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Life Sciences
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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.
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June 24, 2024
Ark. AG Sues Pharmacy Benefit Managers Over Opioids
The Arkansas attorney general said Monday that he had sued pharmacy benefit managers Optum Inc. and Express Scripts Inc. in state court, claiming they contributed to the opioid crisis and profited from the drug epidemic.
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June 24, 2024
Suit Over Medical Screws Filed Too Late, Texas Panel Finds
A Texas appeals court won't revive a woman's suit against BioPro Inc. alleging that surgical screws used in her feet were defective, saying the evidence establishes that she filed her suit after the two-year statute of limitations had expired.
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June 24, 2024
Jurisdictional Discovery Ordered In NJ COVID Test Fraud Suit
A New Jersey federal court has denied without prejudice a dismissal bid and ordered "tightly-targeted and prompt jurisdictional discovery" in a Garden State medical supply business' complaint accusing a Texas attorney and his solo practice of aiding in an alleged $2.45 million fraud scheme involving COVID-19 test kits that were never delivered.
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June 24, 2024
Catching Up With Delaware's Chancery Court
Amendments to Delaware's General Corporation Law topped the news out of the Court of Chancery again last week, as the hotly contested measure sailed through the state's legislature. Tesla and its shareholders continued their tug-of-war over attorney fees for Chancery litigation about Elon Musk's pay package, and new cases were filed involving biotechs, car rental companies, workout platforms, telecom towers, and a cargo ship fire in Brazil.
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June 24, 2024
Justices Pass On Conn. School Vaccine Mandate Fight
The U.S. Supreme Court on Monday declined to review a Second Circuit decision that largely upheld the dismissal of a suit challenging a Connecticut law passed during the COVID-19 pandemic that revoked religious exemptions to student vaccine mandates.
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June 24, 2024
Cooley-Led Therapy Developer Alumis Aims For $300M IPO
Venture-backed drug developer Alumis Inc. launched plans on Monday for an estimated $300 million initial public offering, guided by Cooley LLP and underwriters' counsel Latham & Watkins LLP, joining an active pipeline of IPO prospects this week.
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June 24, 2024
Altria Subsidiary Allowed To Sell Menthol-Flavored Vapes
Altria Group Inc. subsidiary NJOY has secured permission from the U.S. Food and Drug Administration to sell four menthol-flavored vapes, marking the first time any kind of flavored e-cigarette has secured federal approval.
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June 24, 2024
Biotech Co. Hits Ch. 11 With Plans For Sale And 'Reboot'
Virginia-based synthetic biology products maker Solar Biotech Inc. filed for Chapter 11 bankruptcy in Delaware with plans to sell its assets, saying a difficult capital market, the loss of a major client and the pandemic drained its cash and caused it to furlough employees.
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June 24, 2024
Justices Pass On Rutgers COVID-19 Vax Mandate Case
The U.S. Supreme Court declined on Monday to review a split Third Circuit ruling that Rutgers University students cannot challenge the school's COVID-19 vaccine policy because, under the high court's 1905 precedent in Jacobson v. Massachusetts, there is no fundamental right to refuse vaccinations.
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June 21, 2024
Drug Cos., IP Attys Back Cellect In High Court Efforts
A petition by patent litigation outfit Cellect that is looking to persuade the U.S. Supreme Court to wade into a double patenting dispute has drawn support from even more lawyers as well as a handful of major drugmakers and small tech companies like Sonos.
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June 21, 2024
Drugmakers Decline To Drop Patent Listings After FTC Letters
The eight pharmaceutical companies that the Federal Trade Commission warned in April may have improperly listed patents for its products in a key federal database have chosen not to remove any patents or otherwise alter their listings, according to a document released Friday.
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June 21, 2024
After Fed. Circ. Win, Bausch Sues Alvogen Over Drug Patents
Bausch's Salix Pharmaceuticals has launched a lawsuit against Alvogen's Norwich Pharmaceuticals unit in a New Jersey federal court, claiming that its planned generic version of Xifaxan, a blockbuster diarrhea and brain disorder drug, infringes a set of patents.
Expert Analysis
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Trending At The PTAB: Permissible New Reply Arguments
In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.
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Wave Of Final Rules Reflects Race Against CRA Deadline
The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.
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'Beauty From Within' Trend Poses Regulatory Risks For Cos.
Companies capitalizing on the current trend in oral supplements touting cosmetic benefits must note that a product claim that would be acceptable for an externally applied cosmetic may draw much stronger scrutiny from the U.S. Food and Drug Administration when applied to a supplement, say Natalie Rainer and Katherine Staba at K&L Gates.
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McKesson May Change How AKS-Based FCA Claims Are Pled
The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.
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Series
Being An Equestrian Makes Me A Better Lawyer
Beyond getting experience thinking on my feet and tackling stressful situations, the skills I've gained from horseback riding have considerable overlap with the skills used to practice law, particularly in terms of team building, continuing education, and making an effort to reset and recharge, says Kerry Irwin at Moore & Van Allen.
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7th Circ. Mootness Fee Case May Curb Frivolous Merger Suits
On April 15, the Seventh Circuit in Jorge Alcarez v. Akorn Inc. mapped out a framework for courts to consider mootness fees paid to individual shareholders after the voluntary dismissal of a challenge to a public company merger, which could encourage objections to mootness fees and reduce the number of frivolous merger challenges filed, say attorneys at Skadden.
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Fintiv Denials Are On The Rise At PTAB
Following last year's CommScope v. Dali decision, the Patent Trial and Appeal Board is increasingly using Fintiv factors to discretionarily deny inter partes review petitions — and attorneys ignore it at their peril, say Josepher Li and Michelle Armond at Armond Wilson.
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4 Ways To Refresh Your Law Firm's Marketing Strategy
With many BigLaw firms relying on an increasingly obsolete marketing approach that prioritizes stiff professionalism over authentic connection, adopting a few key communications strategies to better connect with today's clients and prospects can make all the difference, say Eric Pacifici and Kevin Henderson at SMB Law.
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Cos. Must Prepare For Calif. Legislation That Would Ban PFAS
Pending California legislation that would ban the sale or distribution of new products containing intentionally added per- and polyfluoroalkyl substances could affect thousands of businesses — and given the bill's expected passage, and its draconian enforcement regime, companies must act now to prepare for it, say attorneys at Alston & Bird.
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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.