Posts

API and IP Newsletter

Image
Contents 505 (b) (2) approvals in January 2025 General information Delhi High Court bars use of NOVITAS after pharma giant Novartis alleges trademark violation Microsoft sued by software company Veeva over 'Viva' branding Intellectual Proper ty Astellas Vs Synthon   505 (b) (2) approvals in January 2025   We follow 505 (b) (2) approvals every month. This month, there are two approvals.   General information   Delhi High Court bars use of NOVITAS after pharma giant Novartis alleges trademark violation The Delhi High Court on February 3 passed an interim injunction restraining a pharmaceutical company from using the trademark "NOVITAS" in response to a trademark infringement suit filed by global pharmaceutical giant, Novartis   News here   Microsoft sued by software company Veeva over 'Viva' branding Pharmaceutical software company Veeva Systems  has sued Microsoft  in California federal court, alleging Microsoft's Viva business software infringes ...

API and IP Newsletter

Image
  Contents DMF filings in November 2024 General information Merck Issues Statement on GARDASIL® Litigation Indian pharma faces decline in R&D productivity, patent expiries, turns to AI to mitigate challenges Intellectual Property Taiho Pharmaceutical Vs MSN DMF filings in November 2024   The FDA publishes a list of DMF filings every quarter. The four th quarter (CY 24) list was recently published. This month, we are analysing November 2024 DMF filings. Of the 70 DMFs filed that month, 36 were submitted by Chinese companies and 29 by Indian companies.   The top DMF filing companies are listed below: Some of our other DMF-specific comments are as below. General information   Merck Issues Statement on GARDASIL® Litigation Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today reaffirmed its commitment to defending the safety and efficacy of its HPV vaccines. Merck is a defendant in product liability lawsuits in the United States involving GA...

API and IP Newsletter

Image
  Contents DMF filings in October 2024 General information Patent Litigation Impacts on US Biosimilar Market Entry West Virginia AG Reaches $17M Settlement With Pfizer and Ranbaxy Over Antitrust and Consumer Protection Violation Claims Intellectual Property Bausch and Lomb Vs Sandoz AG     DMF filings in October 2024   FDA publishes a list of DMF filings every quarter. The 4 th quarter (CY 24) list was published recently. This month, we are analysing October 2024 DMF filings. Of the 78 DMFs filed that month, 35 were submitted by Chinese companies and 28 by Indian companies.   The top DMF filing companies are listed below: Some of our other DMF-specific comments are as below. General information   Patent Litigation Impacts on US Biosimilar Market Entry 1. Patent litigation reform could accelerate US biosimilar market entry, which lags behind the EU due to protracted legal processes. 2. Biosimilar manufacturers face options like pre-clearance, "at-risk...