Invitrogen Corp. v. Biocrest Mfg., L.P.

• Decision Date: 05 October 2005
• Docket Number: No. 04-1273.,No. 04-1274.,04-1273.,04-1274.
• Citation: 424 F.3d 1374
• Parties: INVITROGEN CORPORATION, Plaintiff-Appellant, v. BIOCREST MANUFACTURING, L.P., Stratagene Holding Corp., and Stratagene, Inc., Defendants-Cross Appellants.
• Court: U.S. Court of Appeals — Federal Circuit

424 F.3d 1374

INVITROGEN CORPORATION, Plaintiff-Appellant, v. BIOCREST MANUFACTURING, L.P., Stratagene Holding Corp., and Stratagene, Inc., Defendants-Cross Appellants.

No. 04-1273.

No. 04-1274.

United States Court of Appeals, Federal Circuit.

October 5, 2005.

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Francis M. Wikstrom, Parsons Behle & Latimer, of Salt Lake City, Utah, argued for plaintiff-appellant. With him on the brief were C. Kevin Speirs and Kristine Edde Johnson. Of counsel on the brief was Alan W. Hammond, Invitrogen Corporation, of Carlsbad, California.

Marc R. Labgold, Patton Boggs LLP, of McLean, Virginia, argued for defendants-cross appellants. With him on the brief were Scott A.M. Chambers and Kevin M. Bell; and Richard J. Oparil, of Washington, DC.

Before RADER, DYK, and PROST, Circuit Judges.

RADER, Circuit Judge.

On remand from this court, the United States District Court for the Western District of Texas, on summary judgment, determined that Biocrest Manufacturing, L.P., Stratagene Holding Corporation, and Stratagene, Inc. (collectively Stratagene) infringed Invitrogen Corporation's (Invitrogen's) U.S. Patent No. 4,981,797 (issued Jan. 1, 1991) (the '797 patent), and that the '797 patent was not invalid for indefiniteness, although it was invalid because of public use under 35 U.S.C. § 102(b). Invitrogen Corp. v. Biocrest Mfg., No. A-01-CA-167-SS (W.D.Tex. Feb. 12, 2004) (Invitrogen II). Although not specifically enumerating all of the counterclaims on which judgment was obviated due to its holding on invalidity, the trial court rendered final judgment sufficient to give this court jurisdiction under 28 U.S.C. § 1295(a)(1) (2000). See Pandrol v. Airboss, 320 F.3d 1354, 1362-63 (Fed.Cir.2003) ("What essentially is required is some clear and unequivocal manifestation by the trial court of its belief that the decision made, so far as it is concerned, is the end of the case."). This court affirms the trial court's decisions on infringement and on non-invalidity due to indefiniteness. Because the district court relied on an incorrect understanding of public use, this court reverses the trial court's judgment of invalidity on that ground and remands.

I.

The '797 patent involves the introduction of recombinant DNA molecules into receptive E. coli cells to improve the cells' "competence," i.e., their ability to take up and establish exogenous DNA and replicate this DNA as they multiply. See '797 patent col. 1, ll. 11-13. A cell that accepts alien DNA is called a transformable cell.

Claim 1 of the '797 patent claims:

A process for producing transformable E. coli cells of improved competence by a process comprising the following steps in order:

(a) growing E. coli in a growth-conductive medium at a temperature of 18 C to 32 C;

(b) rendering said E. coli cells competent; and

(c) freezing the cells.

'797 patent, col. 10, ll. 27-32 (emphasis added). Stratagene makes thirty-four competent E. coli cell lines by a process "including the steps of incubating cells at 37 C, growing the cells in a fermenter at 26 C, and freezing the cells."

Invitrogen sued Stratagene for infringement on March 12, 2001. The district court construed the claims and then granted Stratagene's summary judgment motion of non-infringement. Invitrogen appealed to this court, disputing the lower court's construction of both "improved competence" in the preamble and "growing" in step (a). This court decided that the trial court had correctly construed the term "improved competence." Invitrogen Corp. v. Biocrest Mfg., 327 F.3d 1364, 1370 (Fed.Cir.2003) (Invitrogen I). This court noted that the term required only a general increase in competence, as compared with that generally obtained when cells are prepared by either (1) growing the cells at 37 C, rendering them competent, and freezing them, or (2) growing the cells at 37 C, rendering them competent, and not freezing them. Id. At the same time, however, this court decided that the trial court had incorrectly construed "growing." Id. This court construed that term to permit preparatory steps in advance of step (a), including growth of E. coli at a temperature outside the range in step (a). Id. Thus, the trial court received the case on remand.

On remand, the trial court properly applied this court's construction of "growing" by stating that "the temperature of the medium in which the E. coli cells are grown" before step (a) "does not matter." The district court then found literal infringement of claims 1, 2, 4, 5, 7, 8, 11, 14, and 15 of the '797 patent; decided that Claim 1 was not indefinite under 35 U.S.C. § 112, ¶ 2; and found the claims invalid under the public use provision of 35 U.S.C. § 102(b). The court dismissed all other motions as moot. See Invitrogen II.

II.

This court reviews a grant of summary judgment de novo, determining whether the evidence in the record raises any genuine dispute about material facts. In this review, all reasonable factual inferences are drawn in favor of the non-moving party. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1346 (Fed.Cir.2002), cert. denied, 538 U.S. 907, 123 S.Ct. 1487, 155 L.Ed.2d 227 (2003). Whether a patent is invalid due to public use under § 102(b) is a question of law based on underlying questions of fact. Netscape Communications Corp. v. Konrad, 295 F.3d 1315, 1321 (Fed.Cir.2002). A patent is presumed valid. 35 U.S.C. § 282 (2000). Overcoming the presumption requires a showing of facts proved by clear and convincing evidence. Connell v. Sears Roebuck & Co., 722 F.2d 1542, 1549 (Fed.Cir.1983). That standard of proof also applies in the summary judgment context. Nat'l Presto Indus., Inc. v. W. Bend Co., 76 F.3d 1185, 1189 (Fed.Cir.1996). Overall, this court makes an independent determination, applying the standards for summary judgment. Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041, 1045 (Fed.Cir.2001).

The Federal Circuit applies its own law with respect to issues of substantive patent law and certain procedural issues pertaining to patent law, but applies the law of the regional circuits on non-patent issues. Institut Pasteur v. Cambridge Biotech Corp., 186 F.3d 1356, 1368 (Fed.Cir.1999). Therefore, this court reviews the district court's evidentiary rulings under the law of the United States Court of Appeals for the Fifth Circuit for an abuse of discretion. Snap-Drape, Inc. v. Comm'r of Internal Revenue, 98 F.3d 194, 197 (5th Cir.1996).

The parties do not dispute that Invitrogen used the claimed process before the critical date, in its own laboratories, to produce competent cells. Invitrogen did not sell the claimed process or any products made with it. The record also shows that Invitrogen kept its use of the claimed process confidential. The process was known only within the company. Stratagene does not dispute that the claimed process was maintained as a secret within Invitrogen until some time after the critical date.

35 U.S.C. § 102(b) states that a person shall be entitled to a patent unless "the invention was . . . in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States." 35 U.S.C. § 102(b) (2000) (emphasis added). In Pfaff v. Wells, the Supreme Court considered the meaning of the phrase "the invention" in § 102(b). Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 60, 119 S.Ct. 304, 142 L.Ed.2d 261 (1998). The Court explained that analysis under § 102(b) involves two separate inquiries, one evaluating whether "the invention" was complete and ready for patenting, and the other evaluating whether that invention was "on sale." Id. at 66-67, 119 S.Ct. 304. In that context, the Court found no role for this court's "totality of the circumstances" test, which directed a court to consider the circumstances surrounding the alleged offer for sale together with the circumstances surrounding the stage of development of the invention that may have been prematurely exploited in the market. See id. at 66, n. 11, 119 S.Ct. 304. In place of that "totality of the circumstances" test, the Court formulated the now-familiar test that evaluates both whether the product was subject to a commercial offer for sale (i.e., was it "on sale") and whether the invention was "ready for patenting" (i.e., was there an "invention" at the time of the sale). See id. at 67, 119 S.Ct. 304. Following the Court's guidance in Pfaff, this court rejected the totality of the circumstances test in the context of statutory bar disputes. See EZ Dock v. Schafer Sys., Inc., 276 F.3d 1347, 1351 (Fed.Cir.2002) ("[T]his court now `follows the Supreme Court's two-part test without balancing various policies according to the totality of the circumstances.'") (quoting Weatherchem Corp. v. J.L. Clark, Inc., 163 F.3d 1326, 1333 (Fed.Cir.1998)).

In Pfaff, the Court specifically considered the "on sale" portion of the § 102(b) statutory bar language, but in so doing, the Court noted that both the "on sale" and "public use" bars were based on the same policy considerations. Id. at 64, 119 S.Ct. 304. The Court noted that both the on sale and public use bars of § 102 stem from the same "reluctance to allow an inventor to remove existing knowledge from public use." Id. In Pfaff, the Court applied the separate components of its test to facts raising the "on sale" issue. Nonetheless, the Court's analysis of the statutory term "invention," or the ready for patenting prong, applies to both of the other parts of section 102(b), "on sale" and "public use." Thus, the Supreme Court's "ready for patenting test" applies to the public use bar under § 102(b). A bar under § 102(b) arises where, before the critical date, the invention is in public use and ready for patenting. This court notes that in applying the Pfaff two-part test in the context of a public use bar, evidence of experimental use may negate either the "ready for patenting" or "public use" prong. See EZ Dock, 276...