Update on WARF Stem Cell Patent Challenge

15 September 2013 Personalized Medicine Bulletin Blog

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 states, the Federal Circuit affirmed an agency decision on alternate grounds, relying on well-established precedent that, for reasons of judicial economy, a court can affirm an agency decision on a legal ground not relied on by the agency if there is no issue of fact, policy or agency expertise.

WARF also noted that CW cannot rely on the U.S. Supreme Court’s Myriad decision (Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 2013 LEXIS 4540 June 13, 2013)) because Myriad could not have materially altered the decision below of the USPTO Board because the Board did not have jurisdiction to resolve an issue raised under Section 101.

In Vitro, Cultured Human Embryonic Stem Cells Are Patent-Eligibility

The patent-eligibility issue also was addressed. Representative claim 1 of the ‘913 Patent recites:

1.  A replicating in vitro cell culture of pluripotent human embryonic stem cells derived from a pre-implantation embryo, wherein the stem cells (i) will proliferate in an in vitro culture for over one year in an undifferentiated state without the application of exogenous leukemia inhibitory factor, (ii) maintain a karyotype in which the chromosomes are euploid through prolonged culture, (iii) maintain the potential to differentiate to derivatives of endoderm, mesoderm, and ectoderm tissues throughout the culture, (iv) are inhibited from differentiation when cultured on a fibroblast feeder layer. (Emphasis Added).

All claims of the ‘913 Patent recite a in vitro culture of hESCs. WARF explains that these cells are distinct from cells in an embryo in their cellular composition and properties as they are cultured cells. Cultured cells are described in the ‘913 Patent to exist as a composition containing culture medium, nutrients, and other components that sustain the cells outside the body in plastic culture dish.

CW’s Brief in Reply

On August 29, 2013, CW filed its reply brief. CW reiterated that the Federal Circuit may, and should, address patent-eligibility in this proceeding. CW concedes that the issue of patent-eligibility of the claims could not have been raised during the reexamination, but argues that the Federal Circuit may nonetheless consider the issue as it is a “threshold” issue, citing the U.S. Supreme Court’s Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010) decision. Moreover, CW argues, addressing Section 101 issues in this proceeding would alleviate the need for any separate or further action addressing patent-eligibility in light of Myriad.

CW also argues that the Federal Circuit should address this issue in light of Myriad because the Supreme Court’s decision reversed what had been the prevailing rules from the Federal Circuit’s precedents. CW urges that moreover, under Myriad, the addition of “culture medium” is akin to the argument the Supreme Court rejected in Myriad, i.e., that the claimed isolated DNA is different from that found in the body. CW also called WARF’s characterization of the claim term “cultured” to include “culture medium” improper because it fails to give the claims the broadest reasonable interpretation. 

Myriad Applied ?

If the Federal Circuit decides to rule on the patent eligibility issue, it will be the court’s first application of the Myriad decision to another naturally-occurring patented technology – isolated stem cells – providing additional guidance as the bar and USPTO navigate the post-Myriad reality of patenting naturally-occurring products.

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