Pronova Biopharma Norge v. Teva Pharms., No. 2012-1498 (Fed. Cir.)
It is not unusual for a defendant in an ANDA case to assert invalidity due to prior public use, but it is rare that such a defense succeeds. In a unanimous decision last week, the Federal Circuit held the asserted claims of Pronova's U.S. Patent No. 5,656,667 invalid as anticipated by prior public use, reversing a District of Delaware trial decision in the process.
Pronova's '667 patent protects Lovaza capsules, a drug product derived from fish oil and indicated to reduce triglyceride levels. The asserted claims of the '667 patent were directed to pharmaceutical compositions comprising specific concentrations of different omega fatty acids.
The parties agreed that more than one year before the priority date of the '667 patent, Pronova's predecessor shipped two vials of a composition that met all of the limitations of the asserted claims to a third-party researcher, Dr. Skrinska. Evidence at trial showed that Skrinska "tested the two samples to confirm (and did confirm) their content." There was no evidence, however, that Skrinska used the samples to reduce triglyceride levels in a person.
The primary issue on appeal was whether Pronova's shipment of the samples and Skrinka's testing amounted to an invalidating public use. Pronova argued that to be invalidating under § 102(b), an invention must be used by someone other than the inventor for its intended purpose—here, to reduce triglyceride levels. The ANDA filers, on the other hand, contended that an invalidating public use need not be the intended use of the invention, as long as the invention is fully disclosed without restriction.
The Federal Circuit explained the test for "public use" in Invitrogen v. Biocrest:
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, inter alia, 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 Federal Circuit held that the "use" in Pronova met this test, stating:
Because we find that [Pronova] sent samples of the invention claimed in the '667 patent Skrinska . . . without restriction and Skrinska thereafter tested the samples, we hold that [Pronova] put its invention to an invalidating public use.
The court contrasted this case to Dey v. Sunovion, another recent case in which an ANDA filer asserted prior public use as an invalidity defense. There, the purported public use was a clinical trial of the claimed pharmaceutical composition. But there, as the court explained:
Because only the clinical trial administrator, not the subjects taking the medication, was made aware of the invention's claimed formulation and stability characteristics, and the administrator had signed a pledge of confidentiality, we held that "a finder of fact could conclude that the study was conducted with a reasonable expectation of confidentiality as to the nature of the formulations being tested, [such that] summary judgment on the public use issue was inappropriate." A fact finder could so conclude even though the subjects did not likewise sign a confidentiality pledge because "they were given incomplete descriptions of the treatment formulation."
Finally, the court addressed Pronova's argument that only the "intended use" of a pharmaceutical can qualify as a "public use":
We are not persuaded by Pronova's argument that "use" of a pharmaceutical formulation cannot occur until it is used to treat the condition it is intended to counteract, or at least physically ingested. Certainly, where . . . unsophisticated users are provided a compound with no detail regarding its formulation—as in Dey—there will be no public use. Where, as here, however, a compound is provided without restriction to one highly skilled in the art, that compound's formulation is disclosed in detail, and the formulation is subject to confirmatory testing, no other activity is needed to render that use an invalidating one. Once the formulation was disclosed in full to Skrinska, without any restriction on its use, it had been released into the "public domain" for purposes of 102(b).