Life Sciences

  • October 31, 2014

    Sanofi's Duty To Detail FDA Concerns Key To Lemtrada Cases

    A New York federal judge asked Friday whether Sanofi's "very happy opinion" shared with investors about prospects for on-time approval of its potential blockbuster Lemtrada multiple sclerosis drug carried with it a duty to detail concerns among regulators about bias in the single-blind method by which the drug giant and its recently acquired Genzyme Corp. unit were conducting trials.

  • October 31, 2014

    Medicare-Medicaid Billing To Face HHS Scrutiny In 2015

    The Office of Inspector General at the U.S. Department of Health and Human Services on Friday detailed its investigative priorities for fiscal 2015, vowing to scrutinize Medicare and Medicaid billing by insurance plans, medical device makers and an array of health care providers.

  • October 31, 2014

    Consumer Group Takes Stem Cell Patent Fight To High Court

    A consumer group that was barred by the Federal Circuit from challenging a University of Wisconsin-Madison stem cell patent asked the U.S. Supreme Court Friday to review the ruling, saying the appeals court's finding that it lacks standing "violates fundamental fairness and plain common sense."

  • October 31, 2014

    7th Circ. Casts A Wary Eye On Supplement Labeling Deal

    A Seventh Circuit panel on Friday grilled NBTY Inc. and plaintiffs’ attorneys about the $6.5 million settlement they struck in a glucosamine supplement false labeling class action, questioning how the class ended up with only $900,000 and a dubious label change.

  • October 31, 2014

    Actavis, NY AG Spar Over Antitrust Suit Injunction Bid

    The New York attorney general has urged a federal judge to block Actavis PLC from pulling its widely used dementia drug Namenda from the market until the office's antitrust suit concludes, while the drugmaker countered that the standards required for an injunction have not been met.

  • October 31, 2014

    Atossa Beats Claims It Duped Investors In $4M Offering

    A Washington federal court on Friday dismissed a proposed class action alleging breast cancer detection device maker Atossa Genetics Inc. misled investors into buying $3.7 million worth of shares in an initial public offering, saying the plaintiffs failed to adequately prove the company had acted unlawfully.

  • October 31, 2014

    8 Ballot Measures Attorneys Will Be Watching

    Voters on Tuesday will decide the fate of myriad state and local initiatives that address issues as varied as fracking, medical marijuana and care for terminally ill patients. Here, Law360 looks at eight ballot initiatives that could have significant nationwide implications, should they pass or fail.

  • October 30, 2014

    Eli Lilly, Takeda Plan Appeal Of $37M Actos Ruling

    Takeda Pharmaceuticals International Inc. and Eli Lilly & Co. said Thursday they will appeal a $37 million punitive damages ruling against them in a suit that alleged the company hid the cancer risks of diabetes drug Actos to keep sales high.

  • October 30, 2014

    BMS, Sanofi Get Gene Patent Partially Invalidated In IP Suit

    A Delaware federal judge invalidated part of a DNA technology patent Genetic Technologies Ltd. accused Bristol-Myers Squibb Co. and a Sanofi-Aventis SA unit of infringing because it merely described a natural law, dooming the claim under the U.S. Supreme Court’s landmark Mayo v. Prometheus decision.

  • October 30, 2014

    Insurer On The Hook For Stryker Defect Claims, Judge Rules

    TIG Insurance Co. is liable for $7.6 million in excess coverage obligations for Stryker Corp.’s settlement of artificial knee defect lawsuits, a Michigan federal judge ruled Thursday, finding the insurer wasn’t required to consent to the deals for Stryker to secure coverage.

  • October 30, 2014

    Merck Unit Says Fed. Circ. Erred In AllPure Patent Ruling

    Merck KGaA unit EMD Millipore Corp. urged the Federal Circuit to reconsider its decision that rival AllPure Technologies Inc. didn't infringe a device patent for withdrawing fluid from a container, saying Wednesday that the panel’s decision was contrary to “well-settled law” on prosecution history estoppel.

  • October 30, 2014

    SEC Hits InterMune Exec With Insider Trading Suit

    The U.S. Securities and Exchange Commission on Thursday filed suit against a former director of pharmaceutical company InterMune Inc., alleging he and his friends made more than $1 million using insider information to trade on the news of European regulators’ approval of a lung disease drug.

  • October 30, 2014

    Life Sciences Groups Assail SF’s Drug 'Take-Back' Plan

    Five drug manufacturing and health care organizations spoke out on Thursday against a proposed San Francisco ordinance requiring pharmaceutical companies to pay for the collection of unwanted drugs, saying it would have little positive health impact while forcing drug companies to bear the full burden of running the program.

  • October 30, 2014

    9th Circ. Revives Amgen ERISA Suit After High Court Remand

    The Ninth Circuit on Thursday revived a putative Employee Retirement Income Security Act class action against Amgen Inc. for a second time, after the U.S. Supreme Court vacated its first ruling, saying the high court's ruling doesn't shield Amgen from liability for a dip in the company's stock price.

  • October 30, 2014

    Anemia Biotech FibroGen Readies For $124M IPO

    Anemia treatment developer FibroGen. Inc. fine-tuned its initial public offering plans Thursday, setting the stage to raise about $124 million and become the largest biotech by diluted market capitalization in a decade.

  • October 30, 2014

    Rhythm Drops $86M IPO Plan After Actavis Deal

    Rhythm Pharmaceuticals Inc. on Wednesday pulled its planned $86 million initial public offering after the company reached a deal last week with Actavis PLC for an exclusive option to purchase one of its gastrointestinal drug subsidiaries.

  • October 30, 2014

    Convicted Ex-Pfizer Manager Won't Testify In Off-Label Suit

    A former Pfizer Inc. sales manager who was convicted in 2009 for illegal drug marketing can’t be forced to testify in a class action suit alleging the pharmaceutical giant concealed a broader fraud scheme from investors, a New York federal judge ruled Thursday.

  • October 30, 2014

    11th Circ. Sends Trade Secret Dispute To Arbitration

    The Eleventh Circuit on Thursday sent to arbitration a dispute brought by U.S. Nutraceuticals LLC alleging that microalgae products maker Cyanotech Corp. breached an agreement by stealing confidential information.

  • October 30, 2014

    Jones Day Adds Ex-Womble Carlyle Tobacco Litigator

    Jones Day has strengthened its business and tort litigation practice by adding to its Atlanta office a former federal prosecutor and Womble Carlyle Sandridge & Rice PLLC partner who has extensive experience in tobacco and pharmaceutical litigation.

  • October 29, 2014

    GSK, Apexus Escape Drug Discount Antitrust Suit

    A Nevada federal judge on Wednesday tossed a private clinic’s suit accusing GlaxoSmithKline LLC, nonprofit Apexus Inc. and a public health agency of abusing a federal drug-discount program, ruling the agency’s purchase of vaccines was exempted from an antitrust law.

Expert Analysis

  • Recall Or Enhancement? Read These Medical Device Rules

    Pamela F. Forrest

    A significant departure in the U.S. Food and Drug Administration's final guidance on distinguishing medical device recalls from enhancements involves changes to references of nonviolative devices and nonviolative labels — the addition of a new warning now will not be considered a recall, say attorneys at King & Spalding LLP.

  • New Guidelines Suggest A Friendlier European Patent Office

    Philip Cupitt

    While many of the changes in the latest European Patent Office guidelines reflect the current practice of the EPO’s boards of appeal, they also suggest that the first-instance departments of the EPO may be moving toward a less rigid and formalistic approach to some issues, say Philip Cupitt and Hazel Ford of Finnegan Henderson Farabow Garrett & Dunner LLP.

  • HHS Looks To Existing Procurement Tool For Ebola Drugs

    Jennifer Plitsch

    For companies with an interest in assisting the government in its Ebola prevention and treatment efforts, a strong working understanding of a broad agency announcement originally issued by the U.S. Department of Health and Human Services in 2009 is vital, say Jennifer Plitsch and Michael Wagner of Covington & Burling LLP.

  • A Look At The First Ebola-Related Securities Lawsuit

    Kevin M. LaCroix

    It is obvious that there is a segment of the investment marketplace convinced there is money to be made out of the Ebola outbreak by trying to pick the winners on the Ebola drug derby. Among the companies that got caught up in the frenzy was iBio Inc., says Kevin LaCroix of RT ProExec.

  • A Close Look At The First 2 Post-Grant Review Petitions

    Lisa Mueller

    Not surprisingly, it took a while before the first petitions for post-grant review were filed, but LaRose Industries LLC and Toys “R” Us-Delaware Inc. filed in August, and Accord Healthcare Inc. filed in September. If one or both petitions are granted, one question will be whether the Patent Trial and Appeal Board will be able to issue a decision within the mandatory 12-18 months, says Lisa Mueller of Michael Best & Friedrich LLP.

  • Looking At Lanham Act Claims Against Drug Cos. Post-Pom

    Maia H. Harris

    A California district court's ruling in JHP Pharmaceuticals LLC v. Hospira Inc. may persuade other courts to either extend the U.S. Supreme Court's generally permissive view of Lanham Act claims to drugs and cosmetics or find some claims that previously required U.S. Food and Drug Administration expertise may now be precluded after Pom Wonderful LLC v. The Coca-Cola Company, say attorneys at Nixon Peabody LLP.

  • Use Social Media For Legal Service Only As A Last Resort

    Steven Richard

    Courts remain largely skeptical about allowing litigants to serve and notify evasive parties of legal proceedings through their social media accounts. A recent split ruling by the Oklahoma Supreme Court shows the competing considerations, say Steven Richard and Britt Killian of Nixon Peabody LLP.

  • New Restrictions On Int'l Trade In Genetic Resources

    Bruce Manheim

    Although the U.S. has not signed or ratified the Nagoya Protocol, U.S. companies that utilize genetic resources from other countries for scientific research or commercial purposes will be subjected to these new requirements and restrictions. With many countries already vigorously enforcing such restrictions, the consequences of not fully complying may be draconian, says Bruce Manheim of WilmerHale.

  • OIG Remains Focused On Pharmaceutical Copayment Coupons

    Eve M. Brunts

    A report and special advisory bulletin from the U.S. Department of Health and Human Services' Office of Inspector General are the latest examples of ongoing scrutiny and challenges involving copayment coupons offered by pharmaceutical manufacturers, say Eve Brunts and Smita Singh of Ropes & Gray LLP.

  • New Jurisdictional Issues When Moving To Quash A Subpoena

    Steven Luxton

    The Nevada federal court's recent ruling in Agincourt Gaming LLC v. Zynga Inc. is an important reminder that a nonparty wanting to challenge a civil subpoena should consider carefully the appropriate jurisdiction in which to file a motion to quash under recently enacted Rule 45, say Steven Luxton and Brad Nes of Morgan Lewis & Bockius LLP.