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Life Sciences
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June 17, 2024
DOJ Wants 15 Years For Outcome CEO's $1B Fraud
Federal prosecutors said former Outcome Health CEO Rishi Shah should serve 15 years in prison while Outcome's co-founder and ex-financial chief each serve 10 years following their convictions for running a $1 billion fraud that affected lenders, investors and clients.
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June 17, 2024
Top Patent Eligibility Rulings In The Decade Since Alice
The U.S. Supreme Court's Alice v. CLS Bank decision 10 years ago this week led to scores of inventions being found ineligible for patenting, and rulings since then have fleshed out the law on the contentious topic. Here's a look at the most notable patent eligibility decisions after Alice.
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June 17, 2024
Ex-Stimwave CEO Gets 6 Years For Dummy Implant Scheme
The founder and former CEO of Stimwave Technologies was sentenced to six years in prison Monday after tearfully proclaiming her innocence to healthcare fraud charges, with a Manhattan federal judge saying it's "sad" the defendant doesn't recognize the harm she inflicted by selling nonfunctional pain management device components.
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June 17, 2024
HUD Freed From Pa. Pot Patients' Suit Over Housing Rebuff
Unless the U.S. Department of Housing and Urban Development fulfills its threat to withhold a Pennsylvania county housing agency's funding for complying with a state court order to admit licensed medical marijuana patients, a lawsuit by the county agency and two potential tenants is premature, a federal judge ruled Monday.
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June 17, 2024
Drugmaker, PE Investor Sued In Del. Over 'Unfair' Deal Terms
Clinical-stage biotechnology firm Omega Therapeutics' board entered into an "unfair" agreement to develop a new drug with the company's controlling private equity stockholder that was heavily tilted in favor of the majority equity holder and Omega insiders, an investor alleged in a lawsuit in Delaware's Chancery Court.
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June 17, 2024
Zantac Suits Must Exit State Court, Conn. Judge Told
A Connecticut state court judge must relinquish jurisdiction over two lawsuits claiming that generic versions of the heartburn drug Zantac caused cancer because state statutes do not subject entities with foreign business registrations to the auspices of Constitution State judges, a pharmaceutical industry attorney argued at a hearing Monday morning.
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June 17, 2024
Fed. Circ. Says Errors Led To Injunction In Trade Secrets Suit
A Federal Circuit panel on Monday overturned a preliminary injunction against a South Korean insulin pump patch manufacturer that allegedly stole trade secrets from a rival, saying a Massachusetts federal court made a series of errors in its determination to grant an injunction.
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June 17, 2024
Catching Up With Delaware's Chancery Court
Proposed amendments to Delaware's General Corporation Law that were prompted by several recent Chancery Court rulings sailed through the state Senate last week despite loud opposition from corporate law professors and other Chancery Court watchers, and Tesla shareholders filed two new suits against CEO Elon Musk.
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June 17, 2024
Talc Claimants Want Documents In Fight Over J&J Unit Venue
Cancer patients with talc damage claims against Johnson & Johnson have urged a New Jersey federal court to give them access to transcripts and exhibits from depositions of top executives at the company's talc unit, saying the information will aid their effort to bar the J&J spinoff from filing a third Chapter 11 outside the Garden State.
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June 14, 2024
Justices Are Asked To Wade Into Blood Pressure Drug IP Fight
United Therapeutics is taking its patent case seeking to stop a rival from selling a drug that competes with its blockbuster treatment for high blood pressure to the U.S. Supreme Court.
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June 14, 2024
Janssen Hit With $150M Verdict In HIV Drug False Claims Suit
A New Jersey federal jury hit Janssen with a $150 million False Claims Act verdict in a 12-year-old whistleblower suit, finding that the drugmaker violated the federal law as well as 27 related state FCA statutes by illegally profiting from the off-label marketing of two popular Janssen HIV medications.
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June 14, 2024
3rd Circ. Merges 3 Challenges To Medicare Drug Price Talks
The Third Circuit will hear three separate appeals challenging Medicare's drug price negotiations together, according to a new order consolidating cases brought by AstraZeneca, Bristol-Myers Squibb and Janssen Pharmaceuticals in New Jersey and Delaware federal courts.
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June 14, 2024
Judge Won't Undo Save Of J&J Patent After Fed. Circ. Ruling
A federal court has refused to reconsider a March decision finding Tolmar failed to show a patent on Janssen's blockbuster schizophrenia drug Invega Sustenna was invalid as obvious.
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June 14, 2024
Pfizer Worker's Ex-Wife Can't Raid 401(k) To Collect Damages
The ex-wife of a former Pfizer employee can't use her ex-husband's 401(k) account to collect damages awarded in a defamation suit against him, a Pennsylvania federal judge ruled, saying federal benefits law prevents her from seizing his retirement contributions.
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June 14, 2024
Australian Biotech Firm Telix Pharmaceuticals Pulls US IPO
Australian biotechnology firm Telix Pharmaceuticals Ltd., whose U.S. shares were set to debut trading on Friday, canceled plans for an estimated $202 million U.S. initial public offering, citing unfavorable market conditions.
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June 14, 2024
Biotech Clinches Latest Funding Round With $55M In Tow
Biotechnology company Enveda Biosciences on Friday announced that it has closed its most-recent financing round after raising $55 million from investors, bringing the Boulder, Colorado-based company's total capital fundraising to $230 million.
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June 13, 2024
IP Forecast: Cooley Atty Faces DQ Bid Over Past Patent Work
A prominent Cooley LLP lawyer will face questions next week in a Philadelphia courtroom over her work a decade ago at her former firm defending a cloud software startup that is now suing a Cooley client. Here's a spotlight on that case — plus all the other major intellectual property matters on deck in the coming week.
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June 13, 2024
Justices Hand Abortion Advocates An Incomplete Win
The U.S. Supreme Court's rejection Thursday of a challenge to the abortion drug mifepristone will do little to safeguard long-term access to the medication while suggesting that it will be up to voters, not judges, to settle some of the nation's abortion debates, attorneys say.
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June 13, 2024
Cooley-Led Diagnostics Firm Tempus AI Raises $411M IPO
Artificial intelligence-powered diagnostics company Tempus AI inc. priced a $410.7 million initial public offering Thursday at the top of its range, represented by Cooley LLP and underwriters counsel Davis Polk & Wardwell LLP.
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June 13, 2024
Thomas Targets Group Standing In Mifepristone Ruling
U.S. Supreme Court Justice Clarence Thomas joined his colleagues Thursday to unanimously uphold broad access to the abortion medication mifepristone for now, but he wrote separately to challenge a standing rule that often serves as the key to the courthouse doors for litigants of all varieties.
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June 13, 2024
Full Fed. Circ. Rejects Rehearing Bids In Xifaxan Case
The Federal Circuit has shot down bids for rehearing filed by both sides in a case involving an April decision that prevents an Alvogen unit from releasing a generic version of Bausch Health's diarrhea and brain disorder drug Xifaxan until 2029.
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June 13, 2024
Feds' Forfeiture Error Won't Tank Outcome Execs' Conviction
Outcome Health executives can't wipe out their $1 billion fraud convictions or receive a new trial despite arguing that improperly frozen assets prevented them from hiring their chosen lawyers, an Illinois federal judge said Wednesday, ruling that they waived their challenge to the forfeiture by waiting too long.
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June 13, 2024
Cannabis Cos. Make Deal Ahead Of Expected DEA Downgrade
An attorney and cannabis entrepreneur is betting that the federal government will reschedule marijuana before winter, announcing his equipment manufacturing firm will ally with a Native American-owned cannabis oil processing company to build out a pharmaceutical cannabis extraction facility.
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June 13, 2024
North Carolina Lawmakers Mull Outlawing 'Gas Station Heroin'
A bill to make the drug tianeptine a scheduled substance in the Tar Heel state that passed in the North Carolina House of Representatives this week has been kicked over to the state Senate for consideration.
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June 13, 2024
Teva Wins Pause Of Order Ousting Patents From Orange Book
A New Jersey federal judge ordered on Thursday a 30-day stay of his Monday ruling that a handful of patents covering Teva-brand asthma inhalers were improperly listed in the federal Orange Book, saying he wanted the matter to reach the Federal Circuit in the most orderly way possible.
Expert Analysis
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Cos. Must Prepare For Calif. Legislation That Would Ban PFAS
Pending California legislation that would ban the sale or distribution of new products containing intentionally added per- and polyfluoroalkyl substances could affect thousands of businesses — and given the bill's expected passage, and its draconian enforcement regime, companies must act now to prepare for it, say attorneys at Alston & Bird.
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FDA Warning Letter Tightens Reins On 'Research Only' Labels
A recent warning letter from the U.S. Food and Drug Administration to Agena Bioscience alleged the company’s diagnostic devices were labeled for research use only, but improperly promoted for human clinical purposes, signifying a reinforcement — and a potential narrowing — of the agency's policy on products labeled “research only,” say attorneys at Sheppard Mullin.
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Practical Pointers After Fed. Circ. Double-Patenting Decision
With the Federal Circuit recently denying a full court review of In re: Cellect, a decision regarding obviousness-type double-patenting, affected patent family holders should evaluate their rights through both patent prosecution and future litigation lenses to minimize risks, say Austin Lorch and Jeff Wolfson at Haynes Boone.
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Highlights From The 2024 ABA Antitrust Spring Meeting
U.S. merger enforcement and cartels figured heavily in this year's American Bar Association spring antitrust meeting, where one key takeaway included news that the Federal Trade Commission's anticipated changes to the Hart-Scott-Rodino form may be less dramatic than many originally feared, say attorneys at Freshfields.
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Strategies For Challenging A Fla. Grand Jury Report's Release
A Florida grand jury’s recent report on potential wrongdoing related to COVID-19 vaccines should serve as a reminder to attorneys to review the myriad legal mechanisms available to challenge the lawfulness of a grand jury report’s publication and expunge the names of their clients, says Cary Aronovitz at Holland & Knight.
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Patent Lessons From 8 Federal Circuit Reversals In March
A number of Federal Circuit patent decisions last month reversed or vacated underlying rulings, providing guidance regarding the definiteness of a claim that include multiple limitations of different scopes, the importance of adequate jury instruction, the proper scope of the precedent, and more, say Denise De Mory and Li Guo at Bunsow De Mory.
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A Look At Ex Parte Seizures 8 Years Post-DTSA
In the eight years since the Defend Trade Secrets Act was enacted, not much has changed for jurisprudence on ex parte seizures, but a few seminal rulings show that there still isn’t a bright line on what qualifies as extraordinary circumstances warranting a seizure, say attorneys at Finnegan.
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Series
Whitewater Kayaking Makes Me A Better Lawyer
Whether it's seeing clients and their issues from a new perspective, or staying nimble in a moment of intense challenge, the lessons learned from whitewater kayaking transcend the rapids of a river and prepare attorneys for the courtroom and beyond, says Matthew Kent at Alston & Bird.
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AI In The Operating Room: Liability Issues For Device Makers
As healthcare providers consider medical devices that use artificial intelligence — including systems to help surgeons make decisions in the operating room — and lobby to shift liability to device manufacturers, companies making these products must review potential product liability risks and important design considerations for such equipment, say attorneys at Troutman Pepper.
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Del. Lessons For Director-Nominees On Sharing With Activists
The Delaware Chancery Court's recent decision in Icahn Partners v. deSouza finding that a director wasn't permitted to share certain privileged information with the activist stockholders that nominated him shows the need for companies to consider imposing appropriate confidentiality requirements on directors, say attorneys at Sullivan & Cromwell.
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10 Years After Alice, Predictability Debate Lingers
A decade after the U.S. Supreme Court’s Alice ruling, critics continue to argue that the subject matter eligibility framework it established yields inconsistent results, but that contention is disproved by affirmance data from the Federal Circuit, district courts and the Patent Trial and Appeal Board, say Dennis Abdelnour and David Thomas at Honigman.
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This Earth Day, Consider How Your Firm Can Go Greener
As Earth Day approaches, law firms and attorneys should consider adopting more sustainable practices to reduce their carbon footprint — from minimizing single-use plastics to purchasing carbon offsets for air travel — which ultimately can also reduce costs for clients, say M’Lynn Phillips and Lisa Walters at IMS Legal Strategies.
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Questions Persist After Ruling Skirts $925M TCPA Award Issue
After an Oregon federal court's recent Wakefield v. ViSalus ruling that the doctrine of constitutional avoidance precluded it from deciding whether a $925 million Telephone Consumer Protection Act damages award was constitutionally sound, further guidance is needed on when statutory damages violate due process, says Michael Klotz at O'Melveny.
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Benzene Contamination Concerns: Drugmakers' Next Steps
After a citizen petition to the U.S. Food and Drug Administration and a flurry of class actions over benzene contamination in benzoyl peroxide acne products, affected manufacturers should consider a thoughtful approach that includes assembling internal data and possibly contacting the FDA for product-specific discussions, say attorneys at Morgan Lewis.
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Opinion
States Should Follow Federal Lead On Expert Evidence Rules
The recently amended Federal Rule of Evidence 702 will help ensure expert testimony in federal courts reflects adequate data and reliable methods properly applied to a given case, and state courts — home to the overwhelming majority of U.S. litigation — should adopt similar changes, says retired attorney Michael Harrington.