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Life Sciences
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April 09, 2025
Mich. Panel: Gilead Immune From Recalled COVID Drug Suit
Gilead Sciences Inc. has escaped a lawsuit pinning a man's strokes on doses of an antiviral COVID-19 medication that were later recalled, with a Michigan state appeals court finding that the company is protected by a public health law's liability shield.
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April 09, 2025
Full Fed. Circ. Lets Stand Patent Tied To $400M Labcorp Loss
The full Federal Circuit on Wednesday rejected Labcorp's request for a review of a panel decision foiling its bid to challenge patent claims underpinning an infringement judgment against it that now totals $400 million.
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April 09, 2025
9th Circ. Won't Restore Competing TM Claims In Vitamin Row
The Ninth Circuit on Wednesday refused to revive competing trademark infringement claims between a pair of vitamin and supplement companies, backing a lower court's finding that neither party was able to prove their case.
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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.
Expert Analysis
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Imagine The Possibilities Of Openly Autistic Lawyering
Andi Mazingo at Lumen Law, who was diagnosed with autism about midway through her career, discusses how the legal profession can create inclusive workplaces that empower openly autistic lawyers and enhance innovation, and how neurodivergent attorneys can navigate the challenges and opportunities that come with disclosing one’s diagnosis.
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Top 10 Healthcare And Life Sciences Issues To Watch In 2025
Under the new Trump administration, this coming year may benefit some healthcare and life sciences stakeholders, while creating new challenges for others amid an increasingly complex regulatory environment, say attorneys at Debevoise.
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Parsing 3rd Circ. Ruling On Cannabis, Employee Private Suits
The Third Circuit recently upheld a decision that individuals don't have a private right of action for alleged violations of New Jersey's Cannabis Regulatory, Enforcement Assistance and Marketplace Modernization Act, but employers should stay informed as the court encouraged the state Legislature to amend the law, say attorneys at Mandelbaum Barrett.
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4 Keys To Litigating In An Active Regulatory Environment
For companies facing litigation influenced by government regulatory action — a recent trend that a politically charged atmosphere will exacerbate — there are a few principles that can help to align litigation strategy with broader public positioning in the regulatory and oversight context, say attorneys at Jenner & Block.
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Kiromic SEC Order Shows Importance Of Self-Reporting
The U.S. Securities and Exchange Commission's recently filed settled charges against Kiromic BioPharma illustrate the critical intersection between U.S. Food and Drug Administration regulatory processes and investor disclosures under the securities laws, and showcase how responding promptly to internal whistleblower reports may reap benefits, say attorneys at Arnold & Porter.
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Series
Documentary Filmmaking Makes Me A Better Lawyer
Becoming a documentary filmmaker has allowed me to merge my legal expertise with my passion for storytelling, and has helped me to hone negotiation, critical thinking and problem-solving skills that are important to both endeavors, says Robert Darwell at Sheppard Mullin.
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Litigation Funding Disclosure Debate: Strategy Considerations
In the ongoing debate over whether courts should require disclosure of litigation funding, funders and plaintiffs tend to argue against such mandates, but voluntarily disclosing limited details about a funding arrangement can actually confer certain benefits to plaintiffs in some scenarios, say Andrew Stulce and Marc Cavan at Longford Capital.
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2025 May Be A Breakout Year For The Cannabis Industry
The cannabis industry faced a slow and frustrating 2024, but consumer trends continue to shift in favor of cannabis, and the new administration may provide the catalyst that the industry needs, says Lynn Gefen at TerrAscend.
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FDA's Red No. 3 Ban Reshapes Food Safety Legal Landscape
The U.S. Food and Drug Administration's recent ban on Red No. 3 represents more than the end of a controversial dye — it signals a shift in regulatory priorities, consumer expectations, intellectual property strategy, compliance considerations and litigation risk, says Dino Haloulos at Foley Mansfield.
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Scope And Nature Of Judicial Relief Will Affect Loper's Impact
The practical result of post-Loper Bright rulings against regulatory actions will depend on the relief courts grant — and there has been controversy in these types of cases over whether the ruling is applied just to the parties or nationwide, and whether the action can be left in place while it's corrected, says Steven Gordon at Holland & Knight.
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The Implications Of E-Cigarette Cos. Taking Suits To 5th Circ.
The U.S. Supreme Court recently heard oral arguments in U.S. Food and Drug Administration v. R.J. Reynolds over the definition of an "adversely affected" person under the Tobacco Control Act, and the justices' ruling will have important and potentially wide-ranging implications for forum shopping claims, says Trillium Chang at Zuckerman Spaeder.
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Series
Adventure Photography Makes Me A Better Lawyer
Photographing nature everywhere from Siberia to Cuba and Iceland to Rwanda provides me with a constant reminder to refresh, refocus and rethink the legal issues that my clients face, says Richard Birmingham at Davis Wright.
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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.