Update On WARF Stem Cell Patent Challenge

As reported in my July 8, 2013 post, Consumer Watchdog (formerly known as The Foundation for Taxpayer and Consumer Rights) and the Public Patent Foundation (collectively "CW") asked the Federal Circuit to determine if in vitro cultured human embryonic stem cells (hESCs) are patent-eligible. Consumer Watchdog v. Wisconsin Alumni Research Foundation, No. 13-1377 (Fed. Cir. 2013). The issue is presented in an appeal from the inter partes reexamination (No. 95/000,154) of U.S. Patent No. 7,029,913 (the '913 Patent) wherein the USPTO Board of Patent Appeals confirmed the patentability of the claims of the '913 Patent, entitled "Primate Embryonic Stem Cells". The '913 Patent issued on April 18, 2006 naming Dr. James A. Thomson of the University of Wisconsin as the sole inventor and is assigned to Appellee Wisconsin Alumni Research Foundation ("WARF"). WARF has now responded to CW's challenge, urging the Federal Circuit to dismiss the patent-eligibility challenge on procedural and substantive grounds.

Although the appeal raises several issues including whether the claims satisfy 35 U.SC. § 102 (novelty) and 35 U.SC. § 103 (non-obviousness), the issue that would impact the patenting of, and likely investment in regenerative medicine and personalized therapies that rely on them is whether the claimed hESCs are patent-eligible and satisfy 35 U.SC. § 101. Thus, this post focuses on the Section 101 issue.

Patent-Eligibility Challenges Are Improper in Inter Partes Reexamination Proceedings

WARF argues that the patent-eligibility challenge is improper on procedural grounds because questions related to patent-eligibility (35 U.S.C. § 101 or Section 101) are not grounds to challenge a patent claim in an inter partes reexamination proceeding. Instead, only questions related to Sections 102 (novelty) and 103 (non-obviousness) based on prior art patents and printed publications, or compliance with Section 112 requirements for new or deleted matter, are allowed by statute or regulation in such a proceeding. Alternatively, WARF argues that, if the Federal Circuit determines that the PTO could have considered the patent-eligibility challenge, the challenge should nonetheless be rejected as CW failed to raise it during the PTO reexamination proceedings.

WARF also notes that CW's reliance on a prior proceeding wherein a Section 101 issue was addressed on appeal from an agency proceeding (In re Comisky, 554 F.3d 967 (Fed. Cir. 2007)) is misplaced. In Comisky, WARF...