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Life Sciences
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March 27, 2025
Diopsys Inks $14M Deal Resolving Vision Testing FCA Claims
Medical device maker Diopsys Inc. has agreed to pay up to $14.25 million to put to rest allegations it violated the False Claims Act by submitting false Medicare and Medicaid claims for certain vision testing services, according to a U.S. Department of Justice announcement Thursday.
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March 27, 2025
New Procedures Expected To Result In More PTAB Denials
Under new procedures where the director of the U.S. Patent and Trademark Office will decide whether petitions challenging patents should be denied for discretionary reasons, such denials will likely increase, although the policy leaves many unanswered questions, attorneys say.
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March 27, 2025
Vaping Interests Take Challenge To FDA Rule To 5th Circ.
A coalition of vaping interests challenging the U.S. Food and Drug Administration's marketing and recordkeeping regulations has taken the dispute to the Fifth Circuit after a lower district judge tossed the lawsuit, which claimed many in the industry were prohibited from seeking FDA approval for multiple products at once because of the high cost of applying.
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March 27, 2025
Fertility Co. Wants To Pull Device Maker Into Negligence Suit
A fertility products company wants two other companies to share potential liability from a Connecticut state lawsuit alleging that a recalled culture medium was responsible for the loss of embryos a couple were planning to use for in vitro fertilization.
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March 27, 2025
Texas Judge 'Disturbed' By Filings In Weight Loss Drug Case
A Texas federal judge had stern words for a group of compounding pharmacies while refusing to allow them to manufacture Eli Lilly's lucrative weight loss drug, saying he was "increasingly exasperated" with the pharmacies' attempts to dictate how he manages the case.
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March 27, 2025
Fed. Circ. Revives Recor's PTAB Challenge To Medtronic IP
The Federal Circuit on Thursday revived medical technology company Recor Medical's challenge to a Medtronic Ireland Manufacturing patent on a way to treat heart and renal failure, telling the Patent Trial and Appeal Board to once again review the fight.
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March 27, 2025
Fitch Even Sues Ex-IP Client In Effort To End Malpractice Case
Fitch Even Tabin & Flannery LLP has launched a lawsuit asking an Illinois federal court to declare that the co-founder of a former client isn't the inventor behind a prenatal test patent, which the firm said would put a stop to a malpractice case against it in state court.
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March 27, 2025
Oura Gets Samsung's Preemptive IP Strike Tossed, For Now
Samsung Electronics cannot yet seek a declaration that its Galaxy Ring brand of wearable, health-tracking devices does not infringe Oura Health's smart ring patents, a California federal judge ruled Thursday, saying Samsung hasn't shown the Finnish company is threatening to sue for infringement.
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March 27, 2025
Ga. Therapy Clinic Accused Of Refusing OT Payments
A Georgia mental health clinic was sued Wednesday by a former aide who alleged that she was forced to resign her position with the company last year when it refused to give her thousands of dollars of overtime pay she claims she was owed.
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March 27, 2025
Eli Lilly Says Michigan AG's Insulin Pricing Probe Is Baseless
Michigan Attorney General Dana Nessel's case for investigating Eli Lilly's insulin prices is based on fundamentally flawed premises, such as comparing what consumers pay in Michigan to Canada, the drugmaker has told the Michigan Supreme Court in a new brief.
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March 27, 2025
Walgreens To Pay $2.8M For Alleged Medicaid Overcharges
Walgreens will pay $2.8 million under an agreement with federal prosecutors to settle allegations that it submitted inflated prices for some generic medications to Medicaid programs in Massachusetts and Georgia.
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March 27, 2025
Mich. Judge Deflects Criticism Of Atty Fees In $53M Flint Deal
A Michigan federal judge on Thursday defended her decision to grant a third of a $53 million settlement to attorney fees for lawyers who represented Flint claimants who alleged a water firm prolonged the water crisis, saying many members of the public don't understand the complexities of the case.
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March 27, 2025
Fox Rothschild Adds McCarter & English IP Litigator In NJ
Fox Rothschild LLP grew its Princeton, New Jersey, office this week with the addition of an intellectual property partner from McCarter & English LLP specializing in patent prosecution for medical devices, technology-enabled hardware and more.
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March 27, 2025
Texas Law Firm Must Face 2nd Firm's Paxil Fees Suit
A Texas appellate court affirmed Thursday that a law firm battling its former co-counsel over the proceeds of lawsuits concerning the antidepressant drug Paxil can't use the state's anti-SLAPP statute to avoid a breach of contract claim but tossed an award of $100,000 in attorney fees.
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March 27, 2025
Top EU Court Urged To Uphold €60M Teva Pay-For-Delay Fine
An adviser to the European Union's top court said Thursday that it should uphold €60.5 million ($70.7 million) in fines against Teva and its subsidiary Cephalon for an alleged conspiracy to keep a generic version of Provigil off the shelves.
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March 27, 2025
1st Circ. Denies Gov't Bid To Enforce Funding Freeze
The First Circuit has declined to interfere with a Rhode Island federal judge's order that the government continue releasing federal funds while the Trump administration appeals a ruling blocking its efforts to enforce the freeze.
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March 27, 2025
HHS To Cut 10,000 Jobs As RFK Jr. Reorganizes Agency
The U.S. Department of Health and Human Services said Thursday that it would lay off 10,000 employees as part of a "dramatic" plan to restructure the agency and downsize its workforce by about 24%.
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March 26, 2025
Sotomayor Urges Caution On Nondelegation Doctrine Revamp
U.S. Supreme Court Justice Sonia Sotomayor cautioned her colleagues during oral arguments Wednesday against using a challenge to the Federal Communications Commission's administration of a broadband subsidy program as a way to resurrect the long-dormant nondelegation doctrine. Several conservative justices, however, seemed willing to disregard that admonition.
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March 26, 2025
7 Firms Compete To Lead Novo Nordisk Securities Suit
Levi & Korsinsky LLP, Pomerantz LLP and the Rosen Law Firm PA are among seven law firms vying to lead proposed class claims accusing Novo Nordisk A/S of misleading investors about a clinical trial for an obesity drug.
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March 26, 2025
23andMe Says Ch. 11 Privacy Ombudsman Not Required
DNA testing company 23andMe Inc.'s customer data will be protected in Chapter 11, its attorneys told a Missouri bankruptcy judge Wednesday as it argued that the appointment of a consumer privacy ombudsman is not required.
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March 26, 2025
Full Fed. Circ. Won't Look At Injunction On MSN's Generic Drug
The full Federal Circuit won't revisit a panel's January order barring MSN Laboratories Pvt. Ltd. from launching a generic version of Novartis' bestseller, the cardiovascular drug Entresto, as part of a flurry of moves in litigation related to the treatment.
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March 26, 2025
Drugmaker Execs Hid Approval Process Roadblocks, Suit Says
A Sage Therapeutics Inc. investor sued the company's executives in New York federal court Wednesday alleging they hid significant setbacks affecting the regulatory approval for its drug candidates intended to treat mood disorders and other conditions including Parkinson's and Alzheimer's diseases.
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March 26, 2025
Women Make Up 13% Of Attys In Front Of The PTAB
Women account for 13% of attorneys appearing in front of the Patent Trial and Appeal Board in post-grant proceedings going back to the board's founding in 2012 despite comprising up to 30% of all patent attorneys, according to a report from the PTAB Bar Association.
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March 26, 2025
Walgreens, Kroger Claim Takeda Cut Illegal TWi Generics Deal
Walgreens, Kroger, Albertsons and H-E-B hit Takeda and TWi Pharmaceuticals with an antitrust suit in California federal court Tuesday, accusing the pharmaceutical companies of conspiring to delay the release of the generic version of Takeda's heartburn medication Dexilant, causing the retailers to pay more for the brand-name drug.
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March 26, 2025
Del. Justices Back Axing Suit Over $3B AstraZeneca Viela Sale
The Delaware Supreme Court on Wednesday upheld without elaboration the dismissal of a Court of Chancery lawsuit accusing AstraZeneca PLC of lining up a conflicted, underpriced $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc.
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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Patent Drafting Pointers From Fed. Circ. COVID Test Ruling
The Federal Circuit's recent decision in DNA Genotek v. Spectrum Solutions provides several best practice pointers for drafting and prosecuting patent applications, highlighting how nuances in wording can potentially limit the scope of claims or otherwise affect claim constructions, says Irah Donner at Manatt.
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Opinion
Congress Must Reform The PTAB To Protect Small Innovators
Lawmakers must reintroduce the Promoting and Respecting Economically Vital American Innovation Leadership Act or similar legislation to prevent larger companies from leveraging the Patent Trial and Appeal Board to target smaller patent holders, says Schwegman Lundberg's Russell Slifer, former deputy director of the U.S. Patent and Trademark Office.
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Series
Baseball Fantasy Camp Makes Me A Better Lawyer
With six baseball fantasy experiences under my belt, I've learned time and again that I didn't make the wrong career choice, but I've also learned that baseball lessons are life lessons, and I'm a better lawyer for my time at St. Louis Cardinals fantasy camp, says Scott Felder at Wiley.
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Series
Adapting To Private Practice: From Fed. Prosecutor To BigLaw
Making the jump from government to private practice is no small feat, but, based on my experience transitioning to a business-driven environment after 15 years as an assistant U.S. attorney, it can be incredibly rewarding and help you become a more versatile lawyer, says Michael Beckwith at Dickinson Wright.
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What To Expect For Stem Cell Regulation Under Trump Admin
The new administration's push for deregulation, plus the post-Chevron legal landscape, and momentum from key political and industry players to facilitate stem cell innovation may create an opportune backdrop for a significant reduction in the U.S. Food and Drug Administration's regulatory framework for stem cells, say attorneys at Sheppard Mullin.
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Firms Still Have Lateral Market Advantage, But Risks Persist
Partner and associate mobility data from the fourth quarter of 2024 shows that we’re in a new, stable era of lateral hiring where firms have the edge, but leaders should proceed cautiously, looking beyond expected revenue and compensation analyses for potential risks, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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10 Practical Takeaways From FDA's Biopharma AI Guidance
Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.
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Opinion
We Must Allow Judges To Use Their Independent Judgment
As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.
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Series
Performing Stand-Up Comedy Makes Me A Better Lawyer
Whether I’m delivering a punchline on stage or a closing argument in court, balancing stand-up comedy performances and my legal career has demonstrated that the keys to success in both endeavors include reading the room, landing the right timing and making an impact, says attorney Rebecca Palmer.
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Unpacking The Illicit E-Cigarette Crackdown By State AGs
A bipartisan coalition of attorneys general for nine states and the District of Columbia announced a coordinated effort to curb illicit electronic cigarette sales, illustrating the rising prominence of state attorneys general using consumer protection laws to address issues of national scope, especially when federal efforts prove ineffective, say attorneys at Troutman.
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Lawmakers Shouldn't Overlook Rare Disease Therapies' Value
As the ORPHAN Cures Act is pending in Congress, policymakers assessing the value of certain drugs for price regulation should consider data beyond what is collected in clinical trials, say Alice Chen at the University of Southern California, and Molly Frean and Yao Lu at Analysis Group.
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Series
Adapting To Private Practice: From SEC To BigLaw
As I adjusted to the multifaceted workflow of a BigLaw firm after leaving the U.S. Securities and Exchange Commission, working side by side with new colleagues on complex matters proved the fastest way to build a deep rapport and demonstrate my value, says Jennifer Lee at Jenner & Block.
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China High Court Ruling Could Encourage Antitrust Litigation
Practitioners defending U.S. companies in China should take note of a Chinese Supreme Court ruling that plaintiffs can file suits based on either where the alleged action, or where the result of such action, occurred — which will promote civil litigation by minimizing procedural battles over forum selection, says Yang Yang at Leaqual Law Firm.
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Making The Case For Rest In The Legal Profession
For too long, a culture of overwork has plagued the legal profession, but research shows that attorneys need rest to perform optimally and sustainably, so legal organizations and individuals must implement strategies that allow for restoration, says Marissa Alert at MDA Wellness, Carol Ross-Burnett at CRB Global, and Denise Robinson at The Still Center.
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How Amended Rule 702 Affects Testimony In Patent Litigation
In 2023, Federal Rule of Evidence 702 was amended to address the apparent failure of some courts to prevent unreliable expert evidence from reaching a jury, but a statistical analysis of Daubert decisions in 2022 and 2024 shows that courts remain divided about how to apply consistent evidence standards, say attorneys at Perkins Coie.