Takeda Pharmaceutical Co., Ltd. v. Doll

• Decision Date: 10 April 2009
• Docket Number: No. 2008-1131.,2008-1131.
• Citation: 561 F.3d 1372
• Parties: TAKEDA PHARMACEUTICAL CO., LTD., Plaintiff-Appellee, v. John J. DOLL, Acting Under Secretary of Commerce for Intellectual Property and Acting Director, United States Patent and Trademark Office, Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

561 F.3d 1372

TAKEDA PHARMACEUTICAL CO., LTD., Plaintiff-Appellee, v. John J. DOLL, Acting Under Secretary of Commerce for Intellectual Property and Acting Director, United States Patent and Trademark Office, Defendant-Appellant.

No. 2008-1131.

United States Court of Appeals, Federal Circuit.

April 10, 2009.

Harold C. Wegner, Foley & Lardner LLP., of Washington, DC, argued for plaintiff-appellee. With him on the brief were Stephen B. Maebius, Leon Radomsky, and C. Edward Polk, Jr.

Sarang Vijay Damle, Attorney, Commercial Litigation Branch, Civil Division, United States Department of Justice, of Washington, DC, argued for defendant-appellant. With him on the brief was Scott R. McIntosh, Attorney. Of counsel on the brief was William G. Jenks, Associate Solicitor, Office of the Solicitor, United States Patent and Trademark Office, of Arlington, VA. Of counsel were Raymond T. Chen, Solicitor, and Shannon M. Hansen, Associate Solicitor.

Before RADER, SCHALL, and MOORE, Circuit Judges.

Opinion by the court filed by Circuit Judge RADER. Opinion concurring-in-part and dissenting-in-part filed by Circuit Judge SCHALL.

RADER, Circuit Judge.

The United States District Court for the District of Columbia held that later developments in the art may inform the "patentably distinct" determination for double patenting. Double patenting doctrines and case law permit this court to agree in part, but only to the extent that the subsequent developments predate the secondary application that triggers a double patenting rejection. Because genuine issues of fact cloud the date of availability of materially distinct processes, as well as the viability of those processes, this court vacates and remands.

I.

Takeda Pharmaceutical Co., Ltd. (Takeda) filed a patent application disclosing certain cephem compounds and the process for making those compounds in Japan on December 19, 1974. Takeda filed later applications in the United Kingdom on June 9, 1975, and in the United States on December 19, 1975. Takeda developed these new cephem compounds through an acylation process, introducing a new acyl group (RC=O) to an amino group (-NR₃).

Takeda obtained a number of patents claiming these cephem compounds through a series of continuations, continuations-in-part, and divisional applications, including the compound patents that issued as U.S. Patent No. 4,098,888 (the '888 product patent) (application filed Dec. 19, 1975) and its divisional, U.S. Patent No. 4,298,606 (the '606 product patent) (application filed Aug. 28, 1979). This court refers to the December 19, 1975 application as the "primary application." Takeda filed these applications before June 8, 1995, making them subject to the seventeen year patent term regime. See 35 U.S.C. § 154(c). In other words, the patent terms on these inventions began on their grant date, not on their filing date.

On January 8, 1990, Takeda filed its secondary 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 '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.

In 1998, the United States Patent and Trademark Office (PTO) received two anonymous requests for reexamination of the '216 process patent. These requests asserted that the '216 process patent was invalid for "obviousness-type" double patenting in view of Takeda's prior patents, as well as other prior art. During reexamination, Takeda relied upon the declaration of Dr. Wuest disclosing an alternative process (displacement process) for making the cephem compounds claimed in the '216 patent. Not persuaded by the Wuest declaration, the examiner rejected the '216 process patent claims as patentably indistinct over the '606 product patent claims. Takeda appealed the rejection to the Board of Patent Appeals and Interferences (the Board). The Board dismissed Dr. Wuest's declaration as "speculative" and upheld the examiner's double patenting rejection.

Takeda challenged the Board's decision in the District Court for the District of Columbia under 35 U.S.C. § 145. Before the district court, Takeda presented new evidence in the form of a declaration of Dr. Duggan. In her declaration, Dr. Duggan explained 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.

For purposes of cross-motions for summary judgment, the parties stipulated that "Method B" of the Duggan declaration described a materially distinct alternative process. Therefore, before the district court, the parties disputed 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. Takeda Pharm. Co. v. Dudas, 511 F.Supp.2d 81, 91 (D.D.C.2007). Relying on Dr. Duggan's disclosure of Method B (published in the Gerlach and Monguzi patents in 2002 and 2005, respectively) the district court found that the product and process are "patentably distinct" and overturned the double patenting rejection. Id. at 92. The district court therefore granted Takeda's motion for summary judgment that it was entitled to a reexamination certificate, confirming its right to the '216 patent. At the same time, the court denied the PTO's motion for summary judgment. The PTO timely filed a notice of appeal with this court.

II.

This court reviews a grant of summary judgment without deference. Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp., 149 F.3d 1309, 1315 (Fed.Cir. 1998). Summary judgment is appropriate if the record discloses no genuine issues of material fact. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A material fact is one "that might affect the outcome of the suit under the governing law"; an issue is genuine "if the evidence is such that a reasonable [factfinder] could return a verdict for the nonmoving party." Id. at 248, 106 S.Ct. 2505. This court reviews the Board's factual findings for "substantial evidence." Mazzari v. Rogan, 323 F.3d 1000, 1005 (Fed.Cir.2003). However, this court reviews the ultimate legal conclusion regarding double patenting without deference. In re Goodman, 11 F.3d 1046, 1050 (Fed.Cir.1993).

A.

Double patenting generally prevents a patentee from receiving two patents and extending the term of exclusivity for a single invention. See Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1372 (Fed.Cir.2005). The proscription against double patenting takes two forms: statutory and non-statutory. Id. Statutory, or "same invention," double patenting finds its origin in the statutory grant of "a patent" for any new and useful invention. 35 U.S.C. § 101; Perricone, 432 F.3d at 1372-73. 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 timewise 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, 53 C.C.P.A. 1187, 360 F.2d 232, 234 (1966); In re Cady, 22 C.C.P.A. 1190, 77 F.2d 106, 109 (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") (quotation marks omitted). 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 agree that product and process claims are patentably distinct if multiple processes for creating a product exist at the time of the invention. See, e.g., In re Cady, 77 F.2d at 109 (finding that the process of manufacturing roofing material was patentably distinct from roofing composition when "appellant's product as defined in the appealed claims may be produced by processes other than the processes patented").

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...