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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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Opinion
Anti-Kickback Statute Does Not Require But-For Causation
A proper interpretation of the Anti-Kickback Statute clearly indicates that but-for causation is not required for False Claims Act Liability, and courts that hold otherwise will make it significantly easier for fraudsters to avoid accountability, says Kenneth Capesius at Baron & Budd.
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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.