What Evidence Can Demonstrate That A Printed Publication Was Publicly Accessible?

On April 7, 2020, the Patent Trial and Appeal Board (PTAB) clarified what evidence can demonstrate that an asserted reference qualifies as a printed publication. This two-section article will first address four decisions designated informative, which shed light on how a petitioner in an IPR might successfully show a reference is a printed publication. Secondly, it will address a fifth decision, designated precedential, that clarified the difference between the burden to show a reference is a printed publication during ex parte examination versus in an inter partes review (IPR).

PART I: Burden to show a prior art printed publication in IPR

The four decisions summarized below provide guidance for Petitioners about the types of evidence of public accessibility the PTAB finds compelling, whereas Patent Owners should note how to challenge such evidence when it is insufficient.

Petitioner unsuccessful:

In Argentum Pharmaceuticals LLC v. Research Corp. Techs., Inc., IPR2016-00204, Paper 19 (informative), the petitioner was unable to demonstrate that a doctoral thesis from the University of Houston was a printed publication. One argument was that the patent owner had already conceded public accessibility in an unrelated district court case. But the PTAB found it was not sufficient to demonstrate the same in the IPR because the concession was limited to the litigation and not applicable to the IPR. Nor did the PTAB find the petitioner’s assertion that theses from University of Houston are generally publicly available enough. Petitioner argued that citations in academic papers to other University of Houston theses should be enough evidence. But the PTAB disagreed because none of the citations were to the thesis of interest. Denial by the University of the petitioner’s request for information on public access to the thesis was equally unpersuasive to the PTAB.

In In-Depth Geophysical, Inc. v. ConocoPhillips Co., IPR2019-00849, Paper 14 (informative), the petitioner was unable to demonstrate that a conference paper was a prior art printed publication. The petitioner relied upon an entry in the Researchgate website that listed the paper’s title next to a date of “September 2012” – a date more than one year prior to the challenged patent’s November 1, 2013 priority date. However, the petitioner presented no evidence as to what the Researchgate date meant. More damning was that the patent owner provided expert testimony that the paper was presented in a conference in November 2012, and papers were generally not release until the first day of the conference: in this case, November 4, 2012, less than one year before the critical date. Based on this publication date, the reference did not qualify as prior art under AIA 35 U.S.C. § 102(b)(1). Even the fact that a European patent examiner had relied upon the same paper in an Office Action of the European equivalent was unpersuasive to the PTAB because of Europe’s absolute novelty provisions, which do not contain a 1-year grace period like the U.S.

Petitioner successful:

In Seabery N. Am. Inc. v. Lincoln Global, Inc., IPR2016-00840, Paper 11 (informative), the petitioner, like in Argetnum above, relied on a thesis, this time from the University of Bremen, Germany. The petitioner also provided testimony from the author’s thesis advisor that: (1) the University’s rules at the time the thesis was written required the thesis to be deposited at the library; (2) he personally confirmed it was deposited and available for public retrieval; (3) the work was indexed in Germany’s national library system; (4) a reprint of the dissertation bears a copyright and publication date; and (5) excerpts based on the dissertation were published elsewhere. This was sufficient to demonstrate public accessibility for institution.

In Sandoz Inc. v. AbbVie Biotechnology Ltd., IPR2018-00156, Paper 11 (informative), the petitioner relied on a drug package insert providing evidence from the Internet Archive and Wayback Machine to demonstrate that the package insert was publicly available on the FDA’s website. The petitioner also provided expert testimony that (i) a skilled artisan would know that labels for drugs were available for review on the FDA website, (ii) physicians could and did access that website, and (iii) a skilled artisan could have easily accessed the website and found the specific drug package insert relied on by the petitioner. While the PTAB denied institution on the merits, it did, nonetheless, find the proffered evidence sufficient at institution to show the drug package insert to be a printed publication.

PART II: Burden to show prior art printed publication in ex parte examination is different than that in IPRs

In Ex Parte Grillo-Lopez, Appeal 2018-006082 (precedential), the patent applicant was faced with the same potential prior art that a petitioner presented in IPR proceedings. In the IPR proceedings, the PTAB held that the petitioner did not carry its burden to establish that the publication in question was prior art. In the ex parte prosecution appeal, however, the PTAB held that the patent examiner established prior art status sufficiently to shift the burden to the applicant.

During prosecution, the Examiner had rejected Grillo-Lopez’s patent application, in part, over a transcript of an FDA committee meeting. The Examiner asserted that the transcript was a printed publication by providing (i) publication of the Notice of Hearing of the July 25, 1997 meeting in the Federal Register, (ii) attendance of the hearing by interested members of the public, and (iii) legislation supporting public accessibility of FDA transcripts. Rather than rebut this evidence, Grillo-Lopez instead cited to PTAB decisions in which an IPR petitioner had failed to establish that the same or similar transcripts were printed publications.

In its appeal decision, the PTAB first clarified that burden framework during examination is different from that in an IPR. In a IPR, “at the institution stage, the petition must identify, with particularity, evidence sufficient to establish a reasonable likelihood that the reference was publicly accessible before the critical date of the challenged patent and therefore that there is a reasonable likelihood that it qualifies as a printed publication.” However, as earlier PTAB decisions, held, in ex parte examination, “the examiner met his burden of proof by setting forth the nominal publication date. . . . The Patent and Trademark Office is in no position to establish any thing beyond that. The burden is clearly upon appellants to disprove the prima facie publication date established by the examiner.” Based on this, the PTAB concluded that “the framework set forth [] for IPR proceedings does not apply to [patent] examination.”

It is this difference in burden that allowed the PTAB to find that the Examiner could demonstrate public availability of an FDA transcript that had not been shown to be publicly available in an IPR: “Given the different legal frameworks and burdens for establishing a reference as prior art in IPR proceedings [compared to ex parte patent] examination, the Decision is not contrary to the Board decisions finding that a petitioner failed to meet its burden of showing that the FDA transcript is a printed publication.”

This decision highlights the different between an examiner’s low threshold to meet their burden compared to a higher burden placed on a Petitioner for the same document.

* * *

The takeaways here are two-fold. First, patent practitioners should not expect Examiners to meet a high burden to show that a reference is a “printed publication.” Instead, practitioners should be prepared to present compelling rebuttal evidence. Second, post-grant practitioners challenging a patent should evaluate whether a prior art reference, whose status as a “printed publication” is arguable, might be better suited to file a request for ex parte reexamination rather than an IPR/PGR petition.

This article appeared in the April 2020 issue of PTAB Strategies and Insights. To view our past issues, as well as other firm newsletters, please click here.