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Life Sciences
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May 07, 2024
Pharma Co. Falsely Touted Obesity Drug Results, Suit Claims
Biopharmaceutical company Altimmune Inc. and three of its executives were hit with a proposed class action alleging they overstated the clinical trial results and prospects of its obesity drug and its ability to compete with other weight loss medications like Ozempic.
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May 07, 2024
Fed. Circ. Seems Wary Of Broad's CRISPR Inventorship Win
Federal Circuit Judge Todd Hughes on Tuesday suggested that the Patent Trial and Appeal Board cited the correct standard when reviewing who first invented a particular use of the gene-editing technology CRISPR-Cas9, but then applied an improper standard when ruling in favor of a Massachusetts research team.
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May 07, 2024
Colo. Judge Tells Cos. Their Warring Briefs Aren't Helping
A Colorado federal judge has warned a medical device distributor and a Stryker subsidiary warring over a $2.3 million sanctions request that neither of their briefs appeared to provide "meaningful assistance" to help him determine what to award.
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May 07, 2024
Fla. Schools And Hospitals Fight To Save Opioid Claims
Five public hospital districts and two school districts told a Florida appeals court Tuesday that their claims for damages from the opioid crisis should not be eclipsed by the attorney general's settlements with opioid makers and distributors, arguing that she did not have the authority to bring claims on their behalf.
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May 07, 2024
Gov't Seeks Early Win In Ga. Medicaid Expansion Suit
The Biden administration is urging a federal judge to take its side in a lawsuit in which Georgia is attempting to keep its Medicaid program for low-income residents running until 2028, arguing that the state never properly asked for a program extension and that the court lacks jurisdiction to extend its end date.
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May 07, 2024
NJ Law Firm Scores Exit In Benicar MDL Fees Suit
A New Jersey federal judge on Tuesday granted Mazie Slater Katz & Freeman LLC attorneys a quick win in a proposed class action claiming they took excessive fees from plaintiffs' settlements in multidistrict litigation over the blood pressure drug Benicar, ruling the suit alleges identical claims to another suit that has been dismissed.
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May 07, 2024
Prepetition Waivers Sway Invitae Judge On Kirkland Hire
A New Jersey bankruptcy judge approved the retention of Kirkland & Ellis LLP as bankruptcy counsel for debtor Invitae Corp. Tuesday, the same day he approved a $239 million sale of its assets to Labcorp.
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May 07, 2024
1st Circ. Questions SEC Walk-Back In Conn. Atty's Fraud Case
A First Circuit panel indicated Tuesday that the Securities and Exchange Commission is trying to have it both ways by avoiding a retrial of a fraud case against a Connecticut attorney while keeping in place an earlier win.
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May 07, 2024
Law Firm Must Face COVID Test-Kit Fraud Suit, NJ Court Told
A medical supply business has urged a New Jersey federal court to reject a Texas law firm's bid to walk away from or transfer a more than $2.45 million lawsuit alleging it took part in a scheme to dupe the company into paying for COVID-19 test kits that were never delivered.
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May 07, 2024
Birth Control Cos. Can't Dodge Conn. Injury Suit, Court Told
An Illinois woman who sued after her Filshie Clip birth control device migrated inside of her and "wreaked havoc on her body" has urged a state court not to let the manufacturers of the device and the seller's parent companies dodge her claims.
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May 06, 2024
US Thrashes Mexico's 'Inaccurate' Portrayal Of GMO Corn
The United States has responded to Mexico's ban on imports of genetically modified corn, calling its portrayal of the risks of such crops an unscientific and "inaccurate" description as well as a violation of the United States-Mexico-Canada Agreement.
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May 06, 2024
Biotech Co. Wants To Appeal Red Cross Antitrust Immunity
A biotech company has told a Massachusetts federal court that giving the American Red Cross immunity from claims that it smothered competition in the platelet bacteria mitigation market is unprecedented and leaves the organization free to fix prices or buy up its competitors.
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May 06, 2024
Warranty Claims Trimmed From Bone Graft Tuberculosis Suit
A North Carolina federal judge has thrown out breach of warranty claims against three companies in a suit alleging their bone repair product gave a woman tuberculosis, saying it's subject to a state law blocking warranty liability for services involving human tissue.
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May 06, 2024
Chickasaw Can't Reopen Optum Prescription Payback Suit
An Oklahoma federal judge has denied a bid by the Chickasaw Nation to reopen its lawsuit over prescription reimbursement claims, ruling that the tribe has not met its burden of showing that provider UnitedHealth Group's Optum waived its right to arbitration.
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May 06, 2024
Paul Weiss Lands M&A Pro Who Sees Strong Deals Pipeline
James "Jim" Langston has joined Paul Weiss Rifkind Wharton & Garrison LLP as a partner in its mergers and acquisitions practice in New York, telling Law360 the move presented an irresistible opportunity to team up with attorneys he previously admired from across the bargaining table.
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May 06, 2024
Catching Up With Delaware's Chancery Court
A record $100 million settlement, a fishy Facebook decision, a canceled Amazon delivery and an upended $7.3 billion sale dispute topped the news out of Delaware's Court of Chancery last week. There were also new cases involving Hess, Microsoft and the 2022 World Cup.
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May 06, 2024
SEC Settles Insider Info Charges With CBD Co.'s Ex-Chairman
The U.S. Securities and Exchange Commission has announced a settlement with the former chairman of Neptune Wellness Solutions Inc. to resolve charges that he leaked inside information about the company's then-pending purchase of SugarLeaf Labs Inc. to a friend's wife.
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May 06, 2024
Mintz Adds Proskauer Life Sciences IP Litigation Team
Mintz Levin Cohn Ferris Glovsky and Popeo PC has brought on a life sciences patent litigation team of roughly a dozen attorneys from Proskauer Rose LLP in Los Angeles, Boston and New York led by the former chair of Proskauer's life sciences patent practice, the firm announced Monday.
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May 03, 2024
Ala. High Court Won't Rethink Decision On Frozen Embryos
The Alabama Supreme Court on Friday refused to revisit its February decision finding that frozen embryos count as children, a first-of-its-kind decision that has been received as potentially ruinous for in vitro fertilization services in the Yellowhammer State.
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May 03, 2024
FTC Requests Additional Info On $16.5B Novo-Catalent Deal
The Federal Trade Commission is seeking additional information on Novo Holdings' planned $16.5 billion acquisition of pharmaceutical services company Catalent in order to examine whether the blockbuster deal passes antitrust muster, according to a Friday securities filing.
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May 03, 2024
Publix Can't Send Questions To Ga. Justices In Opioid Suit
A federal judge overseeing national opioid litigation has rejected Publix's bid to ask the Georgia Supreme Court "convoluted and confusing" questions about if the state's public nuisance law applied to allegations the supermarket chain overdistributed painkillers.
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May 03, 2024
Medical Testing Co. Not In Health Field For Taxes, IRS Says
A company that fills medical testing orders for its customers is nonetheless not a business involved in performing services in the health field for certain tax purposes, the Internal Revenue Service said in a private letter ruling released Friday.
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May 03, 2024
4th Circ. Preview: Hemp, Wells And A Withdrawal
The Fourth Circuit's second session of 2024 will have the court pondering the tension between Virginia's recent hemp restrictions and federal regulations, and how the Truth in Lending Act impacts a case accusing PNC Bank of an unauthorized account withdrawal.
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May 03, 2024
UK Litigation Roundup: Here's What You Missed In London
The past week in London has seen rapper Ivorian Doll hit with a copyright claim, private members club Aspinalls file a claim against a Saudi sheikh, and Motorola Solutions file a claim against the British government on the heels of its dispute over losing a £400 million ($502 million) government contract. Here, Law360 looks at these and other new claims in the U.K.
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May 03, 2024
6 States Strike $270M Opioid Deal With Amneal
The New York state attorney general on Friday said that a $270 million multistate deal had been reached with opioid manufacturer Amneal Pharmaceuticals for its role in the addiction epidemic over allegations that the company failed to report suspicious orders of the narcotics.
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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Mid-2024 FCA Enforcement And Litigation Trends To Watch
Reviewing notable False Claims Act trends and enforcement efforts in the last year and a half reveals that healthcare is a key enforcement priority for the U.S. Department of Justice, and the road ahead may bring clarification on Anti-Kickback Statute causation and willfulness standards, along with increased focus on private equity, cybersecurity and self-disclosure, say attorneys at Epstein Becker.
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What 100 Federal Cases Suggest About Changes To Chevron
With the U.S. Supreme Court poised to overturn or narrow its 40-year-old doctrine of Chevron deference, a review of 100 recent federal district court decisions confirm that changes to the Chevron framework will have broad ramifications — but the magnitude of the impact will depend on the details of the high court's ruling, say Kali Schellenberg and Jon Cochran at LeVan Stapleton.
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Why High Court May Have Rejected IP Obviousness Appeal
Attorneys at Womble Bond analyze possible reasons the U.S. Supreme Court rejected Vanda Pharmaceuticals' request to review the Federal Circuit’s reasonable expectation of success standard for determining obviousness, including that the court was unpersuaded by the company's argument that Amgen v. Sanofi places a bind on drug developers.
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Microplastics At The Crossroads Of Regulation And Litigation
Though there are currently not many federal regulations specifically addressing microplastics as pollutants, regulatory scrutiny and lawsuits asserting consumer protection claims are both on the rise, and manufacturers should take proactive steps to implement preventive measures accordingly, say Aliza Karetnick and Franco Corrado at Morgan Lewis.
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The Fed. Circ. In April: Hurdles Remain For Generics
The Federal Circuit’s recent Salix v. Norwich ruling — where Salix's brand-name drug's patents were invalidated — is a reminder to patent practitioners that invalidating a competitor's patents may not guarantee abbreviated new drug application approval, say Sean Murray and Jeremiah Helm at Knobbe Martens.
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Tylenol MDL Highlights Expert Admissibility Headaches
A New York federal court's decision to exclude all plaintiff experts in a multidistrict litigation concerning prenatal exposure to Tylenol highlights a number of expert testimony pitfalls that parties should avoid in product liability and mass tort matters, say Rand Brothers and Courtney Block at Winston & Strawn.
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Don't Use The Same Template For Every Client Alert
As the old marketing adage goes, consistency is key, but law firm style guides need consistency that contemplates variety when it comes to client alert formats, allowing attorneys to tailor alerts to best fit the audience and subject matter, says Jessica Kaplan at Legally Penned.
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Don't Fall On That Hill: Keys To Testifying Before Congress
Because congressional testimony often comes with political, reputational and financial risks in addition to legal pitfalls, witnesses and their attorneys should take a multifaceted approach to preparation, walking a fine line between legal and business considerations, say attorneys at Crowell & Moring.
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Online Portal Helps Fortify Feds' Unfair Health Practices Fight
The Federal Trade Commission, U.S. Justice Department and the U.S. Department of Health and Human Services recently launched an online portal where the public can report potentially unfair healthcare practices, effectively maximizing enforcers' abilities to police anti-competitive actions that can drive up healthcare costs and chill innovation, say attorneys at Seyfarth.
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Series
Walking With My Dog Makes Me A Better Lawyer
Thanks to my dog Birdie, I've learned that carving out an activity different from the practice of law — like daily outdoor walks that allow you to interact with new people — can contribute to professional success by boosting creativity and mental acuity, as well as expanding your social network, says Sarah Petrie at the Massachusetts Attorney General’s Office.
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Think Like A Lawyer: Follow The Iron Rule Of Trial Logic
Many diligent and eager attorneys include every good fact, point and rule in their trial narratives — spurred by the gnawing fear they’ll be second-guessed for leaving something out — but this approach ignores a fundamental principle of successful trial lawyering, says Luke Andrews at Poole Huffman.
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The Art Of Asking: Leveraging Your Contacts For Referrals
Though attorneys may hesitate to ask for referral recommendations to generate new business, research shows that people want to help others they know, like and trust, so consider who in your network you should approach and how to make the ask, says Rebecca Hnatowski at Edwards Advisory.
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Trending At The PTAB: Permissible New Reply Arguments
In the time since the Federal Circuit’s Axonics ruling, the Patent Trial and Appeal Board has allowed petitioners to raise new unpatentability grounds in response to unforeseeable claim constructions in petitions, and reiterated that a petition need not anticipate every argument that may be raised in the response, say Joseph Myles and Timothy May at Finnegan.
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Wave Of Final Rules Reflects Race Against CRA Deadline
The flurry of final rules now leaping off the Federal Register press — some of which will affect entire industries and millions of Americans — shows President Joe Biden's determination to protect his regulatory legacy from reversal by the next Congress, given the impending statutory look-back period under the Congressional Review Act, say attorneys at Jenner & Block.
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'Beauty From Within' Trend Poses Regulatory Risks For Cos.
Companies capitalizing on the current trend in oral supplements touting cosmetic benefits must note that a product claim that would be acceptable for an externally applied cosmetic may draw much stronger scrutiny from the U.S. Food and Drug Administration when applied to a supplement, say Natalie Rainer and Katherine Staba at K&L Gates.