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Life Sciences
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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.
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April 07, 2025
AGs Announce $335M Opioid Deal With Mylan
New York Attorney General Letitia James on Monday said her office and those of other states reached a $335 million deal with Mylan to help combat the opioid crisis.
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April 07, 2025
Monthly Merger Review Snapshot
The Federal Trade Commission sued to block GTCR BC's planned purchase of a medical device coatings company, the Justice Department's antitrust case against Live Nation survived a dismissal bid and a New York state court found a ski mountain deal hurt competition. Here, Law360 looks at the major merger review developments from March.
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April 07, 2025
Compensation Up For Quest Diagnostics GC After Earlier Dip
Quest Diagnostics' longtime senior vice president and general counsel brought home $2.43 million in 2024, up from $2.25 million in 2023, according to a proxy statement filed recently by the company.
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April 04, 2025
AbbVie Says Aurobindo's Rinvoq Generic Infringes Patent
AbbVie on Friday launched a patent infringement lawsuit in Delaware federal court over Aurobindo Pharma's tentatively approved generic version of the blockbuster immunosuppressant Rinvoq, the latest in a series of intellectual property litigation over the treatment.
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April 04, 2025
Fed. Circ. Backs Ruling Against Parents In Vaccine Case
The Federal Circuit has upheld a lower court's ruling in a Vaccine Act case brought by parents of a child who has seizures and developmental delays, finding that they failed to show that his conditions were caused by vaccines.
Expert Analysis
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What Bisphenol S Prop 65 Listing Will Mean For Industry
The imminent addition of bisphenol S — a chemical used in millions of products — to California's Proposition 65 list will have sweeping compliance and litigation implications for companies in the retail, food and beverage, paper, manufacturing and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Ruling Shows Importance Of Trial Expert Specificity
The Federal Circuit’s recent ruling in NexStep v. Comcast highlights how even a persuasive expert’s failure to fully explain the basis of their opinion at trial can turn a winning patent infringement argument into a losing one, say attorneys at Barnes & Thornburg.
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Think Like A Lawyer: Note 3 Simple Types Of Legal Complexity
Cases can appear complex for several reasons — due to the number of issues, the volume of factual and evidentiary sources, and the sophistication of those sources — but the same basic technique can help lawyers tame their arguments into a simple and persuasive message, says Luke Andrews at Poole Huffman.
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Justices Mull Sex-Based Classification In Trans Law Case
After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.
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Series
Gardening Makes Me A Better Lawyer
Beyond its practical and therapeutic benefits, gardening has bolstered important attributes that also apply to my litigation practice, including persistence, patience, grit and authenticity, says Christopher Viceconte at Gibbons.
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Litigation Inspiration: Reframing Document Review
For attorneys — new ones especially — there is much fulfillment to find in document review by reflecting on how important, interesting and pleasant it can be, says Bennett Rawicki at Hilgers Graben.
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Key Takeaways From FDA's Latest Social Media Warnings
The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.
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Expect More State Scrutiny Of PE In Healthcare M&A
While a California bill that called for increased antitrust scrutiny of many healthcare private equity transactions was recently vetoed by the governor, state legislatures are likely to continue introducing similar laws, particularly if the Trump administration eases federal enforcement, say attorneys at Morgan Lewis.
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Declaring Unexpected Results: Pitfalls For Rule 132 At PTAB
Rule 132 declarations are frequently used in life sciences patent prosecution for rebutting obviousness rejections by establishing that an applicant's invention produces unexpected results, and the Patent Trial and Appeal Board's Eidschun ruling highlights when this important tool may be ineffective, say attorneys at Morrison Foerster.
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IP Ruling Likely To Limit Arguments Against Qualified Experts
The Federal Circuit's recent decision in Osseo v. Planmeca, clarifying when experts may offer testimony from the perspective of a skilled artisan, provides helpful guidance on expert qualifications and could quash future timing arguments regarding declarants' expertise, says Whitney Jenkins at Marshall Gerstein.
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How Boards And Officers Should Prep For New Trump Admin
In anticipation of President-elect Donald Trump's proposed tariffs and mass deportation campaign, company officers and board members should pursue proactive, comprehensive contingency planning to not only advance the best interests of the companies they serve, but to also properly exercise their fiduciary duty of care, say attorneys at Winston & Strawn.
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Dissecting The Obviousness-Type Double Patenting Debate
The Federal Circuit's recent decision in Allergan v. MSN highlights the ongoing evolution of the obviousness-type double patenting doctrine, revealing increasing tension between expiration-based interpretations and procedural flexibility, says Jeremy Lowe at Leydig Voit.
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Service Providers Must Mitigate 'Secondary Target' Risks
A lawsuit recently filed in an Illinois federal court against marketing agency Publicis over its work for opioid manufacturers highlights an uptick in litigation against professional service providers hired by clients that engaged in alleged misconduct — so potential targets of such suits should be sure to conduct proper risk analysis and mitigation, say attorneys at Dechert.
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Health Policy Predictions For Trump's Second Administration
As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.
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Series
Flying Makes Me A Better Lawyer
Achieving my childhood dream of flying airplanes made me a better lawyer — and a better person — because it taught me I can conquer difficult goals when I leave my comfort zone, focus on the demands of the moment and commit to honing my skills, says Ivy Cadle at Baker Donelson.