BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
    • Index insights
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Coronavirus
    • More reports can be found here

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Monday, July 14, 2025
Home » Topics » Regulatory » Courts

Courts
Courts RSS Feed RSS

Fed Circuit resuscitates skinny label infringement challenge

June 26, 2024
By Mari Serebrov
In reviving another case involving drug label carveouts, the U.S. Court of Appeals for the Federal Circuit insisted that its June 25 decision in Amarin Pharma Inc. v. Hikma Pharmaceuticals plc will not kill so-called skinny labels that allow generics to come to market when some of the brand’s indications still have patent protection.
Read More
Cyber security padlock

Insulet, Eoflow trade secret scrum may end on statute of limitations

June 25, 2024
By Mark McCarty
The trade secret dispute between Acton, Mass.-based Insulet Corp. and Eoflow Co. Ltd., of Seongnam, South Korea, addresses several key questions in the area of intellectual property law, including the circumstances in which injunctive relief is and is not appropriate.
Read More
Mifeprex

Supremes shoot down abortion pill challenge, raise new concern

June 13, 2024
By Mari Serebrov
The U.S. Supreme Court unanimously upheld the FDA’s relaxed regulation of the abortion drug mifepristone when it ruled June 13 that the organizations challenging those changes lacked the standing to do so.
Read More
FDA Orange Book

US court adopts FTC stance in Orange Book listing challenge

June 12, 2024
By Mari Serebrov
The U.S. FTC’s campaign against the Orange Book listing of patents claiming device components gained momentum when a federal judge in New Jersey ordered Teva Pharmaceuticals USA Inc. to delist five device patents pertaining to its Proair HFA (albuterol sulfate) inhaler.
Read More

US argues for drug, device companies in terrorism case

May 24, 2024
By Mari Serebrov
Weighing in on the side of 21 drug and device companies accused of knowingly aiding and abetting terrorist attacks against U.S. troops and civilians in Iraq from 2005 to 2011, the U.S. solicitor general is asking the Supreme Court to grant the companies’ petition for cert and then vacate a 2022 appellate court decision in Joshua Atchley v. Astrazeneca plc, remanding it for reconsideration in light of a related opinion the justices handed down a year ago.
Read More

Interchangeable exclusivity not limited to first-to-file

May 22, 2024
By Mari Serebrov
In lieu of pending guidance, the U.S. FDA’s approval May 20 of Biocon Biologics Ltd.’s Yesafili and Samsung Bioepis Co. Ltd.’s Opuviz as interchangeable biosimilars to Regeneron Pharmaceuticals Inc.’s Eylea (aflibercept) provides further insight into how the agency is approaching the market exclusivity the Biologics Price Competition and Innovation Act awards to the first approved interchangeable for any given biologic.
Read More

Appeals court: HHS overstepped its 340B role

May 21, 2024
By Mari Serebrov
The Department of Health and Human Services (HHS) has no rulemaking authority over the 340B prescription drug discount program, the U.S. Court of Appeals for the District of Columbia Circuit said May 21 as it handed the government its second big loss in the ongoing debate over whether drug manufacturers have to give unlimited contract pharmacies the steep discounts the program provides to certain health care providers.
Read More

Citing Supreme Court, Second Circuit rules against FTC position

May 14, 2024
By Mari Serebrov
Buyers challenging patent settlements involving Forest Laboratories LLC’s blood pressure drug, Bystolic (nebivolol), failed to show the deals were illegal pay-for-delay arrangements, the U.S. Court of Appeals for the Second Circuit said in unanimously affirming a lower court’s two-time dismissal of the buyers’ antitrust suit.
Read More

Debate over Orange Book device listings heard on multiple fronts

May 1, 2024
By Mari Serebrov
Just a few days after the U.S. Congressional Research Service issued a report suggesting ways Congress could resolve the unanswered questions about patent listings in the FDA’s Orange Book, the FTC sent a second round of warning letters to eight biopharma companies and their subsidiaries, citing the listing of device patents for combination products.
Read More
Dollar signs in blister packs

Two more challenges to US Rx price negotiations dismissed

April 30, 2024
By Mari Serebrov
The U.S. government chalked up another win April 29 against the constitutional challenges to the Inflation Reduction Act’s provision mandating direct Medicare price negotiations for selected prescription drugs.
Read More
Previous 1 2 3 4 5 6 7 8 9 10 11 … 15 16 Next

Popular Stories

  • Today's news in brief

    BioWorld
    BioWorld briefs for July 11, 2025.
  • Today's news in brief

    BioWorld MedTech
    BioWorld MedTech briefs for July 11, 2025.
  • News in brief

    BioWorld Asia
    BioWorld Asia briefs for July 8, 2025
  • 3D rendering of a molecular glue mediating the interaction between two proteins

    With surface mimicry, molecular glues shed hairpin need

    BioWorld Science
    Degradation is a therapeutic strategy that could offer possibilities to get at currently undruggable target proteins. In targeted degradation, compounds induce...
  • Incurix describes new c-Myc inhibitors

    BioWorld Science
    Incurix Co. Ltd. has identified Myc proto-oncogene protein (c-Myc) inhibitors reported to be useful for the treatment of cancer.
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Index insights
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing