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Life Sciences
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August 12, 2024
Glass Tempering Co. Loses Early Exit Bid In NC Patent Fight
A glass processing equipment distributor can't ditch a Finnish competitor's patent infringement suit, a North Carolina federal judge has ruled, finding its rival has sufficiently alleged "exclusionary rights" to the patents for glass tempering.
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August 12, 2024
Paragard IUD Makers Gearing Up For Defect Dismissal Bid
Teva Pharmaceuticals and The Cooper Cos. have five days to reach out to plaintiffs who may be included in a motion to dismiss the sprawling litigation over alleged defects in the Paragard IUD, a Georgia federal judge said Monday.
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August 12, 2024
States Oppose Shkreli High Court Bid For $64M Disgorgement
State enforcers are opposing a petition from ex-pharmaceutical executive Martin Shkreli asking the U.S. Supreme Court to review a disgorgement order requiring him to pay up to $64 million for an alleged scheme to increase the price of a life-saving drug by 4,000%
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August 12, 2024
Pacira Patent On Surgery Pain Drug Voided In Win For Generic
Pacira Pharmaceuticals Inc.'s patent on a nonopioid painkiller is invalid, a New Jersey federal judge has ruled, opening the way for generic versions of Exparel, a long-acting injectable for managing postsurgical pain.
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August 12, 2024
King & Spalding Adds Freshfields M&A Ace In Silicon Valley
King & Spalding LLP is expanding its corporate team, announcing Monday it is bringing in a Freshfields Bruckhaus Deringer LLP mergers and acquisitions expert as a partner in its Silicon Valley office.
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August 12, 2024
Del. Judge Says Vaccine IP Claim Actually Mandates Vaccine
Delaware's chief judge was baffled by Alnylam Pharmaceuticals' argument that the word "vaccine" in a patent it claims Pfizer and BioNTech have infringed doesn't actually require a vaccine, leading him to reject the trip down the rabbit hole presented by the company in exchange for "common sense."
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August 12, 2024
The Biggest Georgia Rulings Of 2024 So Far
From upholding a win for a transgender sheriff's deputy who challenged a county health plan's refusal to pay for gender-affirmation surgery, to ruling that a judicial emergency order issued during the pandemic can be used to toll the state's medical malpractice statute of repose, Georgia courts have been busy in the first half of 2024.
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August 12, 2024
Catching Up With Delaware's Chancery Court
Multimillion-dollar share conversions, power struggles in a classic rock band, a good deal for fandom collectibles, and a pindown by two heavyweights were all part of the spectacle in Delaware's Court of Chancery last week. New cases involved pharmaceutical companies, cannabis, drones and liquid-gas exports. In case you missed it, here's the latest from the Chancery Court.
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August 12, 2024
3 Firms Rep As Crown Buys Revance In $924M Deal
Skincare company Crown Laboratories Inc. on Monday announced that it has agreed to merge with aesthetic healthcare biotechnology company Revance Therapeutics Inc. in a $924 million deal built by three law firms.
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August 09, 2024
Takeda Should Face Certified Antitrust Classes, Judge Says
A New York federal judge on Friday recommended certifying two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.
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August 09, 2024
Delaware Jury Says Fecal Treatment Patents Are Worth $25M
A Delaware federal jury decided Friday that a Swiss drugmaker owes a smaller drug rival at least $25 million in a patent case involving an experimental enema used to treat a particularly deadly form of diarrhea.
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August 09, 2024
Valeant's Legal Gripe A Total 'Nothingburger,' Justices Told
A lawyer who assembled a whistleblower lawsuit against a major pharmaceutical company using publicly available patent board filings says the larger legal question of whether he can do that is way too niche for the U.S. Supreme Court to bother thinking about.
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August 09, 2024
Medicare Drug Price Suit Nixed Over 'Forum Shopping' In Ohio
The Department of Health and Human Services has notched yet another win in litigation challenging the constitutionality of the Medicare drug price negotiation program, securing the dismissal of a suit brought by several chambers of commerce.
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August 09, 2024
Biotech Firms Mull Acquisition Offers Amid Shaky IPO Climate
Amid a shaky outlook for initial public offerings, more private biotechnology firms are exploring acquisition offers from larger pharmaceutical companies as a more certain exit strategy, according to experts who advise emerging drug developers.
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August 09, 2024
FDA Rejects Latest Effort To Treat PTSD With MDMA
The U.S. Food and Drug Administration has rejected a new drug application to treat post-traumatic stress disorder with the psychedelic drug MDMA, an entactogen also known as ecstasy or molly, the company that backed the effort announced Friday.
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August 09, 2024
Biopharm Co. Alector Sued In Del. For Docs On Director Pay
A stockholder of small cap biopharmaceutical venture Alector Inc has sued the business in Delaware's Court of Chancery for books and records releases, citing company payment of directors at rates roughly twice the amount paid to nonemployee directors of large cap companies in the same sector.
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August 09, 2024
Novartis Wants DC Judge To Quickly Block Entresto Generic
Novartis Pharmaceuticals urged a D.C. federal judge Friday to temporarily restrain the U.S. Food and Drug Administration from officially approving a generic version of the company's blockbuster heart failure medication Entresto.
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August 09, 2024
Pharmacy Escapes Recklessness Claim In Septic Shock Suit
A Pennsylvania federal judge has dismissed a claim seeking punitive damages from a northern Pennsylvania pharmacist brought by a patient who alleges that her endocrinologist and the pharmacy overprescribed corticosteroids that opened holes in her intestines and subsequently made her go into septic shock and become suicidal.
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August 09, 2024
Vidal's Sanctions Make It Clear: Don't Mess With The PTAB
The Patent Trial and Appeal Board has only faced a handful of instances where sanctions took center stage, but the U.S. Patent and Trademark Office director's rulings have made attorneys increasingly aware that pushing ethical boundaries at the board could put their cases and their careers at risk.
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August 09, 2024
Wash. AG Says Kroger Refusing To Delay Merger For Ruling
The Washington Attorney General's Office told a state court that Kroger will not agree to put off closing its planned merger with Albertsons until after a final ruling in the state's merger challenge, but the companies say they've already agreed not to finalize the deal until litigation plays out in another state.
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August 09, 2024
Merck To Buy Autoimmune Treatment Drug For Up To $1.3B
Pharmaceutical giant Merck, advised by Hogan Lovells, said Friday it has agreed to buy a novel, investigational, clinical-stage, bispecific antibody used to treat B cell-associated diseases from Goodwin Procter LLP-led Curon Biopharmaceutical for up to $1.3 billion.
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August 09, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen China Evergrande Group file a commercial fraud claim against its founder's ex-wife, legal action by Manolete Partners against the directors of an insolvent construction company, VietJet tackle a claim by French banking group Natixis and more developments in the "Dieselgate" scandal. Here, Law360 looks at these and other new claims in the U.K.
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August 08, 2024
Mass. Atty, 2 Others Settle SEC Insider Trading Claims
A Massachusetts business lawyer, his friend and his friend's father have agreed to collectively pay more than $230,000 to settle the U.S. Securities and Exchange Commission's allegations they used intel to trade ahead of an announcement made by the biotechnology company Frequency Therapeutics Inc., the SEC said Thursday.
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August 08, 2024
Pot Cos. Get Creative To Boost Brands Despite Feds' TM Ban
The marijuana industry still lives in the shadows of trademark law while the drug remains federally illegal, leaving businesses and their lawyers to seek workarounds to protect their brands.
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August 08, 2024
Apple Wins Bid For 2 Trials In IP Dispute With Masimo
A California federal judge will hold separate trials on Masimo Corp.'s trade secrets and patent claims over the Apple Watch, siding with Apple Inc. and rejecting Masimo's request for one later trial on all the issues, in a case with potentially billions of dollars at stake.
Expert Analysis
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Regulating Resurrected Species Under The ESA
As the prospect of extinct species being resurrected from DNA and reintroduced into the wild grows closer, an analysis of the Endangered Species Act suggests that it could provide a thoughtful, flexible governance framework for such scenarios, say Caroline Meadows and Shelby Bobosky at the SMU Dedman School of Law.
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E-Discovery Quarterly: Recent Rulings On Text Message Data
Electronically stored information on cellphones, and in particular text messages, can present unique litigation challenges, and recent court decisions demonstrate that counsel must carefully balance what data should be preserved, collected, reviewed and produced, say attorneys at Sidley.
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What CRA Deadline Means For Biden Admin. Rulemaking
With the 2024 election rapidly approaching, the Biden administration must race to finalize proposed agency actions within the next few weeks, or be exposed to the chance that the following Congress will overturn the rules under the Congressional Review Act, say attorneys at Covington.
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5 Takeaways From FDA's Biosimilars Promotion Guidance
New draft guidance from the U.S. Food and Drug Administration expands upon other recent efforts to clarify expectations for biosimilar and interchangeable labeling, highlighting a number of potential missteps that could draw attention from regulators, say attorneys at Arnold & Porter.
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Dual-Track IPO-M&A Exit Strategies For Life Science Cos.
A dual-track process for life sciences companies offers a proven path to securing favorable deal terms for an exit, and strategic moves can include running a crossover financing round in the lead-up, say attorneys at McDermott.
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Does Expert Testimony Aid Preliminary IPR Responses?
Dechert attorneys analyze six years of patent owners' preliminary responses to inter partes review petitions to determine whether the elimination of the presumption favoring the petitioner as to preinstitution testimonial evidence affected the usefulness of expert testimony in responses.
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Are Concessions In FDA's Lab-Developed Tests Rule Enough?
Although the U.S. Food and Drug Administration's new policy for laboratory-developed tests included major strategic concessions to help balance patient safety, access and diagnostic innovation, the new rule may well face significant legal challenges in court, say Dominick DiSabatino and Audrey Mercer at Sheppard Mullin.
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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.