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Life Sciences
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March 21, 2024
Teleflex Catheter Patent Makes It Through Fed. Circ.
The Federal Circuit on Thursday opted to leave untouched an administrative patent board ruling that rejected a legal effort to invalidate a patent covering a type of catheter that's sold by Teleflex.
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March 21, 2024
Woman Lost Independence Due To Strattice Mesh, Jurors Told
A Kentucky woman told New Jersey state jurors on Thursday that LifeCell skipped important safety steps while designing its Strattice surgical mesh, and that those skipped steps caused a hernia to reoccur and ultimately resulted in the loss of her independence.
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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.
Expert Analysis
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Series
Playing In A Rock Cover Band Makes Me A Better Lawyer
Performing in a classic rock cover band has driven me to hone several skills — including focus, organization and networking — that have benefited my professional development, demonstrating that taking time to follow your muse outside of work can be a boon to your career, says Michael Gambro at Cadwalader.
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AI May Help Patent Applicants With Functional Claiming
The U.S. Supreme Court recently set what many patent practitioners consider too high a bar for functional claims, but artificial intelligence could alter functionality analysis — conferring predictability that alleviates courts' concerns that practicing the claims requires undue experimentation, say Brian Nolan and Ying-Zi Yang at Mayer Brown.
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How Int'l Regulatory Collabs Can Expedite Pharma Approvals
Recent announcements highlight the growing importance of international regulatory collaboration for drug approval, which can greatly streamline the process for companies seeking to market their drugs in other countries, say Geneviève Michaux and Christina Markus at King & Spalding.
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How Executives' Deposition Standards Can Differ
The recent Trustees of Purdue University v. Wolfspeed Inc. decision granting a motion on a protective order for a high-level witness shows how courts can vary in the application of the apex doctrine and analysis under Rule 26 of the Federal Rule of Civil Procedure, say Genevieve Halpenny and John Cook at Barclay Damon.
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Series
The Pop Culture Docket: Judge Espinosa On 'Lincoln Lawyer'
The murder trials in Netflix’s “The Lincoln Lawyer” illustrate the stark contrast between the ethical high ground that fosters and maintains the criminal justice system's integrity, and the ethical abyss that can undermine it, with an important reminder for all legal practitioners, say Judge Adam Espinosa and Andrew Howard at the Colorado 2nd Judicial District Court.
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Calif. GHG Disclosure Law Will Affect Companies Worldwide
California's Climate Corporate Data Accountability Act, which will require comprehensive greenhouse gas emissions disclosures from large companies operating in the state, will mean compliance challenges for a wide range of industries, nationally and globally, as the law's requirements will ultimately trickle out and down, say attorneys at Brownstein Hyatt.
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Questions Linger After FDA's Lab-Developed Tests Proposal
The U.S. Food and Drug Administration's recently proposed rule regarding its plan to regulate lab-developed tests is light on details, leaving many fundamental questions about the agency's authority and ability to execute its plans, say attorneys at Covington.
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Lessons For Biosimilar And Biologic Antitrust Litigation
Aaron Marks at Cohen Milstein considers emerging ways in which biosimilar markets differ from traditional small-molecule drug markets, and recommends how pharmaceutical antitrust litigators can account for these market dynamics in biosimilar-delay cases.
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Balancing Justice And Accountability In Opioid Bankruptcies
As Rite Aid joins other pharmaceutical companies in pursuing bankruptcy following the onslaught of state and federal litigation related to the opioid epidemic, courts and the country will have to reconcile the ideals of economic justice and accountability against the U.S. Constitution’s promise of a fresh start through bankruptcy, says Monique Hayes at DGIM Law.
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How To Navigate The FTC's New Private Equity Frontier
The Federal Trade Commission's recent district court complaint against an anesthesia firm and its private equity partner tests key bounds of the agency's stand-alone authority, and defense strategies can include challenges to both the geographic and the service market fronts, say attorneys at Baker McKenzie.
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Opinion
Newman Suspension Shows Need For Judicial Reform
The recent suspension of U.S. Circuit Judge Pauline Newman following her alleged refusal to participate in a disability inquiry reveals the need for judicial misconduct reforms to ensure that judges step down when they can no longer serve effectively, says Aliza Shatzman at The Legal Accountability Project.
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An Overview Of Congress' Proposed Drug Shortage Solutions
Recently, Congress has seen a number of bipartisan bills that seek to prevent and respond to national drug shortages, though disagreements over the right vehicle and timeline have slowed progress, says Miranda Franco at Holland & Knight.
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Considerations And Calculations For DOJ Clawback Program
The U.S. Department of Justice’s clawback pilot program announced earlier this year presents numerous questions for businesses, and both hypothetical and recent real-world examples capture how companies’ cost-benefit analyses about whether to claw back compensation in exchange for penalty reductions may differ, say Yogesh Bahl and Jonathan Hecht at Resolution Economics.
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SEC's Life Sciences Actions Utilize Novel Tools And Theories
Recent enforcement actions show that the U.S. Securities and Exchange Commission is employing new forms of data analytics and noteworthy applications of insider trading laws in its scrutiny of fraud within the life sciences and health industries, say Edward Imperatore and Jina Choi at MoFo.
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What Case Trends Reveal About Life Sciences Results At ITC
A look at recent U.S. International Trade Commission case data shows that pharmaceuticals, medical devices and other life sciences products constitute a growing share of the technologies involved in Section 337 investigations, with overwhelmingly positive results for companies seeking to protect their IP rights from foreign competitors, say Brian Busey and Daniel Muino at MoFo.