The Software IP Report

Clinical Research Methods Not Patent-Eligible Under 35 U.S.C. § 101

By Charles Bieneman

Categories: Patent Eligibility, Software Patents, The Software IP Report

Five patents claiming methods of performing and managing clinical research were held patent-ineligible under the Alice/Mayo abstract idea test in eResearchTechnology, Inc. v. CRF, Inc., No. 15-918 (W.D. Pa. May 10, 2016).  After finding each of U.S. Patent Nos. 8,065,180; 8,145,519; 8,433,605; 6,879,970; and 7,415,447 invalid under 35 U.S.C. § 101, the court granted a defense motion to dismiss under FRCP 12(b)(6).

The court described the patents-in-suit as “collectively directed to improving clinical trials.”  Claim construction was not necessary, because the plaintiff had not identified any claim construction on which the patent-eligibility question turned.  Further, it was appropriate for the court to look to representative claims in evaluating patents under Section 101.  The court then considered each patent in turn.

Looking first at the ’180 patent, the defendant had argued that the representative claim was “directed to the simple abstract idea of determining whether a clinical trial participant is entering his data on time consistent with past experience, i.e., ‘historical data’ and, if not, calling to remind him.”  The court agreed, rejecting the plaintiff’s argument that the claim could not be abstract because it was directed to solving s problem in a specific realm, i.e., clinical trials.  Looking at the second prong of the Alice/Mayo test, there was nothing in the claim to transform the abstract idea into something patent-eligible.  Use of a database or a computer, or gathering and organizing data, did not constitute inventiveness.

The claims of the other patents-in-suit fell under similar analysis.  Enough said.