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Life Sciences
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August 08, 2025
Trump Admin Threatens To Take Harvard's Patents
The U.S. Department of Commerce on Friday threatened to invoke the government's so-called march-in rights to take control of patents owned by Harvard University, accusing the Ivy League institution of not meeting its obligations tied to federally funded research.
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August 08, 2025
MSN Calls On Full Fed. Circ. To Rethink Double Patenting Rule
MSN Laboratories urged the full Federal Circuit on Friday to reconsider a decision on when patents can be invalidated for double patenting, arguing in a Parkinson's disease drug case that the court has improperly limited the free use of expired patents and permitted harassing lawsuits.
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August 08, 2025
How Patent Attys Can Limit 'Skinny Label' Risks In Ads
The Federal Circuit has twice cited a company's marketing practices to allow arguments that a generic drug's "skinny label" could induce patent infringement, and here, Law360 offers tips on how patent attorneys can take a more active role in making sure company and client advertisements pass muster.
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August 08, 2025
GlaxoSmithKline Will Get $500M In CureVac-Pfizer Patent Deal
British pharmaceutical company GlaxoSmithKline said Friday it stands to make up to $500 million from settlements between German biotech companies CureVac and BioNTech after their legal disputes were squashed by a merger.
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August 08, 2025
FTC Maintains Support For Right-To-Repair In Med Robot Case
The Federal Trade Commission is providing important backing for a surgical repair company's Ninth Circuit bid to revive claims accusing Intuitive Surgical of blocking third parties from refurbishing components for its popular da Vinci surgery robot, in an amicus brief suggesting defending right-to-repair work remains important for the Republican-controlled agency.
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August 08, 2025
Trump EO Requires Appointee Oversight Of US Grantmaking
President Donald Trump has issued an executive order requiring that all funding opportunity announcements and grant awards be reviewed by his political appointees and allowing for grants to be terminated that fall outside the administration's priorities.Â
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August 08, 2025
NJ Nonprofit Says Foundation Trying To Take Over Business
A nonprofit organization that trains law enforcement officers and educators to teach children about the dangers of drugs and violence has sued the foundation that provides its curriculum, alleging that the foundation is attempting to put it out of business.
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August 08, 2025
Pa. Pharmacy To Pay $825K To Resolve False Claims Case
A Pennsylvania pharmacy has agreed to pay $825,000 to resolve claims that it defrauded Medicare, the latest in a recent string of such settlements in the Eastern part of the state, according to the Philadelphia-based U.S. Attorney's Office.
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August 08, 2025
Iowa PBM Law Challengers Seek Wider Block At 8th Circ.
Employers and benefit plans challenging an Iowa law aiming to limit pharmacy benefit managers' power to set drug prices will seek Eighth Circuit review of a district court judge's decision from July that temporarily blocked parts of the new policy as preempted by federal benefits law.
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August 08, 2025
Attys Seek Final OK Of $100M Walgreens Rx Cost Settlement
An Illinois federal judge should greenlight a $100 million settlement to claims that Walgreens overcharged insured customers for generic prescription drugs, the plaintiffs' attorneys said, asking the judge to wrap up the 8-year-old consumer protection litigation.
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August 08, 2025
Stewart Rejects 8 IPR Petitions While Overriding May Denial
Acting U.S. Patent and Trademark Office Director Coke Morgan Stewart used her director review powers to grant a petition for inter partes review that she'd previously denied, but otherwise largely supported patent owners in the small batch of recent discretionary denial reviews.
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August 08, 2025
Medical Tech Startup Heartflow's Upsized IPO Raises $317M
Venture-backed medical technology company Heartflow Inc. began trading publicly on Friday after raising nearly $317 million in an upsized initial public offering that exceeded its initial price range, marking the latest in a wave of medtech startups to go public recently.
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August 08, 2025
Taxation With Representation: Latham, Alston & Bird, Orrick
In this week's Taxation With Representation, fiber optic connector systems maker Amphenol Corp. buys CommScope's connectivity and cable solutions business, Blackstone acquires Enverus from private equity firms, investors buy a majority stake in medical device company HistoSonics Inc., and ESPN swaps an equity stake for the National Football League's NFL Network and other intellectual property.
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August 08, 2025
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen the U.S. Securities and Exchange Commission target a British investor over a $10 million microcap fraud scheme, Merck Sharp & Dohme move against Halozyme Inc. following a recent clash over its patented cancer medicine, and Birmingham City Council sue a school minibus operator years after ending its contract over DBS check failures. Here, Law360 looks at these and other new claims in the U.K.Â
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August 07, 2025
HHS Wins Another Round In Medicare Drug Negotiation Battle
A Texas federal court dealt another blow to the pharmaceutical industry Thursday when it ruled in favor of Medicare's Drug Price Negotiation Program, turning away arguments that the program is unconstitutional — the third such decision in two days.
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August 07, 2025
BioNTech's Acquisition Of CureVac Ends COVID Vax Case
CureVac's case alleging Pfizer and BioNTech infringed patents related to messenger RNA technology is set to be dismissed after BioNTech announced in June that it would be acquiring CureVac, canceling what would have been the first-ever trial over COVID-19 vaccine patents in the U.S.
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August 07, 2025
BioPharma Co.'s $15M Deal Over Ruined J&J Vaccines OK'd
A Maryland federal judge on Thursday granted final approval to a $15 million settlement to close out a stockholder derivative suit claiming Emergent BioSolutions Inc. and its top brass made a mint selling stock before their allegedly lax oversight led to the contamination of over 15 million Johnson & Johnson COVID-19 vaccine doses.
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August 07, 2025
Michigan AG Fights Bid To Pause PBM Price-Fixing Suit
Michigan's attorney general has said there is no reason to pause her price-fixing suit against pharmacy benefit managers Express Scripts and Prime Therapeutics for a pending dismissal motion, urging a federal judge not to put discovery on ice.Â
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August 07, 2025
Ex-Worker Sues Firm For Bias After Work On CDC Contract
A former employee sued a management consulting and professional services firm in Georgia federal court Wednesday, alleging he was discriminated against and ultimately fired because of his Islamic faith and PTSD while working on a three-year Centers for Disease Control and Prevention contract.
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August 07, 2025
Novartis Faces $291M Trade Secrets Suit From Hedge Fund
A hedge fund on Thursday accused Novartis, a former investment executive and the executive's longtime friend and business partner of scheming to steal its "innovative hedge fund strategy" after an investment deal between the biotech giant and the hedge fund went south.Â
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August 07, 2025
Anthem Seeks Exit From Lab's $3.8M Insurance Suit
Anthem Blue Cross Blue Shield of Connecticut again asked a federal judge to let it out of a lab's $3.8 million suit alleging the company failed to pay 3,000 insurance claims for medical tests, arguing that the lab's second amended complaint didn't make up for the deficiencies that got most of the first one dismissed.
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August 07, 2025
2nd Circ. Axes Challenge To Medicare Drug Price Negotiations
In a published opinion Thursday, the Second Circuit turned away Boehringer Ingelheim's constitutional and administrative challenge to the Medicare Drug Price Negotiation Program, finding that the program is voluntary and it was lawfully implemented under the Inflation Reduction Act.
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August 07, 2025
Rising Star: Goodwin's Laura Umbrecht Gulick
Laura Umbrecht Gulick of Goodwin Procter LLP advised Human Immunology Biosciences and Mariana Oncology in billion-dollar deals with Big Pharma last year, earning her a spot among the life sciences law practitioners under age 40 honored by Law360 as Rising Stars.
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August 07, 2025
Investors Back Cancer Ultrasound Tech Firm At $2.25B Value
HistoSonics Inc. said Thursday it has secured a majority stake acquisition led by its management team and backed by a syndicate of investors including K5 Global, Bezos Expeditions and Wellington Management, valuing the maker of the Edison Histotripsy System at about $2.25 billion.
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August 07, 2025
Fed. Circ. Affirms PTAB Ax Of Bone Fusion Device Patents
The Federal Circuit on Thursday upheld Patent Trial and Appeal Board rulings that invalidated claims in a pair of Stryker Corp. patents for a surgical implant that a Berkshire Hathaway-owned rival had challenged.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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The Evolving Legal Landscape For THC-Infused Beverages
A recent Eighth Circuit ruling, holding that states may restrict the sale of intoxicating hemp-derived products without violating federal law, combined with ongoing regulatory uncertainty at both the federal and state levels, could alter the trajectory of the THC-infused beverage market, say attorneys at Pashman Stein.
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Series
Creating Botanical Art Makes Me A Better Lawyer
Pressing and framing plants that I grow has shown me that pursuing an endeavor that brings you joy can lead to surprising benefits for a legal career, including mental clarity, perspective and even a bit of humility, says Douglas Selph at Morris Manning.
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Opinion
The Legal Education Status Quo Is No Longer Tenable
As underscored by the fallout from California’s February bar exam, legal education and licensure are tethered to outdated systems, and the industry must implement several key reforms to remain relevant and responsive to 21st century legal needs, says Matthew Nehmer at The Colleges of Law.
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2nd Circ. Reinforces Consensus On Vacating Foreign Awards
In Molecular Dynamics v. Spectrum Dynamics Medical, the Second Circuit recently affirmed that federal district courts do not possess subject matter jurisdiction to vacate foreign arbitral awards, strengthening this consensus across the circuits most active in recognition and enforcement actions, says Ed Mullins at Reed Smith.
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E-Discovery Quarterly: Rulings On Relevance Redactions
In recent cases addressing redactions that parties sought to apply based on the relevance of information — as opposed to considerations of privilege — courts have generally limited a party’s ability to withhold nonresponsive or irrelevant material, providing a few lessons for discovery strategy, say attorneys at Sidley.
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How DOJ's New Data Security Rules Leave HIPAA In The Dust
The U.S. Department of Justice's recently effective data security requirements carry profound implications for how healthcare providers collect, store, share and use data — and approach vendor oversight — that go far beyond the Health Insurance Portability and Accountability Act, say attorneys at Nelson Mullins.
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Opinion
Section 1983 Has Promise After End Of Nationwide Injunctions
After the U.S. Supreme Court recently struck down the practice of nationwide injunctions in Trump v. Casa, Section 1983 civil rights suits can provide a better pathway to hold the government accountable — but this will require reforms to qualified immunity, says Marc Levin at the Council on Criminal Justice.
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Trump's 2nd Term Puts Merger Remedies Back On The Table
In contrast with the Biden administration, the second Trump administration has signaled a renewed willingness to resolve merger enforcement concerns through remedies from the outset, particularly when the proposed fix is structural, clearly addresses the harm and does not require burdensome oversight, say attorneys at Cooley.
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Patent Ambiguity Persists After Justices Nix Eligibility Appeal
The Supreme Court recently declined to revisit the contentious framework governing patent eligibility by denying certiorari in Audio Evolution Diagnostics v. U.S., suggesting a necessary recalibration of both patent application and litigation strategies, say attorneys at Skadden.
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Texas Med Spas Must Prepare For 2 New State Laws
Two new laws in Texas — regulating elective intravenous therapy and reforming healthcare noncompetes — mark a pivotal shift in the regulatory framework for medical spas in the state, which must proactively adapt their operations and contractual practices, says Brad Cook at Munsch Hardt.
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Fed. Circ. In June: Transitional Phrases In Patent Claims
The Federal Circuit's recent decision in Eye Therapies v. Slayback Pharma takes on the rarely addressed topic of transitional phrases in patent claims, providing some useful lessons regarding restating claim language and broadly distinguishing prior art, say attorneys at Knobbe Martens.
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Series
Playing Soccer Makes Me A Better Lawyer
Soccer has become a key contributor to how I approach my work, and the lessons I’ve learned on the pitch about leadership, adaptability, resilience and communication make me better at what I do every day in my legal career, says Whitney O’Byrne at MoFo.
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Strategies For Cos. Navigating US-Indian Pharma Partnerships
Recent policy adjustments implemented by the U.S. government present both new opportunities and heightened regulatory scrutiny for the Indian life sciences industry, amplifying the importance of collaboration between the Indian and U.S. pharmaceutical sectors, say Bryant Godfrey at Foley Hoag and Jashaswi Ghosh at Holon Law Partners.
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DOJ-HHS Collab Crystallizes Focus On Health Enforcement
The recently announced partnership between the U.S. Department of Justice and U.S. Department of Health and Human Services to combat False Claims Act violations, following a multiyear trend of high-dollar DOJ recoveries, signals a long-term enforcement horizon with major implications for healthcare entities and whistleblowers, say attorneys at RJO.
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Series
Law School's Missed Lessons: Learning From Failure
While law school often focuses on the importance of precision, correctness and perfection, mistakes are inevitable in real-world practice — but failure is not the opposite of progress, and real talent comes from the ability to recover, rethink and reshape, says Brooke Pauley at Tucker Ellis.