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Life Sciences
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September 26, 2024
Senate Patent Bill Markups Delayed Until After Election
Congressional hearings scheduled for Thursday to mark up several bills related to patents, including measures dealing with patent eligibility, validity challenges and drug patents, have been postponed until after Election Day due to the Senate's adjournment.
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September 26, 2024
Nobel Winners Behind Gene Editor Seek To Nix Own Patents
The scientists credited with inventing the gene-editing tool CRISPR have voluntarily requested that two key patents be revoked in Europe, after officials suggested they might get nixed over technical issues.
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September 26, 2024
Quest Diagnostics Escapes 401(k) Mismanagement Suit
A New Jersey federal judge tossed a proposed class action alleging Quest Diagnostics Inc. mismanaged its $5 billion retirement plan by failing to chop under performing investment funds from its lineup, pointing to proof that the company acted to rein in questionable funds.
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September 25, 2024
In-House Counsel To Play Central Role At AI Cos., VCs Say
Venture capital firms expect in-house counsel at artificial intelligence companies to play a bigger role in their businesses due to regulatory uncertainties around AI, while a professor who helped pioneer the technology warned that transparency of commercial AI businesses should be "top of mind," attorneys heard at the seventh annual Berkeley Law AI Institute Wednesday.
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September 25, 2024
NY Judge Pauses Abortion 'Reversal' Case As AG Files Appeal
A New York federal judge has ruled that two more anti-abortion pregnancy centers are free to promote abortion pill "reversal" while a legal clash continues over whether the First Amendment protects their right to market the treatment, which is doubted by major medical groups.
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September 25, 2024
Ascension Must Face Additional Suit Over Vaccine Mandate
Ascension Health Alliance must face another proposed class action challenging its 2021 COVID-19 vaccination policy, an Indiana federal judge ruled Wednesday, holding that a group of workers who were suspended or fired after refusing the vaccine on religious grounds have a case against the Catholic healthcare system.
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September 25, 2024
Generics Group Names Ex-BIO, PhRMA Exec As New CEO
The generic drug industry group the Association for Accessible Medicines on Wednesday announced it has appointed a new chief executive officer who brings over a decade of experience in the branded drug industry.
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September 25, 2024
3rd Circ. Preserves Monsanto's Win In Cancer Warning Suit
The Third Circuit refused to reconsider its ruling that federal law preempts a more stringent Pennsylvania statute that mandates cancer warnings on chemicals, preserving Monsanto's win against a man who alleged the company's Roundup herbicide caused his illness.
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September 25, 2024
7th Circ. Judge Surprised Key Argument Left In Footnote
A Seventh Circuit judge seemed unsure Wednesday whether an insurer for Sterigenics could avoid a $75 million legal bill for defending the company from pollution suits, noting that the insurer addressed "the biggest issue in the case" in just a single, vague footnote.
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September 25, 2024
NJ Pharmacy Execs Cop To $33M Kickback Scheme
Two men who ran a New Jersey mail-order pharmacy admitted their roles in a $33 million medication kickback scheme, U.S. Attorney Philip R. Sellinger announced Wednesday.
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September 25, 2024
Wyden Pitches New Bill To Regulate Intoxicating Hemp
U.S. Senator Ron Wyden, D-Ore., introduced a new bill on Wednesday to more tightly regulate products with hemp-derived cannabinoids, with an emphasis on age gating, manufacturing standards and labeling requirements.
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September 25, 2024
DC Circ. Judges Ask If It's Too Late To Fast-Track Gastro Drug
A panel of D.C. Circuit judges grilled an attorney for Vanda Pharmaceuticals on Wednesday over claims Vanda's gastroparesis drug was improperly denied fast-track designation by the Food and Drug Administration, questioning why the company declined to complete animal toxicological studies even after the FDA paused the drug's human trials.
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September 25, 2024
Expect More R&D Guidance Before Regs, IRS Atty Says
The Internal Revenue Service plans to release more guidance governing the tax treatment of research and development expenses before it formally issues proposed regulations that implement the 2017 federal tax law's changes to the incentive, an agency attorney said Wednesday.
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September 25, 2024
Cancer Detection Biz To Go Public Via $694M SPAC Merger
Special purpose acquisition company Breeze Holdings Acquisition Corp. on Wednesday announced that it has agreed to merge with and take public clinical-stage biopharmaceutical company YD Biopharma Ltd. in a deal that gives the combined company an estimated enterprise value of $694 million and was built by three firms.
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September 25, 2024
AmerisourceBergen Can't Escape Workers' 401(k) Fee Suit
AmerisourceBergen Corp. can't escape a proposed class action alleging it allowed its employee 401(k) plan to be saddled with excessive recordkeeping costs, a Kentucky federal judge ruled, saying the workers' claims and calculations were detailed enough to move forward.
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September 24, 2024
Google Can't Ditch Privacy Suit Over Period App Data Sharing
A California federal judge has refused to release Google from a proposed class action alleging the company used a data analytics tool to wrongfully retrieve data from menstruation tracking app Flo, rejecting the tech giant's arguments that the plaintiffs lacked standing and had consented to the disclosures.
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September 24, 2024
Biotech RenovaCare Investors Seek OK Of $2M Deal
Biotechnology company RenovaCare Inc. has reached a $2 million deal to end a consolidated proposed class action alleging it pumped its stock prices by using a secret paid promotional campaign, the company's investors have told a New Jersey federal judge.
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September 24, 2024
P&G Says FDA Review Moots Class Suit Over Lead In Tampons
Since the FDA has announced it will be looking into claims that commercially available tampons contain harmful levels of heavy metals, Tampax owner Procter & Gamble believes it shouldn't have to keep fighting a proposed California federal class action targeting alleged lead levels in its own products.
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September 24, 2024
Philips Must Face Investor Suit Over FDA Compliance Issues
Health technology company Koninklijke Philips and its former CEO cannot escape a suit accusing them of misleading investors about the safety and compliance of its subsidiary's sleep and respiratory care products, which were recalled in 2021, but its chief financial officer and a former CEO of a Philips subsidiary were allowed to exit the case for good.
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September 24, 2024
Buyers Seek $97M Fees From $335M Drug Price-Fixing Deals
A class of direct purchaser plaintiffs in the multidistrict antitrust litigation over generic drug pricing asked a Pennsylvania federal judge Monday to award them $97 million in fees across six settlements with pharmaceutical firms, arguing its attorneys "spent the better part of a decade and hundreds of thousands of hours litigating this case."
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September 24, 2024
Novo Nordisk Tells Sens. Ozempic Costs Are Linked To PBMs
Novo Nordisk's CEO argued Tuesday that the high prices of the company's diabetes and weight loss drugs Ozempic and Wegovy primarily stem from the actions of pharmacy benefit managers, earning support from many members of a Senate committee and frustrating others who wanted more direct answers on the Danish drugmaker's own responsibilities.
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September 24, 2024
Trio Used Penny Stock Co. For Wide-Ranging Fraud, SEC Says
A trio of defendants faces U.S. Securities and Exchange Commission allegations they orchestrated a wide-ranging investment scheme to illegally profit off of a purported solar company and bogus claims about a rapid COVID-19 test, targeting investors and even the company's own transfer agent to enrich themselves.
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September 24, 2024
Moderna Execs Hyped Ineffective RSV Vax, Suit Says
Officers and directors of Moderna misled investors about the efficacy of its RSV vaccine, causing share prices to dive when it was revealed in June to have only about a 50% efficacy rate after 18 months, a new shareholder suit alleges.
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September 24, 2024
Firms Allowed To Exit IP Case After Gaining Philips' Consent
A North Carolina federal judge allowed Dentons and Morningstar Law Group to withdraw as Transtate Equipment Co. Inc.'s counsel in a copyright and unfair competition case, after a stipulation was struck with opposing attorneys representing a Dutch health technology conglomerate that initially scoffed at the request.
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September 24, 2024
8th Circ. Won't Revive Pot Shop's Discrimination Suit
The Eighth Circuit won't reinstate discrimination and interference claims by a would-be cannabis distributor against a firm contracted to evaluate applicants for Arkansas' dispensary licenses, saying the complaint lacks specificity to support its claims.
Expert Analysis
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2 Options For Sackler Family After High Court Purdue Ruling
After the U.S. Supreme Court recently blocked Purdue Pharma's plan to shield the family that owns the company from bankruptcy lawsuits, the Sacklers face the choice to either continue litigation, or return to the bargaining table for a settlement that doesn't eliminate creditor claims, says Gregory Germain at Syracuse University.
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.
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Fed. Circ. Skinny Label Ruling Guides On Infringement Claims
The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.
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4 Takeaways From Biotech Patent Invalidity Ruling
The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.
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How To Clean Up Your Generative AI-Produced Legal Drafts
As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.
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Calif. Ruling Heightens Medical Product Maker Liability
The California Supreme Court's decision in Himes v. Somatics last month articulates a new causation standard for medical product manufacturer liability that may lead to stronger product disclosures nationwide and greater friction between manufacturers and physicians, say attorneys at Cooley.
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Constitutional Protections For Cannabis Companies Are Hazy
Cannabis businesses are subject to federal enforcement and tax, but often without the benefit of constitutional protections — and the entanglement of state and federal law and conflicting judicial opinions are creating confusion in the space, says Amber Lengacher at Purple Circle.
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USPTO Disclaimer Rule Would Complicate Patent Prosecution
The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.
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Series
Boxing Makes Me A Better Lawyer
Boxing has influenced my legal work by enabling me to confidently hone the skills I've learned from the sport, like the ability to remain calm under pressure, evaluate an opponent's weaknesses and recognize when to seize an important opportunity, says Kirsten Soto at Clyde & Co.
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Purdue Ch. 11 Ruling Reinforces Importance Of D&O Coverage
The U.S. Supreme Court's recent decision in Harrington v. Purdue Pharma, holding that a Chapter 11 reorganization cannot discharge claims against a nondebtor without affected claimants' consent, will open new litigation pathways surrounding corporate insolvency and increase the importance of robust directors and officers insurance, says Evan Bolla at Harris St. Laurent.
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Opinion
Industry Self-Regulation Will Shine Post-Chevron
The U.S. Supreme Court's Loper decision will shape the contours of industry self-regulation in the years to come, providing opportunities for this often-misunderstood practice, says Eric Reicin at BBB National Programs.
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3 Ways Agencies Will Keep Making Law After Chevron
The U.S. Supreme Court clearly thinks it has done something big in overturning the Chevron precedent that had given deference to agencies' statutory interpretations, but regulated parties have to consider how agencies retain significant power to shape the law and its meaning, say attorneys at K&L Gates.
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Roundup
After Chevron
Since the U.S. Supreme Court overturned the Chevron deference standard in June, this Expert Analysis series has featured attorneys discussing the potential impact across 36 different rulemaking and litigation areas.