On April 7, the PTAB designated five decisions as either precedential or informative on establishing a printed publication. Importantly, the PTAB held that Examination and IPR proceedings use different standards. These decisions also provide guidance on how various types of references qualify as printed publications, including conference materials, drug product labels, and theses.
Ex parte Grillo-Lopez, No. Appeal 2018-006082 (P.T.A.B. Jan. 31, 2020) (Precedential)
This decision concerned whether an FDA Advisory Committee meeting transcript relied on by an Examiner was “sufficiently accessible to the public interested in the art so as to render it a printed publication” under 35 U.S.C. § 102(b). This issue was heard by the USPTO’s Precedential Opinion Panel (POP).
The POP held that the framework for establishing a printed publication outlined in Hulu v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 13 (P.T.A.B. Dec. 20, 2019) (precedential) does not apply to Examination. We previously discussed that decision here. The POP based its reasoning on the different “legal frameworks and burdens” between IPRs and Examination. In IPRs, the burden rests with the Petitioner to establish a reasonable likelihood that the challenged claims are unpatentable, whereas Examination involves a burden-shifting framework where the burden shifts to the applicant to rebut a prima facie case.
The POP concluded that the Examiner had sufficiently established that the transcript was publicly accessible because the “publication of the notice of the advisory committee meeting [was] intended to ‘insure that all interested persons are notified of such meeting prior thereto.'” Because persons of ordinary skill in the art would be such “interested persons,” and FDA transcripts of advisory committee meetings would be publicly available at “a designated place at the agency,” the transcript satisfied the requirements to be a printed publication.
In-Depth Geophysical, Inc. v. ConocoPhillips Co., Case IPR 2019-00849, Paper No. 14 (P.T.A.B. Sept. 6, 2019) (Informative as to § I. E)
The primary issue at IPR institution was whether “Li,” a conference paper, was publicly accessible as of November 1, 2012, because the patent-at-issue’s priority date was one year later. The Petitioner asserted that Li was publicly available because a Researchgate webpage referred to it as a “Conference Paper” and stated “September 2012 with 45 Reads.” The Petitioner also argued that Li bore a copyright date of “2012 SEG” and was the primary reference in the European Patent Office (EPO) examination of the European patent application corresponding with the U.S. patent-at-issue here. That European patent application also listed Li in its “Background” section.
The Patent Owner responded as follows:
- The date of “September 2012” listed on Li is not identified as a publication date.
- Li provides a copyright date of 2012, along with “SEG Las Vegas 2012 Annual Meeting.”
- The copy of Li submitted with the petition contained a download date of February 25, 2013.
- The Patent Owner relied on the declaration of an SEG member of over 40 years who testified that the “September 2012” date is not a publication date and that Li was likely first made available at the SEG 2012 Annual Meeting, which was several days after the critical date.
- Li does not qualify as prior art in the United States simply because it was referenced in the EPO prosecution because the EPO uses an absolute novelty standard for qualifying prior art.
The PTAB found the Patent Owner’s declaration evidence “compelling” and that “Li was potentially first disseminated” after the critical date. The PTAB found that the “September 2012” date on the document and the copyright notice “shed[] virtually no light on whether the document was publically accessible before November 1, 2012.” Finally, the “consideration of Li in the EPO prosecution is not compelling evidence of a specific publication date because of the EPO’s absolute novelty provisions,” which could ensnare a broader scope of references as prior art publications. As a result, Li was not considered to be a printed publication.
Sandoz Inc. v. Abbvie Biotechnology Ltd., Case IPR2018-00156, Paper No. 11 (P.T.A.B. June 5, 2018) (Informative as to § III.C.1)
The issue here was whether a “2003 Humira Package Insert” sufficiently qualified as a printed publication at IPR institution because, as alleged by the Petitioner, it was publicly available on the FDA’s website “no later than March 21, 2013[,] as demonstrated by the Internet Archive and the Wayback Machine service.” The Petitioner provided a screenshot of the Internet Archive webpage and an affidavit from an office manager of the Internet Archive, along with testimony from Dr. Bjarnson regarding the accessibility of FDA drug product inserts (or labels).
The Patent Owner argued that the Petitioner had failed to provide adequate evidence that the product insert was indexed on the FDA website. The PTAB agreed with the “Patent Owner that evidence of indexing is probative of public accessibility, [but] such evidence is not necessarily required in all cases.”
The PTAB additionally explained that testimony can substitute for evidence of indexing in some instances:
[A]bsent evidence of indexing, testimony indicating that the particular online publication or website on which the reference was published was well-known to the community interested in the subject matter of the reference, and that, upon accessing the website, those interested would have found the reference using the website’s own search functions can support the ultimate determination that a given reference was publicly accessible.
The Petitioner provided a Wayback Machine screenshot from the Internet Archive along with an affidavit explaining the Wayback Machine information, and the evidence of Dr. Bjarnson’s testimony explaining “how persons interested and ordinarily skilled in the art exercising reasonable diligence could have located 2003 Humira Package Insert on the FDA website.” The PTAB was persuaded by this evidence and thus found that reference qualified as a printed publication.
Seaberry North America Inc. v. Lincoln Global, Inc., Case IPR2016-00840, Paper No. 11 (P.T.A.B. Oct. 6, 2016) (Informative as to § II. A. i)
This case involved establishing a dissertation (“Aiteanu”) as a printed publication at IPR institution. The PTAB found that the Petitioner had demonstrated sufficiently that Aiteanu qualifies as a printed publication based on the declaration of Dr. Graeser, Aiteanu’s thesis advisor.
Dr. Graeser testified that Aiteanu’s thesis was supervised by him at the University of Bremen. And, he testified regarding the following:
- “[A]ccording to the rules at that time, Aiteanu’s dissertation had to be deposited in the library.”
- “[H]e confirmed it was deposited and thereafter available for retrieval by the public” by the patent’s prior art date.
- “[T]he work is indexed in the national library system.”
- A reprint of the dissertation “bears a copyright and publication date.”
- “[E]xcerpts based on the dissertation were published elsewhere.”
Argentum Pharm. LLC, Research Corp. Tech, Inc., Case IPR2016-00204, Paper No. 19 (P.T.A.B. May 23, 2016) (Informative as to § II.B)
This decision also concerned whether a thesis (“LeGall”) sufficiently qualified as a printed publication at IPR institution. The Petitioner asserted three reasons as to why it did:
(1) “Patent Owner has now admitted that LeGall qualifies as prior art;” (2) the University of Houston (where the thesis is located) has denied Petitioner’s request for information regarding public access to the thesis; and (3) evidence indicates “that the University of Houston’s theses were generally accessible to the public” in the relevant time frame.
To support its first argument, the Petitioner relied on a “Joint Statement of Uncontested Facts” where the parties agreed in the corresponding district court litigation that LeGall was a prior art printed publication “for the purposes of this litigation….” The PTAB was not swayed by this evidence because the “Patent Owner may have agreed to stipulate to certain facts to streamline matters at trial…or had other reasons to stipulate on the issue in a case involving different parties in a different forum.”
The PTAB was likewise not persuaded by the University of Houston declining Petitioner’s request because it did not “give[] rise to a rebuttable presumption that the information both exists and establishes a reasonable likelihood that LeGall is prior art.”
As to the third argument, the articles submitted by the Petitioner “that ‘reference theses of other students in other departments at the University of Houston'” likewise failed to satisfy the Petitioner’s burden because “‘in each of Petitioner’s examples … the article was authored by the student who wrote the thesis or by the student’s thesis advisor,’ thereby indicating the authors had personal knowledge regarding the cited thesis work, even if others did not have public access to any of those theses per se.”
The PTAB was not persuaded by the Petitioner’s attempt at establishing LeGall as a printed publication, noting that:
Absent in the evidence cited by Petitioner is information related to whether the LeGall thesis itself was publicly accessible in the relevant time frame, how one might have obtained a copy of the thesis, or whether the thesis was reasonably accessible through generally available means.
Conclusion
Establishing a printed publication during Examination differs dramatically from IPRs. During Examination, after a prima facie case is shown, there is a burden shift to the applicant.
At IPR institution time, however, the burden is on the Petitioner to show a reasonable likelihood of success that the challenged claims are unpatentable. This means that the Petition should provide evidence establishing that a document qualifies as a printed publication because it was publicly accessible as of the relevant time frame. Vague time stamps simply will not suffice. Preferably, Petitioners should have a declaration from a qualified person explaining all the public-availability proof, of which there should be plenty.
On the other hand, Patent Owners could have an easy win if the Petitioner does not satisfy their burden. Patent Owners should, therefore, provide their own declaratory evidence casting doubt on a reference’s public accessibility if there is a substantial question.
