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Life Sciences
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October 31, 2024
Teva Fined €463M For Blocking Rival MS Drug Launch
The European Union antitrust enforcer hit pharmaceutical giant Teva with a €463 million ($502 million) fine Thursday for launching a smear campaign against a rival multiple sclerosis drug and misusing the patent system to thwart the competitor's attempt to enter the market.
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October 30, 2024
FDA Didn't Flub Approval In Orphan Drug Case, DC Court Says
The U.S. Food and Drug Administration didn't err in determining that a rival narcolepsy treatment is not the "same drug" as Jazz Pharmaceuticals' exclusive treatment, a D.C. federal judge ruled Wednesday, holding that the FDA's approval of the rival drug didn't run afoul of the Orphan Drug Act.
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October 30, 2024
Alleged Kickback Plotters Can Waive Conflict Over Attorney
A Colorado federal judge on Wednesday concluded that a lab testing company owner charged with participating in a kickback scheme to defraud Medicare and a man who pled guilty to participating in a connected conspiracy could waive any conflicts that might arise from both using the same attorney.
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October 30, 2024
Cigna Wants $16.1M, Florida Labs Seek $5.1M In Benefits Feud
Cigna should pay $5.1 million for harming three Florida laboratories by wrongfully declaring thousands of substance abuse treatment tests medically unnecessary, the labs told a Connecticut jury Wednesday, while Cigna asked to recoup $16.1 million in payouts to the labs for what it called "wasteful" tests.
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October 30, 2024
LA Times Owner Faces Investor Suit Over Drug Co.'s Woes
Officers and directors of biotechnology company ImmunityBio Inc., including L.A. Times owner Patrick Soon-Shiong, face a shareholder's derivative complaint alleging the company concealed issues affecting a path to regulatory approval for one of its key product candidates.
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October 30, 2024
After Exeltis Win, Judge Won't Allow Suits On Dropped Patents
A Delaware federal judge has shot down a request that seven patents Insud Pharma's New Jersey-based division Exeltis USA Inc. dropped in patent litigation against Lupin Pharmaceuticals Inc. be dismissed in a way where they could be refiled later.
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October 30, 2024
Publix Denied Early Win Over Opioid Coverage Defense
A Florida federal court rejected Publix's bid for defense cost coverage for dozens of public nuisance lawsuits related to the opioid crisis, finding that the damages sought are too far removed from particular bodily injuries caused "because of" opioid addiction, as required in Publix's policies.
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October 30, 2024
3rd Circ. Told Medicare Drug Price Talks Not Voluntary
Three pharmaceutical companies told the Third Circuit on Wednesday the Medicare drug price negotiation program is anything but voluntary, arguing the appeals court should revive their challenges to the program because it is unconstitutional.
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October 30, 2024
Biopharma Co. Can't Knock Ex-CFO's Bias Suit Out Of Court
A biopharmaceutical development company can't kick a fired executive's bias suit to arbitration, a California federal judge said, ruling that the harassment she said she faced on the job was gendered enough to invoke a federal law curbing out-of-court-resolutions of sex harassment claims.
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October 30, 2024
Ex-Takeda Exec. Gets Nearly 4 Years For Fake Invoice Scam
A former Takeda Pharmaceuticals executive was sentenced Wednesday to 46 months in prison for stealing millions from the drug company through a fake invoice scam that a Boston federal judge characterized as "utterly unnecessary and pointless" and carried out for no other reason than to fund a luxurious lifestyle.
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October 30, 2024
Yale Researcher's Suit Over Loss Of 'Life's Work' Transferred
A Connecticut state court judge in Fairfield is passing on a researcher's lawsuit accusing Yale School of Medicine of destroying two decades of research worth $28 million, transferring the case to the complex litigation docket in Hartford.
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October 30, 2024
Ohio PBM Case Will Wait For High Court Ruling
The Sixth Circuit agreed to pause a case from Ohio state enforcers accusing Express Scripts and Prime Therapeutics of driving up prescription drug prices while the U.S. Supreme Court decides another case dealing with federal versus state jurisdiction.
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October 30, 2024
DLA Piper's FDA Regulation Vice Chair Joins White & Case
The former vice chair of DLA Piper's FDA regulatory practice has joined White & Case LLP's global life sciences and healthcare group and intellectual property practice.
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October 29, 2024
NY Judge Tosses $14B Decongestant MDL
A New York federal judge threw out a streamlined complaint in a multidistrict litigation accusing companies such as Target and Bayer of making and selling ineffective over-the-counter decongestants, finding Tuesday the state claims are expressly preempted, and the proposed class lacks standing on a federal racketeering claim as indirect purchasers.
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October 29, 2024
Y-mAbs Therapeutics Investors Get Final OK For $19.7M Deal
A New York federal judge has granted final approval to a $19.7 million settlement between Y-mAbs Therapeutics and investors who claim the company misrepresented the likelihood that the U.S. Food and Drug Administration would approve the company's signature pediatric nerve cancer treatment, giving class counsel a $6.5 million cut of the deal.
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October 29, 2024
Retired Fed. Circ. Judge Backs Invisalign In Monopoly Cases
Retired Federal Circuit Judge Paul R. Michel warned the Ninth Circuit on Tuesday that reversing a lower court's decision to toss a pair of class actions accusing Invisalign of monopolizing the clear braces and teeth scanners market by illegally refusing to deal with a rival would increase patent owners' legal uncertainties.
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October 29, 2024
Patent Partner Moves From King & Spalding To Steptoe
A former King & Spalding LLP partner has made the jump to Steptoe LLP, filling out the firm's team of California-based litigators who take on patent cases.
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October 29, 2024
4th Circ. Quizzes Drugmaker Challenging W.Va. Abortion Law
An attorney arguing that West Virginia is preempted by federal law from restricting access to an abortion medication faced skeptical questions Tuesday from two judges who suggested it's entirely normal for states to regulate the practice of medicine.
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October 29, 2024
Biopharma Co. Escapes Investor Suit Over Drug Approval Lies
Biopharmaceutical company Spero Therapeutics Inc. has escaped a proposed investor class action accusing it of concealing warning signs that it would not secure regulatory approval of one of its drugs, with the court ruling that Spero's interactions with the U.S. Food and Drug Administration do not indicate Spero should have known its application would be rejected.
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October 29, 2024
Medical Co. Gets No Coverage For Toxic Tort
An insurer for B. Braun Medical Inc. has no duty to defend or indemnify the company against numerous lawsuits accusing B. Braun of exposing residents near one of its medical device manufacturing plants to a carcinogenic gas, a Pennsylvania federal court ruled, finding a pollution exclusion applicable.
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October 29, 2024
Investors Float $21M Deal To End Life Sciences SPAC Suit
Shareholders in special purpose acquisition company CM Life Sciences Holdings have reached a tentative $21 million class settlement in Delaware's Court of Chancery after suing over alleged missing or misleading disclosures in the lead-up to the take-public merger of clinical data and genomics company Sema4 Holdings in July 2021.
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October 29, 2024
Beyond Abortion, 7 Ballot Questions Set To Shape Care
While reproductive rights have led the healthcare debate this election season, voters across the country will shape state policies on a number of other hot issues, including a Medicaid work requirement and coverage for IVF. Law360 Healthcare Authority looks at seven ballot measures that go beyond abortion.
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October 29, 2024
Allergan, Mankind Settle IP Fight Over Lumigan Generic
Allergan Inc. and Mankind Pharma Ltd. asked a Delaware federal court Tuesday to dismiss infringement litigation over Mankind's proposed generic of Allergan's glaucoma drug Lumigan, stipulating that the patent is valid and has been infringed.
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October 29, 2024
Purdue Creditors Can Sue Sacklers For $11.5B
Creditors of bankrupt OxyContin maker Purdue Pharma LP will get the right to sue the company's owners — certain members of the Sackler family — and others for $11.5 billion, should they choose to do so, a New York judge said on Tuesday.
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October 29, 2024
Pa. DA Says ATF's Pot Patients Ban Doesn't Fit With Bruen
A Pennsylvania district attorney is urging a federal judge not to throw out his suit challenging a Bureau of Alcohol, Tobacco, Firearms and Explosives policy blocking medical cannabis patients from buying or owning firearms, saying the U.S. Supreme Court's recent precedent preempts the restriction.
Expert Analysis
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Budding Lessons From Landmark Plant Seed Patent Battle
The Corteva v. Inari case involving intellectual property rights in genetically modified plants is now proceeding through discovery and potentially to trial, and will raise critical questions that could have a major impact on the agriculture technology industry, say Tate Tischner and Andrew Zappia at Troutman Pepper.
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The Key To Solving High Drug Costs Is Understanding Causes
One-sided views on who or what contributes to the high cost of pharmaceuticals render possible solutions much harder to discover and implement, and a better approach would be to examine history and learn why costs have increased and what legislation has and hasn't helped, says Nancy Linck at NJ Linck Consulting.
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Opinion
Legal Institutions Must Warn Against Phony Election Suits
With two weeks until the election, bar associations and courts have an urgent responsibility to warn lawyers about the consequences of filing unsubstantiated lawsuits claiming election fraud, says Elise Bean at the Carl Levin Center for Oversight and Democracy.
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Opinion
Bring Back Patent Models To Shut Down The Patent Trolls
By reintroducing the requirement that inventors submit a miniature working model of their inventions along with their patent, legislators could help to deter patent trolls, reduce frivolous litigation and support legitimate inventors in protecting their innovations, says Darin Gibby at Kilpatrick.
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Strategies To Avoid Patent Issues In AI Drug Discovery
Artificial intelligence has the potential to improve drug discovery and design, but companies should consider a variety of factors when patenting drugs created using AI systems, including guidance from the U.S. Patent and Trademark Office and methods for protecting patent eligibility, say attorneys at Ropes & Gray.
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How Cos. Can Build A Strong In-House Pro Bono Program
During this year’s pro bono celebration week, companies should consider some key pointers to grow and maintain a vibrant in-house program for attorneys to provide free legal services for the public good, says Mary Benton at Alston & Bird.
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Bristol-Myers Win Offers Lessons For Debt Security Holders
A New York federal judge's recent dismissal of a $6.4 billion lawsuit against Bristol-Myers Squibb, due to plaintiff UMB Bank's lack of standing, serves as an important reminder to debt security holders to obtain depositary proxies before pursuing litigation, say attorneys at Milbank.
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Series
Home Canning Makes Me A Better Lawyer
Making my own pickles and jams requires seeing a process through from start to finish, as does representing clients from the start of a dispute at the Patent Trial and Appeal Board through any appeals to the Federal Circuit, says attorney Kevin McNish.
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Navigating The Bankruptcy Terrain After Purdue Pharma
The U.S. Supreme Court’s June ruling in Harrington v. Purdue Pharma is having a significant impact on bankruptcies, with recent cases addressing nonconsensual third-party releases and opt-out mechanisms, and highlighting strategies practitioners can employ to avoid running afoul of the decision, say Brett Axelrod and Agostino Zammiello at Fox Rothschild.
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5 Considerations For Obviousness-Type Double Patenting
The U.S. Supreme Court’s recent denial of certiorari for In re: Cellect highlights the current state of obviousness-type double patenting based on that case and another recent Federal Circuit decision, including that ODP is not fatal, that divisional applications are protected from ODP and more, says Fabian Koenigbauer at Ice Miller.
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Patent Lessons From 7 Federal Circuit Reversals In August
The Federal Circuit’s seven vacated or reversed cases from August provide helpful clarity on obviousness-type double patenting, written description and indefiniteness, and suggest improved practices for petitioners and patent owners in inter partes review, say Denise De Mory and Li Guo at Bunsow De Mory.
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Use The Right Kind Of Feedback To Help Gen Z Attorneys
Generation Z associates bring unique perspectives and expectations to the workplace, so it’s imperative that supervising attorneys adapt their feedback approach in order to help young lawyers learn and grow — which is good for law firms, too, says Rachael Bosch at Fringe Professional Development.
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Opinion
Congress Can And Must Enact A Supreme Court Ethics Code
As public confidence in the U.S. Supreme Court dips to historic lows following reports raising conflict of interest concerns, Congress must exercise its constitutional power to enact a mandatory and enforceable code of ethics for the high court, says Muhammad Faridi, president of the New York City Bar Association.
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Perspectives
Pop Culture Docket: Justice Lebovits On Gilbert And Sullivan
Characters in the 19th century comic operas of Gilbert and Sullivan break the rules of good lawyering by shamelessly throwing responsible critical thought to the wind, providing hilarious lessons for lawyers and judges on how to avoid a surfeit of traps and tribulations, say acting New York Supreme Court Justice Gerald Lebovits and law student Tara Scown.
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New HHS Research Misconduct Rules Bring Seismic Changes
The U.S. Department of Health and Human Services' new rule regarding research misconduct investigations brings significant changes that focus on remediation, appeals and confidentiality, while other changes could result in institutions causing undue harm to scientists accused of such misconduct, say attorneys at Cohen Seglias.