Life Sciences

  • July 24, 2014

    Stryker Can't Ax Counterclaims In Customer Sabotage Row

    A Michigan federal judge shot down Stryker Corp.'s attempt to nix an ex-employee's counterclaims concerning a noncompete agreement in a suit over an alleged scheme to harm the company's relationships with customers, finding Thursday that the allegations were not a “mirror image” of the company’s own breach of contract claim.

  • July 24, 2014

    Biosimilars Clarity Coming As FDA Eyes Sandoz Application

    The U.S. Food and Drug Administration's acceptance of a biosimilar application from Novartis AG unit Sandoz Inc. is a landmark event that should finally lead to answers about how the copycat products will be named and deemed interchangeable with their branded counterparts, experts say.

  • July 24, 2014

    FDA Gives Equivalent Rating To Perrigo's Testosterone Gel

    The U.S. Food and Drug Administration on Thursday granted Perrigo Co. an AB therapeutic equivalent rating for its testosterone gel, concluding that the generics maker's product is therapeutically equivalent to AbbVie's AndroGel and effectively mooting a suit by Perrigo seeking such a determination.

  • July 24, 2014

    Pa. Risperdal Judge Won't Change Mind On Nixing Punitives

    A Pennsylvania judge presiding over hundreds of cases concerning physical and mental injuries allegedly caused by the antipsychotic drug Risperdal has reiterated his decision denying punitive damages to plaintiffs claiming the warning labels on the Janssen Pharmaceuticals Inc. drug were inadequate.

  • July 24, 2014

    Walgreen Wins Dismissal In Pharmacy Buyout Suits

    A federal judge on Thursday dismissed two New Jersey pharmacies' suits against a Walgreen Co. subsidiary, finding that they failed to show the company breached asset purchase agreements that tied certain payouts to future prescriptions from the pharmacies' onetime customers.

  • July 24, 2014

    2nd Circ. Sides With FDA In Livestock Antibiotics Spat

    The U.S. Food and Drug Administration doesn’t need to launch hearings on whether to ban certain antibiotics from animal feed, the Second Circuit ruled Thursday, dealing a blow to consumer groups that claim rampant use of the drugs is fueling the rise of dangerous antibiotic-resistant bacteria.

  • July 24, 2014

    Janssen Hits Mylan With Generic Prezista Patent Suit

    Janssen Products LP on Wednesday hit generic-drug maker Mylan Pharmaceuticals Inc. with a lawsuit in New Jersey federal court over Mylan’s plans to make and market its generic versions of the HIV medication Prezista.

  • July 24, 2014

    Diet Drug Maker's Last-Ditch Suit Against FTC Dismissed

    A Georgia federal judge on Wednesday dismissed Hi-Tech Pharmaceuticals Inc.’s action seeking a declaratory judgment from the Federal Trade Commission after a court ordered the company and its directors to pay $40 million in sanctions and to recall four products whose labels falsely advertise substantial weight loss.

  • July 24, 2014

    House Reps. Press For Change After Ackman Allergan Bid

    A member of the House Financial Services Committee said Thursday that he may take legislative action if the U.S. Securities and Exchange Commission doesn't take steps to prohibit an unusual bidder-hedge fund partnership pioneered earlier this year by famed activist Bill Ackman and Valeant Pharmaceuticals International Inc.

  • July 24, 2014

    Dechert Picks Up IP, Life Science Pro From Goodwin Procter

    Dechert LLP has beefed up its intellectual property roster in New York by adding a Goodwin Procter LLP attorney with a background in handling matters involving the life science sector.

  • July 24, 2014

    Gordon & Rees Nabs Weber Gallagher Product Liability Atty

    Gordon & Rees LLP said Wednesday that it has strengthened its Philadelphia office with the addition of a former Weber Gallagher Simpson Stapleton Fires & Newby LLP attorney who will practice in the firm’s environmental, construction, drug and medical device, international and tort and product liability groups.

  • July 24, 2014

    FDA Accepts First Biosimilar Application From Sandoz

    Novartis AG unit Sandoz Inc. announced Thursday that the U.S. Food and Drug Administration is reviewing its request to market a biosimilar version of Amgen Inc.'s Neupogen, a milestone that marks the first publicly disclosed application along an Affordable Care Act approval pathway.

  • July 24, 2014

    Valeant Files Another Complaint Over 'False' Allergan Info

    Valeant Pharmaceuticals International Inc. on Thursday filed another complaint, this time with a Canadian regulator, accusing $53 billion takeover target Allergan Inc. of making "false and misleading" statements about Valeant's business to erode support for the proposed tie-up.

  • July 23, 2014

    3rd Time's A Charm For Miss. AG's Plavix Remand Motion

    After twice failing to have his lawsuit against Bristol-Meyers Squibb Co. and Sanofi-Aventis U.S. LLC remanded, Mississippi Attorney General Jim Hood won a bid to move the suit back to state court after a New Jersey federal judge on Tuesday made an about-face in the venue dispute.

  • July 23, 2014

    Rare Fed. Circ. Reversal Spurs Trial On Inequitable Conduct

    A rare case where the Federal Circuit reversed a finding that a patent owner did not commit inequitable conduct, despite a tough new standard for proving that defense, will be back before a district court judge for a bench trial on the issue next week.

  • July 23, 2014

    GNC Ducks Herbal Testosterone Supplement RICO Action

    A California federal judge on Wednesday tossed a Racketeer Influenced and Corrupt Organizations Act class action against Gencor Nutrients Inc., oral supplement manufacturers and GNC Corp. over an allegedly discredited herbal extract touted as a testosterone-boosting silver bullet, ruling the claims were insufficient.

  • July 23, 2014

    Apotex Blocked From Continuing Generic Paxil Sales

    A New Jersey federal judge on Tuesday issued an injunction to block generic-drug manufacturer Apotex Inc. from continuing to sell generic Paxil CR in violation of rival Mylan Inc.'s exclusivity agreement with GlaxoSmithKline PLC, which was barred last week from supplying Apotex with the drug.

  • July 23, 2014

    Bioplastics Sister Cos. Meredian, DaniMer Agree To Merge

    Biopolymer manufacturer Meredian Inc. and sustainable, renewable and biodegradable resources company DaniMer Scientific LLC said Wednesday that they had merged under a holding company called Meredian Holdings Group Inc.

  • July 23, 2014

    AIG Unit Can't Escape $3.75M Verdict In Ad Injury Case

    A California federal judge on Tuesday upheld a $3.75 million jury verdict against AIG unit National Union Fire Insurance Co. of Pittsburgh in laryngeal mask maker LMA North America Inc.’s suit seeking coverage for underlying claims that its advertisements allegedly suggested a competitor's products were unsafe.

  • July 22, 2014

    Out-Of-State Accutane Users Shut Out Of Calif. Litigation

    A California judge stayed two suits in the consolidated injury litigation against Swiss drugmaker Hoffman-La Roche Inc. over its acne medication Accutane, saying Monday that California has a "miniscule interest" in the claims brought by the out-of-state plaintiffs who were prescribed the drug by non-California doctors.

Expert Analysis

  • 6 Years In, Why Haven't FRE 502(d) Orders Caught On?

    John A. Rosans

    In this e-discovery era, why aren't more litigants using Federal Rule of Evidence 502(d) orders and affording themselves basic protection of their most sensitive information? Or, if they are moving for such orders, why are they doing it wrong? asks John Rosans of Katten Muchin Rosenman LLP.

  • Prosecutions Loom Large In China's Food Regulatory Regime

    John Balzano

    Most ominous in China's draft Food Safety Law is the pledge to strengthen the "link" between food safety regulation and criminal penalties, indicating criminal prosecutions could likely continue increasing once the law is adopted, say attorneys at Covington & Burling LLP.

  • Amid M&A Uptick, Bidders Must Heed UK Code Changes

    Ilan Kotkis

    Potential bids by U.S. suitors for U.K. target companies in the pharmaceutical and health care sectors seem to be a recurring theme this year

  • Generic Drugs At 30: Fulfilling The Promise And Path Ahead

    Alan Klein

    Although challenges remain for generics, it is clear at the 30-year mark that the promise of Hatch-Waxman has been realized, quite possibly beyond the dreams of Senator Orrin Hatch and Congressman Henry Waxman, say Alan Klein and Solomon David of Duane Morris LLP.

  • Government Seeks To Outsource Criminal Enforcement

    Nathan Hochman

    The prosecution of FedEx Corp. for allegedly failing to heed signs that illegal Internet pharmacies were using its facilities represents a significant expansion of the U.S. Department of Justice’s efforts to outsource law enforcement to private third parties and then go after these third parties when they fail to meet an undefined standard of compliance, rather than focus on the criminals, say attorneys with Bingham McCutchen LLP.

  • Trial-Ready In 180 Days: Prepare For SDNY's Rocket Docket

    Isaac S. Greaney

    A growing trend in the Southern District of New York akin to a sua sponte rocket docket can provide defendants with an opportunity to set the tone of discovery and shift the burden and risks of the schedule to their adversaries, say Isaac Greaney and Jackie Lu of Sidley Austin LLP.

  • The Promise And Problem Of Genomic Marketing

    Ivan J. Wasserman

    Genomic scientific advances have brought the promise of "personalized medicines" to consumers, creating opportunities for marketers that have in turn brought the attention of the Federal Trade Commission and U.S. Food and Drug Administration, say Ivan Wasserman and La Toya Sutton of Manatt Phelps & Phillips LLP.

  • EPA May Threaten Reverse Distribution Of Pharmaceuticals

    Jonathan E. Wells

    The U.S. Environmental Protection Agency may adopt starkly different approaches toward regulating nonhazardous pharmaceuticals and pharmaceuticals containing hazardous ingredients, with additional inconsistencies between health care facilities and other retailers — a regulatory nightmare for industry, say Jonathan Wells and Elise Paeffgen of Alston & Bird LLP.

  • Powerful Tools For Discovery And Litigation Strategy

    Nathalie Hofman

    Analytics offer opportunities for refining both discovery strategy and overall litigation strategy by providing information to support better informed decisions. As an added bonus, they can result in significant cost savings, say Nathalie Hofman and Carolyn Southerland of Huron Consulting Group Inc.

  • Growing Insistence Among Courts For Ascertainability

    David E. Kouba

    The Third Circuit's ruling in Carrera v. Bayer Corp. has proven to be no outlier as federal courts — with growing frequency — are rejecting class certification where class members lack receipts and other objective proofs of purchase, say David Kouba and Carolyn Pearce of Arnold & Porter LLP.