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Life Sciences
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March 28, 2024
McCarter & English Wins Extra $1.8M In Client Billing Suit
A Connecticut federal judge has found that McCarter & English LLP is entitled to another $1.8 million on top of the $1.85 million it has already been granted as a prejudgment remedy in a contract dispute, saying the former client on the hook for the award must also disclose assets under oath that could support the total $3.65 million award.
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March 27, 2024
Merger News Boosts Rivals, 'Shadow Trading' Jury Told
Medivation's 2016 sale announcement would have an expected positive "spillover effect" on rival Incyte's stock price, a U.S. Securities and Exchange Commission expert testified Wednesday in a "shadow trading" trial over claims an ex-Medivation executive exploited confidential news of his company's imminent acquisition to buy shares in the competitor.
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March 27, 2024
Latham, Cooley Steer Oncology Firm's $100M IPO
Clinical-stage oncology firm Boundless Bio Inc. raised a $100 million initial public offering at the middle of its price range late on Wednesday, represented by Latham & Watkins LLP and underwriters' counsel Cooley LLP, joining a potentially recovering IPO market.
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March 27, 2024
ITC Judge Recommends Exclusion Order In Tourniquet IP Row
A U.S. International Trade Commission administrative judge has recommended the commission order that imports of products related to blood flow restriction be banned, handing a win to a pair of American medical product manufacturers.
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March 27, 2024
NY AG, Others Blast Sandoz Deal 'Tax' On Future Settlements
New York's attorney general was one of three objectors Tuesday to a provision in Sandoz's proposed $265 million settlement with a class of drug wholesalers in Pennsylvania federal court that they say will delay any future generic-drug price-fixing litigation deals by taxing agreements over $119.25 million.
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March 27, 2024
Eli Lilly Age Bias Suit Over Promotions Nabs Collective Status
An age discrimination suit accusing Eli Lilly of passing over older workers for promotions in favor of millennials can move forward as a collective action, an Indiana federal judge ruled, finding thousands of workers may have been affected by the same policy.
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March 27, 2024
BCBS Can't Escape Therapy Coverage Suit
A North Carolina federal judge refused to throw out a proposed class action accusing Blue Cross Blue Shield of unlawfully refusing to cover proton beam therapy to treat prostate cancer, saying the case could remain in court if a state worker health plan is added as a defendant.
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March 26, 2024
Jackson Paints Abortion Clash As Microcosm Of Bigger Brawl
A war of words Tuesday at the U.S. Supreme Court over access to abortion medication marked a climactic moment after a lengthy legal slugfest. But probing questions from Justice Ketanji Brown Jackson illustrated that the main event for reproductive rights was also simply a single round in a much larger fight over the government's regulatory powers.
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March 26, 2024
Banker Describes Confidential Work In 'Shadow Trading' Trial
An Evercore investment banker who worked on Medivation's 2016 sale to Pfizer testified Tuesday in the U.S. Securities and Exchange Commission's novel "shadow trading" trial, saying the defendant was involved in a confidential process that identified biopharma company Incyte as comparable to Medivation — information the defendant is accused of trading on.
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March 26, 2024
Pharmacy Owner Gets 42 Months For $25M Kickback Scam
A medical equipment pharmacy owner was sentenced to 42 months in prison Tuesday for carrying out a $25 million kickback scheme with a patient-leads broker as part of a scheme to falsely bill the federal government for care.
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March 26, 2024
FTC Urges Court To Pause Novant's NC Hospital Deal
The Federal Trade Commission is urging a North Carolina federal court to pause Novant Health's $320 million deal for a pair of hospitals, contending the move would give Novant an "eye-popping" share of the hospital market in a Charlotte suburb.
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March 26, 2024
Opioid Public Nuisance Claims 'Unique,' Ohio High Court Told
Counsel for two Ohio counties that won a $650 million verdict against Walmart, CVS and Walgreens told the Ohio Supreme Court on Tuesday that opioids are a "unique" problem during oral arguments about whether the counties' public nuisance claims are blocked by the state's product liability law.
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March 26, 2024
In Abortion Case, Gorsuch Frets 'Rash' Of National Injunctions
U.S. Supreme Court Justice Neil Gorsuch renewed his criticisms of nationwide injunctions Tuesday, saying a Texas judge's universal order limiting access to popular abortion medication mifepristone turned a potentially small legal challenge into a national debate.
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March 26, 2024
6 Firms Build $340M SPAC Merger For AI-Driven Medicine Biz
Precision medicine company OmnigenicsAI Corp. on Tuesday announced it and artificial intelligence-enabled preventative medicine company MultiplAI Health Ltd., which it recently agreed to acquire, will go public through a merger with blank-check company APx Acquisition Corp. I in a deal built by six firms, valuing the two businesses at a combined $340 million.
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March 26, 2024
Pet Drug Maker Faces EU Probe For Axing Pipeline Dog Med
The European Union's antitrust authority said Tuesday it has launched a probe into whether Zoetis Inc. had illegally blocked competition by acquiring a pipeline product designed to treat pain in dogs and axing a potential rival's deal to sell it.
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March 26, 2024
High Court Wary Of Bid To Limit Abortion Pill Access
The U.S. Supreme Court seemed skeptical Tuesday of efforts by anti-abortion groups to severely limit access to the abortion medication mifepristone, with several justices appearing unconvinced that the groups had the right to sue over the Food and Drug Administration's regulation of the pill.
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March 25, 2024
SEC Kicks Off 'Shadow Trading' Case Against Drug Exec
The U.S. Securities and Exchange Commission said at the start of a California federal "shadow trading" trial that a former Medivation executive made $120,000 by buying stock in a rival after learning his company would be acquired by Pfizer, while the defense said he didn't believe the trades violated securities law.
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March 25, 2024
COVID 'Cure' Claims Can't Sustain Fraud Suit, 9th Circ. Rules
A biopharmaceutical company's "enthusiastic" statements to Fox News and others about a potential COVID-19 cure do not amount to fraud and cannot sustain a shareholder lawsuit accusing the company and its top executives of deceiving the market by pretending that a breakthrough was much more consequential than it actually was, the Ninth Circuit ruled on Monday.
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March 25, 2024
J&J Exec 'Shocked' Over Atty's Ties With Talc Plaintiffs
Johnson & Johnson's vice president of litigation said on Monday he was "utterly shocked and appalled" upon learning an attorney who served as the company's outside counsel was working with its adversary Beasley Allen Law Firm and one of its attorneys in litigation over the alleged link between the company's talcum powder products and ovarian cancer.
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March 25, 2024
Amgen Sues Colorado After Drug's 'Unaffordable' Rating
Amgen has sued the Colorado Prescription Drug Affordability Review Board in federal court after receiving a determination that one of its arthritis drugs is "unaffordable," saying the board is using unconstitutionally "unguided discretion" to impose arbitrary price controls on patent-protected drugs.
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March 25, 2024
PacBio CEO's Words Haunt Patent Invalidity Arguments
A California federal judge concluded Monday that statements made by the chief executive officer of biotech company Pacific Biosciences to investors at an earnings call undermined the company's invalidity arguments in a patent suit it's facing.
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March 25, 2024
PTAB Splits On Medtronic Bladder And Bowel Control Patents
The Patent Trial and Appeal Board has issued split decisions that upheld one Medtronic patent covering an electrical stimulation system used to treat loss of bladder and bowel control and trimmed another patent in challenges brought by a smaller rival in the medical device field.
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March 25, 2024
What To Watch As Opioid Litigation Goes To Ohio High Court
The Ohio Supreme Court on Tuesday will become only the second state high court to hear oral arguments on whether the opioid epidemic is a public nuisance, the controversial legal theory underpinning numerous suits across the country including a $650 million award that two Ohio counties won against Walmart, CVS and Walgreens.
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March 25, 2024
Fed. Circ. Dissent Raises Alarm Over IP Safe Harbor Use
A California federal judge rightly dismissed Edwards Lifesciences Corp.'s infringement suit against Meril Life Sciences Pvt. Ltd., the Federal Circuit held Monday, with a dissent arguing such a holding would "create future mischief."
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March 25, 2024
FTC Intervenes In Teva-Amneal Row To Push Patent Delisting
The Federal Trade Commission waded into another patent fight Friday with a New Jersey federal court amicus brief targeting the same Teva Pharmaceuticals asthma inhaler patents it has already included in a roster of over 100 it believes were improperly listed in a key federal database.
Expert Analysis
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Tips For Litigating Against Pro Se Parties In Complex Disputes
Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.
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What Pharma Cos. Must Know About FDA Off-Label Guidance
The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.
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It's Time To Prescribe Frameworks For AI-Driven Health Care
As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.
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The Murky World Of IP Protection For Gene-Edited Plants
The recently filed Corteva v. Inari lawsuit, which accuses a plant trait developer of using a front company for commercial development, underscores the legal challenges in protecting and determining the ownership of new, genetically edited plant varieties, and emphasizes why joint development arrangements must be carefully navigated, say Andrew Zappia and Tate Tischner at Troutman Pepper.
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New Initiatives Will Advance Corporate Biodiversity Reporting
Two important recent developments — the launch of the Taskforce on Nature-related Financial Disclosures' framework on nature and biodiversity reporting, and Nature Action 100's announcement of the 100 companies it plans to engage on biodiversity issues — will help bring biodiversity disclosures into the mainstream, say David Woodcock and Maria Banda at Gibson Dunn.
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Opinion
Alternative Patents Would Solve Many Inventor Woes
A fundamental reform that gives inventors the option of alternative patents tailored to the value of an invention offers a potential solution for resolving patent-system problems, says John Powers of The Powers IP Law Firm.
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Class Action Defense: Don't Give Up On Bristol-Myers Squibb
Federal appellate court decisions in the six years since the U.S. Supreme Court decided Bristol-Myers Squibb show that it's anyone's ballgame in class action jurisdictional arguments, so defendants are encouraged to consider carefully whether, where and when arguing lack of specific personal jurisdiction may be advantageous, say attorneys at K&L Gates.
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Pro Bono Work Is Powerful Self-Help For Attorneys
Oct. 22-28 is Pro Bono Week, serving as a useful reminder that offering free legal help to the public can help attorneys expand their legal toolbox, forge community relationships and create human connections, despite the challenges of this kind of work, says Orlando Lopez at Culhane Meadows.
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FDA Proposals Clarify Rules For Devices With Predicates
As medical devices continue to grow in complexity, U.S. Food and Drug Administration policies surrounding premarket submissions for devices with existing predicates have fallen behind, but new draft guidances from the agency help fill in some gaps, say attorneys at Hogan Lovells.
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State Regs Sow Discord Between Cannabis, Hemp Industries
Connecticut, Maryland and Washington are the latest states choosing to require intoxicating hemp products to comply with the states' recreational marijuana laws, resulting in a widening rift between cannabis and hemp as Congress works on crafting new hemp legislation within the upcoming 2023 Farm Bill, say attorneys at Wilson Elser.
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Series
Playing In A Rock Cover Band Makes Me A Better Lawyer
Performing in a classic rock cover band has driven me to hone several skills — including focus, organization and networking — that have benefited my professional development, demonstrating that taking time to follow your muse outside of work can be a boon to your career, says Michael Gambro at Cadwalader.
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AI May Help Patent Applicants With Functional Claiming
The U.S. Supreme Court recently set what many patent practitioners consider too high a bar for functional claims, but artificial intelligence could alter functionality analysis — conferring predictability that alleviates courts' concerns that practicing the claims requires undue experimentation, say Brian Nolan and Ying-Zi Yang at Mayer Brown.
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How Int'l Regulatory Collabs Can Expedite Pharma Approvals
Recent announcements highlight the growing importance of international regulatory collaboration for drug approval, which can greatly streamline the process for companies seeking to market their drugs in other countries, say Geneviève Michaux and Christina Markus at King & Spalding.
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How Executives' Deposition Standards Can Differ
The recent Trustees of Purdue University v. Wolfspeed Inc. decision granting a motion on a protective order for a high-level witness shows how courts can vary in the application of the apex doctrine and analysis under Rule 26 of the Federal Rule of Civil Procedure, say Genevieve Halpenny and John Cook at Barclay Damon.
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Series
The Pop Culture Docket: Judge Espinosa On 'Lincoln Lawyer'
The murder trials in Netflix’s “The Lincoln Lawyer” illustrate the stark contrast between the ethical high ground that fosters and maintains the criminal justice system's integrity, and the ethical abyss that can undermine it, with an important reminder for all legal practitioners, say Judge Adam Espinosa and Andrew Howard at the Colorado 2nd Judicial District Court.