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Life Sciences
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August 08, 2024
Rising Star: Williams & Connolly's Elise Baumgarten
Elise Baumgarten of Williams & Connolly LLP was counsel for Endo Pharmaceuticals in a "pay for delay" class action arising from a patent settlement that ended with a verdict in Endo's favor, and she won a major trial for Merck & Co. Inc. in Hatch-Waxman patent litigation, earning her a spot among healthcare law practitioners under age 40 honored by Law360 as Rising Stars.
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August 07, 2024
Exec Unlikely To Get New Trial In SEC's 'Shadow Trading' Suit
A California federal judge said at a hearing Wednesday that he wasn't inclined to grant a new trial in a novel SEC "shadow trading" case, saying "there's no question" that a former executive of Medivation, a pharmaceutical company, knew that he was using inside information from his company when he purchased a rival's stock.
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August 07, 2024
Biotech Firm Can't Pause SEC Action During Appeal
A Colorado federal magistrate judge won't pause a lawsuit by securities regulators against a biotech company accused of misappropriating roughly $9 million while the company appeals an asset freeze, agreeing in a Wednesday order with the SEC's argument that investors would be better served if the case moved ahead.
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August 07, 2024
Abbott Brass Trim But Can't Nix Investors' Formula Recall Suit
A Chicago federal judge on Wednesday substantially trimmed a derivative suit accusing Abbott Laboratories leaders of concealing known safety issues related to recalled infant formula but rejected the defendants' argument that tossing the suit in its entirety was in shareholders' "best interest."
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August 07, 2024
Judge's Pharma Comments Could Decide Ineligibility Appeal
A Federal Circuit panel on Wednesday was willing to explore Astellas Pharma's argument that a Nebraska federal judge should be taken off its infringement case over the bladder medication Myrbetriq, given statements that showed a potential bias against the pharmaceutical industry, but also made clear that such reassignments are rare and difficult.
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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.
Expert Analysis
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Defense Attys Must Prep For Imminent AI Crime Enforcement
Given recent statements by U.S. Department of Justice officials, white collar practitioners should expect to encounter artificial intelligence in federal criminal enforcement in the near term, even in pending cases, say Jarrod Schaeffer and Scott Glicksman at Abell Eskew.
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Planning For Healthcare-Private Equity Antitrust Enforcement
U.S. antitrust agency developments could mean potential enforcement actions on healthcare-related acquisitions by private equity funds are on the way, and entities operating in this space should follow a series of practice tips, including early assessment of antitrust risks on both the state and federal level, say Ryan Quillian and John Kendrick at Covington.
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Opinion
Why USPTO Should Issue Inherency Guidance Memo
The U.S. Patent and Trademark Office should issue a new guidance memo in regard to the standard for inherency during the examination process, as the standard is frequently misapplied during prosecution, and consistency of the standard in the USPTO should match that in the federal courts, says Irving Feit at Lucas & Mercanti.
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How Purdue Pharma High Court Case May Change Bankruptcy
The U.S. Supreme Court’s upcoming ruling in Purdue Pharma may be the death of most third-party releases in Chapter 11 cases, and depending on the decision’s breadth, could have much more far-reaching effects on the entire bankruptcy system, say Brian Shaw and David Doyle at Cozen O'Connor.
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3 Health Insurance Paths For Psychedelic-Assisted Therapy
Ahead of potential U.S. Food and Drug Administration approvals for psychedelics as insured treatments, attorneys at Husch Blackwell review pathways for these drugs to achieve coverage as treatments for complex mental health conditions.
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Series
Serving As A Sheriff's Deputy Made Me A Better Lawyer
Skills developed during my work as a reserve deputy — where there was a need to always be prepared, decisive and articulate — transferred to my practice as an intellectual property litigator, and my experience taught me that clients often appreciate and relate to the desire to participate in extracurricular activities, says Michael Friedland at Friedland Cianfrani.
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Fears About The End Of Chevron Deference Are Overblown
While some are concerned about repercussions if the U.S. Supreme Court brings an end to Chevron deference in the Loper and Relentless cases this term, agencies and attorneys would survive just fine under the doctrines that have already begun to replace it, say Daniel Wolff and Henry Leung at Crowell & Moring.
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Negotiating Milestones In Pharma Licenses Requires Care
For life sciences companies, understanding the unique issues that arise in licensing agreements' milestone payment provisions can increase the likelihood and amount of payments received by the licensor and ensure payments are carefully and closely tied to events that truly drive value for the licensee, say Edward Angelini at Amneal Pharmaceutical and Lori Waldron at Sills Cummis.
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Former Minn. Chief Justice Instructs On Writing Better Briefs
Former Minnesota Supreme Court Chief Justice Lorie Gildea, now at Greenberg Traurig, offers strategies on writing more effective appellate briefs from her time on the bench.
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Stay Interviews Are Key To Retaining Legal Talent
Even as the economy shifts and layoffs continue, law firms still want to retain their top attorneys, and so-called stay interviews — informal conversations with employees to identify potential issues before they lead to turnover — can be a crucial tool for improving retention and morale, say Tina Cohen Nicol and Kate Reder Sheikh at Major Lindsey.
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Direct Claims Ruling May Alter Gov't Ties To Software Firms
A recent Federal Circuit decision allowing a software developer to pursue legal action under the Contract Disputes Act could change the government's relationship with commercial software providers by permitting direct claims, even in third-party purchase situations, say Dan Ramish and Zach Prince at Haynes Boone.
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Opinion
Intoxicating Hemp Products: It's High Time For Clarity
Thanks to ambiguity in the 2018 Farm Bill, intoxicating hemp cannabinoid products are largely unregulated and are widely available without restrictions on who can buy the products, and although there are several possible solutions, voluntary industry action by good actors is the best option, say Andrew Kline and Tommy Tobin at Perkins Coie.
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And Now A Word From The Panel: Benefits Of MDL Transfers
A recent order from the Judicial Panel on Multidistrict Litigation highlights a critical part of the panel's work — moving cases into an existing MDL — and serves as a reminder that common arguments against such transfers don't outweigh the benefits of coordinating discovery and utilizing lead counsel, says Alan Rothman at Sidley Austin.
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What Rescheduling Could Mean For Cannabis Bankruptcies
Bankruptcy courts have historically been closed for cannabis-related businesses, but recent case law coupled with a possible reclassification of cannabis provides cautious optimism, say attorneys at Duane Morris.
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Opinion
Pharmacies Need More Protection Against PBM Fee Practices
The Centers for Medicare & Medicaid Services' recent reform regarding direct and indirect remuneration fees will mitigate the detrimental effects that pharmacy benefit manager policies have on struggling pharmacies, but more is needed to prevent PBMs from exploiting loopholes, says Bhavesh Desai at Mazina Law.