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Later Developments in the Art May Inform the “Patentably Distinct” Determination for Double Patenting but Only to the Extent That the Subsequent Developments Predate the Secondary Application That Triggers a Double Patenting Rejection

April 10, 2009

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Last Month at the Federal Circuit - May 2009

Judges: Rader (author), Schall (concurring-in-part and dissenting-in-part), Moore

[Appealed from: D.D.C., Judge Hogan]

In Takeda Pharmaceutical Co. v. Doll, No. 08-1131 (Fed. Cir. Apr. 10, 2009), the Federal Circuit held that the relevant time frame for determining whether a product and process are “patentably distinct” is at the filing date of the later-filed application. However, as genuine issues of fact clouded the date of availability of materially distinct processes, as well as the viability of those processes, the Court vacated the district court’s ruling and remanded for further proceeding.

In 1975, Takeda Pharmaceutical Company, Ltd. (“Takeda”) filed a primary application claiming priority to a 1974 Japanese patent application, covering certain cephem compounds, which issued as U.S. Patent No. 4,098,888 (“the ’888 patent”). In 1979, Takeda filed a divisional application covering cephem compounds, which issued as U.S. Patent No. 4,298,606 (“the ’606 patent”). In 1990, Takeda filed its secondary application covering the process for making the cephem compounds, which issued as U.S. Patent No. 5,583,216 (“the ’216 patent”), claiming the sole process known and disclosed in the Japanese priority patent application.

In 1998, the PTO received two anonymous requests for reexamination of the ’216 patent, asserting that it was invalid for “obviousness-type” double patenting. During reexamination, Takeda relied on the declaration of Dr. Wuest disclosing an alternative process (displacement process) for making the cephem compounds claimed in the ’216 patent. The examiner rejected the ’216 patent claims as patentably indistinct overthe ’606 patent claims. Takeda appealed to the Board. The Board rejected the Wuest declaration as speculative. Takeda challenged the Board’s decision in the District Court for the District of Columbia. In those proceedings, Takeda presented new evidence in the form of a declaration of Dr. Duggan, which explained that the process disclosed in two other patents provided a viable alternative, noninfringing process for making the cephem compounds claimed in the ’606 patent. The parties stipulated that the method in the Duggan declaration described a materially distinct alternative process. The district court concluded that “subsequent developments in the art [are relevant to] determining whether alternative processes exist” when weighing patentable distinctions for double patenting. Slip op. at 4 (alteration in original) (quoting Takeda Pharm. Co. v. Dudas, 511 F. Supp. 2d 81, 91 (D.D.C. 2007)). As a result, the district court overturned the double patenting rejection and granted Takeda’s motion for SJ that it was entitled to a reexamination certificate. The PTO appealed.

On appeal, the Federal Circuit recognized that the novel legal question in this case is whether later-developed alternative processes are relevant in the product-process “patentably distinct” inquiry. The PTO argued that the date of invention governs the relevance of products and processes in the double patenting context. Takeda argued that a court can look to processes developed after the date of invention. Takeda relied on a district court case that considered a process developed in 1954, one year after the date of invention, and “decline[d] to conduct the double patenting analysis with blinders so as to avoid recognition or discourage disclosure of advances in process technology as a means of making a product patent.” Id. at 7 (quoting Phillips Petroleum Co. v. U.S. Steel Corp., 604 F. Supp. 555 (D. Del. 1985)). Takeda argued that, because the Phillips case had been affirmed by the Federal Circuit, that case affirmatively rejected the PTO’s exact “date of invention” position. The Court recognized, however, that the Federal Circuit’s affirmance of Phillips without addressing the issue of double patenting did not constitute precedent to be followed in a subsequent case in which the issue arises.

The Federal Circuit found neither party’s approach persuasive. The Court recognized that the secondary application actually triggers the potential of an “unjustified extension of patent term,“ and that when filing the secondary application, the applicant essentially avers that the product and process are patentably distinct. Thus, the Court concluded 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 articulated that this rule gives the applicant the benefit of future developments in the art to rely on to show that the product and process are “patentably distinct.” At the same time, this approach prevents the inequitable situation that arises when an applicant attempts to rely on developments occurring decades after the filing date of the secondary application. The Court further reasoned that this approach should encourage the swift development of materially distinct, alternative processes.

Ultimately, the Court held that genuine issues of material fact existed with respect to (1) the viability of the displacement process from the Wuest declaration, and (2) the disclosure date of the method described in the Duggan declaration. Accordingly, the Court vacated and remanded for further factual development.

Judge Schall concurred-in-part but dissented-in-part from the majority’s decision allowing Takeda to use developments in the art that post-date the date of invention in arguing against the obviousness-type double patenting rejection.

Summary authored by Sulay D. Jhaveri, Ph.D., student associate at Finnegan.