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Life Sciences
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June 26, 2024
Justices Chide 5th Circ. In Biden Social Media Case
The Fifth Circuit relied on "clearly erroneous" facts and an overgeneralized view of standing when it ordered the Biden administration to stop working with social media platforms to combat COVID-19 and election misinformation, the U.S. Supreme Court ruled Wednesday as it threw out a challenge to the government's actions.
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June 26, 2024
Ga. High Court Told To Skip Inventor's 'Clerical Mistake' Fight
A unit of the analytics giant Clarivate is telling Georgia's highest court that a neurosurgeon's $102 million legal malpractice case over "a clerical mistake" in a patent filing from an aggrieved former FisherBroyles client is definitely "not a cert-worthy case."
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June 26, 2024
State Data Privacy Law Patchwork: Midyear Report
States jumped on the consumer data privacy law bandwagon at a brisk clip in the first half of 2024, although it remains unclear if this push will be enough to encourage Congress to finally enact a nationwide framework this year.
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June 26, 2024
Choctaw Nation Wants 9th Circ. Rehearing In CVS Arb. Dispute
The Choctaw Nation has asked the Ninth Circuit for a rehearing in an effort to undo the court's decision forcing it to arbitrate a dispute over prescription drug reimbursements with subsidiaries of CVS Health Corp., arguing it never waived sovereign immunity and did not agree to such proceedings on its Recovery Act claims.
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June 26, 2024
Apple Watch Improvement Is 'Inferior,' Docs Tell 9th Circ.
Four cardiac specialists backed medical monitoring startup AliveCor against Apple in a Ninth Circuit amicus brief Tuesday arguing a district court wrongly nixed antitrust claims by crediting the phaseout of a heart rate monitoring algorithm as an improvement when all it did was deny patient access to "potentially life-saving" technology.
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June 26, 2024
House GOP Gears Up For The End Of Chevron Deference
A new memo outlines how House Republicans are gearing up for the U.S. Supreme Court to potentially overturn the decades-old precedent that courts defer to agencies' interpretations of ambiguous statutes, as an opportunity to roll back the Biden administration's policies and reclaim Congress' power.
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June 26, 2024
Squire Patton Adds Epstein Becker Healthcare Atty In DC
An experienced healthcare and life sciences industries attorney has jumped from Epstein Becker Green PC to Squire Patton Boggs LLP in Washington, D.C., the latter firm has announced.
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June 26, 2024
Pharma Co. PhaseBio Can Exit Ch. 11 With Wind-Down Plan
A Delaware bankruptcy judge on Wednesday gave her blessing for pharmaceutical developer PhaseBio Pharmaceuticals Inc. to liquidate its assets and wind down after settlement agreements with creditors and a business partner cleared a path for it to exit Chapter 11 after roughly 19 months.
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June 26, 2024
High Court 'Inadvertently' Posts Order Punting Abortion Case
The U.S. Supreme Court mistakenly released a draft order Wednesday that would allow emergency abortions in Idaho, with a majority saying the court was wrong to consider a state challenge at this time.
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June 26, 2024
High Court Axes Challenge To Biden Admin's Social Media Work
The U.S. Supreme Court wiped out a Fifth Circuit order prohibiting the Biden administration and several federal agencies from working with social media platforms to combat the spread of misinformation Wednesday, finding the states and individuals challenging the collaboration don't have standing to sue.
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June 25, 2024
Riley Safer Expands IP Practice With Chicago Partner
Chicago firm Riley Safer Holmes & Cancila LLP has bolstered its intellectual property practice by bringing on board an experienced litigator from Goldman Ismail Tomaselli Brennan & Baum, the law firm announced Tuesday.
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June 25, 2024
PTAB Wipes Out UMass Skin Disease Treatment Patent
The Patent Trial and Appeal Board has sided with Forte Biosciences in invalidating a University of Massachusetts patent on treating the skin disease vitiligo, ruling that the patent does not adequately describe the invention or enable a skilled person to make and use it.
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June 25, 2024
Fed. Circ. Restores Amarin's Skinny Label Suit Against Hikma
The Federal Circuit revived litigation Tuesday accusing Hikma Pharmaceuticals USA Inc. of inducing physicians to infringe patents covering Amarin Pharma Inc.'s blockbuster cardiovascular drug Vascepa in a case over limited-use generics.
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June 25, 2024
Sarissa Capital, Founder Settle Bioverativ Suit In Del. For $40M
Remaining parties in a Delaware Court of Chancery class action over the $11.6 billion sale of biotech venture Bioverativ Inc. to Sanofi Inc. in 2018 have agreed to settle their outstanding claims for $40 million in cash, according to a stipulation filed with the court Tuesday.
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June 25, 2024
Indiana U Settles Ricin-Carrying Fruit Fly Export Violations
Indiana University has escaped fines, but it must instead educate the broader academic community at large on export controls under a settlement with the U.S. Department of Commerce after the institution sent unlicensed shipments overseas, of fruit flies carrying a subunit of ricin.
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June 25, 2024
Plaintiffs Firms Appealing $2.1B Fee Order In Opioid Case
Motley Rice LLC, Weisman Kennedy & Berris Co. LPA, Stranch Jennings & Garvey PLLC, Crueger Dickinson LLP, Goldstein & Russell PC, Kelley & Ferraro LLP, Spangenberg Shibley & Liber LLP and Meyers & Flowers LLC are appealing $2.13 billion in attorney fees stemming from opioid settlements awarded earlier this month.
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June 25, 2024
Chancery OKs $71M Premier Deal, $14M Four-Firm Fee
Shareholder attorneys led by Friedlander & Gorris who negotiated a $71 million settlement to end derivative Delaware Chancery Court litigation with healthcare-purchasing giant Premier Inc. will get $14 million for their efforts, the total fee award they sought.
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June 25, 2024
UK Billionaire's Pilot Avoids Prison For Insider Trading
A Manhattan federal judge sentenced a former private jet pilot to house arrest Tuesday for insider trading on stock tips from his billionaire boss Joe Lewis, finding that a prison term would be unfair in comparison to Lewis' non-incarceratory sentence.
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June 25, 2024
Lye Buyers Can't Get Court OK For $38.5M Antitrust Deals
A federal judge in Buffalo has rejected three settlements totaling $38.5 million for a proposed class of lye purchasers who alleged producers of the chemical colluded to inflate prices, ruling exceptions to who qualifies for the class make it impossible to determine membership.
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June 25, 2024
Litigation Pro Rejoins GRSM50 In Calif. From DeHay & Elliston
Gordon Rees Scully Mansukhani LLP has strengthened its litigation bench with a partner in Walnut Creek, California, who arrived from DeHay & Elliston LLP and who worked for six years earlier in his career as a senior counsel for GRSM50.
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June 24, 2024
Alleged Contract Killing Sparks Delaware Chancery Lawsuit
Los Angeles biotech firm Renovaro Inc. has sued a former, purported scientific adviser and his husband in Delaware's Court of Chancery for damages tied to an assortment of fraudulent schemes allegedly shielded in part by a contract killing linked to a separate alleged international oil trading scam.
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June 24, 2024
Judge Mulls BioXcel's Duty To Tell Investors Of FDA Troubles
A Connecticut federal judge wondered Monday if executives at the artificial intelligence-driven drugmaker BioXcel Therapeutics Inc. had an opportunity to correct problems that government regulators identified with a key clinical trial and, if so, whether their statements on the subject to investors could be considered false or misleading.
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June 24, 2024
NYC Pharmacy Owners Get Jail Time For $18M Med Fraud
Two brothers who own several New York pharmacies will each have to pay over $18 million in restitution in addition to serving jail time for submitting fraudulent claims to Medicare for pricey cancer medication and funneling illicit proceeds through several shell companies, the U.S. Department of Justice announced Monday.
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June 24, 2024
Justices Undo Terror Victims' Win, Citing Twitter Decision
The U.S. Supreme Court on Monday swept aside a D.C. Circuit ruling that threatened to expose major pharmaceutical companies to liability for terrorist attacks that injured or killed hundreds of U.S. soldiers and civilians in Iraq.
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June 24, 2024
LA Schools Says Pseudoscience Infected 9th Circ. Vax Ruling
The Los Angeles Unified School District said Friday that a split Ninth Circuit panel leaned on pseudoscience when ruling that a rescinded employee COVID-19 vaccination mandate implicated the right of district employees to refuse medical treatment, urging an en banc panel to correct the "fatally flawed" decision.
Expert Analysis
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FDA Warning Letter Tightens Reins On 'Research Only' Labels
A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.
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Practical Pointers After Fed. Circ. Double-Patenting Decision
With the Federal Circuit recently denying a full court review of In re: Cellect, a decision regarding obviousness-type double-patenting, affected patent family holders should evaluate their rights through both patent prosecution and future litigation lenses to minimize risks, say Austin Lorch and Jeff Wolfson at Haynes Boone.
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Highlights From The 2024 ABA Antitrust Spring Meeting
U.S. merger enforcement and cartels figured heavily in this year's American Bar Association spring antitrust meeting, where one key takeaway included news that the Federal Trade Commission's anticipated changes to the Hart-Scott-Rodino form may be less dramatic than many originally feared, say attorneys at Freshfields.
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Strategies For Challenging A Fla. Grand Jury Report's Release
A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.
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Patent Lessons From 8 Federal Circuit Reversals In March
A number of Federal Circuit patent decisions last month reversed or vacated underlying rulings, providing guidance regarding the definiteness of a claim that include multiple limitations of different scopes, the importance of adequate jury instruction, the proper scope of the precedent, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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A Look At Ex Parte Seizures 8 Years Post-DTSA
In the eight years since the Defend Trade Secrets Act was enacted, not much has changed for jurisprudence on ex parte seizures, but a few seminal rulings show that there still isn’t a bright line on what qualifies as extraordinary circumstances warranting a seizure, say attorneys at Finnegan.
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Series
Whitewater Kayaking Makes Me A Better Lawyer
Whether it's seeing clients and their issues from a new perspective, or staying nimble in a moment of intense challenge, the lessons learned from whitewater kayaking transcend the rapids of a river and prepare attorneys for the courtroom and beyond, says Matthew Kent at Alston & Bird.
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AI In The Operating Room: Liability Issues For Device Makers
As healthcare providers consider medical devices that use artificial intelligence — including systems to help surgeons make decisions in the operating room — and lobby to shift liability to device manufacturers, companies making these products must review potential product liability risks and important design considerations for such equipment, say attorneys at Troutman Pepper.
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Del. Lessons For Director-Nominees On Sharing With Activists
The Delaware Chancery Court's recent decision in Icahn Partners v. deSouza finding that a director wasn't permitted to share certain privileged information with the activist stockholders that nominated him shows the need for companies to consider imposing appropriate confidentiality requirements on directors, say attorneys at Sullivan & Cromwell.
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10 Years After Alice, Predictability Debate Lingers
A decade after the U.S. Supreme Court’s Alice ruling, critics continue to argue that the subject matter eligibility framework it established yields inconsistent results, but that contention is disproved by affirmance data from the Federal Circuit, district courts and the Patent Trial and Appeal Board, say Dennis Abdelnour and David Thomas at Honigman.
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This Earth Day, Consider How Your Firm Can Go Greener
As Earth Day approaches, law firms and attorneys should consider adopting more sustainable practices to reduce their carbon footprint — from minimizing single-use plastics to purchasing carbon offsets for air travel — which ultimately can also reduce costs for clients, say M’Lynn Phillips and Lisa Walters at IMS Legal Strategies.
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Questions Persist After Ruling Skirts $925M TCPA Award Issue
After an Oregon federal court's recent Wakefield v. ViSalus ruling that the doctrine of constitutional avoidance precluded it from deciding whether a $925 million Telephone Consumer Protection Act damages award was constitutionally sound, further guidance is needed on when statutory damages violate due process, says Michael Klotz at O'Melveny.
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Benzene Contamination Concerns: Drugmakers' Next Steps
After a citizen petition to the U.S. Food and Drug Administration and a flurry of class actions over benzene contamination in benzoyl peroxide acne products, affected manufacturers should consider a thoughtful approach that includes assembling internal data and possibly contacting the FDA for product-specific discussions, say attorneys at Morgan Lewis.
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Opinion
States Should Follow Federal Lead On Expert Evidence Rules
The recently amended Federal Rule of Evidence 702 will help ensure expert testimony in federal courts reflects adequate data and reliable methods properly applied to a given case, and state courts — home to the overwhelming majority of U.S. litigation — should adopt similar changes, says retired attorney Michael Harrington.
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The Pros And Cons Of NIST's Proposed March-In Framework
Recent comments for and against the National Institute of Standards and Technology’s proposed guidance on march-in rights — which permit the government to seize federally funded patents — highlight how the framework may promote competition, but could also pose a risk to contractors and universities, say Nick Lee and Paul Ragusa at Baker Botts.