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Life Sciences
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September 19, 2024
Norwich Asks Justices To Allow Sale Of Generic Diarrhea Drug
A New York drugmaker has told the U.S. Supreme Court that the courts have gone too far in preventing the release of a generic version of a blockbuster diarrhea drug, after a lower court found there was a way of using the drug that would infringe certain patents.
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September 19, 2024
Conn. Justices Wonder How 'Malicious' Firm's Ex-Client Was
The Connecticut Supreme Court on Thursday questioned whether an ex-McCarter & English LLP client was "wanton" and "malicious" enough to justify the firm's novel $3.6 million punitive damages bid in a protracted billing dispute that has already fetched the firm judgments totaling more than $2 million on contract claims.
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September 19, 2024
Airline Sinks Bias Suit From Worker Fired Over Drug Test
A Pennsylvania federal judge tossed a race and disability bias suit from an American Airlines worker who said she was fired over a positive drug test triggered by her ADHD medication, ruling she hadn't presented evidence that bias drove the decision to let her go.
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September 18, 2024
Axonics Didn't Infringe Medtronic Patents, Calif. Jury Says
Axonics did not infringe three of Medtronic's patents related to its bladder and bowel control device, a California federal jury determined Wednesday.
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September 18, 2024
CVS Unit Pays $60M Over Alleged Insurance Kickback Scheme
CVS Health subsidiary Oak Street will pay $60 million to settle allegations it violated the False Claims Act by paying illegal kickbacks to third-party insurers in return for scouting and inducing Medicare and Medicaid beneficiaries to enroll in its primary care clinics, the U.S. Department of Justice announced Wednesday.
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September 18, 2024
7th Circ. Questions Nixing $183M Eli Lilly Drug Rebate Verdict
A Seventh Circuit judge seemed unsure Wednesday whether to disturb a $183 million verdict against Eli Lilly in a false claims case targeting more than a decade of drug rebate miscalculations, questioning whether the company skipped checking legal guidance before calling its price reporting requirements unclear.
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September 18, 2024
Fed. Circ. Revives Astellas Patent Axed As Natural Law
The Federal Circuit on Wednesday vacated a lower court's invalidation of an Astellas Pharma overactive bladder medication patent for claiming only a natural law, saying the holding was improper because the generics makers accused of infringement never made that argument.
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September 18, 2024
Rescheduling Pot Would Not Hasten Research, Report Says
A recently enacted law will continue to make it difficult for medical researchers to conduct studies on marijuana, even if federal restrictions are loosened on the drug, according to a new report published Monday by the Congressional Research Service.
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September 18, 2024
Georgia High Court Won't Hear Missed Patent Deadline Case
The highest court in Georgia has decided not to take up an appeal from a neurosurgeon in his nearly $102 million lawsuit, letting stand a lower court's finding that a patent docketing contractor used by remote law firm FisherBroyles can't be held liable for a missed patent application deadline.
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September 18, 2024
SEC Settles Latest Covington Info Theft Case For $33K
A New Jersey man will pay a $33,000 civil penalty to the U.S. Securities and Exchange Commission for insider trading on confidential merger tips that his cousin stole from a Covington & Burling LLP lawyer, according to a settlement filed in New York federal court on Wednesday.
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September 18, 2024
Ex-Amgen Rep Wasn't Original Whistleblower, Judge Says
A Brooklyn federal judge tossed a former Amgen sales representative's whistleblower suit on Wednesday, saying many elements of his allegations of a kickback scheme had been disclosed in news reports and civil lawsuits prior to his filing.
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September 18, 2024
ITC Looking At Advanced Bionics Implant Patent Claims
The U.S. International Trade Commission said it will look into allegations from Switzerland's Advanced Bionics that Austria's Med-El has been infringing cochlear implant hearing aid technology.
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September 18, 2024
Thermo Fisher Late To Pay Departing Workers, Engineer Says
Thermo Fisher Scientific Inc. and a subsidiary failed to promptly pay all final wages and unused vacation time to departing employees and must now cough up three times the amount of that compensation because of its violation of Massachusetts law, according to a proposed class action filed in state court.
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September 18, 2024
GSK Inks 2 Calif. Zantac Deals
GlaxoSmithKline LLC on Wednesday said that it had reached two settlements in California state court over allegations that its heartburn drug Zantac had caused cancer, although the company did not disclose the deal amounts.
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September 18, 2024
Biotech Co. Escapes Stock-Drop Suit Over COVID-19 Drug
A Massachusetts biotech company won dismissal Wednesday from a proposed class action by investors who say their shares tanked in value after it allegedly came to light that executives had falsely touted an unproven prospective COVID-19 medicine.
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September 18, 2024
Organon To Buy Psoriasis Treatment Biz For Up To $1.2B
Women's healthcare-focused company Organon, advised by Covington & Burling LLP, on Wednesday announced it will purchase Freshfields Bruckhaus Deringer LLP-led Dermavant, a subsidiary of Roivant that develops and commercializes therapies in immuno-dermatology.
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September 17, 2024
Benefit Funds Sue Sandoz Over Alleged Fraudulent Transfers
Several health and welfare funds have filed a class action against Sandoz Inc. and affiliates in Pennsylvania federal court, alleging the drugmaker engaged in fraudulent transfers designed to evade liabilities stemming from drug-pricing antitrust litigation.
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September 17, 2024
GC Base Salaries At Big Companies On The Rise
General counsel base salaries at companies making $5 billion or more in revenue has increased from last year, while their total compensation has decreased, according to a report released Tuesday by the Association of Corporate Counsel and Empsight International LLC.
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September 17, 2024
Philip Morris To Part With Inhaler Maker In Up To £258M Deal
Philip Morris International is spacing itself from the British inhaler maker it purchased in 2021 through an up to £258 million ($339.6 million) sale that preserves a commercial relationship, amid what the tobacco company called "unwarranted opposition" to its role in developing inhaled therapeutics.
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September 17, 2024
Express Scripts Blasts 'Biased' FTC Drug Middlemen Report
The Federal Trade Commission defamed Express Scripts and violated its constitutional rights with an inaccurate report that ripped the role pharmacy benefit managers play as middlemen between drugmakers and insurers, according to a lawsuit lodged Tuesday in Missouri federal court.
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September 17, 2024
Merit Medical To Buy Rival's Heart Implant Biz For $210M
Merit Medical Systems Inc. said Tuesday it has agreed to buy Cook Medical Inc.'s heart device implant portfolio for $210 million, as the U.S. medical product maker looks to capture a slice of the growing global cardiac intervention market.
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September 16, 2024
Teleflex Gets Another Chance In Catheter Patent Feud
The Federal Circuit on Monday held that a Minnesota district court was wrong to invalidate claims in seven catheter patents Teleflex LLC asserted against Medtronic Inc. as indefinite, finding the lower court took an overly narrow view of how claims are construed.
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September 16, 2024
Injectable Analgesic Maker Wants Generic Version Blocked
Mallinckrodt Pharmaceuticals has sued a rival drugmaker in Delaware federal court, alleging the company copied its injectable version of acetaminophen and infringed four patents in the process.
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September 16, 2024
Pot Co. Execs Go To 9th Circ. In Investment Scam Case
A California cannabis company and its co-founders on Monday appealed a federal court decision booting them from the securities industry and holding them liable for roughly $6 million tied to a medical marijuana investment scam, the same day that the U.S. Securities and Exchange Commission asked the court to order a third individual to pay up for his part in the alleged scam.
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September 16, 2024
5th Circ. Judge Chides High Court Calls in Abortion Pill Case
U.S. Circuit Judge James C. Ho on Monday threw shade at the U.S. Supreme Court and the Biden administration over what he described as side-switching on federal conscience laws for doctors.
Expert Analysis
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Trending At The PTAB: Permissible New Reply Arguments
In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.
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Wave Of Final Rules Reflects Race Against CRA Deadline
The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.
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'Beauty From Within' Trend Poses Regulatory Risks For Cos.
Companies capitalizing on the current trend in oral supplements touting cosmetic benefits must note that a product claim that would be acceptable for an externally applied cosmetic may draw much stronger scrutiny from the U.S. Food and Drug Administration when applied to a supplement, say Natalie Rainer and Katherine Staba at K&L Gates.
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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.