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Life Sciences
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November 21, 2024
MVP: Fenwick's Douglas Cogen
Douglas Cogen of Fenwick & West LLP's life sciences practice guided cardiovascular device company Shockwave Medical through a record-breaking acquisition by Johnson & Johnson, while he simultaneously shepherded multiple biopharma companies through multibillion-dollar deals, earning him recognition as a 2024 Law360 Life Sciences MVPs.
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November 20, 2024
Musk, Ramaswamy Say High Court Rulings OK Federal Cuts
Billionaire Elon Musk and former presidential candidate Vivek Ramaswamy, President-elect Donald Trump's picks to lead a newly created "Department of Government Efficiency," on Wednesday said two recent U.S. Supreme Court rulings will give them the authority to cut off power to regulatory agencies and conduct massive federal layoffs.
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November 20, 2024
Ex-Pharma CEO Demands Legal Fees For SEC Probe
Cancer treatment development company Eagle Pharmaceuticals Inc.'s founder and ex-CEO told Delaware's Chancery Court Wednesday that he is entitled to legal fees he says the company owes him in connection with a U.S. Securities and Exchange Commission probe into the company's accounting practices, saying he continues to incur fees in addition to the $875,000 he has already requested.
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November 20, 2024
USPTO Unveils Patent Fee Hikes Set To Take Effect In January
The U.S. Patent and Trademark Office on Wednesday released a final rule that will increase many patent-related fees on Jan. 19, recalibrating some proposed hikes that had drawn criticism from attorneys and industry groups while leaving others intact.
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November 20, 2024
DEA Accused Of Colluding With Reform Foes In Pot Row
Cannabis reform advocates have alleged that the Drug Enforcement Administration "stacked the deck" by colluding with anti-legalization interests and giving them improper opportunities to participate in upcoming hearings on a proposal to loosen federal restrictions on the drug.
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November 20, 2024
PBMs Sue To Block FTC's In-House Insulin Pricing Case
Caremark Rx, Express Scripts and OptumRx have lodged a constitutional challenge of the Federal Trade Commission's in-house case accusing the pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes.
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November 20, 2024
3 States To Challenge Abortion Regs After Docs Drop Claims
Anti-abortion medical groups that were dealt a loss by the U.S. Supreme Court earlier this year have now dropped out of their lawsuit challenging federal approvals for mifepristone, leaving Missouri, Idaho and Kansas to carry on litigation over the abortion medication.
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November 20, 2024
Beasley Allen And J&J Tussle Over Atty Sanctions Bid
Beasley Allen Law Firm accused a Johnson & Johnson talc unit of using "deposition notices as weapons" in its quest to sanction a firm lawyer, while the company said the firm "refused to meaningfully subject itself or its members to any discovery" in its bankruptcy case.
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November 20, 2024
Weil Litigation Leaders Jump To Paul Weiss In NY
The co-chair of Weil Gotshal & Manges LLP's global litigation department and the co-head of Weil's patent litigation practice will soon be joining Paul Weiss Rifkind Wharton & Garrison LLP in New York, the latter firm announced Wednesday.
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November 20, 2024
MVP: Williams & Connolly's David I. Berl
David I. Berl of Williams & Connolly LLP's patent litigation practice helped win a first-of-its-kind trial victory on behalf of Regeneron Pharmaceuticals by employing a novel legal strategy that allowed the biotech giant to quickly adjudicate its patent rights to an eye care medicine, earning him a spot as one of the 2024 Law360 Life Sciences MVPs.
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November 19, 2024
Pfizer Unit Can't Get $75M Left In Insider Trading Deal Fund
A New York federal judge Tuesday agreed with the U.S. Securities and Exchange Commission that roughly $75.2 million leftover in settlement funds should be transferred to the U.S. Treasury — not a Pfizer subsidiary — now that distribution of the $602 million insider trading deal has concluded.
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November 19, 2024
High Court Urged To Let Courts Scrutinize Agency Rulings
District courts should be allowed to question rather than grant "absolute deference" to the Federal Communications Commission's interpretation of key statutory terms in the Telephone Consumer Protection Act, a chiropractic group contended Monday in calling on the U.S. Supreme Court to revive a junk fax class action.
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November 19, 2024
DC Circ. Wonders Where To Land On Terrorism Liability Claims
Hypotheticals were flying Tuesday morning at the D.C. Circuit, where a three-judge panel spent more than two hours trying to figure out whether a recent U.S. Supreme Court decision means they need to stop the revival of a suit accusing pharmaceutical companies of funding terrorism in Iraq.
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November 19, 2024
Blood Vessel Maker Faces Investor Suit Over FDA Findings
Biotechnology company Humacyte Inc. faces an investor's proposed class action alleging the company failed to disclose quality assurance issues at its manufacturing facilities that allegedly delayed regulatory review for its bioengineered blood vessel product candidate, leading to stock price declines.
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November 19, 2024
Costco Shoppers Say Kirkland Fish Oil Pills Hide Heart Risks
Costco shoppers filed a putative false advertising class action in California federal court Monday accusing the big-box retailer of misleading consumers to believe its Kirkland brand of fish oil omega-3 supplements have heart health benefits, despite there being increased risks associated with fish oil, including atrial fibrillation.
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November 19, 2024
Calif. Biotech Firm Vera Taps Veteran Chief Legal Officer
Biotechnology firm Vera Therapeutics is welcoming a new chief legal officer in advance of an anticipated biologics submission to the U.S. Food and Drug Administration for a treatment targeting an autoimmune kidney disease.
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November 19, 2024
10th Circ. Iffy On Colo.'s Remedy To Generic EpiPen Takings
A Tenth Circuit panel on Tuesday pressed Colorado regulators on whether requiring epinephrine auto-injector makers to repeatedly sue over the cost of complying with a state program provides an adequate legal remedy, with one judge saying that that route offers no finality for manufacturers.
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November 19, 2024
J&J Wants Beasley Allen Atty Sanctioned For Depo No-Show
Johnson & Johnson's talc unit called on a Texas bankruptcy court to sanction a Beasley Allen Law Firm attorney for "unilaterally" deciding not to attend a scheduled deposition in the company's bankruptcy case.
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November 19, 2024
McGuireWoods Lands Health Ace, Former GC From Akin In NY
A veteran healthcare and life sciences attorney who previously served as general counsel at pharmaceutical companies Novo Nordisk and Daiichi Sankyo has made the move from Akin Gump Strauss Hauer & Feld LLP to McGuireWoods LLP.
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November 19, 2024
Akin Adds Another Healthcare Expert To DC Lobbying Team
The former chief health adviser for the Senate Finance Committee's majority has joined Akin Gump Strauss Hauer & Feld LLP's lobbying team in Washington, D.C., weeks after the firm added another healthcare advocate from the national association representing pharmacy benefit managers.
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November 19, 2024
MVP: Covington's Catherine Dargan
Catherine Dargan of Covington & Burling LLP represented Bristol Myers Squibb Co. in its $14 billion acquisition of the company that developed Cobenfy — the first new drug in 35 years to be approved by the Food and Drug Administration for treating schizophrenia — earning her a spot among the 2024 Law360 Life Sciences MVPs.
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November 19, 2024
McDermott Adds IP Pro From Gibson Dunn In Los Angeles
McDermott Will & Emery LLP announced Tuesday that it has hired partner Timothy Best from Gibson Dunn & Crutcher LLP to help bolster its intellectual property practice group, especially its efforts serving life sciences and biotechnology clients.
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November 18, 2024
'You Stepped Over The Line': Judge Rips Quinn Emanuel Atty
A California federal judge told a Quinn Emanuel partner defending Natera Inc. at trial Monday in Guardant Health Inc.'s false advertising case that she'd be sanctioned over her questioning of a Natera expert about Guardant's alleged damages, saying, "You stepped over the line, and you did it several times."
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November 18, 2024
J&J Posts $1.17B Bond For Del. Merger Milestone Appeal
Johnson & Johnson Inc. has posted a $1.167 billion surety-backed bond ahead of its planned appeal challenging a Delaware Chancery Court's finding that it owes more than $1 billion to a medical robotics developer's former shareholders caught up in a post-acquisition dispute.
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November 18, 2024
Melinta Obtains Ban On Generic Antibiotic Injections In IP Row
A drugmaker that recently sold a manufacturing facility to Eli Lilly for nearly $1 billion has failed to persuade a federal judge in Chicago to wipe out patents covering a line of injections that treat infections developed by a recently bankrupt antibiotic developer.
Expert Analysis
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It's No Longer Enough For Firms To Be Trusted Advisers
Amid fierce competition for business, the transactional “trusted adviser” paradigm from which most firms operate is no longer sufficient — they should instead aim to become trusted partners with their most valuable clients, says Stuart Maister at Strategic Narrative.
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Vertex Suit Highlights Issues For Pharma Fertility Support
Vertex Pharmaceuticals' recent lawsuit challenging the U.S. Department of Health and Human Services' interpretation of the Anti-Kickback Statute is influenced by a number of reproductive rights and health equity issues that the Office of Inspector General should address more concretely, including in vitro fertilization and fertility preservation programs, says Mary Kohler at Kohler Health Law.
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Opinion
CMS' New 'Breakthrough' Device Policy Shows Little Promise
The Centers for Medicare & Medicaid Services’ recent procedural notice outlining a new Medicare coverage pathway for breakthrough medical devices will, at best, be a failed experiment and, at worst, result in Medicare beneficiaries denied access to innovative treatments, say attorneys at King & Spalding.
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New Lessons On Managing Earnout Provision Risks
Earnout provisions can be a useful tool for bridging valuation gaps in M&A, particularly in developmental-stage pharmaceutical transactions, but the Delaware Chancery Court’s recent decision in Shareholder Representative Services v. Alexion sheds new light on the inherent risks and best practices for managing them, say attorneys at Cleary.
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3 Patent Considerations For America's New Quantum Hub
Recent developments signal an incredibly bright future for Chicago as the new home of quantum computing, and it is crucial that these innovators — whose technology has the potential to transform many industries — prioritize intellectual property strategy, says Andrew Velzen at McDonnell Boehnen.
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A Preview Of AI Priorities Under The Next President
For the first time in a presidential election, both of the leading candidates and their parties have been vocal about artificial intelligence policy, offering clues on the future of regulation as AI continues to advance and congressional action continues to stall, say attorneys at Mintz.
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How Companies Are Approaching Insider Trading Policies
An analysis of insider trading policies recently disclosed by 49 S&P 500 companies under a new U.S. Securities and Exchange Commission rule reveals that while specific provisions vary from company to company, certain common themes are emerging, say attorneys at Gibson Dunn.
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11 Patent Cases To Watch At Fed. Circ. And High Court
As we head into fall, there are 11 patent cases to monitor, touching on a range of issues that could affect patent strategy, such as biotech innovation, administrative rulemaking and patent eligibility, say Edward Lanquist and Wesley Barbee at Baker Donelson.
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Opinion
3rd. Circ. Got It Right On Cancer Warning Claims Preemption
The Third Circuit's recent, eminently sensible ruling in a failure-to-warn case against Roundup manufacturer Monsanto, holding that the Federal Insecticide, Fungicide and Rodenticide Act preempts state law claims, provides a road map that other courts should adopt, says Lawrence Ebner at the Atlantic Legal Foundation.
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Opinion
To Lower Drug Prices, Harris Must Address Patent Thickets
If Vice President Kamala Harris is serious about her pledge to address high drug prices, she must begin by closing loopholes that allow pharmaceutical companies to develop patent thickets that can deter generic or biosimilar companies from entering the market, says Tahir Amin at the Initiative for Medicines, Access & Knowledge.
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How Methods Are Evolving In Textualist Interpretations
Textualists at the U.S. Supreme Court are increasingly considering new methods such as corpus linguistics and surveys to evaluate what a statute's text communicates to an ordinary reader, while lower courts even mull large language models like ChatGPT as supplements, says Kevin Tobia at Georgetown Law.
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Trending At The PTAB: Obviousness In Director Reviews
Three July decisions from the U.S. Patent and Trademark Office favoring petitioners indicate a willingness by the director to review substantive issues, such as obviousness, particularly in cases where the director believes the Patent Trial and Appeal Board provided incorrect or inadequate rationale to support its decisions, say attorneys at Finnegan.
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Why Attorneys Should Consider Community Leadership Roles
Volunteering and nonprofit board service are complementary to, but distinct from, traditional pro bono work, and taking on these community leadership roles can produce dividends for lawyers, their firms and the nonprofit causes they support, says Katie Beacham at Kilpatrick.
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Opinion
Agencies Should Reward Corporate Cyber Victim Cooperation
The increased regulatory scrutiny on corporate victims of cyberattacks — exemplified by the U.S. Securities and Exchange Commission's case against SolarWinds — should be replaced with a new model that provides adequate incentives for companies to come forward proactively and collaborate with law enforcement, say attorneys at McDermott.
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Firms Must Offer A Trifecta Of Services In Post-Chevron World
After the U.S. Supreme Court’s Loper Bright Enterprises v. Raimondo decision overturning Chevron deference, law firms will need to integrate litigation, lobbying and communications functions to keep up with the ramifications of the ruling and provide adequate counsel quickly, says Neil Hare at Dentons.