Life Sciences

April 29, 2025
Full Fed. Circ. Urged To Undo 'Onerous' Jepson Claim Ruling

Xencor has urged the full Federal Circuit to review a decision rejecting its application for an antibody patent that used the so-called Jepson claim format, saying the case set an "onerous requirement" that is nearly impossible to meet and "eliminates any incentive" to use the format.
April 29, 2025
Fed. Circ. Backs TM Denial Of Dark Green Gloves As Generic

The Federal Circuit on Tuesday adopted a test for determining if trademarks are generic when considering claims on distinctive colors, affirming a trademark board precedent used to reject an Indonesian medical supply company's efforts to claim a trademark for dark green surgical gloves.
April 29, 2025
GenBioPro Can Defend FDA Approval In Mifepristone Suit

A Texas federal judge has allowed drugmaker GenBioPro to join a legal fight over access to the abortion drug mifepristone, finding that the company has a distinct interest in defending federal approval of the generic version of the medication.
April 29, 2025
Mexico Put On Latest USTR Priority IP Watch List

The Office of the U.S. Trade Representative on Tuesday issued its annual global intellectual property report that has placed close trading partner Mexico on its list of countries to keep the closest eye on.
April 29, 2025
Cooley Life Sciences Ace Rejoins Latham In Bay Area

Latham & Watkins LLP has welcomed back an intellectual property attorney who spent the past nine years at Cooley LLP to bolster its healthcare and life sciences practice, including advising clients about licensing and transactional matters.
April 29, 2025
Opioid MDL Judge Won't Recuse Over Ex Parte Allegations

An Ohio federal judge will not step aside from multidistrict opioid litigation after the plaintiffs' attorney, who had alleged the judge "regularly communicates" with other lawyers involved in the litigation, testified that there was no such communication after all, the judge ruled Tuesday.
April 29, 2025
High Court Backs HHS In Hospital Pay Formula Dispute

The U.S. Supreme Court on Tuesday sided with federal health officials in a challenge over a formula used to calculate billions of dollars in annual payments to hospitals treating indigent patients, saying that those entitled to Supplemental Security Income should be collecting cash payments before they're counted in the formula.
April 28, 2025
Chinese Cos. Lose Immunity Fight In 9th Circ. IP Case

The Ninth Circuit on Monday shot down arguments from related Chinese steel companies that they shouldn't have to face espionage charges that they stole DuPont trade secrets for creating titanium dioxide, saying they aren't protected by foreign sovereign immunity.
April 28, 2025
Veolia Settles Flint Water Crisis Claims For $53M

A Michigan federal judge entered final judgment Monday in litigation brought by the state of Michigan and about 26,000 individuals against Veolia North America alleging it prolonged the water crisis in Flint, Michigan, after a $53 million settlement was approved earlier this month.
April 28, 2025
Gov't Reverses Position On Surgery For Trans Prisoners

The Trump administration is rejecting the federal government's previous stance that prison officials are constitutionally required to provide gender confirmation surgery to incarcerated people with gender dysphoria who request the treatment, noting the shift in recent statements to a Georgia federal court.
April 28, 2025
Ziploc 'Microwave Safe' Bags Shed Microplastics, Buyer Says

S.C. Johnson & Son Inc. falsely markets Ziploc bags and containers as "microwave safe" and suitable for use in freezers despite knowing they are made from materials that shed microplastics into food when the products are used as directed, according to a proposed class action filed in California federal court.
April 28, 2025
Walgreens Opposes Merging 'Non-Drowsy' Labeling Suits

Walgreens is pushing back on a bid to consolidate two Illinois federal lawsuits alleging the "non-drowsy" label on some of the retailer's cough suppressant medications is misleading, saying the two cases involve different allegations and are at different stages, and arguing that consolidation would cause a delay in the litigation.
April 28, 2025
Sanofi Challenges Jurisdiction In Conn. Zantac Lawsuits

Sanofi-Aventis U.S. LLC on Monday sought to exit nine combined Connecticut lawsuits claiming the heartburn drug ranitidine degraded into a compound that causes cancer, saying it is beyond the state's long-arm statute and that due process guarantees prevent it from being sued in Connecticut.
April 28, 2025
Ala. Medical Pot Commission Sued Over Patient Registry

A group of Alabama medical cannabis patients sued the state's Medical Cannabis Commission over the lack of a patient registry despite what they said were numerous laws obligating it to create one.
April 28, 2025
Sullivan & Cromwell-Led Merck To Buy SpringWorks For $3.9B

Merck KGaA said Monday it has agreed to acquire U.S. biotech company SpringWorks Therapeutics for $3.9 billion, as the German science and technology group aims to grow its cancer drug business and its global presence.
April 25, 2025
HHS Says Cuts Target Excess After Judge Seeks More Info

The U.S. Department of Health and Human Services told a Rhode Island federal judge that a group of states has no basis to challenge the cancellation of billions in grants supporting public health programs because they already received the funds appropriated to them by Congress.
April 25, 2025
SPAC Deals Are Buzzing Again Despite Tariff Turmoil

Amid heavy volatility that has largely frozen traditional initial public offerings, deal teams are launching more special purpose acquisition companies, an alternative market to typical IPOs that so far has shown few ill effects from tariff-related uncertainty.
April 25, 2025
Local Gov'ts, Union Sue Over COVID Grant Cancellations

Four local governments have joined with a government employees union to challenge the federal government's termination of $11 billion in grants stemming from the COVID-19 pandemic, seeking an injunction restoring the funds and a declaration that the decision to mass-terminate the grants was unlawful.
April 25, 2025
Judge Says FDA Can Take Ozempic Off Shortage List

A Texas federal judge has sided with arguments from Ozempic maker Novo Nordisk A/S not to block the U.S. Food and Drug Administration from moving forward with an administrative decision stopping "unsafe, knockoff versions" of the blockbuster diabetes and weight loss drug from flooding the market.
April 25, 2025
J&J Unit Sees Claims Trimmed In Engineer's Bias Suit

A Johnson & Johnson-owned prosthetics company does not have to face claims that an engineer filed his lawsuit, alleging violations of the Family and Medical Leave Act, too late, a Massachusetts federal judge ruled Friday, but determined some of the allegations are timely and can proceed.
April 25, 2025
Aggressive USPTO Policy Push Suggests 'It's Lutnick's Show'

U.S. Patent and Trademark Office acting Director Coke Morgan Stewart's three months in charge have featured an unprecedented level of policymaking for an interim leader, suggesting that Secretary of Commerce Howard Lutnick has a vision for the agency and he's not waiting for the U.S. Senate to confirm a new director to pursue it.
April 25, 2025
Ozempic Maker Settles Infringement Claims With Atlanta Clinic

Novo Nordisk, the pharmaceutical manufacturer behind Ozempic and other weight loss drugs, said Friday it has reached a settlement to end a series of claims that a Georgia anti-aging clinic was using the company's name and reputation to sell off-brand versions of its treatments.
April 25, 2025
Insulet's $452M Trade Secrets Award Reduced To $59.4M

A $452 million trade secrets jury award for Insulet Corp. has been cut to $59.4 million by a Massachusetts federal judge who said the reduction is necessary to avoid double recovery and to comply with the law, following a trend where courts have reduced large jury awards in trade secret cases.
April 25, 2025
11th Circ. Backs FDA In Denial Of Bidi's Vape Application

The Eleventh Circuit has affirmed the denial of a marketing application for a tobacco-flavored electronic cigarette made by Bidi Vapor LLC, finding that the U.S. Food and Drug Administration did not act arbitrarily or capriciously in finding that the company failed to show the product would promote public health.
April 24, 2025
Circuit-By-Circuit Guide As Justices Confront Class Cert. Split

The U.S. Supreme Court is set for climactic arguments over class certification standards that have cleaved circuits from coast to coast for much of the past two decades, teeing up a make-or-break ruling for many class actions and a transformative event for legal practice in the swelling litigation realm.

Editor's Picks

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.
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.
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

Legal Ethics Considerations For Law Firm Pro Bono Deals

If a law firm enters into a pro bono deal with the Trump administration in exchange for avoiding or removing an executive order, it has an ethical obligation to create a written settlement agreement with specific terms, which would mitigate some potential conflict of interest problems, says Andrew Altschul at Buchanan Angeli.
Reproductive Health Under Trump So Far, And What's Next

Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.
Series

Playing Football Made Me A Better Lawyer

While my football career ended over 15 years ago, the lessons the sport taught me about grit, accountability and resilience have stayed with me and will continue to help me succeed as an attorney, says Bert McBride at Trenam.
10 Arbitrations And A 5th Circ. Ruling Flag Arb. Clause Risks

The ongoing arbitral saga of Sullivan v. Feldman, which has engendered proceedings before 10 different arbitrators in Texas and Louisiana along with last month's Fifth Circuit opinion, showcases both the risks and limitations of arbitration clauses in retainer agreements for resolving attorney-client disputes, says Christopher Blazejewski at Sherin and Lodgen.
Keys To Handling Digital Investigations In Pharma IP Litigation

In the high-stakes realm of pharmaceutical intellectual property litigation, efficient e-discovery and digital investigation workflows are essential to supporting strategic arguments, building defensible cases and proving that the requirements for market entry have been adequately met, says Jerry Lay at FTI Consulting.
Perspectives

The Benefits Of Aligning States On Legal Paraprofessionals

Texas' proposal to become the latest state to license paraprofessional providers of limited legal services could help firms expand their reach and improve access to justice, but consumers, attorneys and allied legal professionals would benefit even more if similar programs across the country become more uniform, says Michael Houlberg at the University of Denver.
What's Next For Lab Test Regulation Without FDA Authority

A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.
10 Soft Skills Every GC Should Master

As businesses face shifting regulatory and technological uncertainty, general counsel will need to strengthen certain soft skills to succeed, from admitting when they make a mistake to maintaining a healthy dose of dispassion, says Douglas Brown at Manatt.
6 Criteria Can Help Assess Executive Branch Actions

With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.
An Unrestrained, Bright-Eyed View Of Legal AI's Future

Todd Itami at Covington offers a bright-eyed, laughing-all-the-way, skydive look at what the legal industry could look like after an artificial intelligence revolution, which he believes may happen much sooner and more dramatically than we expect.
Tracking The Evolution In Litigation Finance

Despite continued innovation, litigation finance remains an immature market with borrowers recieving significantly different terms as lenders learn to value cases, which firms need a strong handle on to ensure lending terms do not overwhelm collateral value, says Robert Wilkins at Lightfoot Franklin.
Keys To Regulatory Diligence In Life Sciences Transactions

Conducting effective regulatory due diligence for life sciences deals requires careful review of a target company's activities, and separate sets of considerations for commercial and pipeline products, says Anna Zhao at GunnerCooke.
How Courts Weigh Section 1782 Discovery For UPC Cases

A look at cases from six different federal district courts reveals a number of discretionary factors that influence how courts consider Section 1782 discovery applications in connection with Unified Patent Court proceedings, say attorneys at Finnegan.
Opinion

In Vape Case, Justices Must Focus On Agencies' Results

With the U.S. Supreme Court's ruling in U.S. Food and Drug Administration v. Wages and White Lion Investments having put off the question of whether agency decisions arrived at erroneously are always invalid, the court should give the results of agency actions more weight than the reasoning behind them when it revisits this case, says Jonathan Sheffield at Loyola University Chicago School of Law.
Series

Volunteer Firefighting Makes Me A Better Lawyer

While practicing corporate law and firefighting may appear incongruous, the latter benefits my legal career by reminding me of the importance of humility, perspective and education, says Nicholas Passaro at Ford.