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Life Sciences
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May 20, 2024
USPTO Clarifies Means-Plus-Function Claims For Antibodies
The U.S. Patent and Trademark Office's new Appeals Review Panel clarified the use of means-plus-function claiming when patenting antibodies, while continuing to reject claims of a Xencor Inc. patent application related to treating autoimmune diseases.
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May 20, 2024
McKinsey Can't Nix Pregnant Women's Claims In Opioid MDL
A California federal judge has cut some claims from multidistrict litigation seeking to hold McKinsey & Co. Inc. liable for infant neonatal abstinence syndrome caused by pregnant women's use of opioids, trimming fraud and nuisance-based claims, but allowing conspiracy and aiding-and-abetting claims to proceed against the consulting firm.
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May 20, 2024
Judge Tosses Acuitas' COVID Biotech IP Suit
A New Jersey federal judge on Monday threw out a lawsuit from a maker of a component of a COVID-19 vaccine relating to patent infringement litigation brought by two other companies against Pfizer and BioNTech.
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May 20, 2024
Local Governments Seek Sanctions For PBMs In Opioid MDL
Four municipalities are asking an Ohio federal court overseeing the national opioid litigation to sanction pharmacy benefit managers Express Scripts Inc. and OptumRX Inc., saying they've willfully defied the court's order to provide complete responses to discovery requests.
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May 20, 2024
iRhythm Brass Face Suit Over FDA's Heart Monitor Inquiry
Several current and former directors and executives of medical technology company iRhythm are named in a shareholder derivative suit alleging they failed to disclose an inquiry by the Food and Drug Administration that found iRhythm's heavily touted and high-cost real-time heart monitoring device failed to meet the company's claims.
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May 20, 2024
J&J Says Beasley Allen Looking To 'Bias' Vote On $6.5B Plan
Johnson & Johnson's bankrupt talc unit accused the Beasley Allen Law Firm of attempting to intentionally "bias" the vote against its recently announced proposal to pay out $6.5 billion in a prepackaged reorganization plan to resolve claims that its talc-based baby powder causes ovarian cancer.
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May 20, 2024
Latham Hires 2 Skadden Healthcare Partners In DC
Latham & Watkins LLP has picked up two healthcare and life sciences partners from Skadden Arps Slate Meagher & Flom LLP in Washington, D.C., the firm announced Monday.
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May 20, 2024
Catching Up With Delaware's Chancery Court
Delaware was full of drama last week, as proposed changes to the state's corporate law statutes raised eyebrows and a professor's friend-of-the-court brief sparked a very unfriendly public exchange. Delaware's court of equity banged the gavel on pipeline and social media disputes, and shareholders filed new suits alleging insider trading, vote bungling, unfair stock buybacks and merger shenanigans. In case you missed any of it, here's the recap of all the top news last week from Delaware's Chancery Court.
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May 20, 2024
Ga. Judge OKs $5M Atty Fees In $41M Acella Thyroid Deal
A Georgia federal judge has signed off on a nearly $41.5 million class action settlement with Acella Pharmaceuticals LLC over faulty thyroid medication, while awarding the class attorneys another $5 million in legal fees courtesy of the pharma company.
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May 20, 2024
Moderna Fends Off Pfizer's MRNA Patent Challenge
Moderna has successfully defended a key patent underpinning its COVID-19 vaccine, after rivals Pfizer and BioNTech attempted to convince the European Patent Office that the IP protections should be nixed.
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May 20, 2024
Shah Ends Novavax Proxy Fight Following Sanofi Deal
Hedge fund Shah Capital Management Inc. told fellow Novavax Inc. shareholders Monday that it is ending its fight to remove certain members of the biotech company's board, citing its favorable view of Novavax's licensing deal with Sanofi earlier this month.
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May 17, 2024
VA Deal Winner Says Protest Not Based On Common Sense
The winner of a U.S. Department of Veterans Affairs mail-order pharmacy deal urged the U.S. Court of Federal Claims to toss a competitor's protest of the award, saying the protester's challenge was based on an incorrect reading of applicable regulations.
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May 17, 2024
Allergan Says Deserted Drug Rule Weakens $680M Fraud Suit
Allergan drew a Maryland federal court's attention to the Centers for Medicare & Medicaid Services' abandonment of a regulation clarifying drug pricing, arguing the move undermined a whistleblower's claims that it overcharged Medicaid by over $680 million.
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May 17, 2024
Patent Office Gets Another Earful About 'March-In' Plan
Industry groups of all stripes have lined up at the U.S. Patent and Trademark Office to complain yet again about a Biden administration proposal from last year to potentially use "march-in" rights and seize pharmaceutical patents using the Bayh-Dole Act.
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May 17, 2024
Pfizer Unit Wins $107.5M Patent Verdict Against AstraZeneca
A Delaware federal jury on Friday said that AstraZeneca Pharmaceuticals LP should pay $107.5 million in royalty damages for infringing a Pfizer-brand cancer treatment patent, although a final decision won't be issued until after a bench trial on some of AstraZeneca's additional defenses.
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May 17, 2024
FCA Relators Seek Finders Fee For SpineFrontier Doc Deals
Three whistleblowers who tipped off the federal government to a medical device company's multimillion-dollar kickback scheme said Friday the Justice Department is refusing to pay them a cut of the $3 million in False Claims Act settlements paid by surgeons who admitted participating in the sham consulting ploy.
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May 17, 2024
Judge Won't Bar Thermo Fisher Exec's Jump To Repligen
A Massachusetts judge won't block a former Thermo Fisher Scientific executive from jumping to smaller rival Repligen, calling a noncompete agreement signed by the employee overbroad and suggesting that it was really aimed at stifling competition in a ruling released Friday.
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May 17, 2024
EndoStim Emerges From Delaware Insolvency Proceeding
Delaware's Court of Chancery has approved the final accounting for medical device company EndoStim Inc.'s state-administered insolvency proceeding after no creditor or other party raised any objections at a final hearing on Friday.
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May 17, 2024
Industry Emboldened After Justices Galvanize Agency Attacks
In the year since the U.S. Supreme Court said "extraordinary" and "far-reaching" attacks on administrative enforcers can skip agency tribunals and go straight to federal district court, ambitious challenges to regulatory powers are rapidly gaining traction, and the high court is poised to put them on an even firmer footing.
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May 17, 2024
Texas Justices Let Fen-Phen Atty Malpractice Fight Roll On
The Texas Supreme Court ruled Friday that roughly 4,000 former clients of a Houston mass tort lawyer can continue pressing their claims that the lawyer improperly kept millions of dollars in fen-phen diet drug settlement money.
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May 17, 2024
Winston & Strawn Leads Asia-Focused SPAC $100M IPO
Shares of RF Acquisition II, a special-purpose acquisition company targeting the technology sector in Asia, began trading publicly on Friday following the company's $100 million initial public offering.
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May 17, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen a wave of claims filed against Verity Trustees Ltd., Harley-Davidson hit retailer Next with an intellectual property claim, Turkish e-commerce entrepreneur Demet Mutlu sue her ex-husband and Trendyol co-founder Evren Üçok and the Solicitors Regulation Authority file a claim against the former boss of collapsed law firm Axiom. Here, Law360 looks at these and other new claims in the U.K.
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May 16, 2024
Ointment Scheme Conned Gov't Out Of Millions, Fla. Suit Says
Two Florida brothers and one of their former employees are accused of running a years-long fraudulent scheme billing government healthcare programs and receiving millions of dollars after paying kickbacks to generate prescriptions for ointments that were not needed, according to a False Claims Act lawsuit.
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May 16, 2024
3rd Circ. Shuns Teva's 'Novel' Appeal On Israeli Investor Class
The Third Circuit on Thursday turned away an appeal brought by Teva Pharmaceutical Industries Ltd., saying the class certification stage was not the right time to hear arguments over the "novel" question of the applicability of U.S. securities laws to Israeli-listed shares.
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May 16, 2024
FTC Deputy Director Rao On Healthcare Antitrust Agenda
The reason behind the Federal Trade Commission's changed attitude toward antitrust in healthcare in recent years isn't simple, according to Rahul Rao, deputy director of the FTC's Bureau of Competition.
Expert Analysis
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Calif. Verdict Showcases SEC's New 'Shadow Trading' Theory
Last week's insider trading verdict, delivered against biopharmaceutical executive Matthew Panuwat by a California federal jury, signals open season on a new area of regulatory enforcement enabled by the U.S. Securities and Exchange Commission's shadow trading theory, say Perrie Weiner and Aaron Goodman at Baker McKenzie.
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Series
Playing Hockey Makes Me A Better Lawyer
Nearly a lifetime of playing hockey taught me the importance of avoiding burnout in all aspects of life, and the game ultimately ended up providing me with the balance I needed to maintain success in my legal career, says John Riccione at Taft.
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For Lawyers, Pessimism Should Be A Job Skill, Not A Life Skill
A pessimistic mindset allows attorneys to be effective advocates for their clients, but it can come with serious costs for their personal well-being, so it’s crucial to exercise strategies that produce flexible optimism and connect lawyers with their core values, says Krista Larson at Stinson.
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HHS Opioid Rule Generally Benefits Providers And Patients
The U.S. Department of Health and Human Services' newly effective rule, the first substantial change to opioid treatment programs and delivery standards in over 20 years, significantly expands access and reduces stigma around certain medications, though the rule is narrow in scope and does have some limitations, say attorneys at Alston & Bird.
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Trump's NY Civil Fraud Trial Spotlights Long-Criticized Law
A New York court’s recent decision holding former President Donald Trump liable for fraud brought old criticisms of the state law used against him back into the limelight — including its strikingly broad scope and its major departures from the traditional elements of common law fraud, say Mark Kelley and Lois Ahn at MoloLamken.
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Opinion
Requiring Leave To File Amicus Briefs Is A Bad Idea
A proposal to amend the Federal Rules of Appellate Procedure that would require parties to get court permission before filing federal amicus briefs would eliminate the long-standing practice of consent filing and thereby make the process less open and democratic, says Lawrence Ebner at the Atlantic Legal Foundation and DRI Center.
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2 Recent Suits Show Resiliency Of Medicare Drug Price Law
Though pharmaceutical companies continue to file lawsuits challenging the Inflation Reduction Act, which enables the federal government to negotiate for lower prescription drug prices, recent decisions suggest that the reduced drug prices are likely here to stay, says Jose Vela Jr. at Clark Hill.
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4 Ways To Motivate Junior Attorneys To Bring Their Best
As Gen Z and younger millennial attorneys increasingly express dissatisfaction with their work and head for the exits, the lawyers who manage them must understand and attend to their needs and priorities to boost engagement and increase retention, says Stacey Schwartz at Katten.
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Defense Attys Must Prep For Imminent AI Crime Enforcement
Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.
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Planning For Healthcare-Private Equity Antitrust Enforcement
U.S. antitrust agency developments could mean potential enforcement actions on healthcare-related acquisitions by private equity funds are on the way, and entities operating in this space should follow a series of practice tips, including early assessment of antitrust risks on both the state and federal level, say Ryan Quillian and John Kendrick at Covington.
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Opinion
Why USPTO Should Issue Inherency Guidance Memo
The U.S. Patent and Trademark Office should issue a new guidance memo in regard to the standard for inherency during the examination process, as the standard is frequently misapplied during prosecution, and consistency of the standard in the USPTO should match that in the federal courts, says Irving Feit at Lucas & Mercanti.
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How Purdue Pharma High Court Case May Change Bankruptcy
The U.S. Supreme Court’s upcoming ruling in Purdue Pharma may be the death of most third-party releases in Chapter 11 cases, and depending on the decision’s breadth, could have much more far-reaching effects on the entire bankruptcy system, say Brian Shaw and David Doyle at Cozen O'Connor.
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3 Health Insurance Paths For Psychedelic-Assisted Therapy
Ahead of potential U.S. Food and Drug Administration approvals for psychedelics as insured treatments, attorneys at Husch Blackwell review pathways for these drugs to achieve coverage as treatments for complex mental health conditions.
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Series
Serving As A Sheriff's Deputy Made Me A Better Lawyer
Skills developed during my work as a reserve deputy — where there was a need to always be prepared, decisive and articulate — transferred to my practice as an intellectual property litigator, and my experience taught me that clients often appreciate and relate to the desire to participate in extracurricular activities, says Michael Friedland at Friedland Cianfrani.
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Fears About The End Of Chevron Deference Are Overblown
While some are concerned about repercussions if the U.S. Supreme Court brings an end to Chevron deference in the Loper and Relentless cases this term, agencies and attorneys would survive just fine under the doctrines that have already begun to replace it, say Daniel Wolff and Henry Leung at Crowell & Moring.