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Life Sciences
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October 07, 2024
ITC Judge Pushes For Import Ban In Liver Drug Secrets Row
The U.S. International Trade Commission's chief judge is recommending the agency block a Hong Kong-listed drug developer from potentially marketing unapproved treatments for a type of liver disease for the next seven years, a win for another company behind a different unapproved treatment for the same type of liver disease.
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October 07, 2024
Fed. Circ. Questions If Safer OxyContin Profits Came From IP
An attorney for Purdue Pharma didn't seem to find much purchase at the Federal Circuit on Monday as he argued that the company's patents for abuse-deterrent OxyContin weren't obvious, claiming other companies had ample opportunity to reach a solution and failed to do so.
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October 07, 2024
Merck Immune For 'Inflated' Vax Claims To FDA, 3rd Circ. Says
A divided Third Circuit panel inoculated Merck from claims that it tried to prevent competition by making inflated declarations to federal regulators about its mumps vaccine, with the majority ruling Monday that because Merck convinced federal regulators it had extended the vaccine's long-term potency, those assertions can't have been an anticompetitive "sham."
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October 07, 2024
Biotech, Medical Device Firms Prep Three IPOs Totaling $376M
Two venture-backed biotechnology startups and a medical device maker launched plans on Monday for three initial public offerings projected to raise about $376 million combined, adding to a busy schedule of IPOs this week.
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October 07, 2024
Mich. Supreme Court Snapshot: Insulin Prices, Disney Audit
The Michigan Supreme Court's first oral argument session of the 2024-25 term promises to be a busy one, involving an investigation into Eli Lilly's insulin prices with big implications for the scope of Michigan's consumer protection law and Disney's appeal of an order to turn over decades-old uncashed checks to the state treasurer.
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October 07, 2024
Mylan, Novo Nordisk Settle Ozempic Patent Dispute
Mylan Pharmaceuticals and Novo Nordisk have asked the Patent Trial and Appeal Board to terminate Mylan's request to review whether a patent covering Novo Nordisk's blockbuster diabetes and weight-loss drug Ozempic holds up, telling the board the two sides have resolved their dispute.
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October 07, 2024
5 Decisions To Know By Outgoing Mass. Chief Judge
Chief Massachusetts U.S. District Judge F. Dennis Saylor IV, who announced Monday that he will step back from full-time judicial service next summer, has presided over numerous significant cases in recent years, including a dispute over the U.S. Securities and Exchange Commission's disgorgement powers and a birth defects suit against GlaxoSmithKline.
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October 07, 2024
Trio Of 1st Circ. Criminal Cases Turned Away By Top Court
The U.S. Supreme Court on Monday declined to review three white collar cases on appeal from the First Circuit, including challenges to a cryptocurrency founder's conviction for investor theft and an Illinois attorney's fraud and money laundering conspiracy verdict.
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October 07, 2024
Justices Won't Hear Kickback Statute 'Willfulness' Case
The U.S. Supreme Court on Monday declined to consider whether a "willful" act under federal anti-kickback law requires a defendant to know their actions violate the law.
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October 07, 2024
High Court Rejects Pleas To Hear 7 Patent Cases
The U.S. Supreme Court on Monday turned down seven petitions seeking review of decisions in patent cases, including appeals dealing with double patenting, patent eligibility and Patent Trial and Appeal Board procedures.
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October 07, 2024
High Court Won't Look At Alabama Frozen Embryo Decision
The U.S. Supreme Court on Monday said it won't consider a challenge to a first-of-its-kind Alabama state court ruling that frozen embryos are legally children.
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October 07, 2024
Justices Won't Hear Shkreli's Bid To Undo $64M Disgorgement
The U.S. Supreme Court refused Monday to review former pharmaceutical executive Martin Shkreli's challenge of 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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October 04, 2024
Top 5 Supreme Court Cases To Watch This Fall
The U.S. Supreme Court will hear several cases in its October 2024 term that could further refine the new administrative law landscape, establish constitutional rights to gender-affirming care for transgender minors and affect how the federal government regulates water, air and weapons. Here, Law360 looks at five of the most important cases on the Supreme Court's docket so far.
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October 04, 2024
NJ, Ethics Board Must Hand Over Docs In Retaliation Fight
A New Jersey state judge has ordered the state and its ethics commission to hand over to an ex-state health official internal documents in his lawsuit alleging that he was wrongly fired in 2020 for raising concerns about the earmarking of COVID-19 tests for relatives of another state official.
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October 04, 2024
DOJ Charges Execs, Sales Reps Over Texas 'Pill Mills' Sales
Tens of millions of opioid pills ended up in the black market by way of pharmaceutical distribution executives and sales representatives who targeted a Houston "hot zone" for drug diversion, the U.S. Department of Justice said in unsealing several indictments in Texas, Florida, Missouri and North Carolina.
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October 04, 2024
Regeneron Can't Ax Willful Infringement In COVID Patent Case
Regeneron Pharmaceuticals Inc. cannot boot a willful infringement claim from Allele Biotech's patent suit over the development of COVID-19 vaccines and treatments, a New York federal judge ruled Friday, saying it was up to Regeneron to establish that Allele failed to show the defendant had presuit knowledge of the patent.
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October 04, 2024
Healthcare Co. Inks Deal In DOL Equal Pay Investigation
A healthcare diagnostics company has agreed to pay nearly $60,000 to the U.S. Department of Labor to end an agency probe over concerns that a New Jersey manufacturing facility undercompensated female employees compared to their male colleagues.
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October 04, 2024
There May Not Be Life On Mars, But There Could Be IP
The rapidly expanding space tourism industry is raising a vast universe of potential intellectual property issues. Experts say most of the laws governing extraterrestrial IP are as unexplored as space itself.
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October 04, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen GMB Union sued by the makers of Tetley Tea after a staff walkout in September, boxer Mike Tyson hit with legal action from a marketing company and the Met Police face a misuse of private data claim from a woman who had a relationship with an undercover police officer. Here, Law360 looks at these and other new claims in the U.K.
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October 04, 2024
High Court Takes Up E-Cig 'Forum Shopping' Appeal
The U.S. Supreme Court on Friday agreed to review a Fifth Circuit ruling that allowed out-of-circuit e-cigarette manufacturers to seek judicial review before the New Orleans-based court so long as the petition is joined by a seller located in the circuit.
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October 04, 2024
High Court Will Hear TCPA Case Over Online Junk Faxes
The U.S. Supreme Court said Friday it will review whether district courts must follow a Federal Communications Commission ruling that the Telephone Consumer Protection Act does not prohibit junk faxes that are received only via electronic inboxes.
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October 03, 2024
Gilead Makes Generic HIV Drug Plan, Advocates Urge Expansion
Gilead Sciences Inc. this week announced a plan to allow six drugmakers to produce generic lenacapavir to help combat the HIV pandemic in 120 lower-income countries, an initiative that won praise as a welcome step Thursday, although advocacy groups urged the company to expand the effort.
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October 03, 2024
Boston Pharma Co. Drops Another Moderna Patent Suit
A Boston pharmaceutical developer once again has agreed to drop a patent lawsuit against Moderna over its popular coronavirus vaccines after losing a claim construction ruling in front of Delaware's top judge.
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October 03, 2024
Del. Vice Chancellor Slams Fee Terms In Advancement Case
A Delaware vice chancellor balked Thursday at "success fee" terms in a fee advancement case that she suggested made the clients a "human shield" in litigation over attorney expenses in connection with a New Jersey legal malpractice case.
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October 03, 2024
Trulieve Sues Fla. Republican Party Over Anti-Weed Ads
Trulieve, which is Florida's largest medical marijuana company and the principal backer of a ballot initiative to legalize cannabis in the Sunshine State, has sued the state's Republican Party and a pair of television stations for defamation, alleging that they ran misleading anti-weed ads.
Expert Analysis
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Protecting Trade Secrets In US, EU Gov't Agency Submissions
Attorneys at Mintz compare U.S. and European Union trade secret laws, and how proprietary information in confidential submissions to the U.S. Food and Drug Administration and the European Medicines Agency is protected in the face of third-party information requests under government transparency laws.
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Recruitment Trends In Emerging Law Firm Frontiers
BigLaw firms are facing local recruitment challenges as they increasingly establish offices in cities outside of the major legal hubs, requiring them to weigh various strategies for attracting talent that present different risks and benefits, says Tom Hanlon at Buchanan Law.
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4 Tips For Drafting Earnouts To Avoid Disputes
Amid slowed merger and acquisition activity, buyers and sellers are increasingly turning to earnout provisions to get deals done, but these must be carefully drafted to avoid interpretative differences that can lead to later disputes, say attorneys at Cooley.
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Series
Glassblowing Makes Me A Better Lawyer
I never expected that glassblowing would strongly influence my work as an attorney, but it has taught me the importance of building a solid foundation for your work, learning from others and committing to a lifetime of practice, says Margaret House at Kalijarvi Chuzi.
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Opinion
Flawed Fintiv Rule Should Be Deemed Overreach In Tech Suit
A pending federal lawsuit over the U.S. Patent and Trademark Office's unilateral changes to key elements of the America Invents Act, Apple v. Vidal, could shift the balance of power between Congress and federal agencies, as it could justify future instances of unelected officials unilaterally changing laws, say Patrick Leahy and Bob Goodlatte.
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How Associates Can Build A Professional Image
As hybrid work arrangements become the norm in the legal industry, early-career attorneys must be proactive in building and maintaining a professional presence in both physical and digital settings, ensuring that their image aligns with their long-term career goals, say Lana Manganiello at Equinox Strategy Partners and Estelle Winsett at Estelle Winsett Professional Image Consulting.
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High Court's Abortion Pill Ruling Shuts Out Future Challenges
The U.S. Supreme Court's unanimous ruling in U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine maintains the status quo for mifepristone access and rejects the plaintiffs' standing theories so thoroughly that future challenges from states or other plaintiffs are unlikely to be viable, say Jaime Santos and Annaka Nava at Goodwin.
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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.