an alleged monopolist patent-holding drug manufacturer’s alleged breach of an agreement to supply a patented drug to competing manufacturers did not violate the Sherman Act. This decision provides yet another illustration of the limits of the U.S. Supreme Court's decision in Aspen Skiing, say John Elliott and Irving Scher of Greenberg Traurig LLP.