Life Sciences

  • 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 Trader 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.

  • October 23, 2014

    Jury Clears J&J In 1st Bellwether Over Pinnacle Hip Implant

    A Texas federal jury on Thursday unanimously cleared Johnson & Johnson's DePuy Orthopedics Inc. unit of accusations it manufactured a dangerous and defective metal-on-metal hip implant, in a bellwether trial in multidistrict litigation over the company's Pinnacle device.

  • October 23, 2014

    Scientists Can't Shake $10M Gov't Contract Fraud Charges

    A Florida federal judge on Wednesday refused to dismiss an indictment against two scientists charged with fraudulently obtaining $10 million in government research grants through wire fraud and identity theft, saying there was no prosecutorial misconduct in the handling of the case.

  • October 22, 2014

    Pfizer's Cancer Drug Patent Withstands Mylan Challenge

    A Delaware federal judge ruled Wednesday that Pfizer Inc.’s patent for cancer drug Sutent was nonobvious and could stand, despite a challenge from Mylan Pharmaceuticals Inc. in Pfizer's suit seeking to stop its rival from introducing a generic version. 

  • October 22, 2014

    Grunenthal Dodges Thalidomide Suit In Spain

    German drugmaker Grunenthal GmbH dodged a Spanish court's damages award in a thalidomide injury dispute in which it stood to payout as much as an estimated $44 million to a group of plaintiffs, according to Wednesday news reports.

  • October 22, 2014

    Lupin, Amneal Lose Bid To Reverse Birth Control IP Ruling

    The Federal Circuit on Wednesday shot down Lupin Ltd. and Amneal Pharmaceuticals LLC’s bid to reverse a lower court’s finding that Warner Chilcott Co. LLC’s patent for the oral contraceptive Lo Loestrin Fe wasn’t shown to be obvious, finding the appellants’ arguments “unpersuasive.”

  • October 22, 2014

    Bard Says Expert Can't Switch Sides In Pelvic Mesh MDL

    C.R. Bard Inc. argued Tuesday that the plaintiffs in pelvic mesh multidistrict litigation consolidated in West Virginia federal court should not be allowed to name as an expert one of Bard's own retained experts, saying that he is familiar with Bard's litigation strategy from his role in prior cases.

  • October 22, 2014

    Biotech IPO Market Hits Turbulence As Several Price Low

    After a year of flying high, biotechs are running into trouble this week, as several have priced below their range or pulled the plug on the float entirely, with satiated investor appetites and overall market volatility the likely culprits for the lull, experts say.

  • October 22, 2014

    Deals Rumor Mill: Apollo Global, Advent, Sterigenics

    Apollo Global Management LLC is looking to raise between $2 billion and $3 billion for a second natural resources private equity fund, while Advent International Corp. and Avista Capital Partners are nearing a deal to buy Kremers Urban Pharmaceuticals Inc. from Belgium's UCB SA for as much as $2 billion.

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.