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Life Sciences
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March 22, 2024
Md. University Says Psilocybin Trade Theft Suit Belongs In US
A London-based biochemical company cannot be allowed to escape across the pond with trade secrets related to using psilocybin as a mental health treatment, the University of Maryland, Baltimore, told a federal court, saying the company's minimum contacts with the state was its "months-long fraudulent scheme" to swipe intellectual property.
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March 22, 2024
$900M Trade Secrets Case Against Kaiser Foundation Flops
A California state judge has ruled that, after more than five years of litigation against the Kaiser Foundation, a pastor's small medical technology startup cannot "explain what was unique or secret about its conception for transmitting patient data" that was purportedly worth beyond $900 million.
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March 22, 2024
Final OK Sought For Economic Loss Deal In CPAP Recall MDL
Users of Philips' recalled CPAP breathing machines have asked a Pennsylvania federal judge to give her final OK to their $467.5 million settlement with the company to cover economic loss claims, arguing only a few objections to the deal remain.
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March 22, 2024
Radiology Co., Trustee Must Face Ex-Worker's ESOP Suit
A Colorado federal judge refused to toss a proposed class action accusing a radiology company and its trustee of overcharging the company's employee stock ownership plan in a $163.7 million sale, saying the former workers' complaint puts forward enough details to back up their allegations.
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March 22, 2024
Vanda's Obviousness Appeal Isn't Worthwhile, Teva Tells Justices
Teva Pharmaceuticals and Apotex have said the U.S. Supreme Court should reject a petition from Vanda Pharmaceuticals, which said the Federal Circuit "charted its own course" when it invalidated its sleep drug patents as obvious.
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March 22, 2024
High Court Mifepristone Battle Goes Beyond Abortion
The first major abortion battle to reach the U.S. Supreme Court since the Dobbs decision is about a lot more than abortion.
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March 22, 2024
Ex-Drug Rep Won't Serve More Time After 1st Circ. Victory
The second sentencing of a former Aegerion Pharmaceuticals Inc. salesman did not add a day in prison to the roughly seven months he served before the First Circuit wiped away his initial conviction on charges he schemed to fraudulently sell the company's cholesterol treatment.
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March 22, 2024
NJ Appeals Court Shuts Down Fired White Worker's Bias Suit
A New Jersey appeals court backed a life sciences company's win in a former manager's suit claiming she was unlawfully fired for posting statistics about police violence on social media following the 2020 murder of George Floyd, ruling she hadn't shown the company discriminated against white workers.
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March 22, 2024
US Greenlights Novartis' $2.9B MorphoSys Takeover
Germany's MorphoSys AG said Friday it has received U.S. antitrust clearance for the biopharmaceutical company's planned $2.9 billion sale to Swiss Pharma giant Novartis AG, a development that clears the final regulatory hurdle needed before closing the deal.
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March 22, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen the BBC and Wall to Wall Media hit with a passing off lawsuit by musician BOSSIIE, Poundland parent company Pepco Group file a commercial fraud claim against several mobile network giants, family law specialists Alexiou Fisher Philipps LLP start proceedings against former oil trader Michael Prest, and a transgender lawyer file a libel claim against a blogger. Here, Law360 looks at these and other new claims in the U.K.
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March 22, 2024
87-Year-Old Billionaire Lewis Seeks No Jail For Insider Trading
Lawyers for British billionaire Joe Lewis have asked a Manhattan federal judge not to impose any prison time after his plea to insider trading, saying a term of probation is appropriate because the 87-year-old is "nearing the end of life in declining health."
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March 22, 2024
Del. Courts Examining 'Colonoscopy'-Like Bylaw Rules
Invasive advance-notice bylaws that some observers say make shareholder board nominations as intrusive as a "colonoscopy" are reviving old questions in Delaware courts about how far boards can go to protect themselves against shareholder activism.
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March 22, 2024
LifeCell Cleared Of Liability In NJ Strattice Hernia Mesh Trial
New Jersey state jurors on Friday cleared LifeCell of liability in a Kentucky woman's suit alleging the design of its Strattice surgical mesh is defective and caused a hernia to reoccur and ultimately resulted in "life-altering" surgery, giving the medical device company the first win in a venue with at least 93 pending cases with tort claims over the mesh.
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March 21, 2024
SEC's 'Shadow Trading' Trial To Test Insider Info Boundaries
If the U.S. Securities and Exchange Commission can convince jurors hearing its first-ever "shadow trading" case next week to find a former executive in the wrong for buying up a competitor's securities while having insider information about his own company, the floodgates could open to civil and criminal prosecution of other corporate insiders under the novel legal theory, attorneys told Law360.
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March 21, 2024
Colo. Distributor Seeks $2.3M Sanction For Stryker Spoilation
A Colorado medical device distributor urged a federal judge to make Stryker and its lawyers pay $2.3 million in attorney fees as sanctions for "pervasive misconduct" throughout discovery and trial, arguing discovery violations will otherwise become the "cost of doing business" for the medical technology giant.
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March 21, 2024
Schumer Urges Texas District To Adopt Judge-Shopping Rule
Senate Majority Leader Chuck Schumer on Thursday urged the chief judge of the Northern District of Texas to quickly implement the Judicial Conference of the United States' updated policy that looks to prevent litigants from judge shopping, arguing that the district's current practices are "dangerous."
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March 21, 2024
Ill. Judge Leaves Outcome Health Execs' Convictions Intact
An Illinois federal judge said Thursday that he wouldn't disturb three former Outcome Health executives' convictions for carrying out a massive billion-dollar fraud scheme to grow their health advertising business, saying the jury heard enough evidence to support its verdict.
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March 21, 2024
MDL Claims Over Merck's Gardasil Vax Get Trimmed
Pharmaceutical giant Merck need not face many of the claims by patients who allege their autoimmune conditions were caused by its HPV vaccine, a North Carolina federal judge overseeing multidistrict litigation ruled, saying the National Childhood Vaccine Injury Act bars most claims made in the first two bellwethers.
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March 21, 2024
6th Circ. Revives McKee's Network Plan Fight With Thrifty Med
The Sixth Circuit reinstated on Thursday McKee Foods Corp.'s suit against Thrifty MedPlus Pharmacy alleging Tennessee law requiring pharmacy benefit managers to let "any willing pharmacies" participate in a network was preempted by the Employee Retirement Income Security Act, finding that amendments made to the statute didn't render McKee's claims moot.
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March 21, 2024
Calif. Panel Revives Diner's COVID Sanitization Coverage Bid
A California state appeals court revived a diner's bid for property insurance coverage of COVID-19 losses after it determined the restaurant credibly alleged direct physical losses and that the policy's language covering losses attributable to a virus applied to COVID-19 sanitization efforts.
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March 21, 2024
Tribe's Opioid Suit Can Head To State Court, Okla. Judge Says
An Oklahoma federal magistrate judge has granted the Cherokee Nation's bid to move to state court its suit accusing pharmaceuticals distributor Morris & Dickson of flooding the tribe's communities with opioids, saying the company only fulfilled one of four prongs necessary for establishing federal jurisdiction.
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March 21, 2024
CymaBay Investor Sues For Books On $4.3B Gilead Merger
A shareholder of liver disease-focused biopharmaceutical company CymaBay Therapeutics Inc. sued the company in Delaware Chancery Court to extract more information over a proposed $4.3 billion merger with Gilead Sciences Inc., saying CymaBay has refused to hand over previously requested documents regarding the valuation analyses without a legitimate excuse.
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March 21, 2024
Avoid Major Extension Of Merger Reach, EU High Court Urged
An important tool for extending European Union antitrust officials' merger scrutiny appears to be in jeopardy after a European Court of Justice advocate general effectively recommended Thursday that the bloc's high court restrict the ability to investigate transactions that don't normally trigger EU thresholds.
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March 21, 2024
Business Coalition Rebuffs Biden Plan To Seize Drug Patents
The Biden administration's proposal to exercise so-called march-in rights to seize drug patents would harm innovation in the U.S., according to an assemblage of business-focused groups.
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March 21, 2024
Home Health Cos. Stiffed Workers On OT Pay, Suit Claims
The operators of several Ohio-based home care staffing agencies have been failing to pay their employees for all the overtime hours they worked, according to a recent proposed class and collective action.
Expert Analysis
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Opinion
Life Sciences Regulators Must Write Cloud-Specific Guidance
As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.
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Fed. Circ. Elekta Holding May Make Patent Prosecution Harder
The Federal Circuit's recent analysis of obviousness in its Elekta v. Zap Surgical Systems decision will make prosecuting patents harder, as parties will now need to consider whether to argue that cited patents are nonanalogous, say Sean Murray and Jeremiah Helm of Knobbe Martens.
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Attorneys, Law Schools Must Adapt To New Era Of Evidence
Technological advancements mean more direct evidence is being created than ever before, and attorneys as well as law schools must modify their methods to account for new challenges in how this evidence is collected and used to try cases, says Reuben Guttman at Guttman Buschner.
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Series
ESG Around The World: The UK
Following Brexit, the U.K. has adopted a different approach to regulating environmental, social and governance factors from the European Union — an approach that focuses on climate disclosures by U.K.-regulated entities, while steering clear of the more ambitious objectives pursued by the EU, say attorneys at Dechert.
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Boeing Opinion Strikes Blow Against Overpayment Theory
The Fifth Circuit's decision in Earl v. Boeing Co. casts doubt on consumers' standing to bring claims of overpayment for products later revealed to have defects — and suggests that it's more likely that those products would have been removed from the market, driving up the price of alternatives, say attorneys at Bush Seyferth.
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Tips For Litigating Against Pro Se Parties In Complex Disputes
Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.
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What Pharma Cos. Must Know About FDA Off-Label Guidance
The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.
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It's Time To Prescribe Frameworks For AI-Driven Health Care
As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.
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The Murky World Of IP Protection For Gene-Edited Plants
The recently filed Corteva v. Inari lawsuit, which accuses a plant trait developer of using a front company for commercial development, underscores the legal challenges in protecting and determining the ownership of new, genetically edited plant varieties, and emphasizes why joint development arrangements must be carefully navigated, say Andrew Zappia and Tate Tischner at Troutman Pepper.
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New Initiatives Will Advance Corporate Biodiversity Reporting
Two important recent developments — the launch of the Taskforce on Nature-related Financial Disclosures' framework on nature and biodiversity reporting, and Nature Action 100's announcement of the 100 companies it plans to engage on biodiversity issues — will help bring biodiversity disclosures into the mainstream, say David Woodcock and Maria Banda at Gibson Dunn.
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Opinion
Alternative Patents Would Solve Many Inventor Woes
A fundamental reform that gives inventors the option of alternative patents tailored to the value of an invention offers a potential solution for resolving patent-system problems, says John Powers of The Powers IP Law Firm.
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Class Action Defense: Don't Give Up On Bristol-Myers Squibb
Federal appellate court decisions in the six years since the U.S. Supreme Court decided Bristol-Myers Squibb show that it's anyone's ballgame in class action jurisdictional arguments, so defendants are encouraged to consider carefully whether, where and when arguing lack of specific personal jurisdiction may be advantageous, say attorneys at K&L Gates.
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Pro Bono Work Is Powerful Self-Help For Attorneys
Oct. 22-28 is Pro Bono Week, serving as a useful reminder that offering free legal help to the public can help attorneys expand their legal toolbox, forge community relationships and create human connections, despite the challenges of this kind of work, says Orlando Lopez at Culhane Meadows.
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FDA Proposals Clarify Rules For Devices With Predicates
As medical devices continue to grow in complexity, U.S. Food and Drug Administration policies surrounding premarket submissions for devices with existing predicates have fallen behind, but new draft guidances from the agency help fill in some gaps, say attorneys at Hogan Lovells.
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State Regs Sow Discord Between Cannabis, Hemp Industries
Connecticut, Maryland and Washington are the latest states choosing to require intoxicating hemp products to comply with the states' recreational marijuana laws, resulting in a widening rift between cannabis and hemp as Congress works on crafting new hemp legislation within the upcoming 2023 Farm Bill, say attorneys at Wilson Elser.