Lead Opinion
Opinion by the court filed by Circuit Judge RADER. Opinion concurring-in-part and dissenting-in-part filed by Circuit Judge SCHALL.
The United States District Court for the District of Columbia held that later developments in the art may inform the “pat-entably 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 matеrially distinct processes, as well as the viability of those processes, this court vacates and remands.
I.
Takeda Pharmaceutical Co., Ltd. (Take-da) 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 nеw acyl group (RC=0) 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
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 procеss 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 reexаmination, 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 comрounds 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 alternativе processes exist” when weighing patentable distinctions for double patenting. Takeda Pharm. Co. v. Dudas,
II.
This court reviews a grant оf summary judgment -without deference. Ethicon Endo-Surgery, Inc. v. U.S. Surgical Corp.,
A.
Double patenting generally prevеnts a patentee from receiving two patents and extending the term of exclusivity for a single invention. See Perricone v. Medicis Pharm. Corp.,
In other words, the double patenting doctrine is designed to prevent “unjustified timewise extension of the right to exclude.” In re Van Ornum,
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,
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
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. Acknowledging that this court has not directly addressed this legal question before, Takeda relies on a district court case for the proposition that a court can look to processes developed after the date of invention for product-process double patenting situаtions. See Phillips Petroleum Co. v. U.S. Steel Corp.,
In Phillips, the district court considered a process developed in 1954, one year after the date of invention. Id. at 567. In a footnote, the district court noted that courts have considered developments in the art arising after the date of invention when resolving double patenting issues. In those cases, however, the parties did not object to the court’s consideration of post-date inventive developments. Id. at 568. The district court further noted the Board’s discussion in Ex Parte Hogan, No. 436-63, (Pat. & Tr. Office Bd.App. Mar. 30, 1981), a non-precedential case from the Board of Patent Appeals. In Ex Parte Hogan, the Board considered a later-disclosed process in a double patenting challenge. See slip op. at 5. Agreeing that later-developed processes are relevant to the “patentably distinct” inquiry, the Phillips Court “deeline[d] to conduct the double patenting analysis with blinders so as to avoid recognition or discourage disclosure of advances in process technology as a means of making a product patent.” Phillips,
In this case, Takeda argues that this court’s affirmance of Phillips rejected the PTO’s exact “date of invention” position. But on closer lоok, the only mention of double patenting in Phillips II is in the penultimate paragraph:
III. Remaining Arguments
We have carefully considered defendants’ arguments regarding: (1) double patenting .... We find none persuasive of error in the district court’s disposition of any of those issues and none of sufficient import to require discussion here of that disposition.
IV. Conclusion
The judgment of the district court is affirmed in all respects.
Id. at 1253 (emphasis added). While Phillips II affirmed Phillips “in all respects,” this court did not address the double patenting argument. Thus, Phillips II did not present a rule or reasoning that decides the case before this court in this appeal. See Nat’l Cable Television Ass’n, Inc. v. Am. Cinema Editors, Inc.,
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
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 pat-entee 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 аrt, 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 рroduct 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 “patent-ably 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 аpplicant 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. It is also consistent with the district court’s opinion in Phillips,
Therefore, in this case, the applicant can rely on subsequent developments in the art up to January 8, 1990, the filing date of the secondary application, in order to show a patentable distinction between the cephem compounds claimed in the '606 product patent and the process for making those compounds claimed in the '216 process patent. In that regard, Takeda indicates that it disclosed an unclaimed process (which it terms the “Displacement Process” or thе “Unelected Method”) in the '888 product patent application. The PTO, however, has continually “dispute[d] the viability of the ... [Displacement [P]roeess.” Additionally, Takeda asserts that Method B, disclosed in the Gerlach and Monguzzi patents and described in the Duggan Declaration, was disclosed as early as 1979. On this point, the PTO states that it “di[d] not dispute the technical merits of Dr. Duggan’s declaration” only for purposes of cross-motions for summary judgment. Further, the PTO stated in its motion for summary judgment that “[t]he only ‘alternative’ processes that Takeda (through Dr. Duggan’s declаration) has identified to this Court are the processes described in ... the ‘Gerlach’ patent[ ] and in ... the ‘Monguzzi’ patent[ ].” Today, this court holds that the district court may not rely on the Gerlach and Monguzzi patents. But questions of material fact remain as to (1) the viability of the Displacement Process, and (2) the disclosure date of Method B. On remand, the district court should determine whether these processes were disclosed before January 8, 1990, the date of filing of the '216 process patent.
III.
Because genuine issues of material fact exist with respeсt to whether the cephem compound and later-developed processes are “patentably distinct,” this court vacates and remands for further factual development.
VACATED AND REMANDED.
COSTS
Each party shall bear its own costs.
Notes
. The dissent's hypothetical is a stretch. It assumes nineteen years of co-pendency. Today, patent terms are triggered by the filing date, not the grant date. In other words, both the product and process patents will expire around the same time (although there may be slight variance due to patent term adjustment). As such, an applicant is less likely to maintаin co-pendency for nineteen years. Moreover, this court’s prosecution laches doctrine "may render a patent unenforceable when it has issued only after an unreasonable and unexplained delay in prosecution.” Symbol Techs., Inc. v. Lemelson Med., Educ. & Research Found.,
Concurrence Opinion
concurring-in-part and dissenting-in-part.
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 Mon-guzzi 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.
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
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,
In a difficult case, the majority settles upon what I would characterize as a not-unreasonable attempt at compromise. Rejecting the approaches of both Takeda and the government, it holds that “the relevant time frame for determining whether a product and process are ‘patentably distinct’ should be at the filing date of the [’216 process patent application].” It thus concludes, in the setting of a pre-1995 filing, that art developed after a prоduct/process invention date, but before a subsequent process patent application fil
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.,
I am also concerned that the majority’s approach could, in certain cases, result in the upsetting of rеasonable expectations as to what is in the public domain. For example, let us assume we are in the seventeen-year regime, as we are in this case. Takeda is granted a product patent in year one. At that time, only one process exists (Process A). That process is disclosed, but not claimed, in the patent. In year eighteen, the product patent expires, putting Process A fully into the public domain. In addition, during the seventeen-year patent term, no other process has been developed, and thus Process A remains unpatentable separately because it is coextensive with the product patent. See In re Taylor,
Finally, the majority sets forth various questions which it says counsel toward its approach:
[A]dopting the PTO’s approach of the “date of invention” is only appealing at*1381 first glance. It аppears 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 supрort 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?
Maj. op. at 1376-77.
I do not share the majority’s concern. I think we must keep in mind these kinds of questions are faced regularly and have been manageable. For example, interference proceedings provide a parallel to double-patenting: a court (or the Board of Patent Appeals and Interferences) must look to the date of invention while evaluating two competing applications. That additional questions may have to be addressed if the approach urged by the government is adopted does not mean that we should ignore that approach if we feel it is correct.
It may be that the new patent term will cure many of the concerns enumerated in this opinion. However, that does not mean that we should ignore those concerns. Obviousness-type double patenting is a judicially created doctrine, and using the date of invention best comports with our previously stated policy goals underlying thе doctrine. For the foregoing reasons, I respectfully dissent from the majority’s decision allowing Takeda to use developments in the art that post-date the date of invention in arguing against the obviousness-type double patenting rejection.
. The PTO and Takeda used this date as the “presumed date of invention” in briefing and argument, so I will use it here as well.
. Although this view is admittedly overly simplistic, tracing the product-process double patenting doctrine back to its § 101 origins serves to bolster the connection between the doctrine and other questions of patentability.