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Life Sciences
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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.
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May 16, 2024
NJ Judge Scrutinizes J&J Unit's Libel Claim Over Talc Study
A bankrupt Johnson & Johnson unit's libel claims over a scientific article linking talcum powder to mesothelioma intrigued a New Jersey federal judge during an oral argument on Thursday, prompting her to muse that the author's consideration of other exposures seemed to bolster the study at issue.
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May 16, 2024
IQVIA To Pay $3.5M To Resolve Ex-Workers' 401(k) Suit
Healthcare technology company IQVIA agreed to pay $3.5 million to end a 9,000-member class action accusing it of choosing investments that consistently underperformed and had excessive risk and expense for its $1.13 billion 401(k) plan, a filing in North Carolina federal court said.
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May 16, 2024
Ex-Pharma Exec Cops To Contempt For Barred Finance Work
A Boston federal judge on Thursday accepted a former pharmaceutical company executive's guilty plea to a criminal contempt charge for using an alias to work on a finance venture despite a U.S. Securities and Exchange Commission ban.
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May 16, 2024
Gilead, Teva Want 17 HIV Drug Antitrust Appeals Consolidated
Gilead Sciences Inc. and Teva Pharmaceuticals are asking the Ninth Circuit to consolidate 17 appeals contesting their win in a case alleging they delayed generic versions of HIV medications, saying the three groups of buyers are raising largely the same issues but refuse to commit to combining their briefs.
Expert Analysis
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Notes Of Interest From 5th Circ. Illumina-Grail Merger Ruling
Attorneys at Simpson Thacher consider the Fifth Circuit's recent decision upholding the Federal Trade Commission's challenge of the Illumina merger with Grail, its much-needed boost to the Biden administration's antitrust agenda, and some silver linings the decision offers to merging parties.
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DOJ's Biopharma Settlement Raises Anti-Kickback Questions
In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.
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Where Justices Stand On Chevron Doctrine Post-Argument
Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.
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Precise Advance Notice Bylaws May Help Prevent Disputes
While the Chancery Court's December decision in Kellner v. AIM Immunotech shows that Delaware courts won't always uphold advance notice bylaws, and its willingness to selectively enforce or invalidate individual provisions doesn't create an incentive for companies to be surgical in their drafting, companies should nonetheless be precise when drafting such bylaws to avoid unnecessary disputes, say attorneys at Debevoise.
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Perspectives
6 Practice Pointers For Pro Bono Immigration Practice
An attorney taking on their first pro bono immigration matter may find the law and procedures beguiling, but understanding key deadlines, the significance of individual immigration judges' rules and specialized aspects of the practice can help avoid common missteps, says Steven Malm at Haynes Boone.
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Series
ESG Around The World: Canada
In Canada, multiple statutes, regulations, common law and industry guidance address environmental, social and governance considerations, with debate over ESG in the business realm potentially growing on the horizon, say attorneys at Blakes.
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5 Legal Considerations For Psychedelic Therapy Sector
With multiple developments signaling the rise of psychedelic-assisted psychotherapy, it is imperative that clinicians understand unique legal nuances ranging from corporate formation to specialized insurance coverage, say Kimberly Chew and Natasha Sumner at Husch Blackwell.
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Lessons From Country Singer's Personal Service Saga
Recent reports that country singer Luke Combs won a judgment against a Florida woman who didn’t receive notice of the counterfeit suit against her should serve as a reminder for attorneys on best practices for effectuating service by electronic means, say attorneys at Jenner & Block.
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A Potential Proactive Tool For Public-Private Joint Ventures
In the current environment of heightened antitrust enforcement, the National Cooperative Research and Production Act seems tailor-made for the collaborative work among competitors encouraged by the Biden administration's infrastructure and green energy funding legislation, say Jeetander Dulani and Susan Ebner at Stinson.
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Patent Prosecution Carries Consequences For Later Litigation
The Federal Circuit's recent Mylan v. Actelon holding, along with three other 2023 decisions, underscores the continued need for patent prosecutors to make note of potential claim construction issues that may arise in subsequent litigation, says Steven Wood at Hunton.
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10 Global Antitrust Trends To Anticipate In 2024
Proactive navigation of the antitrust enforcement environment remains crucial this year as legal policy and tools evolve to meet intensifying global economic complexity, including geopolitical tensions, trade realignment, market volatility and inflation, say attorneys at Freshfields.
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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.