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Life Sciences
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December 18, 2024
FDA's Gastro Drug Fast-Track Denial Survives DC Circ.
A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.
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December 18, 2024
J&J Unit Beats Schizophrenia Drug IP Challenge On Remand
Teva Pharmaceuticals USA Inc. has failed to invalidate claims in a patent for a Johnson & Johnson unit's blockbuster schizophrenia medicine, according to a New Jersey federal judge who rejected the generic-drug maker's assertions that the formula was obvious.
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December 18, 2024
State AGs, Generic Cos. Fight Over Price-Fixing Trial Order
A contingent of state-level enforcers told a Connecticut federal court there is no need to reconsider prioritizing a sprawling generic drug price-fixing case that involves more than 100 medications over a narrower case the drugmakers are asking to have tried first.
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December 18, 2024
Judge Eyes Limits To Medical Device Co.'s Poaching Verdict
A Boston federal judge on Wednesday considered interpreting twin $5 million jury awards against medical device sales employees as a subset of the $15 million in damages awarded against their employer in a rival company's poaching case.
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December 18, 2024
CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say
The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety.
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December 18, 2024
Amgen Hit With $50M Infringement Verdict Over Leukemia Drug
Germany's Lindis Biotech has persuaded a Delaware federal jury that Amgen should pay $50.3 million in damages for encouraging healthcare providers to infringe the Munich company's immunotherapy patents through administering the leukemia drug Blincyto.
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December 18, 2024
FTC Wants Express Scripts' Defamation Suit Tossed
The Federal Trade Commission told a Missouri federal court that Express Scripts Inc. has no basis to challenge an interim agency report that only offered "qualified conclusions" from an ongoing study about how pharmacy benefit managers affect prescription drug prices.
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December 18, 2024
RJ Reynolds Asks Justices To Toss Forum Shopping Argument
R.J. Reynolds Vapor Co. is urging the U.S. Supreme Court to reject the U.S. Food and Drug Administration's argument that the vape company engaged in forum shopping when it challenged denial of one of its applications in the Fifth Circuit, saying its Texas- and Mississippi-based co-petitioners make the Fifth Circuit the proper venue.
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December 18, 2024
SiteOne Gets $100M To Advance Non-Opioid Pain Treatments
SiteOne Therapeutics Inc., a biopharmaceutical company focusing on pain treatment, on Wednesday announced that it clinched a Series C funding round after securing $100 million from investors.
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December 17, 2024
11th Circ. Urged To Block Abortion Clinic Buffer Zone Law
A Florida anti-abortion group urged the Eleventh Circuit on Tuesday to give it another shot at an injunction preventing the city of Clearwater from enforcing a buffer zone ordinance that blocks the group from getting within five feet of the driveway to the city's only abortion clinic.
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December 17, 2024
Laser Maker Loses Bid To Trim Patent Suit In Mass.
A Massachusetts federal judge has shot down laser maker NKT Photonics' bid to dodge allegations it infringed one of the patents asserted in a lawsuit from a company owned by a University of Michigan professor.
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December 17, 2024
Express Scripts, OptumRx Can't Ditch LA County Opioid Suit
A California judge ruled Tuesday that Los Angeles County can keep pursuing a lawsuit claiming pharmacy benefit managers Express Scripts and OptumRx colluded with drugmakers to fuel the opioid epidemic, though the county must rework its complaint to specify how regulators were allegedly deceived.
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December 17, 2024
Sandoz Cuts $275M Deal For More Price-Fixing Claims
Swiss drugmaker Sandoz said Tuesday it has reached a $275 million settlement to end claims from consumers, insurers and others in the sprawling multidistrict litigation over alleged price-fixing in the generic-drug industry.
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December 17, 2024
Stanford Profs Say Roche's Trade Secret Claims Time-Barred
Stanford University's trustees and three of its professors have asked a California federal court to dismiss trade secret theft claims bought by subsidiaries of F. Hoffmann-La Roche AG, arguing that the allegations are time-barred because the companies were on notice of the purported misappropriation for over three years before filing suit.
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December 17, 2024
House GOP Asks CVS How Its PBM Treats Smaller Pharmacies
Lawmakers on Capitol Hill are demanding documents from CVS on its pharmacy benefit manager's treatment of independent pharmacies, continuing to press the healthcare giant over potentially anticompetitive conduct.
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December 17, 2024
The Biggest Georgia Legal Developments Of 2024
From navigating bombshell prosecutor romance allegations in the Georgia election interference case against President-elect Donald Trump and his co-defendants to vacating a $1.7 billion verdict against Ford Motor Co. in a fatal "Super Duty" rollover case, to seeing the state's longest-running criminal trial to a close, 2024 was a busy year for courts in the Peach State.
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December 17, 2024
Feds Intervene In $200M FCA Case Against CVS
The federal government has intervened in a whistleblower case accusing CVS and its subsidiaries of pocketing more than $200 million in overpayments, in order to defend the constitutionality of the False Claims Act's whistleblower provisions.
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December 17, 2024
Drug Co. Investor Sues In Del. Over $140M Insider Windfall
A pension fund investor in Cerevel Therapeutics Holdings Inc. has sued Bain Capital Investors LLC and other alleged insiders of the company in Delaware's Court of Chancery, accusing them of lining up a secondary offering in the biopharmaceutical venture before disclosure of its planned sale to AbbVie.
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December 16, 2024
Ginkgo Bioworks Investors Get Final OK Of $17.8M Settlement
Investors in biotech company Ginkgo Bioworks Holdings Inc. have gotten final approval for their $17.75 million deal to end proposed class action claims that the company and its leaders distorted Ginkgo's finances, mischaracterizing certain related party deals, to garner shareholder support for its merger with a special purpose acquisition company.
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December 16, 2024
Becton Dickinson To Pay SEC $175M Over Pump Claims
Becton Dickinson & Co. has agreed to pay $175 million to settle the U.S. Securities and Exchange Commission's allegations that the medical device manufacturer misled investors about the risks of selling its Alaris infusion pump and overstated its income, the agency announced Monday.
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December 16, 2024
11th Circ. Appears Wary Of Doc's New Trial Bid In $27.5M Case
The Eleventh Circuit on Monday questioned whether a Georgia doctor and his medical practice should get a new trial in a $27.5 million False Claims Act case on the basis that he and an expert who wasn't allowed to testify at trial believed the thousands of treatments he billed for were medically necessary and could be covered by Medicare, saying that contention seems to contradict the doctor's prior statements.
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December 16, 2024
The Biggest Patent Decisions Of 2024
This year's notable patent decisions from the Federal Circuit provided clearer guidelines on double patenting and opened the door for new ways to invalidate design patents. Here's a look at the cases from 2024 that will shape patent litigation going forward.
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December 16, 2024
Allele, Regeneron Settle COVID Treatment Patent Suit
Allele Biotechnology and Regeneron Pharmaceuticals have settled litigation accusing the latter of infringing a patent used in developing treatments and vaccines for COVID-19, a New York federal judge said Monday.
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December 16, 2024
Supreme Court Rejects Salix Appeal In IBS Drug Case
The U.S. Supreme Court has turned away a bid by a Bausch Health unit to undo a Federal Circuit ruling that invalidated some of its patents on a blockbuster drug for irritable bowel syndrome with diarrhea.
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December 16, 2024
With Legal Battle Looming, Neb. Legalizes Medical Marijuana
Nebraska became the 39th state to legalize medical marijuana after supermajorities of voters approved ballot measures to decriminalize and regulate its sale, but the state Supreme Court has agreed to hear a challenge from state officials that could invalidate it before implementation.
Expert Analysis
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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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Series
The 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.
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State Of The States' AI Legal Ethics Landscape
Over the past year, several state bar associations, as well as the American Bar Association, have released guidance on the ethical use of artificial intelligence in legal practice, all of which share overarching themes and some nuanced differences, say Eric Pacifici and Kevin Henderson at SMB Law Group.