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Life Sciences
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May 14, 2024
Norwich, Bausch Ask Fed. Circ. To Rethink Xifaxan IP Ruling
Alvogen's Norwich Pharmaceuticals unit and Bausch Health have launched bids for the Federal Circuit to rehear a case in which it affirmed a Delaware federal court's decision preventing the release of a generic version of Bausch's blockbuster diarrhea and brain disease drug, Xifaxan, until 2029.
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May 14, 2024
Calif. City Sues Dow, Shell Over TCP-Tainted Water
Dow Chemical and Shell USA are facing a negligence suit in California federal court by the city of Pomona, alleging the companies are responsible for manufacturing commercial products containing the toxic 1,2,3-trichloropropane that has migrated into the city's water supply and seeking to recoup costs over response efforts.
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May 14, 2024
Vein Tech Maker Faces Investor Suit Over DOJ Kickback Probe
Vein disease device maker Inari Medical Inc. and three of its current and former executives face a proposed investor class action over claims that the company's share price fell after it disclosed an investigation into its compliance with federal anti-kickback laws.
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May 14, 2024
Jury's $2M Medical Device Infringement Verdict Upended
A Delaware federal judge ruled Tuesday that Kurin Inc. did not infringe claims of a Magnolia Medical Technologies Inc. patent tied to sepsis testing, reversing a 2022 jury verdict that Kurin had infringed the patent and should pay $2 million.
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May 14, 2024
States Accuse EEOC Of 'Smuggling' Abortion Into PWFA Rule
Louisiana and Mississippi have sued the U.S. Equal Employment Opportunity Commission seeking to invalidate regulations implementing the Pregnant Workers Fairness Act, claiming the agency's stance that employers must provide workers accommodations if they get an abortion flouts U.S. Supreme Court precedent and the PWFA itself.
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May 14, 2024
Biotech Co. Hits Bankruptcy With Creditor Deal In Hand
Biotech company Gamida Cell Inc. filed for Chapter 11 protection in Delaware bankruptcy court after reaching a take-private deal with its largest creditor to extend up to $45 million in new capital and forgive more than $4 million in secured debt.
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May 14, 2024
Congressional IP Attorneys Keeping Close Watch On AI
Top intellectual property attorneys from the U.S. Senate and U.S. House of Representatives told a room full of Federal Circuit practitioners on Tuesday that artificial intelligence is the biggest thing to watch within IP law over the next few years.
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May 14, 2024
Mich. AG Says Eli Lilly 'Cherry-Picking' Enforcement Data
Michigan's attorney general has hit back against Eli Lilly's arguments that recent consumer protection law recoveries show her office is not being hampered in its investigations, as she seeks subpoenas in a probe of the pharmaceutical giant's pricing for an insulin drug.
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May 14, 2024
Shire Settles Claims Over Alleged ADHD Generic Delay
Purchasers of the medication Intuniv have settled a years-old class action against drugmaker Shire PLC and manufacturer Actavis over allegations that the companies struck an anti-competitive deal to delay the production of a generic version of the attention-deficit/hyperactivity disorder drug.
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May 14, 2024
Chinese Drug Co. Sanctioned After 'Tortuous' 3-Year Info Fight
Chinese drug firm Zhejiang Huahai Pharmaceutical Co. Ltd. has been hit with sanctions after its chief executive officer failed to sit for a court-ordered deposition in sprawling multidistrict litigation taking place in New Jersey over generic drugs that U.S. authorities say were contaminated with carcinogens.
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May 13, 2024
USPTO Eyes Change To Patent Applicants' Disclaimer Practice
The U.S. Patent and Trademark Office is looking to add a requirement for patent applicants filing so-called terminal disclaimers in order to overcome rejections by patent examiners over obviousness-type double patenting, a move that lawyers and a former USPTO official say could change the agency's approach considerably, especially for patents covering brand-name drugs.
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May 13, 2024
Biogen Investors Seek Class Cert. In Alzheimer's Drug Suit
A proposed class of Biogen shareholders urged a Massachusetts federal court to certify their now-revived class action alleging the drugmaker made misleading statements about a deficient Alzheimer's drug, arguing it can sufficiently lead the suit with Block & Leviton LLP as class counsel.
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May 13, 2024
2nd Circ. Affirms Dismissal Of Bystolic Antitrust Suit
The Second Circuit issued its first decision under the high court's Actavis "pay for delay" ruling on Monday, affirming the dismissal of a case alleging that an AbbVie predecessor delayed competition for its hypertension treatment Bystolic through deals with several generic makers.
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May 13, 2024
SEC Says Biotech Co., Atty Should Pay $14M For Investor Lies
Federal securities regulators have said a Colorado biotech startup and two of its founders should pay more than $14 million in ill-gotten profits, including interest, for lying to investors about the company's financial position, arguing that the founders showed a "total disregard" for investors.
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May 13, 2024
Ga. Dental Imaging Co. Pushes For Ax Of X-Ray IP Row
A dental imaging company is urging a Georgia federal judge to slash a suit lodged against it by a competitor alleging that the company sold 3D dental imaging systems and software that infringe its patents, arguing that the claims are directed to "abstract ideas" that are ineligible for patent protection.
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May 13, 2024
Ex-Police Chief Gets 3 Months For Alexion Insider Trading
The former police chief of a town in Massachusetts was sentenced Monday to three months in prison after pleading guilty to trading on confidential information about a pending Alexion Pharmaceuticals merger that he said was provided by a "lifelong friend."
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May 13, 2024
Calif. Jury Awards Ex-UCLA Doctor $14M In 2nd Bias Trial
A California state jury awarded $14 million to a former UCLA oncologist and professor who said she was discriminated against and constructively discharged from her job due to her gender, four years after the state appeals court threw out a $13 million jury verdict from the first trial.
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May 13, 2024
Philips Wants Cleaner Co. To Chip In For $1B CPAP Deal
Koninklijke Philips NV has filed a third-party complaint in Pennsylvania federal court against SoClean Inc., which sells cleaning products for breathing devices, claiming SoClean and its parent should contribute to Philips' $1 billion settlement because its cleaners allegedly exacerbated the foam breakdown at the heart of the litigation.
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May 13, 2024
McCarter & English Aims To Sink Biotech Malpractice Suit
McCarter & English LLP has asked a New Jersey state judge to toss a legal malpractice suit filed by a former biopharmaceutical client who claims the firm is responsible for the company's financial struggles.
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May 13, 2024
'Prolific' Asbestos Injury Firm Accused Of Fraud, Racketeering
A "prolific" Illinois-based asbestos litigation law firm allegedly engaged in a yearslong scheme involving perjured testimony, suppressed evidence and baseless claims to extract as much money from as many companies as possible, according to one of the companies repeatedly targeted by the firm.
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May 13, 2024
Haynes Boone Lands Procopio Life Sciences Leader In Calif.
Haynes and Boone LLP announced Monday it welcomed to the firm's intellectual property practice a new partner who most recently led Procopio Cory Hargreaves & Savitch LLP's life sciences group.
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May 10, 2024
Retail Group Opposes $1B Arbitral Award Against Walgreens
An advocacy group for the retail industry is backing Walgreens as it looks to set aside a nearly $1 billion arbitral award in a dispute with a COVID test maker, telling a Delaware federal judge that judicial intervention is warranted in this case.
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May 10, 2024
Pharma Cos., FDA Debate 'Same Drug' In Orphan Drug Case
Two pharmaceutical companies and the U.S. Food and Drug Administration faced off in D.C. federal court Friday over allegations that the federal agency wrongly approved a treatment that rivals Jazz Pharma's narcolepsy drug despite Jazz's exclusivity rights under the Orphan Drug Act.
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May 10, 2024
Lab Exec Sentenced For Deadly Fungal Meningitis Outbreak
The founder of a Massachusetts drug compounding center was sentenced in Michigan to 10 to 15 years in prison for his role in a fungal meningitis outbreak after he agreed to a plea deal with state prosecutors earlier this year.
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May 10, 2024
Pharmaceutical Cos. Can't Nix Parkinson's Drug Antitrust Suit
A Delaware federal judge has issued a sealed order refusing to dismiss drugmakers Sage Chemical Inc. and TruPharma's antitrust suit accusing rival Supernus Pharmaceuticals and others of suppressing generic versions of the Parkinson's treatment Apokyn.
Expert Analysis
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Opinion
Intoxicating Hemp Products: It's High Time For Clarity
Thanks to ambiguity in the 2018 Farm Bill, intoxicating hemp cannabinoid products are largely unregulated and are widely available without restrictions on who can buy the products, and although there are several possible solutions, voluntary industry action by good actors is the best option, say Andrew Kline and Tommy Tobin at Perkins Coie.
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And Now A Word From The Panel: Benefits Of MDL Transfers
A recent order from the Judicial Panel on Multidistrict Litigation highlights a critical part of the panel's work — moving cases into an existing MDL — and serves as a reminder that common arguments against such transfers don't outweigh the benefits of coordinating discovery and utilizing lead counsel, says Alan Rothman at Sidley Austin.
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What Rescheduling Could Mean For Cannabis Bankruptcies
Bankruptcy courts have historically been closed for cannabis-related businesses, but recent case law coupled with a possible reclassification of cannabis provides cautious optimism, say attorneys at Duane Morris.
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Opinion
Pharmacies Need More Protection Against PBM Fee Practices
The Centers for Medicare & Medicaid Services' recent reform regarding direct and indirect remuneration fees will mitigate the detrimental effects that pharmacy benefit manager policies have on struggling pharmacies, but more is needed to prevent PBMs from exploiting loopholes, says Bhavesh Desai at Mazina Law.
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Contract Disputes Recap: Facts Differ But Same Rules Apply
Zachary Jacobson and Sarah Barney at Seyfarth examine two decisions illustrating that reliance on a technicality may not save an otherwise untimely appeal, and that enforcement of commercial terms and conditions under a federal supply schedule contract may be possible.
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Series
Spray Painting Makes Me A Better Lawyer
My experiences as an abstract spray paint artist have made me a better litigator, demonstrating — in more ways than one — how fluidity and flexibility are necessary parts of a successful legal practice, says Erick Sandlin at Bracewell.
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Takeaways From The 2023 DOJ Fraud Section Report
Attorneys at Wiley discuss notable trends from the U.S. Department of Justice's recently reported Fraud Section activity last year and highlight areas of enforcement to watch for in the future, including healthcare fraud and Foreign Corrupt Practices Act violations.
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Judge-Shopping Policy Revisal May Make Issue Worse
The Judicial Conference at its March meeting unveiled a revised policy with the stated goal of limiting litigants’ ability to judge-shop in patent cases, but the policy may actually exacerbate the problem by tying the issue to judge-shopping in polarizing political cases, making reform more difficult, say Robert Niemeier and William Milliken at Sterne Kessler.
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2nd Circ. Baby Food Ruling Disregards FDA's Expertise
The Second Circuit's recent decision in White v. Beech-Nut Nutrition, refusing to defer litigation over heavy metals in baby food until the U.S. Food and Drug Administration weighs in on the issue, provides no indication that courts will resolve the issue with greater efficiency than the FDA, say attorneys at Phillips Lytle.
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Assessing FDA Pathways For Genome-Edited Plant Foods
The U.S. Food and Drug Administration's recent clarification of the regulatory pathways for foods produced from genome-edited plants seeks to strike a balance between public health and innovation, and may hold broader significance for developers of novel human foods subject to voluntary notification programs, say Emily Marden and Diane McEnroe at Sidley Austin.
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Opinion
Proposed MDL Management Rule Needs Refining
Proponents of the recently proposed Federal Rule of Civil Procedure 16.1 believe it may enhance efficiency in multidistrict litigation proceedings if adopted, but there are serious concerns that it could actually hinder plaintiffs' access to justice through the courts — and there are fundamental flaws that deserve our attention, says Ashleigh Raso at Nigh Goldenberg.
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Why Oncology Deal Making Continues To Fuel Biotech M&A
The biotech sector's potential for advancements in cancer care continues to attract deal-maker interest, and the keys to successful mergers and acquisitions include the ability to integrate innovative therapies, leverage technological advancements and respond to the dynamic needs of patients, say Bryan Luchs and Mike Weir at White & Case.
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Opinion
Judicial Independence Is Imperative This Election Year
As the next election nears, the judges involved in the upcoming trials against former President Donald Trump increasingly face political pressures and threats of violence — revealing the urgent need to safeguard judicial independence and uphold the rule of law, says Benes Aldana at the National Judicial College.
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Opinion
NIST March-In Framework Is As Problematic As 2021 Proposal
While the National Institute of Standards and Technology's proposed march-in framework on when the government can seize patents has been regarded as a radical departure that will support lowering prescription drug costs, the language at the heart of it is identical to a failed 2021 notice of proposed rulemaking, says attorney Kelly Morron.
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Document Retention Best Practices To Lower Litigation Risks
As new technologies emerge and terabytes of data can be within the purview of a single discovery request, businesses small and large should take four document management steps to effectively minimize risks of litigation and discovery sanctions long before litigation ensues, says Kimbrilee Weber at Norris McLaughlin.