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Life Sciences
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November 22, 2024
MVP: Skadden's Graham Robinson
Graham Robinson of Skadden Arps Slate Meagher & Flom LLP represented Iveric Bio in its $5.9 billion sale to global pharmaceutical company Astellas Pharma Inc., earning him a spot among the 2024 Law360 Life Sciences MVPs.
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November 22, 2024
UK Litigation Roundup: Here's What You Missed In London
This past week in London has seen cash-strapped Thurrock Borough Council bring a £40 million ($50 million) negligence claim against 23 other local authorities over its solar investments from a not-for-profit local government body, AstraZeneca sue a fire safety company following a blaze at its Cambridge headquarters last year, and a director who was convicted in 2016 for corporate manslaughter face action by Manolete Partners. Here, Law360 looks at these and other new claims in the U.K.
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November 21, 2024
SEC Denied Civil Penalties Over Pot Pill Exec's 'Inexperience'
The SEC will score $86,000 in disgorgement and interest from a former executive of C3 International Inc. for falsely claiming the company's cannabis pill was projected to generate millions of dollars in revenue, but the court found the defendant's conduct did not warrant the civil penalty the agency requested.
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November 21, 2024
Boehringer Trial Over Zantac's Cancer Link Ends In Mistrial
A California state judge declared a mistrial Thursday, ending a monthslong trial over product liability claims by a bladder cancer survivor who alleges Boehringer Ingelheim Pharmaceuticals Inc. failed to disclose cancer risks associated with the company's Zantac heartburn medication, according to the plaintiff's counsel.
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November 21, 2024
SEC Seeks More Data On Nasdaq Plan To Speed Up Delistings
The U.S. Securities and Exchange Commission has postponed deciding on a Nasdaq proposal that would accelerate delistings of companies with low-priced stocks that take extended time to regain compliance or rely on reverse-stock splits to elevate their share prices, saying more data is needed before it takes action.
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November 21, 2024
Trump Selects Ex-Fla. AG Pam Bondi As New AG Pick
President-elect Donald Trump announced Thursday that he has selected Pam Bondi, a former attorney general of Florida, as his new pick for U.S. attorney general, just hours after former U.S. Rep. Matt Gaetz withdrew his name from consideration amid allegations of sexual misconduct and drug use.
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November 21, 2024
IP Atty Fights To Revive Allergan FCA Suit At 9th Circ.
A patent attorney urged the Ninth Circuit on Thursday to revive False Claims Act allegations against Allergan over dementia drug patents, arguing his client used his expertise to discover the patents were fraudulently issued to block generics and that these are the kinds of FCA cases the government welcomes from experts.
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November 21, 2024
In Tight Vote, Senate Panel OKs Bill To Set New PTAB Limits
The Senate Judiciary Committee on Thursday narrowly voted to advance a bill that would impose new restrictions on Patent Trial and Appeal Board challenges, with several members expressing concern that it could drive up the cost of prescription drugs.
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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.
Expert Analysis
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Series
Being A Navy Reservist Makes Me A Better Lawyer
Serving this country in uniform has not only been one of the greatest honors of my life, but it has also provided me with opportunities to broaden my legal acumen and interpersonal skills in ways that have indelibly contributed to my civilian practice, says Phillip Smith at Weinberg Wheeler.
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Incoming Admin May Shake Up Life Sciences Regulation
Though President-elect Donald Trump has not yet articulated policy priorities regarding the life sciences industry, the sector is positioned to see significant changes that could affect everything from drug exclusivity and generic drug approvals, to the availability of over-the-counter drugs, to laboratory-developed tests and digital health, say attorneys at Morgan Lewis.
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Next Steps In The $2.8B Blue Cross Payout To Providers
Healthcare providers deciding whether to participate in Blue Cross Blue Shield network's recent $2.8 billion antitrust class action settlement must weigh key recovery factors, including provider type and litigation cost, say attorneys at Hall Render.
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So You Want To Move Your Law Practice To Canada, Eh?
Google searches for how to move to Canada have surged in the wake of the U.S. presidential election, and if you’re an attorney considering a move to the Great White North, you’ll need to understand how the practice of law differs across the border, says David Postel at Henein Hutchison.
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What To Expect Next From Federal Health Tech Regulation
Healthcare organizations should pay close attention to federal health information technology regulators' recent guidance concerning barriers to accessing electronic health information, which signals that more enforcement in this area is likely forthcoming, say attorneys at Ropes & Gray.
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Trump Rollback Of Biden Enviro Policies: What To Expect
Donald Trump's upcoming second presidential term will usher significant shifts in U.S. environmental and natural resource law and policy — and while the Biden administration is racing to secure its legacy, the incoming Trump administration is making plans to dramatically roll back most, if not all, of Biden's environmental initiatives, say attorneys at Beveridge & Diamond.
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Takeaways From State Votes On Abortion In The 2024 Election
Attorneys at Epstein Becker discuss how 10 states voted on ballot initiatives to either protect or restrict access to abortion in the 2024 general election, and analyze overarching trends.
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Key Territory-Split Licensing Lessons For Life Sciences Cos.
Territory-split deals can allow life sciences companies to maximize products' potential across a range of geographic areas, but these deals also present unique challenges requiring highly bespoke structures that can make or break the value of an asset, say attorneys at Covington.
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Legislation Most Likely To Pass In Lame Duck Session
As Congress begins its five-week post-election lame duck session, attorneys at Greenberg Traurig break down the legislative priorities and which proposals can be expected to pass.
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Justices Must Weigh Reach Of Civil RICO In Cannabis Case
Oral arguments in Medical Marijuana Inc. v. Horn suggest that a majority of the U.S. Supreme Court may agree that a truck driver's losing his job after unknowingly ingesting THC and failing a drug test does not merit a racketeering claim — but the court may not buy the other side's theory of the case either, say attorneys at Lewis Baach.
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Litigation Strategies In View Of New Double Patenting Rulings
Recent Federal Circuit decisions, including in Allergan v. MSN, raise several issues that patent owners should understand and consider addressing proactively regarding obviousness-type double patenting, at least in their prosecution strategies, say attorneys at Dentons.
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Promoting Diversity In The Selection Of ADR Neutrals
Excerpt from Practical Guidance
Choosing neutrals from diverse backgrounds is an important step in promoting inclusion in the legal profession, and it can enhance the legitimacy and public perception of alternative dispute resolution proceedings, say attorneys at Lowenstein Sandler.
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Series
Playing Ultimate Makes Us Better Lawyers
In addition to being fun, ultimate Frisbee has improved our legal careers by emphasizing the importance of professionalism, teamwork, perseverance, enthusiasm and vulnerability, say Arunabha Bhoumik and Adam Bernstein at Regeneron.
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E-Discovery Quarterly: Recent Rulings On Metadata
Several recent rulings reflect the competing considerations that arise when parties dispute the form of production for electronically stored information, underscoring that counsel must carefully consider how to produce and request reasonably usable data, say attorneys at Sidley.
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Opinion
PREVAIL Bill Is Another Misguided Attempt To Restrict PTAB
The decade-long campaign against the U.S. Patent and Trademark Office's Patent Trial and Appeal Board — currently focused on the PREVAIL Act that's slated for markup in the Senate — is not really about procedural issues, and it is not aimed at securing more accurate patentability decisions, says Clear IP's Joseph Matal, former acting director at the USPTO.