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Life Sciences
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August 06, 2024
Tech Giants' Fight To Ax Fintiv Rule Returns To Fed. Circ.
Apple and three other major technology companies have again asked the Federal Circuit to abolish a rule allowing the Patent Trial and Appeal Board to refuse to review patents based on related litigation in court, saying it is unlawful because it was implemented without formal rulemaking.
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August 06, 2024
Denver Food Co. Fired VP For Younger Male, Suit Claims
A former vice president of a Denver-area food biotech firm has filed a suit claiming the company violated Colorado's gender and age anti-discrimination laws when it fired and ultimately replaced her after she finished training a younger male successor, who was intended to only take over some of her duties.
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August 06, 2024
Life Sciences Credit Firm Symbiotic Launches With $600M
A new credit firm led by veterans in the healthcare industry announced its launch Tuesday, with more than $600 million in capital earmarked for loans to life sciences companies.
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August 06, 2024
FDA Posts Two Policy Memos On E-Cig Applications
The U.S. Food and Drug Administration on Monday posted two memos outlining the agency's thoughts on two aspects of their reviews of applications to market e-cigarettes, which include chemical components that may pose a risk of cancer.
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August 06, 2024
Pharma Co. Founder Beats Suit Over Short-Swing Trading
The founder of Y-mAbs Therapeutics Inc. beat back a suit alleging he realized more than $2.5 million in so-called short-swing profits after he exchanged his Y-mAbs stock for those of another company, with a New York federal judge saying in a ruling of first impression that the founder does not need to return the gains he received.
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August 06, 2024
Dem Lawmakers Back FTC's Kroger-Albertsons Challenge
A group of Democratic lawmakers is supporting the Federal Trade Commission in its suit to block Kroger's $25 billion acquisition of Albertsons, telling an Oregon federal judge in a friend-of-the-court brief that the agency's fears the deal would harm grocery workers and consumers are well-founded.
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August 06, 2024
Ex-Pfizer Worker Who Traded On Paxlovid Secrets Gets 9 Mos.
A Manhattan federal judge sentenced a former Pfizer Inc. statistician from New Jersey to nine months in prison Tuesday after a jury convicted him of insider trading on secrets about his former company's COVID-19 therapy trials for an illegal $272,000 profit.
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August 06, 2024
Penn Says BioNTech Owes Royalties For COVID-19 Vax
BioNTech was hit with a breach of contract suit Monday in Pennsylvania federal court by the University of Pennsylvania over alleged unpaid royalties on global net sales of its blockbuster COVID-19 vaccine Comirnaty, which was developed using the school's crucial messenger RNA patents and has made more than $75 billion.
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August 06, 2024
Rising Star: White & Case's Adam Acosta
Adam Acosta of White & Case LLP helped secure a Second Circuit win for AbbVie Inc. in a "pay for delay" suit over its hypertension drug Bystolic, earning him a spot among life sciences attorneys under age 40 honored by Law360 as Rising Stars.
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August 05, 2024
Inari Agriculture Can't Sink Patent Case Over Corn Seed
A legal fight between a DowDuPont spinoff and a Massachusetts plant breeding startup over the exporting of patent-protected corn seed will continue to grow in Delaware federal court, unimpeded by DuPont researchers' decision to publicly deposit their seeds.
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August 05, 2024
Indivior Accused Of Overstating Prospects Of 3 Opioid Drugs
Drugmaker Indivior PLC has been hit with a proposed investor class action in Virginia federal court over claims it overstated the financial prospects of its drugs used to treat opioid use disorders and the company's ability to forecast such financial projections.
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August 05, 2024
Chinese Drug Co. Says Sanctions In Valsartan MDL Too Harsh
Chinese drug firm Zhejiang Huahai Pharmaceutical Co. Ltd. told a New Jersey federal court Friday that sanctions authorizing two adverse jury instructions in multidistrict litigation over generic drugs contaminated with carcinogens should be overturned, arguing the plaintiffs did not allege the bad faith required for such a harsh penalty.
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August 05, 2024
J&J, Generics Spar In Remand On Schizophrenia Drug Patent
Following a Federal Circuit ruling that gave generics makers Teva and Viatris a new shot at trying to invalidate the last remaining patent on Johnson & Johnson's blockbuster schizophrenia drug Invega Sustenna, the parties are sparring over the impact of the appeals court's decision.
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August 05, 2024
GSK Wins Second Ill. Trial On Zantac Cancer Claims
A Chicago jury held Monday that GlaxoSmithKline is not liable for a woman's colorectal cancer, handing the drugmaker a second straight trial victory in hundreds of Illinois suits targeting Zantac heartburn medication and its generic counterparts.
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August 05, 2024
Spectrum, Assertio Hit With Double-Derivative Suit In Del.
Former Spectrum Pharmaceuticals Inc. shareholders sued the company and its acquirer Assertio Inc. in Delaware's Court of Chancery on Monday, asserting double-derivative claims in connection with Spectrum's alleged misleading of investors regarding its development of the lung-cancer drug poziotinib.
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August 05, 2024
Fla. Man Gets 44 Months For $5M MilliporeSigma Export Scam
A Florida federal judge sentenced a Taiwanese citizen who lives in the Sunshine State to three years and eight months in prison for his role in a $5 million scheme to defraud life sciences company MilliporeSigma and the U.S. government by illegally exporting MilliporeSigma products to China.
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August 05, 2024
Centessa Beats Shareholder Suit Over Kidney Drug
A New York federal judge has tossed a shareholder lawsuit alleging that Centessa Pharmaceuticals PLC overstated the prospects of its kidney disease treatment ahead of the drugmaker's initial public offering, saying the plaintiffs have failed to allege any actionable misleading statements or omissions.
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August 05, 2024
Catching Up With Delaware's Chancery Court
Sunken treasure, rock band discord, a wrestling competition, and more news about Elon Musk — all in all, a colorful week in Delaware's Court of Chancery. The First State's famous court of equity also pushed forward on disputes involving a famous social media app, Delaware's largest hospital system, an artificial intelligence company and a budding commodity futures exchange.
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August 05, 2024
CooperSurgical Says Lab Hid Flawed IVF Product Tests
Fertility technology company CooperSurgical Inc. has accused a Massachusetts testing lab of failing to follow proper procedures and misrepresenting the results of quality assurance testing on a product used in the in vitro fertilization process, leading to a recall.
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August 05, 2024
Freshfields, Wachtell Guide $925M CVC, Mallinckrodt Deal
Dublin-based pharmaceutical company Mallinckrodt has inked a deal to sell its immunotherapy business Therakos to Luxembourg-based private equity firm CVC Capital Partners for $925 million, Mallinckrodt said in a Monday statement.
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August 05, 2024
Rising Star: Ropes & Gray's Tara Fisher
Tara M. Fisher of Ropes & Gray LLP advised cancer drugmaker ImmunoGen Inc. as it navigated a bidding war that culminated in its sale to pharmaceutical giant AbbVie in a $10.1 billion transaction, earning her a spot among the life sciences law practitioners under age 40 honored by Law360 as Rising Stars.
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August 02, 2024
Health Tech Co. Beats Investor Data Platform Fraud Claim
A healthcare technology company has escaped an investor suit challenging the existence of a data platform it touted, as a Connecticut federal judge found a former employee's assertions at the center of the proposed class action weren't enough to show the company knowingly misled investors about the offering.
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August 02, 2024
Ex-Exec Can't Escape Drug Co.'s Trade Secret Suit
The North Carolina Business Court refused to give a win before trial to the former president of a United Therapeutics Corp. subsidiary on a claim that he took trade secrets to a rival, with the court reasoning the drug company took reasonable steps to protect the secrets beyond a three-year limit in his employment agreement.
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August 02, 2024
Wheeling & Appealing: The Latest Must-Know Appellate Action
In this inaugural edition of Wheeling & Appealing, Law360 recaps recent appellate opinions that made waves, quizzes readers about a new word for judicial grievances, and previews August arguments in circuit courts over controversial wage rules and a seven-figure attorney fee award after a digital age intellectual property trial.
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August 02, 2024
US Cannabis Policy Thwarts Research, Health Officials Say
A recent report from federal health regulators confirms what cannabis reform advocates have long said, that placing marijuana in the most restrictive tier under the federal Controlled Substances Act has hindered researchers' ability to study the drug's potential benefits and risks.
Expert Analysis
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In Memoriam: The Modern Administrative State
On June 28, the modern administrative state, where courts deferred to agency interpretations of ambiguous statutes, died when the U.S. Supreme Court overruled its previous decision in Chevron v. Natural Resources Defense Council — but it is survived by many cases decided under the Chevron framework, say Joseph Schaeffer and Jessica Deyoe at Babst Calland.
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Series
After Chevron: Expect Limited Changes In USPTO Rulemaking
The U.S. Supreme Court’s recent ruling overturning Chevron deference will have limited consequences for the U.S. Patent and Trademark Office given the USPTO's unique statutory features, but it is still an important decision for matters of statutory interpretation, especially those involving provisions of the America Invents Act, say Andrei Iancu and Cooper Godfrey at Sullivan & Cromwell.
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How High Court Approached Time Limit On Reg Challenges
The U.S. Supreme Court's decision in Corner Post v. Federal Reserve Board effectively gives new entities their own personal statute of limitations to challenge rules and regulations, and Justice Brett Kavanaugh's concurrence may portend the court's view that those entities do not need to be directly regulated, say attorneys at Snell & Wilmer.
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Fed. Circ. Skinny Label Ruling Guides On Infringement Claims
The Federal Circuit's recent decision in Amarin v. Hikma shows generic drug manufacturers must pay close attention to the statements in their abbreviated new drug application labels to put themselves in the best position in defending against an induced infringement claim, say Luke Shannon and Roshan Shrestha at Taft Stettinius.
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4 Takeaways From Biotech Patent Invalidity Ruling
The recent Patents Court decision in litigation between Advanced Cell Diagnostics and Molecular Instruments offers noteworthy commentary on issues related to experiments done in the ordinary course of business, joint importation, common general knowledge and mindset, and mosaicking for anticipation, say Nessa Khandaker and Darren Jiron at Finnegan.
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How To Clean Up Your Generative AI-Produced Legal Drafts
As law firms increasingly rely on generative artificial intelligence tools to produce legal text, attorneys should be on guard for the overuse of cohesive devices in initial drafts, and consider a few editing pointers to clean up AI’s repetitive and choppy outputs, says Ivy Grey at WordRake.
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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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Roundup
After Chevron
In the month since the U.S. Supreme Court overturned the Chevron deference standard, this Expert Analysis series has featured attorneys discussing the potential impact across 26 different rulemaking and litigation areas.
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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.