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Life Sciences
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June 26, 2024
Design Patent Attys Wary Of Applicant Disclosure Proposal
Various intellectual property trade groups are expressing some skepticism toward a proposal over the United Nations using a new treaty to force design patent applicants to disclose more details in their applications.
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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.
Expert Analysis
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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Rebuttal
Double-Patenting Ruling Shows Terminal Disclaimers' Value
While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.
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Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
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Why High Court May Have Rejected IP Obviousness Appeal
Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.
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Microplastics At The Crossroads Of Regulation And Litigation
Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.
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The Fed. Circ. In April: Hurdles Remain For Generics
The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Tylenol MDL Highlights Expert Admissibility Headaches
A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.
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Don't Fall On That Hill: Keys To Testifying Before Congress
Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.
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Online Portal Helps Fortify Feds' Unfair Health Practices Fight
The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.
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Series
Walking With My Dog Makes Me A Better Lawyer
Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.
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Think Like A Lawyer: Follow The Iron Rule Of Trial Logic
Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.
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The Art Of Asking: Leveraging Your Contacts For Referrals
Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.