Digene Corp. v. Third Wave Technologies, Inc.

323 F. App'x 902
CourtCourt of Appeals for the Federal Circuit
DecidedApril 1, 2009
Docket2008-1242, 2008-1243
StatusUnpublished
Cited by2 cases

This text of 323 F. App'x 902 (Digene Corp. v. Third Wave Technologies, Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Digene Corp. v. Third Wave Technologies, Inc., 323 F. App'x 902 (Fed. Cir. 2009).

Opinion

LOURIE, Circuit Judge.

Digene Corporation (“Digene”) appeals from the judgment of the United States District Court for the Western District of Wisconsin holding that Third Wave Technologies, Inc. (“Third Wave”) did not infringe the Digene patent in suit. See Digene Corp. v. Third Wave Techs., No. 07-C-0022-C, 2007 WL 5425947, 2007 U.S. Dist. Lexis 58882 (W.D.Wis. July 28, 2007) (“Claim Construction Opinion ”); Digene Corp. v. Third Wave Techs., Inc., No. 07-C-0022-C, 2007 WL 5614110, 2007 U.S. Dist. Lexis 73010 (W.D.Wis. Sept. 26, 2007) (“Opinion Denying Reconsideration”). Third Wave cross-appeals from the court’s grant of summary judgment dismissing Third Wave’s antitrust counterclaims. See Digene Corp. v. Third Wave Techs., Inc., 536 F.Supp.2d 996 (W.D.Wis. 2008) (“Opinion Dismissing Counterclaims ”). Because the district court did not err in its determinative claim constructions or in granting summary judgment on Third Wave’s antitrust counterclaims, we affirm.

BACKGROUND

Digene owns U.S. Patent 5,643,715 (“the '715 patent”), which relates to diagnosis of human papillomavirus (“HPV”) type 52. According to the '715 patent specification, “HPVs are grouped into types based on the similarity of their” deoxyribonucleic acid (“DNA”) sequences. '715 patent col.l 11.49-50. When Digene applied for the '715 patent, HPV type 52 was newly discovered and was known to be a common sexually-transmitted disease and a primary cause of cervical cancer. The '715 patent describes characterizing and diagnosing HPV type 52, and differentiating it from other HPV types by providing “nucleic acid hybridization probes which are specific for HPV type 52.” Id. at col.4 11.30-32. At the time of filing, HPV types 1-51 were known, but other types have since been discovered.

Digene makes DNA-based HPV testing systems that are approved by the U.S. Food and Drug Administration (“FDA”). Third Wave makes non-FDA-approved HPV test systems consisting of nucleotides that are designed to target HPV 52 and other dangerous HPV types by using a DNA fragment that is homologous to (i.e., will bind with) HPV 52 DNA, combined with an extra fragment of DNA that functions as an indicator of the HPV’s presence.

In January 2007, Digene sued Third Wave for infringement of claims 8, 10-12, and 18-27 of the '715 patent. Each of the asserted claims recites “HPV 52 DNA” that “consists of all or a fragment of an *905 HPV DNA.” Id. at col.16 1.43-col.l8 1.65. Claims 18 and 21 together contain all the limitations that are contested on appeal, and they read as follows:

18. An HPV 52 hybridization probe comprising a member selected from the group consisting of
(i) HPV 52 DNA labelled with a detectable label, and
(ii) HPV 52 RNA labelled with a detectable label,
wherein the length of the HPV 52 DNA or HPV 52 RNA is between approximately 15 and 8000 nucleotide bases,
wherein the HPV 52 DNA consists of all or a fragment of an HPV DNA, wherein the HPV DNA cross-hybridizes to the HPV portion of clone pCD15 to greater than 50% under moderately stringent conditions, wherein the HPV 52 RNA consists of all or a fragment of an HPV RNA, wherein the HPV RNA eross-hybri-dizes to the HPV portion of clone pCD15 to greater than 50% under moderately stringent conditions, and wherein the HPV 52 DNA and HPV 52 RNA do not hybridize to DNA from HPV types 1 through 51 under stringent conditions.

21. An HPV hybridization probe composition comprising

(a) a member selected from the group consisting of
(i) HPV 52 DNA labelled with a detectable label and
(ii) HPV 52 RNA labelled with a detectable label,
wherein the length of the HPV 52 DNA or HPV 52 RNA is . between approximately 15 and 8000 nucleotide bases,
wherein the HPV 52 DNA consists of all or a fragment of an HPV DNA, wherein the HPV DNA cross-hybridizes to the HPV portion of clone pCD15 to greater than 50% under moderately stringent conditions,
wherein the HPV 52 RNA consists of all or a fragment of an HPV RNA, wherein the HPV RNA cross-hybridizes to the HPV portion of clone pCD15 to greater than 50% under moderately stringent conditions, and
wherein the HPV 52 DNA and HPV 52 RNA do not hybridize to DNA from HPV types 1 through 51 under stringent conditions, and
(b) DNA or RNA of at least one other HPV type labelled with a detectable label.

'715 patent col. 17 1.22-col. 18 1.2 (emphases added).

In July 2007, the district court construed certain claim terms from the '715 patent. Among others, the court construed the term “HPV 52 DNA” to mean “a DNA molecule that is only type 52 HPV.” Claim Construction Opinion, 2007 WL 5425947, *1, 2007 U.S. Dist. Lexis 53882, *2. The court reasoned that the applicant had disclaimed a molecule including fragments of later-discovered HPV types by stating during prosecution that “the claimed HPV 52 DNA must be derived from only type 52 HPV DNA,” and the applicant had changed the transitional phrase after “HPV 52 DNA” from “comprising” to “consists of.” Id. 2007 WL 5425947, at *7, 2007 U.S. Dist. Lexis 53882, at *17-18. The court construed the phrase “consists of all or a fragment of an HPV DNA” to mean “consists of all or a fragment of one HPV DNA that does not contain any other DNA,” reasoning that “an” means “one and only one” when following the transitional phrase “consists of,” and that this definition accorded with the court’s definition of “HPV 52 DNA.” *906 Id. 2007 WL 5425947, at *1, *5-6, 2007 U.S. Dist. Lexis 53882, at *2, *14-15. Di-gene later moved for reconsideration of certain claim terms, and on reconsideration, the court added that its constructions did not exclude mutations or subtypes within HPV 52 DNA, as those are found in HPV 52 DNA and would be covered by the claim. Opinion Denying Reconsideration, 2007 WL 5614110, *6, 2007 U.S. Dist. Lexis 73010, *15-16.

The district court further construed the limitation “between approximately 15 and 8000 nucleotide bases” to mean “between 15 and approximately 8000 nucleotide bases,” reasoning that the applicant had disavowed fewer than 15 bases during prosecution. Claim Construction Opinion, 2007 WL 5425947, *7-10, 2007 U.S. Dist. Lexis 53882, *19-25. The court construed the term “HPV 52 DNA labeled with a detectable label” to mean “HPV 52 DNA that has a detectable label that is not DNA,” reasoning that, given previous constructions, the label could not be DNA. Id. 2007 WL 5425947, at *10, 2007 U.S. Dist. Lexis 53882, at *26.

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