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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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Global Cartel Enforcement Looks Set To Intensify In 2024
The cartel enforcement winds may strengthen this year, with the U.S. Department of Justice, as well as regulators in other countries, placing a renewed focus on pursuing international cartels and more traditional, hard-core cartel conduct, say attorneys at Simpson Thacher.
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Series
Baking Bread Makes Me A Better Lawyer
After many years practicing law, and a few years baking bread, I have learned that there are a few keys to success in both endeavors, including the assembly of a nourishing and resilient culture, and the ability to learn from failure and exercise patience, says Rick Robinson at Reed Smith.
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Supreme Court Amgen Ruling's Major Effect On Enablement
The U.S. Supreme Court's Amgen v. Sanofi invalidity holding continues to significantly affect technologies and all aspects of the patent system by providing confidence in the Federal Circuit's approach and a clearer understanding on enforceability and the disclosure needed for compliance, say Irena Royzman and Daniel Williams at Kramer Levin.
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Federal Courts And AI Standing Orders: Safety Or Overkill?
Several district court judges have issued standing orders regulating the use of artificial intelligence in their courts, but courts should consider following ordinary notice and comment procedures before implementing sweeping mandates that could be unnecessarily burdensome and counterproductive, say attorneys at Curtis.
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7 E-Discovery Predictions For 2024 And Beyond
The legal and technical issues of e-discovery now affect virtually every lawsuit, and in the year to come, practitioners can expect practices and policies to evolve in a number of ways, from the expanded use of relevancy redactions to mandated information security provisions in protective orders, say attorneys at Littler.
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Top Considerations For Retailers Using AI To Combat Theft
The Federal Trade Commission's recent enforcement action against Rite Aid indicates a significant evolution in the landscape surrounding biometric information and artificial intelligence data collection by retailers, meaning retailers should take reasonable measures to prevent harm to customers, say attorneys at Dentons.
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2 FCPA Settlements Illuminate Self-Disclosure, Disgorgement
Two of last year’s Foreign Corrupt Practices Act settlements — with biomedical company Lifecore and mining company Corsa Coal — suggest that the government will be much more flexible in negotiating disgorgement amounts if an entity voluntarily self-discloses misconduct, say Michael Gilbert and Lucas Amodio at Sheppard Mullin.
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Opinion
Anti-Kickback Statute Does Not Require But-For Causation
A proper interpretation of the Anti-Kickback Statute clearly indicates that but-for causation is not required for False Claims Act Liability, and courts that hold otherwise will make it significantly easier for fraudsters to avoid accountability, says Kenneth Capesius at Baron & Budd.
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5 Litigation Funding Trends To Note In 2024
Over the next year and beyond, litigation funding will continue to evolve in ways that affect attorneys and the larger litigation landscape, from the growth of a secondary market for funded claims, to rising interest rates restricting the availability of capital, says Jeffery Lula at GLS Capital.
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Medtronic's Cautionary Tale Of Fed. Circ. Word Limits
The Federal Circuit's ruling in Medtronic v. Teleflex that Medtronic waived an argument that it had sought to incorporate by reference illustrates the pitfalls facing parties in complex patent cases involving numerous issues that cannot all be addressed within the strict word limits for appellate briefs, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Key Legal Trends For Healthcare And Life Sciences In 2024
Due to the impact of contentious legal battles over drug pricing negotiations, the growing integration of artificial intelligence into drug development and manufacturing, and the publication of industry segment-specific guidance, the year ahead promises to be a dynamic period of changes and challenges, say Xin Tao and Lois Liu at Baker McKenzie.
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Series
ESG Around The World: South Africa
While South Africa has yet to mandate the reporting of nonfinancial and environmental, social, and corporate governance issues, policy documents and recent legislative developments are likely to have a material impact in the country's transition to a low-carbon economy and in meeting its international obligations, say Glynn Kent at Eversheds Sutherland.
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FOIA Exemption Questions On Redacted HHS Cannabis Letter
The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.
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Fed. Circ. Ruling Seemingly Offers PTAB Deadline Immunity
The Federal Circuit's recent Purdue Pharma v. Collegium Pharmaceutical Inc. decision that the Patent Trial and Appeal Board had authority to issue a final written decision in a post grant review after the prescribed statutory deadline underscores how courts should consider the overall objective of the statutory scheme when balancing the classic conflict between bright-line rules and flexible standards, says Matthew Dowd at Dowd Sheffel.
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Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal
In assessing whether a new Michigan law lifting drugmakers' blanket immunity from product liability suits will apply retroactively, there are four key factors that Michigan courts will likely consider, say Sherry Knutson and Brenda Sweet at Tucker Ellis.