Eresearchtechnology, Inc. v. CRF, Inc., No. CV 15-918, 2016 WL 2643264, at *1 (W.D. Pa. May 10, 2016)
- 8,065,180 | Entitled “System for Clinical Trial Subject Compliance”
- 8,145,519 | Entitled “System for Clinical Trial Subject Compliance”
- 8,433,605 | Entitled “System for Clinical Trial Subject Compliance”
- 6,879,970 | Entitled “Apparatus and Method for Prediction and Management of Subject Compliance in Clinical Research;”
- 7,415,447 | Entitled “Apparatus and Method for Prediction and Management of Participant Compliance in Clinical Research”
Motion to dismiss for invalidity granted.
Yes for all patents.
No for all patents.
Patents are collectively directed towards improving clinical drug trials.
The Court examined each of the five steps, running each through the two-step Alice analysis as follows:
The heart of the ‘180 patent was related to “using an electronic device to obtain clinical trial data that would otherwise be collected by pen-and-paper diary, and analyzing the data to decide whether to prompt action.” Comparing this method to other similar methods of analyzing basic date inputs, the court held that computer-based programs like this one were abstract ideas. Turning to step 2, the Court found that there was no added inventiveness because the elements were all generic computer elements. Therefore, the ‘180 patent was ruled ineligible because it could not pass the Alice test.
The ‘519 and ‘605 patents were continuations of the ’180 patent, and failed patent eligibility for similar reasons. Under step 1 of the Alice test, the Court found that the patents, which involve obtaining data from portable electronic devices, evidenced a “common method of organizing human activity' or 'longstanding commercial practice.” Therefore they are abstract ideas. Under step 2, the Court found no added inventiveness because the patents just involve routine data gathering and performing conventional applications to the data.
The ‘970 and ‘470 patents, which describe a method of predicting subject noncompliance in a clinical trial, were found invalid for similar reasons to those listed above. First, the method articulated in the patents involved: obtaining data, generating an algorithm, and translating it into a rule. The Court found that was an abstract idea. Second, there was no inventive element added because the method for formulating the data and the formula used to create the rule did not create an inventive step necessary to transform the abstract idea into patent-eligible subject matter.