Life Sciences

  • October 07, 2024

    ITC Judge Pushes For Import Ban In Liver Drug Secrets Row

    The U.S. International Trade Commission's chief judge is recommending the agency block a Hong Kong-listed drug developer from potentially marketing unapproved treatments for a type of liver disease for the next seven years, a win for another company behind a different unapproved treatment for the same type of liver disease.

  • October 07, 2024

    Fed. Circ. Questions If Safer OxyContin Profits Came From IP

    An attorney for Purdue Pharma didn't seem to find much purchase at the Federal Circuit on Monday as he argued that the company's patents for abuse-deterrent OxyContin weren't obvious, claiming other companies had ample opportunity to reach a solution and failed to do so.

  • October 07, 2024

    Merck Immune For 'Inflated' Vax Claims To FDA, 3rd Circ. Says

    A divided Third Circuit panel inoculated Merck from claims that it tried to prevent competition by making inflated declarations to federal regulators about its mumps vaccine, with the majority ruling Monday that because Merck convinced federal regulators it had extended the vaccine's long-term potency, those assertions can't have been an anticompetitive "sham."

  • October 07, 2024

    Biotech, Medical Device Firms Prep Three IPOs Totaling $376M

    Two venture-backed biotechnology startups and a medical device maker launched plans on Monday for three initial public offerings projected to raise about $376 million combined, adding to a busy schedule of IPOs this week.

  • October 07, 2024

    Mich. Supreme Court Snapshot: Insulin Prices, Disney Audit

    The Michigan Supreme Court's first oral argument session of the 2024-25 term promises to be a busy one, involving an investigation into Eli Lilly's insulin prices with big implications for the scope of Michigan's consumer protection law and Disney's appeal of an order to turn over decades-old uncashed checks to the state treasurer.

  • October 07, 2024

    Mylan, Novo Nordisk Settle Ozempic Patent Dispute

    Mylan Pharmaceuticals and Novo Nordisk have asked the Patent Trial and Appeal Board to terminate Mylan's request to review whether a patent covering Novo Nordisk's blockbuster diabetes and weight-loss drug Ozempic holds up, telling the board the two sides have resolved their dispute.

  • October 07, 2024

    5 Decisions To Know By Outgoing Mass. Chief Judge

    Chief Massachusetts U.S. District Judge F. Dennis Saylor IV, who announced Monday that he will step back from full-time judicial service next summer, has presided over numerous significant cases in recent years, including a dispute over the U.S. Securities and Exchange Commission's disgorgement powers and a birth defects suit against GlaxoSmithKline.

  • October 07, 2024

    Trio Of 1st Circ. Criminal Cases Turned Away By Top Court

    The U.S. Supreme Court on Monday declined to review three white collar cases on appeal from the First Circuit, including challenges to a cryptocurrency founder's conviction for investor theft and an Illinois attorney's fraud and money laundering conspiracy verdict.

  • October 07, 2024

    Justices Won't Hear Kickback Statute 'Willfulness' Case

    The U.S. Supreme Court on Monday declined to consider whether a "willful" act under federal anti-kickback law requires a defendant to know their actions violate the law.

  • October 07, 2024

    High Court Rejects Pleas To Hear 7 Patent Cases

    The U.S. Supreme Court on Monday turned down seven petitions seeking review of decisions in patent cases, including appeals dealing with double patenting, patent eligibility and Patent Trial and Appeal Board procedures.

  • October 07, 2024

    High Court Won't Look At Alabama Frozen Embryo Decision

    The U.S. Supreme Court on Monday said it won't consider a challenge to a first-of-its-kind Alabama state court ruling that frozen embryos are legally children.

  • October 07, 2024

    Justices Won't Hear Shkreli's Bid To Undo $64M Disgorgement

    The U.S. Supreme Court refused Monday to review former pharmaceutical executive Martin Shkreli's challenge of a disgorgement order requiring him to pay up to $64 million for an alleged scheme to increase the price of a life-saving drug by 4,000%.

  • October 04, 2024

    Top 5 Supreme Court Cases To Watch This Fall

    The U.S. Supreme Court will hear several cases in its October 2024 term that could further refine the new administrative law landscape, establish constitutional rights to gender-affirming care for transgender minors and affect how the federal government regulates water, air and weapons. Here, Law360 looks at five of the most important cases on the Supreme Court's docket so far.

  • October 04, 2024

    NJ, Ethics Board Must Hand Over Docs In Retaliation Fight

    A New Jersey state judge has ordered the state and its ethics commission to hand over to an ex-state health official internal documents in his lawsuit alleging that he was wrongly fired in 2020 for raising concerns about the earmarking of COVID-19 tests for relatives of another state official.

  • October 04, 2024

    DOJ Charges Execs, Sales Reps Over Texas 'Pill Mills' Sales

    Tens of millions of opioid pills ended up in the black market by way of pharmaceutical distribution executives and sales representatives who targeted a Houston "hot zone" for drug diversion, the U.S. Department of Justice said in unsealing several indictments in Texas, Florida, Missouri and North Carolina.

  • October 04, 2024

    Regeneron Can't Ax Willful Infringement In COVID Patent Case

    Regeneron Pharmaceuticals Inc. cannot boot a willful infringement claim from Allele Biotech's patent suit over the development of COVID-19 vaccines and treatments, a New York federal judge ruled Friday, saying it was up to Regeneron to establish that Allele failed to show the defendant had presuit knowledge of the patent.

  • October 04, 2024

    Healthcare Co. Inks Deal In DOL Equal Pay Investigation

    A healthcare diagnostics company has agreed to pay nearly $60,000 to the U.S. Department of Labor to end an agency probe over concerns that a New Jersey manufacturing facility undercompensated female employees compared to their male colleagues.

  • October 04, 2024

    There May Not Be Life On Mars, But There Could Be IP

    The rapidly expanding space tourism industry is raising a vast universe of potential intellectual property issues. Experts say most of the laws governing extraterrestrial IP are as unexplored as space itself.

  • October 04, 2024

    UK Litigation Roundup: Here's What You Missed In London

    This past week in London has seen GMB Union sued by the makers of Tetley Tea after a staff walkout in September, boxer Mike Tyson hit with legal action from a marketing company and the Met Police face a misuse of private data claim from a woman who had a relationship with an undercover police officer. Here, Law360 looks at these and other new claims in the U.K.

  • October 04, 2024

    High Court Takes Up E-Cig 'Forum Shopping' Appeal

    The U.S. Supreme Court on Friday agreed to review a Fifth Circuit ruling that allowed out-of-circuit e-cigarette manufacturers to seek judicial review before the New Orleans-based court so long as the petition is joined by a seller located in the circuit.

  • October 04, 2024

    High Court Will Hear TCPA Case Over Online Junk Faxes

    The U.S. Supreme Court said Friday it will review whether district courts must follow a Federal Communications Commission ruling that the Telephone Consumer Protection Act does not prohibit junk faxes that are received only via electronic inboxes.

  • October 03, 2024

    Gilead Makes Generic HIV Drug Plan, Advocates Urge Expansion

    Gilead Sciences Inc. this week announced a plan to allow six drugmakers to produce generic lenacapavir to help combat the HIV pandemic in 120 lower-income countries, an initiative that won praise as a welcome step Thursday, although advocacy groups urged the company to expand the effort.

  • October 03, 2024

    Boston Pharma Co. Drops Another Moderna Patent Suit

    A Boston pharmaceutical developer once again has agreed to drop a patent lawsuit against Moderna over its popular coronavirus vaccines after losing a claim construction ruling in front of Delaware's top judge.

  • October 03, 2024

    Del. Vice Chancellor Slams Fee Terms In Advancement Case

    A Delaware vice chancellor balked Thursday at "success fee" terms in a fee advancement case that she suggested made the clients a "human shield" in litigation over attorney expenses in connection with a New Jersey legal malpractice case.

  • October 03, 2024

    Trulieve Sues Fla. Republican Party Over Anti-Weed Ads

    Trulieve, which is Florida's largest medical marijuana company and the principal backer of a ballot initiative to legalize cannabis in the Sunshine State, has sued the state's Republican Party and a pair of television stations for defamation, alleging that they ran misleading anti-weed ads.

Expert Analysis

  • Cannabis Biz Real Estate Loan Considerations For Lenders

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    Now that cannabis sales are legal in some states, real estate lenders are interested in financing the land used by cannabis companies, but because cannabis sales are still illegal under federal law, lenders must make adjustments for cannabis-adjacent transactions, say Mark Levenson and Jeffrey Wendler at Sills Cummis.

  • E-Discovery Quarterly: Rulings On Hyperlinked Documents

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    Recent rulings show that counsel should engage in early discussions with clients regarding the potential of hyperlinked documents in electronically stored information, which will allow for more deliberate negotiation of any agreements regarding the scope of discovery, say attorneys at Sidley.

  • Loper Bright Limits Federal Agencies' Ability To Alter Course

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    The U.S. Supreme Court's recent decision to dismantle Chevron deference also effectively overrules its 2005 decision in National Cable & Telecommunications Association v. Brand X, greatly diminishing agencies' ability to change regulatory course from one administration to the next, says Steven Gordon at Holland & Knight.

  • A Primer On EU's Updated Human Substance Regulations

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    The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.

  • Series

    Teaching Scuba Diving Makes Me A Better Lawyer

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    As a master scuba instructor, I’ve learned how to prepare for the unexpected, overcome fears and practice patience, and each of these skills – among the many others I’ve developed – has profoundly enhanced my work as a lawyer, says Ron Raether at Troutman Pepper.

  • The Road Ahead For Regulation Of Digital Twins In Healthcare

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    Digital replicas of cells, organs and people — known as digital twins — can facilitate clinical trials for new drugs by reducing the number of patients required, but data limitations can create logistical hurdles and regulatory efforts addressing digital twins are still in early stages, say consultants at Keystone Strategy.

  • Lawyers Can Take Action To Honor The Voting Rights Act

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    As the Voting Rights Act reaches its 59th anniversary Tuesday, it must urgently be reinforced against recent efforts to dismantle voter protections, and lawyers can pitch in immediately by volunteering and taking on pro bono work to directly help safeguard the right to vote, says Anna Chu at We The Action.

  • 3rd Circ. Ruling Shows Benefits Of IP Licenses In Bankruptcy

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    The Third Circuit’s recent ruling in Mallinckrodt’s Chapter 11 filing, which held that Mallinckrodt could sever its obligations to pay Sanofi royalties on sales of an autoimmune disease drug, highlights the advantages of structuring transactions as nonexclusive licenses for developers of intellectual property, say Gregory Hesse and Kaleb Bailey at Hunton.

  • Opinion

    Unclear Intellectual Property Laws Are Stifling US Innovation

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    U.S. intellectual property law’s lack of predictability means far less job-creating investments for companies that need patent protection to compete, and Congress must step in with legislation like the Patent Eligibility Restoration Act to help address the problem, says Michael Gulliford at Soryn IP Capital Management.

  • The Fed. Circ. In June: More Liability For Generic-Drug Makers

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    The Federal Circuit’s June ruling in Amarin v. Hikma will likely result in more allegations of induced infringement by generic drugs postapproval, with more of those cases proceeding to at least the summary judgment stage instead of being cut off at the outset, say Jeremiah Helm and Sean Murray at Knobbe Martens.

  • Opinion

    Expert Witness Standards Must Consider Peer Review Crisis

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    For nearly two decades, the so-called replication crisis has upended how the scientific community views the reliability of peer-reviewed studies, and it’s time for courts to reevaluate whether peer review is a trustworthy proxy for expert witness reliability, say Jeffrey Gross and Robert LaCroix at Reid Collins.

  • Analyzing Advance Notice Bylaws On 'Clear' Or 'Cloudy' Days

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    In Kellner v. AIM ImmunoTech, the Delaware Supreme Court recently clarified the framework for judicial review of advance notice bylaws adopted, amended or enforced on "clear" or "cloudy" days, underscoring the responsibility of boards to ensure that their scope does not overreach or prevent the possibility of a contested election, say attorneys at Venable.

  • How To Grow Marketing, Biz Dev Teams In A Tight Market

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    Faced with fierce competition and rising operating costs, firms are feeling the pressure to build a well-oiled marketing and business development team that supports strategic priorities, but they’ll need to be flexible and creative given a tight talent market, says Ben Curle at Ambition.

  • Patent Lessons From 5 Federal Circuit Reversals In June

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    A look at June cases where the Federal Circuit reversed or vacated decisions by the Patent Trial and Appeal Board or a federal district court highlights a potential path for branded drugmakers to sue generic-drug makers for off-label uses, potential downsides of violating a pretrial order offering testimony, and more, say Denise De Mory and Li Guo at Bunsow De Mory.

  • Unpacking HHS' Opinion On Cell Therapy Refund Programs

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    A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.

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