How PTAB Is Defining Printed Publication
8 min read
Authored by Marie A. McKiernan, John L. Strand(as published by Law360)
What constitutes a prior art “printed publication” is a significant question in many patent validity challenges. The Federal Circuit has wrestled with the question since the court was created in 1982. However, despite its much shorter history, the Patent Trial and Appeal Board has likely issued more decisions addressing this question than any other forum. Therefore, petitioners who ignore what the PTAB thinks a printed publication is do so at their own peril.
The Federal Circuit, whose decisions are binding on the PTAB, has addressed some interesting and repeated questions about various documents, including:
- University theses: They can be printed publications, if properly indexed and accessible to the relevant public.
- Conference presentations: They can be printed publications, if “presented in such a way that copying of the information it contained would have been a relatively simple undertaking for those to whom it was exposed.”
- Company documents only indexed at the company: No, even if distributed outside of the company to others.
Over the past 10 months, the PTAB has issued dozens of decisions that address whether certain references are printed publications. The range of documents that the PTAB has found to constitute printed publications is broad and includes: technical proposals; journal articles; a document distributed at conferences; an article from a personal website; a guide given to participants in the Tokyo Stock Exchange; a book that was properly indexed in a university library; and online descriptions of a video game.
However, in many instances where the issue has been contested, the PTAB found the petitioner had failed to prove a document was a printed publication. The following decisions where a reference was found not to be printed publications should serve as guidance to petitioners and patent owners:
- A copy of a journal article publicly available in a university library: This was insufficient to corroborate the petitioner’s claim that the originally submitted document was a prior art publication because there was no evidence that the original document was a “true copy” of the journal the petitioner identified in its supplemental submission. The lesson here is that the PTAB will take seriously even “minor” differences between what may appear to be the same publication; it is the petitioner’s burden to account for any of those differences.
- Another journal article in a university library: This article was determined not to be a printed publication because the librarian’s declaration that it was available included “hedging language” and ”lack[ed] any acknowledgement … that willful false statements are punishable by fine, imprisonment, or both, or that the statements are true under penalty of perjury.” This decision presents a lesson on producing complete and clear declarations in support of printed publication evidence.
- A patient consent form: The patient consent form was not a printed publication even though it was freely disseminated to prospective patients and indexed on an oncology group’s website, primarily because the petitioner did not submit sufficient evidence to show “ordinary skilled artisans” would have found the document in a reasonably diligent search for information relevant to the invention. The PTAB made this determination at the institution stage, reinforcing that petitioners should endeavor, if possible, to provide all evidence they can access with the petition as they may not be able to supplement.
- U.S. Food and Drug Administration approval of a drug label: A petitioner could not rely on the FDA approval date of a drug label as a printed publication because there was no evidence of the specific date on which the label was publicly accessible, and no evidence that those skilled in the art would have reason to look to the label when exercising reasonable diligence. In another decision, the PTAB held that a drug label with a copyright date prior to December 1997 and FDA approval of sale of the drug with that label prior to December 1997 were insufficient evidence that the drug was sold with that specific label in December 1997. Petitioners relying on a product label must present evidence that a product with that label was publicly accessible, and not merely that it could have been publicly accessible.
- Document published on a website: This document was not proven to be a prior art printed publication, even when corroborated by a declaration, printout from the internet archive, and comments posted on the website, because, among other things, the testimony did not reflect that the website was publicly accessible or that the information “published” on the site was accessible, catalogued, indexed or searchable to skilled practitioners.
- An engineering master’s thesis: The thesis for an engineering department that typically published theses to the university library was not a prior art printed publication because there was no evidence of precisely when the thesis was submitted to the department and no evidence of how long it generally took for a thesis to be added to the searchable index of the university library.
- A date-stamped FDA transcript: The transcript was not a printed publication because it was not sufficiently available to the public. Specifically, the petitioner failed to put forth evidence that the transcript was available “in a manner and to an extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence would have been able to locate it” in the FDA’s reading room.
- A product package insert: A package insert for a medicine was not a printed publication in 2002 even though it included a Dec. 22, 2002 date because the petitioner did not show “a reasonable likelihood” that the insert was “publicly available” on that date. This reiterates the point that dates are not determinative of when a document becomes a printed publication and, in fact, the patent owner produced an FDA approval letter showing that the product would be marketed after 2002.
- A poster handed out at a conference: The PTAB found that there was insufficient evidence that the poster was available where the petitioner provided a joint declaration laying out details of the conference and the poster’s availability because a joint declaration “presents practical difficulties in the ability to determine the reliability of the statements made and the knowledge of each of the individual declarants.” The PTAB made clear once again the importance of proper declarations in support of prior art evidence, and petitioners should avoid the use of joint declarations.
- A draft report distributed at a board meeting: The draft report was distributed at a board meeting “without indicia of confidentiality” but was nevertheless not a printed publication because petitioner failed to show that the report was distributed outside of the meeting and thereby publicly accessible.
- Picture of a product label on a lighting fixture: The PTAB held that presenting a picture of a label on a lighting fixture was trying to introduce the product, not a printed publication, into evidence as prior art and therefore inappropriate for inter partes review.
Even if PTAB decisions are not designated informative, representative or precedential, they are a significant source of guidance as to whether something actually is a printed publication. Petitioners and patent owners alike should consider that guidance. Before filing their petitions, petitioners must think of all potential avenues of dissemination to connect all of the dots between the prior art, its publication, and public accessibility to that publication. On the flip side, the PTAB’s willingness to find that documents are not proven to be printed publication should encourage patent owners to challenge petitioners’ prior art evidence on those grounds. Finally, all parties and attorneys engaging with the PTAB should watch out for future determinations regarding what constitutes a printed publication for further guidance.