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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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Opinion
New Rule 702 Helps Judges Keep Bad Science Out Of Court
A court's recent decision to exclude dubious testimony from the plaintiffs' experts in multidistrict litigation over acetaminophen highlights the responsibility that judges have to keep questionable scientific evidence out of courtrooms, particularly under recent amendments to Federal Rule of Evidence 702, says Sherman Joyce at the American Tort Reform Association.
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SG's Office Is Case Study To Help Close Legal Gender Gap
As women continue to be underrepresented in the upper echelons of the legal profession, law firms could learn from the example set by the Office of the Solicitor General, where culture and workplace policies have helped foster greater gender equality, say attorneys at Ocean Tomo.
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Opinion
Patent Waiver For COVID Meds Would Harm US Biopharma
If the Biden administration backs the World Trade Organization in waiving patent rights on COVID-19 treatments, it would negatively affect the U.S. biopharmaceutical industry and help foreign competitors, without necessarily expanding global access to COVID-19 care, says clinical pathologist Wolfgang Klietmann.
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Skirting Anti-Kickback Causation Standard Amid Circuit Split
Amid the federal circuit court split over the causation standard applicable to False Claims Act cases involving Anti-Kickback Statute violations, which the First Circuit will soon consider in U.S. v. Regeneron, litigators aiming to circumvent the heightened standard should contemplate certain strategies, say Matthew Modafferi and Terence Park at Frier Levitt.
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10 Lessons From A Deep Dive Into IP Damages
Decisions on challenging an intellectual property expert's opinion can benefit from the in-depth study of court rulings on admissibility grounds, where the findings include the fact that patent cases see the most challenges of any IP area, say Deepa Sundararaman and Cleve Tyler at Berkeley Research.
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What Shareholder Approval Rule Changes Mean For Cos.
The U.S. Securities and Exchange Commission recently approved proposed rule changes to shareholder requirements by the New York Stock Exchange, an approval that will benefit listed companies in many ways, including by making it easier to raise capital from passive investors, say attorneys at Baker Botts.
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Reimagining Law Firm Culture To Break The Cycle Of Burnout
While attorney burnout remains a perennial issue in the legal profession, shifting post-pandemic expectations mean that law firms must adapt their office cultures to retain talent, say Kevin Henderson and Eric Pacifici at SMB Law Group.
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Expediting Psychedelics Approvals In The EU, UK, Australia
Accelerated pathways for regulatory approvals for psychedelic drugs in the European Union, U.K. and Australia is indispensable to facilitate a seamless advancement of treatments from the research environment to the consumer, say Kimberly Chew at Husch Blackwell, and Ana Dukic and Sabrina Ramkellawan at AxialBridge.
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Series
ESG Around The World: Brazil
Environmental, social and governance issues have increasingly translated into new legislation in Brazil since 2020, and in the wake of these recently enacted regulations, we are likely to see a growing number of legal disputes in the largest South American country related to ESG issues such as greenwashing if companies are not prepared to adequately adapt and comply, say attorneys at Mattos Filho.
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Opinion
Gilead Ruling Signals That Innovating Can Lead To Liability
A California appeals court's ruling last month in Gilead Life Sciences v. Superior Court of San Francisco that a drug manufacturer can be held liable for delaying the introduction of an improved version of its medication raises concerns about the chilling effects that expansive product liability claims may have on innovation, says Gary Myers at the University of Missouri School of Law.
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Opinion
Vidal Should Amend USPTO Precedent In Automaker Review
U.S. Patent and Trademark Office Director Kathi Vidal's recent decision to review Ford and Honda patent challenges that were rejected by the Patent Trial and Appeal Board provides an opportunity to revisit precedents that have unfairly denied companies a fair review process and align them with commonsense principles of legal equity, says former Sen. Patrick Leahy.
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Grant Compliance Takeaways From Ga. Tech's FCA Settlement
Georgia Tech’s recent False Claims Act settlement over its failure to detect compliance shortcomings in a grant program was unique in that it involved a voluntary repayment of funds prior to the resolution, offering a few key lessons for universities receiving research funding from the government, says Jonathan Porter at Husch Blackwell.
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Series
Competing In Dressage Makes Me A Better Lawyer
My lifelong participation in the sport of dressage — often called ballet on horses — has proven that several skills developed through training and competition are transferable to legal work, especially the ability to harness focus, persistence and versatility when negotiating a deal, says Stephanie Coco at V&E.
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How Poor Governance, Weak Contracts Harm Cannabis Cos.
Decades into cannabis decriminalization and legalization, many companies in the industry still operate on a handshake basis or fail to keep even minimally required records, which can have devastating effects and lead to costly, business-killing litigation, says Griffen Thorne at Harris Bricken.
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Del. Ruling Adds Momentum For Caremark Plaintiffs
The Delaware Supreme Court's recent opinion in Lebanon County Employees' Retirement Fund v. Collis could be viewed as expanding plaintiffs' ability to viably plead a Caremark claim against directors, so Delaware companies should be on heightened alert and focus on creating a record of board oversight, say attorneys at V&E.