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Life Sciences
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April 29, 2025
Omnicare Hit With $136M Jury Verdict For Bilking Feds
A New York federal jury on Tuesday returned a verdict finding that CVS Health Corp. subsidiary Omnicare illegally billed the federal government to the tune of $135.6 million, one of the largest jury verdicts in a False Claims Act case, according to a statement from the U.S. Department of Justice.
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April 29, 2025
Justices Wary Of Issuing 'Advisory' Ruling In Class Cert. Row
The U.S. Supreme Court's latest attempt to address a pressing question about class certification standards may be doomed by a procedural hiccup, with a majority of justices expressing concern Tuesday that they didn't have the authority to wade into a dispute over approval of a class that contains uninjured members.
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April 29, 2025
DC Judge Worries About 340B Rebate Program Without 'Teeth'
The D.C. federal judge tasked with deciding dueling summary judgments in litigation accusing the government of blocking drugmakers' efforts to reshape the way they do rebates seemed skeptical of endorsing a vision of the program that could have "potentially devastating consequences."
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April 29, 2025
23andMe Agrees To Privacy Ombudsman In Ch. 11
A Missouri bankruptcy judge on Tuesday signed off on a consumer privacy watchdog for 23andMe's Chapter 11 after the genetic testing group and 30 states agreed that a statutorily authorized ombudsman would be the best way to vet a Chapter 11 sale that includes 15 million users' DNA information.
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April 29, 2025
Full Fed. Circ. Urged To Undo 'Onerous' Jepson Claim Ruling
Xencor has urged the full Federal Circuit to review a decision rejecting its application for an antibody patent that used the so-called Jepson claim format, saying the case set an "onerous requirement" that is nearly impossible to meet and "eliminates any incentive" to use the format.
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April 29, 2025
Fed. Circ. Backs TM Denial Of Dark Green Gloves As Generic
The Federal Circuit on Tuesday adopted a test for determining if trademarks are generic when considering claims on distinctive colors, affirming a trademark board precedent used to reject an Indonesian medical supply company's efforts to claim a trademark for dark green surgical gloves.
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April 29, 2025
GenBioPro Can Defend FDA Approval In Mifepristone Suit
A Texas federal judge has allowed drugmaker GenBioPro to join a legal fight over access to the abortion drug mifepristone, finding that the company has a distinct interest in defending federal approval of the generic version of the medication.
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April 29, 2025
Mexico Put On Latest USTR Priority IP Watch List
The Office of the U.S. Trade Representative on Tuesday issued its annual global intellectual property report that has placed close trading partner Mexico on its list of countries to keep the closest eye on.
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April 29, 2025
Cooley Life Sciences Ace Rejoins Latham In Bay Area
Latham & Watkins LLP has welcomed back an intellectual property attorney who spent the past nine years at Cooley LLP to bolster its healthcare and life sciences practice, including advising clients about licensing and transactional matters.
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April 29, 2025
Opioid MDL Judge Won't Recuse Over Ex Parte Allegations
An Ohio federal judge will not step aside from multidistrict opioid litigation after the plaintiffs' attorney, who had alleged the judge "regularly communicates" with other lawyers involved in the litigation, testified that there was no such communication after all, the judge ruled Tuesday.
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April 29, 2025
High Court Backs HHS In Hospital Pay Formula Dispute
The U.S. Supreme Court on Tuesday sided with federal health officials in a challenge over a formula used to calculate billions of dollars in annual payments to hospitals treating indigent patients, saying that those entitled to Supplemental Security Income should be collecting cash payments before they're counted in the formula.
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April 28, 2025
Chinese Cos. Lose Immunity Fight In 9th Circ. IP Case
The Ninth Circuit on Monday shot down arguments from related Chinese steel companies that they shouldn't have to face espionage charges that they stole DuPont trade secrets for creating titanium dioxide, saying they aren't protected by foreign sovereign immunity.
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April 28, 2025
Veolia Settles Flint Water Crisis Claims For $53M
A Michigan federal judge entered final judgment Monday in litigation brought by the state of Michigan and about 26,000 individuals against Veolia North America alleging it prolonged the water crisis in Flint, Michigan, after a $53 million settlement was approved earlier this month.
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April 28, 2025
Gov't Reverses Position On Surgery For Trans Prisoners
The Trump administration is rejecting the federal government's previous stance that prison officials are constitutionally required to provide gender confirmation surgery to incarcerated people with gender dysphoria who request the treatment, noting the shift in recent statements to a Georgia federal court.
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April 28, 2025
Ziploc 'Microwave Safe' Bags Shed Microplastics, Buyer Says
S.C. Johnson & Son Inc. falsely markets Ziploc bags and containers as "microwave safe" and suitable for use in freezers despite knowing they are made from materials that shed microplastics into food when the products are used as directed, according to a proposed class action filed in California federal court.
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April 28, 2025
Walgreens Opposes Merging 'Non-Drowsy' Labeling Suits
Walgreens is pushing back on a bid to consolidate two Illinois federal lawsuits alleging the "non-drowsy" label on some of the retailer's cough suppressant medications is misleading, saying the two cases involve different allegations and are at different stages, and arguing that consolidation would cause a delay in the litigation.
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April 28, 2025
Sanofi Challenges Jurisdiction In Conn. Zantac Lawsuits
Sanofi-Aventis U.S. LLC on Monday sought to exit nine combined Connecticut lawsuits claiming the heartburn drug ranitidine degraded into a compound that causes cancer, saying it is beyond the state's long-arm statute and that due process guarantees prevent it from being sued in Connecticut.
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April 28, 2025
Ala. Medical Pot Commission Sued Over Patient Registry
A group of Alabama medical cannabis patients sued the state's Medical Cannabis Commission over the lack of a patient registry despite what they said were numerous laws obligating it to create one.
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April 28, 2025
Sullivan & Cromwell-Led Merck To Buy SpringWorks For $3.9B
Merck KGaA said Monday it has agreed to acquire U.S. biotech company SpringWorks Therapeutics for $3.9 billion, as the German science and technology group aims to grow its cancer drug business and its global presence.
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April 25, 2025
HHS Says Cuts Target Excess After Judge Seeks More Info
The U.S. Department of Health and Human Services told a Rhode Island federal judge that a group of states has no basis to challenge the cancellation of billions in grants supporting public health programs because they already received the funds appropriated to them by Congress.
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April 25, 2025
SPAC Deals Are Buzzing Again Despite Tariff Turmoil
Amid heavy volatility that has largely frozen traditional initial public offerings, deal teams are launching more special purpose acquisition companies, an alternative market to typical IPOs that so far has shown few ill effects from tariff-related uncertainty.
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April 25, 2025
Local Gov'ts, Union Sue Over COVID Grant Cancellations
Four local governments have joined with a government employees union to challenge the federal government's termination of $11 billion in grants stemming from the COVID-19 pandemic, seeking an injunction restoring the funds and a declaration that the decision to mass-terminate the grants was unlawful.
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April 25, 2025
Judge Says FDA Can Take Ozempic Off Shortage List
A Texas federal judge has sided with arguments from Ozempic maker Novo Nordisk A/S not to block the U.S. Food and Drug Administration from moving forward with an administrative decision stopping "unsafe, knockoff versions" of the blockbuster diabetes and weight loss drug from flooding the market.
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April 25, 2025
J&J Unit Sees Claims Trimmed In Engineer's Bias Suit
A Johnson & Johnson-owned prosthetics company does not have to face claims that an engineer filed his lawsuit, alleging violations of the Family and Medical Leave Act, too late, a Massachusetts federal judge ruled Friday, but determined some of the allegations are timely and can proceed.
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April 25, 2025
Aggressive USPTO Policy Push Suggests 'It's Lutnick's Show'
U.S. Patent and Trademark Office acting Director Coke Morgan Stewart's three months in charge have featured an unprecedented level of policymaking for an interim leader, suggesting that Secretary of Commerce Howard Lutnick has a vision for the agency and he's not waiting for the U.S. Senate to confirm a new director to pursue it.
Expert Analysis
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What's At Stake In High Court Transgender Care Suit
The outcome of U.S. v. Skrmetti will have critical implications for the rights of transgender youth and their access to gender-affirming care, and will likely affect other areas of law and policy involving transgender individuals, including education, employment, healthcare and civil rights, say attorneys at ArentFox Schiff.
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6th Circ. Ruling Paves Path Out Of Loper Bright 'Twilight Zone'
The U.S. Supreme Court’s Loper Bright ruling created a twilight zone between express statutory delegations that trigger agency deference and implicit ones that do not, but the Sixth Circuit’s recent ruling in Moctezuma-Reyes v. Garland crafted a two-part test for resolving cases within this gray area, say attorneys at Wiley.
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A Reminder On Avoiding Improper Venues In Patent Cases
A Texas federal court's recent decision in the Symbology and Quantum cases shows that baseless patent venue allegations may be subject to serious Rule 11 sanctions, providing venue-vetting takeaways for plaintiffs and defendants, say attorneys at Bond Schoeneck.
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NIH Cuts To Indirect Costs May Stifle IP Generation
Although currently blocked by a preliminary injunction, the National Institutes of Health's new policy to cut down on indirect cost funding creates challenges for university research projects, and may hamper the development of intellectual property — which is considered an indirect cost — for years to come, say attorneys at Snell & Wilmer.
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Recent Cases Clarify FCA Kickback Pleading Standards
Two recently resolved cases involving pharmaceutical manufacturers may make it more difficult for False Claims Act defendants facing kickback scheme allegations to get claims dismissed for lack of evidence, say Li Yu at Bernstein Litowitz, Ellen London at London & Noar, and Gregg Shapiro at Gregg Shapiro Law.
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Opinion
Antitrust Analysis In Iowa Pathologist Case Misses The Mark
An Iowa federal court erred in its recent decision in Goldfinch Laboratory v. Iowa Pathology Associates by focusing exclusively on market impacts and sidestepping key questions that should be central to antitrust standing analysis, says Daniel Graulich at Baker McKenzie.
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Opinion
State FCAs Should Cover Local Fund Misuse, State Tax Fraud
New Jersey and other states with similar False Claims Acts should amend them to cover misappropriated municipal funding, and state and local tax fraud, which would encourage more whistleblowers to come forward and increase their recoveries, says Kenneth Levine at Stone & Magnanini.
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7 Tips For Associates To Thrive In Hybrid Work Environments
Excerpt from Practical Guidance
As the vast majority of law firms have embraced some type of hybrid work policy, associates should consider a few strategies to get the most out of both their in-person and remote workdays, says James Argionis at Cozen O’Connor.
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Series
Playing Beach Volleyball Makes Me A Better Lawyer
My commitment to beach volleyball has become integral to my performance as an attorney, with the sport continually reminding me that teamwork, perseverance, professionalism and stress management are essential to both undertakings, says Amy Drushal at Trenam.
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What To Expect From 'Make America Healthy Again' Actions
The Make America Healthy Again Commission recently established by President Donald Trump and chaired by Robert F. Kennedy Jr. will potentially bring energy and attention to important public health topics, and stakeholders should be aware of pathways for sharing their input and proactively informing proceedings, says Nicholas Manetto at Faegre Drinker.
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How Law Firms Can Counteract The Loneliness Epidemic
The legal industry is facing an urgent epidemic of loneliness, affecting lawyer well-being, productivity, retention and profitability, and law firm leaders should take concrete steps to encourage the development of genuine workplace connections, says Michelle Gomez at Littler and Gwen Mellor Romans at Herald Talent.
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What's At Stake In High Court's Class Member Standing Case
The U.S. Supreme Court’s eventual decision in Labcorp v. Davis could significantly alter how parties prosecute and defend class actions in federal court, particularly if the court determines some proof of member standing is required before a class may be certified, say attorneys at Reed Smith.
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How Citizen Petitions Have Affected Drug Competition
In light of recent citizen petitions and proposed legislation regulating such petitions, Omar Robles at Managing Health analyzes the statistics of the extent to which citizen petitions have been filed, and to what extent they have delayed competition in prescription pharmaceuticals.
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5 Keys To Building Stronger Attorney-Client Relationships
Attorneys are often focused on being seen as the expert, but bonding with clients and prospects by sharing a few key personal details provides the basis for a caring, trusted and profoundly deeper business relationship, says Deb Feder at Feder Development.
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Drug Kickback Ruling Will Make FCA Liability Harder To Prove
The First Circuit's ruling in U.S. v. Regeneron Pharmaceuticals, requiring the government to prove but-for causation to establish False Claims Act liability based on violations of the Anti-Kickback Statute, raises the bar for FCA enforcement and deepens a circuit split that the U.S. Supreme Court may need to resolve, say attorneys at Baker Donelson.