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Life Sciences
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September 24, 2024
Moderna Execs Hyped Ineffective RSV Vax, Suit Says
Officers and directors of Moderna misled investors about the efficacy of its RSV vaccine, causing share prices to dive when it was revealed in June to have only about a 50% efficacy rate after 18 months, a new shareholder suit alleges.
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September 24, 2024
Firms Allowed To Exit IP Case After Gaining Philips' Consent
A North Carolina federal judge allowed Dentons and Morningstar Law Group to withdraw as Transtate Equipment Co. Inc.'s counsel in a copyright and unfair competition case, after a stipulation was struck with opposing attorneys representing a Dutch health technology conglomerate that initially scoffed at the request.
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September 24, 2024
8th Circ. Won't Revive Pot Shop's Discrimination Suit
The Eighth Circuit won't reinstate discrimination and interference claims by a would-be cannabis distributor against a firm contracted to evaluate applicants for Arkansas' dispensary licenses, saying the complaint lacks specificity to support its claims.
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September 24, 2024
NJ Judge Leaves J&J Ch. 11 Venue Change To Texas Judge
A New Jersey bankruptcy judge on Tuesday declined the U.S. trustee's request to move Johnson & Johnson's latest talc-unit Chapter 11 from Texas to the Garden State, saying the issue could be as ably decided by a Texas court while avoiding a thorny issue of authority.
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September 23, 2024
J&J Talc Claims Paused In Latest Spinoff Ch. 11
A Texas bankruptcy judge Monday froze certain talc personal injury litigation against Johnson & Johnson, saying a three-week administrative stay will give the court time to decide key jurisdictional issues in the Chapter 11 case of Red River Talc LLC, a newly created J&J spinoff and the pharmaceutical and cosmetics giant's latest attempt to settle claims in bankruptcy that its baby powder caused cancer.
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September 23, 2024
Mallinckrodt Brass Can't Avoid Investor Suit Over 2nd Ch. 11
A New Jersey federal judge ruled Monday that senior leaders of drugmaker Mallinckrodt cannot escape a lawsuit brought by shareholders alleging the company tricked them into thinking it had recovered from bankruptcy and would make a $200 million payment to opioid claimants, finding the investors sufficiently pleaded securities law violations.
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September 23, 2024
Bio Lab Settles Conn. False-Claims Allegations For $1.73M
Enzo Biochem Inc. and subsidiary Enzo Clinical Labs Inc. will pay nearly $1.73 million to settle accusations that the companies' former Farmingdale, New York, laboratory billed higher rates to the state of Connecticut's Medicaid coffers than it billed to other payers, the state attorney general announced Monday.
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September 23, 2024
Fired Sotera Exec's Vesting Suit Goes Forward In Del.
Delaware's Court of Chancery dismissed on Monday some claims in a former Sotera Health Co. executive's suit accusing the lab-testing and sterilization firm of wrongly refusing to grant him severance benefits and equity awards worth millions, while holding other claims for trial.
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September 23, 2024
GSK Claims Pfizer Hasn't Proven Misconduct In Vax IP Fight
GlaxoSmithKline is urging a Delaware federal judge to block Pfizer and BioNTech's claims that it has misused its patents tied to COVID-19 vaccination technology, or that it and a predecessor acted inappropriately when applying for those patents.
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September 23, 2024
Fed. Circ. OKs Novartis Loss In Eye Syringe Patent Feud
The Federal Circuit has backed a Patent Trial and Appeal Board finding that more than two dozen claims in a Novartis pre-filled eye injection syringe patent weren't patentable.
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September 23, 2024
Amneal Latest Generic EpiPen Maker To Fight Colo. Law
Amneal Pharmaceuticals has sued Colorado in federal court alleging that a state drug affordability program resulted in unconstitutional takings of its generic epinephrine auto-injectors.
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September 23, 2024
Cancer Test Cos. Strike Deal For Partial End To Patent Row
Natera Inc. and Neogenomics Laboratories Inc. said they reached a confidential yet partial settlement Friday in their dispute covering intellectual property for a Natera DNA test meant to detect cancer.
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September 23, 2024
Insurer Freed From Damaged Blood Plasma Suit
A supplier of blood plasma can't secure coverage for a nearly $820,000 blood plasma shipment declared a total loss because of excessive temperature variation and shipping delays, a Georgia federal court ruled, finding the supplier failed to abide by separate temperature and delay warranties in its policy.
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September 23, 2024
J&J Accuses Beasley Allen Of Casting Bogus Talc Ballots
Johnson & Johnson has accused the Beasley Allen Law Firm of casting about two dozen false ballots against the company's latest talc bankruptcy plan without voters' consent and urged a New Jersey federal court to remove the firm from the plaintiff's steering committee as a consequence.
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September 23, 2024
RSV Vaccine Biz Secures $100M For Series B Funding Round
Biopharmaceutical company Vicebio Ltd. on Monday announced that it secured its Series B funding round after securing $100 million led by science-focused investment firm TCGX.
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September 23, 2024
Kratom Co. Gets Claims Trimmed In Addiction False Ad Row
A California federal judge has tossed four out of six claims from a proposed class action alleging Ashlynn Marketing Group Inc. hid from buyers the addictive qualities of its kratom products, leaving only fraud and Consumer Legal Remedies Act claims.
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September 20, 2024
House To Weigh Patent Bill Aimed At Cutting Drug Prices
The U.S. House of Representatives is expected to consider a bill soon that has already cleared the Senate and could streamline patent litigation by curbing the number of patents that makers of biologic drugs can assert over biosimilar drugs.
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September 20, 2024
ITC Has Been Launching Fewer Section 337 Investigations
Intellectual property activity at the U.S. International Trade Commission has "decreased somewhat," the agency said in a report Friday.
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September 20, 2024
Alnylam Seeks To End Inventorship Suit Tied To COVID Vax
Alnylam Pharmaceuticals, which alleges that COVID-19 vaccines made by Pfizer and Moderna infringe its patents, has moved in Delaware federal court to dismiss a suit by former collaborator Acuitas Therapeutics Inc. seeking to have its scientists added as inventors on the patents.
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September 20, 2024
3rd Circ. Rejects 'Close' Case For Preemption In Fosamax MDL
A U.S. Food and Drug Administration letter denying changes to the label of Merck's osteoporosis drug Fosamax does not count as a final agency action triggering federal preemption of state law "failure to warn" claims, the Third Circuit ruled Friday in a precedential decision.
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September 20, 2024
Del. Justices Uphold Toss Of AmerisourceBergen Syringe Suit
Delaware's Supreme Court upheld with little comment Friday a lower court dismissal of a nearly 5-year-old shareholder derivative suit accusing AmerisourceBergen Corp. directors of failing to investigate and stop illegal repackaging of cancer drugs.
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September 20, 2024
IPO Trio Looks To Raise $536M Combined As Autumn Begins
Three companies spanning the energy, healthcare and life sciences industries are preparing initial public offerings that could raise $536 million combined in the coming week, guided by six law firms, signaling an upturn in IPOs as autumn begins.
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September 20, 2024
DuPont Cos. Can't Escape Cape Fear River PFAS Suit
A North Carolina federal judge said DuPont and several corporate spin-offs can't escape a lawsuit brought by four Tar Heel State residents who claim the companies knowingly poisoned the Cape Fear River with toxic forever chemicals pollution.
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September 20, 2024
Lawmakers Ask USPTO To Fix Patent Calculation Problem
Federal patent officials need to change standards that could let drug companies hold on to patent rights beyond the time frame they are entitled to, according to federal lawmakers.
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September 20, 2024
Plaintiffs Firms Battle Over Proposed $9B Deal In J&J Talc Suit
Two leading plaintiffs law firms in the multibillion-dollar litigation over Johnson & Johnson's tainted talcum powder are now warring among themselves, with Smith Law Firm PLLC suing Beasley Allen Law Firm for defamation after Beasley Allen accused the former of selling out clients to pay off litigation funders.
Expert Analysis
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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
Since the U.S. Supreme Court overturned the Chevron deference standard in June, this Expert Analysis series has featured attorneys discussing the potential impact across 36 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.
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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.
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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.