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Life Sciences
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August 07, 2024
Advocates Tell 9th Circ. To Revive Invisalign Monopoly Suit
Competition advocates are backing the revival of a class action accusing the makers of Invisalign of monopolizing the market for clear dental aligners, telling the Ninth Circuit in a new amicus brief that a district court summary judgment ruling for Align Technology creates a dangerous precedent for refusal-to-deal cases.
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August 07, 2024
Teva Finds Some Big-Pharma Friends In Inhaler Patent Fight
Two large pharmaceutical companies have weighed in to ask the Federal Circuit to overturn a ruling that found that Teva's branded drugmaking operation misused a key federal patent database in order to block the release of competing generic asthma inhalers.
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August 07, 2024
NC Biz Court Bulletin: The Battles Making Summer Sizzle
A 1983 championship basketball team's intellectual property rights and a public feud between Cadwalader Wickersham & Taft LLP and its insurer are among the legal battles that have kept North Carolina Business Court judges and Tar Heel state private practice attorneys busy this summer. In case you missed those and others, here are the highlights.
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August 07, 2024
Amgen Waged Lawfare To Overcharge For Drug, Suit Claims
Maryland-based independent licensees of the Blue Cross Blue Shield Association claim pharmaceutical giant Amgen Inc. and its subsidiaries have engaged in unlawful monopolistic practices that have inflated the cost of the blockbuster drug Enbrel.
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August 07, 2024
Ex-Pharma Exec Gets 20 Months In SEC Contempt Case
A former pharmaceutical executive who used an alias to flout a 2016 U.S. Securities and Exchange Commission consent judgment barring him from the securities industry was sentenced Wednesday to 20 months in prison by a judge who called him "incorrigible."
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August 07, 2024
Law Firms Fight J&J Bid To Revive Talc Subpoenas
The Beasley Allen Law Firm, the steering committee of talc plaintiffs suing Johnson & Johnson, and a third-party law firm urged the New Jersey federal court this week to reject a bid from the pharmaceutical company to reinstate subpoenas seeking evidence of alleged third-party litigation funding.
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August 07, 2024
3 Firms Steer $405M G1-Pharmacosmos Pharma Deal
G1 Therapeutics Inc., a North Carolina-based developer of cancer therapies, has agreed to sell the business to the U.S. subsidiary of Denmark's Pharmacosmos A/S, for approximately $405 million, the companies said Wednesday.
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August 07, 2024
2 FDA Pros Join McGuireWoods From Reed Smith, DOJ
McGuireWoods LLP said Wednesday it has added two U.S. Food and Drug Administration regulatory lawyers to its Washington, D.C., office — one who joins from Reed Smith LLP and another who joins from the U.S. Department of Justice.
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August 07, 2024
Jury Deadlocks In Third Illinois Zantac Cancer Trial
An Illinois state judge declared a mistrial Wednesday in a man's lawsuit claiming Boehringer Ingelheim's over-the-counter Zantac caused him to develop prostate cancer, after a jury signaled it could not reach a unanimous verdict.
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August 07, 2024
Rising Star: King & Spalding's Julia Zousmer
Julia Zousmer of King & Spalding LLP helped Boehringer Ingelheim nix roughly 50,000 claims by plaintiffs and an entire cohort of experts in multidistrict litigation over its heartburn medication Zantac, earning her a spot among life sciences attorneys under age 40 honored by Law360 as Rising Stars.
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August 07, 2024
Pennsylvania Legislation Passed In 2024: A Midyear Report
Despite a divided legislature in Pennsylvania — the parties have been trading a narrow majority in the House of Representatives and Republicans compose most of the state Senate — lawmakers have managed to send dozens of bills to Democratic Gov. Josh Shapiro's desk in the first half of 2024, including tighter controls on a veterinary drug showing up in heroin, changes to business registrations with the state, and adding arbitration to the tools for family courts.
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August 06, 2024
AstraZeneca Can't Duck $107.5M Patent Loss To Pfizer Unit
An Illinois federal judge on Tuesday refused to upend a jury's determination that AstraZeneca owes $107.5 million in royalty damages for infringing Pfizer-brand cancer treatment patents, rejecting AstraZeneca's arguments that the patents are unenforceable and the asserted claims are invalid.
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August 06, 2024
Baby Sock Co. Can't Beat Investor Suit, But SPAC Brass Can
Digital baby monitoring device manufacturer Owlet Inc. cannot escape a suit accusing it of misleading investors about approvals required from the U.S. Food and Drug Administration to sell its "smart socks," but brass at a blank check company that it merged with will be allowed to exit the suit.
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August 06, 2024
Fed. Circ. Told Edwards Filed Safe Harbor Suit With Bad Intent
The Federal Circuit rightfully held Meril Life Sciences was protected by a patent safe harbor when bringing its preapproval transcatheter heart valve system to an industry conference and that Edwards Lifesciences' attempts to prove otherwise are just delay tactics, Meril told the full court.
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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.
Expert Analysis
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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.
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Unpacking The Circuit Split Over A Federal Atty Fee Rule
Federal circuit courts that have addressed Rule 41(d) of the Federal Rules of Civil Procedure are split as to whether attorney fees are included as part of the costs of a previously dismissed action, so practitioners aiming to recover or avoid fees should tailor arguments to the appropriate court, says Joseph Myles and Lionel Lavenue at Finnegan.
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Del. Bankruptcy Ruling Will Give D&O Insureds Nightmares
In Henrich v. XL Specialty Insurance, the Delaware Bankruptcy Court recently found that a never-served qui tam claim had been "brought" before a D&O policy's retroactive date, thereby eliminating coverage, and creating a nightmare scenario for directors and officers policyholders facing whistleblower claims, says David Klein at Pillsbury.
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Opinion
No Matter The Purdue Ruling, Mass Tort Reform Is Needed
The U.S. Supreme Court will soon issue its opinion in the bankruptcy of Purdue Pharma LP, and regardless of the outcome, it’s clear legal and policy reforms are needed to address the next mass tort, says William Organek at Baruch College.
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After A Brief Hiccup, The 'Rocket Docket' Soars Back To No. 1
The Eastern District of Virginia’s precipitous 2022 fall from its storied rocket docket status appears to have been a temporary aberration, as recent statistics reveal that the court is once again back on top as the fastest federal civil trial court in the nation, says Robert Tata at Hunton.
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Protecting Trade Secrets In US, EU Gov't Agency Submissions
Attorneys at Mintz compare U.S. and European Union trade secret laws, and how proprietary information in confidential submissions to the U.S. Food and Drug Administration and the European Medicines Agency is protected in the face of third-party information requests under government transparency laws.
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Recruitment Trends In Emerging Law Firm Frontiers
BigLaw firms are facing local recruitment challenges as they increasingly establish offices in cities outside of the major legal hubs, requiring them to weigh various strategies for attracting talent that present different risks and benefits, says Tom Hanlon at Buchanan Law.
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4 Tips For Drafting Earnouts To Avoid Disputes
Amid slowed merger and acquisition activity, buyers and sellers are increasingly turning to earnout provisions to get deals done, but these must be carefully drafted to avoid interpretative differences that can lead to later disputes, say attorneys at Cooley.
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Series
Glassblowing Makes Me A Better Lawyer
I never expected that glassblowing would strongly influence my work as an attorney, but it has taught me the importance of building a solid foundation for your work, learning from others and committing to a lifetime of practice, says Margaret House at Kalijarvi Chuzi.
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Opinion
Flawed Fintiv Rule Should Be Deemed Overreach In Tech Suit
A pending federal lawsuit over the U.S. Patent and Trademark Office's unilateral changes to key elements of the America Invents Act, Apple v. Vidal, could shift the balance of power between Congress and federal agencies, as it could justify future instances of unelected officials unilaterally changing laws, say Patrick Leahy and Bob Goodlatte.
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How Associates Can Build A Professional Image
As hybrid work arrangements become the norm in the legal industry, early-career attorneys must be proactive in building and maintaining a professional presence in both physical and digital settings, ensuring that their image aligns with their long-term career goals, say Lana Manganiello at Equinox Strategy Partners and Estelle Winsett at Estelle Winsett Professional Image Consulting.