Clontech Laboratories, Inc. v. Invitrogen Corp.

• Decision Date: 05 May 2005
• Docket Number: No. 03-1464.,No. 04-1099.,03-1464.,04-1099.
• Parties: CLONTECH LABORATORIES, INC., Plaintiff-Appellee, v. INVITROGEN CORPORATION (formerly Life Technologies, Inc.), Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

Page 1347

406 F.3d 1347

CLONTECH LABORATORIES, INC., Plaintiff-Appellee, v. INVITROGEN CORPORATION (formerly Life Technologies, Inc.), Defendant-Appellant.

No. 03-1464.

No. 04-1099.

United States Court of Appeals, Federal Circuit.

May 5, 2005.

COPYRIGHT MATERIAL OMITTED

Marc R. Labgold, Patton Boggs LLP, of McLean, Virginia, argued for plaintiff-appellee. With him on the brief were Michael J. Schaengold, Richard J. Oparil, and Kevin M. Bell. Of counsel was Scott A.M. Chambers.

Jay I. Alexander, Milbank, Tweed, Hadley & McCloy LLP, of Washington, DC, argued for defendant-appellant. With him on the brief were Robert J. Koch, of Washington, DC, and James Pooley, of Palo Alto, California. Of counsel on the brief were Kevin R. Casey and Harrie R. Samaras, RatnerPrestia P.C., of Valley Forge, Pennsylvania; and, Alan W. Hammond, Invitrogen Corporation, of Carlsbad, California.

Before CLEVENGER, DYK, and PROST, Circuit Judges.

CLEVENGER, Circuit Judge.

Invitrogen Corporation appeals the judgment of the United States District Court for the District of Delaware holding that Invitrogen falsely marked certain of its molecular biology products. Clontech Labs., Inc. v. Invitrogen Corp., 263 F.Supp.2d 780 (D.Del.2003). Because the evidence does not support the court's finding that the relevant tests put Invitrogen on clear notice that certain products were not covered by the patents used to mark those products, we affirm-in-part, reverse-in-part, vacate-in-part, and remand for further proceedings consistent with this opinion.

I

This appeal arises from a 1998 lawsuit filed by Clontech Laboratories, Incorporated ("Clontech") against Invitrogen Corporation ("Invitrogen") (formerly Life Technologies, Incorporated) alleging, inter alia, false marking under 35 U.S.C. § 292. The patents involved in the suit all claim priority to U.S. Patent Application No. 143,396, which was filed on January 13, 1988. The '396 application was continued as U.S. Patent Application 671,156, filed March 18, 1991, which issued as U.S. Patent No. 5,244,797 ("the '797 patent"). The '156 application was divided, giving rise to U.S. Patent Application No. 825,260, filed January 24, 1992, which issued as U.S. Patent No. 5,405,776 ("the '776 patent"). The '260 application was continued as U.S. Patent Application No. 404,907, filed March 15, 1995, and was again continued as U.S. Patent Application No. 614,260, filed March 12, 1996, which issued as U.S. Patent No. 5,668,005 ("the '005 patent"). The 614,260 application was continued as U.S. Patent Application No. 798,458, filed February 10, 1997, which issued as U.S. Patent No. 6,063,608 ("the '608 patent").

All four patents share the same title: "Cloned Genes Encoding Reverse Transcriptase Lacking RNase H Activity." The claims in all four patents are generally directed to RNase H deficient Reverse Transcriptase ("RT") polypeptides, see, e.g., the '797 patent (claim 1), the '608 patent (claim 1); polynucleotides encoding RT polypeptides, see, e.g., the '776 patent (claim 1), the '005 patent (claim 1), the '608 patent (claim 185); methods of using RTs to prepare DNA molecules, see, e.g., the '005 patent (claim 8), the '608 patent (claim 189); and kits for preparing DNA molecules using RTs, see, e.g., the '005 patent (claim 25), the '608 patent (claim 195).

Invitrogen markets RNase H deficient RTs known as SUPERSCRIPT ("SS") and SUPERSCRIPT II ("SSII"). 263 F.Supp.2d at 786. SS and SSII are virally derived RTs either missing sequences important for RNase H activity, e.g., SS, or containing point mutations in regions of the RT coding sequence important for RNase H activity, e.g., SSII. Id. Invitrogen also produces and sells kits containing SSII as well as a wide variety of cDNA libraries purportedly made using SSII. Id. SS and SSII have been marked with all four patents. Id. at 788. In addition, the kits containing SSII and the many cDNA libraries have been marked with some of the patents at issue. See (J.A. at 2742-61).

II

Below, the parties disputed whether Invitrogen's SS, SSII, kits, and cDNA library products were falsely marked. In particular, the parties contested whether the patents at issue covered Invitrogen's many cDNA library products and whether the kits and SUPERSCRIPT products failed to meet the "substantially no RNase H activity" limitation of this family of patents, see, e.g., the '797 patent (claim 1), the '776 patent (claims 1 and 5), the '005 patent (claims 1, 8, 21, 30, and 34), and the alternative language of the most recent family member, the '608 patent, see, e.g., claim 1 ("substantially reduced RNase H activity"), claim 3 ("no detectable RNase H activity"), claim 24 ("does not significantly degrade an mRNA template"), claim 31 ("no detectable RNase H activity").

The trial court held that Invitrogen's SS, SSII, kits, and cDNA library products had been falsely marked with the patents in suit. 263 F.Supp.2d at 793. The trial court determined that "[n]one of Invitrogen's patents in suit are directed to cDNA libraries," id. at 790, and that the claim limitation "substantially no RNase H activity," as used in this family of patents, was defined in the written description. Id. at 785. Specifically, the court concluded that the written description defines "substantially no RNase H activity" in terms of an assay that measures how active a nearly pure population of RT polypeptides is at cutting RNA:

By the terms `substantially no RNase H activity' is intended reverse transcriptase purified to near homogeneity and having an RNase H activity of less than 0.001 pmoles [³H](A)_n solubilized per ¢g protein with a [³H](A)_n-(dT)_n substrate in which the [³H](A)n [sic] has a specific radioactivity of 2,200 cpm/pmole. RNase H activities of this specific activity or less allows the preparation of cDNA without significant degradation of the mRNA template during first-strand synthesis. The '797 patent, col. 9, ll. 14-22; see also the '776 patent, col. 9, ll. 14-22; the '005 patent, col. 9, ll. 19-27; the '608 patent, col. 9, ll. 21-29.¹ The court did not distinguish between the "substantially no RNase H activity" used in the claims of the '797,-'776, and '005 patents and the alternative language used in the claims of the '608 patent.

Interpreting 35 U.S.C. § 292, the trial court placed the burden on Clontech to prove four elements: "(1) a marking importing that an object is patented (2) falsely affixed to (3) an unpatented article (4) with intent to deceive the public." 263 F.Supp.2d at 791. Then the court considered these elements in light of evidence pertaining to Invitrogen's products and patents as well as several RNase H activity experiments performed over the life of this patent family by the inventors and other Invitrogen scientists and experts. Id. at 787-88, 792-93. The evidence included experimental results from solubilization and gel assays performed in 1990, 1991, 1996, and 2000. Id. at 787-88. In contrast to the earlier experiments, the 2000 experiments were performed using the solubilization assay defined in the written description for the "express purpose" of determining whether Invitrogen's SS and SSII meet the limitation of "substantially no RNase H activity." Deciding that the 2000 experiments were dispositive, the court found that "[a]t the very least, these tests put [Invitrogen] on notice that its products were not covered by the patents in suit and any good faith belief that [Invitrogen] had that its products were covered by the patents was lost." Id. at 793. The court reasoned that after this notice, "[Invitrogen's] failure to correct its mistaken mismarking of its products rose to the level of deceptive intent." Id. Accordingly, the court held Invitrogen liable for falsely marking its products in violation of 35 U.S.C. § 292.

Invitrogen appeals, arguing that the trial court miscomprehended the legal standard applicable to the element of intent to deceive, committed clear factual error in interpreting the results of the 2000 experiments, and erred by interpreting 35 U.S.C. § 292 as prohibiting marking where the patent does not cover the product at issue. Clontech responds, arguing that the trial court applied the correct legal standards and did not err in its interpretation of the 2000 test results. We have jurisdiction to hear this case pursuant to 28 U.S.C. § 1338(a) (2000) and 28 U.S.C. § 1295(a)(1) (2000).

III

We begin with the statute in suit, which provides that:

Whoever marks upon, or affixes to, or uses in advertising in connection with any unpatented article, the word `patent' or any word or number importing that the same is patented for the purpose of deceiving the public ... [s]hall be fined not more than $500 for every such offense.

35 U.S.C. § 292(a) (2000).

The case law of this circuit on the statute in suit is sparse. In fact, only one precedent has substantively addressed the statute, and in that case, we affirmed, without discussion of the text of the statute, the trial court's holding that no violation of the statute had occurred because the plaintiff failed "to produce any evidence of intent to deceive the public." Arcadia Mach. & Tool, Inc. v. Sturm, Ruger & Co., 786 F.2d 1124, 1125 (Fed.Cir.1986). Consequently, this case presents us with virtually an issue of first impression.

The statute supplies a civil fine for false marking of articles. Id. at 1125. According to the statute, when an unpatented article is marked with the word "patent" or any word or number that imports that the article is patented, and such marking is for the purpose of deceiving the public, the fine is invoked. When the statute refers to an "unpatented article" the statute means that the article in question is not covered by at least one claim of each patent with which the article is marked. Thus, in order to determine if an article is "unpatented" for purposes of section 292, it must be first determined whether the claims of a patent cover the article in question. To make...