This case was about a double-patenting issue and a patent policy concern. Cases of Interest Cases of Interest >  IP >  Patent

Takeda Pharmaceutical Co., Ltd. v. Doll

2009 WL 961386 (C.A. Fed. (Dist.Col.))


On December 19, 1974, Takeda Pharmaceutical Co., Ltd. filed a patent application that revealed the process for making cephem compounds in Japan. Then, on June 9, 1975, Takeda filed a patent application in the United Kingdom and subsequently filed an application in the United States on December 19, 1975. These cephem compounds were developed by introducing a new acyl group and amino group that was part of the cephem compound.

Takeda’s patents were obtained through several continuations, continuations-in-part, and divisional applications, including U.S. Patent No. 4,098,888 and its divisional, U.S. Patent No. 4,298,606. The December 19, 1975 patent application was the “primary application.” Because Tekeda’s patents were filed before June 8, 1995, they were subject to 35 USC §154(c) “Seventeen Year Patent Regime.”

Takeda filed its secondary application on January 8, 1990. This patent explained the process for making the cephem compounds claimed in the ‘606 and ‘888 patents. This was issued as U.S. Patent No. 5,583,216. This patent led to an issue concerning double patenting.

The United States Patent and Trademark Office received two anonymous requests in 1998 that asked for a reexamination of the '216 process patent. The two requests stated that the ‘216 patent was not valid because of “obvious-type” double patenting, considering the other patents filed by Takeda. Takeda claimed that according to Dr. Wuest, the alternative process that was submitted in the ‘216 process was distinct from the ‘606 patent. The USPTO examiner rejected this claim. Takeda appealed this rejection to the Board of Patent Appeals and Interferences, but they dismissed Dr. Wuest's statement, declaring it “speculative.” The Board upheld the rejection made by the examiner that asserted that this was double-patenting.

Procedural History

Takeda filed suit, challenging the Board’s double-patenting rejection of its ‘216 patent. The United States District Court for the District of Columbia granted Takeda summary judgment. PTO appealed to the Court of Appeals.


1. Whether later-developed alternative processes are relevant in the product-process “patentably distinct” inquiry?
2. Whether there are disputed genuine issues of material fact that would preclude summary judgment?


The Court of Appeals, Rader, Circuit Judge, held that:

1. Information subsequently disclosing developments in the compound, double-patenting, must predate a secondary patent application.
2. It is an issue of fact as to whether the product of the first patent and the subsequent alternative process were patentably distinct precluded summary judgment.

The District Court’s holding was vacated and the case was remanded. Circuit Court Judge Schall filed an opinion, concurring in part and dissenting in part.


1. The PTO asserted that the date of invention governs the timing of double-patenting analyses because other issues relating to patentability are judged from the date of invention. The PTO believes that alternative processes must at least appear before issuance of the primary patent application. Takeda alternatively argued that the PTO's approach is too limited, and processes developed after the date of invention deserve a role in the double-patenting calculus. The Court of Appeals agreed with PTO that alternative processes must appear before the issuance of the secondary patent application.
2. PTO asserted that the product and process were not “patentably distinct” as of the date of invention, so the double-patenting should bar consideration of the subsequently filed process claims. The district court developed a “doing away with blinders” approach that allows an applicant to come forward with any evidence that its product and process are patentably distinct, even if the alternative process is developed decades after the filing dates of the product and process applications. The Court of Appeals ruled that this approach provides the patentee with the best of both worlds: the applicant can use the filing date as a shield, enjoying the earlier priority date in order to avoid prior art, and rely on later-developed alternative processes as a sword to defeat double patenting challenges. In this case, the primary application, directed to certain cephem compounds, was filed in the United States on December 19, 1975. The secondary application, directed to the process for making these cephem compounds, was filed in 1990. The district court relied on patent applications published several decades later to show a patentable distinction between the product and process. The Court of Appeals was not persuaded by either the PTO’s or the District Court’s approach because neither approach addresses the policies underlying the double patenting doctrine. Therefore, because questions of material fact remain as to the viability of the Displacement Process and the disclosure date of Method B, the case should be remanded for determinations to made.

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