The U.S. Court of Appeals for the Federal Circuit (CAFC) yesterday affirmed a district court’s ruling that Novartis’ U.S. Patent No. 9,187,405 is not invalid and that HEC Pharm Co., Ltd. and HEC Pharm USA Inc.’s Abbreviated New Drug Application (ANDA) infringed the patent. The CAFC found no clear error in the district court’s finding that the patent’s claims did not fail the written description requirement under 35 U.S.C. § 112(a). Chief Judge Moore dissented, arguing that the district court’s analysis was inconsistent with the CAFC’s established precedent. The ‘405 patent covers methods of treating relapsing remitting multiple sclerosis (RRMS) with fingolimod (an immunomodulating medication) or a fingolimod salt “at a daily dosage of 0.5 mg without an immediately preceding loading dose.”
Litigation
- What I’ll Be Watching for in the Amgen Oral Arguments
- A Dog’s Day in Court: Implications of the ‘Bad Spaniels’ Arguments on Parody Determinations and Noncommercial Use
- SCOTUS Skeptical that Bad Spaniels is Parody, But Questions Need to Overturn Rogers
- Justices Seek Abitron Parties’ Help in Articulating Bounds of Extraterritorial Application of Lanham Act
- U.S. Taxpayers Should Not Be Paying for Private Patent Infringement
Recent Posts
- What I’ll Be Watching for in the Amgen Oral Arguments
- A Dog’s Day in Court: Implications of the ‘Bad Spaniels’ Arguments on Parody Determinations and Noncommercial Use
- Other Barks & Bites for Friday, March 24: Non-DOCX Fee Delayed Further; SCOTUS Petition Says Hirshfeld’s Review of PTAB Decision Violated Federal Vacancies Reform Act; Moderna CEO Grilled by Senate Committee over COVID Vaccine Price Hike
- Bayh-Dole Opponents Slam-Dunked Once Again
- SCOTUS Skeptical that Bad Spaniels is Parody, But Questions Need to Overturn Rogers