Life Sciences

  • 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."

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • May 23, 2024

    Fed. Circ. Upends Inventors' Interference Win Over Time-Bar

    The Patent Trial and Appeal Board wrongly chose inventors tied to Cook Medical, rather than ones tied to Medtronic, when determining who should prevail in an interference proceeding over catheters, the Federal Circuit held Thursday.

  • May 23, 2024

    Ex-Judge Pushed False Narrative On Atty Romance, Firm Says

    U.S. Bankruptcy Judge David R. Jones of Texas, who resigned last year after his secret relationship with a Jackson Walker LLP partner was revealed, attempted to head off rumors about the relationship by asking the firm to file a false, partial disclosure in 2022, the firm alleged.

  • May 23, 2024

    Merck To Pay $600M For KKR-Backed Life Sciences Biz

    Menlo Park, California-based Gamma Biosciences said Thursday it has agreed to sell its operating company Mirus Bio for $600 million in cash to Merck KGaA, inking the deal under the guidance of Sidley Austin LLP. 

  • May 23, 2024

    Just 57% Of Complex Global Deals Closed Since 2020

    About 43% of complex cross-border global deals have failed to close since the start of 2020, while the remaining 57% did close but were highly likely to involve remedies, according to a new report from Weil Gotshal & Manges LLP.

  • May 23, 2024

    J&J Loses Expedited Bid For Beasley Allen Docs In Talc MDL

    Johnson & Johnson has lost its bid in New Jersey federal court to have the Beasley Allen Law Firm quickly produce documents related to what J&J said seems to be an "intentional effort" by the firm to "bias the vote" against a proposed $6.5 billion reorganization plan for its talc subsidiary.

  • May 23, 2024

    GSK, Boehringer Prevail In 1st Zantac Cancer Trial

    A Chicago jury found Thursday that Zantac heartburn medication and its generic counterparts sold by GlaxoSmithKline and Boehringer Ingelheim are not responsible for an Illinois woman's colon cancer and her subsequent, debilitating symptoms, handing the drug companies a decisive victory in the first of hundreds of such cases to go to trial.

  • May 22, 2024

    Inventor To Take $102M IP Malpractice Row To Ga. High Court

    A neurosurgeon pursuing a nearly $102 million legal malpractice case against FisherBroyles LLP and a legal services contractor over a missed patent filing deadline said Wednesday that he is planning to take the dispute to the highest court in the Peach State.

  • May 22, 2024

    Cancer Patients Target J&J Talc Unit's Asset Shuffles

    Cancer patients who have sued Johnson & Johnson alleging that its talcum powder caused their illness alleged Wednesday that the company has tried to intentionally prevent tort victims from getting their day in court through a scheme of fraudulent corporate transactions.

  • May 22, 2024

    Justices' CFPB Alliance May Save SEC Courts, Not Chevron

    A four-justice concurrence to the U.S. Supreme Court's decision upholding the Consumer Financial Protection Bureau's unique funding scheme last week carries implications for other cases pending before the court that challenge the so-called administrative state, or the permanent cadre of regulatory agencies and career government enforcers who hold sway over vast swaths of American economic life.

  • May 22, 2024

    FDA Must Act On Sexual Side Effects Of SSRIs, Suit Says

    The Food and Drug Administration should be forced to warn the public about the serious sexual side effects of a certain class of depression medications after sitting on a petition asking it to do just that for more than six years, a new lawsuit says.

  • May 22, 2024

    Evidence Shaky In First Zantac Cancer Trial, Drugmakers Say

    Attorneys for GlaxoSmithKline and Boehringer Ingelheim told a Chicago jury Wednesday that no one besides a plaintiff's paid witnesses have said publicly that Zantac heartburn medication causes colon cancer, calling on the jurors to reject claims that the companies owe $640 million for a woman's cancer diagnosis.

  • May 22, 2024

    Doc Gets 3 Mos. For Alexion Trades Despite 'Meaningful Job'

    A doctor was sentenced to three months in prison Wednesday for insider trading on an Alexion Pharmaceuticals acquisition, with a Manhattan federal judge saying the defendant's treatment of critically ill, underserved kidney disease patients does not amount to a "get out of jail free card."

  • May 22, 2024

    DuPont 'Document Dump' Rattles NC In PFAS Suit

    North Carolina and DuPont on Wednesday battled over what the state called a roughly 5 million-page "document dump" ahead of a looming June 3 discovery deadline in its contamination lawsuit, irking a business court judge in the process.

Expert Analysis

  • Opinion

    New Rule 702 Helps Judges Keep Bad Science Out Of Court

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    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.

  • SG's Office Is Case Study To Help Close Legal Gender Gap

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    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.

  • Opinion

    Patent Waiver For COVID Meds Would Harm US Biopharma

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    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.

  • Skirting Anti-Kickback Causation Standard Amid Circuit Split

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    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.

  • 10 Lessons From A Deep Dive Into IP Damages

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    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.

  • What Shareholder Approval Rule Changes Mean For Cos.

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    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.

  • Reimagining Law Firm Culture To Break The Cycle Of Burnout

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    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.

  • Expediting Psychedelics Approvals In The EU, UK, Australia

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    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.

  • Series

    ESG Around The World: Brazil

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    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.

  • Opinion

    Gilead Ruling Signals That Innovating Can Lead To Liability

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    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.

  • Opinion

    Vidal Should Amend USPTO Precedent In Automaker Review

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    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.

  • Grant Compliance Takeaways From Ga. Tech's FCA Settlement

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    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.

  • Series

    Competing In Dressage Makes Me A Better Lawyer

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    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.

  • How Poor Governance, Weak Contracts Harm Cannabis Cos.

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    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.

  • Del. Ruling Adds Momentum For Caremark Plaintiffs

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    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.

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