Life Sciences

  • May 29, 2015

    Namenda Not End Of NY AG's Pharma Work: Antitrust Chief

    The New York attorney general's antitrust chief told Law360 Friday that the enforcer would stay active in the pharmaceutical product-hopping arena in the wake of the Second Circuit's recent ruling against Actavis PLC that "sets a very useful framework up for future enforcement."

  • May 29, 2015

    21 Investigations Added To HHS Oversight Agenda

    The Office of Inspector General at the U.S. Department of Health and Human Services on Thursday added 21 reports to its investigative plans for next year, including reviews of billing trends in Medicare Part D and compliance with mandatory disclosure of drugmaker payments to doctors.

  • May 29, 2015

    Ex-Merck Director's Pregnancy Bias Suit Heads To Jury

    Counsel for a former Merck & Co. Inc. executive claiming gender and pregnancy discrimination cost her a promotion and then her job made a final pitch to jurors on Friday, trying to paint the business reasons the pharmaceutical giant has offered for those moves as mere pretext.

  • May 29, 2015

    Brand Battles: Bayer, Lego, Coca-Cola

    In Law360's latest roundup of new actions at the Trademark Trial and Appeal Board, Bayer picks another trademark fight over Aleve, Lego claims exclusive rights in knight-related toys, and Coca-Cola reminds the world of the strange trademark history behind Barq's root beer.

  • May 29, 2015

    4 IPOs Eye $552M To Start June After Brief Slowdown

    June is set to start off with something of a bang as four companies — a master limited partnership, a private equity-backed health care analytics firm, a medical device maker and a specialty tea retailer — look to raise a total of $552 million during the first week of the month, ending a brief drop-off in initial public offering activity.

  • May 29, 2015

    FDA Asked To Add HIV Warning To Birth Control Label

    Nearly two dozen doctors and scientists have signed off on a citizen petition to the U.S. Food and Drug Administration urging the agency to add language to Pfizer Inc.’s Depo-Provera birth control shot indicating that the shot could increase a woman’s chances of being infected with HIV.

  • May 29, 2015

    New Wash. Law Invites Tribes Mulling Marijuana Biz

    A first-of-its-kind Washington law allowing the state to negotiate compacts with Native American tribes to sell and distribute marijuana offers the enticement of a reliable regulatory framework while shielding the state from the risk of revenue loss and federal intervention should tribes strike out on their own, experts say.

  • May 29, 2015

    FDA Botched Amarin's Vascepa Exclusivity, Judge Rules

    A D.C. federal judge on Thursday vacated the U.S. Food and Drug Administration’s decision to limit market exclusivity for Amarin Pharmaceuticals Ireland Ltd.’s fish oil drug Vascepa, finding that the agency exceeded its authority to interpret the Hatch-Waxman Act.

  • May 29, 2015

    FTC Sues To Block $1.9B Steris-Synergy Merger

    The Federal Trade Commission issued an administrative complaint on Friday seeking to block a $1.9 billion deal merging sterilization providers Steris Corp. and Synergy Health PLC, claiming the cross-border tie-up would harm competition for radiation-based sterilization services.

  • May 29, 2015

    Pa. Judge Urged To Keep 1st Pelvic Mesh Cases In Philly

    A Pennsylvania state judge was recently urged to reject a Johnson & Johnson unit’s contention that Philadelphia County was too inconvenient of a forum to allow the court the continue presiding over a cluster of cases that allege injuries from pelvic mesh products.

  • May 28, 2015

    Bio-Rad's Ex-GC Sues Over Firing Amid Bribery Investigation

    Bio-Rad Laboratories Inc.’s former general counsel hit it with a suit in California federal court Wednesday claiming the life sciences research company illegally fired him after he reported that its leadership may be engaging in bribery in China.

  • May 28, 2015

    Pay-For-Delay Questions Linger After $1.2B Cephalon Deal

    The Federal Trade Commission's record-setting $1.2 billion settlement with Cephalon Inc. on Thursday gives the antitrust watchdog a boost as it continues to challenge so-called pay-for-delay settlements. But the eleventh-hour deal disappointed observers who had hoped for answers to lingering questions about how to prosecute the complex cases.

  • May 28, 2015

    2nd Circ. Says Coercion Key To Namenda Injunction Ruling

    The Second Circuit explained Thursday that Actavis PLC's plan to force Alzheimer's patients using its Namenda dementia drug to switch to a newer version by pulling the older formulation from the shelves likely violated federal antitrust law because it moved from "persuasion to coercion."

  • May 28, 2015

    FTC's $1.2B Win Shows Pay-For-Delay Deals On Thin Ice

    The Federal Trade Commission's $1.2 billion settlement with Cephalon Inc. over the company's huge payments to rivals is a fresh sign that so-called pay-for-delay deals involving big exchanges of money will be difficult to defend in the wake of a landmark U.S. Supreme Court decision from two years ago, experts say.

  • May 28, 2015

    No More Delays, Plaintiffs In Shire Pay-For-Delay Suit Told

    A federal judge shot down a request by a group of consumers to amend their complaint for a second time against Shire US Inc. in a pay-for-delay suit, noting Wednesday that the case has already been bogged down by delays.

  • May 28, 2015

    Daiichi Sankyo Looks To Fuse NJ Benicar Suits

    Japanese pharmaceutical giant Daiichi Sankyo Inc. is pressing the New Jersey Supreme Court to formally centralize dozens of lawsuits in the state blaming Benicar and its other blood pressure medications for gastrointestinal problems, according to a notice posted Wednesday.

  • May 28, 2015

    Paying The Price For Pay-For-Delay: Cephalon's 7-Year Saga

    With a $1.2 billion settlement on Thursday ending the Federal Trade Commission’s long-running case against Cephalon Inc. for allegedly paying rivals to hold off selling generic versions of the narcolepsy drug Provigil, Law360 takes a look back at the seven-year antitrust fight.

  • May 28, 2015

    Blue Cross Sued For Denying Gilead Hep C Drug Coverage

    Blue Cross and Blue Shield of Florida Inc. wrongfully denied policyholders Gilead Sciences Inc.’s newly approved yet expensive treatment for hepatitis C, according to a putative class action filed Wednesday in Florida federal court.

  • May 28, 2015

    Nautilus Asks Full Fed. Circ. To Review Indefiniteness Case

    Nautilus Inc. urged the full Federal Circuit Wednesday to review a ruling that a Biosig Instruments Inc. heart rate monitor patent is not indefinite, saying that the panel ignored clear instructions from the U.S. Supreme Court, which used the case to set a new indefiniteness standard.

  • May 28, 2015

    Allergan Shakes Shareholders' Off-Label Botox Case

    A California federal judge Wednesday tossed a derivative shareholder suit accusing Allergan Inc.’s board members of improperly marketing the cosmetic drug Botox for off-label uses after a voluntary dismissal by the plaintiffs, who the pharmaceutical giant argued no longer had standing following an acquisition by Actavis PLC.

Expert Analysis

  • 4 In-House Preferences For Better Outside Counsel

    Patrick H. Reilly

    The best outside counsel change their optics to think like the client. For these lawyers, client service is not just about top-notch legal work — it is about making life easier for the entire in-house team. In the words of litigation counsel at medical device company Zimmer Inc. and outside counsel at Faegre Baker Daniels LLP, here are four ways outside counsel can better serve clients.

  • Shining A Light On Conn.'s Version Of The Sunshine Act

    Andrew J. Finan

    Connecticut's recently enacted reporting requirement regulating the payment of advanced practice registered nurses, which is modeled off of the federal Sunshine Act, reduces the overall administrative burden on applicable manufacturers and aligns the Connecticut General Statutes more closely with other, comparable state reporting requirements, says Andrew Finan of Day Pitney LLP.

  • Analyzing Data Trends To Shape Complex Litigation Strategy

    Elizabeth Figueira

    With the understanding that jurisdictional data trends can shape complex litigation strategy, Crowell & Moring LLP attorneys Keith Harrison and Elizabeth Figueira offer a snapshot of the time to resolution of recent disputes in the U.S. District Courts and Courts of Appeals.

  • Persuasive Experts At Trial: 3 Times A Charm

    Nancy J Geenen

    Attorneys spend significant hours finding, vetting and legally qualifying subject matter experts who will offer the opinion that supports the client’s “truth.” The expert spends considerable time as well — from research and analysis to issuing the report and defending the opinion at deposition. These pretrial skills do not necessarily translate to persuasive testimony at trial, say Nancy Geenen and Suann Ingle of Suann Ingle Associates LLC.

  • And Now A Word From The Panel: The MDL Lexicon

    Alan E. Rothman

    As the Judicial Panel on Multidistrict Litigation heads to Minneapolis, Minnesota — currently home to 10 MDL proceedings — for its post-Memorial Day hearing, this month’s column recaps the March session and explores the “MDL Lexicon,” says Alan Rothman of Kaye Scholer LLP.

  • FDA Biosimilar Policy: More Questions, More Answers

    Jennifer M. Dienes

    The U.S. Food and Drug Administration's latest draft guidance on biosimilars, which contains new questions and answers not previously provided by the FDA, arrives on the heels of last month's release of three other biosimilar guidance documents, which also included a Q&A regarding implementation of the Biologics Price Competition and Innovation Act, say attorneys at K&L Gates LLP.

  • A New Compliance Challenge For Cos. Doing Business In UK

    T. Markus Funk

    On the heels of the U.K. Bribery Act of 2010 — a close copy of the U.S. Foreign Corrupt Practices Act — the United Kingdom has now taken cues from another novel U.S. enactment, this time the California Transparency in Supply Chains Act, and delivered its own disclosure regime on the doorsteps of the international business world, say attorneys with Perkins Coie LLP.

  • Insurance Risks Surrounding Legal Cannabis

    John G. Nevius

    For companies engaged directly in cannabis-related business, the starting point in this nascent industry is identifying the risks and rewards present. Identifying these risks, particularly for employees, doctors and dispensaries, can be difficult when insurance laws dramatically vary among the states, says John Nevius of Anderson Kill PC.

  • A Route To Directors' Early Exit From Merger Litigation

    Kevin C. Logue

    It has become all too common in transaction-related stockholder litigation for the pleading net to be cast widely, embroiling disinterested and independent directors into long and costly litigation. The Delaware Supreme Court's decision in the case of Cornerstone Therapeutics Inc. should lead to closer scrutiny of allegations against individual directors, say attorneys with Paul Hastings LLP.

  • Congress Could Be Coming For Dietary Supplements Soon

    Douglas F. Gansler

    The next chapter in the saga of New York State Attorney General Eric T. Schneiderman and company's investigation into the dietary supplements industry may take place on Capitol Hill given their recent letter to Congress requesting an investigation of the industry as well as stronger oversight from the U.S. Food and Drug Administration, say attorneys at BuckleySandler LLP, including the former attorney general of Maryland.