Takeda Pharmaceutical Co., LTD. v. John J. Doll

Court of Appeals for the Federal Circuit

decided on 2009-04-10 00:00:00

panel: Rader, Schall, Moore,

Overview

In Takeda Pharmaceutical v. Doll (08-1131), the Court of Appeals for the Federal Circuit considered a question of first impression - whether later-developed alternative processes for making a patented product can be relied upon to demonstrate a patentable distinction between product and process claims for purposes of obviousness-type double patenting. Appealing a decision of the Board of Patent Appeals and Interferences stemming from a reexamination proceeding on a process patent, Takeda argued that any evidence of a patentable distinction - even alternative processes developed decades after the date of invention and the application filing date - should be available for consideration. The Office, in contrast, argued that the date of invention should serve to cut-off the availability of such evidence, effectively barring an applicant from pointing to alternative processes developed after the date of invention to show that a process claim is patentably distinct from an existing product claim. The court rejected both approaches, holding instead that "the relevant time frame for determining whether a product and process are 'patentably distinct' should be at the filing date of the secondary application." The court offered a policy-based rationale for its decision, but failed to support it with significant analysis. Judge Schall, writing in dissent, agreed with the Office that the date of invention should be a cut-off date because "the invention date is most commensurate with patent law as a whole and the policy goals relating to obviousness-type double patenting."

Keywords

double patenting - Developments in the art up to the filing date of the second application can be relied upon to show that product and process claims are patentably distinct for purposes of obviousness-type double patenting.

standard of review - The court reviews the factual findings underlying a conclusion of double patenting for substantial evidence, but reviews the ultimate legal conclusion regarding double patenting without deference.

Detailed review

[1] DOUBLE PATENTING - A 'MIDDLE-OF-THE-RAOD APPROACH' TO THE CUT-OFF DATE FOR EVIDENCE OF A 'PATENTABLE DISTINCTION' FOR OBVIOUSNESS-TYPE DOUBLE PATENTING

After considering the extreme positions of Takeda and the Office, the court adopted a middle-of-the-road approach that is grounded in concepts of fairness to both the patent applicant and the public:

"This approach allows an applicant to rely on some later-developed methods to show that the product and process are 'patentably distinct,' even though the alternative processes for making that product may not have been known at the filing date of the primary application. This rule gives the applicant the benefit of future developments in the art. At the same time, however, it prevents the inequitable situation that arises when an applicant attempts to rely on developments occurring decades after the filing date of the secondary application."

Using the filing date of the second application against the applicant is fair, the court reasoned, because it is at that point in time that the applicant "avers that the product and process are 'patentably distinct'" and "triggers the potential of an unjustified extension of the patent term." (internal quotations omitted)

[2] DOUBLE PATENTING - AN UNEXPLAINED POLICY RATIONALE

The court even offered a policy-based rationale for its "middle-of-the-road" approach, noting that it "should encourage the swift development of materially distinct, alternative processes."

Unfortunately, the majority offered no analysis of this reasoning, effectively missing an opportunity to create a strong link between its holding and the policy goal of the judicially-created doctrine of obviousness-type double patenting - preventing unjustified extensions of patent terms.