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Life Sciences
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May 29, 2024
South Baltimore Citizens Call On EPA For Incinerator Relief
Baltimore has turned a blind eye to South Baltimore residents suffering from respiratory diseases and persistently urging the city to transition away from Maryland's largest trash incinerator to zero-waste infrastructure for dealing with refuse, two environmental groups and a residents group say in an administrative complaint Wednesday.
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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.
Expert Analysis
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3 Health Insurance Paths For Psychedelic-Assisted Therapy
Ahead of potential U.S. Food and Drug Administration approvals for psychedelics as insured treatments, attorneys at Husch Blackwell review pathways for these drugs to achieve coverage as treatments for complex mental health conditions.
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Series
Serving As A Sheriff's Deputy Made Me A Better Lawyer
Skills developed during my work as a reserve deputy — where there was a need to always be prepared, decisive and articulate — transferred to my practice as an intellectual property litigator, and my experience taught me that clients often appreciate and relate to the desire to participate in extracurricular activities, says Michael Friedland at Friedland Cianfrani.
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Fears About The End Of Chevron Deference Are Overblown
While some are concerned about repercussions if the U.S. Supreme Court brings an end to Chevron deference in the Loper and Relentless cases this term, agencies and attorneys would survive just fine under the doctrines that have already begun to replace it, say Daniel Wolff and Henry Leung at Crowell & Moring.
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Negotiating Milestones In Pharma Licenses Requires Care
For life sciences companies, understanding the unique issues that arise in licensing agreements' milestone payment provisions can increase the likelihood and amount of payments received by the licensor and ensure payments are carefully and closely tied to events that truly drive value for the licensee, say Edward Angelini at Amneal Pharmaceutical and Lori Waldron at Sills Cummis.
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Former Minn. Chief Justice Instructs On Writing Better Briefs
Former Minnesota Supreme Court Chief Justice Lorie Gildea, now at Greenberg Traurig, offers strategies on writing more effective appellate briefs from her time on the bench.
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Stay Interviews Are Key To Retaining Legal Talent
Even as the economy shifts and layoffs continue, law firms still want to retain their top attorneys, and so-called stay interviews — informal conversations with employees to identify potential issues before they lead to turnover — can be a crucial tool for improving retention and morale, say Tina Cohen Nicol and Kate Reder Sheikh at Major Lindsey.
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Direct Claims Ruling May Alter Gov't Ties To Software Firms
A recent Federal Circuit decision allowing a software developer to pursue legal action under the Contract Disputes Act could change the government's relationship with commercial software providers by permitting direct claims, even in third-party purchase situations, say Dan Ramish and Zach Prince at Haynes Boone.
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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.