CAFC Emphasizes Flexibility of its Printed Publication Jurisprudence
Last week, I pointed out that the Federal Circuit faulted the Patent Trial & Appeal Board (PTAB) for its narrow public accessibility analysis in Medtronic, Inc. v. Barry. Given the de novo review of printed publication status at the Federal Circuit, it is an issue that is frequently challenged on appeal.
Last Friday the Court took another opportunity to apply its multi-factor analysis to a printed publication dispute in GoPro Inc., v. Cointour IP Holdings, LLC. In GoPro, the Court once again emphasized that focusing on a single factor (expertise of the audience) to the exclusion of others is reversible error. In reversing the Board’s decision in GoPro, the Court emphasized (here) that the reasonable diligence standard is applied to those skilled in the art. And that, proof of actual dissemination is not required, only that a person of skill could have located the publication with reasonable diligence.
In still another recent case, the Court explained that a commonly emphasized factor at the PTAB, indexing/searchability, is not a requirement to prove a printed publication publicly accessible.
In Jazz Pharms., Inc. v. Amneal Pharms., LLC the Court affirmed the PTAB and rejected the argument that public accessibility required that the printed publication be indexed/searchable. The Court found no requirement for index/searchable documents in its printed publication jurisprudence. Instead, it emphasized (1) breadth of dissemination; (2) Length of time the information was made available; and (3) lack of expectation of confidentiality, explaining (here):
The parties’ current dispute centers on the Board’s determination that the ACA materials were publicly accessible. The ACA materials consist of four documents associated with the public meeting held by the Xyrem advisory committee . . . . The Board determined that the ACA materials were publicly accessible on an FDA website listed in the Notice no later than October 4, 2001, over two months prior to the critical date of December 17, 2001.
A reference is considered publicly accessible “upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” “If accessibility is proved, there is no requirement to show that particular members of the public actually received the information.”
We agree with Amneal that substantial evidence supports the Board’s finding that the ACA materials were publicly accessible. . . . [¶] On May 14, 2001, the FDA announced a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee through the Notice in the Federal Register. . . . [¶] The Notice also included a hyperlink to an FDA website where background material from the drug sponsor and the FDA would be posted before the meeting, and the meeting minutes, transcript, and slides would be posted after the meeting.
First, the breadth of the dissemination here to persons of ordinary skill is significant. “[A] printed publication need not be easily searchable after publication if it was sufficiently disseminated at the time of its publication.” . . . [T]he Notice in the Federal Register widely disseminated the ACA materials through a hyperlink to a public FDA website where the ACA materials could be accessed. . . . [¶] Whether the disseminated material is addressed to or of interest to persons of ordinary skill is also relevant to the public accessibility inquiry. . . . As relevant here, wide dissemination of a reference through a publication like the Federal Register that those of ordinary skill would be motivated to examine is a factor strongly favoring public accessibility.
Second, the ACA materials were available online for a substantial time before the critical date of the patents in suit. “[T]he longer a reference is displayed, the more likely it is to be considered a ‘printed publication.’” . . . Here, the ACA materials were available on a public FDA website for at least two months before the critical date of the patents in suit.
Third, the ACA materials were distributed via public domain sources with no possible expectation that the materials would remain confidential or not be copied. We have consistently emphasized the importance of such expectations in determining whether a reference is publicly accessible. There can be no dispute that materials disclosed in the Federal Register and available online on a public FDA website have no expectation of confidentiality.
In sum, after considering the relevant factors identified in our public accessibility cases, the record here demonstrates that the ACA materials were widely disseminated to persons of ordinary skill for a substantial time with no reasonable expectation of confidentiality. They were “in the possession of the public,” and cannot be withdrawn from it.
The Court has issued a number of noteworthy decisions on public accessibility over the past few months. While the Court has repeatedly emphasized its multi-factor analysis, lack of confidentiality seems to hold significant sway in the ultimate determinations.