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Life Sciences
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April 02, 2024
Mich. Warns PFAS Ruling Could Fuel More Agency Challenges
Michigan has warned the state's high court that an appellate decision invalidating PFAS drinking water limits could pave the way for future litigants to attack state regulations by pointing to imperfect cost estimates, urging the court to revive the PFAS rules.
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April 02, 2024
NM Medical Cannabis Insurance Row To Stay In Federal Court
The federal court is the proper place for a proposed class action seeking to make Blue Cross and Blue Shield and other insurers cover medical cannabis, a New Mexico federal judge has ruled, rejecting objections by patients who said the state's high court will eventually need to get involved.
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April 02, 2024
Daiichi Gets Award Nixing Seagen Cancer Drug Claims OK'd
A Washington federal judge has refused to revive U.S. biotech company Seagen Inc.'s claims seeking billions of dollars in damages in a dispute with Japanese drugmaker Daiichi Sankyo Co. Ltd. over cancer drug patents, ruling that an arbitrator who tossed the claims did not disregard the law.
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April 02, 2024
McCarter & English's Client Contract Win Heads To Mediation
The law firm McCarter & English LLP will hold settlement talks in June with an ex-client who has already lost a jury trial over $2 million in unpaid legal bills and potentially faces $3.6 million in punitive damages after an anticipated decision by Connecticut's highest court, a federal magistrate judge ruled Tuesday.
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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.
Expert Analysis
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HHS Advisory Highlights Free Product Inducement Risks
A recent U.S. Department of Health and Human Services advisory opinion highlights concerns that valuable free products and other inducements may influence patients and providers to choose one manufacturer’s product over another, notwithstanding that such free healthcare products may be a benefit, say attorneys at Morgan Lewis.
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Attorneys' Busiest Times Can Be Business Opportunities
Attorneys who resolve to grow their revenue and client base in 2024 should be careful not to abandon their goals when they get too busy with client work, because these periods of zero bandwidth can actually be a catalyst for future growth, says Amy Drysdale at Alchemy Consulting.
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2024 Trends To Watch As AI And IP Litigation Intersect
Just as generative artificial intelligence tools have proven unpredictable, the resulting legal disputes may also hold a few surprises in store for 2024, as intellectual property litigation related to AI inputs, outputs and the tools themselves takes shape, say Philip Warrick and Chengming Liu at Irell & Manella.
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9th Circ. Scienter Ruling May Strengthen FDA's Leverage
A recent Ninth Circuit decision in U.S. v. Marschall — regarding scienter and violations of the Federal Food Drug and Cosmetic Act — appears to give the U.S. Food and Drug Administration another arrow in its quiver to lob in the direction of any repeat offender, with potentially very broad applications, say Elena Quattrone and Zachary Taylor at Epstein Becker.
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In The World Of Legal Ethics, 10 Trends To Note From 2023
Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.
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What China's New Rare Disease Catalog Means For Drug Cos.
A new list of rare diseases released by the Chinese government may present opportunities for multinational developers of designated orphan drugs to take advantage of preferential policies including exemption from clinical trials, priority review and tax incentives, say attorneys at Zhong Lun Law Firm.
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How Attorneys Can Be More Efficient This Holiday Season
Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.
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3 Defense Takeaways From The Bankman-Fried Trial
FTX founder and former CEO Sam Bankman-Fried’s recent fraud conviction offers several key lessons for future white collar defendants, from the changing nature of cross-examination to the continued risks of taking the stand, say Jonathan Porter and Gregg Sofer at Husch Blackwell.
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Series
Children's Book Writing Makes Me A Better Lawyer
Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.
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How The PTAB Landscape Shifted In 2023
Attorneys at Finnegan consider the impact of noteworthy Patent Trial and Appeal Board developments in 2023, including rulemaking, litigation, precedential decisions and director reviews that affected PTAB practice, and offer a reference for examining future proceedings and strategies.
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New Pharma Guidelines Bring Pitfalls For Compounders
New guidelines from U.S. Pharmacopeia, which went into effect last month, require some extensive and potentially expensive compliance efforts from hospitals and compounding pharmacies, and smaller compounders could particularly struggle, says Natalia Mazina at Mazina Law.
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Opinion
What Happens If High Court Rejects Releases In Purdue Ch. 11
Reading the tea leaves following the U.S. Supreme Court's recent arguments in Harrington v. Purdue Pharma, it appears likely that the justices will decide that bankruptcy courts lack the power to release third-party claims against nondebtors, which would result in one of three scenarios, says Gregory Germain at Syracuse University.
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FDA's Recent Litigation Records Are Strong, But Imperfect
The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.
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Coming To Terms With Means-Plus-Function Patent Claims
Made-up patent claim terms can open arguments that means-plus-function claim interpretation applies under the Patent Act, but a series of practice tips, including the use of structural language immediately after introducing a claim element, can help avoid such perceptions, says Brad Luchsinger at Harness IP.
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5 Steps For Healthcare Companies After Biden's AI Order
Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.