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Life Sciences
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March 29, 2024
Biotech Co. Inflated Gene Therapy Prospects, Investors Claim
Massachusetts-based biotechnology company Bluebird Bio Inc. misled investors by understating the safety concerns of a gene therapy for sickle cell, causing damages when stock prices dropped, according to a proposed class action suit filed Thursday in Massachusetts district court.
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March 28, 2024
Penile Implant Doc Awarded $18.3M After Trade Secrets Trial
A California federal judge on Thursday awarded more than $18.3 million in royalties and damages to a urologist who won a jury trial verdict last year over a competitor's theft of penile implant trade secrets.
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March 28, 2024
Accused 'Shadow Trader' Can't Recall Why He Bought Stock
A California federal jury considering regulators' claims that an ex-Medivation executive engaged in "shadow trading" of a rival's stock heard video-recorded testimony Thursday from the executive, who said he couldn't recall why he purchased the securities just minutes after learning Pfizer was close to acquiring his own company.
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March 28, 2024
Fed. Circ. Won't Stop Sales Of Heart Valve Testers
The Federal Circuit held Thursday that a California federal judge wasn't wrong to deny an injunction request after declaring that a "substantial question of validity" had been raised over a patent covering a way of testing the durability of a heart valve.
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March 28, 2024
2 Firms Steer Close Of Hildred's $750M Continuation Fund
Healthcare-focused private equity firm Hildred Capital, advised by Kirkland & Ellis LLP and Lowenstein Sandler LLP, on Thursday said it clinched a multiasset continuation fund after securing more than $750 million in commitments, which will be used to acquire two companies from the firm's previous funds.
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March 28, 2024
Pfizer Wants Moderna Vax IP Case Paused For PTAB Review
Pfizer Inc. and BioNTech SE have asked a Massachusetts federal court to put on hold a COVID-19 vaccine patent case brought by rival biotechnology giant Moderna Inc. while they await a decision from the Patent Trial and Appeal Board on the validity of two of the three patents at issue.
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March 28, 2024
Fees Awarded For 'Feeble' Milk Vitamin Eligibility Argument
A Delaware federal judge has ordered ChromaDex Inc. and Dartmouth College to pay attorney fees to Elysium Health for making a "feeble" and failed argument defending their milk vitamin patents from an eligibility challenge, saying he's rarely been more confident that a suit was unreasonable.
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March 28, 2024
Rite Aid Says It Has Creditor Deal, Gets OK For Plan Vote
A New Jersey bankruptcy judge Thursday gave Rite Aid the go-ahead to send its Chapter 11 plan out for a creditor vote after hearing it has reached a $47.5 million deal with unsecured creditors and is close to a settlement on state and federal claims over drug sales.
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March 28, 2024
MSG-Maker Says Chinese Exporters Skirting Duties Via Malaysia
The U.S. arm of Japanese monosodium glutamate manufacturer Ajinomoto Co. Inc. claims Chinese MSG producers are using a Malaysian competitor to evade duties on the umami flavor enhancer, saying the Malaysian company's facility isn't big enough to produce the product.
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March 28, 2024
Implant Maker's Bribe Case Ripe For Trimming, Judge Says
A money laundering charge levied against implant manufacturer SpineFrontier Inc. and its executives may be dropped from the broader bribery and kickback prosecution as a Boston federal judge Thursday struggled to square up how the company could have allegedly concealed the unlawful transfers to surgeons while also disclosing them publicly.
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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.
Expert Analysis
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Boeing Opinion Strikes Blow Against Overpayment Theory
The Fifth Circuit's decision in Earl v. Boeing Co. casts doubt on consumers' standing to bring claims of overpayment for products later revealed to have defects — and suggests that it's more likely that those products would have been removed from the market, driving up the price of alternatives, say attorneys at Bush Seyferth.
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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.