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Life Sciences
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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.
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August 08, 2024
Cooley Hit With Fla. Malpractice Suit Over Financial Docs
Genetic Networks LLC has sued California-based Cooley LLP in Florida state court, alleging the law firm failed to file documentation needed to secure a lien when preparing loan papers for $1.2 million lent to ECI Pharmaceuticals.
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August 08, 2024
Wilson Sonsini, A&O Shearman Guide $688M Biotech Merger
Salt Lake City-based Recursion said Thursday it has inked a deal to purchase fellow drug design and development company Exscientia for approximately $688 million, under the guidance of Wilson Sonsini Goodrich & Rosati PC.
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August 08, 2024
Deals Rumor Mill: Roche, Thoma Bravo, Klarna
Roche is considering divesting cancer data specialist Flatiron Health, Thoma Bravo is exploring a sale of compliance software maker Cority, and fintech startup Klarna is preparing a secondary-share sale ahead of a planned IPO. Here, Law360 breaks down these and other notable deal rumors from the past week.
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August 08, 2024
Rising Star: Williams & Connolly's Elise Baumgarten
Elise Baumgarten of Williams & Connolly LLP was counsel for Endo Pharmaceuticals in a "pay for delay" class action arising from a patent settlement that ended with a verdict in Endo's favor, and she won a major trial for Merck & Co. Inc. in Hatch-Waxman patent litigation, earning her a spot among healthcare law practitioners under age 40 honored by Law360 as Rising Stars.
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August 07, 2024
Exec Unlikely To Get New Trial In SEC's 'Shadow Trading' Suit
A California federal judge said at a hearing Wednesday that he wasn't inclined to grant a new trial in a novel SEC "shadow trading" case, saying "there's no question" that a former executive of Medivation, a pharmaceutical company, knew that he was using inside information from his company when he purchased a rival's stock.
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August 07, 2024
Biotech Firm Can't Pause SEC Action During Appeal
A Colorado federal magistrate judge won't pause a lawsuit by securities regulators against a biotech company accused of misappropriating roughly $9 million while the company appeals an asset freeze, agreeing in a Wednesday order with the SEC's argument that investors would be better served if the case moved ahead.
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August 07, 2024
Abbott Brass Trim But Can't Nix Investors' Formula Recall Suit
A Chicago federal judge on Wednesday substantially trimmed a derivative suit accusing Abbott Laboratories leaders of concealing known safety issues related to recalled infant formula but rejected the defendants' argument that tossing the suit in its entirety was in shareholders' "best interest."
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August 07, 2024
Judge's Pharma Comments Could Decide Ineligibility Appeal
A Federal Circuit panel on Wednesday was willing to explore Astellas Pharma's argument that a Nebraska federal judge should be taken off its infringement case over the bladder medication Myrbetriq, given statements that showed a potential bias against the pharmaceutical industry, but also made clear that such reassignments are rare and difficult.
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August 07, 2024
Advocates Tell 9th Circ. To Revive Invisalign Monopoly Suit
Competition advocates are backing the revival of a class action accusing the makers of Invisalign of monopolizing the market for clear dental aligners, telling the Ninth Circuit in a new amicus brief that a district court summary judgment ruling for Align Technology creates a dangerous precedent for refusal-to-deal cases.
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August 07, 2024
Teva Finds Some Big-Pharma Friends In Inhaler Patent Fight
Two large pharmaceutical companies have weighed in to ask the Federal Circuit to overturn a ruling that found that Teva's branded drugmaking operation misused a key federal patent database in order to block the release of competing generic asthma inhalers.
Expert Analysis
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Emerging Trends In ESG-Focused Securities Litigation
Based on a combination of shareholder pressure, increasing regulatory scrutiny and proposed rulemaking, there has been a proliferation of litigation over public company disclosures and actions regarding environmental, social, and governance factors — and the overall volume of such class actions will likely increase in the coming years, say attorneys at Mintz.
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Orange Book Warnings Highlight FTC's Drug Price Focus
In light of heightened regulatory scrutiny surrounding drug pricing and the Federal Trade Commission's activity in the recent Teva v. Amneal case, branded drug manufacturers should expect the FTC's campaign against allegedly improper Orange Book listings to continue, say attorneys at Ropes & Gray.
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Firms Must Rethink How They Train New Lawyers In AI Age
As law firms begin to use generative artificial intelligence to complete lower-level legal tasks, they’ll need to consider new ways to train summer associates and early-career attorneys, keeping in mind the five stages of skill acquisition, says Liisa Thomas at Sheppard Mullin.
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A Plaintiffs-Side Approach To Cochlear Implant Cases
As the number of cochlear implants in the U.S. continues to grow, some will inevitably fail — especially considering that many recalled implants remain in use — plaintiffs attorneys should proactively prepare for litigation over defective implants, says David Shoop at Shoop.
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Think Like A Lawyer: Always Be Closing
When a lawyer presents their case with the right propulsive structure throughout trial, there is little need for further argument after the close of evidence — and in fact, rehashing it all may test jurors’ patience — so attorneys should consider other strategies for closing arguments, says Luke Andrews at Poole Huffman.
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Tracking China's Push To Invalidate Foreign Patents
China’s increasing use of courts and administrative panels to nullify patents in strategically important industries, such as technology, pharmaceuticals and rare-earth minerals, raises serious concerns about the intellectual property rights of foreign businesses operating there, say Rajat Rana and Manuel Valderrama at Selendy Gay.
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Takeaways From Nat'l Security Division's Historic Declination
The Justice Department National Security Division's recent decision not to prosecute a biochemical company for an employee's export control violation marks its first declination under a new corporate enforcement policy, sending a clear message to companies that self-disclosure of misconduct may confer material benefits, say attorneys at Perkins Coie.
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Series
Playing Chess Makes Me A Better Lawyer
There are many ways that chess skills translate directly into lawyer skills, but for me, the bigger career lessons go beyond the direct parallels — playing chess has shown me the value of seeing gradual improvement in and focusing deep concentration on a nonwork endeavor, says attorney Steven Fink.
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Litigation Inspiration: Attys Can Be Heroic Like Olympians
Although litigation won’t earn anyone an Olympic medal in Paris this summer, it can be worthy of the same lasting honor if attorneys exercise focused restraint — seeking both their clients’ interests and those of the court — instead of merely pursuing every advantage short of sanctionable conduct, says Bennett Rawicki at Hilgers Graben.
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Updated Federal Rules Can Improve Product Liability MDLs
The recent amendment of a federal evidence rule regarding expert testimony and the proposal of a civil rule on managing early discovery in multidistrict legislation hold great promise for promoting the uniform and efficient processes that high-stakes product liability cases particularly need, say Alan Klein and William Heaston at Duane Morris.
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Lean Into The 'Great Restoration' To Retain Legal Talent
As the “great resignation,” in which employees voluntarily left their jobs in droves, has largely dissipated, legal employers should now work toward the idea of a “great restoration,” adopting strategies to effectively hire, onboard and retain top legal talent, says Molly McGrath at Hiring & Empowering Solutions.
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How Cannabis Rescheduling May Alter Paraphernalia Imports
The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.
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What The NYSE Proposed Delisting Rule Could Mean For Cos.
The New York Stock Exchange's recently proposed rule would provide the exchange with discretionary authority to commence delisting proceedings for a company substantially shifting its primary business focus, raising concerns for NYSE-listed companies over the exact definition of the exchange's proposed "substantially different" standard, say attorneys at Winston & Strawn.
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FDA Warning Indicates Scrutiny Of Regenerative Health Cos.
The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.
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2 Regulatory Approaches To Psychedelic Clinical Trials
Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.