Invalidity Of Broad Claims For Lack Of Enablement In The Absence Of Sufficient Disclosure Of The Structure/Function Correlation And Unpredictability In The Art

Author:Ms Marina I. Miller
Profession:Oblon, McClelland, Maier & Neustadt, L.L.P

Enzo Life Sciences, Inc. ("Enzo") appealed the decision of the U.S. District Court for the District of Delaware granting summary judgment against Enzo and holding that the asserted claims were invalid for lack of enablement. The Federal Circuit affirmed.

In 1981, Dr. David Ward and others at Yale University successfully developed a nonradioactive probe by attaching a label to a polynucleotide via a chemical linker at a base position of a nucleotide. Dr. Ward demonstrated that attaching labels at certain positions of the nucleotide ("the Ward positions") would not disrupt the polynucleotide's ability to hybridize and be detected upon hybridization. In December 1981, Enzo licensed the exclusive rights to the patent portfolio covering Dr. Ward's discovery. In June 1982, Enzo filed a patent application covering non-radioactive labeling at additional positions on a nucleotide. The two patents in the appeal generally relate to the use of non-radioactively labeled polynucleotides in nucleic acid hybridization and detection applications. The patents share the same specification in relevant parts.

U.S. Patent No. 6,992,180 ("the '180 patent") relates to non-radioactive labeling of polynucleotides where the label is attached at the phosphate position of a nucleotide. The claims are not directed to any specific polynucleotide, nor do they focus on the chemistry or linker used to attach a label, the number of labels to attach to a polynucleotide, or where within the polynucleotide to attach those labels. Instead, the claims encompass all polynucleotides with labels attached to a phosphate, as long as the polynucleotide remains hybridizable and detectable upon hybridization. The claims of U.S. Patent No. 8,097,405 ("the '405 patent") are in situ hybridization claims and liquid phase hybridization claims. In January 2012, Enzo filed suit against Roche Molecular Systems, Inc., Roche Diagnostics Corp., Roche Diagnostics Operations, Inc., and Roche Nimblegen, Inc. ("Roche") alleging infringement of the '180 patent. In March 2012, Enzo filed separate suits against Becton, Dickinson and Co., Becton Dickinson Diagnostics Inc., and GeneOhm Sciences, Inc. ("BD"); and Abbott Laboratories and Abbott Molecular, Inc. ("Abbott") alleging infringement of the '180 patent.

The Court of Appeals for the Federal Circuit ("the Court") identified the issue in the appeal as being "not simply whether the specification enables labeling; the question is whether it enables...

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