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Life Sciences
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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 Third 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.
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June 12, 2024
Directors Of Defunct Med Tech SPAC Seek Toss Of Del. Suit
Directors of a special purpose acquisition company that merged with now-defunct medical technology company Better Therapeutics Inc. urged Delaware's Court of Chancery on Wednesday to toss a shareholder's suit about the $15 million de-SPAC merger, saying it wasn't like other problematic SPAC deals.
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June 12, 2024
Forte Biosciences Reaches $2M Deal To End Chancery Suit
Clinical-stage biopharmaceutical company Forte Biosciences has reached a multipart, $2 million concession-plus-cash settlement in Delaware's Court of Chancery with a private investment fund that ran a board proxy contest after its calls to liquidate the business were met with poison pill pushback.
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June 12, 2024
'Natural' Toothpaste Brand Loaded With PFAS, Moms Say
Natural toothpaste company RiseWell LLC falsely advertised its kids toothpaste as "natural" and "safe to swallow," two mothers alleged Tuesday in a proposed class action, saying a U.S. Department of Defense-certified laboratory test found 750 times more "forever chemicals" in the toothpaste than researchers found in heavily tainted kale.
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June 12, 2024
32 AGs Urge Justices Take Up Okla. PBM Law Fight
Thirty-two attorneys general urged the U.S. Supreme Court to take up Oklahoma's petition for review of a Tenth Circuit decision holding that federal law preempted portions of a state law regulating pharmacy benefit managers, arguing the justices needed to intervene to resolve a circuit split.
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June 11, 2024
Martin Shkreli Told To Hand Over Wu-Tang Album
A New York federal judge ordered Martin Shkreli on Tuesday to hand over any copies he might have of the Wu-Tang Clan's album he once bought before it was sold off by the federal government to settle a $7.3 million tab from Shkreli's criminal judgment on securities fraud.
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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Series
Playing Chess Makes Me A Better Lawyer
There are many ways that chess skills translate directly into lawyer skills, but for me, the bigger career lessons go beyond the direct parallels — playing chess has shown me the value of seeing gradual improvement in and focusing deep concentration on a nonwork endeavor, says attorney Steven Fink.
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Litigation Inspiration: Attys Can Be Heroic Like Olympians
Although litigation won’t earn anyone an Olympic medal in Paris this summer, it can be worthy of the same lasting honor if attorneys exercise focused restraint — seeking both their clients’ interests and those of the court — instead of merely pursuing every advantage short of sanctionable conduct, says Bennett Rawicki at Hilgers Graben.
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Updated Federal Rules Can Improve Product Liability MDLs
The recent amendment of a federal evidence rule regarding expert testimony and the proposal of a civil rule on managing early discovery in multidistrict legislation hold great promise for promoting the uniform and efficient processes that high-stakes product liability cases particularly need, say Alan Klein and William Heaston at Duane Morris.
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Lean Into The 'Great Restoration' To Retain Legal Talent
As the “great resignation,” in which employees voluntarily left their jobs in droves, has largely dissipated, legal employers should now work toward the idea of a “great restoration,” adopting strategies to effectively hire, onboard and retain top legal talent, says Molly McGrath at Hiring & Empowering Solutions.
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How Cannabis Rescheduling May Alter Paraphernalia Imports
The Biden administration's recent proposal to loosen federal restrictions on marijuana use raises questions about how U.S. Customs and Border Protection enforcement policies may shift when it comes to enforcing a separate federal ban on marijuana accessory imports, says R. Kevin Williams at Clark Hill.
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What The NYSE Proposed Delisting Rule Could Mean For Cos.
The New York Stock Exchange's recently proposed rule would provide the exchange with discretionary authority to commence delisting proceedings for a company substantially shifting its primary business focus, raising concerns for NYSE-listed companies over the exact definition of the exchange's proposed "substantially different" standard, say attorneys at Winston & Strawn.
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FDA Warning Indicates Scrutiny Of Regenerative Health Cos.
The U.S. Food and Drug Administration's recent warning letter to Akan Biosciences is a quintessential example of the agency's enforcement priorities for certain products involving human cells and tissues, and highlights ongoing scrutiny placed on manufacturers, say Dominick DiSabatino and Cortney Inman at Sheppard Mullin.
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2 Regulatory Approaches To Psychedelic Clinical Trials
Comparing the U.S. and Canada's regulatory frameworks for clinical trials of psychedelic drugs can be useful for designing trial protocols that meet both countries' requirements, which can in turn help diversify patient populations, bolster data robustness and expedite market access, say Kimberly Chew at Husch Blackwell and Sabrina Ramkellawan at AxialBridge.
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Opinion
Bankruptcy Judges Can Justly Resolve Mass Tort Cases
Johnson & Johnson’s recent announcement of a prepackaged reorganization plan for its talc unit highlights that Chapter 11 is a continually evolving living statute that can address new types of problems with reorganization, value and job preservation, and just treatment for creditors, says Kenneth Rosen at Ken Rosen Advisors PC.
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Series
Fishing Makes Me A Better Lawyer
Atop the list of ways fishing makes me a better lawyer is the relief it offers from the chronic stress of a demanding caseload, but it has also improved my listening skills and patience, and has served as an exceptional setting for building earnest relationships, says Steven DeGeorge at Robinson Bradshaw.
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A Healthier Legal Industry Starts With Emotional Intelligence
The legal profession has long been plagued by high rates of mental health issues, in part due to attorneys’ early training and broader societal stereotypes — but developing one’s emotional intelligence is one way to foster positive change, collectively and individually, says attorney Esperanza Franco.
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To Make Your Legal Writing Clear, Emulate A Master Chef
To deliver clear and effective written advocacy, lawyers should follow the model of a fine dining chef — seasoning a foundation of pure facts with punchy descriptors, spicing it up with analogies, refining the recipe and trimming the fat — thus catering to a sophisticated audience of decision-makers, says Reuben Guttman at Guttman Buschner.
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Circuit Judge Writes An Opinion, AI Helps: What Now?
Last week's Eleventh Circuit opinion in Snell v. United Specialty Insurance, notable for a concurrence outlining the use of artificial intelligence to evaluate a term's common meaning, is hopefully the first step toward developing a coherent basis for the judiciary's generative AI use, says David Zaslowsky at Baker McKenzie.
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Fed. Circ. Rulings Crystallize Polymorph Patent 'Obviousness'
A comparison of two recent Federal Circuit obviousness challenge decisions regarding polymorph patents provides helpful insight into the assessment of screening arguments, particularly the issue of reasonable expectation of success, say Michael Green and John Molenda at Steptoe.
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DC Circ. Ruling Heightens HHS Contract Pharmacy Challenges
The D.C. Circuit's recent ruling that the Section 340B program does not bar manufacturers from restricting deliveries of discounted drugs to contract pharmacies represents a second strike against the U.S. Department of Health and Human Services' current contract pharmacy policy and raises the stakes surrounding an upcoming Seventh Circuit ruling on the same issue, say attorneys at Foley Hoag.