Category Archives: Enablement

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Takeda Prevacid SoluTab Patent Valid, But Not Infringed

In Takeda Pharmaceutical Company Ltd. v. Zydus Pharmaceuticals USA, Inc., the Federal Circuit reversed the district court’s finding that Zydus’s proposed generic product infringed Takeda’s Prevacid® SoluTab™ patent, but agreed with the district court that Zydus had failed to prove that the patent is invalid. However, the Federal Circuit also explained that it would have … Continue reading this entry

Federal Circuit Upholds Lyrica Patents

In a non-precedential decision issued February 6, 2014, the Federal Circuit affirmed a district court decision that upheld the four Orange Book listed patents for Pfizer’s Lyrica® product. According to the court’s rules, the non-precedential designation of Pfizer Inc. v. Teva Pharmaceuticals USA, Inc. means that the panel determined that it did not add significantly to … Continue reading this entry

Federal Circuit Finds Wyeth Restenosis Claims Invalid As Not Enabled

In Wyeth v. Abbott Laboratories, the Federal Circuit affirmed the district court’s decision that the claims at issue are invalid for failing to satisfy the enablement requirement of 35 USC § 112. The court took only 10 pages to explain why a specification that describes one specific compound did not enable claims encompassing tens of … Continue reading this entry

Federal Circuit Upholds Fentora Patents, But Affirms Non-Infringement

In Cephalon, Inc. v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court’s finding that two Orange Book-listed patents for Cephalon’s FENTORA® product were invalid, but affirmed the district court’s finding that Watson’s ANDA product would not infringe the patents. The Federal Circuit decision reviews the “undue experimentation” standard for lack of enablement, and … Continue reading this entry