Life Sciences

  • June 21, 2024

    Drugmakers Decline To Drop Patent Listings After FTC Letters

    The eight pharmaceutical companies that the Federal Trade Commission warned in April may have improperly listed patents for its products in a key federal database have chosen not to remove any patents or otherwise alter their listings, according to a document released Friday.

  • June 21, 2024

    After Fed. Circ. Win, Bausch Sues Alvogen Over Drug Patents

    Bausch's Salix Pharmaceuticals has launched a lawsuit against Alvogen's Norwich Pharmaceuticals unit in a New Jersey federal court, claiming that its planned generic version of Xifaxan, a blockbuster diarrhea and brain disorder drug, infringes a set of patents.

  • June 21, 2024

    Pay-For-Delay Drug Case Not Time-Barred, UK Tribunal Says

    The U.K. Competition Appeal Tribunal refused Friday to apply a much more restrictive statute of limitations that would toss government claims that Danish pharmaceutical company Lundbeck Ltd. and generic drug manufacturers anticompetitively agreed to delay generic competition to an antidepressant.

  • June 21, 2024

    Ex-CEO Found Liable For $1 Now Seeks Atty Fees For Del. Suit

    The ex-CEO of a biopharma company who was found liable in 2021 for breaching his fiduciary duties but ordered to pay just $1 in damages after Delaware's Court of Chancery found that no real harm had been done is now suing for his attorney's fees and court costs.

  • June 21, 2024

    Costco Sued Over PFAS In Kirkland Brand Baby Wipes

    Costco is facing a proposed class action over its fragrance-free "natural" baby wipes, which consumers claim are made with toxic levels of forever chemicals, rendering them unsafe for use on children.

  • June 21, 2024

    8 Firms To Lead 4 IPOs Totaling $806M As Action Heats Up

    Eight law firms are slated to guide four initial public offerings estimated to raise a combined $806 million during the week of June 24, potentially closing a slow month for new listings with a bang.

  • June 21, 2024

    Taxation With Representation: Travers Smith, Potamitis Vekris

    In this week's Taxation With Representation, RSK Group Ltd. gets a £500 million ($632 million) investment, Boston Scientific Corp. acquires Silk Road Medical Inc., Masdar takes a part of Terna Energy SA, and Tate & Lyle PLC buys CP Kelco from JM Huber Corp.

  • June 20, 2024

    Ex-DEA Heads Echo GOP AGs' Call For Pot Rescheduling Hearing

    A group of former U.S. Drug Enforcement Administration leaders and Republican attorneys general have formally requested administrative hearings on the U.S. attorney general's proposal to reschedule cannabis, according to separate letters sent this week that distinctly echo each other.

  • June 20, 2024

    Patent Owners, Challengers Spar Over PTAB Rule Proposal

    The U.S. Patent and Trademark Office's scaled-back package of Patent Trial and Appeal Board rules has drawn a mixed reaction from legal and industry groups, which offered praise and concern about both the proposal and the topics it does not address.

  • June 20, 2024

    Eli Lilly Launches Round Of Diabetes Drug Suits

    Eli Lilly on Thursday hit various compounding pharmacies and medical spas in five states and the District of Columbia with suits saying that they trick consumers into thinking that they sell Eli Lilly medications that treat diabetes and obesity when actually they are copycats and are untested by the U.S. Food and Drug Administration.

  • June 20, 2024

    Spinal Implant Maker Can Liquidate Under Ch. 11 Plan

    A Delaware bankruptcy judge agreed Thursday to approve the Chapter 11 liquidation and wind-down plan of biotechnology developer InVivo, which reported it landed a buyer for its spinal cord implant technology following an unsuccessful bankruptcy auction.

  • June 20, 2024

    11th Circ. Upholds $2.5M Pelvic Mesh Verdict, Rules Suit Timely

    The Eleventh Circuit on Thursday refused to throw out a woman's $2.5 million victory against Coloplast Corp. in a suit alleging she was implanted with defective pelvic mesh, saying the evidence does not support a conclusion that her claim was filed too late.

  • June 20, 2024

    No Access To Ethics Docs For Ex-NJ Official Yet, Judge Rules

    A New Jersey judge has rejected a bid by a former Garden State health official asking the court to compel the state and its ethics commission to produce documents related to claims he was fired in 2020 for raising concerns over the earmarking of COVID-19 tests for relatives of a state administration official, according to Wednesday orders.

  • June 20, 2024

    No Atty, No Case: Judge Tosses Attack On Psychedelics Ban

    A federal judge in Washington state threw out a challenge to the U.S. Drug Enforcement Administration's efforts to ban two psychedelic substances in an order Thursday that chided a psychedelic research company for doing "an end run" around requirements that corporations be represented by an attorney.

  • June 20, 2024

    HHS Drug Pricing Program Flouts Constitution, Boehringer Says

    An "unprecedented" new Medicare price negotiation program deprives drugmakers of their constitutional rights and forces them to make declarations on issues of public concern that reflect poorly on them, Boehringer Ingelheim Pharmaceuticals Inc. argued Thursday in Connecticut federal court as it echoed the industry chorus seeking to strike the initiative.

  • June 20, 2024

    11th Circ. Nixes J&J Sunscreen Benzene MDL Settlement

    The Eleventh Circuit on Thursday vacated an order granting approval to a settlement resolving claims that Johnson & Johnson sold sunscreens containing benzene, saying a pair of circuit court decisions since the approval mean the deal needs another look.

  • June 20, 2024

    Theravance, Mylan Say Chinese Co. Copied COPD Drug

    Theravance Biopharma and Mylan Specialty have sued a Chinese drugmaker, alleging it copied Yupelri, one of its chronic obstructive pulmonary disease drugs, and infringed several patents in the process.

  • June 20, 2024

    USPTO's AI-Assisted Inventions Guidance Irks ABA IP Section

    The U.S. Patent and Trademark Office's guidance on when inventions developed using artificial intelligence can be patented generated criticism from the American Bar Association's Section of Intellectual Property Law, expressing concern that it could be detrimental as it "casts doubt on inventorship through general acts of human direction."

  • June 20, 2024

    11th Circ. Backs Stryker's Defeat Of Fired Worker's Leave Suit

    The Eleventh Circuit refused Thursday to revive a suit claiming medical technology company Stryker illegally fired a worker on leave awaiting the birth of his child, ruling that because the leave didn't formally kick in until the child was born, his termination was fair game.

  • June 18, 2024

    High Court Petition Asks Justices: What's A 'Willful' Kickback?

    Does a "willful" act under federal anti-kickback law require a defendant to know that the conduct violates the law? That's the question a whistleblower is asking the U.S. Supreme Court to answer in order to resolve what the petition calls a circuit split on a key question of federal fraud prosecutions.

  • June 18, 2024

    Company, States Battle In Court Over At-Home Rape Kits

    A fight is brewing in federal and state courts between a company that purports to be the nation's only purveyor of self-administered sexual assault DNA collection kits and state attorneys general who believe it is misleading sexual assault victims.

  • June 20, 2024

    CORRECTED: Drug Cos., PBMs Score Win In Calif. AG's Insulin Price Suit

    A Los Angeles judge ruled Tuesday that the statute of limitations bars the California Attorney General's unfair competition law and unjust enrichment claims against drugmakers and pharmacy benefit managers over an alleged conspiracy to spike insulin costs, but granted leave to amend the allegations.

  • June 18, 2024

    Fla. Immune To Contract Suit Over COVID Tests, 4th Circ. Says

    The Fourth Circuit reversed on Tuesday a district court decision denying a motion to dismiss by a Florida state agency in a breach of contract case involving COVID-19 tests, finding the lower court erred in ruling that the state did not have sovereign immunity and remanding the case for further proceedings.

  • June 18, 2024

    11th Circ. Orders New Shrimp Secrets Trial Over Judge's Exit

    The Eleventh Circuit ordered a new trial in a trade secrets dispute involving breeders of disease-resistant shrimp, saying Tuesday that a magistrate judge who oversaw the trial's conclusion so that a federal judge could catch a flight exceeded his authority by answering jury questions and rejecting a defense counsel's request for clarification on damages awarded.

  • June 18, 2024

    COVID Test Maker Can't Shake All Of $30M Faulty Kit Suit

    A New Jersey federal judge won't let California-based laboratory equipment maker Atila Biosystems Inc. out of a suit alleging it sold faulty COVID-19 testing kits, saying Fusion Diagnostic Laboratories LLC has adequately pled a breach of contract claim.

Expert Analysis

  • McKesson May Change How AKS-Based FCA Claims Are Pled

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    The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.

  • Series

    Being An Equestrian Makes Me A Better Lawyer

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    Beyond getting experience thinking on my feet and tackling stressful situations, the skills I've gained from horseback riding have considerable overlap with the skills used to practice law, particularly in terms of team building, continuing education, and making an effort to reset and recharge, says Kerry Irwin at Moore & Van Allen.

  • 7th Circ. Mootness Fee Case May Curb Frivolous Merger Suits

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    On April 15, the Seventh Circuit in Jorge Alcarez v. Akorn Inc. mapped out a framework for courts to consider mootness fees paid to individual shareholders after the voluntary dismissal of a challenge to a public company merger, which could encourage objections to mootness fees and reduce the number of frivolous merger challenges filed, say attorneys at Skadden.

  • Fintiv Denials Are On The Rise At PTAB

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    Following last year's CommScope v. Dali decision, the Patent Trial and Appeal Board is increasingly using Fintiv factors to discretionarily deny inter partes review petitions — and attorneys ignore it at their peril, say Josepher Li and Michelle Armond at Armond Wilson.

  • 4 Ways To Refresh Your Law Firm's Marketing Strategy

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    With many BigLaw firms relying on an increasingly obsolete marketing approach that prioritizes stiff professionalism over authentic connection, adopting a few key communications strategies to better connect with today's clients and prospects can make all the difference, say Eric Pacifici and Kevin Henderson at SMB Law.

  • Cos. Must Prepare For Calif. Legislation That Would Ban PFAS

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    Pending California legislation that would ban the sale or distribution of new products containing intentionally added per- and polyfluoroalkyl substances could affect thousands of businesses — and given the bill's expected passage, and its draconian enforcement regime, companies must act now to prepare for it, say attorneys at Alston & Bird.

  • FDA Warning Letter Tightens Reins On 'Research Only' Labels

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    A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.

  • Practical Pointers After Fed. Circ. Double-Patenting Decision

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    With the Federal Circuit recently denying a full court review of In re: Cellect, a decision regarding obviousness-type double-patenting, affected patent family holders should evaluate their rights through both patent prosecution and future litigation lenses to minimize risks, say Austin Lorch and Jeff Wolfson at Haynes Boone.

  • Highlights From The 2024 ABA Antitrust Spring Meeting

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    U.S. merger enforcement and cartels figured heavily in this year's American Bar Association spring antitrust meeting, where one key takeaway included news that the Federal Trade Commission's anticipated changes to the Hart-Scott-Rodino form may be less dramatic than many originally feared, say attorneys at Freshfields.

  • Strategies For Challenging A Fla. Grand Jury Report's Release

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    A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.

  • Patent Lessons From 8 Federal Circuit Reversals In March

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    A number of Federal Circuit patent decisions last month reversed or vacated underlying rulings, providing guidance regarding the definiteness of a claim that include multiple limitations of different scopes, the importance of adequate jury instruction, the proper scope of the precedent, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

  • A Look At Ex Parte Seizures 8 Years Post-DTSA

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    In the eight years since the Defend Trade Secrets Act was enacted, not much has changed for jurisprudence on ex parte seizures, but a few seminal rulings show that there still isn’t a bright line on what qualifies as extraordinary circumstances warranting a seizure, say attorneys at Finnegan.

  • Series

    Whitewater Kayaking Makes Me A Better Lawyer

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    Whether it's seeing clients and their issues from a new perspective, or staying nimble in a moment of intense challenge, the lessons learned from whitewater kayaking transcend the rapids of a river and prepare attorneys for the courtroom and beyond, says Matthew Kent at Alston & Bird.

  • AI In The Operating Room: Liability Issues For Device Makers

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    As healthcare providers consider medical devices that use artificial intelligence — including systems to help surgeons make decisions in the operating room — and lobby to shift liability to device manufacturers, companies making these products must review potential product liability risks and important design considerations for such equipment, say attorneys at Troutman Pepper.

  • Del. Lessons For Director-Nominees On Sharing With Activists

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    The Delaware Chancery Court's recent decision in Icahn Partners v. deSouza finding that a director wasn't permitted to share certain privileged information with the activist stockholders that nominated him shows the need for companies to consider imposing appropriate confidentiality requirements on directors, say attorneys at Sullivan & Cromwell.

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