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April 12, 2009

Double Patenting Dilemma

Takeda Pharmaceutical filed a patent application for cephem antibiotic compounds, and the process for making those compounds, in Japan, in December 1974. Takeda in 1975 filed corresponding applications in the UK and US. The US family started with 4,098,888 & 4,298,606. In 1990, Takeda filed for what became  5,583,216, which covered a process for making the compounds claimed in '888 and '606. Anonymous requests for reexamination of '216 led to a double patenting dilemma, which the appeals court resolved badly, not thinking through the implications of its ruling.

Takeda Pharmaceutical v. John J. Doll & the USPTO (CAFC 2008-1131)

Judge Rader, writing for himself and Judge Moore.

In reexam, '216 was rejected by the examiner as being "patentably indistinct over the '606 product patent claims." Takeda appealed before the BPAI and lost, so it appealed to the "the District Court for the District of Columbia under 35 U.S.C. § 145." At issue was whether an alternative process, called in court documents as "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). 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.

The PTO appealed.

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, 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") (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 must at least appear before issuance of the primary patent application.

Takeda, on the other hand, argues that the PTO's approach is too limited. In its view, processes developed after the date of invention deserve a role in the double patenting calculus.

The CAFC affirmed the district court, disagreeing with the patent office.

The PTO argues that here, the product and process were not "patentably distinct" as of the date of invention, so the double patenting doctrine should bar consideration of later-filed process claims. However, adopting the PTO's approach of the "date of invention" is only appealing at first glance. It appears to provide a bright-line test that conforms to the perspective used in other patentability determinations. But as Takeda points out in its brief, the "date of invention" raises other substantive questions such as: is the filing date the presumptive "date of invention"? If so, what is the date of invention, the domestic or foreign filing date? If foreign, must a claim have been "perfected" under § 119(e) with the filing of a certified copy of the original foreign application and an English language translation? What if the priority application contains support for some but not all of the patent claims? Would some of the claims be judged as of different cutoff dates? What if the inventor swears behind a reference?

In contrast, the district court's "doing away with blinders" approach 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 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. Here, 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. Yet the district court relied on patent applications published several decades later to show a patentable distinction between the product and process.

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. In this case, Takeda filed the '216 process patent application on January 8, 1990. 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.

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

Back to district court for reassessment of developments only to filing date of the secondary process patent application, in this case, 1990.

Because genuine issues of material fact exist with respect to whether the cephem compound and later-developed processes are "patentably distinct," this court vacates and remands for further factual development.

Vacated and remanded.

Judge Schall dissented, agreeing with the PTO.

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.

First, it seems to me that the date of invention is most appropriate because it comports with current patentability doctrines, and, as I explain later, I view product-process obviousness-type double patenting as a patentability doctrine. See, e.g., 35 U.S.C. § 102(a) ("A person shall be entitled to a patent unless . . . the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent." (emphasis added)); 35 U.S.C. § 102(e) ("A person shall be entitled to a patent unless . . . the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent . . . ." (emphases added)); Apotex Corp. v. Merck & Co., 507 F.3d 1357, 1359 (Fed. Cir. 2007) ("35 U.S.C. § 102(g) provides that an applicant is not entitled to a patent if 'before such person's invention thereof, the invention was made in this country by another, who had not abandoned, suppressed, or concealed it.'" (quoting 35 U.S.C. § 102(g)) (emphasis added)); In re Translogic Tech., Inc., 504 F.3d 1249, 1259 (Fed. Cir. 2007) ("An invention is unpatentable as obvious if the differences between the patented subject matter and the prior art would have been obvious at the time of invention to a person of ordinary skill in the art." (emphasis added)); cf. Phillips v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc) ("We have made clear . . . that the ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application." (emphasis added)); Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339 (Fed. Cir. 2003) ("Enablement is determined as of the effective filing date of the patent." (emphasis added)).

Second, we have previously emphasized the invention date with respect to obviousness-type double patenting:

The public should . . . be able to act on the assumption that upon the expiration of the patent it will be free to use not only the invention claimed in the patent but also modifications or variants which would have been obvious to those of ordinary skill in the art at the time the invention was made, taking into account the skill of the art and prior art other than the invention claimed in the issued patent.

In re Longi, 759 F.2d 887, 893 (Fed. Cir. 1985) (emphases from original omitted, emphasis added). Pertinent to this case, I view product-process obviousness-type double patenting as a patentability doctrine. At the date of invention, if only one process exists to make the product, the two are "substantially co-extensive." See PTO's Br. 17. To allow two patents to issue at that time would essentially run afoul of 35 U.S.C. § 101, as the applicant would be receiving two patents on one invention. See, e.g., In re Vogel, 422 F.2d 438, 441 (CCPA 1970); In re Ockert, 245 F.2d 467, 469 (CCPA 1957).

As correctly stated by the majority, "'[t]he 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.'" Eli Lilly & Co. v. Barr Labs., Inc., 251 F.3d 955, 967-68 (Fed. Cir. 2001) (quoting In re Van Ornum, 686 F.2d 937, 943-44 (CCPA 1982)) (alterations in original). The majority's approach, it seems to me, allows for such an extension. The product and the unpatentable process should both have entered into the public domain in 1998, when the '606 patent expired. At that point, members of the public should have been able to make the cephem compounds without paying royalties to Takeda or to another company. However, Takeda's rights in the '216 process patent will not expire until 2013--almost forty years after its process was first disclosed. In my view, this is an "unjustified timewise extension" of the right to exclude. Although the cephem compounds are in the public domain, no currently unpatented method exists for making them.

I am also concerned that the majority's approach could, in certain cases, result in the upsetting of reasonable expectations as to what is in the public domain.

Posted by Patent Hawk at April 12, 2009 9:32 AM | Prosecution

Comments

Double Patenting always bugged me, plus patenting in different countries. I couldn't even imagine the chaos. Thanks for this good read.

Posted by: patent enforcement at May 10, 2009 10:30 PM