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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.
Editor's Picks
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Supreme Court Will Tackle Patent Enablement In Amgen Case
The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
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A Circuit-By-Circuit Guide To FCA Suits After High Court Snub
The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
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Inside The Collapse Of A Pioneering Opioid Case For DOJ
The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.
Expert Analysis
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Series
Circus Arts Make Me A Better Lawyer
Performing circus arts has strengthened my ability to be more thoughtful, confident and grounded, all of which has enhanced my legal practice and allowed me to serve clients in a more meaningful way, says Bailey McGowan at Stinson.
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3 Ways To Train Junior Lawyers In 30 Minutes Or Less
Today’s junior lawyers are experiencing a skills gap due to pandemic-era disruptions, but firms can help bring them up to speed by offering high-impact skill building content in bite-sized, interactive training sessions, say Stacey Schwartz at Katten, Diane Costigan at Winston & Strawn and Lauren Tierney at Freshfields.
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How AstraZeneca Ruling Could Change Dosage Patent Claims
If affirmed on appeal, the rationale employed by the Delaware federal court in Wyeth v. AstraZeneca to find "unit dosage"-related patent claims invalid could lead to a significant paradigm shift in how active-ingredient-focused patent applications are drafted and litigated, say Matthew Zapadka and John Schneible at Arnall Golden.
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Failed W.Va. Patent Challenge Reveals Secret Prior Art's Risks
A West Virginia federal court's recent ruling — that references used by a patent challenger to establish an ordinarily skilled artisan's existing knowledge must be published before a patent's filing — may discourage claim construction challenges based on secret prior art and steer drafters away from externally defined terms, says Brianna Potter at Baker Botts.
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Navigating Decentralized Clinical Trials With FDA's Guidance
The U.S. Food and Drug Administration's recently finalized guidance on conducting decentralized clinical trials, while not legally binding, can serve as a road map for sponsors, investigators and others to ensure trial integrity and participant safety, say attorneys at Phillips Lytle.
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The Bar Needs More Clarity On The Discovery Objection Rule
Almost 10 years after Federal Rule of Civil Procedure 34 was amended, attorneys still seem confused about what they should include in objections to discovery requests, and until the rules committee provides additional clarity, practitioners must beware the steep costs of noncompliance, says Tristan Ellis at Shanies Law Office.
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How Patent Landscape Analysis Drives Business Growth
Keegan Caldwell at Caldwell Law explores how patent landscape analysis serves as a key driver of sustainable growth — examining how its components, strategic advantages and implementation best practices are reshaping innovation leadership.
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In Terror Case, DC Circ. Must Weigh Justices' Twitter Ruling
When the D.C. Circuit hears oral argument in AstraZeneca UK v. Atchley, how the court interprets the U.S. Supreme Court's 2023 ruling in Twitter v. Taamneh will have a significant impact on future claims brought under the Anti-Terrorism Act and Justice Against Sponsors of Terrorism Act, say attorneys at Lewis Baach.
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Marching In On Orange Book Drugs May Have Limited Effect
Statistical analysis shows that marching in on Orange Book drug patent holders to require additional licensees would have a relatively minimal impact on drug prices, and should be weighed against the harms it could have on pharmaceutical innovation, say researchers at Competition Dynamics.
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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.