
""Even if that claim term required clinical efficacy, such a requirement would in no way alter the claimed method of administering rivaroxaban and aspirin in the amounts and frequencies recited, the CAFC held." Today, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision in Bayer Pharma Aktiengesellschaft v. Mylan Pharmaceuticals Inc. affirming-in-part a final written decision by the Patent Trial and Appeal Board (PTAB) invalidating Bayer's patent claims for methods of reducing the risk of cardiovascular events in patients."
"The Federal Circuit nixed Bayer's arguments that the claim term "clinically proven effective" requires proof of clinical efficacy, although the appellate court did agree that the PTAB erred in construing a different claim term, vacating and remanding the Board's decision with respect to some of Bayer's claims. Patentees Cannot Add Unrelated Limitations to Indefinitely Patent Known Methods The present appeal stems from inter partes review (IPR) proceedings petitioned by Mylan and other respondents to challenge claims of Bayer's U.S. Patent No. 10828310,"
The Federal Circuit affirmed-in-part the PTAB's invalidation of Bayer's U.S. Patent No. 10828310 for methods to reduce cardiovascular risk by administering rivaroxaban and aspirin. The court held that the phrase "clinically proven effective" does not impose an independent clinical-efficacy requirement that would change the claimed dosing methods. The appellate court determined the PTAB erred in construing another claim term and vacated and remanded the Board's decision as to some claims. The PTAB had invalidated all claims, including independent claims reciting specific administration regimens. Mylan's obviousness challenges relied on journal articles describing trials without disclosing results.
Read at IPWatchdog.com | Patents & Intellectual Property Law
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