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Life Sciences
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May 29, 2024
FDA Sued Over Controversial Lab Test Rule
A clinical lab trade group that has been highly critical of the U.S. Food and Drug Administration's new final rule on laboratory-developed tests filed a lawsuit late Wednesday, saying the agency doesn't have the authority to regulate the tests as medical devices.
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May 29, 2024
Israeli Nanotech Startup, Canadian Biotech Plot US IPOs
An Israeli nanotech startup launched plans Wednesday for an estimated $75 million U.S. initial public offering, while a Canadian-listed biotechnology company also filed documents to tap U.S. markets, adding to a recent spate of cross-border listings.
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May 29, 2024
Chicago IP Firm Accused Of Botching Fetal Biotech Patent
A company that makes technology that can detect fetal asphyxia and distress has alleged in Illinois state court that Chicago law firm Fitch Even Tabin & Flannery LLP cost it millions when it registered the company's patents under one of its former employees, who then used its intellectual property to launch a competing company.
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May 29, 2024
Wilson Sonsini Adds 2 Attys In Salt Lake City From Kirkland
Wilson Sonsini Goodrich & Rosati PC has continued to expand its growing, three-year-old Salt Lake City, Utah, office with the recent addition of two experienced litigators who moved their practices from Kirkland & Ellis.
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May 29, 2024
Gibson Dunn, Skadden Guide $3B Merck-EyeBio Deal
Gibson Dunn-led Merck said Wednesday it has agreed to purchase ophthalmology-focused biotech company Eyebiotech Ltd., or EyeBio, which is represented by Skadden, for up to $3 billion.
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May 29, 2024
3 Firms Build $627M Take-Private Sale Of Medical Device Biz
Medical device company Surmodics Inc. on Wednesday revealed it has agreed to be bought by private equity giant GTCR for $627 million in a take-private deal built by Kirkland & Ellis, Faegre Drinker and Cleary Gottlieb.
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May 29, 2024
Greenberg Traurig Adds IP Atty From Eversheds Sutherland
Greenberg Traurig LLP has bolstered its California bench of attorneys with an Eversheds Sutherland lawyer who has years of experience advising digital health and medical device companies on intellectual property issues.
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May 29, 2024
Whistleblower Counsel Can't Get 'Exorbitant' $11.5M Fee
A Boston federal judge slashed an "exorbitant" $11.5 million fee request made by counsel for a False Claims Act whistleblower in a case involving lab testing company Fresenius Medical Care, hammering the attorneys for inflated hourly rates, inflated time entries and a host of questionable billing practices.
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May 28, 2024
Abbott, Dexcom Call For New Glucose Monitor Patent Trial
Just over two months after a jury in Wilmington, Delaware, handed down a mixed verdict in a patent lawsuit over glucose monitors, both sides are now asking the judge to give them another trial.
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May 28, 2024
J&J To Pay $1.25B For Global Rights To Eczema Treatment
Johnson & Johnson has agreed to buy the rights to an experimental treatment for eczema from Baker McKenzie-advised Numab Therapeutics for approximately $1.25 billion, the companies announced on Tuesday.
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May 28, 2024
HIV Drug Buyers Fight Bid To Combine 9th Circ. Appeal Briefs
Drug buyers that allege Gilead Sciences Inc. and Teva Pharmaceuticals delayed generic versions of HIV medications told the Ninth Circuit it would be unfair to grant the companies' call for a single brief addressing the 17 appeals filed after a jury rejected the claims last year.
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May 28, 2024
Catching Up With Delaware's Chancery Court
Delaware Court of Chancery watchers shifted their focus last week from the courtroom to Dover's legislative hall, as proposed amendments to Delaware's corporate code were finally introduced to state lawmakers. Hearings, decisions and reversals involved Kraft-Heinz, AMC Entertainment and the merger of cryptocurrency companies BitGo and Galaxy. In case you missed it, here's the latest from Delaware's Chancery Court.
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May 28, 2024
Ga. Dental Imaging Co. Fights To Keep X-Ray IP Suit Alive
A dental technology company accusing a competitor of ripping off a 3D imaging system has urged a Georgia federal judge to keep its claims alive, telling the court its rival's defense amounts to a "whitewash" of the patent infringement allegations.
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May 28, 2024
Edwards Urges Full Fed. Circ. To Limit FDA Safe Harbor
Edwards Lifesciences has petitioned the full Federal Circuit to narrow its interpretation of a U.S. Food and Drug Administration safe harbor that essentially allows patent infringement during drug development, arguing that if Congress wanted the statute to be interpreted broadly, "it would have said exactly that."
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May 28, 2024
Beasley Allen, J&J Trade Barbs Over DQ Bid In Talc Litigation
Johnson & Johnson and the Beasley Allen Law Firm have accused each other by turns of "gamesmanship" and "unscrupulous conduct" in New Jersey courts in a fight over whether the firm should be disqualified from talcum powder litigation for allegedly collaborating in secret with a former J&J outside counsel.
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May 24, 2024
Esperion Launches Suits Over Cholesterol Drug Patents
Esperion Therapeutics has sued Dr. Reddy's, Sandoz, Hetero and MSN in New Jersey, alleging that their planned generic versions of cholesterol drugs infringe a variety of patents on its treatments.
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May 24, 2024
Treaty Wants Patents To Cite Ties To 'Traditional Knowledge'
Members of the United Nations announced a treaty Friday that would potentially change mandatory patent disclosure rules in order to require applicants to cite "traditional knowledge" developed by "indigenous peoples," requirements that have drawn concerns from lawyers for the pharmaceutical industry in the U.S. and at least one former federal judge.
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May 24, 2024
Petition Watch: Forum Shopping, Monopolies & Gun Safety
Law360 looks at four U.S. Supreme Court petitions filed in the past two weeks, including the FDA's request that the justices curb an increase in forum shopping at the Fifth Circuit, and two veterinarians who want the justices to allow plaintiffs to pursue antitrust claims for actions allegedly leading to the creation of a monopoly.
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May 24, 2024
Fla. Lab Owner Will Pay $27M To End False Billing Suit
A Florida medical lab owner who pled guilty to charges related to accusations he billed Medicare for $53 million in unnecessary genetic cancer screening tests has agreed to pay more than $27 million to resolve three whistleblower suits over the same conduct, according to an announcement Friday from the U.S. Department of Justice.
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May 24, 2024
Shuttered Paper Mill Flouted $12M Incentive Deal, NC AG Says
The state of North Carolina is suing food and beverage packaging company Pactiv Evergreen to recoup $12 million in economic incentives the company allegedly accepted to keep a local mill up and running after it abruptly shuttered the facility last year.
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May 24, 2024
NY AG Sues Over Illegal Long Island Wetland Construction
New York prosecutors on Friday sued to force a contractor to pay nearly $600,000 and restore a Long Island wetland area the company has been using as a storage site after illegally clearing vegetation and building a parking lot more than a decade ago.
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May 24, 2024
Biden's Judicial Impact And What's Left On The Wish List
President Joe Biden secured confirmation of his 200th federal judge Wednesday and has transformed the judiciary by picking more women and people of color than any other president. But the upcoming election season could derail his hopes of confirming many more judges.
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May 24, 2024
NYSE Companies Could Face Heat If Business Focus Changes
A New York Stock Exchange proposal seeking additional authority to delist companies that enact wholesale business changes after going public could subject certain companies to more scrutiny, attorneys say, though such drastic actions are expected to be rare.
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May 24, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen an IT engineer seek permission to search a landfill hiding a hard drive supposedly storing millions of pounds in bitcoin, Glencore take on legal action by American Century Investments, gold payment app Glint bring a breach of duty claim against FRP Advisory, and an ongoing dispute between a solicitor and the Solicitors Regulation Authority. Here, Law360 looks at these and other new claims in the U.K.
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May 23, 2024
NJ Justices Toss Direct Appeals Over Hospital Contract Bid
The New Jersey Supreme Court ruled Thursday that an independent state-owned teaching hospital's conduct cannot be challenged directly in the state's intermediate appellate court because it isn't considered an administrative agency, affirming the dismissal of two protests over the hospital's selection of a pharmacy vendor.
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.