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Life Sciences
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April 09, 2025
Bristol Myers Beats Pomalyst Antitrust Suit Alleging IP Fraud
A New York federal judge has tossed a proposed antitrust class action accusing Bristol Myers' Celgene subsidiary of fraudulently obtaining patents and filing "sham" infringement lawsuits to block generic versions of its blood-cancer drug Pomalyst, finding that the indirect drug buyer plaintiffs lack standing and haven't plausibly alleged fraud.
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April 09, 2025
Ga. Hospital Faces Suit Over Toddler's Death From Ant Bites
The parents of a Georgia toddler who allegedly died from an allergic reaction to ant bites have filed a wrongful death lawsuit against Piedmont Healthcare Inc. and others, claiming their daughter died "needlessly because of sub-standard medical care" she received after being rushed to the hospital.
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April 09, 2025
FDA: Pharmacies' Bid To Keep Making Eli Lilly Drug Is 'Absurd'
The U.S. Food and Drug Administration said it played by the book when it removed Eli Lilly & Co.'s lucrative weight loss drug from the shortage list and ended compounding pharmacies' right to make the drug, asking a Texas federal judge to grant judgment in the agency's favor.
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April 09, 2025
2nd Circ. Allows Takeda To Appeal Actos Antitrust Class Cert.
A split Second Circuit will allow Takeda Pharmaceuticals Co. to immediately appeal a New York federal judge's ruling certifying two classes of direct purchasers and end payors in consolidated antitrust actions accusing the company of unlawfully inflating the price of its diabetes treatment Actos by delaying the entry of generic alternatives.
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April 09, 2025
White & Case-Led EQT Inks Nearly $3B Health Deal With KKR
KKR & Co. has agreed to acquire Sweden's Karo Healthcare from EQT, marking the handover of a company that has quadrupled in sales over the past five years, the companies said Wednesday, in a deal worth up to a reported 2.6 billion euros ($2.85 billion).
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April 09, 2025
FDA Slow To Act On Hemp And Vapes, Congress Hears
Federal health officials' inaction on flavored vapes and hemp-derived consumables has led to a proliferation of loosely regulated products, members of a U.S. House of Representatives committee heard on Wednesday.
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April 09, 2025
Ex-Client Wants $1M Cut From McCarter & English Fee Win
A former McCarter & English LLP client on Wednesday sought to shave more than $1 million from the law firm's $3.8 million win in an attorney fee feud, challenging interest calculations that nearly doubled underlying compensatory damages rulings.
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April 09, 2025
Religious Mission Justifies Philly Injection Site, 3rd Circ. Told
Counsel for a nonprofit seeking to open a safe injection site in Philadelphia told the Third Circuit Wednesday that it qualified as a religious organization immune from prosecution, despite not having any spiritual language in its incorporation documents.
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April 09, 2025
New Mexico 3rd State To Legalize Psilocybin Therapy
New Mexico Gov. Michelle Lujan Grisham has signed a bill legalizing psilocybin therapy in the state, making it the third state to create legal access to the active ingredient in psychoactive mushrooms.
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April 09, 2025
Pillsbury Expands Houston Office With 3 Corporate Attys
Pillsbury Winthrop Shaw Pittman LLP has added three attorneys with unique dealmaking experience to its growing Houston office.
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April 08, 2025
Jazz Agrees To Pay $145M To Settle Xyrem Antitrust Fight
Jazz Pharmaceuticals has agreed to pay $145 million to resolve antitrust litigation accusing it of working with its rival Hikma Pharmaceuticals to stave off generic competitors to Jazz's narcolepsy drug Xyrem, the Ireland-based pharmaceutical company revealed Tuesday.
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April 08, 2025
Expert And 'Worthlessness Theory' Ejected In Valsartan MDL
Patients and insurers who claim they were ripped off when purchasing the contaminated blood pressure medication Valsartan won't be able to argue that the drug was worthless as a matter of law, a New Jersey federal judge overseeing the multidistrict litigation has ruled, casting doubt that the plaintiffs will secure a full refund for their purchase.
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April 08, 2025
Medicare Drug Price Plan Tramples Constitution, 3rd Circ. Told
New Jersey federal court rulings preserving the Centers for Medicare & Medicaid Services' ability to negotiate prices with drug companies should be overturned on constitutional grounds, pharmaceutical giants Novo Nordisk and Novartis told the Third Circuit during oral arguments Tuesday.
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April 08, 2025
Fed. Circ. Considers Sandoz's Bid To Undo $39M Patent Loss
The Federal Circuit on Tuesday grappled with Sandoz's challenge to a $39 million verdict against it in Allergan's eyelash growth drug patent infringement case, with one judge questioning the generic-drug maker's argument that a decade-old decision involving a similar patent forestalls the current case.
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April 08, 2025
Pacira Reaches IP Deal Allowing Generic Painkiller In 2030
Pacira BioSciences has agreed to settle a series of patent infringement lawsuits against Fresenius Kabi and other pharmaceutical companies over Pacira's drug Exparel, a long-acting injectable for managing postsurgical pain.
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April 08, 2025
Judge Preserves Psilocybin Trade Secrets Theft Suit
A Maryland federal judge has denied a British healthcare company's bid to dismiss a lawsuit alleging it stole trade secrets relating to a novel method of treating depression with psilocybin, the active ingredient in psychoactive mushrooms.
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April 08, 2025
Fed. Circ. Affirms Alkem's Generic Antibiotic Not Barred By IP
A Delaware federal court rightly found that Alkem Laboratories' generic version of Azurity Pharmaceuticals' antibiotic Firvanq doesn't infringe the latter's patent, the Federal Circuit said Tuesday.
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April 08, 2025
Bernstein Litowitz, Kessler Topaz Seek To Lead GSK Investors
Bernstein Litowitz Berger & Grossmann LLP and Kessler Topaz Meltzer & Check LLP are seeking lead counsel roles in a proposed securities class action against GSK PLC in Pennsylvania federal court, citing a long history of collaboration and billions recovered for shareholders.
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April 08, 2025
Longtime Cooley Life Sciences Ace Jumps To Wilson Sonsini
Wilson Sonsini Goodrich & Rosati PC has hired a former Cooley LLP partner for its corporate department to strengthen the services offered by its life sciences practice, it announced on Tuesday.
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April 07, 2025
Ruling Adds To Risk Of Patent Format Tied To Improvements
A Federal Circuit decision from last month has created pitfalls for entities using a type of patent claim that describes an improvement on previous technology, making the so-called Jepson format, which is already uncommon, even less appealing for applicants, attorneys said.
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April 07, 2025
Torrent Seeks Arbitration In Drug Commercialization Fight
A subsidiary of Indian multinational company Torrent Pharmaceuticals is urging a Delaware judge to force OWP Pharmaceuticals to arbitrate a dispute over issues that allegedly delayed the U.S. commercialization of its epilepsy and anti-seizure medications.
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April 07, 2025
Policy Group Tells 4th Circ. Drug Discount Law Needs Reform
The Fourth Circuit on Monday allowed a Boston-based think tank to file an amicus brief supporting a district court's injunction against a West Virginia law that pharmaceutical companies and lobbyists claim unconstitutionally expands a federal drug discount program.
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April 07, 2025
Birth Control Companies Escape Conn. Long-Arm Injury Suits
Eight women who claim to have suffered severe and debilitating injuries after a birth control device — the Filshie Clip — implanted in their body migrated cannot sue in Connecticut state court the companies that designed, manufactured and distributed the clip, a judge has ruled, saying he doesn't have jurisdiction over the out-of-state companies.
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April 07, 2025
Drug Buyers, Generics Cos. Fight Over Bellwether Litigation
Generic drug buyers vied Friday with the pharmaceutical companies they've accused of price-fixing over how to shape the first rounds of long-gestating Pennsylvania federal court litigation that the plaintiffs want heard in separate consecutive trials and that the drugmakers want combined.
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April 07, 2025
Incyte Can't Get Pretrial Win In Novartis Royalty Fight
A New York federal judge has disagreed with Incyte Corp.'s argument that its interpretation of a drug commercialization contract at the heart of a royalties dispute with Novartis Pharma AG is the right one, ahead of a jury trial scheduled next month.
Expert Analysis
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What Vinyl Acetate's Prop 65 Listing Means For Cos.
California's recent move to add vinyl acetate to the Proposition 65 list of carcinogens, with enforcement starting later this year, will have sweeping compliance and risk implications for businesses in the retail, food and beverage, paint, adhesive, industrial manufacturing, and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Inherency Ruling Refines Obviousness Framework
The Federal Circuit's December decision in Cytiva v. JSR has definitively eliminated the requirement of "reasonable expectation of success" analysis for inherent properties in obviousness determinations, while providing some key clarifications for patent practitioners, says Lawrence Kass at Steptoe.
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Navigating The Potential End Of GLP-1 Drug Shortages
The U.S. Food and Drug Administration's determination of whether GLP-1 products are in shortage may affect how compounders provide these products and spur a range of litigation including patent disputes and unfair competition suits, say attorneys at Goodwin.
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High Court Could Further Limit Deference With TCPA Fax Case
The Supreme Court's decision to hear McLaughlin Chiropractic Associates v. McKesson, a case involving alleged junk faxes that centers whether district courts are bound by Federal Communications Commission rules, offers the court a chance to possibly further limit the judicial deference afforded to federal agency interpretations of statutes, says Samantha Duke at Rumberger Kirk.
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5 Ways To Create Effective Mock Assignments For Associates
In order to effectively develop associates’ critical thinking skills, firms should design mock assignments that contain a few key ingredients, from messy fact patterns to actionable feedback, says Abdi Shayesteh at AltaClaro.
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Calif. Cannabis Decision Deepens Commerce Clause Divide
In Peridot Tree v. Sacramento, the Eastern District of California joined a growing minority of courts that have found the dormant commerce clause inapplicable to state-regulated marijuana, and the Ninth Circuit will soon provide important guidance on this issue, say attorneys at Perkins Coie.
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Opinion
IVF Suits Highlight Need For Better Legal Frameworks
The high number of in vitro fertilization embryo losses underscores the need for more cohesive legal and regulatory guidance related to human errors, property versus personhood, and liability, says Jeff Korek at Gersowitz Libo.
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Recent Suits Show Antitrust Agencies' Focus On HSR Review
The U.S. Department of Justice's suit this month against KKR for inaccurate and incomplete premerger filings, along with other recent cases, highlights the agency's increasing scrutiny of Hart-Scott-Rodino Act compliance for private equity firms, say attorneys at Willkie.
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The 7th Circ.'s Top 10 Civil Opinions Of 2024
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2024, and explain how they may affect issues related to mass arbitration, consumer fraud, class certification and more.
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Royal Canin Ruling Won't Transform Removal Jurisdiction
The U.S. Supreme Court's ruling in Royal Canin USA v. Wullschleger means that federal district courts must now remand whenever an amended complaint excises grounds for federal jurisdiction — but given existing litigation strategy and case law trends, this may ultimately preserve, rather than alter, the status quo, say attorneys at Norton Rose.
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Lessons From The Pharma Industry On Patent Cliffs
In the next five years, patents for drugs that have generated billions in global sales are set to expire, and companies that view this imminent patent cliff as an opportunity for strategic renewal rather than a challenge will be best positioned to maintain market leadership, says Keegan Caldwell at Caldwell Law.
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Mentorship Resolutions For The New Year
Attorneys tend to focus on personal achievements or career milestones when they set yearly goals, but one important area often gets overlooked in this process — mentoring relationships, which are some of the most effective tools for professional growth, say Kelly Galligan at Rutan & Tucker and Andra Greene at Phillips ADR.
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What Nearshoring Growth In Americas Means For Patents
With the new U.S. administration potentially focused on implementing draconian trade restrictions, nearshoring in the Americas is expected to grow, and patent prosecution attorneys will be kept on their toes as the patent landscape from country to country continues to evolve, says Ernest Huang at Procopio.
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Takeaways From FDA's Updated Confirmatory Trial Guidance
The U.S. Food and Drug Administration's latest draft guidance about accelerated drug approval indicates the FDA's intent to address the significant lag time between accelerated approval and full approval of drugs and may help motivate the industry to complete confirmatory trials, say attorneys at Sheppard Mullin.
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The Most Important Schedule I Drug Regulatory Shifts Of 2024
In 2024, psychedelics and cannabis emerged as focal points in medical research, marking a pivotal year in their legal and regulatory journey, but these developments presented both opportunities and challenges within this evolving field, say Kimberly Chew at Husch Blackwell and Stephen Kim at Avicanna.