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Life Sciences
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June 24, 2024
Alleged Contract Killing Sparks Delaware Chancery Lawsuit
Los Angeles biotech firm Renovaro Inc. has sued a former, purported scientific adviser and his husband in Delaware's Court of Chancery for damages tied to an assortment of fraudulent schemes allegedly shielded in part by a contract killing linked to a separate alleged international oil trading scam.
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June 24, 2024
Judge Mulls BioXcel's Duty To Tell Investors Of FDA Troubles
A Connecticut federal judge wondered Monday if executives at the artificial intelligence-driven drugmaker BioXcel Therapeutics Inc. had an opportunity to correct problems that government regulators identified with a key clinical trial and, if so, whether their statements on the subject to investors could be considered false or misleading.
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June 24, 2024
NYC Pharmacy Owners Get Jail Time For $18M Med Fraud
Two brothers who own several New York pharmacies will each have to pay over $18 million in restitution in addition to serving jail time for submitting fraudulent claims to Medicare for pricey cancer medication and funneling illicit proceeds through several shell companies, the U.S. Department of Justice announced Monday.
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June 24, 2024
Justices Undo Terror Victims' Win, Citing Twitter Decision
The U.S. Supreme Court on Monday swept aside a D.C. Circuit ruling that threatened to expose major pharmaceutical companies to liability for terrorist attacks that injured or killed hundreds of U.S. soldiers and civilians in Iraq.
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June 24, 2024
LA Schools Says Pseudoscience Infected 9th Circ. Vax Ruling
The Los Angeles Unified School District said Friday that a split Ninth Circuit panel leaned on pseudoscience when ruling that a rescinded employee COVID-19 vaccination mandate implicated the right of district employees to refuse medical treatment, urging an en banc panel to correct the "fatally flawed" decision.
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June 24, 2024
Ark. AG Sues Pharmacy Benefit Managers Over Opioids
The Arkansas attorney general said Monday that he had sued pharmacy benefit managers Optum Inc. and Express Scripts Inc. in state court, claiming they contributed to the opioid crisis and profited from the drug epidemic.
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June 24, 2024
Suit Over Medical Screws Filed Too Late, Texas Panel Finds
A Texas appeals court won't revive a woman's suit against BioPro Inc. alleging that surgical screws used in her feet were defective, saying the evidence establishes that she filed her suit after the two-year statute of limitations had expired.
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June 24, 2024
Jurisdictional Discovery Ordered In NJ COVID Test Fraud Suit
A New Jersey federal court has denied without prejudice a dismissal bid and ordered "tightly-targeted and prompt jurisdictional discovery" in a Garden State medical supply business' complaint accusing a Texas attorney and his solo practice of aiding in an alleged $2.45 million fraud scheme involving COVID-19 test kits that were never delivered.
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June 24, 2024
Catching Up With Delaware's Chancery Court
Amendments to Delaware's General Corporation Law topped the news out of the Court of Chancery again last week, as the hotly contested measure sailed through the state's legislature. Tesla and its shareholders continued their tug-of-war over attorney fees for Chancery litigation about Elon Musk's pay package, and new cases were filed involving biotechs, car rental companies, workout platforms, telecom towers, and a cargo ship fire in Brazil.
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June 24, 2024
Justices Pass On Conn. School Vaccine Mandate Fight
The U.S. Supreme Court on Monday declined to review a Second Circuit decision that largely upheld the dismissal of a suit challenging a Connecticut law passed during the COVID-19 pandemic that revoked religious exemptions to student vaccine mandates.
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June 24, 2024
Cooley-Led Therapy Developer Alumis Aims For $300M IPO
Venture-backed drug developer Alumis Inc. launched plans on Monday for an estimated $300 million initial public offering, guided by Cooley LLP and underwriters' counsel Latham & Watkins LLP, joining an active pipeline of IPO prospects this week.
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June 24, 2024
Altria Subsidiary Allowed To Sell Menthol-Flavored Vapes
Altria Group Inc. subsidiary NJOY has secured permission from the U.S. Food and Drug Administration to sell four menthol-flavored vapes, marking the first time any kind of flavored e-cigarette has secured federal approval.
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June 24, 2024
Biotech Co. Hits Ch. 11 With Plans For Sale And 'Reboot'
Virginia-based synthetic biology products maker Solar Biotech Inc. filed for Chapter 11 bankruptcy in Delaware with plans to sell its assets, saying a difficult capital market, the loss of a major client and the pandemic drained its cash and caused it to furlough employees.
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June 24, 2024
Justices Pass On Rutgers COVID-19 Vax Mandate Case
The U.S. Supreme Court declined on Monday to review a split Third Circuit ruling that Rutgers University students cannot challenge the school's COVID-19 vaccine policy because, under the high court's 1905 precedent in Jacobson v. Massachusetts, there is no fundamental right to refuse vaccinations.
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June 21, 2024
Drug Cos., IP Attys Back Cellect In High Court Efforts
A petition by patent litigation outfit Cellect that is looking to persuade the U.S. Supreme Court to wade into a double patenting dispute has drawn support from even more lawyers as well as a handful of major drugmakers and small tech companies like Sonos.
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June 21, 2024
Drugmakers Decline To Drop Patent Listings After FTC Letters
The eight pharmaceutical companies that the Federal Trade Commission warned in April may have improperly listed patents for its products in a key federal database have chosen not to remove any patents or otherwise alter their listings, according to a document released Friday.
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June 21, 2024
After Fed. Circ. Win, Bausch Sues Alvogen Over Drug Patents
Bausch's Salix Pharmaceuticals has launched a lawsuit against Alvogen's Norwich Pharmaceuticals unit in a New Jersey federal court, claiming that its planned generic version of Xifaxan, a blockbuster diarrhea and brain disorder drug, infringes a set of patents.
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June 21, 2024
Pay-For-Delay Drug Case Not Time-Barred, UK Tribunal Says
The U.K. Competition Appeal Tribunal refused Friday to apply a much more restrictive statute of limitations that would toss government claims that Danish pharmaceutical company Lundbeck Ltd. and generic drug manufacturers anticompetitively agreed to delay generic competition to an antidepressant.
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June 21, 2024
Ex-CEO Found Liable For $1 Now Seeks Atty Fees For Del. Suit
The ex-CEO of a biopharma company who was found liable in 2021 for breaching his fiduciary duties but ordered to pay just $1 in damages after Delaware's Court of Chancery found that no real harm had been done is now suing for his attorney's fees and court costs.
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June 21, 2024
Costco Sued Over PFAS In Kirkland Brand Baby Wipes
Costco is facing a proposed class action over its fragrance-free "natural" baby wipes, which consumers claim are made with toxic levels of forever chemicals, rendering them unsafe for use on children.
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June 21, 2024
8 Firms To Lead 4 IPOs Totaling $806M As Action Heats Up
Eight law firms are slated to guide four initial public offerings estimated to raise a combined $806 million during the week of June 24, potentially closing a slow month for new listings with a bang.
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June 21, 2024
Taxation With Representation: Travers Smith, Potamitis Vekris
In this week's Taxation With Representation, RSK Group Ltd. gets a £500 million ($632 million) investment, Boston Scientific Corp. acquires Silk Road Medical Inc., Masdar takes a part of Terna Energy SA, and Tate & Lyle PLC buys CP Kelco from JM Huber Corp.
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June 20, 2024
Ex-DEA Heads Echo GOP AGs' Call For Pot Rescheduling Hearing
A group of former U.S. Drug Enforcement Administration leaders and Republican attorneys general have formally requested administrative hearings on the U.S. attorney general's proposal to reschedule cannabis, according to separate letters sent this week that distinctly echo each other.
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June 20, 2024
Patent Owners, Challengers Spar Over PTAB Rule Proposal
The U.S. Patent and Trademark Office's scaled-back package of Patent Trial and Appeal Board rules has drawn a mixed reaction from legal and industry groups, which offered praise and concern about both the proposal and the topics it does not address.
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June 20, 2024
Eli Lilly Launches Round Of Diabetes Drug Suits
Eli Lilly on Thursday hit various compounding pharmacies and medical spas in five states and the District of Columbia with suits saying that they trick consumers into thinking that they sell Eli Lilly medications that treat diabetes and obesity when actually they are copycats and are untested by the U.S. Food and Drug Administration.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
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.