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Life Sciences
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July 18, 2024
Ga. Mineral Co. Can't Nab Win In Row Over Talc Suit Coverage
A Georgia federal judge declined to grant a win to a mineral products company trying to compel a Travelers unit to defend it against an underlying suit claiming that it supplied asbestos-containing talc products.
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July 18, 2024
PharMerica Inks $100M Deal In 13-Year-Old Whistleblower Suit
PharMerica Corp. has agreed to pay $100 million to settle a former New Jersey nursing home owner's long-running whistleblower litigation over an alleged drug kickback scheme, according to the plaintiff's law firm.
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July 17, 2024
ITC Affirms Lab Equipment Co.'s Patent Wasn't Infringed
The U.S. International Trade Commission has upheld an administrative law judge's finding that a California biotechnology outfit did not infringe a German laboratory equipment supplier's patent.
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July 17, 2024
Many AI Patent Eligibility Issues Still Hazy After Guidance
The U.S. Patent and Trademark Office's new guidance on patent eligibility for inventions involving artificial intelligence provides some helpful details for patent applicants, but attorneys say it leaves unanswered questions that will likely require court decisions or legislation to sort out.
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July 17, 2024
Pharma Co. Slams Magistrate's Venue Report In Opioid Suit
A pharmaceuticals distributor is objecting to an Oklahoma federal magistrate judge's recent recommendation to deny as moot the company's bid to dismiss a Cherokee Nation suit accusing it of flooding tribal communities with opioids, saying the case shouldn't be sent to state court.
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July 17, 2024
Chancery Again Spikes Biopharm Board Pay Deal, $600K Fee
A Delaware vice chancellor on Wednesday rejected a second attempt by California-based Iovance Biotherapeutics Inc.'s board to settle a derivative suit challenging allegedly excessive compensation for non-employee directors, citing in part a seeming "end-run" around earlier proposed reforms.
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July 17, 2024
Hospital Trims Its Insulin Pen Claims Against Novo Nordisk
A Connecticut hospital and Novo Nordisk Inc. have agreed to dismiss several of the pharmaceutical giant's corporate entities from a suit seeking to make the company pay for the hospital's $1 million settlement from an underlying patient class action over allegedly defective insulin pens the firm made.
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July 17, 2024
Ex-Genentech Worker Seeks Revival Of 401(k) Investment Suit
A former Genentech employee asked the Ninth Circuit to reopen his proposed class action alleging the biotechnology company kept unwise investment options in its 401(k) plan for years, arguing a trial court applied an erroneously high standard when it tossed the claim.
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July 17, 2024
Boehringer Wants Inhaler Antitrust Case Moved To Mass.
Boehringer Ingelheim Pharmaceuticals Inc. has urged a Connecticut federal court to transfer a proposed class action accusing it of blocking generic versions of two inhaler medications, saying a similar case was filed in Massachusetts several weeks earlier.
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July 17, 2024
Bruised SPAC Market Pins Revival Hopes On Veteran Backers
More special-purpose acquisition companies are conducting initial public offerings, mostly backed by dealmakers who have completed prior mergers, bringing life to a listings market that was largely barren over the past year.
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July 17, 2024
ADA Can't Shield Worker From Failed Drug Test, Co. Says
A chemical transportation company urged a South Carolina federal court to toss a former lift operator's lawsuit alleging he was fired for taking legal CBD because of cysts on his brain and spinal cord, arguing disability law doesn't protect workers from positive drug tests for THC.
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July 16, 2024
Gilead Asks Calif. Supreme Court To Ax 'Disastrous' Decision
Gilead Sciences on Monday urged the California Supreme Court to overturn an appellate panel's decision that the company can't ditch claims it held back a safer HIV drug to maximize profits on an older medication, saying that holding manufacturers liable for non-defective products would "yield disastrous policy consequences."
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July 16, 2024
UPC Knocks Out Amgen's Cholesterol Drug Patent
The Unified Patent Court on Tuesday ruled that Amgen's patent covering the cholesterol drug Repatha isn't valid in the European Union, less than a year after justices on the U.S. Supreme Court made a somewhat similar call on U.S. patents covering the same drug.
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July 16, 2024
Chancery Orders Illumina Docs Released In Grail Merger Fight
Benefit fund shareholders of biotech giant Illumina Inc. won a Delaware Court of Chancery order on Tuesday for a rare, limited release of legal advice documents on Illumina's merger agreement with cancer-testing firm Grail Inc., a deal that has cost the company billions in fines and lost value.
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July 16, 2024
Tycoon's Pilot Says Feds' Stock Tip Claims Don't Add Up
A private pilot who used to work for convicted insider trader and U.K. billionaire Joe Lewis is arguing federal prosecutors can't use allegations that his own trades were suspicious to ramp up a sentence for a separate tax evasion charge.
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July 16, 2024
FDA Vet Joins Arnold & Porter As Counsel On Healthcare
After nearly a decade in high-level roles at the U.S. Food and Drug Administration, regulatory pro Andrew Zacher has joined the life sciences and healthcare team at Arnold & Porter.
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July 16, 2024
Drugmaker BioLineRx Beats Investor Suit Over Cash Shortfall
Israeli biotech company BioLineRx has, for now, beaten a proposed class action over claims that it misled investors on its capital shortfall, which caused a major decline in its share price, with a New Jersey federal judge saying the plaintiffs have failed to plead any actionable misleading or false statements.
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July 16, 2024
3rd Circ. Backs Tossing Over 1K Suits In Merck Vaccine MDL
The Third Circuit on Tuesday affirmed the dismissal with prejudice of 1,189 cases in multidistrict litigation alleging Merck & Co. Inc.'s shingles vaccine, Zostavax, caused the disease, saying the district court did not abuse its discretion by requiring medical tests to support the claims.
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July 16, 2024
Manatt Adds Healthcare Transactions Partner From McDermott
Manatt Phelps & Phillips LLP has added a new healthcare partner to its Boston office.
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July 16, 2024
Heart-Focused Biotech Closes $260M Series B Funding Round
Clinical-stage biotechnology company Cardurion Pharmaceuticals Inc. on Tuesday announced that it has raised $260 million in Series B financing that will go toward helping the Burlington, Massachusetts-based company continue developing therapies for the treatment of cardiovascular diseases.
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July 16, 2024
Ex-CBD Exec Gets $533K In Fla. Investment Fraud Suit
A Florida federal judge has awarded $533,600 to a former executive of a CBD company who alleged he was duped by his family members into investing, following a jury trial that ended with a mixed verdict.
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July 16, 2024
Vertex Pharma Widens War On Watchdog's Kickback Views
A lawsuit from gene therapy-drug maker Vertex Pharmaceuticals over fertility treatment access is a new battle over enforcement kickback theories and health officials' interpretation of "inducement."
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July 16, 2024
The 2024 Diversity Snapshot: What You Need To Know
Law firms' ongoing initiatives to address diversity challenges have driven another year of progress, with the representation of minority attorneys continuing to improve across the board, albeit at a slower pace than in previous years. Here's our data dive into minority representation at law firms in 2023.
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July 16, 2024
These Firms Have The Most Diverse Equity Partnerships
Law360’s law firm survey shows that firms' efforts to diversify their equity partner ranks are lagging. But some have embraced a broader talent pool at the equity partner level. Here are the ones that stood out.
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July 15, 2024
Acuitas Seeks Credit For IP Tied To COVID Vax
Acuitas Therapeutics wants to set the record straight about its involvement in a handful of patents that Alnylam Pharmaceuticals asserts were swiped to create the COVID-19 vaccine developed by Pfizer, BioNTech and Acuitas, saying in a lawsuit in Delaware federal court Monday that Acuitas scientists should be listed as co-inventors.
Expert Analysis
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What The NYSE Proposed Delisting Rule Could Mean For Cos.
The New York Stock Exchange's recently proposed rule would provide the exchange with discretionary authority to commence delisting proceedings for a company substantially shifting its primary business focus, raising concerns for NYSE-listed companies over the exact definition of the exchange's proposed "substantially different" standard, say attorneys at Winston & Strawn.
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FDA Warning Indicates Scrutiny Of Regenerative Health Cos.
The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.
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2 Regulatory Approaches To Psychedelic Clinical Trials
Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.
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Opinion
Bankruptcy Judges Can Justly Resolve Mass Tort Cases
Johnson & Johnson’s recent announcement of a prepackaged reorganization plan for its talc unit highlights that Chapter 11 is a continually evolving living statute that can address new types of problems with reorganization, value and job preservation, and just treatment for creditors, says Kenneth Rosen at Ken Rosen Advisors PC.
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Series
Fishing Makes Me A Better Lawyer
Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge at Robinson Bradshaw.
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A Healthier Legal Industry Starts With Emotional Intelligence
The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.
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To Make Your Legal Writing Clear, Emulate A Master Chef
To deliver clear and effective written advocacy, lawyers should follow the model of a fine dining chef — seasoning a foundation of pure facts with punchy descriptors, spicing it up with analogies, refining the recipe and trimming the fat — thus catering to a sophisticated audience of decision-makers, says Reuben Guttman at Guttman Buschner.
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Circuit Judge Writes An Opinion, AI Helps: What Now?
Last week's Eleventh Circuit opinion in Snell v. United Specialty Insurance, notable for a concurrence outlining the use of artificial intelligence to evaluate a term's common meaning, is hopefully the first step toward developing a coherent basis for the judiciary's generative AI use, says David Zaslowsky at Baker McKenzie.
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Fed. Circ. Rulings Crystallize Polymorph Patent 'Obviousness'
A comparison of two recent Federal Circuit obviousness challenge decisions regarding polymorph patents provides helpful insight into the assessment of screening arguments, particularly the issue of reasonable expectation of success, say Michael Green and John Molenda at Steptoe.
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DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges
The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.
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3 Infringement Defenses To Consider 10 Years Post-Nautilus
In the 10 years since the U.S. Supreme Court’s influential Nautilus ruling, the spirit of the “amenable to construction” test that the opinion rejected persists with many patent litigators and judges, so patent infringement defense counsel should always consider several key arguments, says John Vandenberg at Klarquist Sparkman.
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9th Circ. COVID 'Cure' Case Shows Perks Of Puffery Defense
The Ninth Circuit's March decision in a case surrounding a company's statements about a potential COVID-19 cure may encourage defendants to assert puffery defenses in securities fraud cases, particularly in those involving optimistic statements about breakthrough drugs that are still untested, say attorneys at Cahill Gordon.
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FTC Focus: Exploring The Meaning Of Orange Book Letters
The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.
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Investors Can Aid In The Acceptance Of Psychedelic Medicine
Psychedelic medicine is ready to have its breakthrough moment, and although it still faces political, legal and communications challenges, private equity investors can play a significant role in changing the public perception on psychedelics from taboo to acceptance, say Kimberly Chew at Husch Blackwell, Charlie Panfil at the Daschle Group and Ethan Lutz at FTI Consulting.
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Class Actions At The Circuit Courts: May Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy discusses four notable circuit court decisions on topics from automobile insurance to securities — and provides key takeaways for counsel on issues including circuit-specific ascertainability requirements and how to conduct a Daubert analysis prior to class certification.