The United States Court of Appeals for the Federal Circuit took up the question of internal use of an invention as it relates to a public use in determining patentability in Invitrogen Corp. v. Biocrest Mfg., L.P., Stratagene Holding Corp., & Stratagene, Inc., 04-1273, -1274.

On an earlier remand from the CAFC, the District Court, 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).

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. 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.

Stratagene made 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 and the district court construed the claims and then granted Stratagene’s summary judgment motion of non-infringement. Invitrogen appealed, disputing the lower court’s construction of both “improved competence” in the preamble and “growing” in step (a).

The CAFC decided that the trial court had correctly construed the term “improved competence.” The CAFC 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. The CAFC also noted that the trial court had incorrectly construed “growing.” The CAFC then 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).

On remand, the district court found literal infringement 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.

Undisputed was 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. Invitrogen kept its use of the claimed process confidential. The process was known only within the company. Stratagene did 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.” The Supreme Court considered the meaning of the phrase “the invention” in § 102(b) in Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 60 (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.”

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.” A bar under § 102(b) arises where, before the critical date, the invention is in public use and ready for patenting. The proper test for the public use prong of the § 102(b) statutory bar is whether the purported use: (1) was accessible to the public; or (2) was commercially exploited. Commercial exploitation is a clear indication of public use, but it likely requires more than, for example, a secret offer for sale. Thus, the test for the public use prong includes the consideration of evidence relevant to experimentation, as well as, , the nature of the activity that occurred in public; public access to the use; confidentiality obligations imposed on members of the public who observed the use; and commercial exploitation,

The district court reasoned that Stratagene had used the claimed process in its own laboratories, more than one year before the ’797 application was filed, to “further other projects” beyond development of the claimed process and to acquire a commercial advantage. Stratagene admitted that it used the claimed process in its own laboratories before the critical date to grow cells to be used in other projects within the company. The district court determined that use of the invention in Stratagene’s general business of widespread research generated commercial benefits. The district court found that this use was “public.” Stratagene argued that this secret internal use was not “public use” under the applicable test, because it neither sold nor offered for sale the claimed process or any product derived from the process, nor did it otherwise place into the public domain either the process or any product derived from it.

The CAFC then held that:

The basic tenet of U.S. patent law is that an original inventor gains an exclusive right to the invention. U.S. Const. art. I, § 8, cl. 8. Thus, an inventor’s own work cannot be used to invalidate patents protecting his own later inventive activities unless, inter alia, he places it on sale or uses it publicly more than a year before filing. 35 U.S.C. § 102(b); see also In re Katz, 687 F.2d 450, 454 (CCPA. 1982); In re Facius, 408 F.2d 1396, 1406 (CCPA 1969) (“[C]ertainly one’s own invention, whatever the form of disclosure to the public, may not be prior art against oneself, absent a statutory bar.”). Section 102(a) denies any applicant for a patent an exclusive right to any invention already “known or used by others in this country” (emphasis added). On the other hand, § 102(b) can apply to the inventor’s own actions. Section 102(b) expressly requires a “public use” in this country for a statutory bar to arise based on use by the inventor himself. See Pennock v. Dialogue, 27 U.S. 1, 23 (1829) (an applicant must be the “first and true” inventor to obtain a patent, but “if he shall put [the invention] into public use, or sell it for public use before he applies for a patent . . . this should furnish , 104 U.S. 333, 336 (1881); another bar to his claim”); Katz, 687 F.2d at 454 (“Disclosure to the public of one’s own work constitutes a bar to the grant of a patent claiming the subject matter so disclosed (or subject matter obvious therefrom).”). Further, to qualify as “public,” a use must occur without any “limitation or restriction, or injunction of secrecy.” Egbert v. Lippmann; In re Smith, 714 F.2d 1127, 1134 (Fed. Cir. 1983).

* * *

While there are instances in which a secret or confidential use of an invention will nonetheless give rise to the public use bar, this is not such a case. In Metallizing Engineering Co. v. Kenyon Bearing & Auto Parts Co., 153 F.2d 516 (2d Cir. 1946), the patentee used a secret process to recondition worn metal parts for its customers before the critical date. The Second Circuit correctly held “that it is a condition upon an inventor’s right to a patent that he shall not exploit his discovery competitively after it is ready for patenting; he must content himself with either secrecy, or [a patent].” Id. at 520. In contrast, there is no evidence that Invitrogen received compensation for internally, and secretly, exploiting its cells. The fact that Invitrogen secretly used the cells internally to develop future products that were never sold, without more, is insufficient to create a public use bar to patentability.

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