Late last year, the PTAB's Precedential Opinion Panel clarified that in an IPR, it is the petitioner's burden to show a reasonable likelihood that an asserted reference qualifies as a printed publication. See Hulu, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 (Dec. 20, 2019) (designated precedential Dec. 20, 2019). On April 7, the PTAB further clarified what evidence can meet that burden. One decision, designated precedential, discusses what is required to show a reference is a printed publication in the examination context. Four other decisions, designated informative, shed light on how a petitioner in an IPR can successfully show a reference is a printed publication.

Examination

Ex parte Grillo-Lopez, Appeal 2018-006082 (Jan. 31, 2010) (precedential)

In denying the applicant's request for rehearing in Ex parte Grillo-Lopez, the PTAB interpreted what qualifies as a printed publication during ex parte examination. Grillo-Lopez's patent application was rejected, in part because the Examiner determined that a transcript of an FDA committee meeting that anticipated the claimed invention was a printed publication available to the public before Grillo-Lopez's submitted his application.

Grillo-Lopez argued that the transcript was not a printed publication, citing to PTAB decisions in which an IPR petitioner had failed to establish that the same or similar transcripts were printed publications. The Board disagreed, clarifying that there is a different burden framework during ex parte examination compared to an IPR. In an IPR, the petitioner is required to present evidence showing that it is reasonably likely to prevail in establishing unpatentability of the challenged claims. In ex parte examination, however, after the USPTO has made a prima facie case, it can then shift the burden to the applicant to overcome that case.

In this case, the Examiner noted that a skilled artisan would find it reasonably likely that the FDA would publish such transcripts in the Federal Register. In addition, the Examiner identified at least one member of the public who actually attended the committee meeting from which the transcript was generated. This evidence was enough for the USPTO to make a prima facie case, and the patent applicant had not sufficiently rebutted the USPTO's position. The Board thus declined to rehear its previous decision

Inter Partes Review (IPR)

Argentum Pharmaceuticals LLC v. Research Corp. Techs., Inc., IPR2016-00204, Paper 19 (May 23, 2016) (informative as to section II.B)

The asserted reference: A doctoral thesis from the University of Houston.

The petitioner's evidence: (1) The patent owner, in a district court case not involving the petitioner, submitted a "Joint Statement of Uncontested Facts" agreeing that for purposes of the litigation, the thesis was a publicly accessible printed publication. (2) The University of Houston denied the petitioner's request for information on public access to the thesis, which the petitioner believed entitled it to a rebuttable presumption that the information would establish the thesis as a printed publication. (3) Theses at the University of Houston are generally publicly accessible, as indicated by other theses' citation in academic papers before the patent's critical date.

Was it enough? No. The joint statement, submitted in a case not involving the petitioner, expressly stated that it agreed the thesis was a printed publication only for purposes of that specific litigation. Because parties may agree to stipulate to certain facts for many reasons, the Board found that the statement was not persuasive evidence that the thesis was a publicly accessible printed publication. Further, the University of Houston refusing to provide information to the petitioner did not create a presumption that the thesis was publicly accessible. And, finally, the petitioner did not sufficiently show that other theses at the University were available to the public, since each article cited by the petitioner that referenced theses by University of Houston students was either authored by the student who wrote the thesis or the student's advisor. According to the Board, none of petitioner's evidence showed that the asserted thesis was publicly accessible. The Board thus found that the asserted thesis did not qualify as a printed publication.

Seabery N. Am. Inc. v. Lincoln Global, Inc., IPR2016-00840, Paper 11 (Oct. 6, 2016) (informative as to section II.A.i)

The asserted reference: A doctoral dissertation from the University of Bremen, Germany.

The petitioner's evidence: The author's thesis advisor testified 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.

Was it enough? Yes. Without further explanation, the Board found that the petitioner had sufficiently demonstrated that the asserted thesis qualified as a printed publication based on the thesis advisor's testimony.

Sandoz Inc. v. AbbVie Biotechnology Ltd., IPR2018-00156, Paper 11 (June 5, 2018) (informative as to section III.C.1)

The asserted reference: A drug package insert.

The petitioner's evidence: (1) The package insert was publicly available on the FDA's website, as demonstrated by the Internet Archive and Wayback Machine.  (2) Expert testimony stating that a skilled artisan would know that labels for drugs were available for review on the FDA website, physicians including himself could and did access that website, and a skilled artisan could have easily accessed the website and found the specific drug package insert asserted by the petitioner.

Was it enough? Yes. The Board acknowledged that the petitioner had not provided evidence of indexing, which can be probative of public accessibility, but found that "evidence of indexing is not necessarily required in all cases." Despite lacking indexing evidence, the petitioner had submitted unrebutted expert testimony showing that the reference was publicly available to those interested. According to the Board, this was enough to make a threshold showing that the reference qualified as a printed publication.

In-Depth Geophysical, Inc. v. ConocoPhillips Co., IPR2019-00849, Paper 14 (Sept. 6, 2019) (informative as to section I.E)

The asserted reference: A conference paper.

The petitioner's evidence: (1) According to the Researchgate website, the paper was published by September 2012 (and thus just outside the one-year grace period). (2) An office action issued by the European Patent Office ("EPO") in a related European counterpart application referenced the paper.

Was it enough? No. Although the Researchgate website listed the paper's title next to a date of "September 2012," there was nothing to indicate what that date represented. Further, the petitioner had not attempted to authenticate the Researchgate exhibit. The only date evidence on the paper itself indicated that the paper was presented at the "2012 SEG Conference," which occurred in November 2012, well within the 1-year grace period. The patent owner's expert testified that typically, authors confidentially submit their papers several months before a conference, but the papers are not released until the first day of the conference itself. Because the petitioner's remaining evidence related to the paper's citation by a foreign patent office, the Board determined that this evidence could not persuasively establish a specific publication date in view of the EPO's absolute novelty provisions, which do not contain a 1-year grace period. The Board thus found that the petitioner had not shown that the conference paper qualified as a printed publication.

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