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Life Sciences
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August 30, 2024
Fall IPO Pickup Could Be A Prelude For 2025 Recovery
More companies are preparing to go public after Labor Day, signaling a modest increase in initial public offerings that capital markets advisers say could presage a stronger recovery in 2025, assuming next year brings more clarity regarding interest-rate policy and the result of the presidential election.
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August 29, 2024
Pa. Justices To Examine Axing Of 'Red Book' Drug Pricing
The Supreme Court of Pennsylvania has agreed to review a decision tossing the "Red Book" pricing values used by the state's Bureau of Workers' Compensation to calculate reimbursement for prescription drug costs.
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August 29, 2024
Jury Clears Ore. Hospital That Implanted FDA-Flagged Mesh
A state jury cleared an Oregon hospital system and a surgeon of liability Wednesday over a patient's claims that prolapse mesh was implanted almost two weeks after the U.S. Food and Drug Administration ordered its maker to stop selling it.
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August 29, 2024
Lannett Says Areva Reneged On Cancer-Drug Deal After Ch. 11
Lannett Pharmaceuticals hit generic-drug maker Areva Pharmaceuticals with a contract suit in Delaware's Court of Chancery on Thursday, accusing Areva of breaching their 2022 agreement that gave Lannett exclusive rights to distribute Areva's injectable anticancer drug after Lannett emerged from a prepackaged Chapter 11 bankruptcy.
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August 29, 2024
Comer Tells PBMs To Correct Record On Role In Drug Pricing
Rep. James Comer, R-Ky., chair of the House Oversight and Accountability Committee, is demanding that the heads of three major pharmacy benefit managers "correct the record" on their testimony made before his committee in July about their roles in drug pricing, including company claims that the PBMs don't steer customers to in-house pharmacies and that they allow non-affiliated pharmacies to negotiate contracts.
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August 29, 2024
Seattle Biotech Can't Immediately Force Out LA Times Owner
Billionaire and Los Angeles Times owner Dr. Patrick Soon-Shiong will not be forced to recuse himself from a Seattle-based biotech research institute board while the nonprofit's breach-of-fiduciary duty lawsuit against him is pending, a Washington federal judge said on Thursday.
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August 29, 2024
Pacira To Appeal Generic's Win In Pain Drug Patent Fight
Pacira Pharmaceuticals Inc. says it is appealing a New Jersey federal judge's decision invalidating its patent on a nonopioid painkiller and opening the way for generic versions of its drug Exparel, a long-acting injectable for managing postsurgical pain.
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August 29, 2024
Nektar Can't Get Docs It Says Show Lilly As 'Thieves, Liars'
A California federal judge Thursday rejected Nektar Therapeutics' request for internal Eli Lilly documents related to separate litigation as Nektar pursues allegations Eli Lilly ruined prospects for a drug the companies were developing together despite Nektar's counsel saying it would "expose Lilly for being thieves, liars."
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August 29, 2024
Convicted Drexel Prof Says Records Would've Swayed Jury
A Drexel University accounting professor convicted on charges of tax evasion and filing false tax returns after the government accused him of failing to report $3.3 million in income from a Trenton pharmacy has asked a New Jersey federal judge for a new trial.
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August 29, 2024
Jazz Hits Teva With Patent Suit Over Narcolepsy Drug
Teva Pharmaceuticals Inc. is infringing a patent for the narcolepsy drug Xywav, Jazz Pharmaceuticals Inc. said in a complaint filed in New Jersey federal court.
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August 28, 2024
Merck Must Face Class Claims In Vaccine Antitrust Suit
Merck cannot strike class claims in antitrust litigation over its rotavirus vaccine, a Pennsylvania federal judge ruled Wednesday, while also allowing the city of Baltimore to eliminate redundancies in its complaint.
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August 28, 2024
CyDex Says Bexson Breached Deal By Misusing Pharma IP
CyDex Pharmaceuticals hit Bexson Biomedical with a contract breach suit in Delaware Chancery Court accusing it of misusing a CyDex-designed molecule to develop unauthorized non-ketamine formulations, and subsequently filing a patent for those formulations, in violation of the parties' agreement.
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August 28, 2024
J&J Spinoff Beats Suit Over Tylenol 'Rapid Release' Labels
A New York federal judge tossed Tuesday a proposed class action accusing a Johnson & Johnson spinoff of misleading consumers by falsely claiming Tylenol's "Rapid Release" gelcaps relieved pain faster than alternative acetaminophen pills, finding the consumer's state claims are preempted by federal regulations.
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August 28, 2024
Lipitor Buyers Seek Final OK For $35M Deal In Antitrust Fight
End-payor plaintiffs asked a New Jersey federal judge Tuesday to give final approval of a $35 million settlement resolving their antitrust claims against Pfizer over the cholesterol medication Lipitor.
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August 28, 2024
Walgreens Brass Hid Pharmacy Division Woes, Suit Says
Walgreens' directors and officers have been hit with a derivative suit by a shareholder who says the company and its executives inflated stock value by publicly expressing confidence in the pharmacy division's growth while hiding its struggles adapting to industry hurdles.
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August 28, 2024
Jazz, Hikma Must Face Bulk Of Xyrem Antitrust Suit
Jazz Pharmaceuticals and Hikma Pharmaceuticals appear bound for trial against most solo insurer and class action antitrust claims over alleged efforts to block generic competitors to Jazz's Xyrem narcolepsy drug, under a newly unsealed California federal court order largely rejecting competing motions for summary judgment.
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August 28, 2024
Calif. Couples Drop FujiFilm Suit Over Destroyed Embryos
California couples who sued a manufacturer of oil used in the in vitro fertilization process claiming the product killed their embryos are looking to drop their federal suit.
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August 28, 2024
Del. Justices OK Mid-Case Appeal In Zantac Class Suit
The Delaware Supreme Court on Tuesday said it would hear a mid-case appeal in mass tort litigation over claims that the heartburn drug ranitidine, widely sold under the name Zantac, caused cancer.
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August 28, 2024
High Court Told Tyvaso Row Petition Based On 'False' Premise
A small pharmaceutical startup behind a drug that would compete with the blockbuster high blood pressure treatment Tyvaso says United Therapeutics is making a "fundamentally false" argument to the U.S. Supreme Court about why an appeals court rejected United Therapeutics' case.
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August 28, 2024
Regeneron Sues Sandoz Over Dozens Of Eye Drug Patents
Regeneron Pharmaceuticals Inc. has taken competing biomedical company Sandoz Inc. to New Jersey federal court with an extensive complaint asserting 46 patents and claiming Sandoz infringed them all with a biosimilar alternative to Regeneron's Eylea brand ophthalmic disorder drug.
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August 28, 2024
Biotech Biz Hid Risks Of Gene-Editing Trial, Investor Claims
Biotechnology firm Verve Therapeutics was hit with a proposed class suit alleging it misled investors about the risks associated with a clinical trial of an experimental gene-editing drug that was halted and caused the company's stock to tumble.
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August 27, 2024
Cherokee Nation's Opioid Suit Sent Back To State Court
An Oklahoma federal judge has adopted a magistrate judge's recommendation to send a Cherokee Nation opioid lawsuit against pharmaceuticals distributor Morris & Dickson back to state court, agreeing that the negligence case isn't predicated on a duty arising out of the federal Controlled Substances Act.
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August 27, 2024
USPTO Sued For Rejecting Blood Pressure Drug Patent
A small drug developer has hit the U.S. Patent and Trademark Office with a second lawsuit in Virginia federal court over the agency's latest rejection of the company's efforts to patent a different dosage of a drug the company markets to treat low blood pressure.
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August 27, 2024
NY Pension Funds Join Illumina Deal Suit Pile-On In Del.
New York state's retirement system and fund have added a new derivative suit to widening stockholder litigation over Illumina Inc.'s $8 billion reacquisition of cancer testing company Grail Inc. despite European Commission regulatory agency opposition.
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August 27, 2024
Fed. Circ. Won't Speed Up Apple Watch Ban Appeal
The Federal Circuit on Tuesday denied Apple Inc.'s request to expedite oral arguments in its appeal challenging the U.S. International Trade Commission's decision banning the tech giant from selling Apple Watches with a "blood oxygen" feature in the Masimo patent case.
Expert Analysis
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Rebuttal
Double-Patenting Ruling Shows Terminal Disclaimers' Value
While a recent Law360 guest article seems to argue that the Federal Circuit’s Cellect decision last year robs patent owners of lawful patent term, the ruling actually identifies how terminal disclaimers are the solution to the problem of obviousness-type double patenting, say Jane Love and Robert Trenchard at Gibson Dunn.
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Series
Swimming Makes Me A Better Lawyer
Years of participation in swimming events, especially in the open water, have proven to be ideal preparation for appellate arguments in court — just as you must put your trust in the ocean when competing in a swim event, you must do the same with the judicial process, says John Kulewicz at Vorys.
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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
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Why High Court May Have Rejected IP Obviousness Appeal
Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.
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Microplastics At The Crossroads Of Regulation And Litigation
Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.
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The Fed. Circ. In April: Hurdles Remain For Generics
The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Tylenol MDL Highlights Expert Admissibility Headaches
A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.
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Don't Fall On That Hill: Keys To Testifying Before Congress
Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.
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Online Portal Helps Fortify Feds' Unfair Health Practices Fight
The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.
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Series
Walking With My Dog Makes Me A Better Lawyer
Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.
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Think Like A Lawyer: Follow The Iron Rule Of Trial Logic
Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.
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The Art Of Asking: Leveraging Your Contacts For Referrals
Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.
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Trending At The PTAB: Permissible New Reply Arguments
In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.