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Life Sciences

  • December 5, 2018

    Data-Driven Lawyer: Kilpatrick Townsend's Kate Gaudry

    Kilpatrick Townsend’s Kate Gaudry has used data analytics to supercharge her patent prosecution practice, uncover winning strategies for portfolio management and expose a secretive U.S. Patent and Trademark Office program, earning her a spot on our 2018 list of Data-Driven Lawyers.

  • December 4, 2018

    Aralez Ch. 11 Sale Problems Put Case On Path To Mediation

    Disagreements among stakeholders in the Chapter 11 case for Aralez Pharmaceuticals Inc. have led the case in the "wrong direction," a New York bankruptcy judge said Tuesday, as he instructed the parties to mediate fights over sales of the drug company's assets.

  • December 4, 2018

    Tax Court Judge Presses IRS On Mylan Legal Fee Deduction

    A U.S. Tax Court judge on Tuesday questioned the Internal Revenue Service's reasoning for denying Mylan Inc. a $50 million legal fee deduction, challenging the agency’s argument that the deduction could not be taken for litigation related to the generic drug approval process.

  • December 4, 2018

    Justices Ask Tough Questions In AIA On-Sale Bar Case

    U.S. Supreme Court justices on Tuesday wrestled with the idea that the America Invents Act may have narrowed the on-sale bar in patent cases, while leaving open the door for a possible exception to the bar for activities that aren’t commercial sales.

  • December 4, 2018

    FTC Supports FDA’s Plan To Curb Sham Petitioning

    The Federal Trade Commission said Tuesday that it supports the Food and Drug Administration’s plan to prevent drug companies from strategically objecting to generic approvals with the aim of delaying competition, saying the commission was ready to help curb abuse.

  • December 4, 2018

    5 Key Questions As DOJ Torpedoes Gilead FCA Suit

    The U.S. Department of Justice’s bombshell move to let Gilead Sciences Inc. escape a multibillion-dollar False Claims Act suit is sparking speculation about the DOJ’s motivations and the implications for similar suits alleging regulatory violations. Here are five important questions raised by the DOJ’s move.

  • December 4, 2018

    J&J Tells Fed. Circ. Judge Was Wrong To Nix Zytiga Patent

    A district court judge was wrong to invalidate a patent for a Johnson & Johnson unit’s blockbuster cancer drug Zytiga, the company told the Federal Circuit, arguing that the lower court had ignored an America Invents Act provision in finding the patent was obvious.

  • December 4, 2018

    Tribes Can't Seek Info On Fed Contracts, IHS In Opioid MDL

    An Ohio federal judge on Tuesday refused nearly two dozen Indian tribes' request to conduct further discovery of federal contracts so they can avoid being treated disparately from government entities in an ongoing opioid multidistrict litigation, ruling that the court has already identified cases that discuss the tribes' legal issues.

  • December 4, 2018

    Fed. Circ. Questions How Aventis Cancer Drug Is Inventive

    A Federal Circuit panel on Tuesday repeatedly pushed back on claims by Aventis Pharma S.A. that its prostate cancer drug should be patentable because the drug is inventive, questioning how a drug that increased someone’s life was not obvious.

  • December 4, 2018

    FDA Issues Proposed Rule For Novel Medical Devices

    The U.S. Food and Drug Administration on Tuesday released a proposed rule aimed at updating the review process for novel, low- to moderate-risk medical devices before they enter the market that the agency says will clarify the process.

  • December 4, 2018

    11th Circ. Revives Suit Over Protein Powder Labels

    Hi-Tech Pharmaceuticals Inc. will get another shot at rival supplement maker HBS International Corp. over the allegedly misleading labeling on its HexaPro protein powder mix, after the Eleventh Circuit on Tuesday reversed the dismissal of Hi-Tech's Lanham Act claims.

  • December 4, 2018

    Pa. Panel Questions Latest Bid To Ax Out-Of-State Mesh Suits

    A Pennsylvania appeals court panel raised doubts on Tuesday as to whether a Johnson & Johnson unit could challenge an order letting out-of-state plaintiffs pursue pelvic mesh claims in Philadelphia, given a prior ruling upholding an Indiana woman’s win in a mesh case.

  • December 4, 2018

    Fed. Circ. Reluctant To Void CBM Review Of Inventory Patent

    A Federal Circuit panel seemed skeptical Tuesday on being asked to overturn a ruling by the Patent Trial and Appeal Board that a handful of claims of a Unisone patent dealing with inventory restocking technology are invalid, appearing to back the board’s use of a covered business method review in the case.

  • December 4, 2018

    Deals Rumor Mill: Daimler, Ardian, Grail

    Daimler AG is considering taking a larger stake in a joint venture with Beijing-based BAIC Motor Corp., Ardian is looking to raise as much as €6 billion ($6.8 billion) by way of its latest buyout fund, and Grail is considering going public in the U.S.

  • December 4, 2018

    Data-Driven Lawyer: Littler's Scott Forman

    Littler Mendelson PC shareholder Scott Forman's innovative case management platform helps his firm analyze litigation data, craft defense strategies, predict outcomes and greatly reduce client costs, earning him a spot on our 2018 list of Data-Driven Lawyers.

  • December 4, 2018

    Shook Hardy Kicked Off Monster Energy False-Ad Suit

    A partner at Shook Hardy & Bacon LLP has been disqualified from representing Monster Energy Co. in a false advertising suit in California federal court against rival Vital Pharmaceuticals Inc. after a judge found that his past representation of the rival company was enough to kick him and the firm off the case.

  • December 3, 2018

    Calif. Jury Clears Alere In Bio Test Cup Patent Suit

    A California federal jury on Friday cleared Alere Inc. of allegations that its popular drug-screening test product, the iCup A.D., infringed Rembrandt Diagnostics LP’s patent, which describes using strips to quickly test for drugs in urine.

  • December 3, 2018

    Trump Admin. Urges Broad Easing Of Health Laws

    The Trump administration published a sweeping health care manifesto Monday that criticized the ubiquity of comprehensive health insurance and recommended a wide-ranging relaxation of state and federal laws in order to strengthen competition and bring down prices.

  • December 3, 2018

    Atty Fighting Sanctions Says Lies Ignored In Insys Case

    An attorney for the billionaire founder of Insys Therapeutics filed documents in Boston federal court Monday to suggest that prosecutors believed a then-suspect who is now cooperating with prosecutors in the company's bribery case was lying to them in a 2016 proffer, but chose not to prosecute him for the lies.

  • December 3, 2018

    Investor Flags Antibiotics Co. Melinta's $75M Stock Sale

    A stockholder filed a proposed class action in Delaware Chancery Court claiming antibiotics company Melinta Therapeutics Inc.'s board breached its fiduciary duty by entering into an agreement to sell $75 million of the company’s stock to shareholder Vatera Holdings LLC at a time when the stock value is distressed.

Expert Analysis

  • Patent And Copyright Changes In The New NAFTA

    Michele Washington

    The modernized trade agreement between the U.S., Mexico and Canada includes provisions that should improve intellectual property transparency between the member countries and bring a certain degree of procedural uniformity, say attorneys with Snell & Wilmer LLP.

  • World Wide Weed: Best Practices For Internet Cannabis Ads

    John McKay

    For internet publishers that have decided the risks of doing business with cannabis-related companies do not outweigh the value, the most sensible question is not whether there is some risk but how they can minimize it, say John McKay and Chris Morley of Davis Wright Tremaine LLP.

  • When Regulatory Standards And Truth In Advertising Collide

    Terri Seligman

    The Ninth Circuit's decision in Durnford v. MusclePharm Corp. — like two other recent decisions — highlights the balancing act between regulatory standards and truth-in-advertising principles. Compliance with standards doesn't always mean advertisers are in the clear, says Terri Seligman of Frankfurt Kurnit Klein & Selz PC.

  • Opinion

    Time To Reclaim Wellness For All Lawyers

    Leesa Klepper

    The decision last month by Baker McKenzie’s global chairman to step down due to exhaustion indicates that the legal profession needs to mount a broader wellness effort to address long hours, high stress, frequent travel and the daily demands of practice, says Leesa Klepper, director of Thrivewell Coaching.

  • Roundup Verdict Points To Jury Realities In Product Cases

    Matthew Gatewood

    A California jury was recently asked to determine whether the popular herbicide Roundup causes cancer. The case demonstrates how jurors often must draw conclusions on unresolved scientific issues, and how manufacturers that ignore complaints about product risks will struggle to overcome the image of corporate irresponsibility at trial, say attorneys with Eversheds Sutherland LLP.

  • Spotlight On Private Antitrust Enforcement At Seoul Forum

    James Robertson Martin

    At the 10th International Seoul Competition Forum, panelists discussed how private litigation can supplement public enforcement of antitrust laws, and explored how Korea, Hong Kong, China and Europe are all moving in the direction of U.S.-style private enforcement, but to varying degrees, says James Robertson Martin of Zelle LLP.

  • What We Heard At The FTC Hearings: Days 6 And 7

    Eric Weiss

    The fourth hearing in the Federal Trade Commission’s series on competition in the 21st century addressed innovation and intellectual property. Eric Weiss and Nick Hesterberg of Perkins Coie LLP offer some key takeaways.

  • FDA Steps Up Its Focus On Medical Device Cybersecurity

    Michael Buchanan

    Last month, the U.S. Food and Drug Administration announced three new medical device cybersecurity initiatives, including an incident response playbook, a memorandum of agreement with the U.S. Department of Homeland Security and a draft guidance on premarket submissions. The agency is clearly taking device vulnerabilities more seriously than ever, say Michael Buchanan and Joshua Furman of Patterson Belknap Webb & Tyler LLP.

  • Opinion

    CMS Drug Price Proposal Would Harm Patients, Providers

    Justin Linder

    Though the Centers for Medicare & Medicaid Services characterizes a recently proposed drug pricing model as an improvement over the “buy and bill” system, the addition of another middleman to the drug supply chain is likely to complicate logistical burdens related to billing, reimbursement and distribution, says Justin Linder of Dughi Hewit & Domalewski PC.

  • Why Current Laws Won't Protect Property Rights For DNA

    Franklin Zemel

    More than 12 million people have submitted their DNA for analysis to various genealogy companies such as Ancestry.com or 23andMe. But what if they don’t want that DNA shared with third parties? Based on current law, there is little that can be done about it, say Franklin Zemel and Ariel Deray of Saul Ewing Arnstein & Lehr LLP.