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Life Sciences
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February 11, 2025
MSN Urges Fed. Circ. To Reinvalidate Novartis' Entresto IP
A Delaware federal judge properly invalidated a patent covering Novartis Pharmaceuticals' blockbuster cardiovascular drug Entresto for lacking written description, and a panel should never have overridden him, MSN Pharmaceuticals told the full Federal Circuit seeking a rehearing.
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February 11, 2025
Split 3rd Circ. Keeps Merck Vaccine Antitrust Panel Immunity
The full Third Circuit refused to reconsider a ruling that immunized Merck & Co. from antitrust claims over submissions it made to federal regulators for its mumps vaccine, over the objection of a trio of appellate judges.
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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.
Expert Analysis
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5 Litigation Funding Trends To Note In 2025
Lawyers and their clients must be prepared to navigate an evolving litigation funding market in 2025, made more complicated by a new administration and the increasing overall cost of litigation, says Jeffery Lula at GLS Capital.
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A Look At FDA's Plans To Establish New OTC Drug Category
The U.S. Food and Drug Administration's recently finalized rule, creating a new over-the-counter pathway for drugs when patients satisfy certain conditions, may be useful for off-patent drugs with established safety records, though switching to OTC comes with additional costs and considerations, say attorneys at Skadden.
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The Fed. Circ. In 2024: 5 Major Rulings To Know
In 2024, the Federal Circuit provided a number of important clarifications to distinct areas of patent law – including design patent obviousness, expert testimony admissions and patent term adjustments – all of which are poised to have an influence going forward, say attorneys at Knobbe Martens.
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Rethinking Litigation Risk And What It Really Means To Win
Attorneys have a tendency to overestimate litigation risk before summary judgment and underestimate risk after it, but an eight-stage litigation framework can clarify risk at different points and help litigators reassess what true success looks like in any particular case, says Joshua Libling at Arcadia Finance.
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How DOGE's Bite Can Live Up To Its Bark
All signs suggest that the Department of Government Efficiency will be an important part of the new Trump administration, with ample tools at its disposal to effectuate change, particularly with an attentive Republican-controlled Congress, say attorneys at K&L Gates.
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US-China Deal Considerations Amid Cross-Border Uncertainty
With China seemingly set to respond to the incoming U.S. administration's call for strategic decoupling and tariffs, companies on both sides of the Pacific should explore deals and internal changes to mitigate risks and overcome hurdles to their strategic plans, say attorneys at Covington.
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Considering The Status Of The US Doctrine Of Patent Misuse
A recent Ninth Circuit decision and a U.K. Court of Appeal decision demonstrate the impact that the U.S. Supreme Court's 2015 decision in Kimble v. Marvel Entertainment has had on the principle that post-patent-expiration royalty payments amount to patent misuse, not only in the U.S. but in English courts as well, say attorneys at Covington.
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Series
Playing Rugby Makes Me A Better Lawyer
My experience playing rugby, including a near-fatal accident, has influenced my legal practice on a professional, organizational and personal level by showing me the importance of maintaining empathy, fostering team empowerment and embracing the art of preparation, says James Gillenwater at Greenberg Traurig.
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Looking Back At 2024's Noteworthy State AG Litigation
State attorneys general across the U.S. took bold steps in 2024 to address unlawful activities by corporations in several areas, including privacy and data security, financial transparency, children's internet safety, and other overall consumer protection claims, say attorneys at Troutman Pepper.
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Opinion
No, Litigation Funders Are Not 'Fleeing' The District Of Del.
A recent study claimed that litigation funders have “fled” Delaware federal court due to a standing order requiring disclosure of third-party financing, but responsible funders have no problem litigating in this jurisdiction, and many other factors could explain the decline in filings, say Will Freeman and Sarah Tsou at Omni Bridgeway.
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Patent Policy Changes To Track Under New Gov't Leadership
The new federal government will likely bring pivotal shifts in U.S. patent policy through legislation and initiatives that reflect a renewed focus on strengthening intellectual property rights, fostering innovation and enhancing the nation's competitive edge, says PK Chakrabarti at Butzel Long.
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Liability Risk For AI In Medical Devices Demands Greater Care
As regulators push for legal reform surrounding artificial intelligence and cases implicating product liability for AI in medical technology continue to rise, manufacturers must adapt and implement new strategies to accommodate evolving risks, say attorneys at Crowell & Moring.
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5 E-Discovery Predictions For 2025 And Beyond
In the year to come, e-discovery will be shaped by new and emerging trends, from the adoption of artificial intelligence provisions in protective orders, to the proliferation of emojis as a source of evidence in contemporary litigation, say attorneys at Littler.
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4 Trade Secret Developments To Follow This Year
Significant developments in trade secret law are likely in 2025, and areas to watch include protection of AI-related innovations, the fate of the Federal Trade Commission's noncompete ban, and questions of the federal Defend Trade Secrets Act's extraterritorial reach, say attorneys at Faegre Drinker.
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Republican Trifecta Amplifies Risks For Cos. In 3 Key Areas
Expected coordination between a Republican Congress and presidential administration may expose companies to simultaneous criminal, civil and congressional investigations, particularly with regard to supply chain risks in certain industries, government contracting and cross-border investment, say attorneys at Morgan Lewis.