Life Sciences

  • July 05, 2024

    Novartis Allegedly Sat On Drug Rights To Avoid $1B Payment

    Drugmaker Novartis has allowed its right to develop a promising cancer treatment to "wither on the vine" to avoid having to pay nearly $1 billion under an interest purchase agreement with a Massachusetts company, a lawsuit filed in state court alleges.

  • July 05, 2024

    3rd Circ. Preview: Ponzi Scheme, Merck Vaccine Heat Up July

    The Third Circuit's July argument schedule is sizzling with several high-stakes cases, including two whistleblowers attempting to make drugmaker Merck answer for allegedly inducing the U.S. government to pay for substandard mumps vaccines.

  • July 05, 2024

    Top Federal Tax Cases To Watch In The 2nd Half Of 2024

    In the coming months, the U.S. Treasury and the IRS will defend rules designed to go after what they consider as abusive tax practices, including the economic substance doctrine, the Corporate Transparency Act and the moratorium on employee retention tax credits. Here, Law360 looks at key federal tax cases to watch in the rest of 2024.

  • July 05, 2024

    A&O Shearman-Led GSK Signs €1.4B Deal For Vaccines

    British pharma giant GlaxoSmithKline has amended its collaboration agreement with German biopharmaceutical company CureVac to acquire full rights to develop, manufacture and commercialize globally the candidate vaccines for influenza and COVID-19 in an approximately €1.4 billion ($1.5 billion) deal.

  • July 03, 2024

    HHS Scores Early Win In Boehringer's Medicare Pricing Suit

    A Connecticut federal judge on Wednesday sided with the U.S. Department of Health and Human Services in Boehringer Ingelheim's challenge to a new Medicare drug price negotiation program, rejecting the pharmaceutical company's claim that the program is unconstitutional.

  • July 03, 2024

    Humana Drops 6th Circ. Remand Bid In Ohio Collusion Suit

    Humana is being dismissed from Ohio's lawsuit accusing pharmacy benefit managers and insurers of conspiring to inflate prescription prices through international subsidiaries after the company reached a settlement agreement in June.

  • July 03, 2024

    Roche Says Stanford Profs Stole Cancer Detection Tech

    Roche Molecular Systems has accused Stanford University and several faculty members of swiping its proprietary cancer detection technology and secretly founding a new company with it, according to a suit filed in California federal court.

  • July 03, 2024

    Revived Skinny Label Case Is A Warning For Generics

    The Federal Circuit has made clear that generic-drug companies need to pay close attention to public statements when advertising drugs that still have patent-protected uses, even if their so-called skinny labels properly avoid references to those carved-out indications, attorneys say.

  • July 03, 2024

    Appeals Board Tosses Revived License Breach Dispute

    The Civilian Board of Contract Appeals has again tossed a dispute, previously revived by the Federal Circuit, alleging the U.S. Food and Drug Administration breached a software company's end-user license agreement, saying it lacks jurisdiction to enforce the agreement.

  • July 03, 2024

    Cooley DQ'd From IP Case Over Atty's Past Patent Work

    Cooley LLP was disqualified on Wednesday from representing a pharmaceutical customer-support software company against patent infringement claims in Delaware, with the district court citing a Cooley partner's prior work representing the plaintiff and Cooley's refusal to screen its attorney.

  • July 03, 2024

    Penile Implant Doc Seeks $7M Atty Fees, Costs In $18M IP Win

    A urologist who won $18.3 million in royalties and damages after a jury found a rival stole his penile implant trade secrets and infringed his intellectual property asked a California federal judge for $6.5 million in attorney fees and $614,000 in costs, saying he is owed the funds as the prevailing party in the litigation.

  • July 03, 2024

    4 Mass. Rulings You Might Have Missed In June

    Massachusetts state courts last month dealt with thorny contract disputes, mistakenly disclosed emails between a defendant and an attorney, and a company's overtime policy change that may not have been spelled out to workers.

  • July 03, 2024

    1st Circ. Hands Hearing Loss Biotech Win In Stock-Drop Suit

    A panel of the First Circuit declined to revive an investor class action alleging that a hearing loss treatment company and some of its executives concealed disappointing clinical trial results, saying there was no evidence the company had knowingly made false statements about the trial.

  • July 03, 2024

    Cerevel Investors Allege Insider Trades Pre-$8.7B AbbVie Deal

    A pension fund shareholder of Cerevel Therapeutics Holdings Inc. has sued the biopharmaceutical company in Delaware's Court of Chancery, seeking documents to investigate potential fiduciary duty breaches and possible insider trading shortly before the company announced its pending $8.7 billion merger with AbbVie Inc.

  • July 03, 2024

    After Chevron Deference: What Lawyers Need To Know

    This term, the U.S. Supreme Court overturned Chevron deference, a precedent established 40 years ago that said when judges could defer to federal agencies' interpretations of law in rulemaking. Here, catch up with Law360's coverage of what is likely to happen next.

  • July 03, 2024

    Chancery Tosses Challenge To $3B AstraZeneca Viela Bio Sale

    AstraZeneca PLC and a U.K. affiliate beat late Tuesday a Delaware Court of Chancery stockholder suit accusing the company of orchestrating an underpriced, $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc. in order to clear the way for AstraZeneca's purchase of a larger competitor.

  • July 03, 2024

    Quest Diagnostics Paying $985M For OMERS' LifeLabs

    Canadian law firm McCarthy Tétrault LLP is guiding New Jersey-based Quest Diagnostics on a newly inked deal to buy LifeLabs from the Ontario Municipal Employees Retirement System, or OMERS, for about $985 million, Quest said Wednesday. 

  • July 02, 2024

    FTC Investigating Teva Inhaler Patent Listings, Report Says

    The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals after it refused to remove inhaler patents from a key federal database, according to a Washington Post report citing confidential agency documents.

  • July 02, 2024

    Chamber, Pharma Slam Colorado Drug Price Controls

    The U.S. Chamber of Commerce and a prominent pharmaceutical industry group have urged a Colorado federal court to bar a state review board from setting price controls on prescription drugs, arguing that the practice is "irreconcilable" with federal patent law.

  • July 02, 2024

    Biotech Biz Co-Directors Sue Each Other In Del., Cite Breaches

    A California-based biotech company once researching a new class of antiviral therapy for COVID-19 is now the subject of dissolution proceedings in Delaware's Court of Chancery, after the company's two directors filed dueling lawsuits alleging fiduciary duty breaches and a board-level stalemate.

  • July 02, 2024

    Pharma Co. Scores Exit In Investor Suit Over Primate Imports

    A Massachusetts federal judge tossed every claim in a proposed class action claiming that pharmaceutical company Charles River Laboratories and its executives concealed their involvement in the illegal importation of nonhuman primates for research, ruling that the disputed statements are not false or misleading.

  • July 02, 2024

    McKinsey Wants To Arbitrate Ex-Partner's Defamation Suit

    McKinsey & Co. has urged a New York state judge to send to arbitration or dismiss a former partner's defamation lawsuit alleging the consulting giant tried to make him a scapegoat for purported evidence destruction amid a U.S. Department of Justice probe into McKinsey's work with opioid makers.

  • July 02, 2024

    Beasley Allen Slams J&J's DQ Bid 'Check-Up' In Talc Tort

    The Beasley Allen Law Firm and Johnson & Johnson continue to spar over the firm and attorney Andy Birchfield's role in long-running federal and state mass torts over talcum powder injuries, with the firm calling out J&J on Tuesday for "prodding" the New Jersey courts to boot the lawyers from the litigation.

  • July 02, 2024

    High Court Agrees To Review FDA's Flavored E-Cig Denial

    The U.S. Supreme Court on Tuesday granted the U.S. Food and Drug Administration's petition to review a Fifth Circuit decision overturning its denial of a flavored e-cigarette marketing application.

  • July 01, 2024

    High Court's 1-2 Punch Sets Up Long-Standing Regs For KO

    By ending its term with a stinging combination against federal agencies, the U.S. Supreme Court's conservative bloc left behind a bruised bureaucracy and a regulatory system that's now vulnerable to a barrage of incoming attacks.

Expert Analysis

  • How Cannabis Rescheduling May Alter Paraphernalia Imports

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    The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.

  • What The NYSE Proposed Delisting Rule Could Mean For Cos.

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    The New York Stock Exchange's recently proposed rule would provide the exchange with discretionary authority to commence delisting proceedings for a company substantially shifting its primary business focus, raising concerns for NYSE-listed companies over the exact definition of the exchange's proposed "substantially different" standard, say attorneys at Winston & Strawn.

  • FDA Warning Indicates Scrutiny Of Regenerative Health Cos.

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    The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.

  • 2 Regulatory Approaches To Psychedelic Clinical Trials

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    Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.

  • Opinion

    Bankruptcy Judges Can Justly Resolve Mass Tort Cases

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    Johnson & Johnson’s recent announcement of a prepackaged reorganization plan for its talc unit highlights that Chapter 11 is a continually evolving living statute that can address new types of problems with reorganization, value and job preservation, and just treatment for creditors, says Kenneth Rosen at Ken Rosen Advisors PC.

  • Series

    Fishing Makes Me A Better Lawyer

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    Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge​​​​​​​ at Robinson Bradshaw.

  • A Healthier Legal Industry Starts With Emotional Intelligence

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    The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.

  • To Make Your Legal Writing Clear, Emulate A Master Chef

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    To deliver clear and effective written advocacy, lawyers should follow the model of a fine dining chef — seasoning a foundation of pure facts with punchy descriptors, spicing it up with analogies, refining the recipe and trimming the fat — thus catering to a sophisticated audience of decision-makers, says Reuben Guttman at Guttman Buschner.

  • Circuit Judge Writes An Opinion, AI Helps: What Now?

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    Last week's Eleventh Circuit opinion in Snell v. United Specialty Insurance, notable for a concurrence outlining the use of artificial intelligence to evaluate a term's common meaning, is hopefully the first step toward developing a coherent basis for the judiciary's generative AI use, says David Zaslowsky at Baker McKenzie.

  • Fed. Circ. Rulings Crystallize Polymorph Patent 'Obviousness'

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    A comparison of two recent Federal Circuit obviousness challenge decisions regarding polymorph patents provides helpful insight into the assessment of screening arguments, particularly the issue of reasonable expectation of success, say Michael Green and John Molenda at Steptoe.

  • DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges

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    The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.

  • 3 Infringement Defenses To Consider 10 Years Post-Nautilus

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    In the 10 years since the U.S. Supreme Court’s influential Nautilus ruling, the spirit of the “amenable to construction” test that the opinion rejected persists with many patent litigators and judges, so patent infringement defense counsel should always consider several key arguments, says John Vandenberg at Klarquist Sparkman.

  • 9th Circ. COVID 'Cure' Case Shows Perks Of Puffery Defense

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    The Ninth Circuit's March decision in a case surrounding a company's statements about a potential COVID-19 cure may encourage defendants to assert puffery defenses in securities fraud cases, particularly in those involving optimistic statements about breakthrough drugs that are still untested, say attorneys at Cahill Gordon.

  • FTC Focus: Exploring The Meaning Of Orange Book Letters

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    The Federal Trade Commission recently announced an expansion of its campaign to promote competition by targeting pharmaceutical manufacturers' improper Orange Book patent listings, but there is a question of whether and how this helps generic entrants, say Colin Kass and David Munkittrick at Proskauer.

  • Investors Can Aid In The Acceptance Of Psychedelic Medicine

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    Psychedelic medicine is ready to have its breakthrough moment, and although it still faces political, legal and communications challenges, private equity investors can play a significant role in changing the public perception on psychedelics from taboo to acceptance, say Kimberly Chew at Husch Blackwell, Charlie Panfil at the Daschle Group and Ethan Lutz at FTI Consulting.

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