Enablement is Key – Especially in Biotech Patents
April 18 2015
By: Audrey Milleman
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.
Both parties appealed. In ruling on Life Technologies’ motion for summary judgment for lack of enablement, the Federal Circuit Court of Appeals considered the prosecution file histories for Promega’s patents. During prosecution, in order to overcome the patent examiner’s prior art rejections, Promega had stated that the prior art was not sufficient to disclose or predict the invention. The court also noted that Promega had taken inconsistent positions in the litigation. In opposing Life Technologies’ motion for invalidity, Promega had admitted that the field was unpredictable. In arguing for infringement, however, the court said “Promega sings a different tune” — Promega had asserted that its claims were broad enough to cover methods it had referred to as unpredictable.
The Federal Circuit explained that Promega cannot have it both ways. If Promega interpreted the language broadly enough to cover Life Technologies’ products, then the claims, as interpreted broadly, had to be enabled for the full scope of that coverage.
The court found that Promega’s patents covered “a virtually unlimited number” of DNA combinations. 773 F.3d at 1348. According to the court, the patents would not have enabled a person skilled in the field to develop Life Technologies’ products without undue experimentation. The court stated: “the claims at issue here similarly cover potentially thousands of undisclosed embodiments in an unpredictable field.” Id. at 1349. A person skilled in the field would have had to perform “laborious testing” (i.e., undue experimentation) to create Life Technologies’ products. Thus, the court held that the patents were invalid for failure to satisfy the enablement requirement, concluding that “Promega’s ‘difficultly in enabling the asserted claims is a problem of its own making.’” Id.