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Life Sciences

  • December 12, 2018

    FDA Explains Expectations For Drugmakers' Data Retention

    The U.S. Food and Drug Administration answered drugmakers’ questions Wednesday about how to maintain data from drug tests and the manufacturing floor, following an uptick in violations of federal information retention standards.

  • December 12, 2018

    8th Circ. Won't Revive Express Scripts Breach, Antitrust Suit

    The Eighth Circuit on Wednesday summarily shot down a New York pharmacy’s bid to revive its breach of contract and antitrust suit against Express Scripts Holding Co.

  • December 12, 2018

    Boston Scientific Wins $35M Verdict In Heart Valve Patent Suit

    A Delaware federal jury found Tuesday that Edwards Lifesciences Corp. damaged Boston Scientific SciMed Inc. to the tune of $35.4 million by infringing a heart valve patent, while rejecting claims that Boston Scientific infringed three Edwards patents.

  • December 12, 2018

    IMMC Trustee Wants 3rd Circ. Redo In Ch. 11 Transfer Fight

    A liquidating trustee of bankrupt mining company IMMC Corp. asked the full Third Circuit Wednesday to revisit its precedential November decision that a Delaware bankruptcy court lacked jurisdiction to transfer his $250 million adversary proceeding to Pennsylvania district court, arguing that the ruling contravened U.S. Supreme Court precedent along with the applicable law.

  • December 12, 2018

    FDA Boss Vows Crackdown On Stem Cell, Supplement Cos.

    The U.S. Food and Drug Administration’s leader on Wednesday said that tougher enforcement is coming in early 2019 for bogus claims or shoddy manufacturing involving stem cell therapies, dietary supplements and compounded drugs.

  • December 12, 2018

    1-800 Contacts Asks FTC To Stay Ruling Axing Ad Compacts

    Online retailer 1-800 Contacts Inc. has asked the Federal Trade Commission to stay part of its recent ruling knocking out more than a dozen of the lensmaker’s marketing agreements, saying the decision goes too far and blocks the company from enforcing its own trademarks and keeping up with competitors.

  • December 12, 2018

    Fed. Circ. OKs Teva's Patent Win Over Allergan Colitis Drug

    Teva Pharmaceuticals USA Inc. scored a win on Wednesday when the Federal Circuit affirmed an Eastern District of Texas ruling that the generics maker did not infringe Allergan USA’s patent for the ulcerative colitis drug Delzicol, paving the way for Teva to get approval on the generic version of the drug.

  • December 12, 2018

    EU Court Slashes €100M From Servier Pay-For-Delay Fine

    A European court on Wednesday reduced a fine by €102.67 million ($116.73 million) that enforcers levied against pharmaceutical company Servier over allegations it reached several anti-competitive agreements to delay cheaper versions of blood pressure medicine perindopril, but rejected appeals of fines from most of the other companies involved.

  • December 12, 2018

    Synergy Pharma Files Ch. 11, Bausch Health Offers $200M Bid

    Biopharmaceutical company Synergy Pharmaceuticals Inc. filed for Chapter 11 in New York bankruptcy court on Wednesday, with plans to shrug off its $130 million debt load by selling itself to Bausch Health Companies Inc. for an opening bid of roughly $200 million.

  • December 12, 2018

    'Bundle' Buys Don't Avert FCA Liability, Feds Say In Bayer Suit

    The federal government has weighed in on a whistleblower suit accusing Bayer Corp. of paying kickbacks to get doctors to use a surgery drug called Trasylol, saying the company can still be held liable under the False Claims Act even though the government pays for the drugs as part of a bundle rather than individually.

  • December 12, 2018

    Ex-Biotech Exec Avoids Prison For Lying To SEC

    A California biotech entrepreneur avoided jail time Wednesday for lying to the U.S. Securities and Exchange Commission, receiving five months' home confinement and up to five years' probation from a Massachusetts federal judge on a conviction stemming from a pump-and-dump scheme.

  • December 12, 2018

    MVP: Greenberg Traurig's Lori Cohen

    Lori Cohen, co-chair of Greenberg Traurig’s global litigation practice and chair of the firm's trial practice group, spearheaded big wins for life sciences clients in the past year, including the Seventh Circuit's rejection of state lawsuits in national litigation over eye drop doses, earning her a spot among Law360's 2018 Life Sciences MVPs.

  • December 11, 2018

    Amgen's Biosimilar IP Win Was Wrong, Hospira Tells Fed. Circ.

    Hospira has urged the Federal Circuit to toss a $70 million jury verdict finding its biosimilar version of Amgen Inc.’s blockbuster anemia treatment Epogen infringed an Amgen patent, arguing its drug production was protected by a safe harbor for companies seeking federal approval for biosimilar products.

  • December 11, 2018

    Fed. Circ. OKs Stryker's $248M IP Win After High Court Trip

    The Federal Circuit on Monday affirmed Stryker Corp.’s $248 million win in a surgical tool patent dispute that had previously gone to the U.S. Supreme Court as part of a case that set a new and more relaxed standard for awarding enhanced damages in patent suits.

  • December 11, 2018

    Dental Products Maker Expands IP War Against Rival At ITC

    A California-based dental products maker has added to its expanding intellectual property battle with a Danish rival over patents covering intraoral scanners and related equipment, filing two complaints Tuesday in Delaware federal court and one complaint Monday at the U.S. International Trade Commission.

  • December 11, 2018

    Full Fed. Circ. Urged To Review Venue In Cialis Patent Fight

    Weighing in on venue rules in patent infringement disputes, nonprofit Washington Legal Foundation urged the full Federal Circuit on Monday to rehear arguments by Eli Lilly and Co. that a Cialis dispute resulting in a $20 million verdict against the pharma giant shouldn’t have been litigated in East Texas.

  • December 11, 2018

    Accountant Seeks No Prison Time For $18M Tax Return Fraud

    An accountant found guilty of helping a venture capitalist siphon $18 million from a fund through false tax returns has told a California federal court he should serve no time behind bars despite prosecutors' request for a "significant" prison sentence.

  • December 11, 2018

    ImmunoCellular Investors Seek OK Of $1.1M Stock Hype Deal

    Investors suing ImmunoCellular Therapeutics Ltd. over an alleged illegal stock promotion scheme asked a California federal judge Monday to preliminarily approve a $1.1 million settlement nearly equal to the company's entire market capitalization.

  • December 11, 2018

    Hoffman La-Roche Can't Keep Malaria Drug Suit In Fed. Court

    A California federal judge overseeing allegations that Hoffmann La-Roche Inc.'s anti-malarial drug neurologically harmed a Navy veteran has sent the case back to state court, ruling there wasn't federal diversity jurisdiction because the company's principal place of business is in California, not New Jersey.

  • December 11, 2018

    GNC Investors Can't Revive Securities Suit In 3rd Circ.

    GNC knocked down a proposed securities class action accusing the retailer of misleading investors about nutrition supplements that contained unlawful ingredients after the Third Circuit found Tuesday that the plaintiffs have not sufficiently alleged that company executives were knowingly or recklessly deceptive.

Expert Analysis

  • 10 Tips For Law Firms To Drive Revenue Via Sports Tickets

    Matthew Prinn

    Many law firms have tickets or luxury suites at sporting events to host clients and prospects. Matthew Prinn of RFP Advisory Group and Matt Ansis of TicketManager discuss some of the ways that firms can use those tickets effectively.

  • Inside Key ABA Guidance On Attorneys' Cybersecurity Duties

    Joshua Bevitz

    A recent opinion from the American Bar Association provides useful guidance on attorneys’ obligations to guard against cyberattacks, protect electronic client information and respond if an attack occurs, says Joshua Bevitz of Newmeyer & Dillion LLP.

  • Revising FDA 510(k) Poses Challenges For Device Makers

    Patricia Kaufman

    The U.S. Food and Drug Administration wants to "modernize" the approval process for medical devices based on older products by encouraging developers to use more modern devices as predicates. This does not mean older devices are unsafe, but the negative implication seems undeniable, say Patricia Kaufman and Joel Schwartz of Stinson Leonard Street LLP.

  • Fed. Circ. Provides Clarity On Patent Term Questions

    Irena Royzman

    Two recent decisions from the Federal Circuit — Novartis AG v. Ezra Ventures and Novartis Pharmaceuticals v. Breckenridge Pharmaceutical — clarify the law of "obviousness-type double patenting" and give certainty to biopharmaceutical patent owners, say Irena Royzman and Andrew Cohen of Patterson Belknap Webb & Tyler LLP.

  • Opening Comments: A Key Strategic Decision In Mediation

    Jann Johnson

    Opening comments by parties in mediation that are made with the proper content and tone can diffuse pent-up emotion and pave the way for a successful resolution. But an opening presentation can do more harm than good if delivered the wrong way, say Jann Johnson and William Haddad of ADR Systems LLC.

  • Proposed FDA Drug Software Rules Strict On Pharma Cos.

    Albert Cacozza

    If implemented, the U.S. Food and Drug Administration's proposed framework for regulating prescription drug-use-related software would likely mean that pharmaceutical companies will need to exert more control over certain software applications and be more involved in software update processes, say attorneys at Ropes & Gray LLP.

  • Post-Teva Expert Disclosure Trends In 2 Patent-Rich Districts

    Ken Fung

    Local patent rules in the Eastern District of Texas and Northern District of California don’t squarely address the issue of what must be disclosed during claim-construction discovery in order to rely on expert declarations. But thanks to the corpus of post-Teva decisions a clearer picture has emerged, says Ken Fung of Fisch Sigler LLP.

  • State Net

    More State Issues The Blue Wave May Shape In 2019

    Rich Ehisen

    In the second installment of this three-part legislative preview, Rich Ehisen of State Net Capitol Journal examines a number of issues that should keep state lawmakers occupied next year.

  • Why The High Court Will Hear Cochise Consultancy V. US

    Matthew Curley

    The U.S. Supreme Court recently agreed to hear Cochise Consultancy v. United States ex rel. Hunt, which deepened the circuit split over how the False Claims Act’s statute of limitations applies in certain qui tam actions. The decision should bring sorely needed clarity, say Matthew Curley and Scott Gallisdorfer of Bass Berry & Sims PLC.

  • A Firsthand Account Of The Helsinn V. Teva Arguments

    Michael Pomianek

    During U.S. Supreme Court oral arguments in Helsinn Healthcare v. Teva Pharmaceuticals, the justices’ focus on the statutory language, and the relative lack of focus on the specific facts of the case, suggest they may address the meaning of the America Invents Act language broadly, say Michael Pomianek and Michelle Nyein of Wolf Greenfield & Sacks PC.