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Life Sciences
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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.
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May 10, 2024
Fox Rothschild Hires Ex-Seed IP Trio On The West Coast
Fox Rothschild is bringing on more intellectual property talent on the West Coast, announcing Friday that it had added three former Seed IP attorneys to its Seattle offices.
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May 10, 2024
No 'Piecemeal' Fees For Infant Data Win Amid 6th Circ. Appeal
A federal judge said Friday that he wouldn't award attorney fees to children who challenged Michigan's handling of blood samples collected in an infant health screening program until the state's Sixth Circuit appeal is resolved.
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May 10, 2024
Sanofi, Novavax Sign $1.2B Deal For One-Shot COVID, Flu Jab
Sanofi and U.S. vaccine developer Novavax Inc. said on Friday that the French pharmaceutical company has bought a co-exclusive licensing agreement worth up to $1.2 billion, part of a collaboration to create a combined global COVID-19 and influenza shot.
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May 09, 2024
Fed. Circ. Lifts Ban On Generic Cos.' Bladder Drugs
The Federal Circuit on Thursday rejected Astellas Pharma's latest effort to stop the launch of generic drugs that would compete with its own blockbuster overactive bladder medication and lifted a temporary ban that was put in place by the appeals court in April.
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May 09, 2024
Judge Clarifies Gilead Didn't Directly Infringe HIV Drug IP
A Delaware federal judge on Thursday rejected Gilead Sciences' request to amend her judgment finding that two medications in its HIV prevention regimen, Truvada and Descovy, directly infringed the government's invalidated patents, but clarified her judgment to say that non-party patients or physicians committed the infringement.
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May 09, 2024
First Zantac Trial Plaintiff Says She Can't Live Normal Life
An Illinois woman suing the former manufacturers of Zantac heartburn medication and claiming her long-term use of the drug caused her colon cancer testified Thursday that she has struggled to control her bowels since her 2015 diagnosis and has experienced multiple accidents in public places that left her humiliated and fearful to leave her home.
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May 09, 2024
Judge Halts DEA's Hearing On Proposed Psychedelics Ban
An administrative law judge with the U.S. Drug Enforcement Administration has ordered the agency to cancel a June 10 hearing on its proposal to ban two psychedelic substances while a researcher's federal lawsuit challenging the agency's actions plays out in court, according to an order made public Thursday.
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May 09, 2024
Masimo Makes Offer To End Activist Politan's Proxy Contest
Medical technology company Masimo Corp. revealed Thursday that it is willing to appoint one of the director nominees put forth by activist investment firm Politan Capital Management LP in exchange for the company dropping its proxy fight, though Politan signaled distaste with the proposed deal.
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May 09, 2024
Fed. Circ. Skeptical Allergan Illegally Extended Exclusivity
A Federal Circuit panel seemed doubtful Thursday that a patent covering Allergan's bowel treatment drug Viberzi should have its life cut short based on the expiration date of related patents, in oral arguments over obviousness-type double patenting.
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May 09, 2024
Ex-Dental Device CEO Cops To $10.7M Investor Fraud
The former CEO of a dental device company pled guilty Thursday to defrauding investors out of $10.7 million with false claims that his company received the U.S. Food and Drug Administration's approval for a device he promised would take the place of X-rays.
Expert Analysis
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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.
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7 E-Discovery Predictions For 2024 And Beyond
The legal and technical issues of e-discovery now affect virtually every lawsuit, and in the year to come, practitioners can expect practices and policies to evolve in a number of ways, from the expanded use of relevancy redactions to mandated information security provisions in protective orders, say attorneys at Littler.
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Top Considerations For Retailers Using AI To Combat Theft
The Federal Trade Commission's recent enforcement action against Rite Aid indicates a significant evolution in the landscape surrounding biometric information and artificial intelligence data collection by retailers, meaning retailers should take reasonable measures to prevent harm to customers, say attorneys at Dentons.
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2 FCPA Settlements Illuminate Self-Disclosure, Disgorgement
Two of last year’s Foreign Corrupt Practices Act settlements — with biomedical company Lifecore and mining company Corsa Coal — suggest that the government will be much more flexible in negotiating disgorgement amounts if an entity voluntarily self-discloses misconduct, say Michael Gilbert and Lucas Amodio at Sheppard Mullin.
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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.