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Life Sciences

  • December 5, 2018

    Kirkland Taps Allen & Overy Atty To Lead New IP Group In UK

    The former global head of intellectual property at Allen & Overy LLP has been tapped to head the new intellectual property litigation team at Kirkland & Ellis LLP’s London office, Kirkland said.

  • December 5, 2018

    Medtronic To Pay Over $50M To Settle Medical Device Claims

    The world's largest medical device maker, Medtronic PLC, will pay $50.9 million to settle kickbacks and other claims against two companies it owns, including nearly $18 million related to the allegedly reckless marketing of a product designed to treat brain defects, according to the U.S. Department of Justice and a statement from the company.

  • 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.

Expert Analysis

  • 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.

  • Tips For Drafting M&A Agreements After Akorn

    Gail Weinstein

    The Delaware Chancery Court's recent decision in Akorn v. Fresenius has been widely reported because the court, for the first time, found that a target company had suffered a “material adverse effect.” But the 246-page opinion is also a primer on how the court may interpret numerous standard provisions in merger agreements and in corporate contracts generally, say attorneys with Fried Frank Harris Shriver & Jacobson LLP.

  • Assessing Innovations For Medical Device Development

    Ethan Jorgansen-Earp

    Recent comments by Trump administration leaders, as well as regulatory actions, indicate that the landscape for medical device development, approval and reimbursement may be changing for the better, says Ethan Jorgensen-Earp of Holland & Knight LLP.

  • Opinion

    Defendants Can't Be Held To Impossible Discovery Standards

    Michelle Hart Yeary

    In a classic case of overreaching, plaintiffs in the Abilify multidistrict litigation recently sought sanctions against the defendant for not preserving emails from more than a decade before the start of the legal action. But their "everything plus the kitchen sink" approach couldn’t mask the lack of merit in any of their arguments, says Michelle Hart Yeary of Dechert LLP.

  • Building The Regulatory Conversation On Cellular Agriculture

    Brian Sylvester

    The U.S. Department of Agriculture and U.S. Food and Drug Administration recently hosted a joint meeting on the use of animal cell culture technology to develop products derived from livestock and poultry, and related regulation. The specifics of a joint FDA-USDA regulatory framework are expected to come into focus in the months ahead, says Brian Sylvester of Wiley Rein LLP.

  • Protecting Law Firm Talent At Both Ends

    Susan Blakely

    By 2030, it is possible that 75 percent of lawyers practicing in the U.S. will be millennials. A broadened focus on retention and advancement of all young lawyers is therefore a logical step forward but it fails to address another major retention issue that law firms should explore, says Susan Smith Blakely of LegalPerspectives LLC.

  • Q&A

    Wendy Olson Talks Twin Falls, Tribes, Private Practice

    Wendy Olson

    Former U.S. Attorney for the District of Idaho Wendy Olson discusses her decades of experience prosecuting white collar crimes and civil rights violations, her work and challenges as U.S. attorney, and her move to private practice.