The opinion of the court was delivered by: Henry H. Kennedy, Jr. United States District Judge
By this action, plaintiff Intervet, Inc. ("Intervet") seeks a declaratory judgment that its vaccine does not infringe on any valid and enforceable claim of U.S. Patent No. 6,368,601 ("'601 Patent"), a patent that is exclusively licensed to defendant Merial Limited ("Merial"). Before the Court is Intervet's motion for summary judgment of noninfringement [#197]. Upon consideration of the motion, the opposition thereto, and the record of this case, the Court concludes that the motion should be granted.
An inventor seeking to obtain a patent must file a specification of the purported invention with the United States Patent and Trademark Office ("PTO"). 37 C.F.R. § 1.51(b)(1). A specification must include both a written description of the invention and an enablement for a claimed invention that explains the "manner and process of making and using [the invention], in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same." 35 U.S.C. § 112 para. 1; see also 37 C.F.R. § 1.71(a). At the end of the written description and enablement, a proper specification should conclude with a list of "claims," which identify the specific innovations, components or subparts of the invention, the applicant regards as hers. 35 U.S.C. § 112 para. 2. A claim is a single sentence description of what the applicant believes to be her invention, setting the boundaries of the invention the applicant wishes the PTO to examine. A single claim can be composed of multiple elements and/or limitations. Elements are the previously known physical components that make up the claimed invention. Limitations, on the other hand, usually describe the claim's restrictions. An application may contain several claims, and each claim usually contains several restrictions. It is these claims that define the scope of patent protection. Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052 (Fed. Cir. 2002).
After an inventor files her application, the PTO submits the application to an examiner with the necessary technical competence. In re Berg, 320 F.3d 1310, 1315 (Fed. Cir. 2003). Before issuing a patent, the PTO must find that the claimed invention is sufficiently different from "prior art" that it would not have been obvious at the time of its making to a person having ordinary skill in the relevant art. See 35 U.S.C. § 103(a). The patent also must particularly point out and distinctly claim the subject matter which the applicant regards as the invention. 35 U.S.C. § 112. After examining the application, the examiner sends the applicant an "Office action," which may grant or reject the listed claims. 37 C.F.R. § 1.104(a)(2). The applicant may respond by submitting, in writing, a reply that "distinctly and specifically points out the supposed errors in the examiner's action and [replies] to every ground of objection and rejection in the prior Office action."Id. § 1.111(b). An applicant may also respond by amending her claims to address the reasons for the examiner's rejections. If and when the examiner and applicant finally cannot agree on the disposition of certain claims, the applicant may appeal the examiner's decision to a panel of administrative patent judges, and if the panel sustains the rejections, to the Federal Circuit or this Court. 35 U.S.C. §§ 134(a), 141, 145.
B. Factual and Procedural Background
The '601 Patent, held by Merial and at issue in this case, claims certain porcine circoviruses (or PCVs). Prior to the '601 Patent application, the scientific community was aware of the existence of porcine circoviruses, which are small viruses with circular, single-stranded DNA. These circoviruses were known to be nonpathogenic and not associated with Postweaning Multisystemic Wasting Syndrome ("Postweaning Syndrome"), a slow and progressive disease that causes gradual weight loss, lesions, and jaundice in young pigs. The '601 Patent, which is entitled "Porcine Circovirus Vaccine and Diagnostics Reagents," identified five new porcine circoviruses that were unlike the previously known porcine circoviruses. The inventors stated that these five newly discovered porcine circoviruses exhibited extremely strong homology vis-avis each other and were responsible for Postweaning Syndrome.*fn1 In the '601 Patent, the inventors named these five porcine circoviruses "porcine circoviruses of type II" (or "PCV-2") to distinguish them from the previously known porcine circoviruses, which the inventors named "porcine circoviruses of type I" (or "PCV-1"). These new porcine circoviruses can be used to make vaccines to protect against Postweaning Syndrome.
After the '601 Patent application was filed, Intervet began producing a pig vaccine named "Porcine Circovirus Vaccine Type 2" using a porcine circovirus isolate that it named PCV WT2/1.*fn2 Intervet filed the present action seeking a declaratory judgment that its vaccine does not infringe the claims of the '601 Patent and that the claims of the '601 Patent are invalid and unenforceable.
The '601 Patent contains thirty-five specific claims. Merial alleges that Intervet's vaccine infringes on six of these claims - claims 9, 15, 16, 32, 33 and 35. In 2007, the Court conducted a Markman hearingand later construed six terms found in the '601 patent.One of the central issues in that proceeding was how broadly the Court should construe the range of viruses covered by the term "PCV-2." Merial argued that the term "PCV-2" encompassed a broad range of viruses that were homologous to the five strains listed in their patent; Intervet argued that the term "PCV-2" must be construed to include only the five specific strains listed in the '601 Patent. The Court agreed with Intervet. The Court construed the term "PCV-2" to mean "[t]he five viral strains identified in the '601 patent." Intervet v. Merial, 2007 WL 5685349, at *12 (D.D.C. November 28, 2007). Of relevance to this motion, the Court also construed the term "ORFs 1-13"*fn3 to mean "[t]he specific DNA sequences defined as ORFs 1-13 in Example 13 [of the '601 Patent]," and the term "[a]n isolated DNA molecule comprising a nucleotide sequence encoding an epitope which is specific to PCV-2 and not specific to PCV-1"*fn4 to include "[a]n isolated DNA molecule that includes, but is not necessarily limited to, a DNA sequence which codes for an immunodominant region of a protein, wherein the sequence is from the genome of a PCV-2 circovirus and not from the genome of a PCV-1 circovirus." Id.All of these terms will be discussed in greater detail later in this memorandum opinion.
In resolving Intervet's motion for summary judgment of noninfringement, in which Intervet argues that its vaccine does not infringe on the '601 Patent, there are two primary claims at issue -- claim 9 and claim 32 of the '601 Patent. Claim 9 claims "A vector comprising an isolated DNA molecule comprising a sequence selected from the group consisting of ORFs 1 to 13 of porcine circovirus type II."Mot. Summ. J. Infringement Ex. B at INT 0028426.*fn5 Claim 32 claims "An isolated DNA molecule comprising a nucleotide sequence encoding an epitope which is specific to PCV-2 and not specific to PCV-1." Id.
"To support a summary judgment of noninfringement it must be shown that, on the correct claim construction, no reasonable jury could have found infringement on the undisputed facts or when all reasonable factual inferences are drawn in favor of the patentee." TechSearch, L.L.C. v. Intel Corp., 286 F.3d 1360, 1371 (Fed. Cir. 2002). A patent may be infringed both literally and by a substantial equivalent. See id. Intervet argues that its vaccine does not literally infringe the '601 Patent and that Merial cannot resort to an argument that Intervet's vaccine infringes the '601 Patent through substantial equivalence. The Court will address each argument in turn.
A. Intervet's Vaccine Does Not Literally Infringe Claim 9 of the '601 Patent
"To establish literal infringement, all of the elements of the claim, as correctly construed, must be present in the accused [product]." Id. Claim 9 of the '601 patent claims: "A vector comprising an isolated DNA molecule comprising a sequence selected from the group consisting of ORFs 1 to 13 of porcine circovirus type II." INT 0028426. In its claim construction, the Court defined "PCV-2" (or "porcine circovirus type II") to be "the five viral strains identified in the '601 patent."Intervet, 2007 WL 5685349, at *12. The Court defined "ORFs1-13" to be the "specific DNA sequences defined as ORFs 1-13 in Example 13." Id.Therefore, putting together the claim and the Court's prior construction, Intervet's vaccine only literally infringes upon claim 9 of the '601 patent if it: contains a vector comprising an isolated DNA molecule comprising a sequence selected from the group consisting of the specific DNA sequences defined as ORFs 1-13 in Example 13 of the five viral strains identified in the '601 patent.
See id. Intervet argues that there is no issue of material fact that its vaccine is made using a strain that is different than any of the five strains claimed by the '601 Patent and that it employs a DNA sequence that is different from each of ORFs 1-13.
Merialresponds that evidence shows that Intervet's PCV WT2/1 isolate is the same strain as one of the viral strains identified in the '601 patent because the term "strain" includes more than the term "isolate" and because viral isolates do not need to have 100 percent nucleotide sequence identity to be considered the same strain, but need only be highly similar or homologous. Merial states that Intervet's isolate is 99.7 percent identical to the sequence of Imp. 1010, one of the five strains included in its patent. A person of skill in the art would understand that a viral isolate whose sequence is so similar to one or more listed "PCV-2" strains would necessarily be classified as a "PCV-2" strain, according to Merial.Intervet replies that ...