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Life Sciences
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July 05, 2024
5 Moments That Shaped The Supreme Court's Jan. 6 Decision
When the high court limited the scope of a federal obstruction statute used to charge hundreds of rioters who stormed the Capitol, the justices did not vote along ideological lines. In a year marked by 6-3 splits, what accounts for the departure? Here are some moments from oral arguments that may have swayed the justices.
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July 05, 2024
The Funniest Moments Of The Supreme Court's Term
In a U.S. Supreme Court term teeming with serious showdowns, the august air at oral arguments filled with laughter after an attorney mentioned her plastic surgeon and a justice seemed to diss his colleagues, to cite just two of the term's mirthful moments. Here, we look at the funniest moments of the term.
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July 05, 2024
2024 Global M&A, Mega-Deal Values Outpacing 2023
Dealmakers and the attorneys who represent them came into 2024 with a sense of cautious optimism about the mergers and acquisitions market.
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July 05, 2024
The Firms That Won Big At The Supreme Court
This U.S. Supreme Court term featured high-stakes oral arguments on issues including gerrymandering, abortion and federal agency authority, and a hot bench ever more willing to engage in a lengthy back-and-forth with advocates. Here's a look at the law firms that argued the most cases and how they fared.
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July 05, 2024
Novartis Allegedly Sat On Drug Rights To Avoid $1B Payment
Drugmaker Novartis has allowed its right to develop a promising cancer treatment to "wither on the vine" to avoid having to pay nearly $1 billion under an interest purchase agreement with a Massachusetts company, a lawsuit filed in state court alleges.
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July 05, 2024
3rd Circ. Preview: Ponzi Scheme, Merck Vaccine Heat Up July
The Third Circuit's July argument schedule is sizzling with several high-stakes cases, including two whistleblowers attempting to make drugmaker Merck answer for allegedly inducing the U.S. government to pay for substandard mumps vaccines.
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July 05, 2024
Top Federal Tax Cases To Watch In The 2nd Half Of 2024
In the coming months, the U.S. Treasury and the IRS will defend rules designed to go after what they consider as abusive tax practices, including the economic substance doctrine, the Corporate Transparency Act and the moratorium on employee retention tax credits. Here, Law360 looks at key federal tax cases to watch in the rest of 2024.
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July 05, 2024
A&O Shearman-Led GSK Signs €1.4B Deal For Vaccines
British pharma giant GlaxoSmithKline has amended its collaboration agreement with German biopharmaceutical company CureVac to acquire full rights to develop, manufacture and commercialize globally the candidate vaccines for influenza and COVID-19 in an approximately €1.4 billion ($1.5 billion) deal.
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July 03, 2024
HHS Scores Early Win In Boehringer's Medicare Pricing Suit
A Connecticut federal judge on Wednesday sided with the U.S. Department of Health and Human Services in Boehringer Ingelheim's challenge to a new Medicare drug price negotiation program, rejecting the pharmaceutical company's claim that the program is unconstitutional.
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July 03, 2024
Humana Drops 6th Circ. Remand Bid In Ohio Collusion Suit
Humana is being dismissed from Ohio's lawsuit accusing pharmacy benefit managers and insurers of conspiring to inflate prescription prices through international subsidiaries after the company reached a settlement agreement in June.
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July 03, 2024
Roche Says Stanford Profs Stole Cancer Detection Tech
Roche Molecular Systems has accused Stanford University and several faculty members of swiping its proprietary cancer detection technology and secretly founding a new company with it, according to a suit filed in California federal court.
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July 03, 2024
Revived Skinny Label Case Is A Warning For Generics
The Federal Circuit has made clear that generic-drug companies need to pay close attention to public statements when advertising drugs that still have patent-protected uses, even if their so-called skinny labels properly avoid references to those carved-out indications, attorneys say.
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July 03, 2024
Appeals Board Tosses Revived License Breach Dispute
The Civilian Board of Contract Appeals has again tossed a dispute, previously revived by the Federal Circuit, alleging the U.S. Food and Drug Administration breached a software company's end-user license agreement, saying it lacks jurisdiction to enforce the agreement.
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July 03, 2024
Cooley DQ'd From IP Case Over Atty's Past Patent Work
Cooley LLP was disqualified on Wednesday from representing a pharmaceutical customer-support software company against patent infringement claims in Delaware, with the district court citing a Cooley partner's prior work representing the plaintiff and Cooley's refusal to screen its attorney.
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July 03, 2024
Penile Implant Doc Seeks $7M Atty Fees, Costs In $18M IP Win
A urologist who won $18.3 million in royalties and damages after a jury found a rival stole his penile implant trade secrets and infringed his intellectual property asked a California federal judge for $6.5 million in attorney fees and $614,000 in costs, saying he is owed the funds as the prevailing party in the litigation.
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July 03, 2024
4 Mass. Rulings You Might Have Missed In June
Massachusetts state courts last month dealt with thorny contract disputes, mistakenly disclosed emails between a defendant and an attorney, and a company's overtime policy change that may not have been spelled out to workers.
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July 03, 2024
1st Circ. Hands Hearing Loss Biotech Win In Stock-Drop Suit
A panel of the First Circuit declined to revive an investor class action alleging that a hearing loss treatment company and some of its executives concealed disappointing clinical trial results, saying there was no evidence the company had knowingly made false statements about the trial.
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July 03, 2024
Cerevel Investors Allege Insider Trades Pre-$8.7B AbbVie Deal
A pension fund shareholder of Cerevel Therapeutics Holdings Inc. has sued the biopharmaceutical company in Delaware's Court of Chancery, seeking documents to investigate potential fiduciary duty breaches and possible insider trading shortly before the company announced its pending $8.7 billion merger with AbbVie Inc.
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July 03, 2024
After Chevron Deference: What Lawyers Need To Know
This term, the U.S. Supreme Court overturned Chevron deference, a precedent established 40 years ago that said when judges could defer to federal agencies' interpretations of law in rulemaking. Here, catch up with Law360's coverage of what is likely to happen next.
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July 03, 2024
Chancery Tosses Challenge To $3B AstraZeneca Viela Bio Sale
AstraZeneca PLC and a U.K. affiliate beat late Tuesday a Delaware Court of Chancery stockholder suit accusing the company of orchestrating an underpriced, $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc. in order to clear the way for AstraZeneca's purchase of a larger competitor.
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July 03, 2024
Quest Diagnostics Paying $985M For OMERS' LifeLabs
Canadian law firm McCarthy Tétrault LLP is guiding New Jersey-based Quest Diagnostics on a newly inked deal to buy LifeLabs from the Ontario Municipal Employees Retirement System, or OMERS, for about $985 million, Quest said Wednesday.
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July 02, 2024
FTC Investigating Teva Inhaler Patent Listings, Report Says
The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals after it refused to remove inhaler patents from a key federal database, according to a Washington Post report citing confidential agency documents.
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July 02, 2024
Chamber, Pharma Slam Colorado Drug Price Controls
The U.S. Chamber of Commerce and a prominent pharmaceutical industry group have urged a Colorado federal court to bar a state review board from setting price controls on prescription drugs, arguing that the practice is "irreconcilable" with federal patent law.
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July 02, 2024
Biotech Biz Co-Directors Sue Each Other In Del., Cite Breaches
A California-based biotech company once researching a new class of antiviral therapy for COVID-19 is now the subject of dissolution proceedings in Delaware's Court of Chancery, after the company's two directors filed dueling lawsuits alleging fiduciary duty breaches and a board-level stalemate.
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July 02, 2024
Pharma Co. Scores Exit In Investor Suit Over Primate Imports
A Massachusetts federal judge tossed every claim in a proposed class action claiming that pharmaceutical company Charles River Laboratories and its executives concealed their involvement in the illegal importation of nonhuman primates for research, ruling that the disputed statements are not false or misleading.
Expert Analysis
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Exploring An Alternative Model Of Litigation Finance
A new model of litigation finance, most aptly described as insurance-backed litigation funding, differs from traditional funding in two key ways, and the process of securing it involves three primary steps, say Bob Koneck, Christopher Le Neve Foster and Richard Butters at Atlantic Global Risk LLC.
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Del. IP Ruling May Mark Limitation-By-Limitation Analysis Shift
A Delaware federal court's recent ruling in Lindis Biotech v. Amgen, which involved complex technology where the complaint contained neither facts nor a specific allegation directed to a claim limitation, might spark a shift away from requiring a limitation-by-limitation analysis, say Ted Mathias and Ian Swan at Axinn.
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Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors
Though developers of gene and cell therapy products commonly assume that a legal safe harbor protects them from patent infringement suits, recent case law shows that not all preapproval uses of patented technology are necessarily protected, say Natasha Daughtrey and Joshua Weinger at Goodwin.
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Series
Teaching Yoga Makes Me A Better Lawyer
Being a yoga instructor has helped me develop my confidence and authenticity, as well as stress management and people skills — all of which have crossed over into my career as an attorney, says Laura Gongaware at Clyde & Co.
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How Clinical Trials Affect Patentability In US And Europe
A comparison of recent U.S. and European patent decisions — concerning the effect of disclosures in clinical trials on the patentability of products — offers guidance on good practice for companies dealing with public use issues and prior art documents in these commercially important jurisdictions, say lawyers at Finnegan.
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A Vision For Economic Clerkships In The Legal System
As courts handle increasingly complex damages analyses involving vast amounts of data, an economic clerkship program — integrating early-career economists into the judicial system — could improve legal outcomes and provide essential training to clerks, say Mona Birjandi at Data for Decisions and Matt Farber at Secretariat.
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Opinion
State-Regulated Cannabis Can Thrive Without Section 280E
Marijauna's reclassification as a Schedule III-controlled substance comes at a critical juncture, as removing marijuana from being subjected to Section 280E of the Internal Revenue Code is the only path forward for the state-regulated cannabis industry to survive and thrive, say Andrew Kline at Perkins Coie and Sammy Markland at FTI Consulting.
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Key Takeaways From FDA Final Rule On Lab-Developed Tests
Michele Buenafe and Dennis Gucciardo at Morgan Lewis discuss potential consequences of the U.S. Food and Drug Administration's recently finalized rule regulating lab-developed tests as medical devices, and explain the rule's phaseout policy for enforcement discretion.
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Assessing HHS' Stance On Rare Disease Patient Assistance
The U.S. Department of Health and Human Services' recent advisory opinion, temporarily blessing manufacturer-supported copay funds for rare disease patients, carves a narrow path for single-donor funds, but charities and their donors may require additional assistance to navigate programs for such patients, says Mary Kohler at Kohler Health Law.
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Opinion
Feds' Biotech Enforcement Efforts Are Too Heavy-Handed
The U.S. Department of Justice's recent actions against biotech companies untether the Anti-Kickback Statute from its original legislative purpose, and threaten to stifle innovation and undermine patient quality of care, say attorneys at Ropes & Gray.
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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.