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Life Sciences
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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.
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June 13, 2024
CVS Dodges Discovery Audit In Generic Drug Collusion Suit
A federal judge declined to make CVS hire a forensic auditor to evaluate its compliance with information demands in a lawsuit alleging it colluded with drugmakers to keep Medicare beneficiaries from accessing certain generic drugs, despite a whistleblower bemoaning "woefully deficient" discovery on the pharmacy chain's part.
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June 13, 2024
GOP Lawmakers Want China Patent Data Amid Tech Pact Talks
Republican lawmakers are urging the U.S. Commerce Department to provide a full accounting of whether the U.S. government has funded research that resulted in Chinese patents, arguing they need the data to assess potential national security risks as the Biden administration negotiates a new science and technology agreement with China.
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June 13, 2024
Vero Biotech Tried To 'String Along' Safety Monitor, Suit Says
Georgia-based medical device maker Vero Biotech LLC reneged on a payment plan with a consulting firm hired to monitor its products, according to a lawsuit filed in Massachusetts state court on Wednesday.
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June 13, 2024
EU Makes First Ever Formal Pharma Price-Fixing Complaint
European Union antitrust authorities issued their first ever price-fixing complaint in the pharmaceutical industry Thursday, going after the only company that did not agree to a €13.4 million ($14.4 million) settlement in October.
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June 13, 2024
JP Morgan Closes Debut Life Sciences Fund At Over $500M
J.P. Morgan Private Capital on Thursday announced that it clinched its inaugural life sciences private capital offering with more than $500 million in tow.
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June 13, 2024
Abortion Medication Case Ends 'With A Whimper' At High Court
A case that threatened to cut off access to a widely used abortion medication while disrupting the U.S. Food and Drug Administration's authority over drugs and medical devices ended Thursday at the U.S. Supreme Court with a decision concerned solely with challengers' right to sue.
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June 12, 2024
Tillis Told Drug Patents Are Too Complex For Easy Answers
When and how generic drugs enter the marketplace varies widely among different drugs and isn't necessarily related to how many patents are covering those drugs, the U.S. Patent and Trademark Office said Wednesday in a report requested by a top member of the U.S. Senate's Intellectual Property Subcommittee.
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June 12, 2024
Lies At Heart Of Fraud Case Over COVID Test Kits, Jurors Told
The retrial of a securities fraud case over a COVID test kit deal that never materialized will center on lies, according to opening statements delivered in New Jersey federal court Wednesday.
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June 12, 2024
2nd Circ. Backs Brokerage In Suit Over Biotech's Failed IPO
The Second Circuit on Wednesday declined to reinstate a Texas company's suit against an investment brokerage that advised biotech Inpellis on an initial public offering that failed and sent the company to file Chapter 7, ruling a lower court rightly found a global settlement eclipsed the need for a jury trial.
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June 12, 2024
Lipitor Buyers Get Final OK For $93M Deal In Antitrust Fight
A New Jersey federal judge gave final approval Wednesday to a $93 million settlement between a class of buyers of Lipitor and Pfizer, resolving their claims in sprawling antitrust litigation that Pfizer conspired with a drug manufacturer to delay the release of a cheaper generic version of Lipitor and monopolize the market.
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June 12, 2024
SPAC Dealmakers Expect Modest Pickup After Market Bottom
Market professionals expect a slow pickup in deals involving special-purpose acquisition companies starting in the second half of 2024, predicting on Wednesday that a leaner market will emerge following the recent crash and imposition of tighter regulations.
Expert Analysis
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Taking A Closer Look At Fed. Circ. Claim Construction Split
An empirical analysis of a year's worth of claim construction decisions from the Federal Circuit and four key district court jurisdictions shows that these constructions vary in material ways depending on the analysis' source, and this body of case law would benefit from clarification by the Federal Circuit itself, say attorneys at WilmerHale.
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The 7th Circ.'s Top 10 Civil Opinions Of 2023
Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2023, and explain how they may affect issues related to antitrust, constitutional law, federal jurisdiction and more.
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Employee Experience Strategy Can Boost Law Firm Success
Amid continuing business uncertainty, law firms should consider adopting a holistic employee experience strategy — prioritizing consistency, targeting signature moments and leveraging measurement tools — to maximize productivity and profitability, says Haley Revel at Calibrate Consulting.
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Series
Competing In Triathlons Makes Me A Better Lawyer
While practicing law and competing in long-distance triathlons can make work and life feel unbalanced at times, participating in the sport has revealed important lessons about versatility, self-care and perseverance that apply to the office as much as they do the racecourse, says Laura Heusel at Butler Snow.
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Parsing The USPTO's Guidelines For Assessing Enablement
Ryan Hagglund at Loeb & Loeb details the U.S. Patent and Trademark Office's recent guidelines for assessing enablement principles set forth in the U.S. Supreme Court's 2023 Amgen v. Sanofi decision, including how the guidelines can apply to all fields of technology.
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Notes Of Interest From 5th Circ. Illumina-Grail Merger Ruling
Attorneys at Simpson Thacher consider the Fifth Circuit's recent decision upholding the Federal Trade Commission's challenge of the Illumina merger with Grail, its much-needed boost to the Biden administration's antitrust agenda, and some silver linings the decision offers to merging parties.
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DOJ's Biopharma Settlement Raises Anti-Kickback Questions
In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.
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Where Justices Stand On Chevron Doctrine Post-Argument
Following recent oral argument at the U.S. Supreme Court, at least four justices appear to be in favor of overturning the long-standing Chevron deference, and three justices seem ready to uphold it, which means the ultimate decision may rest on Chief Justice John Roberts' vote, say Wayne D'Angelo and Zachary Lee at Kelley Drye.
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Precise Advance Notice Bylaws May Help Prevent Disputes
While the Chancery Court's December decision in Kellner v. AIM Immunotech shows that Delaware courts won't always uphold advance notice bylaws, and its willingness to selectively enforce or invalidate individual provisions doesn't create an incentive for companies to be surgical in their drafting, companies should nonetheless be precise when drafting such bylaws to avoid unnecessary disputes, say attorneys at Debevoise.
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Perspectives
6 Practice Pointers For Pro Bono Immigration Practice
An attorney taking on their first pro bono immigration matter may find the law and procedures beguiling, but understanding key deadlines, the significance of individual immigration judges' rules and specialized aspects of the practice can help avoid common missteps, says Steven Malm at Haynes Boone.
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Series
ESG Around The World: Canada
In Canada, multiple statutes, regulations, common law and industry guidance address environmental, social and governance considerations, with debate over ESG in the business realm potentially growing on the horizon, say attorneys at Blakes.
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5 Legal Considerations For Psychedelic Therapy Sector
With multiple developments signaling the rise of psychedelic-assisted psychotherapy, it is imperative that clinicians understand unique legal nuances ranging from corporate formation to specialized insurance coverage, say Kimberly Chew and Natasha Sumner at Husch Blackwell.
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Lessons From Country Singer's Personal Service Saga
Recent reports that country singer Luke Combs won a judgment against a Florida woman who didn’t receive notice of the counterfeit suit against her should serve as a reminder for attorneys on best practices for effectuating service by electronic means, say attorneys at Jenner & Block.
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A Potential Proactive Tool For Public-Private Joint Ventures
In the current environment of heightened antitrust enforcement, the National Cooperative Research and Production Act seems tailor-made for the collaborative work among competitors encouraged by the Biden administration's infrastructure and green energy funding legislation, say Jeetander Dulani and Susan Ebner at Stinson.
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Patent Prosecution Carries Consequences For Later Litigation
The Federal Circuit's recent Mylan v. Actelon holding, along with three other 2023 decisions, underscores the continued need for patent prosecutors to make note of potential claim construction issues that may arise in subsequent litigation, says Steven Wood at Hunton.