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.”
Recent Posts
- Independent Inventor Seeks New Trial for LG’s Alleged Violations of Sotera Stipulation
- Realtek Denied Mandamus Relief at CAFC in ITC Battle with AMD
- IPWatchdog LIVE 2023 Recap: Video of Judge Newman’s Powerful Remarks and What Sets the LIVE Meeting Apart
- New USPTO Paneling Guidance for TTAB and PTAB Requires Disclosure of Financial Interests Regardless of Dollar Value
- Implementer Arguments at the USPTO Public Listening Session on Standards Ignore Business Realities