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Life Sciences
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May 14, 2024
The PREP Immunity Question Won't Be Decided Yet
The Federal Circuit opted Tuesday not to say whether a 2005 public health law provides any legal immunity in a patent dispute between rival manufacturers of COVID-19 test swabs, leaving the thorny question unanswered.
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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.
Expert Analysis
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Notes Of Interest From 5th Circ. Illumina-Grail Merger Ruling
Attorneys at Simpson Thacher consider the Fifth Circuit's recent decision upholding the Federal Trade Commission's challenge of the Illumina merger with Grail, its much-needed boost to the Biden administration's antitrust agenda, and some silver linings the decision offers to merging parties.
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DOJ's Biopharma Settlement Raises Anti-Kickback Questions
In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.
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Where Justices Stand On Chevron Doctrine Post-Argument
Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.
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Precise Advance Notice Bylaws May Help Prevent Disputes
While the Chancery Court's December decision in Kellner v. AIM Immunotech shows that Delaware courts won't always uphold advance notice bylaws, and its willingness to selectively enforce or invalidate individual provisions doesn't create an incentive for companies to be surgical in their drafting, companies should nonetheless be precise when drafting such bylaws to avoid unnecessary disputes, say attorneys at Debevoise.
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Perspectives
6 Practice Pointers For Pro Bono Immigration Practice
An attorney taking on their first pro bono immigration matter may find the law and procedures beguiling, but understanding key deadlines, the significance of individual immigration judges' rules and specialized aspects of the practice can help avoid common missteps, says Steven Malm at Haynes Boone.
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Series
ESG Around The World: Canada
In Canada, multiple statutes, regulations, common law and industry guidance address environmental, social and governance considerations, with debate over ESG in the business realm potentially growing on the horizon, say attorneys at Blakes.
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5 Legal Considerations For Psychedelic Therapy Sector
With multiple developments signaling the rise of psychedelic-assisted psychotherapy, it is imperative that clinicians understand unique legal nuances ranging from corporate formation to specialized insurance coverage, say Kimberly Chew and Natasha Sumner at Husch Blackwell.
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Lessons From Country Singer's Personal Service Saga
Recent reports that country singer Luke Combs won a judgment against a Florida woman who didn’t receive notice of the counterfeit suit against her should serve as a reminder for attorneys on best practices for effectuating service by electronic means, say attorneys at Jenner & Block.
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A Potential Proactive Tool For Public-Private Joint Ventures
In the current environment of heightened antitrust enforcement, the National Cooperative Research and Production Act seems tailor-made for the collaborative work among competitors encouraged by the Biden administration's infrastructure and green energy funding legislation, say Jeetander Dulani and Susan Ebner at Stinson.
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Patent Prosecution Carries Consequences For Later Litigation
The Federal Circuit's recent Mylan v. Actelon holding, along with three other 2023 decisions, underscores the continued need for patent prosecutors to make note of potential claim construction issues that may arise in subsequent litigation, says Steven Wood at Hunton.
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10 Global Antitrust Trends To Anticipate In 2024
Proactive navigation of the antitrust enforcement environment remains crucial this year as legal policy and tools evolve to meet intensifying global economic complexity, including geopolitical tensions, trade realignment, market volatility and inflation, say attorneys at Freshfields.
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Global Cartel Enforcement Looks Set To Intensify In 2024
The cartel enforcement winds may strengthen this year, with the U.S. Department of Justice, as well as regulators in other countries, placing a renewed focus on pursuing international cartels and more traditional, hard-core cartel conduct, say attorneys at Simpson Thacher.
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Series
Baking Bread Makes Me A Better Lawyer
After many years practicing law, and a few years baking bread, I have learned that there are a few keys to success in both endeavors, including the assembly of a nourishing and resilient culture, and the ability to learn from failure and exercise patience, says Rick Robinson at Reed Smith.
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Supreme Court Amgen Ruling's Major Effect On Enablement
The U.S. Supreme Court's Amgen v. Sanofi invalidity holding continues to significantly affect technologies and all aspects of the patent system by providing confidence in the Federal Circuit's approach and a clearer understanding on enforceability and the disclosure needed for compliance, say Irena Royzman and Daniel Williams at Kramer Levin.
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Federal Courts And AI Standing Orders: Safety Or Overkill?
Several district court judges have issued standing orders regulating the use of artificial intelligence in their courts, but courts should consider following ordinary notice and comment procedures before implementing sweeping mandates that could be unnecessarily burdensome and counterproductive, say attorneys at Curtis.