Life Sciences

  • October 24, 2014

    Liberty Medical Strikes Deal Trimming $160M Medicare Claim

    Bankrupt diabetes testing supply company Liberty Medical Supply Inc. on Friday agreed to settle a $160 million claim lodged by the Centers for Medicare and Medicaid Services for alleged overpayments, reaching a deal that will pay the agency nearly $32 million.

  • October 24, 2014

    NJ Diagnostic Co. Takes Merck Licensing Row To High Court

    Medical diagnostics company Pop Test Cortisol LLC has asked the U.S. Supreme Court to review a New Jersey appellate court decision in a licensing dispute with Merck & Co., in which the state court found the parties were bound to arbitration.

  • October 24, 2014

    US Urged To Pursue Contact Lens Antitrust Case

    A leading antitrust law think tank urged U.S. regulators to take action against the prolific use of what it describes as retail price floors by the nation's top contact lens manufacturers, saying the business practice is illegal and pins consumers with higher prices.

  • October 24, 2014

    Verinata's Fetal Test Patent Survives AIA Review On All Claims

    The Patent Trial and Appeal Board ruled Thursday that Ariosa Diagnostics Inc. hadn’t shown that Verinata Health Inc.’s “fetal abnormality” detection patent was invalid due to obviousness, marking a rare instance in which all of a patent’s challenged claims survived the scrutiny of an America Invents Act review.

  • October 24, 2014

    Nature's Bounty Duped Elderly Into Buying Gingko Biloba: Suit

    Supplement company Nature’s Bounty Inc. was hit with a proposed class action in California state court Wednesday, accusing the company of exaggerating the memory boosting effects of its ginkgo biloba supplements when there’s zero scientific evidence they improve brain function.

  • October 24, 2014

    Hikma Gets FDA Warning After Portugal Facility Review

    Hikma Pharmaceuticals PLC has received a warning letter from the U.S. Food and Drug Administration, which inspected the Jordan-based drugmaker's manufacturing facility in Portugal earlier this year, the company said Friday. 

  • October 24, 2014

    5 Ditch IPO Plans This Week As Markets Continue Volatility

    New issuers faced another bumpy week, with five companies holding off on making a public debut while others determined to move forward discounted their shares, highlighting the continued impact of overall market volatility fueled by concerns over dropping energy prices and economic woes in Europe, experts say.

  • October 24, 2014

    4 Things To Watch As FDA Flexes New Inspection Powers

    New guidance from the U.S. Food and Drug Administration claims sweeping authority to block pharmaceutical sales if drugmakers resist agency requests to interview employees or scour internal records during inspections, experts say. Here are four things to know before the FDA comes calling.

  • October 24, 2014

    Eli Lilly Gets AIA Reviews Of Institute's Fibrosis Patent

    The U.S. Patent and Trademark Office’s patent trial board on Thursday granted Eli Lilly Co.’s requests for inter partes reviews of a fibrosis treatment patent owned by a California-based research institute, which had claimed infringement based on the blockbuster drug Cialis, citing both obvious and anticipation grounds.

  • October 24, 2014

    'Natural' Diet Bars Stuffed With Fake Additives, Class Says

    Fullbar LLC, the maker of popular appetite-curbing snacks, was slapped with a proposed consumer class action in Florida federal court Thursday claiming it tricked consumers into paying more for its “all natural” bars, which actually contain synthetic ingredients such as maltodextrin and soy lecithin.

  • October 24, 2014

    Ex-BNY Mellon Manager Admits Tipping Scheme

    A former Bank of New York Mellon Corp. manager pled guilty on Friday to earning more than $700,000 by trading on inside tips from a business school classmate about impending acquisitions in the pharmaceutical industry.

  • October 24, 2014

    Shire Looks To Sink $1.5B AbbVie Termination Fee Into M&A

    London-based Shire PLC's CEO said in a Friday conference call that the pharmaceutical giant has "significant firepower" and will look to boost its acquisitions, as it rides the windfall of a $1.6 billion termination fee from its canceled $52 billion merger with AbbVie, along with solid quarterly profits. 

  • October 24, 2014

    Coherus Seeks IPO Raising $108.6M To Fund New Drugs

    Coherus BioSciences Inc., a California biotech developing drugs patterned after existing blockbusters about to come off patent, will seek up to $108.6 million in an initial public offering designed to speed development of its pipeline, the company told regulators Friday.

  • October 23, 2014

    Surprise Verdict In Hip Implant Trial Gives J&J The Edge

    Thursday's win for Johnson & Johnson’s DePuy Orthopedics Inc. unit at the first bellwether trial over its Pinnacle line of metal-on-metal hip implants dealt a surprising early blow to plaintiffs' attorneys that lawyers say will have Johnson & Johnson digging in its heels in upcoming trials.

  • October 23, 2014

    Pfizer Unveils Mammoth $11B Buyback Program

    Pharmaceutical titan Pfizer Inc. said Thursday it would redirect its cash stores into an eye-popping $11 billion share buyback program after its attempt at a blockbuster merger with British rival AstraZeneca PLC fell flat earlier this year.

  • October 23, 2014

    FDA Should Nix Drug Risk Proposal, Advocacy Group Says

    Consumer advocacy group Public Citizen argued Wednesday that the U.S. Food and Drug Administration should revoke a proposal that the group said would allow pharmaceutical companies to downplay the risks of medications that are indicated on their FDA-approved labels. 

  • October 23, 2014

    Teva Sues Chicago To Block Painkiller FOIA Disclosure

    Teva Pharmaceutical Industries Ltd. on Wednesday sued Chicago to block it from disclosing, pursuant to a state Freedom of Information Act request, what the drugmaker claims is confidential information obtained in the city’s far-reaching probe of the painkiller industry’s marketing practices.

  • October 23, 2014

    San Francisco Reintroduces Drug 'Take-Back' Proposal

    The San Francisco Board of Supervisors has reintroduced a proposed ordinance requiring pharmaceutical companies who sell products in the city to pay for the collection of unwanted drugs, after a recent Ninth Circuit decision upheld a similar ordinance in nearby Alameda County.

  • October 23, 2014

    Bankrupt Vitamin Maker Natrol Gets Nod For Nov. Auction

    A Delaware bankruptcy judge on Thursday gave Natrol Inc. the green light to hold a November auction, blessing a process that allows potential suitors to submit offers either to acquire the nutritional supplement maker's assets or refinance its debt.

  • October 23, 2014

    FDA Clarifies Oversight Exception For Stem Cell Procedures

    The U.S. Food and Drug Administration on Thursday described when surgeries involving human tissues, stem cells and similar living materials are considered a single procedure that qualifies for relaxed oversight, the latest example of fast-evolving regulation in the specialty field.

Expert Analysis

  • 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.

  • GSK Bribery Conviction Signals Increased Risks In China

    Jay Pomerantz

    China’s anti-corruption efforts have historically focused on the Chinese government officials who solicit or receive bribes, but GlaxoSmithKline PLC's recent bribery conviction demonstrates that companies doing business in China must be mindful of China’s own anti-corruption laws in addition to the Foreign Corrupt Practices Act, say Jay Pomerantz and Catherine Kevane of Fenwick & West LLP.

  • Random Selection Is Best For MDL Bellwether Trials

    Matthew A. Holian

    The inadequacies of party selection are particularly troubling when compared to random selection, which yields representative plaintiffs, is fair to both sides, and also produces valuable information for courts and litigants, say Loren Brown and Matthew Holian at DLA Piper LLP and Dov Rothman at Analysis Group Inc.

  • What Litigators Can Learn From Novelists

    Michael H. Rubin

    Many legal briefs are written in impenetrable jargon and begin with an introduction telling the court what it already knows, using words that stem from the 18th century, such as “hereinafter.” Instead, we should approach briefs the way novelists approach their writing, says Michael Rubin of McGlinchey Stafford PLLC.

  • The Learned Intermediary Doctrine: A Historical Review

    Keri L. Arnold

    In the last 15 years, a few courts have expressed greater resistance to the protection the learned intermediary doctrine provides pharmaceutical companies given the way medications are prescribed and advertised since the rule was originally developed, say Keri Arnold and Sarah Duncan of Arnold & Porter LLP.

  • If High Court Reverses Teva, Litigation Costs May Increase

    Irena Royzman

    The policy arguments presented to the U.S. Supreme Court in Teva Pharmaceuticals USA Inc. v. Sandoz Inc., which was argued Wednesday, are off-base. In fact, increased deference to lower court claim construction determinations is more likely to increase litigation costs than decrease them, say Irena Royzman and Aron Fischer of Patterson Belknap Webb & Tyler LLP and Maggie Wittlin, an associate-in-law at Columbia Law School.

  • Assessing FDA Powers After A Failed 510(k) Rescinding

    Lynn C. Tyler

    It may well be a good thing that the D.C. Circuit's Ivy Sports Medicine LLC v. Burwell decision does not apply to medical devices currently under review — if the U.S. Food and Drug Administration knew it could only rescind a 510(k) clearance through the cumbersome rulemaking process it might become even more conservative about granting clearances, says Lynn Tyler of Barnes & Thornburg LLP.

  • A Convergence Of Antitrust, Anti-Graft Enforcement In China

    Kareena Teh

    In their efforts to combat unfair competition, Chinese authorities have used both antitrust and anti-corruption laws, targeted specific industries, conducted swift investigations, executed dawn raids to obtain evidence, and shared information among different departments. It is highly likely that this will continue for the foreseeable future, impacting the operations of many multinationals, say Kareena Teh and Fabian Roday of Dechert LLP.