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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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Valeant Ruling May Pave Way For Patent-Based FCA Suits
The Ninth Circuit’s recent ruling in Silbersher v. Valeant marks a significant development in False Claims Act jurisprudence, opens new avenues for litigation and potentially raises the stakes for patent applicants who intend to do business with the government, say Joshua Robbins and Rick Taché at Buchalter.
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Opinion
Suits Against Insulin Pricing Are Driven By Rebate Addiction
A growing wave of lawsuits filed by states, cities and counties against insulin manufacturers and pharmacy benefit managers improperly allocate the blame for rising insulin costs, when in actuality the plaintiffs are partially responsible, says Dan Leonard at Granite Capitol Consulting.
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Lessons For D&O Policyholders From Pharma Co. Ruling
A California federal court's recent decision in AmTrust v. 180 Life Sciences, requiring insurers to advance defense costs for a potentially covered claim, provides a valuable road map for directors and officers insurance policyholders, rebutting the common presumption that a D&O insurer's duty to advance costs is more limited than under other policies, say attorneys at Pasich.
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How Firms Can Ensure Associate Gender Parity Lasts
Among associates, women now outnumber men for the first time, but progress toward gender equality at the top of the legal profession remains glacially slow, and firms must implement time-tested solutions to ensure associates’ gender parity lasts throughout their careers, say Kelly Culhane and Nicole Joseph at Culhane Meadows.
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7 Common Myths About Lateral Partner Moves
As lateral recruiting remains a key factor for law firm growth, partners considering a lateral move should be aware of a few commonly held myths — some of which contain a kernel of truth, and some of which are flat out wrong, says Dave Maurer at Major Lindsey.
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Series
Cheering In The NFL Makes Me A Better Lawyer
Balancing my time between a BigLaw career and my role as an NFL cheerleader has taught me that pursuing your passions outside of work is not a distraction, but rather an opportunity to harness important skills that can positively affect how you approach work and view success in your career, says Rachel Schuster at Sheppard Mullin.
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Args In APA Case Amplify Justices' Focus On Agency Power
In arguments last week in Corner Post v. Federal Reserve, the U.S. Supreme Court justices paid particular importance to the possible ripple effects of their decision, which will address when a facial challenge to long-standing federal rules under the Administrative Procedure Act first accrues and could thus unleash a flood of new lawsuits, say attorneys at Snell & Wilmer.
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Series
ESG Around The World: Gulf Cooperation Council
The Gulf Cooperation Council is in the early stages of ESG policy implementation, but recent commitments by both states and corporations — including increases in sustainable finance transactions, environmental commitments, female representation on boards and human rights enforcement — show continuing progress toward broader ESG goals, say attorneys at Cleary.
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Opinion
J&J Bankruptcy Could Thwart Accountability For Victims
Johnson & Johnson's latest attempt at a "Texas Two-Step" bankruptcy proceeding exemplifies the way in which corporate defendants can use bankruptcy to evade accountability, limit resources available to victims, and impose flawed, one-size-fits-all resolutions on diverse groups of plaintiffs, says Michelle Simpson Tuegel at Simpson Tuegel Law.
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Inside The PTAB's Seagen Cancer Drug Patent Decision
The Patent Trial and Appeal Board's recent finding that Seagen's claims for antibody-drug conjugate technology were unpatentable — for lack of enablement, lack of written description and anticipation — mark the latest chapter in the complex patent dispute as the case heads for director review, says Ryan Hagglund at Loeb & Loeb.
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6 Pointers For Attys To Build Trust, Credibility On Social Media
In an era of information overload, attorneys can use social media strategically — from making infographics to leveraging targeted advertising — to cut through the noise and establish a reputation among current and potential clients, says Marly Broudie at SocialEyes Communications.
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Opinion
Biden Admin's March-In Plan Would Hurt Medical Innovation
The Biden administration's proposal to reinterpret the Bayh-Dole Act and allow the government to claw back patents when it determines that a commercialized product's price is too high would discourage private investment in important research and development, says Ken Thorpe at the Rollins School of Public Health.
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A Post-Mortem Analysis Of Stroock's Demise
After the dissolution of 147-year-old firm Stroock late last year shook up the legal world, a post-mortem analysis of the data reveals a long list of warning signs preceding the firm’s collapse — and provides some insight into how other firms might avoid the same disastrous fate, says Craig Savitzky at Leopard Solutions.
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What's On The Horizon In Attorney General Enforcement
A look at recent attorney general actions, especially in the areas of antitrust and artificial intelligence, can help inform businesses on what they should expect in terms of enforcement trends as 10 attorney general races play out in 2024, say attorneys at Cozen O'Connor.
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Preparing For DOJ's Data Analytics Push In FCPA Cases
After the U.S. Department of Justice’s recent announcement that it will leverage data analytics in Foreign Corrupt Practice Act investigations and prosecutions, companies will need to develop a compliance strategy that likewise implements data analytics to get ahead of enforcement risks, say attorneys at Cozen O'Connor.