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Life Sciences
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March 21, 2024
3rd Circ. Agrees Investors Have No Case Against Vax Maker
The Third Circuit on Thursday upheld a Pennsylvania federal judge's ruling that a putative class of investors alleging biopharmaceutical company Ocugen Inc. made misleading statements about its ability to quickly produce a COVID-19 vaccine failed to state a claim against the company.
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March 21, 2024
6th Circ. Doubtful Of Hospital Workers' Vax Exemption Claim
A Sixth Circuit panel appeared skeptical Thursday of an argument from a class of former employees of Ohio Children's Hospital that their First Amendment rights to freedom of religion were violated under the hospital's COVID-19 employee vaccination policy.
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March 21, 2024
Fed. Circ. Upholds Edwards' PTAB Win On Heart Valve Patent
The Federal Circuit has affirmed a Patent Trial and Appeal Board finding that various parts of medical technology maker Cardiovalve's patent on an artificial heart valve implant were invalid as obvious.
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March 21, 2024
6th Circ. Zeroes In On CBA In Vax Bias Preemption Battle
A Sixth Circuit panel pressed on Thursday a cargo airline and pilots who say they were unlawfully fired for refusing COVID-19 vaccinations about the pilots' union contract, with one judge asking whether the open questions about their collective bargaining agreement meant the discrimination case was preempted.
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March 21, 2024
Chancery Denies Icahn Midcase Appeal In Illumina Board Suit
Carl Icahn can't interrupt his Chancery Court lawsuit against biotech Illumina Inc.'s board to appeal a decision about redactions to the Delaware Supreme Court, a vice chancellor ruled Wednesday, saying there are no "exceptional circumstances" that call for a midcase review.
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March 21, 2024
Greenberg Traurig Adds Jackson Walker FDA Pro In Houston
Greenberg Traurig LLP's most recent Houston addition is a shareholder who came aboard from Jackson Walker LLP, where he established and led its U.S. Food and Drug Administration practice.
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March 20, 2024
4th Circ. Backs Rockefeller Group in Guatemalans' Syphilis Suit
A group of Guatemalans who sued The Rockefeller Foundation over venereal disease experiments conducted on prisoners and psychiatric patients in the 1940s did not show an American doctor involved in the gruesome activities acted on behalf of the organization, a Fourth Circuit panel ruled Wednesday.
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March 20, 2024
Endo Plan To Trim $5B In Debt Confirmed By NY Judge
Drugmaker Endo International got a New York bankruptcy judge's approval for its Chapter 11 plan that aims to cut more than $5 billion in debt and hand over ownership to its lenders, roughly a month after it finalized a $465 million deal to resolve criminal and civil opioid claims.
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March 20, 2024
PTAB To Analyze Moderna COVID Vaccine Patents
The Patent Trial and Appeal Board has agreed to review two Moderna COVID-19 vaccine patents challenged by rivals Pfizer and BioNTech as having "unimaginably broad claims directed to a basic idea that was known long before."
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March 20, 2024
Jenner & Block-Led Lonza To Buy Roche's $1.2B US Facility
Swiss healthcare company Lonza said on Wednesday that it has agreed to acquire one of the largest medicine manufacturing facilities in the world from biotech giant Roche for $1.2 billion to increase its manufacturing capacity.
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March 20, 2024
Digital Comms Filings Bolster Record EPO Applications
Companies and inventors filed the highest number of European patent applications to date in 2023, buoyed by marked increases in filings for digital communications and energy technologies.
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March 20, 2024
Int'l Olympic Committee Rips Russia For Politicizing Sports
The International Olympic Committee has slammed Russia's newly created "Friendship Games" as a cynical ploy to politicize sports, saying that the Russian government's plan to host its own summer and winter games runs contrary to resolutions by the United Nations General Assembly.
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March 20, 2024
Top Attorney For Bristol-Myers Squibb Earned $5.9M In '23
The longtime general counsel for biopharma giant Bristol-Myers Squibb earned more than $5.9 million in compensation for last year, a figure that was down slightly from $6.1 million in 2022 but still buoyed by her work on its recent CEO transition and other matters.
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March 20, 2024
Boehringer Wins Diabetes Treatment Patent On Appeal In EU
Boehringer Ingelheim saved its diabetes drug patent from the chopping block after a European appellate board ruled that the treatment for patients with moderately damaged kidneys was new and innovative despite eight oppositions.
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March 20, 2024
How The Supreme Court Could Narrow Chevron
After hours of oral argument in a closely watched administrative law case, it appeared that some U.S. Supreme Court justices could be open to limiting the opportunities for lower courts to defer to federal agencies' legal interpretations in disputes over rulemaking — and legal experts said there are a number of ways they could do it.
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March 20, 2024
2 Biotechs Unveil Separate Fundings Totaling $325M
Life sciences companies Clasp Therapeutics and Cooley-advised Capstan Therapeutics, which develop treatments for a range of health conditions including cancer and autoimmune diseases, separately announced funding rounds Wednesday that together total $325 million.
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March 20, 2024
Law360 Announces The Members Of Its 2024 Editorial Boards
Law360 is pleased to announce the formation of its 2024 Editorial Advisory Boards.
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March 20, 2024
US Chamber's Litigation Funding Concerns Spur 2 State Laws
Amid concerns from the U.S. Chamber of Commerce about third-party litigation funding, including from potentially hostile foreign entities, state legislatures in Indiana and West Virginia have recently passed bills imposing restrictions on the practice.
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March 19, 2024
Healthcare Policy Roundup: HHS Budget, Telehealth, PBMs
Amid a government funding battle, work of interest to healthcare lawyers and agency watchers was getting done on federal legislation and policy in recent days.
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March 19, 2024
Schumer Scolds McConnell For Judge-Shopping Policy Rebuff
Senate Majority Leader Chuck Schumer on Tuesday lauded the Judicial Conference's updated policy on random case assignments to prevent litigants from judge-shopping, saying that Senate Minority Leader Mitch McConnell is pushing back against the policy since it'd make it tough for hard-right partisans "to hijack our courts for their purposes."
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March 19, 2024
Acorda Says Tribunal Ignored Patent Law In MS Drug Feud
Acorda Pharmaceuticals is pressing the Federal Circuit to award it nearly $66 million more than the $16.5 million it won in arbitration against Irish biopharmaceutical company Alkermes in a licensing fight over a multiple sclerosis drug, arguing that the tribunal disregarded clear patent law.
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March 19, 2024
Law Firm Hit With Suit Over Abandoned Patent Application
A Louisiana-based medical software company has sued a law firm that was hired to help it with an application for a patent for its platform, saying the firm's alleged negligence led to the application being abandoned.
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March 19, 2024
NBA Fraudster Dodges Prison After Cooperation, Testimony
A former NBA shooting guard avoided prison Tuesday for participating in a $5 million retiree healthcare fraud scheme after Manhattan federal prosecutors lauded his assistance and testimony at a trial this past fall.
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March 19, 2024
Skin Care Drug Co. Can Ask Creditors To OK Ch. 11 Plan
A Delaware bankruptcy judge said Tuesday she will give a debtor formerly known as Timber Pharmaceuticals Inc. permission to send its Chapter 11 plan out for a vote by the dermatology drug developer's creditors, after counsel for the company explained it had expanded the creditors' ability to opt out of the plan's claim releases.
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March 19, 2024
Cancer Patient Fights Monsanto's Philadelphia Roundup Win
A cancer patient alleging that he developed his illness after using the weed killer Roundup wants to overturn Bayer AG unit Monsanto's first win in Philadelphia's Roundup mass tort, arguing that the judge's erroneous evidentiary rulings caused him to lose the case.
Expert Analysis
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ITC Ban On Apple Watch Could Still Be Reversed
The U.S. International Trade Commission's recent final decision that the Apple Watch infringed two patents owned by Masimo Corp. was a rare instance of a popular consumer product being hit with an absolute importation ban, but it's possible that President Joe Biden could assert his power to reverse the ITC decision, says Benjamin Horton at Marshall Gerstein.
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A Closer Look At Proposed HHS Research Misconduct Rule
The U.S. Department of Health and Human Services' proposed updates to its policies on research misconduct codify many well-known best practices, but also contain some potential surprises for the research community and counsel, say attorneys at Hogan Lovells.
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Incontinence Drug Ruling Offers Key Patent Drafting Lessons
In a long-awaited decision in Astellas v. Teva and Sandoz, an English court found that the patent for a drug used to treat overactive bladder syndrome had not been infringed, highlighting the interaction between patent drafting and litigation strategy, and why claim infringement is as important a consideration as validity, says George McCubbin at Herbert Smith.
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Why Hemp-Synthesized Intoxicants Need Uniform Regs
State laws regulating hemp-synthesized intoxicants are a patchwork with little consistency between any given state, and without the adoption of a uniform regulatory framework, producers and consumers alike will need to be very cautious, say Dylan Anderson and Seth Goldberg at Duane Morris.
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Opinion
Life Sciences Regulators Must Write Cloud-Specific Guidance
As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.
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Fed. Circ. Elekta Holding May Make Patent Prosecution Harder
The Federal Circuit's recent analysis of obviousness in its Elekta v. Zap Surgical Systems decision will make prosecuting patents harder, as parties will now need to consider whether to argue that cited patents are nonanalogous, say Sean Murray and Jeremiah Helm of Knobbe Martens.
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Attorneys, Law Schools Must Adapt To New Era Of Evidence
Technological advancements mean more direct evidence is being created than ever before, and attorneys as well as law schools must modify their methods to account for new challenges in how this evidence is collected and used to try cases, says Reuben Guttman at Guttman Buschner.
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Series
ESG Around The World: The UK
Following Brexit, the U.K. has adopted a different approach to regulating environmental, social and governance factors from the European Union — an approach that focuses on climate disclosures by U.K.-regulated entities, while steering clear of the more ambitious objectives pursued by the EU, say attorneys at Dechert.
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Boeing Opinion Strikes Blow Against Overpayment Theory
The Fifth Circuit's decision in Earl v. Boeing Co. casts doubt on consumers' standing to bring claims of overpayment for products later revealed to have defects — and suggests that it's more likely that those products would have been removed from the market, driving up the price of alternatives, say attorneys at Bush Seyferth.
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Tips For Litigating Against Pro Se Parties In Complex Disputes
Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.
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What Pharma Cos. Must Know About FDA Off-Label Guidance
The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.
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It's Time To Prescribe Frameworks For AI-Driven Health Care
As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.
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The Murky World Of IP Protection For Gene-Edited Plants
The recently filed Corteva v. Inari lawsuit, which accuses a plant trait developer of using a front company for commercial development, underscores the legal challenges in protecting and determining the ownership of new, genetically edited plant varieties, and emphasizes why joint development arrangements must be carefully navigated, say Andrew Zappia and Tate Tischner at Troutman Pepper.
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New Initiatives Will Advance Corporate Biodiversity Reporting
Two important recent developments — the launch of the Taskforce on Nature-related Financial Disclosures' framework on nature and biodiversity reporting, and Nature Action 100's announcement of the 100 companies it plans to engage on biodiversity issues — will help bring biodiversity disclosures into the mainstream, say David Woodcock and Maria Banda at Gibson Dunn.
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Opinion
Alternative Patents Would Solve Many Inventor Woes
A fundamental reform that gives inventors the option of alternative patents tailored to the value of an invention offers a potential solution for resolving patent-system problems, says John Powers of The Powers IP Law Firm.