Tuesday, April 14, 2009

Later-developed alternative processes are relevant in the product-process "patentably distinct" inquiry

In Takeda v. Doll, the issue was what filing date is relevant to an obviousness-type double patenting rejection that was between a product patent filed in 1975 and a process patent filed in 1990. The court explained, "The novel legal question in this case asks if later-developed alternative processes are relevant in the product-process “patentably distinct” inquiry." The court found that they are up to a point.

Takeda filed an application to compounds in 1975, which issued as U.S. Patent No. 4,098,888. On January 8, 1990 Takeda filed a secondary application covering the process for making the claimed compounds, sixteen years after the priority date of the product claims. The process patent issued as U.S. Patent No. 5,583,216 (the ’216 process patent) on December 10, 1996, claiming the sole process known and disclosed in the Japanese priority patent application. The ’216 process patent led to the double patenting issue in this appeal. The process patent was subject to re-exam to determine if the process patent was invalid for obviousness-type double patenting in view of the prior product patent and other prior art. During reexamination, Takeda relied upon the declaration of Dr. Wuest disclosing an alternative process (displacement process) for making the claimed compounds the ’216 patent. The Board found the declaration unconvincing and affirmed the obviousness-type double patenting rejection. Takeda appealed to the district court and provided a new declaration showing that there are other processes that could be used, although some were developed after the priority date of the '216 process patent. 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. The district court found that the processes were patentably distinct and overturned the double patenting rejection.

The CAFC reviewed the double patenting doctrine.

"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.” Perricone, 432 F.3d at 1373."In other words, the double patenting doctrine is designed to prevent “unjustified imewise extension of the right to exclude.” In re Van Ornum, 686 F.2d 937, 943-44 (CCPA 1982). For instance, the doctrine bars an applicant from obtaining separate patents with separate terms for both a product and process for making that product, unless the product and process are “patentably distinct.” See In re Taylor, 360 F.2d 232, 234 (CCPA 1966); In re Cady, 77 F.2d 106, 109 (CCPA 1935) (instructing that “double patenting is not sustainable when the product can be fabricated by processes other than that secured by the issued process patent”) The PTO’s Manual of Patent Examining Procedure (MPEP) explains that a product and its process are patentably distinct if “the product as claimed can be made by another materially different process.” MPEP § 806.05.

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 CAFC framed the question this way:

The novel legal question in this case asks if later-developed alternative processes are relevant in the product-process “patentably distinct” inquiry. The PTO contends that the date of invention, in this case December 19, 1974, governs the relevance of products and processes in the double patenting context. Thus, the PTO submits 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. For example, the patentability requirements set forth in §§ 112, 102, and 103 are judged as of the date of invention or filing. See 35 U.S.C. §§ 112, 102, 103. The PTO does not cite statutory or case support for the “date of invention” approach other than analogizing to these other patentability requirements. In the alternative, the PTO posits that alternative processes must at least appear before issuance of the primary patent application.

Takeda argued the opposite side saying later arising technology to the product claims is relevant.

The CAFC didn't like either approach and came up with its own:

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 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. This approach should encourage the swift development of materially distinct, alternative processes.

Takeda argued that it disclosed a process in the earlier issued product patent that is not now claimed, but the PTO disputed the viability of that process. The court held there were questions of material facts to be resolved and therefore reversed the finding of summary judgment.

The full opinion can be found here