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Life Sciences
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March 25, 2026
PTAB Was Never '100% Discretionary,' Rep. Issa Tells Squires
U.S. Patent and Trademark Office Director John Squires is exceeding the authority Congress intended to grant him in the America Invents Act for discretionarily denying patent challenges, the U.S. House of Representatives' intellectual property leader said Wednesday.
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March 25, 2026
AbbVie, Novartis Sue Wash. Over New 340B Drug-Pricing Law
Pharmaceutical giants Novartis and AbbVie say a new Washington state law illegally expands drugmakers' obligations to provide deeply discounted medications under the federal government's 340B Drug Pricing Program, according to a pair of legal challenges launched in federal court on Wednesday.
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March 25, 2026
Ex-Pharma GC Freed From Trade Secrets Suit Amid Ch. 7 Stay
A Texas federal judge agreed to dismiss claims against the ex-general counsel of a Houston-based pharmaceutical services company, who was accused of helping build a competing venture using confidential information and of destroying a hard drive containing evidence he had a duty to preserve during litigation.
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March 25, 2026
Co.'s Dual Citizenship Doesn't Kill Jurisdiction, 4th Circ. Told
A medical supply company urged the Fourth Circuit on Wednesday to revive its suit against a U.K. company over COVID-19 test kits, arguing the Chinese citizenship of one of its members doesn't destroy a North Carolina federal judge's ability to hear the case.
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March 25, 2026
Mom Tying Abbott Formula To Baby's NEC Takes The Stand
A plaintiff claiming Abbott Laboratories' preterm baby formula contributed to her infant's development of a serious gut condition told an Illinois jury Wednesday that she wouldn't have allowed her baby to consume the formula had she known it increased the risk of the infection, saying her now-teenage daughter still struggles with medical complications as a result.
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March 25, 2026
Fecal Treatment Co. Says Ch. 11 Is Best Option To Sell Assets
Microbiome treatment developer Finch Therapeutics told a Delaware bankruptcy judge Wednesday that its lack of income or ability to collect on a patent judgment justified its Chapter 11 filing despite a lack of secured debts.
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March 25, 2026
Judge Trims SEC Fraud Case Over Cancer Drug Claims
A Massachusetts federal judge greenlighted U.S. Securities and Exchange Commission claims against two of three former pharmaceutical executives accused of concealing from investors the U.S. Food and Drug Administration's "harsh critiques" about a cancer drug.
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March 25, 2026
Insurer Need Not Cover Parkinson's Drug Antitrust Dispute
An insurer does not owe coverage in an antitrust suit accusing a pharmaceutical company of suppressing generic versions of the Parkinson's treatment Apokyn, a Maryland federal judge ruled, finding the dispute does not involve "securities claims" covered under the insurer's policy.
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March 25, 2026
Biotech 'Lowballed' Landlord On Lease Exit, Suit Says
Biopharma company Werewolf Therapeutics has offered its Massachusetts landlord little more than 10 cents on the dollar to buy out the remainder of a lease for its lab space, even as the firm pays out departing executives and other creditors, according to a lawsuit brought in state court.
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March 25, 2026
Dechert Adds Paul Weiss Patent Partners In DC, NY
Dechert LLP has hired two Paul Weiss Rifkind Wharton & Garrison LLP lawyers who have backgrounds in life sciences and electrical engineering, the firm announced Tuesday.
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March 25, 2026
Covington, Freshfields Advise On $6.7B Merck Oncology Deal
Merck & Co. said Wednesday it will acquire clinical-stage oncology company Terns Pharmaceuticals Inc. for $53 per share in cash, giving the deal an equity value of $6.7 billion.
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March 24, 2026
Trump Admin Settles Suit Over Biden Social Media Collabs
The Trump administration on Tuesday agreed to bar three federal agencies from interfering with social media companies' content moderation, resolving a high-profile challenge to the Biden administration's efforts to combat the spread of misinformation in a case that went up to the U.S. Supreme Court.
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March 24, 2026
Nicotine Pouch Maker To Refile FDA Suit In DC After Transfer
The maker and seller of Zone nicotine pouches on Tuesday dismissed its own lawsuit accusing the U.S. Food and Drug Administration of unfairly holding up a market application for its product, promising to refile in D.C. federal court after a Texas federal court transferred it to South Carolina federal court.
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March 24, 2026
Agenus Escapes Investor Fraud Suit Over Cancer Drug
A Massachusetts federal judge on Tuesday tossed securities fraud claims against Agenus Inc., saying the biotech company did not conceal the risk that a colorectal cancer therapy it was developing might face roadblocks.
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March 24, 2026
Drug Co. Atara Hit With Investor Suit Over FDA Denial
Drug company Atara Biotherapeutics Inc. has been hit with a proposed class action accusing it of harming investors by not disclosing certain manufacturing problems and research study deficiencies that made it unlikely the U.S. Food and Drug Administration would approve its new drug application.
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March 24, 2026
Squires Institutes 6 Patent Reviews, Denies 15 Others
U.S. Patent and Trademark Office Director John Squires has granted six petitions seeking America Invents Act reviews of patents and rejected 15 others, according to his latest summary order listing his most recent decisions.
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March 24, 2026
Sarepta Urges Full Fed. Circ. To Wipe Out Gene Therapy IP
Sarepta Therapeutics Inc. wants the full Federal Circuit to rethink a decision reviving a University of Pennsylvania gene therapy patent, saying a panel got its analysis of patent eligibility wrong.
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March 24, 2026
ITC Says Hydrafacial Patent Infringed, But Won't Ban Imports
The U.S. International Trade Commission has found that an aesthetics medical device company infringed a Hydrafacial LLC skin treatment patent, but stopped short of enforcing a ban on imports.
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March 24, 2026
CBP Frees Redesigned Smart Rings From Import Ban
U.S. Customs and Border Protection has lifted an import ban issued by the U.S. International Trade Commission on smart rings made by Ultrahuman, finding that a redesign cleared the product of infringing a patent held by Ouraring.
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March 24, 2026
Fla. Judge Tosses Fired Reporter's Vaccine Suit Against PGA
A Florida federal judge has ruled in favor of the PGA Tour in a lawsuit brought by a reporter who claimed she was fired for not complying with COVID-19 protocols, saying she couldn't claim a religious exemption.
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March 24, 2026
FTC Rejects Bids To Block Gender-Affirming Care Probe
A transgender medical care group and two healthcare trade organizations must turn over documents related to the group's claims made in their marketing and advertising for gender-affirming care for minors, the Federal Trade Commission ordered, denying the groups' motions to quash the agency's consumer protection investigation.
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March 24, 2026
6 Firms Guide Gilead's $2.2B Autoimmune Drug Play
Gilead Sciences Inc. has agreed to acquire privately held Ouro Medicines for up to $2.175 billion and is in advanced discussions with Galapagos NV on a potential research and development collaboration on the assets, according to an announcement late Monday from Gilead.
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March 24, 2026
Alston & Bird Hires Ex-FDA Deputy Counsel From DLA Piper
Alston & Bird LLP announced on Tuesday it has hired a longtime government lawyer and former DLA Piper attorney to assist with the firm's work helping companies handle FDA compliance issues and regulatory disputes over medical products.
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March 24, 2026
FTC To Mull Caremark Deal In PBM Insulin Pricing Case
Federal Trade Commission staffers have asked to let the agency's commissioners consider a potential settlement with Caremark in a case accusing pharmacy benefit managers of inflating insulin prices through rebate schemes, following a recent deal with Express Scripts.
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March 24, 2026
Beasley Allen Says NJ Justices Review Of Talc DQ 'Essential'
Beasley Allen urged the New Jersey Supreme Court to hear its appeal of a lower court's decision to disqualify it from representing plaintiffs in multicounty litigation over Johnson & Johnson's talc-based baby powder, arguing that the court's immediate review of the interlocutory order is "essential."
Expert Analysis
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Series
Trivia Competition Makes Me A Better Lawyer
Playing trivia taught me to quickly absorb information and recognize when I've learned what I'm expected to know, training me in the crucial skills needed to be a good attorney, and reminding me to be gracious in defeat, says Jonah Knobler at Patterson Belknap.
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What FDA Guidance Means For Future Of Health Software
Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a targeted effort to ease innovation friction around specific areas, including singular clinical decision support recommendations and sensor-based wearables, while maintaining established regulatory boundaries, say attorneys at Covington.
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Opinion
Federal Preemption In AI And Robotics Is Essential
Federal preemption offers a unified front at a decisive moment that is essential for safeguarding America's economic edge in artificial intelligence and robotics against global rivals, harnessing trillions of dollars in potential, securing high-skilled jobs through human augmentation, and defending technological sovereignty, says Steven Weisburd at Shook Hardy.
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Series
Law School's Missed Lessons: What Cross-Selling Truly Takes
Early-career attorneys may struggle to introduce clients to practitioners in other specialties, but cross-selling becomes easier once they know why it’s vital to their first years of practice, which mistakes to avoid and how to anticipate clients' needs, say attorneys at Moses & Singer.
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Drafting Tech Patents After USPTO's Eligibility Memos
Two recent U.S. Patent and Trademark Office memos on subject matter eligibility declarations provide an evidentiary playbook for artificial intelligence and software patent applications, highlighting how targeted, stand‑alone SMEDs that present objective, claim‑anchored facts can improve patent application outcomes, say attorneys at Reed Smith.
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How State FCA Activity May Affect Civil Fraud Enforcement
A growing trend of state attorneys general enforcing their False Claims Act analogues independently of the U.S. Department of Justice carries potential repercussions for civil fraud enforcement and qui tam litigation considerations, say Li Yu at Bernstein Litowitz, Ellen London at London & Naor and Gwen Stamper at Vogel Slade.
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Series
Judges On AI: Practical Use Cases In Chambers
U.S. Magistrate Judge Allison Goddard in the Southern District of California discusses how she uses generative artificial intelligence tools in chambers to make work more efficient and effective — from editing jury instructions for clarity to summarizing key documents.
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Assessing Compliance Risks Around TrumpRx Participation
As there are novel compliance obligations and potential political opposition related to the new TrumpRx online drug platform, companies intending to participate on the site should consider the pressure points that are likely to draw enforcement scrutiny, say attorneys at Sheppard.
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USPTO Initiatives May Bolster SEP Litigation In The US
The U.S. Patent and Trademark Office's recent efforts to revitalize standard-essential patent litigation face hurdles in their reliance on courts and other agencies, but may help the U.S. regain its central role in global SEP litigation if successful, say attorneys at Axinn.
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Series
Trail Running Makes Me A Better Lawyer
Navigating the muddy, root-filled path of trail marathons and ultramarathons provides fertile training ground for my high-stakes fractional general counsel work, teaching me to slow down my mind when the terrain shifts, sharpen my focus and trust my training, says Eric Proos at Next Era Legal.
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Predicting Actual Impact From CDC's New Vaccine Guidance
Recent federal changes to the childhood immunization schedule, reducing the number of vaccine recommendations from 18 to 11, do not automatically create enforceable obligations for parents, schools or healthcare providers, but may spur litigation and other downstream effects on school policies and state guidelines, says Mehdi Sinaki at Michelman & Robinson.
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AI Scientific Discovery Order Implications For Life Sciences
President Donald Trump's November executive order establishing a government effort to use artificial intelligence to accelerate scientific discovery has the potential to leverage significant federal resources and data to support research, drug and device approvals, and AI model training in the life sciences sector, say attorneys at Hogan Lovells.
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What Rescheduling Means For Cannabis Labels, Marketing
The proposed reclassification of cannabis is expected to bring heightened scrutiny of labeling, advertising and marketing from the U.S. Food and Drug Administration and the Federal Trade Commission, but the brands that tighten evidence, standardize operations and professionalize marketing controls now will see fewer surprises and better outcomes, say attorneys at Wilson Elser.
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Tips From Del. Decision Nixing Major Earnout Damages Award
The Delaware Supreme Court recently vacated in part the largest earnout-related damages award in Delaware history, making clear that the implied covenant of good faith and fair dealing cannot be used to rescue parties from drafting choices where the relevant regulatory risk was foreseeable at signing, say attorneys at Sullivan & Cromwell.
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USPTO's New Patentability Focus Helps Emerging Tech
The U.S. Patent and Trademark Office's recent efforts to shift patentability criteria back toward traditional standards of novelty, obviousness and adequate disclosure should make it easier for emerging tech, including artificial intelligence, to obtain patents, says Bill Braunlin at Barclay Damon.