Takeda Pharmaceutical Co. v. Doll: Federal Circuit Holds That Later-Developed Alternative Manufacturing Processes May Be "Patentably Distinct" from Their Related Products
By Tyler Lacey - Edited by Evan Kubota
Takeda Pharmaceutical Co. v. Doll, April 10, 2009, No. 2008-1131
On April 10th, the United States Court of Appeals for the Federal Circuit vacated and remanded the decision of the United States District Court for the District of Columbia, holding that manufacturing processes developed after a product is patented may be "patentably distinct" from their related products.
In a non-unanimous opinion written by Circuit Judge Rader, the Federal Circuit held that "the relevant time frame for determining whether a product and process are ‘patentably distinct' should be at the filing date of the [process] application." If there exists only one process to manufacture a product, the process cannot be patented separately from the product because the two are substantially co-extensive. However, if multiple, materially different processes for making a product existed at the time of the product's invention, then those processes are distinct from the product and can therefore be patented separately. See Manual of Patent Examining Procedure §806.05. This decision now allows for processes discovered after the product's invention to be considered "patentably distinct," defeating any patent invalidity claim based on the double patent doctrine. The double patent doctrine prevents a patentee from obtaining extra exclusivity time for a single invention by obtaining two patents for it.
Peter Zura of the 271 Patent Blog summarizes the opinion. The Patent Prospector criticizes the decision arguing that the double patent issue was "resolved badly" and asserting that the court did not "[think] through the implications of its ruling." Patently-O provides a summary of the original district court opinion.
Although the court acknowledged that it was deciding a novel legal issue for the first time, it mentioned that its decision was consistent with the district court's holding in Phillips Petroleum Co. v. U.S. Steel Corp., 604 F. Supp. 555 (D. Del. 1985), which allowed the patenting of an alternative manufacturing process that was invented one year after the related product was patented. While in the present case the district court had held that evidence from any time period could be used in a "patentably distinct" analysis, the Federal Circuit stressed that only development in the relevant art taking place before the filing of the process patent application should be used in such an analysis. According to the court, its holding "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 [process patent] application." The court believes that its "approach should encourage the swift development of materially distinct, alternative processes," thus improving the state of the art.
Circuit Judge Schall dissented in part, disagreeing with the majority that developments occurring after the filing of a product's patent can be used when considering if a process is "patentably distinct" from its related product. The dissent would have held that only evidence from before the invention of the original product should be relevant to "patentably distinct" analysis. The dissent argued 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." Judge Schall agreed that the "fundamental reason for the rule [of obviousness-type double patenting] is to prevent unjustified timewise extension of the right to exclude granted by a patent no matter how the extension is brought about," but argued that the majority's holding allows for exactly the type of extension that the court was trying to avoid.
This decision is significant because it is the first time that the Federal Circuit has addressed the question of whether "later-developed alternative processes are relevant in the product-process ‘patentably distinct' inquiry." In holding that these later-developed processes are relevant, the Federal Circuit may have opened the door to more process patents. This has the potential to encourage innovation in manufacturing processes, but could also limit the methods by which the public may manufacture even products potentially within the public domain.