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Life Sciences
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February 11, 2025
Research Org Faces Investor Suit Over Customer Cost-Cutting
Clinical research organization Icon PLC has been hit with a proposed shareholder class action in New York federal court, alleging it misled investors about a slowdown in demand the company experienced due to customers implementing drastic cost-reduction measures that involved research and development expenditures.
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February 11, 2025
A 'Disaster For Science': Universities Sue Over NIH Grant Cap
Research universities and higher education organizations on Tuesday requested an order from a Massachusetts federal court to halt the Trump administration from capping indirect costs for grants from the National Institutes of Health, one day after a separate Bay State federal judge paused the change from taking effect in a case brought by a group of state attorneys general.
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February 11, 2025
CVS, Aetna Escape Testing Lab's $20.6M Unpaid Invoices Suit
A Connecticut federal judge threw out a testing laboratory's lawsuit seeking $20.6 million in unpaid invoices from Aetna Inc. and its owner CVS Health Corp., saying the complaint lacked detail and left the companies "guessing" which allegations corresponded to which claims.
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February 11, 2025
DC Judge Orders Restoration Of Public Health Webpages
A D.C. federal judge on Tuesday ordered federal agencies to revive public health webpages and datasets taken offline as part of the Trump administration's effort to root out references to "gender ideology."
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February 11, 2025
Novartis To Buy US Pharma Biz Anthos For Up To $3.1B
Novartis AG said Tuesday that it plans to buy Anthos Therapeutics Inc. for up to $3.1 billion, allowing the Swiss pharmaceutical heavyweight to return a drug that originated at the company back into its portfolio of cardiovascular therapies.
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February 10, 2025
Pharma Co. Misled Investors On Depression Drug, Suit Says
Brain disease drugmaker Neumora Therapeutics Inc. has been hit with a proposed shareholder class action alleging that the company and its initial public offering underwriters failed to disclose prior to the $250 million IPO that Neumora's clinical trial for a depression treatment was very unlikely to yield promising results.
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February 10, 2025
Fed. Circ. Preserves Corning's Win In Gene Therapy Fight
The Federal Circuit decided Monday to turn down an appeal from a Minnesota-based gene therapy developer that says it was wrongly denied a jury trial in its failed case seeking to add its name to patents issued to Corning Inc.
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February 10, 2025
GenapSys Can't Claw Back Some Docs From Paul Hastings
A California judge ruled that GenapSys Inc. can claw back some documents it inadvertently released during discovery in a legal malpractice suit against Paul Hastings LLP, but that some documents discussed during depositions cannot be clawed back because attorneys for GenapSys did not lodge proper objections during the proceedings.
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February 10, 2025
DC Judge Questions Abrupt Removal Of Public Health Info
A D.C. federal judge said he was wrestling with some "circular" arguments offered by the government on Monday as he weighed whether to order the restoration of public health web pages and datasets that had been taken down by the Trump administration.
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February 10, 2025
Fed. Circ. Revives Cotter's Radiation Injury Suit Indemnity Bid
The Federal Circuit on Monday revived Cotter Corp.'s bid for federal indemnity after settling claims related to alleged exposure to radioactive residue stemming from the Manhattan Project, saying a Court of Federal Claims judge read an indemnification statute too narrowly.
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February 10, 2025
PBMs Fight To Keep Mich. AG's Opioid Suit In Federal Court
Pharmacy benefit managers' work on behalf of federal health insurance plans entitles them to keep Michigan's lawsuit over their role in the opioid crisis in federal court, the companies told a federal judge last week.
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February 10, 2025
Jazz Pharma Drops Last Defendant From Epidiolex Patent Suit
Jazz Pharmaceuticals Inc. has reached an agreement to dismiss all claims and counterclaims with the last remaining defendant in its consolidated lawsuits over patents covering its epilepsy treatment Epidiolex, according to a filing from the company in New Jersey federal court.
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February 10, 2025
Fighting Cancer Has Impaired Life, Zantac Plaintiff Testifies
One of the men retrying his Zantac cancer claims in Illinois testified Monday that fighting his illness has meant navigating negative side effects and missing the full family life he previously enjoyed.
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February 10, 2025
Mass. Judge Temporarily Blocks NIH Funding Cuts
A Massachusetts federal judge issued a temporary hold Monday on a Trump administration plan to slash grant funding provided by the National Institutes of Health after 22 states sued to block the cuts.
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February 10, 2025
Life Sciences Group Of The Year: Fenwick
Fenwick & West LLP leveraged its broad experience with complex health tech and science to guide large biotech clients through major acquisitions and secured a significant Federal Circuit win for a life sciences client, earning the firm a nod as one of the 2024 Law360 Life Sciences Groups of the Year.
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February 10, 2025
Trump Admin Violating Order To Unfreeze Funds, Judge Says
A Rhode Island federal judge ruled Monday the Trump administration is not complying with the court's temporary restraining order barring a freeze on funding for federal grants and programs, ordering the administration to immediately restore the frozen funds.
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February 10, 2025
Biotech Firm Omega Therapeutics Hits Ch. 11 To Restructure
Biotechnology company Omega Therapeutics hit Chapter 11 in Delaware on Monday, listing over $140 million of debt on its petition and having filed a form with the U.S. Securities and Exchange Commission saying it had entered a restructuring agreement with an affiliate of its controlling stockholder.
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February 07, 2025
Trump Isn't Obeying Order To Unfreeze Funds, States Say
The Trump administration is not complying with a temporary restraining order barring a freeze on funding for federal grant and aid programs, a coalition of states told a Rhode Island federal judge Friday, asking the court to enforce its order and to enter a stiffer injunction blocking the funding freeze.
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February 07, 2025
NC Judge Knocked By Fed. Circ. For Rushing Patent Trial
A Federal Circuit panel on Friday stripped a patent case over respiratory treatment devices away from a North Carolina federal judge, with the appeals court reversing a noninfringement verdict that came out of a jury trial he oversaw and finding that it was at least the second time the judge "did not intend to manage a fair trial."
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February 07, 2025
NJ Statehouse Catch-Up: Offshore Wind, AI, Neurodiversity
The retraction of New Jersey's fourth offshore wind solicitation came alongside a wave of legislative and regulatory activity that also proposed workplace rules to bolster inclusivity and a new compensation path for assault victims
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February 07, 2025
70 Depo-Provera Suits Joined In Florida's Northern District
The U.S. Judicial Panel on Multidistrict Litigation on Friday consolidated more than 70 consumer lawsuits claiming that Pfizer Inc. failed to adequately warn patients and doctors about the risk of brain tumors associated with the hormonal contraceptive drug Depo-Provera in the Northern District of Florida.
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February 07, 2025
SPAC Market Hums Again Following Multiyear Downturn
Special purpose acquisition companies are once again asserting their presence in the capital markets and M&A landscape, forming new vehicles at the highest pace in three years — albeit in leaner form than in the last cycle, when many deals ended in busts.
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February 07, 2025
Fed. Circ. Backs Ventria Cell Culture Patent Win At ITC
In a precedential decision, the Federal Circuit said Friday that the U.S. International Trade Commission's domestic industry requirements have no "threshold dollar value" and that "small market segments" operated by biotech developer Ventria Bioscience can qualify, upholding the ITC's finding that a Chinese maker of vaccine ingredients infringed Ventria's cell culture patent.
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February 07, 2025
Fed. Circ. Considers Some Testing For Avadel Sleep Drug
Judges on the Federal Circuit seemed open to modifying a district court's injunction barring specialty drugmaker Avadel Pharmaceuticals from marketing its on-market narcolepsy drug for use in treating another sleep disorder Friday.
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February 07, 2025
Pa. Medical Pot Co. Beats Consultant's IP Breach Claims
A Pennsylvania federal judge has thrown out a lawsuit filed by a consultant claiming that his methods for growing plant tissue samples was stolen by a medical cannabis company he worked with, ruling that the consultant's system was not a protected trade secret.
Expert Analysis
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Racing Patents To The Fed. Circ.: Collateral Estoppel Lessons
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.
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Series
Circus Arts Make Me A Better Lawyer
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.
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3 Ways To Train Junior Lawyers In 30 Minutes Or Less
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.
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How AstraZeneca Ruling Could Change Dosage Patent Claims
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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Failed W.Va. Patent Challenge Reveals Secret Prior Art's Risks
A West Virginia federal court's recent ruling — that references used by a patent challenger to establish an ordinarily skilled artisan's existing knowledge must be published before a patent's filing — may discourage claim construction challenges based on secret prior art and steer drafters away from externally defined terms, says Brianna Potter at Baker Botts.
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Navigating Decentralized Clinical Trials With FDA's Guidance
The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.
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The Bar Needs More Clarity On The Discovery Objection Rule
Almost 10 years after Federal Rule of Civil Procedure 34 was amended, attorneys still seem confused about what they should include in objections to discovery requests, and until the rules committee provides additional clarity, practitioners must beware the steep costs of noncompliance, says Tristan Ellis at Shanies Law Office.
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How Patent Landscape Analysis Drives Business Growth
Keegan Caldwell at Caldwell Law explores how patent landscape analysis serves as a key driver of sustainable growth — examining how its components, strategic advantages and implementation best practices are reshaping innovation leadership.
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In Terror Case, DC Circ. Must Weigh Justices' Twitter Ruling
When the D.C. Circuit hears oral argument in AstraZeneca UK v. Atchley, how the court interprets the U.S. Supreme Court's 2023 ruling in Twitter v. Taamneh will have a significant impact on future claims brought under the Anti-Terrorism Act and Justice Against Sponsors of Terrorism Act, say attorneys at Lewis Baach.
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Marching In On Orange Book Drugs May Have Limited Effect
Statistical analysis shows that marching in on Orange Book drug patent holders to require additional licensees would have a relatively minimal impact on drug prices, and should be weighed against the harms it could have on pharmaceutical innovation, say researchers at Competition Dynamics.
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Series
Being A Navy Reservist Makes Me A Better Lawyer
Serving this country in uniform has not only been one of the greatest honors of my life, but it has also provided me with opportunities to broaden my legal acumen and interpersonal skills in ways that have indelibly contributed to my civilian practice, says Phillip Smith at Weinberg Wheeler.
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Incoming Admin May Shake Up Life Sciences Regulation
Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.
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Next Steps In The $2.8B Blue Cross Payout To Providers
Healthcare providers deciding whether to participate in Blue Cross Blue Shield network's recent $2.8 billion antitrust class action settlement must weigh key recovery factors, including provider type and litigation cost, say attorneys at Hall Render.
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So You Want To Move Your Law Practice To Canada, Eh?
Google searches for how to move to Canada have surged in the wake of the U.S. presidential election, and if you’re an attorney considering a move to the Great White North, you’ll need to understand how the practice of law differs across the border, says David Postel at Henein Hutchison.
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What To Expect Next From Federal Health Tech Regulation
Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.