Life Sciences

  • September 2, 2015

    Homeopathic Co. CEO Defends Testing At $350M False Ad Trial

    The CEO of Hyland's Inc., an alternative medicine maker accused by a certified class of cheating customers out of $350 million through false advertising, defended his company's product-testing in front of a California federal jury Wednesday, saying studies showing the products don’t work are incomplete or poorly designed.

  • September 2, 2015

    Supreme Court Lifts Stay On Akebia, FibroGen Patent Fight

    The Supreme Court vacated a stay Wednesday that Justice Anthony Kennedy had granted two days before at the request of FibroGen Inc. on discovery sought by Akebia Therapeutics Inc. to aid in its challenges occurring at the European and Japanese patent offices over two FibroGen anemia drug patents.

  • September 2, 2015

    Female Workers Win Conditional Cert In $100M Sex-Bias Row

    A New York federal judge on Wednesday conditionally certified a group of female workers who filed a $100 million gender bias suit accusing Forest Laboratories Inc. of widespread discrimination, saying the employees cleared the minimal hurdle required for initial certification.

  • September 2, 2015

    Trial Wins Boost Eli Lilly In Cymbalta Cases As MDL Bid Looms

    Eli Lilly & Co.'s third straight trial win over the withdrawal risks of its antidepressant Cymbalta sealed the company's success in persuading a federal jury that warnings on the drug were adequate, a key finding that defense attorneys say gives the drugmaker an edge in an upcoming fight with plaintiffs trying to consolidate dozens of similar suits.

  • September 2, 2015

    1st Circ. Ruling Doesn't Apply In Labeling Suit, CVS Says

    A recent First Circuit decision doesn't apply to a proposed class action over vitamin E pills, CVS told a Rhode Island federal court in filings Monday, saying it was a money-back guarantee — not a relief offer — that mooted the claims.

  • September 2, 2015

    Debevoise, Fox Rothschild Rep Lannett In $1.2B Drug Co. Buy

    Debevoise & Plimpton LLP and Fox Rothschild LLP steered Philadelphia-based generic-drug maker Lannett Company Inc. in a $1.23 billion deal to acquire the U.S. specialty generic drugs unit of Belgian pharmaceuticals company UCB SA, Lannett announced Wednesday.

  • September 2, 2015

    Mass. Judge Says Pfizer Whistleblower Suit Likely To Proceed

    The Massachusetts federal judge overseeing two consolidated whistleblower suits accusing the pharmaceutical arm of Pfizer Inc. of overcharging state Medicaid programs hundred of millions of dollars for the acid reflux drug Protonix said Tuesday he was inclined to deny the company’s four-year-old motion for summary judgment.

  • September 2, 2015

    Pharmacia Shakes Schools’ Toxic Light Ballasts Suit

    An Alabama federal judge on Tuesday tossed a putative class action targeting Pharmacia Corp. over costs to replace toxic fluorescent light ballasts in schools nationwide, finding that the Tuscumbia City School System had failed to adequately back up its claims.

  • September 2, 2015

    Real Estate Rumors: Gilead Sciences, Starwood, TGM

    Gilead Sciences has reportedly dropped $120 million on two California development sites, a Starwood affiliate is said to have bought four Florida office buildings from Met Life for $82 million, and TGM Associates has reportedly bought a 400-unit Illinois multifamily property for $65 million.

  • September 2, 2015

    PTAB Denies Hedge Fund's Bid For Biogen Patent Review

    The Patent Trial and Appeal Board has dealt another setback to an organization with close ties to hedge fund manager Kyle Bass, declining Wednesday to institute an America Invents Act review of Biogen MA Inc.'s patent for the multiple sclerosis drug Tecfidera.

  • September 2, 2015

    Abbott, AbbVie Lied To Court In Depakote Suit, Plaintiff Says

    A woman suing Abbott Laboratories and AbbVie Inc. over her daughter's birth defects allegedly caused by the companies' anti-epilepsy drug Depakote pressed an Ohio federal court for sanctions on Tuesday, saying the companies had lied to secure partial summary judgment.

  • September 2, 2015

    2nd Circ. Stays Recall Of Misleading Swiss Pregnancy Tests

    The Second Circuit handed a Swiss company a two-week reprieve from a court-mandated recall of the company's pregnancy tests, which a New York federal court ruled were falsely advertised, on Tuesday referring the motion for a stay pending appeal to a three-judge panel.

  • September 2, 2015

    Amgen Can't Block Sandoz Biosimilar At Fed. Circ.

    A divided Federal Circuit on Wednesday rejected Amgen Inc.’s bid to block sales of Sandoz Inc.’s biosimilar Zarxio during continued litigation between the companies, clearing the way for the first biosimilar approved under the Biologics Price Competition and Innovation Act.

  • September 2, 2015

    Skadden-Led Valeant Inks Deal For Surgical Device Maker

    Valeant Pharmaceuticals International Inc., led by Skadden Arps Slate Meagher & Flom LLP, rolled out a tender offer for surgical device maker Synergetics USA Inc. on Wednesday, marking the deal-hungry pharmaceutical giant’s latest acquisition.

  • September 1, 2015

    PTAB Misconduct Rule Won't Deter Hedge Fund Attacks

    The latest rule package for America Invents Act reviews would arm the Patent Trial and Appeal Board with the ability to sanction attorneys for not doing an adequate prefiling investigation and for making representations to the board for an "improper purpose," a new tool that attorneys say won't likely thwart patent challenges by hedge funds that some view as an abuse of the system.

  • September 1, 2015

    Feds Tells 9th Circ. Ex-Oriole Can't Block Trading Evidence

    Federal prosecutors on Tuesday urged the Ninth Circuit to let them support their insider trading charges against former Baltimore Oriole Doug DeCinces with evidence of trades DeCinces made shortly before his alleged crime, arguing the earlier trades were the “beginning of the scheme” the ballplayer set up.

  • September 1, 2015

    Supreme Court Halts Discovery In Anemia Drug Patent Suit

    Associate Justice of the U.S. Supreme Court Anthony Kennedy on Monday granted biotech company FibroGen Inc.'s bid to pause discovery requested by rival Akebia Therapeutics Inc. to aid in its overseas challenges taking place at the European and Japanese patent offices of two FibroGen patents covering chemical compounds used in treating anemia.

  • September 1, 2015

    FDA Warning Wire: Powdered Caffeine, Kim Kardashian

    In a busy week for U.S. Food and Drug Administration enforcement, highlights included a long-awaited crackdown on producers of potentially lethal powdered caffeine and a social media mea culpa by Kim Kardashian West for dicey drug promotion on behalf of Duchesnay Inc.

  • September 1, 2015

    Plaintiffs Fight 3rd Bid To Toss Protein Powder Ad Suit

    Plaintiffs claiming MusclePharm Corp. lies about how much protein its supplement powders contain defended the proposed class action against yet another bid to toss it on Monday, telling a California federal court they had fixed problems the judge found the last time.

  • September 1, 2015

    Judge Urged To Ax 'Tortured' Zoloft Birth Defect Testimony

    A federal judge was urged during a hearing in Philadelphia on Tuesday to find that an expert witness had relied on what an attorney described as “tortured” data in order to reach his conclusion that the Pfizer Inc. antidepressant Zoloft could be linked to birth defects.

Expert Analysis

  • Patent Invalidity Rates: The Summertime Blues Continue

    Robert Sachs

    In just the first 10 days of July, there were 12 federal court decisions on patent eligibility under Section 101. By the end of July there were 21 decisions, with 17 — 81 percent — invalidating 36 patents, says Robert Sachs of Fenwick & West LLP.

  • The Tension Between Corporate Opportunity And Innovation

    Michael W. Peregrine

    In AngioScore v. TriReme Medical the district court for the Northern District of California articulates the principles of the corporate opportunity doctrine in a manner that should serve as a valuable resource for general counsel to life sciences companies, academic medical centers and other entities that often seek to commercialize health-related technology, says Michael Peregrine at McDermott Will & Emery LLP.

  • How Sequenom Lost Patent Protection For Fetal DNA Test

    David A. Gass

    In Ariosa Diagnostics Inc. v. Sequenom Inc., Federal Circuit Judge Richard Linn spoke effusively about a groundbreaking invention useful in noninvasive prenatal testing that was “deserving of patent protection.” He wrote this in an opinion concurring that the invention was ineligible for patent protection. Who is responsible for such a seemingly anomalous result? asks David Gass of Marshall Gerstein & Borun LLP.

  • How Concerned Is FDA Over Cybersecurity? Look To Hospira

    William R. O'Connor

    The U.S. Food and Drug Administration's recently issued warning over Hospira Inc.'s medical devices is the first time the FDA has recommended discontinuing use of a specific medical device based on cybersecurity concerns. The alert indicates the seriousness of both the vulnerabilities in Hospira devices and the FDA's concern over cybersecurity, says William O'Connor of Baker Donelson Bearman Caldwell & Berkowitz PC.

  • Using Patents To Secure Repeat Customers

    Andrea Merin

    The aftermarket for consumable products — e.g., disposable printer cartridges, razor cartridges, single-serving coffee pods — can be significant and oftentimes more profitable than the sales of the corresponding base products. The high profit margins, however, create an incentive for generic imitations. Fortunately, patent protection can help deter competitors, say Larry Green and Andrea Merin of Wolf Greenfield & Sacks PC.

  • The Road Ahead For Kyle Bass's IPRs

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    Interestingly, in Coalition for Affordable Drugs v. Acorda, the Patent Trial and Appeal Board was able to deny institution without addressing the issue of CFAD’s alleged abuse of process that was raised by the patent owner. But with more institution decisions in the queue, it may not be long before the issue is addressed, say members of Foley & Lardner LLP.

  • 7 Benefits Of Arbitration In A Patent Dispute

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    A recent survey across various industries showed that 73 percent of companies agreed that arbitration is their preferred mechanism for dispute resolution. Arbitration of a patent dispute, especially those with international overtones and complicated subject matter, provides many of the benefits of a courtroom decision with some additional features, say JAMS member Ron Dimock and Michael Rubinger of Dimock Stratton LLP.

  • Tips For Responding To An FTC Subpoena

    Julie A. Flaming

    A subpoena from the Federal Trade Commission can be unnerving and may appear daunting in the scope of its requests. Negotiations with the FTC regarding scope of discovery, time frames and even format of production can assist in reducing the burden for companies, say Julie Flaming and Katie Smith of Nelson Mullins Riley & Scarborough LLP.

  • Don't Ignore Small And Midsize Health FCA Settlements

    Michael A. Filoromo III

    While the dollar figures involved in fraudulent schemes committed by small and midsize health providers pale in comparison to the record-setting $3 billion settlement with GlaxoSmithKline PLC, they are nonetheless substantial and can result in significant awards through the qui tam provisions of the federal False Claims Act, says Michael Filoromo III of Katz Marshall & Banks LLP.

  • Unanswered Questions: China's New Pharma Advertising Rule

    Katherine Wang

    This year, China’s advertising law will see its first amendment in two decades. However, compared with advertisement rules in mature markets China’s rules may not be sufficiently sophisticated to address the more complicated real life questions, like what constitutes promotion and promotional material, say Katherine Wang and Xiaoyi Liu at Ropes & Gray LLP.