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Life Sciences
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October 01, 2024
From AI To Enviro: The Top Biz Bills Calif. Gov. Inked Into Law
California Gov. Gavin Newsom signed hundreds of bills into law ahead of an Oct. 1 deadline, meaning major changes are on the horizon for employers, tech companies, healthcare providers and others doing business in the Golden State.
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October 01, 2024
9th Circ. Cites 'Sunscreen' Song In Reviving Banana Boat Suit
The Ninth Circuit on Tuesday revived a proposed class action claiming Banana Boat sunscreen contains unsafe levels of benzene, citing a one-hit wonder from an Academy Award nominated director and saying a lower court judge erred by prematurely resolving disputed issues of fact and the merits of the consumer case.
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October 01, 2024
Judge Backs Louisiana 340B Law In Loss For Pharma Lobby
A Louisiana federal court has issued a sweeping loss to Big Pharma's top lobbying group and two pharmaceutical companies that argued a state law improperly expands the scope of the federal drug discount program.
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October 01, 2024
Activists Sue Ark. Officials Over Medical Pot Ballot Measure
Activists attempting to put a measure that would expand medical marijuana access in Arkansas on the ballot brought a lawsuit against John Thurston, the state's secretary of state, on Tuesday, one day after he said that the campaign did not have enough signatures to qualify for the ballot.
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October 01, 2024
Ex-CBD Exec Must Face SEC Fraud Suit Over $13M Deal
The U.S. Securities and Exchange Commission sufficiently backed its claims that a former cannabidiol products executive misled investors, including by making false statements in press releases, a Connecticut federal judge has ruled.
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October 01, 2024
DOJ Says It Is Constitutional To Disarm Pot Patients
The U.S. Department of Justice told a Pennsylvania federal judge Tuesday that a federal policy barring medical marijuana patients from lawfully possessing firearms is constitutional, and it urged the court to dismiss a legal challenge to the statute.
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October 01, 2024
Amgen Must Face Suit It Misled Investors On $10.7B Tax Bill
Amgen lost an attempt to escape a potential class action claiming the pharmaceutical giant hid a $10.7 billion tax bill from investors after a New York federal court ruled there was sufficient evidence for the action to proceed.
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October 01, 2024
Biotech Investors Reach $32.5M Deal Over Failed COVID Test
A class of Talis Biomedical Corp. investors accusing the company of inflating their stock price in the run-up to its IPO and then failing to launch a COVID-19 diagnostic test asked a California federal judge on Monday to preliminarily approve their $32.5 million settlement, citing Talis' shrinking cash reserves and imminent plans to file for bankruptcy.
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October 01, 2024
WilmerHale Lands Latham Life Sciences Ace In Bay Area
WilmerHale has brought on a second former Latham & Watkins LLP partner this year to its life sciences practice in its Palo Alto, California, office, strengthening the firm with an attorney who helped lead the team that guided public biopharmaceutical company BridgeBio Pharma to raise up to $1.25 billion in capital in January.
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October 01, 2024
Nostrum Labs Hits Ch. 11 A Year After Medicaid Settlement
Nostrum Laboratories, a New Jersey drugmaker that paid millions to settle allegations that it underpaid Medicaid drug rebates for its bladder infection drug after it hiked the price more than 400%, filed for Chapter 11 protection with nearly $68.3 million in debt.
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September 30, 2024
Takeda End Payors, Direct Buyers Win Antitrust Class Cert.
A New York federal judge Monday adopted a magistrate judge's recommendation to certify two classes of direct purchasers and end payors in consolidated antitrust actions accusing Takeda Pharmaceuticals Co. of unlawfully inflating the price of its diabetes treatment Actos by delaying entry of generic alternatives.
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September 30, 2024
Wheeling & Appealing: The Latest Must-Know Appellate Action
The year's spookiest month is looking scary-good for appellate aficionados, as famed oral advocates joust in October over net neutrality and Uber's extraordinary bid to unravel multidistrict litigation — just two of the high-profile arguments previewed in this edition of Wheeling & Appealing. October also begins with former President Jimmy Carter turning 100, and we'll test your knowledge of his profound impact on the judiciary.
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September 30, 2024
Consumer 'Overslept' On Some Drowsy Cough Syrup Claims
An Illinois federal judge said Monday a consumer can continue her suit alleging Tussin cough syrup's "non-drowsy" label is deceptive because the syrup made her sleepy, but ruled she waited too long to pursue warranty breach claims.
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September 30, 2024
Bristol-Myers Beats Celgene Investors' Drug Delay Suit
A New York federal judge on Monday tossed UMB Bank's claims that Bristol-Myers Squibb improperly delayed U.S. Food and Drug Administration approval of a cancer treatment to avoid paying shareholders $6.4 billion owed from a 2019 acquisition of Celgene Corp., saying the bank lacked standing to sue.
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September 30, 2024
J&J Backs Off 340B Rebate Plan Following Feds' Objections
Johnson & Johnson abandoned its plan Monday to offer rebates rather than upfront discounts for two medications under the 340B drug pricing law, contending it had no choice after a federal agency threatened to impose excessive penalties.
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September 30, 2024
Generic-Drug Co. Says To Think Again About 'Double Patenting'
An Indian generic-drug maker wants the whole Federal Circuit to take a closer look at the issue of "double patenting," telling it that a recent panel ruling mistakenly breathed new life into pharmaceutical patents covering an anti-diarrhea drug.
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September 30, 2024
Medical Device Co. Wins $25M Verdict In Poaching Trial
Medical device company Cynosure has won a $25 million jury award following a weekslong trial in Massachusetts federal court on its claims that a rival business raided its sales and marketing talent and caused the employees to breach their noncompete and nonsolicitation agreements.
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September 30, 2024
J&J Exec Accused Of File Heist Wants Pause Amid DOJ Case
A former competitive strategy director for Johnson & Johnson accused of stealing confidential files as he left the company to work for Pfizer asked a New Jersey federal court to pause the suit after learning he is under criminal investigation.
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September 27, 2024
Kappos' Bayh-Dole Warning To Clients Draws Debate
An advocate for lowering drug prices squared off Friday against a former U.S. Patent and Trademark Office director about the potential risk of accepting government funds to develop drugs, as part of a discussion at New York University School of Law.
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September 27, 2024
9th Circ. Says Stem Cell Treatment Not Exempt From FDA Rule
Two California clinics' experimental stem cell treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations, the Ninth Circuit ruled Friday, reviving the federal government's bid to stop the clinic from marketing the products as cures for certain diseases without U.S. Food and Drug Administration review.
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September 27, 2024
Why Many Drugs Remain Pricey 40 Years After Hatch-Waxman
In the four decades since Congress passed the Hatch-Waxman Act in an effort to make generic drugs more available, the pharmaceutical industry has used patent thickets, "evergreening" and pay-for-delay tactics to block competition and keep prices of life-saving specialty drugs astronomical, several legal experts told Law360, while the industry argues other parties shoulder more of the blame.
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September 27, 2024
Pharma Co. Amarin Beats Class Action Over Patent Issues
A New Jersey federal judge has tossed a proposed class action against pharmaceutical company Amarin and its top brass, alleging they misled shareholders about their products and the prospects of related patent litigation, saying the investors have failed to plead any actionable misleading statements or omissions made by the defendants.
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September 27, 2024
Life Sciences Firms Energize IPO Market As Recovery Builds
Initial public offerings are closing the year's third quarter on an upswing, led mostly by pre-revenue drug developers and select large companies that are seizing opportunities in friendlier capital markets buoyed by interest-rate cuts, generating momentum that experts say could carry over into next year.
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September 27, 2024
Advil Owner Haleon Paying $637M To Up Stake In China JV
British consumer healthcare giant Haleon plc said Friday that it has agreed to pay the equivalent of roughly $637 million to increase its stake in a Chinese joint venture, Tianjin TSKF Pharmaceutical Co., from 55% to 88%.
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September 27, 2024
Medical Equipment Co., Founder Settle FCA Suit For $20M
A Florida-based medical equipment company and its founder will pay $20 million to settle claims under the federal False Claims Act that they improperly billed government healthcare plans for duplicated and unnecessary sales of devices meant to offer pain relief through electrical stimulation, Pennsylvania prosecutors said Friday.
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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Defending AI, Machine Learning Patents In Life Sciences
Ten years after the U.S. Supreme Court's decision in Alice v. CLS Bank, artificial intelligence and machine learning technology remain at risk for Alice challenges, but reviewing recent cases can help life sciences companies avoid common pitfalls and successfully defend their patents, say attorneys at Mintz.
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Litigation Inspiration: Honoring Your Learned Profession
About 30,000 people who took the bar exam in July will learn they passed this fall, marking a fitting time for all attorneys to remember that they are members in a specialty club of learned professionals — and the more they can keep this in mind, the more benefits they will see, says Bennett Rawicki at Hilgers Graben.
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From Concept To Capital: 5 Stages Of Evolving IP Needs
Companies must understand the shifting intellectual property needs throughout an organization’s life cycle in order to protect innovation, which can be done by fortifying the IP portfolio, expanding and leveraging IP assets, and more, says Keegan Caldwell at Caldwell Law.
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Allergan Ruling Reinforces Value Of Patent Term Adjustments
The Federal Circuit’s recent ruling in Allergan v. MSN, which held that patent term adjustment awards for first-filed, first-issued patents cannot be stripped away by later-issuing child patents that expire earlier, means practitioners must consider the potential impact of any action that might reduce the adjustment amount, say attorneys at Cooley.
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FTC Focus: How Scrutiny Of PBMs And Insulin May Play Out
Should Express Scripts' recent judicial challenge to the Federal Trade Commission succeed, any new targets could add litigation and choice of forum to their playbooks, and potential FTC court action on insulin could be forced to parallel venues as the issues between the commission and PBMs evolve, say attorneys at Proskauer.
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Opinion
AI May Limit Key Learning Opportunities For Young Attorneys
The thing that’s so powerful about artificial intelligence is also what’s most scary about it — its ability to detect patterns may curtail young attorneys’ chance to practice the lower-level work of managing cases, preventing them from ever honing the pattern recognition skills that undergird creative lawyering, says Sarah Murray at Trialcraft.
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Series
Round-Canopy Parachuting Makes Me A Better Lawyer
Similar to the practice of law, jumping from an in-flight airplane with nothing but training and a few yards of parachute silk is a demanding and stressful endeavor, and the experience has bolstered my legal practice by enhancing my focus, teamwork skills and sense of perspective, says Thomas Salerno at Stinson.
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And Now A Word From The Panel: The MDL Map
An intriguing yet unpredictable facet of multidistrict litigation practice is venue selection for new MDL proceedings, and the Judicial Panel on Multidistrict Litigation considers many factors when it assigns an MDL venue, says Alan Rothman at Sidley Austin.
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Navigating Restrictions Following Biotech Bill House Passage
Ahead of the BIOSECURE Act’s potential enactment, companies that obtain equipment from certain Chinese biotechnology companies should consider whether the act would restrict their ability to enter into contracts with the U.S. government and what steps they might take in response, say attorneys at Ropes & Gray.
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Why Now Is The Time For Law Firms To Hire Lateral Partners
Partner and associate mobility data from the second quarter of this year suggest that there's never been a better time in recent years for law firms to hire lateral candidates, particularly experienced partners — though this necessitates an understanding of potential red flags, say Julie Henson and Greg Hamman at Decipher Investigative Intelligence.
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A Look At The Economic Impact Of Drug Patent Differentiation
Given the Federal Trade Commission’s recent emphasis on unfair competition based on disputed patent listings, pharmaceutical market participants are likely to require nuanced characterizations of actual and but-for market competition when multiple patents differentiate multiple products, say economists at Competition Dynamics.
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Considering Possible PR Risks Of Certain Legal Tactics
Disney and American Airlines recently abandoned certain litigation tactics in two lawsuits after fierce public backlash, illustrating why corporate counsel should consider the reputational implications of any legal strategy and partner with their communications teams to preempt public relations concerns, says Chris Gidez at G7 Reputation Advisory.
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.