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Life Sciences
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July 03, 2024
HHS Scores Early Win In Boehringer's Medicare Pricing Suit
A Connecticut federal judge on Wednesday sided with the U.S. Department of Health and Human Services in Boehringer Ingelheim's challenge to a new Medicare drug price negotiation program, rejecting the pharmaceutical company's claim that the program is unconstitutional.
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July 03, 2024
Humana Drops 6th Circ. Remand Bid In Ohio Collusion Suit
Humana is being dismissed from Ohio's lawsuit accusing pharmacy benefit managers and insurers of conspiring to inflate prescription prices through international subsidiaries after the company reached a settlement agreement in June.
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July 03, 2024
Roche Says Stanford Profs Stole Cancer Detection Tech
Roche Molecular Systems has accused Stanford University and several faculty members of swiping its proprietary cancer detection technology and secretly founding a new company with it, according to a suit filed in California federal court.
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July 03, 2024
Revived Skinny Label Case Is A Warning For Generics
The Federal Circuit has made clear that generic-drug companies need to pay close attention to public statements when advertising drugs that still have patent-protected uses, even if their so-called skinny labels properly avoid references to those carved-out indications, attorneys say.
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July 03, 2024
Appeals Board Tosses Revived License Breach Dispute
The Civilian Board of Contract Appeals has again tossed a dispute, previously revived by the Federal Circuit, alleging the U.S. Food and Drug Administration breached a software company's end-user license agreement, saying it lacks jurisdiction to enforce the agreement.
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July 03, 2024
Cooley DQ'd From IP Case Over Atty's Past Patent Work
Cooley LLP was disqualified on Wednesday from representing a pharmaceutical customer-support software company against patent infringement claims in Delaware, with the district court citing a Cooley partner's prior work representing the plaintiff and Cooley's refusal to screen its attorney.
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July 03, 2024
Penile Implant Doc Seeks $7M Atty Fees, Costs In $18M IP Win
A urologist who won $18.3 million in royalties and damages after a jury found a rival stole his penile implant trade secrets and infringed his intellectual property asked a California federal judge for $6.5 million in attorney fees and $614,000 in costs, saying he is owed the funds as the prevailing party in the litigation.
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July 03, 2024
4 Mass. Rulings You Might Have Missed In June
Massachusetts state courts last month dealt with thorny contract disputes, mistakenly disclosed emails between a defendant and an attorney, and a company's overtime policy change that may not have been spelled out to workers.
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July 03, 2024
1st Circ. Hands Hearing Loss Biotech Win In Stock-Drop Suit
A panel of the First Circuit declined to revive an investor class action alleging that a hearing loss treatment company and some of its executives concealed disappointing clinical trial results, saying there was no evidence the company had knowingly made false statements about the trial.
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July 03, 2024
Cerevel Investors Allege Insider Trades Pre-$8.7B AbbVie Deal
A pension fund shareholder of Cerevel Therapeutics Holdings Inc. has sued the biopharmaceutical company in Delaware's Court of Chancery, seeking documents to investigate potential fiduciary duty breaches and possible insider trading shortly before the company announced its pending $8.7 billion merger with AbbVie Inc.
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July 03, 2024
After Chevron Deference: What Lawyers Need To Know
This term, the U.S. Supreme Court overturned Chevron deference, a precedent established 40 years ago that said when judges could defer to federal agencies' interpretations of law in rulemaking. Here, catch up with Law360's coverage of what is likely to happen next.
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July 03, 2024
Chancery Tosses Challenge To $3B AstraZeneca Viela Bio Sale
AstraZeneca PLC and a U.K. affiliate beat late Tuesday a Delaware Court of Chancery stockholder suit accusing the company of orchestrating an underpriced, $3 billion sale of clinical stage biopharmaceutical venture Viela Bio Inc. in order to clear the way for AstraZeneca's purchase of a larger competitor.
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July 03, 2024
Quest Diagnostics Paying $985M For OMERS' LifeLabs
Canadian law firm McCarthy Tétrault LLP is guiding New Jersey-based Quest Diagnostics on a newly inked deal to buy LifeLabs from the Ontario Municipal Employees Retirement System, or OMERS, for about $985 million, Quest said Wednesday.
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July 02, 2024
FTC Investigating Teva Inhaler Patent Listings, Report Says
The Federal Trade Commission has opened an investigation into Teva Pharmaceuticals after it refused to remove inhaler patents from a key federal database, according to a Washington Post report citing confidential agency documents.
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July 02, 2024
Chamber, Pharma Slam Colorado Drug Price Controls
The U.S. Chamber of Commerce and a prominent pharmaceutical industry group have urged a Colorado federal court to bar a state review board from setting price controls on prescription drugs, arguing that the practice is "irreconcilable" with federal patent law.
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July 02, 2024
Biotech Biz Co-Directors Sue Each Other In Del., Cite Breaches
A California-based biotech company once researching a new class of antiviral therapy for COVID-19 is now the subject of dissolution proceedings in Delaware's Court of Chancery, after the company's two directors filed dueling lawsuits alleging fiduciary duty breaches and a board-level stalemate.
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July 02, 2024
Pharma Co. Scores Exit In Investor Suit Over Primate Imports
A Massachusetts federal judge tossed every claim in a proposed class action claiming that pharmaceutical company Charles River Laboratories and its executives concealed their involvement in the illegal importation of nonhuman primates for research, ruling that the disputed statements are not false or misleading.
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July 02, 2024
McKinsey Wants To Arbitrate Ex-Partner's Defamation Suit
McKinsey & Co. has urged a New York state judge to send to arbitration or dismiss a former partner's defamation lawsuit alleging the consulting giant tried to make him a scapegoat for purported evidence destruction amid a U.S. Department of Justice probe into McKinsey's work with opioid makers.
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July 02, 2024
Beasley Allen Slams J&J's DQ Bid 'Check-Up' In Talc Tort
The Beasley Allen Law Firm and Johnson & Johnson continue to spar over the firm and attorney Andy Birchfield's role in long-running federal and state mass torts over talcum powder injuries, with the firm calling out J&J on Tuesday for "prodding" the New Jersey courts to boot the lawyers from the litigation.
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July 02, 2024
High Court Agrees To Review FDA's Flavored E-Cig Denial
The U.S. Supreme Court on Tuesday granted the U.S. Food and Drug Administration's petition to review a Fifth Circuit decision overturning its denial of a flavored e-cigarette marketing application.
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July 01, 2024
High Court's 1-2 Punch Sets Up Long-Standing Regs For KO
By ending its term with a stinging combination against federal agencies, the U.S. Supreme Court's conservative bloc left behind a bruised bureaucracy and a regulatory system that's now vulnerable to a barrage of incoming attacks.
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July 01, 2024
UC Riverside Profs Win Combined $6.1M In Retaliation Trial
Two former University of California, Riverside professors were awarded a total of $6.1 million in damages by a jury that found they were retaliated against in violation of the California Whistleblower Protection Act after making official complaints about alleged misdeeds their supervisor was engaging in, including misuse of government funds.
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July 01, 2024
State AGs Get Stay Lifted In Generic Drug Pricing Litigation
A Connecticut federal judge on Monday agreed to lift a partial discovery stay in a trio of generic drug pricing antitrust suits led by the attorneys general of New York and Connecticut, according to a short, text-only order posted to each of the case dockets.
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July 01, 2024
IPO Rebound Leads Capital Markets Recovery At Midyear
Capital markets activity moderately accelerated in the year's first six months, buoyed by the highest level of initial public offerings in three years, signaling a busy second half for deal-makers at least until the November presidential election.
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July 01, 2024
Caribou Bio Inks $3.9M Deal In Investors' Cancer Therapy Suit
Caribou Biosciences Inc. has agreed to pay $3.9 million to settle a proposed class action alleging it misled investors about the durability of its most advanced cancer-fighting therapy before and after the gene-editing biotechnology company went public, investors told a California federal judge on 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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Calif. Ruling Heightens Medical Product Maker Liability
The California Supreme Court's decision in Himes v. Somatics last month articulates a new causation standard for medical product manufacturer liability that may lead to stronger product disclosures nationwide and greater friction between manufacturers and physicians, say attorneys at Cooley.
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Constitutional Protections For Cannabis Companies Are Hazy
Cannabis businesses are subject to federal enforcement and tax, but often without the benefit of constitutional protections — and the entanglement of state and federal law and conflicting judicial opinions are creating confusion in the space, says Amber Lengacher at Purple Circle.
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USPTO Disclaimer Rule Would Complicate Patent Prosecution
The U.S. Patent and Trademark Office's proposed changes to terminal disclaimer practice could lead to a patent owner being unable to enforce a valid patent simply because it is indirectly tied to a patent in which a single claim is found anticipated or obvious in view of the prior art, say attorneys at Sterne Kessler.
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Series
Boxing Makes Me A Better Lawyer
Boxing has influenced my legal work by enabling me to confidently hone the skills I've learned from the sport, like the ability to remain calm under pressure, evaluate an opponent's weaknesses and recognize when to seize an important opportunity, says Kirsten Soto at Clyde & Co.
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Purdue Ch. 11 Ruling Reinforces Importance Of D&O Coverage
The U.S. Supreme Court's recent decision in Harrington v. Purdue Pharma, holding that a Chapter 11 reorganization cannot discharge claims against a nondebtor without affected claimants' consent, will open new litigation pathways surrounding corporate insolvency and increase the importance of robust directors and officers insurance, says Evan Bolla at Harris St. Laurent.
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Opinion
Industry Self-Regulation Will Shine Post-Chevron
The U.S. Supreme Court's Loper decision will shape the contours of industry self-regulation in the years to come, providing opportunities for this often-misunderstood practice, says Eric Reicin at BBB National Programs.
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3 Ways Agencies Will Keep Making Law After Chevron
The U.S. Supreme Court clearly thinks it has done something big in overturning the Chevron precedent that had given deference to agencies' statutory interpretations, but regulated parties have to consider how agencies retain significant power to shape the law and its meaning, say attorneys at K&L Gates.
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Series
After Chevron: Expect Few Changes In ITC Rulemaking
The U.S. Supreme Court's opinion overruling the Chevron doctrine will have less impact on the U.S. International Trade Commission than other agencies administering trade statutes, given that the commission exercises its congressionally granted authority in a manner that allows for consistent decision making at both agency and judicial levels, say attorneys at Polsinelli.
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6 PTAB Events To Know From The Last 6 Months
The first half of 2024 brought a flurry of Patent Trial and Appeal Board developments that should be considered in post-grant strategies, including proposed rules on discretionary denial and director review, and the first decisions of the Delegated Rehearing Panel, say attorneys at Fish & Richardson.
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Opinion
Atty Well-Being Efforts Ignore Root Causes Of The Problem
The legal industry is engaged in a critical conversation about lawyers' mental health, but current attorney well-being programs primarily focus on helping lawyers cope with the stress of excessive workloads, instead of examining whether this work culture is even fundamentally compatible with lawyer well-being, says Jonathan Baum at Avenir Guild.
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Parsing Justices' Toss Of Purdue's Controversial Ch. 11 Plan
The U.S. Supreme Court's recent nixing of OxyContin manufacturer Purdue Pharma's Chapter 11 proposal prevents the Sackler family from settling thousands of civil opioid lawsuits without the consent of all of the plaintiffs, and holds profound implications for bankruptcy cases, say attorneys at MoloLamken.
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How Cannabis Rescheduling May Affect Current Operators
The U.S. Drug Enforcement Agency's proposal to reschedule marijuana to Schedule III provides relief in the form of federal policy from the stigma and burdens of Schedule I, but commercial cannabis operations will remain unchanged until the federal-state cannabis policy gap is remedied by Congress, say Meital Manzuri and Alexis Lazzeri at Manzuri Law.
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Series
Skiing And Surfing Make Me A Better Lawyer
The skills I’ve learned while riding waves in the ocean and slopes in the mountains have translated to my legal career — developing strong mentor relationships, remaining calm in difficult situations, and being prepared and able to move to a backup plan when needed, says Brian Claassen at Knobbe Martens.
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Class Actions At The Circuit Courts: June Lessons
In this month's review of class action appeals, Mitchell Engel at Shook Hardy considers two recent decisions from the Third and Tenth Circuits, and identifies practice tips around class action settlements and standing in securities litigation.
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Tracking Implementation Of IRA Programs As Election Nears
As the Biden administration races to cement key regulations implementing the Inflation Reduction Act, a number of the law's programs and incentives are at risk of delay or repeal if Republicans retake control of Congress, the White House or both — so stakeholders should closely watch ongoing IRA implementation and guidance, say attorneys at Squire Patton.