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Life Sciences
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July 11, 2024
Patent Cases To Watch In The Second Half Of 2024
A U.S. Supreme Court case over the reach of the judicially created double patenting doctrine and a dispute over which patents branded drugmakers can list in a federal database are among the cases attorneys will have their eyes on for the rest of the year.
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July 10, 2024
Roundup Cancer Case Revived By Oregon Appellate Panel
An Oregon appellate panel on Wednesday revived a lawsuit claiming Bayer AG subsidiary Monsanto's weedkiller Roundup caused an Oregon man's cancer, saying the judge who oversaw the trial that cleared the company wrongly excluded testimony from an expert for the plaintiff.
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July 10, 2024
Drug Pricing, Overreach Dominate IP Disclaimer Feedback
The U.S. Patent and Trademark Office has received heated feedback regarding its proposal to make follow-on patents easier to invalidate, with drug pricing advocates applauding it, top technology and pharma companies decrying it, and high-profile officials calling the proposal an overstep of the agency's authority.
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July 10, 2024
Medical Imaging Co. Looking To Vacate 'Tainted' Award
A New York federal court has unsealed medical imaging company Molecular Dynamics Ltd.'s still-pending 2022 petition seeking to vacate an allegedly fraudulent arbitral award favoring its former partner in a project to develop cameras in the field of nuclear medicine, revealing more information about the dispute.
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July 10, 2024
GOP Bombards Agencies With Demands After Chevron's End
Republican leaders of major congressional committees Wednesday demanded details from dozens of agencies on policies suddenly shrouded in uncertainty after U.S. Supreme Court conservatives overturned the so-called Chevron doctrine, which for 40 years gave regulators flexibility in rulemaking and advantages in related litigation.
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July 10, 2024
Meijer Says Takeda Can't Force Antitrust Suit Into Arbitration
Meijer argued before a Massachusetts federal court that Takeda waited far too long to try to force the supermarket chain to arbitrate its proposed class action accusing the Japanese pharmaceutical company of conspiring to delay a generic version of its anti-constipation drug Amitiza.
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July 10, 2024
Skin Care Tech Co. Says Suit Shows 'Rough' Year, Not Fraud
Skin care and beauty technology company Cutera Inc. asked a federal judge to toss a shareholder lawsuit that alleged the company exaggerated its financial sustainability and hid compliance issues, saying the company's "rough" year does not establish securities fraud.
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July 10, 2024
Buyers Say Teva Had Multipart Scheme To Delay Inhaler Rivals
Employee benefit funds accusing Teva of orchestrating a decadelong scheme to delay generic competition for its QVAR asthma inhalers told a Massachusetts federal court the drugmaker is trying to end the case by addressing merely one aspect of a multipart scheme.
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July 10, 2024
RJ Reynolds Urges Toss Of Menthol Suit Against FDA
Tobacco giant R.J. Reynolds has come to the support of the U.S. Food and Drug Administration in a friend-of-the-court brief, arguing that the court should toss a federal lawsuit against the agency over its purported delays in implementing a ban on menthol cigarettes.
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July 10, 2024
Ex-FDA Regulator Joins Chicago Boutique Amin Wasserman
A former high-level attorney within the U.S. Food and Drug Administration is joining Chicago-based boutique Amin Wasserman Gurnani LLP, which specializes in representing food and dietary supplement companies.
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July 10, 2024
Longtime Axinn Atty To Chair Polsinelli's Hatch-Waxman Team
A practice leader from Axinn Veltrop & Harkrider LLP, known in part for his high-profile work on behalf of pharmaceutical clients, is joining Polsinelli PC to chair its Hatch-Waxman and biologics practice, the firm announced on Tuesday.
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July 10, 2024
Ex-CEO Convicted In COVID Test Kit Fraud Case
A former healthcare software executive was found guilty of securities fraud Wednesday by a New Jersey federal jury in the retrial of a case that ended in a hung jury in December.
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July 09, 2024
Pharma Co. Fined $16.9M For Fake Scripts, Ex-VP Arrested
A subsidiary of bankrupt DMK Pharmaceuticals Corp. faces a $16.9 million criminal fine after pleading guilty to conspiring in a scheme to ship drugs using false prescriptions, federal prosecutors announced Tuesday, adding that the subsidiary's former vice president of sales was also arrested.
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July 09, 2024
Bard Fights 'Patent Misuse' Ruling In $53M Suit At 9th Circ.
Bard urged the Ninth Circuit on Tuesday to reverse a lower court's finding that its attempt to collect $53 million in licensing payments from a medical-device company was a clear case of "patent misuse," arguing that the parties' licensing agreement allows for Bard to collect payments even after the patents-in-suit expired.
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July 09, 2024
South Africa Drops J&J Probe After TB Drug Price Cuts
South Africa's antitrust office has said it's going to drop its investigation over whether Johnson & Johnson engaged in anticompetitive conduct by filing a patent there for a tuberculosis drug, after the drugmaker agreed to lower the cost of bedaquiline by 40% and allow generic versions of the drug on the market.
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July 09, 2024
Fla. Judge Won't Nix Antitrust Claims Against Alcon
The Florida federal judge presiding over the multidistrict litigation alleging disposable contact lens sellers conspired to fix prices refused Tuesday to let Alcon escape antitrust claims by an online contact lens reseller and sent the suit back to New York.
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July 09, 2024
HEC Can't Get Damages Over Injunction In Novartis Feud
A Delaware federal court on Tuesday shot down HEC Pharm Co.'s bid for damages stemming from a preliminary injunction against it over the launch of a generic version of Novartis Pharmaceuticals' blockbuster multiple sclerosis treatment Gilenya.
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July 09, 2024
BCBS Unit Fails To Stop Religious Vaccine Objector Suits
A Blue Cross Blue Shield of Michigan subsidiary can't escape claims it treated differently employees who sought accommodations from a COVID-19 vaccine mandate, a Michigan federal judge ruled Tuesday, finding it plausible that religious discrimination "was at least a motivating factor" in the way the workers were dealt with.
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July 09, 2024
3rd Circ. Rips 2nd Circ. In Asset Freeze Ruling For SEC
The Third Circuit is standing by a lower court's decision to freeze a private equity executive's assets as he fights insider trading claims brought by the U.S. Securities and Exchange Commission, criticizing its sister circuit's approach to handling such issues in a precedential ruling Tuesday.
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July 09, 2024
NJ Panel Revokes Coverage For Pharma Co. In Fraud Row
A pharmaceutical company isn't covered for underlying accusations that it was a middleman in a self-dealing scheme orchestrated by its now-deceased board chairman, a New Jersey state appeals court ruled Tuesday, reversing a decision that a capacity exclusion in the company's directors and officers policy didn't apply.
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July 09, 2024
Purdue Plans 'High-Speed' Bid For New Ch. 11 Plan
Purdue Pharma told a New York bankruptcy judge Tuesday that it plans a two-month "high-speed, high-stakes" attempt to replace the Chapter 11 plan shot down by the U.S. Supreme Court last month before unleashing litigation on its former owning family.
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July 09, 2024
NJ Jury Begins Deliberating COVID Test Kit Fraud Case
Jurors began deliberating Tuesday in the retrial of a securities fraud case that ended with a dramatic mistrial after a juror announced in open court last December that he disagreed with the guilty verdict that had just been delivered by the jury forewoman.
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July 09, 2024
Terrorism Victims Push To Keep Pharma Suit In DC Circ.
Terrorism victims warned the D.C. Circuit against sending to a lower court a lawsuit seeking to link pharmaceutical companies to the attacks that injured them, saying a remand could delay the case and frustrate their efforts to collect evidence.
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July 09, 2024
FTC Says Drug Middlemen Inflate Costs, Squeeze Pharmacies
The Federal Trade Commission said Tuesday that its study of pharmacy benefit managers has shown that six large companies now control 95% of all prescriptions filled in the U.S., allowing them to profit at the expense of patients and independent pharmacies.
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July 09, 2024
Gov't Missed Merck Vax Potency Problem, 3rd Circ. Told
Two whistleblowers claiming that Merck & Co. had exaggerated the potency of its mumps vaccine told a Third Circuit panel Tuesday that the U.S. Centers for Disease Control and Prevention's continued purchasing of the vaccine was not proof that the agency knew but didn't care about the alleged deception.
Expert Analysis
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McKesson May Change How AKS-Based FCA Claims Are Pled
The Second Circuit’s analysis in U.S. v. McKesson, an Anti-Kickback Statute-based False Claims Act case, provides guidance for both relators and defendants parsing scienter-related allegations, say Li Yu at Dicello Levitt, Ellen London at London & Stout, and Erica Hitchings at Whistleblower Law.
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Series
Being An Equestrian Makes Me A Better Lawyer
Beyond getting experience thinking on my feet and tackling stressful situations, the skills I've gained from horseback riding have considerable overlap with the skills used to practice law, particularly in terms of team building, continuing education, and making an effort to reset and recharge, says Kerry Irwin at Moore & Van Allen.
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7th Circ. Mootness Fee Case May Curb Frivolous Merger Suits
On April 15, the Seventh Circuit in Jorge Alcarez v. Akorn Inc. mapped out a framework for courts to consider mootness fees paid to individual shareholders after the voluntary dismissal of a challenge to a public company merger, which could encourage objections to mootness fees and reduce the number of frivolous merger challenges filed, say attorneys at Skadden.
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Fintiv Denials Are On The Rise At PTAB
Following last year's CommScope v. Dali decision, the Patent Trial and Appeal Board is increasingly using Fintiv factors to discretionarily deny inter partes review petitions — and attorneys ignore it at their peril, say Josepher Li and Michelle Armond at Armond Wilson.
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4 Ways To Refresh Your Law Firm's Marketing Strategy
With many BigLaw firms relying on an increasingly obsolete marketing approach that prioritizes stiff professionalism over authentic connection, adopting a few key communications strategies to better connect with today's clients and prospects can make all the difference, say Eric Pacifici and Kevin Henderson at SMB Law.
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Cos. Must Prepare For Calif. Legislation That Would Ban PFAS
Pending California legislation that would ban the sale or distribution of new products containing intentionally added per- and polyfluoroalkyl substances could affect thousands of businesses — and given the bill's expected passage, and its draconian enforcement regime, companies must act now to prepare for it, say attorneys at Alston & Bird.
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FDA Warning Letter Tightens Reins On 'Research Only' Labels
A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.
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Practical Pointers After Fed. Circ. Double-Patenting Decision
With the Federal Circuit recently denying a full court review of In re: Cellect, a decision regarding obviousness-type double-patenting, affected patent family holders should evaluate their rights through both patent prosecution and future litigation lenses to minimize risks, say Austin Lorch and Jeff Wolfson at Haynes Boone.
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Highlights From The 2024 ABA Antitrust Spring Meeting
U.S. merger enforcement and cartels figured heavily in this year's American Bar Association spring antitrust meeting, where one key takeaway included news that the Federal Trade Commission's anticipated changes to the Hart-Scott-Rodino form may be less dramatic than many originally feared, say attorneys at Freshfields.
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Strategies For Challenging A Fla. Grand Jury Report's Release
A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.
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Patent Lessons From 8 Federal Circuit Reversals In March
A number of Federal Circuit patent decisions last month reversed or vacated underlying rulings, providing guidance regarding the definiteness of a claim that include multiple limitations of different scopes, the importance of adequate jury instruction, the proper scope of the precedent, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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A Look At Ex Parte Seizures 8 Years Post-DTSA
In the eight years since the Defend Trade Secrets Act was enacted, not much has changed for jurisprudence on ex parte seizures, but a few seminal rulings show that there still isn’t a bright line on what qualifies as extraordinary circumstances warranting a seizure, say attorneys at Finnegan.
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Series
Whitewater Kayaking Makes Me A Better Lawyer
Whether it's seeing clients and their issues from a new perspective, or staying nimble in a moment of intense challenge, the lessons learned from whitewater kayaking transcend the rapids of a river and prepare attorneys for the courtroom and beyond, says Matthew Kent at Alston & Bird.
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AI In The Operating Room: Liability Issues For Device Makers
As healthcare providers consider medical devices that use artificial intelligence — including systems to help surgeons make decisions in the operating room — and lobby to shift liability to device manufacturers, companies making these products must review potential product liability risks and important design considerations for such equipment, say attorneys at Troutman Pepper.
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Del. Lessons For Director-Nominees On Sharing With Activists
The Delaware Chancery Court's recent decision in Icahn Partners v. deSouza finding that a director wasn't permitted to share certain privileged information with the activist stockholders that nominated him shows the need for companies to consider imposing appropriate confidentiality requirements on directors, say attorneys at Sullivan & Cromwell.