Life Sciences RSS

  • April 23, 2014

    Stryker Can't Dodge Howmedica Worker Reimbursement Suit

    A California federal judge on Tuesday refused to toss a putative class action accusing Stryker Corp. of failing to reimburse workers' business expenses, rejecting the medical technology giant's argument that it isn't liable because the workers were instead employed by subsidiary Howmedica Osteonics Corp.

  • April 23, 2014

    Myriad Asks Fed. Circ. To Block Ambry Cancer Test In IP Row

    Myriad Genetics Inc. on Friday asked the Federal Circuit to revive its bid for an injunction on Ambry Genetics Corp.'s cancer-testing products, arguing the lower court judge incorrectly held that Myriad's patents were likely invalid for claiming patent-ineligible subject matter.

  • April 23, 2014

    FDA Warns Of Fatal Risks In Widely Used Epidurals

    The U.S. Food and Drug Administration on Wednesday said warning labels of injectable corticosteroids will be updated to reflect rare but sometimes fatal complications resulting from epidurals, casting a pall over a treatment that has been in widespread use for decades.

  • April 23, 2014

    FDA Gets Heat On Pharma Ad Risk Disclosures

    The U.S. Food and Drug Administration is feeling pressure on multiple fronts as it considers relaxing risk disclosures in prescription drug commercials, according to comments released Wednesday from manufacturers trying to shape the agency's approach and a prominent consumer group expressing strong opposition.

  • April 23, 2014

    Janssen Claims Preemption In $4M Topamax Defect Appeal

    Janssen Pharmaceuticals Inc. urged a Pennsylvania appeals court Monday to overturn a $4 million jury verdict on the grounds that federal preemption barred state-law claims that the company failed to warn consumers about the risk of birth defects associated with its Topamax epilepsy drug.

  • April 23, 2014

    NJ Court Skins Attys For Divulging Merck Deal Months Later

    A New Jersey appellate court chastised attorneys for Merck Sharp & Dohme Corp. and for a woman who appealed a jury verdict absolving osteoporosis drug Fosamax of causing her jaw injuries, saying Wednesday they narrowly escaped sanctions for waiting four months before telling the court they settled.

  • April 23, 2014

    FDA Advisory Panel Votes Down New Opioid Painkiller

    An advisory panel for the U.S. Food and Drug Administration voted Tuesday not to recommend FDA approval of Australian drugmaker QRxPharma Ltd.'s painkiller Moxduo, the first drug to combine the opioids morphine and oxycodone, the agency confirmed Wednesday.

  • April 23, 2014

    USPTO's Verdict-Nixing Power Must Be Reined In, Baxter Says

    Reinforcing its petition to the U.S. Supreme Court to review a Federal Circuit decision upholding the right of the U.S. Patent and Trademark Office to void district court judgments, health care company Baxter International Inc. on Tuesday said rival Fresenius USA Inc. has downplayed the ruling’s chaotic implications on the patent landscape.

  • April 23, 2014

    Generic Cos. Seek To Appeal Androgel Dismissal Denial

    Par Pharmaceutical Cos. Inc. and Paddock Laboratories Inc. on Tuesday moved to immediately appeal a ruling that they were not immune from the Federal Trade Commission's pay-for-delay antitrust claims under the Noerr-Pennington doctrine, even though a federal court signed off on the underlying patent settlement.

  • April 23, 2014

    FDA Rips Providers For Shoddy Clinical Trial Oversight

    The U.S. Food and Drug Administration on Tuesday released highly critical letters related to supervision of clinical trials by two health care providers, dressing down a hospital for allegedly overlooking special safeguards for young patients and criticizing a doctor for allegedly conducting risky research without approval.

  • April 23, 2014

    Supplement Maker Xymogen Faces Toxic Warning Label Suit

    California’s Environmental Research Center sued dietary supplement maker Xymogen in state court Monday for more than $15 million on claims that it manufactures products containing lead without the proper health warnings. 

  • April 23, 2014

    High Health Ad Standards May Hurt Consumers: FTC Commish

    Recent Federal Trade Commission settlement agreements requiring marketers to back up their health benefit claims with two separate studies threaten to impose undue burdens on the businesses and may curtail them from making legitimate health-related claims about their products, a Republican FTC commissioner said Wednesday.

  • April 23, 2014

    Allergan Swallows Poison Pill After $46B Valeant-Ackman Bid

    Botox maker Allergan Inc. adopted a poison pill late Tuesday to insulate itself from hostile takeover plays, a move that came the same day it confirmed an unsolicited offer worth nearly $46 billion from Valeant Pharmaceuticals International Inc. and famed activist Bill Ackman.

  • April 22, 2014

    CVS Decries Novartis Kickback Suit As 'Implausible'

    CVS Caremark Corp. asked a New York federal judge on Monday to toss a False Claims Act whistleblower suit alleging CVS accepted kickbacks from Novartis Pharmaceutical Corp. to push leukemia drugs Gleevec and Tasigna and cystic fibrosis drug TOBI, calling the claims "fundamentally implausible."

  • April 22, 2014

    Ropes & Gray SF Head Jumps To Gibson Dunn

    A Ropes & Gray LLP lawyer has returned to Gibson Dunn where he will serve as co-chair of the firm’s life sciences practice and work closely with technology and life sciences companies as well as their investors on corporate and securities matters in its San Francisco office, the firm said Monday.

  • April 22, 2014

    Hydroxycut Users Settle For Less In $14M False Ad MDL Deal

    The maker of recalled weight-loss supplement Hydroxycut and several retailers who sold the product have reached a $14 million settlement resolving a host of false advertising class actions, according to court documents filed Monday, replacing a significantly larger deal that the court rejected last year.

  • April 22, 2014

    The Accidental Advocate: Judge John E. Jones III

    Pennsylvania Middle District Judge John E. Jones III talks to Law360 about the surreal aftermath of his divisive ruling against intelligent design as he prepares for yet another potentially explosive trial over Pennsylvania's same-sex marriage ban.

  • April 22, 2014

    Ex-Celgene Exec Gets 16 Months For Insider Trading Plot

    A former Celgene Corp. executive was sentenced to 16 months in prison in New Jersey federal court Tuesday, for sharing tips on acquisitions, quarterly earnings and regulatory news during a five-year insider trading scheme also fueled by nonpublic information from Stryker Corp. and Sanofi-Aventis U.S. LLC.

  • April 22, 2014

    Fed. Circ. Revives Tamiflu Case, Expands Double-Patenting

    The Federal Circuit ruled Tuesday that a patent can be rendered invalid for double-patenting based on a patent that expires before it, expanding the double-patenting doctrine and giving Natco Pharma Ltd. another shot at invalidating Gilead Sciences Inc.'s patent on the flu drug Tamiflu.

  • April 22, 2014

    GSK Slams Mylan's Bid For $3.1M Interest In Paxil Row

    GlaxoSmithKline LLC on Monday slammed Mylan Inc.'s bid for $3.1 million in prejudgment interest stemming from the $106.7 million verdict Mylan won after a jury found that GSK breached an exclusive licensing contract arising from an antitrust settlement, saying in New Jersey federal court that the company overstated the amount.

Expert Analysis

  • Major Changes Come To China's Medical Device Industry

    Katherine Wang

    China’s medical device industry is going through rapid growth and change as the country's population ages and urbanizes. Recently promulgated regulations will reward innovative and ethical companies and also provide an opportunity for industry consolidation as noncompliant domestic players may be forced to exit the market, say Katherine Wang and Fan Yang of Ropes & Gray LLP.

  • Mandatory Pro Bono Is Not The Answer For Practitioners

     Amanda D. Smith

    The State Bar of California has decided to follow New York's lead and require prospective attorneys to record 50 hours of pro bono service in order to be eligible for admission. While we applaud the intentions behind these initiatives, there are a number of reasons why state bars should limit any mandatory pro bono requirement to this context, rather than extend it to licensed attorneys as some have suggested, say attorneys with the Association of Pro Bono Counsel.

  • Courts Split On Applying Therasense To Summary Judgment

    Scott Breedlove

    District courts remain split on how to apply Therasense’s intent standard to motions for summary judgment of no inequitable conduct. Parties pleading inequitable conduct should bear in mind that they cannot simply focus on developing evidence that demonstrates the strength of the inference of deceptive intent — they must demonstrate why the patentee’s alternative inferences of no deceptive intent are, in fact, not reasonable, say Scott Breedlove and Andrew Allen of Vinson & Elkins LLP.

  • An Accused Infringer’s Guide To Parallel Proceedings

    Jeffrey Totten

    By managing the timing of post-grant proceedings, an accused infringer may increase its chances of negating a damages award in parallel district court litigation. Taking measures to actively create circumstances like those in Fresenius v. Baxter is a way to insure against a potentially large patent infringement judgment, say Jeffrey Totten and Elizabeth Laughton of Finnegan Henderson Farabow Garrett & Dunner LLP.

  • Cross-Border Complexities: Keep The C-Suite Out Of Prison

    Shari L. Pire

    The potential for significant gains makes high-growth markets, such as Russia, Brazil and India, particularly enticing. But at what cost? Business practices that are both acceptable and customary in other countries may violate U.S. and other anti-bribery and corruption laws. However, there are ways to insulate the corporation from liability, says Shari Pire of Willkie Farr & Gallagher LLP.

  • The Future Of Law Firm PR: The Good, Bad And Ugly

    Paul Webb

    There has been a dramatic change in how public relations professionals interact with the news media to promote or protect a law firm’s brand and reputation. But content is queen and has a bright future in law firm PR — it all begins with a plan that should include goals, performance indicators and a system of assessment, say Paul Webb, director of marketing at Young Conaway Stargatt & Taylor LLP, and Kathy O'Brien, senior vice president at Jaffe PR.

  • FTC Continues To Target Pharmaceutical Mergers

    Bruce Sokler

    The Akorn Inc.-Hi-Tech Pharmacal Co. Inc. acquisition shows that the Federal Trade Commission is unlikely to ease up soon on what has essentially become a bright-line rule in antitrust policy — transactions resulting in three to two and sometimes even four to three reductions in the number of competitors, where there would be no timely entry, face difficult regulatory hurdles, say Bruce Sokler and Helen Kim of Mintz Levin Cohn Ferris Glovsky and Popeo PC.

  • A Blow To State Encroachment On Federal Turf

    Ethan M. Posner

    The Arkansas Supreme Court's decision in Ortho-McNeil-Janssen Pharmaceuticals Inc. v. Arkansas dealt a blow to state attorneys general seeking to take action in matters primarily within the jurisdiction of the U.S. Food and Drug Administration. The case could signal a court pushback against state encroachment into federal regulatory matters, and may curb the outsourcing of litigation to private counsel with financial incentives to pursue enormous recoveries in court, say attorneys at Covington & Burling LLP.

  • Are You Covered For Food Product Recalls?

    Joshua D. Davey

    While relatively few food recall claims have been litigated, there is a small body of case law that has developed in the last few years highlighting important considerations for policyholders. The cases generally hold that there is no coverage for a purely prophylactic recall, a result that has the potential to exclude a significant number of recalls from coverage — policyholders must demonstrate actual contamination or mislabeling, says Joshua Davey of McGuireWoods LLP.

  • Heartbleed Rains On The Legal Cloud Parade

    David Houlihan

    While the actual breaches are unknown, Heartbleed has the potential to expose all of a lawyer's files stored or transmitted online. The bug raises professional responsibility questions and offers confirmation of the greatest anxieties that the legal industry has about online practice. In fact, the timing is poor for many legal tech providers, following a general industry warming to cloud offerings, says David Houlihan of Blue Hill Research Inc.