Life Sciences

  • March 13, 2025

    Merck Asks Justices To Block Fosamax Failure-To-Warn Suits

    Merck has asked the U.S. Supreme Court to review a Third Circuit ruling that allowed more than 1,000 state-law failure-to-warn claims over its osteoporosis drug Fosamax, arguing that the U.S. Food and Drug Administration's formal rejection of a such a proposed warning label should block such lawsuits under federal law.

  • March 13, 2025

    Calif. AG Appealing State Limits On Pay-For-Delay Ban

    California enforcers are appealing to the Ninth Circuit after a lower court found that a new state law restricting "reverse payment" settlements between brand-name and generic-drug makers cannot be used to regulate deals that were struck outside the state.

  • March 13, 2025

    Fed. Circ. Dings Antibody Patent App For Lacking Description

    The Federal Circuit on Thursday affirmed a decision from top U.S. Patent and Trademark Office officials in a highly watched and technical dispute over an antibody patent application, concluding that preambles for so-called Jepson claims need sufficient written descriptions.

  • March 13, 2025

    PBMs Tell FTC 5-Month Delay Too Long For In-House Insulin Trial

    The nation's "Big Three" pharmacy benefit managers say they want to get to trial in the Federal Trade Commission's administrative suit against them sooner rather than later, arguing that the agency's request for a five-month delay would be too long, but they're open to a three-week postponement.

  • March 13, 2025

    HHS Calls Back Terminated Attys Clearing Medicare Appeals

    The U.S. Department of Health and Human Services on Thursday moved to reinstate about 15 attorneys who were cut loose in recent weeks, restoring staff many in the agency saw as critical to clearing a backlog of Medicare appeals.

  • March 13, 2025

    9th Circ. Ends Idaho Abortion Law Row After Mutual Dismissal

    A Ninth Circuit panel has dropped an appeal from Idaho claiming the state's strict abortion ban doesn't conflict with a federal law protecting emergency abortions, after the Trump administration announced its decision to drop the Biden-era legal challenge. 

  • March 13, 2025

    6 Firms Steer $6.7B Mallinckrodt, Endo Pharma Merger

    Six law firms are guiding a $6.7 billion merger between Ireland's Mallinckrodt PLC and Pennsylvania-based Endo Inc. on a deal announced Thursday that the companies said will create a global pharmaceutical industry leader with projected 2025 revenues of $3.6 billion.

  • March 13, 2025

    Full 4th Circ. Urged To Rethink Drug Price-Fixing Class Action

    The Fourth Circuit's dismissal of a proposed class action accusing drug companies of conspiring to inflate the price of a drug for Huntington's disease has deepened a circuit split on proving injury under the Racketeer Influenced and Corrupt Organizations Act, a group of reimbursement recovery entities has said in asking the full court to rethink the ruling.

  • March 13, 2025

    J&J Unit Drops Noncompete Suit Against Ex-Marketing Exec

    Johnson & Johnson's vision unit has agreed to drop its claims against a former marketing director after reaching a settlement on allegations that she breached a noncompete agreement, according to a Thursday order in New Jersey federal court.

  • March 13, 2025

    Days Into New Role, FDA's Top Lawyer Is Out

    The top lawyer of the U.S. Food and Drug Administration resigned just two days after she was selected for the role, according to a Thursday announcement by the agency on social media site X.

  • March 13, 2025

    Lacking Votes, White House Pulls Weldon Nomination At CDC

    The White House pulled Dr. Dave Weldon's nomination to lead the Centers for Disease Control and Prevention on Thursday after support among GOP lawmakers wavered, and it became clear he didn't have the votes to clear a Senate committee.

  • March 12, 2025

    Cancer Cause Or Red Herring? Jury Weighs Plant Bellwether

    A medical sterilization company told a Colorado jury Wednesday that four women can't get millions in damages based on the "possibility" that emissions from a sterilization plant caused their cancer, at the close of a six-week trial in which the plaintiffs argued the company should be punished for its negligence.

  • March 12, 2025

    Del. Justices Told Conflicts Tainted AstraZeneca Co.'s $3B Sale

    A stockholder class attorney told Delaware's Supreme Court on Wednesday that a vice chancellor never addressed the undisclosed conflicts cited in a Court of Chancery suit accusing AstraZeneca PLC of lining up a conflicted, underpriced $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc.

  • March 12, 2025

    Labcorp Warns Fed. Circ. Of 'Balkanization' In Prenatal IP Row

    Labcorp, one of the world's largest chains of clinical lab providers, told the full Federal Circuit that a loss it incurred there over a patent tied to a $384 million judgment in Texas was the result of the "balkanization" of the court's patent obviousness jurisprudence.

  • March 12, 2025

    Law360 Cheat Sheet: Novartis' Fight Over Generic Entresto

    Novartis has led a wide-ranging litigation campaign to block generic versions of its bestselling cardiovascular drug Entresto that has involved multidistrict litigation, trips to several circuit courts and cases against the federal government. Here, Law360 breaks down how the various cases intersect and what's still playing out.

  • March 12, 2025

    SEC Says Ex-Allarity Execs Concealed Doomed FDA Approval

    The U.S. Securities and Exchange Commission sued three former executives of clinical-stage pharmaceutical company Allarity Therapeutics Inc. in Massachusetts federal court, alleging Wednesday that they schemed to conceal from the public that the company's new drug application for its flagship drug had no chance of gaining regulatory approval.

  • March 12, 2025

    Caribou Biosciences Brass Face Investor's Clinical Trials Suit

    Executives and directors of Caribou Biosciences Inc. have been hit with a shareholder's derivative suit alleging that they overstated the safety and efficacy of Caribou's cell therapy and concealed that the company was at risk of being unable to fund its operations.

  • March 12, 2025

    COVID Test Device Maker Settles Fed. Circ. Feuds With Rival

    A company that makes saliva collection devices used for COVID-19 tests says it will drop out of Federal Circuit appeals fights with Longhorn Vaccines & Diagnostics stemming from the Patent Trial and Appeal Board canceling 183 of Longhorn's patent claims as a punishment for "egregious abuse of the PTAB process."

  • March 12, 2025

    Publix Policies Don't Cover Opioid Claims, Court Says

    Insurers for Publix have no duty to defend or indemnify the supermarket chain in dozens of public nuisance lawsuits related to the opioid crisis, a Florida federal court said Wednesday, following Publix's renewed request that the court enter a final judgment so it could proceed with appeal.

  • March 12, 2025

    NC Organ Procurer Sues CMS Over Hospital Waiver

    A North Carolina-based organ procurement organization told a federal court Wednesday that the Centers for Medicare & Medicaid Services has violated federal law by giving a waiver to a hospital to work with another organ procurement service from a different region. 

  • March 12, 2025

    Cannabis Tech Co. Seeks Over $1M Interest On $4.2M Verdict

    A software company that won a $4.2 million judgment last year on claims that it was wrongly pushed out of a state government contract is urging a Pennsylvania federal court to award more than $1 million in pre- and postjudgment interest on the award.

  • March 12, 2025

    HHS To Eliminate 6 Regional Offices For Legal Staff

    The U.S. Department of Health and Human Services said Tuesday it will close six out of 10 regional offices where attorneys for the agency work.

  • March 12, 2025

    Harvard Docs Say Gov't Censored Articles With Gender Terms

    A pair of Harvard Medical School researchers sued the Trump administration in Massachusetts federal court on Wednesday, claiming their work was erased from a government-run patient safety website because their articles contained terms like "LGBTQ" and "transgender."

  • March 12, 2025

    Mallinckrodt Investors Ask NJ Court To Approve $46M Deal

    A group of Mallinckrodt PLC investors has asked a New Jersey federal judge to grant final approval to a $46 million settlement they reached with executives and directors of the pharmaceutical company to resolve claims that they misrepresented the prospects of a drug the company developed.

  • March 12, 2025

    McCarter & English Wins $3.77M From Ex-Client In Billing Spat

    McCarter & English LLP is entitled to nearly $3.77 million from Jarrow Formulas Inc., a nutritional supplement company that refused to pay its legal bills after losing a trade secrets trial and a subsequent malpractice claim against the firm, a Connecticut federal judge has ruled.

Expert Analysis

  • Expect More State Scrutiny Of PE In Healthcare M&A

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    While a California bill that called for increased antitrust scrutiny of many healthcare private equity transactions was recently vetoed by the governor, state legislatures are likely to continue introducing similar laws, particularly if the Trump administration eases federal enforcement, say attorneys at Morgan Lewis.

  • Declaring Unexpected Results: Pitfalls For Rule 132 At PTAB

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    Rule 132 declarations are frequently used in life sciences patent prosecution for rebutting obviousness rejections by establishing that an applicant's invention produces unexpected results, and the Patent Trial and Appeal Board's Eidschun ruling highlights when this important tool may be ineffective, say attorneys at Morrison Foerster.

  • IP Ruling Likely To Limit Arguments Against Qualified Experts

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    The Federal Circuit's recent decision in Osseo v. Planmeca, clarifying when experts may offer testimony from the perspective of a skilled artisan, provides helpful guidance on expert qualifications and could quash future timing arguments regarding declarants' expertise, says Whitney Jenkins at Marshall Gerstein.

  • How Boards And Officers Should Prep For New Trump Admin

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    In anticipation of President-elect Donald Trump's proposed tariffs and mass deportation campaign, company officers and board members should pursue proactive, comprehensive contingency planning to not only advance the best interests of the companies they serve, but to also properly exercise their fiduciary duty of care, say attorneys at Winston & Strawn.

  • Dissecting The Obviousness-Type Double Patenting Debate

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    The Federal Circuit's recent decision in Allergan v. MSN highlights the ongoing evolution of the obviousness-type double patenting doctrine, revealing increasing tension between expiration-based interpretations and procedural flexibility, says Jeremy Lowe at Leydig Voit.

  • Service Providers Must Mitigate 'Secondary Target' Risks

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    A lawsuit recently filed in an Illinois federal court against marketing agency Publicis over its work for opioid manufacturers highlights an uptick in litigation against professional service providers hired by clients that engaged in alleged misconduct — so potential targets of such suits should be sure to conduct proper risk analysis and mitigation, say attorneys at Dechert.

  • Health Policy Predictions For Trump's Second Administration

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    As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.

  • Series

    Flying Makes Me A Better Lawyer

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    Achieving my childhood dream of flying airplanes made me a better lawyer — and a better person — because it taught me I can conquer difficult goals when I leave my comfort zone, focus on the demands of the moment and commit to honing my skills, says Ivy Cadle at Baker Donelson.

  • 9th Circ.'s High Bar May Limit Keyword Confusion TM Claims

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    A recent Ninth Circuit ruling that a law firm did not infringe upon a competitor’s trademarks by paying Google to promote its website when users searched for the rival’s name signals that plaintiffs likely can no longer win infringement suits by claiming competitive keyword advertising confuses internet-savvy consumers, say attorneys at Mitchell Silberberg.

  • Trump Patent Policy May Be Headed In Unexpected Direction

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    While commentators have assumed that the patent policy of President-elect Donald Trump's second administration will largely mirror the pro-patent policy of his first, these predictions fail to take into account the likely oversized influence of Elon Musk, says Jorge Contreras at the University of Utah.

  • What Trump's Next Term May Mean For Biz Immigration

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    Leonard D'Arrigo at Harris Beach discusses the employment-based immigration policies businesses can potentially expect during President-elect Donald Trump’s second term, based on policies enacted during his first administration, statements made during his campaign and proposals in Project 2025.

  • Racing Patents To The Fed. Circ.: Collateral Estoppel Lessons

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    As more and more parties find themselves in two different forums addressing the same issues and then competing in a race to the Federal Circuit, certain strategies can help despite unanswered questions on when Patent Trial and Appeal Board determinations trigger collateral estoppel, say attorneys at Akin.

  • Series

    Circus Arts Make Me A Better Lawyer

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    Performing circus arts has strengthened my ability to be more thoughtful, confident and grounded, all of which has enhanced my legal practice and allowed me to serve clients in a more meaningful way, says Bailey McGowan at Stinson.

  • 3 Ways To Train Junior Lawyers In 30 Minutes Or Less

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    Today’s junior lawyers are experiencing a skills gap due to pandemic-era disruptions, but firms can help bring them up to speed by offering high-impact skill building content in bite-sized, interactive training sessions, say Stacey Schwartz at Katten, Diane Costigan at Winston & Strawn and Lauren Tierney at Freshfields.

  • How AstraZeneca Ruling Could Change Dosage Patent Claims

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    If affirmed on appeal, the rationale employed by the Delaware federal court in Wyeth v. AstraZeneca to find "unit dosage"-related patent claims invalid could lead to a significant paradigm shift in how active-ingredient-focused patent applications are drafted and litigated, say Matthew Zapadka and John Schneible at Arnall Golden.

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