In Takeda Pharma v. John J. Doll (08-1131), the US Court of Appeals for the Federal Circuit looked at an earlier District Court decision holding that later developments in the art may inform the “patentably distinct” determination for double patenting.

The Federal Circuit agreed but only to the extent that the subsequent developments predate the secondary application that triggers a double patenting rejection.

Takeda had obtained a number of patents claiming cephem compounds through a series of continuations, continuations-in-part, and divisional applications. Later, Takeda filed its application covering the process for making the cephem compounds claimed in the ’888 and ’606 product patents sixteen years after the 1974 priority date, and more than fourteen years after the filing of the ’888 product patent application.

The process patent issued as U.S. Patent No. 5,583,216 (the process patent) on December 10, 1996, claiming the sole process known and disclosed in the Japanese priority patent application, which led to the double patenting issue.

After two anonymous requests for reexamination, the examiner rejected the ’216 process patent claims as patentably indistinct over the ’606 product patent claims.  Takeda relied upon the declaration of Dr. Wuest disclosing an alternative process (displacement process) for making the cephem compounds claimed in the ’216 patent. Takeda appealed the rejection to the Board of Patent Appeals and Interferences, which dismissed Dr. Wuest’s declaration as “speculative” and upheld the examiner’s double patenting rejection.

In the District Court, Takeda presented the declaration of Dr. Duggan, which claimed that the process disclosed in U.S. Patent Nos. 6,552,186 (the Gerlach patent, published on Sept. 12, 2002, issued Apr. 22, 2003) and 7,071,329 (the Monguzzi patent, published June 2, 2005, issued July 4, 2006) provides a viable alternative, non-infringing process for making the certain cephem compounds claimed in the ’606 product patent.

Since the parties stipulated that “Method B” of the Duggan declaration described a materially distinct alternative process, the only issue was whether the alternative process—Method B, developed after the date of invention—could defeat the double patenting rejection.

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.

Relying on Dr. Duggan’s disclosure of Method B (published in the Gerlach and Monguzi patents) the district court found that the product and process are “patentably distinct” and overturned the double patenting rejection.

Double patenting generally prevents a patentee from receiving two patents and extending the term of exclusivity for a single invention.  Statutory, or “same invention,” double patenting finds its origin in the statutory grant of “a patent” for any new and useful invention.  Non-statutory, or “obviousness-type,” double patenting is a judicially created doctrine designed to foreclose “claims in separate applications or patents that do not recite the ‘same’ invention, but nonetheless claim inventions so alike that granting both exclusive rights would effectively extend the life of patent protection.”

Here, the parties agreed that product and process claims are patentably distinct if multiple processes for creating a product exist at the time of the invention.  The question in this case is if later-developed alternative processes are relevant in the product-process “patentably distinct” inquiry.  The PTO determined that the date of invention governs the relevance of products and processes in the double patenting context.  The PTO didn’t cite statutory or case support for the “date of invention” approach other than analogizing to the patentability requirements of  §§ 112, 102, and 103.

The Federal Circuit sided with the District Court saying it was not persuaded by the PTO’s approach of the “date of invention” since it only raises other substantive questions such as: is the filing date the presumptive “date of invention”?

It also disagreed with the district court’s “doing away with blinders” approach, which would allow 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. That is, 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.

This court is not persuaded by either approach. Neither approach addresses the policies underlying the double patenting doctrine. The secondary application (in this case, the process application of January 8, 1990) actually triggers the potential of an “unjustified extension of patent term.” When filing the secondary application, the applicant essentially avers that the product and process are “patentably distinct.” Thus, the relevant time frame for determining whether a product and process are “patentably distinct” should be at the filing date of the secondary application.

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.1

Therefore, the court remanded for further factual review.

Circuit Judge Schall dissented-in-part saying:

I agree with the majority that, in arguing against the claim of obviousness-type double patenting in the reexamination proceeding, Takeda should not be able to rely on the disclosures of the Gerlach and Monguzzi patents. However, I respectfully part company with the majority in its conclusion that Takeda should be able to rely on developments in the art up to January 8, 1990, the date of the filing of the ’216 process patent application. In my view, in arguing against the claim of obviousness-type double patenting, Takeda should not be able to rely on disclosures after the December 19, 1974 invention date.

I believe that tying the inquiry to the invention date is most commensurate with patent law as a whole and the policy goals relating to obviousness-type double patenting.

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