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Life Sciences
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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.
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June 20, 2024
Spinal Implant Maker Can Liquidate Under Ch. 11 Plan
A Delaware bankruptcy judge agreed Thursday to approve the Chapter 11 liquidation and wind-down plan of biotechnology developer InVivo, which reported it landed a buyer for its spinal cord implant technology following an unsuccessful bankruptcy auction.
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June 20, 2024
11th Circ. Upholds $2.5M Pelvic Mesh Verdict, Rules Suit Timely
The Eleventh Circuit on Thursday refused to throw out a woman's $2.5 million victory against Coloplast Corp. in a suit alleging she was implanted with defective pelvic mesh, saying the evidence does not support a conclusion that her claim was filed too late.
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June 20, 2024
No Access To Ethics Docs For Ex-NJ Official Yet, Judge Rules
A New Jersey judge has rejected a bid by a former Garden State health official asking the court to compel the state and its ethics commission to produce documents related to claims he was fired in 2020 for raising concerns over the earmarking of COVID-19 tests for relatives of a state administration official, according to Wednesday orders.
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June 20, 2024
No Atty, No Case: Judge Tosses Attack On Psychedelics Ban
A federal judge in Washington state threw out a challenge to the U.S. Drug Enforcement Administration's efforts to ban two psychedelic substances in an order Thursday that chided a psychedelic research company for doing "an end run" around requirements that corporations be represented by an attorney.
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June 20, 2024
HHS Drug Pricing Program Flouts Constitution, Boehringer Says
An "unprecedented" new Medicare price negotiation program deprives drugmakers of their constitutional rights and forces them to make declarations on issues of public concern that reflect poorly on them, Boehringer Ingelheim Pharmaceuticals Inc. argued Thursday in Connecticut federal court as it echoed the industry chorus seeking to strike the initiative.
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June 20, 2024
11th Circ. Nixes J&J Sunscreen Benzene MDL Settlement
The Eleventh Circuit on Thursday vacated an order granting approval to a settlement resolving claims that Johnson & Johnson sold sunscreens containing benzene, saying a pair of circuit court decisions since the approval mean the deal needs another look.
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June 20, 2024
Theravance, Mylan Say Chinese Co. Copied COPD Drug
Theravance Biopharma and Mylan Specialty have sued a Chinese drugmaker, alleging it copied Yupelri, one of its chronic obstructive pulmonary disease drugs, and infringed several patents in the process.
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June 20, 2024
USPTO's AI-Assisted Inventions Guidance Irks ABA IP Section
The U.S. Patent and Trademark Office's guidance on when inventions developed using artificial intelligence can be patented generated criticism from the American Bar Association's Section of Intellectual Property Law, expressing concern that it could be detrimental as it "casts doubt on inventorship through general acts of human direction."
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June 20, 2024
11th Circ. Backs Stryker's Defeat Of Fired Worker's Leave Suit
The Eleventh Circuit refused Thursday to revive a suit claiming medical technology company Stryker illegally fired a worker on leave awaiting the birth of his child, ruling that because the leave didn't formally kick in until the child was born, his termination was fair game.
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June 18, 2024
High Court Petition Asks Justices: What's A 'Willful' Kickback?
Does a "willful" act under federal anti-kickback law require a defendant to know that the conduct violates the law? That's the question a whistleblower is asking the U.S. Supreme Court to answer in order to resolve what the petition calls a circuit split on a key question of federal fraud prosecutions.
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June 18, 2024
Company, States Battle In Court Over At-Home Rape Kits
A fight is brewing in federal and state courts between a company that purports to be the nation's only purveyor of self-administered sexual assault DNA collection kits and state attorneys general who believe it is misleading sexual assault victims.
Expert Analysis
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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.
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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.