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Life Sciences
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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.
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July 15, 2024
Ex-Pfizer Worker Seeks No Time For Paxlovid Insider Trading
A former Pfizer employee argued that he shouldn't go to prison after a Manhattan federal jury convicted him of insider trading over clinical trial results for the drug Paxlovid, pointing out that a friend of his and co-defendant had dodged a custodial sentence in the case after helping prosecutors.
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July 15, 2024
Walgreens Investor Sues Over Challenged Pharmacy Division
Walgreens Boots Alliance Inc. was hit with a proposed shareholder class action alleging it inflated share prices by concealing the lack of viability of its pharmacy division, which it eventually disclosed needed a major overhaul to become sustainable.
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July 15, 2024
AbbVie Can't Keep CoolSculpting Suit In NJ Fed Court
A New Jersey federal judge on Monday sent back to state court a suit against AbbVie Inc. from a woman alleging that she was injured by a CoolSculpting procedure, saying the pharmaceutical company hasn't shown that the case belongs in federal court.
Expert Analysis
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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.
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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.