Life Sciences

  • April 29, 2016

    Mylan, Ranbaxy Push 3rd Circ. To Nix Provigil Class

    Mylan and Ranbaxy said Thursday that purchasers bringing pay-for-delay claims over the narcolepsy drug Provigil have failed to give the Third Circuit any good reason to uphold a class certification order, which the drugmakers have attacked as unsupported by the buyers’ damages theory.

  • April 29, 2016

    FDA To Mull Mandatory Opioid Education For Prescribers

    The U.S. Food and Drug Administration will soon consider whether to make opioid education for prescribers mandatory — it’s currently voluntary — amid other possible modifications to the agency's plan for evaluating and mitigating the risks associated with prescribing opioid painkillers.

  • April 29, 2016

    Alere Refuses Abbott Bid To Back Out Of $5.8B Merger

    Alere Inc. said Thursday that its board of directors rejected a request by Abbott Laboratories, which expressed concerns about the diagnostic services provider’s pending foreign bribery probe and delays with its annual report, to terminate their proposed $5.8 billion tie-up.

  • April 28, 2016

    High Court May Be Next Stop For PTAB Deference Issue

    The Federal Circuit's holding that America Invents Act decisions must be reviewed with deference on appeal could inspire the U.S. Supreme Court to consider requiring greater scrutiny of the Patent Trial and Appeal Board, which could make AIA decisions easier to overturn, attorneys say.

  • April 28, 2016

    Pharma CEO Says He’s An Honest Guy As SEC Trial Wraps

    Attorneys for the CEO of a pharmaceutical company admonished the U.S. Securities and Exchange Commission’s “harsh and hurtful words” Thursday, saying the agency couldn’t prove their client was lying to investors while promoting an experimental medication made from goat’s blood.

  • April 28, 2016

    Abbott's Cardio-Focused $25B Deal Could Raise FTC's Pulse

    Abbott Laboratories has touted its proposed $25 billion acquisition of medical device maker St. Jude Medical as a chance to combine the companies’ cardiovascular device offerings, but any overlap in that area could become a target for a divestiture order from the Federal Trade Commission, attorneys say.

  • April 28, 2016

    Pharmacies Say Express Scripts Conspiracy Suit Has Legs

    Express Scripts’ bid to escape an antitrust suit brought by compounding pharmacies who say it conspired with other pharmacy benefit managers to push them out of the market was little more than “self-serving fiction,” the compounders said in Missouri federal court Wednesday.

  • April 28, 2016

    KaloBios Gets Final Nod On 'Unusual' $3M Ch. 11 Package

    Bankrupt drug developer KaloBios Pharmaceuticals received final approval Thursday for a $3 million debtor-in-possession package that will convert to equity for lenders Black Horse Capital and Nomis Bay once the company successfully reorganizes.

  • April 28, 2016

    FDA Flouting Court On Orphan Drug Exclusivity, Suit Says

    The U.S. Food and Drug Administration is flouting a recent court ruling and federal law by refusing to grant orphan drug exclusivity for chemotherapy infusion Bendeka, according to a complaint filed Wednesday in D.C. federal court.

  • April 28, 2016

    3 Big Plays Make Noise In Muted Health Care M&A Market

    Health care M&A activity got off to a relatively quiet start this year as volatility took hold of the market following a record year for megamergers, but deal-making roared back to life on Thursday when three companies unveiled separate multibillion-dollar plays together worth $40.1 billion.

  • April 28, 2016

    Old Spice Deodorant Causes Rashes, Class Action Claims

    A man who claims he developed rashes and open sores after using Old Spice deodorant filed a putative class action in California federal court on Wednesday, saying Procter & Gamble knows the product can harm users' skin and has done nothing about it.

  • April 28, 2016

    Merck Says Gilead Is Exploiting Atty 'Lie' In $200M Jury Loss

    Merck on Wednesday escalated a war of words with Gilead over accusations that a Merck attorney lied during a deposition over accessing confidential information, saying its biopharmaceutical rival wants to “exploit” the allegation as a “get-out-of-jail-free card” after a California’s federal jury’s recent $200 million damages award in the patent infringement case.

  • April 28, 2016

    Sanofi Leans On Biopharm Firm Medivation To Take $9.3B Bid

    French drugmaker Sanofi S.A. went public Thursday with an all-cash $9.3 billion offer in its hard-driving buyout bid for biopharmaceutical firm Medivation Inc., which responded that its board is already aware of Sanofi’s interest and is taking its time to review the proposal.

  • April 28, 2016

    AbbVie Inks $5.8B Deal For Cancer Drug Maker Stemcentrx

    AbbVie Inc. will buy drug maker Stemcentrx and its potential breakthrough lung cancer treatment in a deal worth at least $5.8 billion in cash and stock, with the potential for another $4 billion should the tie-up lead to certain milestones, the global biopharmaceutical company said Thursday.

  • April 28, 2016

    Wachtell Steers Abbott In $25B Deal For St. Jude Medical

    Abbott Laboratories, led by Wachtell, unveiled on Thursday a $25 billion cash-and-stock acquisition of medical device maker St. Jude Medical, strengthening its position in the cardiovascular market with products that can treat medical issues like atrial fibrillation, structural heart disease and heart failure.

  • April 27, 2016

    22 Firms Win Top Marks From GCs On AFAs

    Twenty-two law firms are the cream of the crop when it comes to delivering alternative fee arrangements, according to a new report. Here’s what clients say sets them apart and how the firms say they make it work.

  • April 27, 2016

    Crede Blasts Tobacco Co. In $250M Suit Over China JV

    22nd Century, a genetic engineering company specializing in low-nicotine tobacco, was hit with a $250 million contract suit in New York federal court Tuesday by its largest investor, private equity fund Crede CG, which alleges 22nd Century cut it out of a lucrative Chinese joint venture.

  • April 27, 2016

    Chancery Suit Targets Fee-Shifting Bylaw Enacted Before Ban

    A shareholder in StemCells Inc. launched a putative class action Wednesday in Delaware Chancery Court challenging the biopharmaceutical company’s fee-shifting bylaw enacted the day the state Senate voted to ban the practice, and a later-added rule that effectively prohibits stockholders from recovering legal costs in a lawsuit.

  • April 27, 2016

    IRS Inversion Regs Don't Solve Tax Code Issues, Rep. Says

    The Internal Revenue Service's recently proposed anti-inversion regulations, which led to the highly publicized death of the $160 billion Pfizer-Allergan merger, are only a bandage fix that fail to address why U.S. companies feel compelled to shift their headquarters to lower-tax jurisdictions, Rep. Kevin Brady said Wednesday.

  • April 27, 2016

    Valeant CEO Says He Was 'Too Aggressive' On Drug Prices

    The outgoing CEO of Valeant Pharmaceuticals International Inc. told a skeptical U.S. Senate panel Wednesday that he and the company were “too aggressive” when increasing drug prices, as hedge fund manager and Valeant board member Bill Ackman promised that “a lot’s going to change” at the company.

Expert Analysis

  • Portfolios With 4 Legs To Stand On: Animal Drug Patent Tips

    Deborah A. Sterling

    Human pharmaceutical companies tend to rely upon a "patent thicket" to obtain overlapping scope designed to deter competitors, and some animal pharmaceutical companies are following this model for their products. Close examination of the filing strategies and drafting considerations that lead to the creation of portfolios like Zoetis’ for Apoquel provides insight for other animal health companies looking to expand market share, say... (continued)

  • Using The New Federal Rules To Rein In Discovery

    Martin J. Healy

    The 2015 amendments to the Federal Rules of Civil Procedure present a fertile opportunity for defendants to leverage the rules' renewed focus on reasonableness and proportionality to rein in rampant discovery abuse. Courts' application of the amended rules has already shown promise in this regard, say Martin Healy and Joseph Fanning of Sedgwick LLP.

  • Why Celebrity Sponsors Aren't Liable For False Advertising

    Christina Guerola Sarchio

    The Ninth Circuit’s recent opinion in a case involving a dietary supplement manufacturer and its celebrity spokesperson, former NFL quarterback Joe Theismann, reaffirms a large body of case law suggesting that public figures who simply endorse a product have a viable defense against claims for false advertising, say Christina Guerola Sarchio and Emily Luken at Orrick Herrington & Sutcliffe LLP.

  • Dentons: A New Kind Of Network?

    MarkACohen.jpg

    Dentons is two different law firm networks in one. So even if the Swiss verein structure should eventually fail and Dentons is forced to operate as a network of independent law firms, it could still be a significant market force, says Mark A. Cohen, a recovering civil trial lawyer and the founder of Legal Mosaic LLC.

  • What's The Big Deal About US Biosimilar Approval?

    Daniel S. Wittenberg

    The U.S. Food and Drug Administration recently approved its second-ever biosimilar product, Inflectra. Daniel Wittenberg at Snell & Wilmer LLP takes a look at the regulatory framework for biosimiliar approval in the U.S., various states’ responses to interchangeability substitution, and the litigation that may delay Inflectra’s U.S. launch.

  • What To Know About Trade Secret Law In Saudi Arabia

    Paul B. Keller

    As Saudi Arabia's market continues to expand and with its stock market becoming increasingly opening to foreign investors, many U.S. companies and banks are expanding operations in and to the kingdom. These expansions pose a great opportunity for many technology and life science companies — and the potential for the theft or misappropriation of a company’s trade secrets by an employee or business partner, say Paul Keller and Jihad ... (continued)

  • Risk Of Future Misconduct Will Guide HHS Investigations

    John T. Bentivoglio

    While the U.S. Department of Health and Human Services' new guidance on the use of its so-called permissive exclusion authority should provide more transparency and predictability, many of its provisions focus on the risk of future misconduct, which run counter to requests for positive incentives for the development and implementation of effective compliance programs, say attorneys at Skadden Arps Slate Meagher & Flom LLP.

  • Quo Vadis FTC?: The Meaning Of FTC Case Against Endo

    Robert Reznick

    The Federal Trade Commission's recent complaint against Endo Pharmaceuticals — the FTC's first lawsuit challenging a "no-authorized-generic" agreement — reflects a number of positions that the FTC has taken in litigation or in amicus briefs, but more broadly reflects two characteristics of commission legal actions against Hatch-Waxman settlements, say Robert Reznick and David Goldstein of Orrick Herrington & Sutcliffe LLP.

  • The D&O Policy Implications Of SEC's Theranos Probe

    Kevin M. LaCroix

    The directors and officers insurance marketplace is built around a basic premise that private companies generally do not have liability exposures under the securities laws. With the advent of the U.S. Securities and Exchange Commission's investigation into high-flying startup Theranos — and the possibility of similar probes into other private companies — a number of D&O policy terms and conditions may need to be reviewed, says Kevi... (continued)

  • Benefits Of Expedited Review Of Sole-Source Drug ANDAs

    Jiazhong Luo

    The U.S. Food and Drug Administration's recently updated expedited review of abbreviated new drug applications for “sole-source” drug products is a positive development that will provide incentives for generic companies to develop generic versions of off-patent one-source drugs, with potential benefits of keeping the cost of generic drugs down and reducing drug shortage, say Jason Luo and Jordana Garellek at Duane Morris LLP.