ENZO LIFE SCIENCES, INC. v. ROCHE MOLECULAR SYSTEMS, INC.

Before Prost, Reyna, and Wallach. Appeal from the United States District Court for the District of Delaware.

Summary: Broad patent claims were invalid as not enabled because the relevant art was unpredictable and practicing the full scope of the claims would require undue experimentation.

Enzo filed suits alleging infringement of the ’180 Patent by Roche, Becton Dickinson, and Abbott, and infringement of the ’405 Patent by Abbott alone. Both patents relate to the use of non-radioactively labeled polynucleotides in nucleic acid hybridization and detection applications. The district court granted summary judgment holding that the asserted claims of the ’180 Patent and ’405 Patent were not enabled. Enzo appealed.

The Federal Circuit analyzed whether the ‘180 Patent specification enabled the creation of a labeled probe that is both hybridizable and detectable upon hybridization, as the asserted claims required. The court noted that the scope of the claims was “quite broad” and “encompasses all phosphate-labeled polynucleotides that are hybridizable and detectable,” placing “almost no limitations on the structure of the claimed polynucleotide,” and providing only “broad categories” of labels to be used. The court noted that the specification’s guidance as to how such variables would affect the functionality of the claimed probes was sparse, and that at the time of the invention, the art was highly unpredictable. Although Enzo argued that the ’180 Patent disclosed a working example, the court found the example to be a “paper” example which was never actually tested. Further, the court explained that even if the paper example worked, each labeled “polynucleotide would need to be tested,” so “undue experimentation would still be required with regard to the many other embodiments of the claims based on the number of possible embodiments and the unpredictability in the art.” As to the ’405 Patent, the court stated that since the claims were broader than those of the ’180 Patent, they were invalid as not enabled for the same reasons. Thus, the Federal Circuit affirmed.

Editor: Paul Stewart

Written by: Alexander D. Zeng & Jeremy Anapol