Terms and Concepts

Validity Challenges

Post-Grant Review Proposals

Original patent claims in both ex parte and inter partes reexamination proceedings are only examined on the basis of patents and printed publications [35 U.S.C. §§ 302, 311; 37 C.F.R. §§ 1.510(a), 1.915(b)].  The full suite of defenses available in patent litigations including statutory subject matter (35 U.S.C. § 101), written description and enablement (35 U.S.C. § 112), public use, prior sale and inequitable conduct are not available in reexamination proceedings.  This disparity between invalidity challenges available in a district court and the patentability challenges in reexamination has spawned efforts to expand the available bases for requesting reexamination to create more equivalence between the two forums.  The PTO takes the position that the reexamination statute does not permit such an expansion [See 37 C.F.R. §§ 1.552, 1.906; M.P.E.P. §§ 2258, 2658].  The CRU has therefore strictly enforced the narrow basis for reexamination of patent claims to rejections based on patents and printed publications. Under this regime, collateral prior art defenses—commercialization activities surrounding a printed publication—cannot be considered in reexamination even though such defenses can be considered in any parallel court litigation under prior art categories such as “on sale” or “public use.”

The efforts to achieve identity between the invalidity challenges available in district court and those available in reexamination have centered primarily on changes to the underlying statute and the introduction of a new post-grant review process.  This post grant review (“PGR”) process has been proposed in several prior versions of patent reform legislation; and Senate Bill S515 contains language for a first window post-grant review. 

Under the current version of the bill, the first-window concept refers to the time period from when the patent issues to when the period for filing a PGR would close—12 months in the current draft.  The PGR would supplement, not replace reexamination.  As part of the legislation, inter partes reexamination would be made available for all unexpired patents. Currently, inter partes reexamination can only be filed for a patent issued from an original application filed on or after November 29, 1999 [37 C.F.R. § 1.913; See also M.P.E.P. § 2611].  The PGR would be an adversarial two-party process in the PTO with expanded grounds for challenging the validity of a patent beyond the limited patents and printed publications available in reexamination. It is also contemplated that the proposed inter partes review would be an adversarial two-party process in the PTO. Limited discovery would be available and oral testimony before administrative law judges (“ALJs”) would be allowed.  Under the current view, the ALJ would rule in a summary-judgment style.  The goal of the PGR and the inter partes review would be a faster, better and cheaper alternative to the courts for decision on the validity of issued patent claims.  The PGR concept as currently envisioned has generated considerable controversy from many stakeholder groups who question whether the professed goals are attainable and whether the PGR would actually improve the patent system and protect legitimate patent rights. Finally, the existing ex parte reexamination procedure would exist, and current inter partes reexamination proceedings would continue to be conducted under the present rules.

Other efforts focus on expanding the examination performed by the CRU, after a request is granted.  As discussed above, the PTO does not address rejections of original patent claims beyond those based on patents or printed publications.  The premise for not addressing these grounds for invalidity, particularly statutory subject matter or 35 U.S.C. § 112 written description and enablement challenges, is that the original patent claims were found patentable under these statutory provisions during prosecution and therefore the claim status under these provisions has not changed.  However, some practitioners argue that decisions by the Federal Circuit and Supreme Court occurring after allowance of the original patent claims undermine this reasoning. 

As an example, the Supreme Court, in the recent Bilski v. Kappos decision, has set forth a more  flexible standard for determining patentable subject matter, and the PTO is in the process of implementing guidelines for this more flexible standard.

As a result of these cases, the authors predict increased pressure on the PTO and Congress to introduce statutory-subject-matter challenges, at a minimum, into reexamination proceedings.  Although statutorily barred from being included in the reexamination request, some practitioners argue that the PTO could, on its own, raise these issues during reexamination, in the same manner that is done during original prosecution.  Although potentially allowable under the current statute, this approach would require a change to the PTO rules and procedures.  Under current PTO procedures, amendments to the original patent claims open the door to these additional invalidity challenges—but only against the amendments.