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Life Sciences
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April 25, 2024
Astellas Can't Block Generic Myrbetriq Amid Patent Suit
A Delaware federal judge has shot down Astellas Pharma's request to issue an injunction blocking rival pharmaceutical companies from selling generic copies of the overactive bladder medication Myrbetriq as they hash out a patent infringement suit, agreeing with a magistrate judge that Astellas isn't likely to win its case.
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April 25, 2024
CureVac, Acuitas Reach Deal In COVID Vax Patent Dispute
CureVac SE told a Virginia federal judge Thursday that it has reached a settlement to resolve Acuitas Therapeutics Inc.'s lawsuit inventorship credit on patents related to lipid nanoparticle technology used to develop the blockbuster Pfizer and BioNTech COVID-19 vaccine.
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April 25, 2024
GSK Hits Pfizer And BioNTech With COVID Vaccine Patent Suit
GlaxoSmithKline alleged in a suit filed Thursday in Delaware federal court that the COVID-19 vaccines made by Pfizer and BioNTech infringe five of its patents on mRNA technology, the latest in a series of lawsuits over the vaccines that have generated tens of billions of dollars in revenue.
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April 25, 2024
Stryker Says Sanctions Bid Goes 'Galaxies Beyond' Law
Medical device maker Stryker urged a Colorado federal judge to reject an ex-distributor's latest request for sanctions, arguing in a brief that the distributor's $2.2 million bid goes "galaxies beyond" what it asked for at trial and what the Tenth Circuit said the court could entertain.
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April 25, 2024
3rd Circ. Lets Mallinckrodt Off Sanofi's Royalty Hook
A Third Circuit panel said Thursday that Mallinckrodt PLC's Chapter 11 bankruptcy could sever its obligation to pay Sanofi-Aventis US LLC royalties on sales of an autoimmune disease drug, finding that Sanofi's contract to sell Mallinckrodt the rights to the drug created a claim ripe to be extinguished.
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April 25, 2024
Becton BIPA Suit Gets Cut Short Under Health Exception
An Illinois federal judge permanently tossed a Chicago health worker's biometric privacy claims targeting Becton Dickinson and Co.'s drug dispensing cabinets, saying his arguments for putting distance between his case and foreclosing precedent "border on the frivolous."
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April 25, 2024
Philips Gets $506M Economic Loss Deal OK'd In CPAP MDL
A Pennsylvania federal judge on Thursday gave final approval to a $506.3 million settlement to end economic loss claims in multidistrict litigation over Philips' recalled CPAP breathing machines, including $94.4 million for the plaintiffs' attorneys.
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April 25, 2024
NC Hospital Leader Condemns FTC's Merger Block Bid
The chief of staff for a North Carolina hospital in the midst of a merger battle ripped the care facility's current owners Thursday in a show of support for new ownership, pleading for federal antitrust regulators to get out of the way lest they usher in "a year long death marked by suffering" for the hospital.
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April 25, 2024
Ex-Burns & Levinson Life Sciences Chair Joins Polsinelli
Polsinelli PC announced that the former life sciences co-chair at New England firm Burns & Levinson LLP has joined its Boston office as a shareholder.
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April 25, 2024
Conn. Judge In Drug Price-Fixing Suit Reveals Day Pitney Ties
U.S. District Judge Michael P. Shea of the District of Connecticut said Thursday he will not recuse himself from overseeing state enforcers' price-fixing claims against Sandoz Inc. and other drug companies despite Sandoz's attorneys being from Day Pitney LLP, where he was once a partner.
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April 25, 2024
Class Counsel Seeks $31M From $93M Lipitor Settlement
Attorneys representing a class of buyers in antitrust litigation against Pfizer over the cholesterol medication Lipitor have asked a New Jersey federal judge to approve their request for $31 million in fees after the two sides agreed to a $93 million settlement in February.
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April 25, 2024
Wachtell Steers Perrigo In €275M Unit Sale To Pharma Biz
Healthcare company Perrigo said Thursday that it has agreed to sell its pharmaceutical division for rare diseases to pharmaceutical company Esteve Healthcare SL for €275 million ($295 million) in a deal guided by Wachtell Lipton Rosen & Katz and Clifford Chance LLP.
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April 24, 2024
Motley Rice, Morgan & Morgan Among Ozempic MDL Leaders
The Pennsylvania federal judge overseeing multidistrict litigation over alleged risks associated with Ozempic and similar drugs has appointed lawyers from Motley Rice LLC, Morgan & Morgan PA and six other firms to leadership roles, according to an order issued Tuesday.
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April 24, 2024
DEA's Upcoming Decision On Cannabis Likely To Be Litigated
The potential loosening of federal restrictions on marijuana is likely to be litigated for years, and the pro-legalization camp would do well to pool resources to build the most persuasive evidentiary record it can, a leading cannabis advocate said Wednesday.
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April 24, 2024
UPMC Affiliate Can't Avoid False Claims Suit Over NIH Grant
A research foundation affiliated with a University of Pittsburgh Medical Center hospital can't duck a former employee's claims that the foundation mishandled grant money and fired her for raising concerns, though UPMC itself is off the hook, a federal judge ruled Wednesday.
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April 24, 2024
NGM Biopharma Investor Seeks Stock Appraisal In Del.
An NGM Biopharmaceuticals Inc. stockholder has sued for court appraisal of his stock in Delaware's Court of Chancery after the company closed on a $1.55 per share cash tender offer with an affiliate of venture fund The Column Group on Feb. 25.
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April 24, 2024
FDA Can Keep Most Docs Hidden From Juul's FOIA Request
A District of Columbia federal judge has largely sided with the U.S. Food and Drug Administration in a suit by Juul Labs Inc. seeking documents related to the FDA's decision to ban its products, saying the bulk of the files fall under a privilege that protects predecision deliberations.
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April 24, 2024
Joe Rogan Brain Health Supplements Don't Work, Suit Claims
A proposed class of supplement buyers is suing a brain health supplement founded and promoted by podcaster Joe Rogan in New York federal court, saying the company's own studies prove false its advertisements claiming the product is "clinically" proven to promote cognitive function.
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April 24, 2024
Private Equity Lag Continues To Stunt M&A Growth
Large leveraged buyout activity remained muted in the first quarter as the refinancing of old private equity loans took precedence over new loans, contributing to a slower-than-anticipated rebound in overall mergers and acquisitions, according to a new report from data provider PitchBook.
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April 23, 2024
Calif. Fertility Clinic Implanted Dead Embryos, Couples Say
An Orange County, California, fertility clinic accidentally destroyed embryos but still implanted them into patients in an attempt to cover up its mistakes, nine couples said in a suit filed Tuesday in Golden State court.
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April 23, 2024
Medtronic Patent Fight With Axonics Set For September Trial
A California federal judge has lifted a stay in Medtronic's patent infringement suit against Axonics over an electrical stimulation system, while also scheduling a trial for September.
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April 23, 2024
GoodRx Hid Revenue Reliance On Kroger, Suit Claims
GoodRx Holdings Inc. has been hit with a proposed class action alleging it concealed from investors the indispensability of its relationship with Kroger, leading to share declines when GoodRx announced revenue would be severely impacted because the grocery chain would no longer be accepting its discount codes.
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April 23, 2024
Israeli Biotech Files Ch. 15 To Implement Take-Private Deal
Gamida Cell Ltd., an Israeli biotechnology company developing immunotherapy products, filed for Chapter 15 protection Monday in Delaware seeking the American court's approval of its foreign take-private proposal with unsecured lenders.
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April 23, 2024
Ex-Takeda Worker, Boyfriend To Plead Guilty In Invoice Scam
A former Takeda Pharmaceutical Co. employee and her boyfriend plan to plead guilty to a $2.3 million phony invoice scheme, their lawyers told a Massachusetts federal judge on Tuesday.
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April 23, 2024
Drugmakers Hit With RICO Suit Over Insulin Price Hikes
The world's three largest insulin manufacturers engineered an enormous increase in the price of the lifesaving diabetes medication through an "unfair and deceptive conspiracy" with household-name pharmacies, letting all involved reap extraordinary profits for 20 years, according to a lawsuit in Connecticut federal court.
Expert Analysis
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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.
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4 Legal Ethics Considerations For The New Year
As attorneys and clients reset for a new year, now is a good time to take a step back and review some core ethical issues that attorneys should keep front of mind in 2024, including approaching generative artificial intelligence with caution and care, and avoiding pitfalls in outside counsel guidelines, say attorneys at HWG.
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FTC Rite Aid Order Holds Biometrics And AI Compliance Tips
The Federal Trade Commission's recent enforcement action against Rite Aid over its use of facial biometric technology on customers provides lessons that can be leveraged to reduce and manage the risk of regulatory scrutiny of biometrics and artificial intelligence, says David Oberly at Baker Donelson.
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Bribery Settlement Gives Insight On DOJ Policies
Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.
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SEC Case May Expand Scope Of Insider Trading Liability
The U.S. Securities and Exchange Commission's first-of-its-kind enforcement action against an individual in a case involving "shadow trading" demarcates an expansion of insider trading liability to circumstances in which there is a market connection between the source of information and the issuer of the securities traded, say attorneys at Steptoe.
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Opinion
Waiving COVID-19 IP Protections Would Harm US Industry
President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.
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Fed. Circ. Patent Decisions In 2023: An Empirical Review
The Federal Circuit decided 306 patent cases last year, which is still well down from the pre-pandemic norm of around 440, and on the whole the court's decisions were markedly less patentee-friendly in 2023 than in 2022, says Dan Bagatell at Perkins Coie.
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What The Law Firm Of The Future Will Look Like
As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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4 PR Pointers When Your Case Is In The News
Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.