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Life Sciences
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April 02, 2024
Feds Seek Leniency For UK Billionaire Lewis In Trading Case
Prosecutors have told a Manhattan federal judge that 87-year-old British billionaire Joe Lewis should serve less than 18 months in prison after he pled guilty to insider trading, citing his age and health and arguing he "has otherwise lived a law-abiding life."
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April 02, 2024
Acorda Therapeutics Hits Ch. 11, Plans $185M Drug Sale
Neurological disorders drugmaker Acorda Therapeutics Inc. filed for Chapter 11 protection in New York bankruptcy court, with plans to sell its assets to another pharmaceutical company for $185 million.
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April 01, 2024
Inotiv Can't Toss Investor Suit Over Feds' 'Puppy Mill' Probe
Medical research services provider Inotiv Inc. must face a proposed investor class action accusing it of failing to disclose that subsidiaries it acquired had come under investigations by the U.S. Department of Justice for animal welfare and smuggling violations, an Indiana federal judge ruled while lamenting the "appalling" mistreatment of beagles that investigators had found.
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April 01, 2024
Pharma Co. Beats Investor Suit Over Wrinkle Drug Approval
A California federal judge has dismissed a lawsuit from the investors of Revance Therapeutics Inc. accusing it and several executives of concealing quality control concerns that eventually led the U.S. Food and Drug Administration to deny the company a license for its wrinkle injectable, saying the defendants may not have known the approval timeline they presented was unattainable.
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April 01, 2024
Apple, Intel Again Lose Fintiv APA Challenge In Calif. Court
A California federal judge on Sunday ended Big Tech's coordinated challenge to Patent Trial and Appeal Board precedent that allows its judges to discretionarily deny patent reviews based on how proposed reviews overlap with related litigation in other forums.
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April 01, 2024
Optical Co. Beats Investor Suit Over Pandemic Staffing Levels
A Georgia federal judge has permanently tossed an investor suit accusing National Vision of failing to disclose issues with its staffing levels during the pandemic, saying the investors did not adequately plead that any of the challenged statements allegedly made by the optical company were false or misleading.
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April 01, 2024
'Unreliable' Theory Dooms City's Acthar Antitrust Cert. Bid
The city of Rockford has presented "unreliable" damages evidence that cannot warrant giving class treatment to its claim that pharmacy benefits manager Express Scripts engaged in a scheme to fix prices for the seizure medication Acthar, an Illinois federal judge has said.
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April 01, 2024
Fed. Circ. Revives Challenges To J&J Schizophrenia Drug
A Federal Circuit panel on Monday gave generics-makers Teva Pharmaceuticals USA Inc. and Viatris Inc. a new chance to prove that a patent on Johnson & Johnson's blockbuster schizophrenia drug Invega Sustenna is invalid, saying a lower court used an "erroneously rigid" analysis when rejecting their challenge.
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April 01, 2024
Catching Up With Delaware's Chancery Court
Last week, Delaware's Court of Chancery saw a $42.5 million settlement, dismissal of two big suits with two more remanded back, and new cases from shareholders of Walt Disney, Donald Trump's Truth Social, Rivian Automotive and BarkBox.
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April 01, 2024
Ex-Pharma Co. Exec Denies Signing Noncompete Deal
The former director of government sales for a pharmaceutical company asked the North Carolina Business Court on Friday to knock out a breach of contract claim in a lawsuit that alleges he took trade secrets to a competitor, arguing the company has no valid noncompete agreement to back it up.
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April 01, 2024
J&J Opted To 'Deny' Talc-Cancer Link, Jury Told
Johnson & Johnson opted to "deny, deny, deny" evidence linking its baby powder to ovarian cancer and continued to market it as safe to use, an attorney for the widower of a longtime baby powder user who died from cancer told jurors in Sarasota, Florida, on Monday.
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April 01, 2024
Gunderson-Led Contineum Joins Pipeline Eyeing $150M IPO
Contineum Therapeutics Inc. launched plans Monday for an estimated $150 million initial public offering, represented by Gunderson Dettmer Stough Villeneuve Franklin & Hachigian LLP and underwriters counsel Sidley Austin LLP, hoping to join a nascent recovery for the IPO market.
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April 01, 2024
Fla. High Court Says Voters Will Choose Whether To Legalize Pot
Florida voters will have the opportunity to legalize recreational marijuana at the ballot box this November, after the state Supreme Court on Monday rejected a challenge brought by the state's attorney general and ruled that the proposal didn't violate a state rule restricting ballot measures to only one subject.
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April 01, 2024
Masimo Rips Politan's New Attempt To Grab Board Seats
Medical technology company Masimo Corp. on Monday pushed back against activist allegations of broken governance and lack of independent oversight, saying investor Politan Capital Management LP's plans to oust its current chairman and CEO contradict shareholders' best interests.
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April 01, 2024
Eiger BioPharmaceuticals Hits Ch. 11 With $53.1M Debt
Eiger BioPharmaceuticals Inc. filed for Chapter 11 protection in Texas bankruptcy court Monday with $53.1 million of debt and plans to sell its assets during the case.
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March 29, 2024
Petition Watch: Off-Label Ads, Retiree Discrimination & PPE
A Utah attorney has asked the U.S. Supreme Court to determine whether allegedly retaliatory IRS summonses can be quashed, and two former pharmaceutical executives are challenging the constitutionality of their convictions for marketing the off-label use of a drug. Here, Law360 looks at recently filed petitions that you might've missed.
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March 29, 2024
Northern Texas Judges Won't Adopt Judge-Shopping Rule
Judges with the Northern District of Texas have opted not to make any changes to how cases are assigned, despite a recent letter from Senate Majority Leader Chuck Schumer urging the district to implement an updated policy aiming to prevent litigants from judge shopping, the district's chief judge said Friday.
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March 29, 2024
Hogan Lovells Vet's High Court Debut A Study In Contrasts
Several weeks ago, when a Hogan Lovells lawyer finally delivered U.S. Supreme Court arguments after 20 years at the firm, she parsed arcane arbitration issues and her words weren't widely heard outside the courtroom. But weeks later and back at the high court podium, her words were heard nationwide when she pointedly spotlighted a judge's use of "anonymous blog posts" in a bombshell abortion ruling.
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March 29, 2024
Alleged 'Shadow Trader's Co-Worker Tells Jury Stocks Not Tied
A co-worker of an ex-Medivation executive accused of "shadow trading" in rival Incyte's stock testified Friday as the first defense witness in his California federal civil trial, telling jurors that the two companies weren't competitors and that he wouldn't expect their stock prices to rise in tandem.
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March 29, 2024
Judge Denies Injunction For Tyvaso Drug Competitor
A D.C. federal judge Friday denied drugmaker United Therapeutics Corp.'s attempt to preemptively block the U.S. Food and Drug Administration from approving a new competitor to its blockbuster pulmonary hypertension medication Tyvaso, saying the company was effectively seeking to challenge an agency action before the FDA made one.
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March 29, 2024
Fed. Circ. Tears Cancer Testing Rivals Apart In Injunction Args
A trio of Federal Circuit judges appeared fed up Friday with a Morrison Foerster LLP attorney who they repeatedly suggested was focusing on arguments not raised to the district court judge who had blocked her client from selling certain cancer tests while facing infringement litigation.
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March 29, 2024
SEC Wins Extended Asset Freeze Against Biotech Co.
A Colorado federal judge on Friday granted the U.S. Securities and Exchange Commission's request to make permanent a restraining order freezing a biotech company's assets while the case proceeds, finding that the regulator is likely to prevail in the suit.
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March 29, 2024
Allergan Scoffs At Sandoz Bid To Undo $39M Patent Loss
Allergan told the Federal Circuit to reject Sandoz's fight over a $39 million verdict against it for infringing an Allergan eyelash growth drug patent, saying Sandoz's reliance on a 2014 decision involving the same drug misses the decision's central point.
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March 29, 2024
Judge Axes UpHealth's Claim Estimation Bid In Bankruptcy
A Delaware bankruptcy judge denied UpHealth Holdings Inc.'s request to treat a potential liability claim as worth nothing, saying the company hadn't shown that the bankruptcy case would be hindered if a state court was left to decide the claim's value.
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March 29, 2024
Hedge Fund Beats Vaxart Investor's 'Short-Swing' Profits Suit
A New York federal judge has granted a win to hedge fund Armistice Capital LLC and its managing member in a derivative suit brought by a shareholder of biotechnology company Vaxart Inc., which sought disgorgement of short-swing profits that allegedly were wrongfully obtained by the investment adviser.
Expert Analysis
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White House Activity Is A Band-Aid For Regulating AI In Health
In the medium term, recent White House actions will have a greater impact on AI in the health care industry than Congress' sluggish efforts to regulate it, but ultimately legislation of AI's development and use in the health space will fall to Congress, say Wendell Bartnick and Vanessa Perumal at Reed Smith.
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Understanding Discovery Obligations In Era Of Generative AI
Excerpt from Practical Guidance
Attorneys and businesses must adapt to the unique discovery challenges presented by generative artificial intelligence, such as chatbot content and prompts, while upholding the principles of fairness, transparency and compliance with legal obligations in federal civil litigation, say attorneys at King & Spalding.
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Kochava Ruling May Hint At Next Privacy Class Action Wave
The Southern District of California's recent ruling in Greenley v. Kochava and increasing complaints alleging that a consumer website is an illegal “pen register” due to the use of third-party marketing software tools foreshadow a new theory of liability for plaintiffs in privacy litigation, say attorneys at Crowell & Moring.
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Forecasting The Impact Of High Court Debit Card Rule Case
John Delionado and Aidan Gross at Hunton consider how the U.S. Supreme Court's forthcoming ruling in a retailer's suit challenging a Federal Reserve rule on debit card swipe fees could affect agency regulations both new and old, as well as the businesses that might seek to challenge them.
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Series
ESG Around The World: Mexico
ESG has yet to become part of the DNA of the Mexican business model, but huge strides are being made in that direction, as more stakeholders demand that companies adopt, at the least, a modicum of sustainability commitments and demonstrate how they will meet them, says Carlos Escoto at Galicia Abogados.
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Opinion
FDA And Companies Must Move Quickly On Drug Recalls
When a drug doesn't work as promised — whether it causes harm, like eyedrops recalled last month by the U.S. Food and Drug Administration, or is merely useless, like a widely used decongestant ingredient recently acknowledged by the agency to be ineffective — the public must be notified in a timely manner, says Vineet Dubey at Custodio & Dubey.
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The Case For Post-Bar Clerk Training Programs At Law Firms
In today's competitive legal hiring market, an intentionally designed training program for law school graduates awaiting bar admission can be an effective way of creating a pipeline of qualified candidates, says Brent Daub at Gilson Daub.
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Opinion
A Telecom Attorney's Defense Of The Chevron Doctrine
The Chevron doctrine, which requires judicial deference to federal regulators, is under attack in two U.S. Supreme Court cases — and while most telecom attorneys likely agree that the Federal Communications Commission is guilty of overrelying on it, the problem is not the doctrine itself, says Carl Northrop at Telecommunications Law Professionals.
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What's At Stake In Bystolic 'Side Deals' Litigation
In re: Bystolic Antitrust Litigation, which has oral argument set for next month, will likely shed light on how the U.S. Court of Appeals for the Second Circuit views side deals, and could create a circuit split in pleading standards for reverse payment cases, say attorneys at Axinn.
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2 HHS Warnings Highlight Anti-Kickback Risks For Physicians
Two recent advisory opinions issued by the U.S. Department of Health and Human Services' Office of Inspector General involve different scenarios and rationales, but together they illustrate the OIG's focus on and disapproval of contractual joint ventures and other revenue-maximizing physician arrangements, say Robert Threlkeld and Elliott Coward at Morris Manning.
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Attorneys Have An Ethical Duty To Protect The Judiciary
The tenor of public disagreement and debate has become increasingly hostile against judges, and though the legislative branch is trying to ameliorate this safety gap, lawyers have a moral imperative and professional requirement to stand with judges in defusing attacks against them and their rulings, says Deborah Winokur at Cozen O'Connor.
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Cross-Market Implications In FTC's Anesthesia Complaint
The Federal Trade Commission's recent complaint against a private equity firm's acquisition of anesthesiology practices highlights the controversial issue of cross-market harm in health care provider mergers, and could provide important insights into how a court may view such theories of harm, say Christopher Lau and Dina Older Aguilar at Cornerstone Research.
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FTC Orange Book Move Signals New Pharma Patent Scrutiny
The Federal Trade Commission's recent dispute against improper listing of drug patents in the U.S. Food and Drug Administration's Orange Book indicates heightened surveillance of the pharmaceutical industry, particularly where competition-related consequences of patent or regulatory processes are concerned, say attorneys at Fenwick.
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AI Can Help Lawyers Overcome The Programming Barrier
Legal professionals without programming expertise can use generative artificial intelligence to harness the power of automation and other technology solutions to streamline their work, without the steep learning curve traditionally associated with coding, says George Zalepa at Greenberg Traurig.
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How Legal Teams Can Prep For Life Sciences' Tech Revolution
The life sciences and health care industries are uniquely positioned to take advantage of new efficiencies created by cloud computing and generative artificial intelligence, but the sensitivity of their data also demands careful navigation of an expanding legislative and regulatory landscape, say Kristi Gedid, Zack Laplante and Lisa LaMotta at Ernst & Young.