Enablement is the requirement that a patent teach a person skilled in the art (the field of the invention) how to make and use the invention without undue experimentation. In other words, a patent must describe the invention clearly enough so that a skilled person in the field can replicate the invention without having to perform experiments to determine how to make and use the invention. The enablement requirement is set forth in 35 U.S.C. §112, first paragraph. If a patent is not enabled, it can be invalidated.

In the fields of biology and chemistry, referred to in the patent world as the “unpredictable” arts, enablement is particularly important. Thus, biotechnology patents must clearly satisfy the enablement requirement or they are at risk of being challenged and held invalid. That is what happened in Promega Corp. v. Life Technologies Corp. (Fed. Cir. 2014) 773 F.3d 1338.

Promega sued Life Technologies for infringement of five patents. The patents covered methods and test kits for analyzing DNA samples and were used in forensic science. Promega alleged that Life Technologies manufactured and sold genetic test kits that infringed Promega’s patents.

Life Technologies moved for summary judgement of invalidity on four of the five Promega patents, arguing that the four patents were not enabled. The district court denied the motion. The court granted Promega’s motion for summary judgment, holding that the patents were infringed. The jury then awarded $52 million in damages to Promega, but the district court granted Life Technologies’ motion for judgment as a matter of law. The court then vacated its previous ruling of infringement.Continue Reading Enablement is Key – Especially in Biotech Patents