Life Sciences

  • February 23, 2018

    Tribe Not Immune From Restasis IP Challenges, PTAB Says

    The Patent Trial and Appeal Board ruled Friday that tribal sovereign immunity does not apply to inter partes reviews and dismissed a motion from the Saint Regis Mohawk Tribe to toss generics companies' challenges to patents for the dry-eye drug Restasis, which Allergan Inc. sold to the tribe last year.

  • February 23, 2018

    Health Hires: Goodwin, Alston & Bird, Lucas & Mercanti

    So far in February, Alston & Bird LLP lost an FDA-focused attorney to Goodwin Procter LLP and gained a government contracts attorney from Dentons, and intellectual property boutique Lucas & Mercanti LLP announced the arrival of three attorneys specializing in pharma.

  • February 23, 2018

    Meningitis Pharmacist Must Forfeit $175K Before Restitution

    A former Massachusetts pharmacist convicted of recklessly mixing drugs that led to a 2012 meningitis outbreak must forfeit $175,000, or less than one-half of his salary from the roughly three years a jury decided his laboratory degenerated into a criminal enterprise, a federal judge decided on Friday.

  • February 23, 2018

    Amgen Denied Full Fed. Circ. Hearing On Repatha Patents

    The full Federal Circuit will not review a panel decision that revived a challenge to Amgen’s patents for Repatha, an antibody-based cholesterol treatment, according to a decision issued by the appeals court Friday.

  • February 23, 2018

    Amgen Fears 'Staggering Loss' After FDA Exclusivity Denial

    Amgen Inc. urged the D.C. Circuit on Friday to quickly block generic versions of its lucrative calcium-control drug Sensipar, saying it faces a “staggering loss” of sales because the U.S. Food and Drug Administration unfairly withheld exclusivity rights.

  • February 23, 2018

    Judge Won't Disturb Jury Verdict On Health Supplement IP

    A Texas federal judge on Thursday denied a bid for a new trial after a jury in January held that a medical company did not infringe the asserted claims of a health supplement patent, holding that the patent’s owner failed to introduce sufficient evidence to disturb the verdict.

  • February 23, 2018

    Fed. Circ. 'Divided' On Patent Eligibility, Justices Told

    Two recent Federal Circuit decisions show the appeals court is hopelessly divided on fundamental issues relating to patent eligibility, the Cleveland Clinic Foundation told the U.S. Supreme Court, saying its case over patents for cardiovascular disease tests “cries out” for review.

  • February 23, 2018

    No 'Rubber Stamp' For SEC Penalties In NJ Biotech Fraud Row

    A New Jersey federal judge on Friday said she would not “rubber-stamp” the U.S. Securities and Exchange Commission's demand for more than $1 million from a onetime biotech chief executive without evidence to back up the agency's claims that he pocketed illicit proceeds from the sale of company stock.

  • February 23, 2018

    Endo, Auxilium And GSK Reach Deal In Testosterone MDL

    Drugmakers Endo, Auxilium and GlaxoSmithKline notified an Illinois federal judge on Friday of a tentative deal to settle their cases in the testosterone replacement therapy MDL, in which thousands of patients claim drugmakers failed to warn of risks of heart attack and other health conditions.

  • February 23, 2018

    Opioid MDL Attys Clash With DEA Over Drug Data

    Attorneys targeting drug manufacturers and distributors in multidistrict litigation over the opioid crisis are clashing with the U.S. Drug Enforcement Administration regarding access to vast amounts of government data on painkiller sales, according to filings in Ohio federal court on Friday.

  • February 23, 2018

    Shkreli Can't Beat Stock Fraud Rap Post-Trial

    A New York federal judge on Friday refused a request by former pharmaceutical executive Martin Shkreli to throw out his conviction for manipulating the stock of Retrophin Inc. while he was its CEO, saying there was sufficient evidence for the jury to find him guilty.

  • February 23, 2018

    Valeant Says Stomach Ulcer Drug Is Being Imported Unfairly

    Valeant Pharmaceuticals Inc. filed a claim with the U.S. International Trade Commission alleging that three American companies sold in the U.S. "falsely and misleadingly labeled" drugs containing clidinium bromide that purported to be generic versions of Valeant's stomach ulcer drug Librax, in violation of the Tariff Act of 1930.

  • February 23, 2018

    US Steps Into Tricare FCA Suit Against Pharmacy, PE Owner

    The government has intervened in a False Claims Act suit accusing a Florida compounding pharmacy and its private equity fund owner of running a kickback scheme that induced Tricare to pay more than $68 million for medically unnecessary prescriptions, the U.S. Department of Justice announced Friday.

  • February 22, 2018

    Man Will Die From J&J Talc-Caused Mesothelioma, Jury Told

    An occupational medicine expert told a New Jersey jury on Thursday that a man alleging Johnson & Johnson’s baby powder contains asbestos faces a painful death from mesothelioma, and that the disease was caused by his daily use of J&J’s products.

  • February 22, 2018

    4th Circ. Resurrects Medical Device Co. Investor Suit

    A split Fourth Circuit panel on Thursday revived a stock fraud suit stemming from accusations that the maker of a spinal surgery system encouraged surgeons using its system to seek fraudulent reimbursement from insurers, finding in part that the company’s alleged failure to disclose the purported scheme counted as an actionable omission.

  • February 22, 2018

    Endo Settles Rest Of Lidoderm Antitrust Suit

    Endo has reached a settlement with the remaining plaintiffs in an antitrust lawsuit over the Lidoderm pain patch on the eve of jury selection for an upcoming trial, court records show, an effort to end the case after a California federal judge refused to enter judgment in its favor.

  • February 22, 2018

    Rituxan Patent Survives Celltrion, Pfizer PTAB Challenges

    The Patent Trial and Appeal Board on Wednesday upheld the validity of a patent covering Biogen Inc. and Genentech Inc.’s rheumatoid arthritis biologic Rituxan, shooting down combined challenges from Celltrion Inc. and Pfizer Inc.

  • February 22, 2018

    2 Biotechs Brave Volatility To Raise $401M In Follow-Ons

    Two publicly traded life science companies braved recent market volatility and priced follow-on offerings that netted $401 million total late on Wednesday, led by Danish firm Ascendis Pharma A/S, which raised money to support development of a product that would treat growth hormone deficiency.

  • February 22, 2018

    6th Circ. Won't Revive Spinal Patients' Bone Growth Suit

    The Sixth Circuit upheld the permanent toss of spinal patients' claims that an unsafe biologic caused excess bone growth and constant, incurable pain, saying Thursday it is too late for the patients to challenge the argument that only the federal government can bring such claims.

  • February 22, 2018

    Horizon Pharma Fired Aegerion's FCA Whistleblower: Suit

    Horizon Pharma PLC fired a senior director after learning that she blew the whistle on off-label drug promotion while employed at Aegerion Pharmaceuticals Inc., according to a complaint filed Wednesday in California federal court.

Expert Analysis

  • Insurance Tips For Defendants In Opioid Litigation

    Anna Engh

    Several types of insurance policies can potentially cover costs of defense and ultimate liability for pharmaceutical manufacturers, wholesale distributors and retailers defending against opioid-related lawsuits, but policyholders must be wary of the potential issues that may arise, say Anna Engh and Cléa Liquard of Covington & Burling LLP.

  • The Continuing Evolution Of Personal Jurisdiction

    Kevin Penhallegon

    It was anticipated that last year's U.S. Supreme Court ruling in Bristol-Myers Squibb would have immediate and significant impacts nationwide. Those impacts have been seen at the state level in recent months, as evidenced by several trial courts dismissing out-of-state plaintiffs’ claims where specific personal jurisdiction could not be established, says Kevin Penhallegon of Miles & Stockbridge PC.

  • A New Weapon To Help FDA Control Enforcement Priorities

    Peter Leininger

    Last month, an internal U.S. Department of Justice memorandum surfaced suggesting that the DOJ may increase its efforts to dismiss meritless qui tams. No agency would welcome this more than the U.S. Food and Drug Administration, which has struggled to deal with endless False Claims Act investigations, says Peter Leininger of King & Spalding LLP.

  • California's Evolving Standard On Expert Opinion Evidence

    Peter Choate

    A California appeals court's recent decision in Apple v. Superior Court explicitly holds that the Sargon standard applies when a party seeks to admit expert opinion evidence. Practitioners should seek to preserve this issue for appeal and urge the California Supreme Court to resolve it, say Peter Choate and William Dance of Tucker Ellis LLP.

  • Emerging Patent Issues In The Cannabis Industry

    Brett Schuman

    As cannabis industry players aggressively build patent portfolios around their products, including marijuana strains, a cannabis patent war is likely on the horizon. Among other issues, the lack of prior art may lead to issuance of overbroad patents, which will pose risks to other market participants, say attorneys with Goodwin Procter LLP.

  • Register Your California Cannabis Trademarks Now

    Joshua Cohen

    Any cannabis business that is holding its breath waiting for the U.S. Patent and Trademark Office to start registering cannabis-related trademarks should give up. But those located in states that have legalized recreational and/or medicinal cannabis should immediately seek state trademark registration where available, says Joshua Cohen, leader of Wendel Rosen Black & Dean LLP's intellectual property group.

  • How Emerging Sources Of ESI Will Impact Discovery

    Charles McGee

    Late last year, the Sedona Conference released the third edition of its principles addressing electronic document production, updated to account for innovations like Snapchat and Twitter. It may be necessary for these principles to be updated more often in order to keep pace with technology, says Charles McGee III of Murphy & McGonigle LLP.

  • Put The Brakes On Acceleration Bay Litigation Funder Ruling

    David Gallagher

    Last week, the District of Delaware raised eyebrows by ruling that documents provided to a litigation funder and its counsel in connection with their due diligence are categorically not attorney work product. Acceleration Bay v. Activision Blizzard seems to be a case of bad facts making bad law, says David Gallagher, investment manager and legal counsel for Bentham IMF.

  • How Natural Experiments Can Help In Estimating Damages

    Niall MacMenamin

    Establishing a causal link between allegedly wrongful conduct and the quantity of damages asserted can be challenging. Fortunately, increasing volumes of real-world data are available to the damages expert, and natural experiments based on such data can be effective in showing causality and estimating damages, says Niall MacMenamin of Analysis Group Inc.

  • Considerations For Attorneys Using Artificial Intelligence

    Ben Allgrove

    Artificial intelligence tools can empower attorneys to work more efficiently, deepen and broaden their areas of expertise, and provide increased value to clients, which in turn can improve legal transparency, dispute resolution and access to justice. But there are some common pitfalls already apparent in the legal industry, say Ben Allgrove and Yoon Chae of Baker McKenzie.