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Life Sciences
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February 18, 2025
Trump Issues Order Calling For Expanded IVF Access
President Donald Trump signed an executive order Tuesday giving his administration 90 days to develop policy recommendations designed to protect access to in vitro fertilization and sharply reduce out-of-pocket costs for IVF treatment.
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February 18, 2025
Trump Trans Order Is Unconstitutional 'End-Run,' Judge Says
A Washington federal judge has further explained her temporary block on President Donald Trump's executive order targeting funding for gender-affirming care for young people, saying the edict threatens a broad swath of congressionally approved research spending and "amounts to an end-run around the separation of powers."
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February 18, 2025
Vaccine Developer Files Ch. 11 Sale Plan With $11.5M Bid
Omega Therapeutics, which develops mRNA vaccines, filed proposed bidding procedures in Delaware bankruptcy court, saying it hopes to get a sale approved by mid-April and has a stalking-horse bid in hand worth about $11.5 million.
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February 18, 2025
Ex-Goldman Atty Squires Expected To Be Named USPTO Head
John A. Squires — Goldman Sachs' longtime chief intellectual property counsel, co-founder of Fortress' IP Investment fund and current Dilworth Paxson LLP partner — is expected to be chosen as the Trump administration's nominee for U.S. Patent and Trademark Office director, about a half-dozen sources with knowledge of the agency said Tuesday.
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February 14, 2025
FTC's Ferguson, PBMs Agree: Nix Leader Removal Safeguards
Federal Trade Commission Chairman Andrew N. Ferguson offered his own support for enabling the president to readily fire independent agency commissioners at the FTC and beyond, a day after pharmacy benefit managers cited the new U.S. Department of Justice policy in their own battle with the FTC.
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February 14, 2025
Digital Health Co. Beats Some Claims In SPAC Investor Suit
A New Jersey federal judge has dismissed, with leave to amend, claims in an investor suit against a blank check company that took digital health equipment venture Butterfly Network Inc. public, finding that some of the shares the plaintiffs purchased are not traceable to the registration statement at issue in the suit.
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February 14, 2025
Fed. Circ. Risks Relying On 'Science Fiction,' Justices Told
The Federal Circuit's presumption that prior art is always enabled can lead it to "sacrifice true innovations based on earlier science fiction," the owner of invalidated food wrapping patents told the U.S. Supreme Court on Thursday.
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February 14, 2025
Trump Admin To Cut Thousands Of Federal Health Employees
The Trump administration has started to cut thousands of federal healthcare employees, following through on its promises to shrink government and enact mass changes to agencies that oversee the health of millions of Americans.
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February 14, 2025
New Delisting Rules Shorten Leash For Distressed Companies
Distressed companies should take heed of new stock exchange rules that are likely to accelerate delistings for stocks that trade below minimum requirements, particularly targeting businesses that rely on reverse stock splits to inflate their share prices, attorneys say.
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February 14, 2025
CVS Wins Arbitration In Medicare Fee Antitrust Suit
An Arizona federal judge ordered four independent pharmacies to arbitrate their claims accusing CVS of exploiting a Medicare loophole to charge them exorbitant fees, saying several unconscionable provisions in an underlying arbitration clause could be severed.
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February 14, 2025
Fed. Circ. Rejects COVID Test Suit In Gilstrap-Authored Ruling
A California federal judge properly found that Spectrum Solutions LLC didn't infringe a COVID-19 test maker's patent directed to preserving biological samples, the Federal Circuit said Friday in an opinion written by a top patent judge visiting the court.
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February 14, 2025
Some Discovery On Hold In Abbott Infant Formula Case
An Illinois federal judge granted in part a request by Abbott Laboratories to pause a shareholder derivative suit over how it managed the 2022 infant formula crisis, allowing written discovery to go on while staying depositions until May.
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February 14, 2025
Fed. Circ. Ruling Shows Even Small Cos. Can Win At ITC
A small biotech company's recent patent win, where the Federal Circuit held that even its limited domestic investments qualified it to sue at the U.S. International Trade Commission, makes clear that the ITC's powerful import bans aren't just available to major businesses, attorneys say.
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February 14, 2025
8 Things Attys Should Know About Conn.'s $55B Budget
Connecticut Gov. Ned Lamont's two-year budget for the years 2026 and 2027 includes drug price limits, an expansion of the state's unfair trade practices act, key changes to hospital ownership laws and slots for 13 new judges.
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February 14, 2025
Judge Upholds Pay-For-Delay Ban Law, But Only In Calif.
A California federal judge has upheld part of a new state law that the Association for Accessible Medicines alleged unlawfully restricted "reverse payment" settlements between makers of brand-name and generic drugs, finding that the law's attempt to regulate deals outside of California runs afoul of the Constitution, but is otherwise valid.
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February 14, 2025
Camston Wrather Files For Ch. 7 With Over $100M In Debt
California-based sustainable resource recovery company Camston Wrather LLC has filed for Chapter 7 bankruptcy listing liabilities between $100 million and $500 million along with up to $50 million in assets, citing insufficient funding to continue operations.
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February 14, 2025
Tariffs On Drugs And Chips May Not Bring Makers Stateside
The White House's planned tariffs on semiconductors, computer chips and pharmaceuticals are likely to raise prices for consumers and businesses, but won't necessarily lead to the president's stated goal of growing domestic manufacturing, attorneys and others told Law360.
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February 14, 2025
2nd Judge Blocks Trump Trans Health Order, Chides DOJ Atty
A Washington federal judge put a second temporary block on President Donald Trump's executive order targeting funding for gender-affirming care for people younger than 19, at a Seattle hearing where the judge said she was extremely frustrated with a federal government attorney's inability to answer questions about the order's discriminatory impact on transgender youth.
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February 13, 2025
Mallinckrodt Fails To Halt Airgas' Generic Nitric Oxide Drug
A Delaware federal judge has rejected Mallinckrodt Pharmaceuticals' attempt to block French industrial gas company Airgas Healthcare from selling a generic version of its inhaled nitric oxide treatment, saying Mallinckrodt didn't show enough evidence that Airgas infringed its patents or that it would suffer irreparable harm.
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February 13, 2025
DC Judge Affirms Approval Of Teva's Generic Sleep Drug
A D.C. federal judge upheld the U.S. Food and Drug Administration's approval of Teva's generic version of Vanda's sleep-walking treatment tasimelteon, ruling Thursday that omitting Braille on the labeling is permissible as it would be "aberrant" to allow safe variations in a drug's substance but not for labeling.
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February 13, 2025
Long-Term Zantac Use Raised Cancer Risks, Jury Hears
Chronic ranitidine ingestion was a factor in the development of prostate cancer in two men who are retrying their claims over the active ingredient in Boehringer Ingelheim's over-the-counter Zantac medication, the University of South Carolina's chief urologist testified in Illinois on Thursday.
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February 13, 2025
Maryland Judge Blocks Trump's Orders On Trans Healthcare
A Maryland federal judge on Thursday temporarily blocked the Trump administration from restricting gender-affirming care for people under the age of 19 and required the administration to keep in place federal funding for healthcare providers that provide transgender care.
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February 13, 2025
Merck Investor Sues Over Gardasil China Market Projections
Pharmaceutical giant Merck & Co. Inc. has been hit with a proposed shareholder class action alleging it overstated global demand for its human papillomavirus vaccine Gardasil, damaging investors when it revealed earlier this month it would not meet its revenue projections for the vaccine and paused shipments to China.
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February 13, 2025
9th Circ. Upholds DEA Denial Of Psilocybin Petition
The Ninth Circuit on Thursday affirmed the U.S. Drug Enforcement Administration's rejection of a Seattle physician's request to treat terminally ill patients with psilocybin.
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February 13, 2025
Musk's $97B OpenAI Bid Dubbed A 'Stunt' Amid Other Rumors
After a Wall Street Journal report on Monday revealed that a consortium of investors led by Elon Musk was offering $97.4 billion to buy the nonprofit that controls OpenAI, rumors began to swirl regarding the true intentions behind the billionaire's bid.
Expert Analysis
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Think Like A Lawyer: 1 Type Of Case Complexity Stands Out
In contrast to some cases that appear complex due to voluminous evidence or esoteric subject matter, a different kind of complexity involves tangled legal and factual questions, each with a range of possible outcomes, which require a “sliding scale” approach instead of syllogistic reasoning, says Luke Andrews at Poole Huffman.
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What Bisphenol S Prop 65 Listing Will Mean For Industry
The imminent addition of bisphenol S — a chemical used in millions of products — to California's Proposition 65 list will have sweeping compliance and litigation implications for companies in the retail, food and beverage, paper, manufacturing and personal care product industries, say attorneys at Alston & Bird.
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Fed. Circ. Ruling Shows Importance Of Trial Expert Specificity
The Federal Circuit’s recent ruling in NexStep v. Comcast highlights how even a persuasive expert’s failure to fully explain the basis of their opinion at trial can turn a winning patent infringement argument into a losing one, say attorneys at Barnes & Thornburg.
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Think Like A Lawyer: Note 3 Simple Types Of Legal Complexity
Cases can appear complex for several reasons — due to the number of issues, the volume of factual and evidentiary sources, and the sophistication of those sources — but the same basic technique can help lawyers tame their arguments into a simple and persuasive message, says Luke Andrews at Poole Huffman.
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Justices Mull Sex-Based Classification In Trans Law Case
After the U.S. Supreme Court heard oral argument in U.S. v. Skrmetti this week, it appears that the fate of the Tennessee law at the center of the case — a law banning gender-affirming healthcare for transgender adolescents — will hinge on whether the majority read the statute as imposing a sex-based classification, says Alexandra Crandall at Dickinson Wright.
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Series
Gardening Makes Me A Better Lawyer
Beyond its practical and therapeutic benefits, gardening has bolstered important attributes that also apply to my litigation practice, including persistence, patience, grit and authenticity, says Christopher Viceconte at Gibbons.
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Litigation Inspiration: Reframing Document Review
For attorneys — new ones especially — there is much fulfillment to find in document review by reflecting on how important, interesting and pleasant it can be, says Bennett Rawicki at Hilgers Graben.
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Key Takeaways From FDA's Latest Social Media Warnings
The U.S. Food and Drug Administration's latest untitled letter concerning a drug company's social media promotion provides lessons for how companies should navigate risk presentation, FDA labeling requirements and superiority claims, say attorneys at Sheppard Mullin.
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Expect More State Scrutiny Of PE In Healthcare M&A
While a California bill that called for increased antitrust scrutiny of many healthcare private equity transactions was recently vetoed by the governor, state legislatures are likely to continue introducing similar laws, particularly if the Trump administration eases federal enforcement, say attorneys at Morgan Lewis.
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Declaring Unexpected Results: Pitfalls For Rule 132 At PTAB
Rule 132 declarations are frequently used in life sciences patent prosecution for rebutting obviousness rejections by establishing that an applicant's invention produces unexpected results, and the Patent Trial and Appeal Board's Eidschun ruling highlights when this important tool may be ineffective, say attorneys at Morrison Foerster.
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IP Ruling Likely To Limit Arguments Against Qualified Experts
The Federal Circuit's recent decision in Osseo v. Planmeca, clarifying when experts may offer testimony from the perspective of a skilled artisan, provides helpful guidance on expert qualifications and could quash future timing arguments regarding declarants' expertise, says Whitney Jenkins at Marshall Gerstein.
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How Boards And Officers Should Prep For New Trump Admin
In anticipation of President-elect Donald Trump's proposed tariffs and mass deportation campaign, company officers and board members should pursue proactive, comprehensive contingency planning to not only advance the best interests of the companies they serve, but to also properly exercise their fiduciary duty of care, say attorneys at Winston & Strawn.
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Dissecting The Obviousness-Type Double Patenting Debate
The Federal Circuit's recent decision in Allergan v. MSN highlights the ongoing evolution of the obviousness-type double patenting doctrine, revealing increasing tension between expiration-based interpretations and procedural flexibility, says Jeremy Lowe at Leydig Voit.
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Service Providers Must Mitigate 'Secondary Target' Risks
A lawsuit recently filed in an Illinois federal court against marketing agency Publicis over its work for opioid manufacturers highlights an uptick in litigation against professional service providers hired by clients that engaged in alleged misconduct — so potential targets of such suits should be sure to conduct proper risk analysis and mitigation, say attorneys at Dechert.
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Health Policy Predictions For Trump's Second Administration
As President-elect Donald Trump's nominations for health policy and enforcement heads work their way through the confirmation process, healthcare organizations can look at nominee backgrounds, campaign statements and actions from Trump's previous presidency to predict incoming priorities, say attorneys at McDermott.