The Supreme Court's two-prong test for determining whether a claimed invention was on sale prior to the critical date (commercial offer for sale, ready for patenting) applies to public use under §102(b) as well. The "totality of the circumstances" analysis is not used to evaluate public use as a basis of invalidity.
In Invitrogen v. Biocrest, Nos. 04-1273, -1274 (Fed. Cir. Oct. 5, 2005), the federal circuit affirmed a district court grant of summary judgment that Invitrogen's `797 patent was not invalid for indefiniteness and was infringed by defendants Biocrest and Stratagene. However, the federal circuit reversed the determination that the patent was invalid under §102(b) for public use prior to the critical date.
The `797 patent is directed to the introduction of recombinant DNA into receptive E. coli cells to improve the cells' ability to take up and establish exogenous DNA and replicate this DNA as they multiply. The district court found the patent invalid under the public use bar of §102(b) based on Invitrogen's use of the claimed process before the critical date in its own laboratories, to produce competent cells, even though Invitrogen never sold the claimed process or any products made with it and kept its use of the claimed process confidential. The claimed process was known only within the company.
On appeal, Invitrogen argued that that its secret internal use was not "public use" under the "totality of the circumstances" test as found by the district court, 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 federal circuit reviewed the policy considerations underlying the "on-sale" and "public use" statutory bars as set forth by the Supreme Court in Pfaff, and rejected a "totality of the circumstances" analysis as the test for public use under §102(b). According to the court, identical policy considerations underlying the two statutory bars justified application of Pfaff's two-part on-sale test to public use bars:
the [Supreme] 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. (emphasis added).
The proper test for the public use prong of the §102(b) statutory bar is therefore whether the purported use: (1) was accessible to the public; or (2) was commercially exploited. Probative is evidence relevant to: experimentation, 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. Because Invitrogen never received compensation for internally and secretly using its cells to develop future products that were never sold, the public use bar to patentability was not triggered.
The court affirmed the finding of infringement, affirming the admissibility of an expert's tests showing that 28 of 33 of Stratagene's cell strains showed "improved competence" as claimed. Finally, the court affirmed the finding that the `797 patent was not indefinite, distinguishing between the requirement that a claim delineate to a skilled artisan the bounds of the invention, and a potential infringer's ability to ascertain the nature of its own accused product to determine infringement.
Please visit http://media.aplf.org/rm/20051012-public/Issue2005-52.pdf for a copy of the case for your reference.
To discuss these topics further, please feel free to contact the author Michael R. Dzwonczyk, (email@example.com), at Sughrue Mion, PLLC in Washington DC, USA.
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