Enablement is the requirement that a patent teach a person Audrey-Millemann-03_webskilled 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

By Audrey A. Millemann

            The Federal Circuit has loosened the standard for recovering attorneys’ fees in patent infringement cases, making it easier for winning defendants to obtain their fees from plaintiffs. 

            The case is Kilopass Technology, Inc. v. Sidense Corp. (Fed. Cir. Dec. 26, 2013), 2013 U.S. App. LEXIS 25671. Kilopass and Sidense were competitors in the market for memory cells used in transistors. Kilopass obtained several patents on its technology. After reviewing a published patent application of Sidense for its memory cells, Kilopass embarked on an interesting course of conduct.

            First, Kilopass engaged counsel to determine whether Sidense infringed Kilopass’ patents. Based on the product described in Sidense’s patent application, Kilopass’ counsel believed that there might be an infringement case, and sent Sidense a letter inviting Sidense to license Kilopass’ patents or explain why Sidense’s products did not infringe Kilopass’ patents. Sidense replied with a specific explanation of why its products did not infringe Kilopass’ patents. Sidense also offered to subject its products to a confidential infringement analysis by a third party expert to prove its position. Kilopass then obtained a diagram of Sidense’s product and provided it to Kilopass’ counsel.  Counsel then concluded that Sidense had designed around Kilopass’ patents and that its products probably did not literally infringe the patents. In response, Kilopass retained a second counsel to analyze infringement. The second counsel made a preliminary finding that Sidense’s products probably did not literally infringe the patents, but might infringe under the doctrine of equivalents, and said that further investigation was needed to confirm this. Kilopass did not conduct further investigation with this counsel, but instead engaged a third counsel to analyze infringement. Then, based primarily on Kilopass’ own engineer’s findings, Kilopass concluded that Sidense infringed under the doctrine of equivalents. 

 Continue Reading Patent Infringement: Attorneys’ Fees A Little Easier to Get