BY ERIC M. BRUSCA
To challenge a patent claim in an inter partes review (IPR) at the Patent Trial and Appeal Board (PTAB), a petitioner must set forth grounds of unpatentability that include challenges based on prior art. It is the petitioner’s burden to prove unpatentability by a preponderance of the evidence, and recent decisions emphasize the difficulty petitioners may face when relying on “non-traditional” prior art.
Petitioners should therefore be prepared to submit sufficient evidence to demonstrate that any prior art relied upon is in fact printed and accessible to persons interested and ordinarily skilled in the art. As highlighted below, there have been several notable PTAB decisions concerning what does and does not qualify as prior art.
Section 311(b) of the patent statute limits the basis for inter partes review to patents and printed publications. Particularly in cases where petitioners rely on non-traditional prior art such as advertisements, dissertations, conference slide presentations, video recordings, web publications, and the like, the PTAB must determine whether the art is actually a prior art publication.
The determination of whether a document is a printed publication involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public. Public accessibility is often referred to as the touchstone in determining whether a reference constitutes a “printed publication” bar under 35 U.S.C. § 102(b).
A reference is considered “publicly accessible” upon a satisfactory showing that the document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the art could find a document using reasonable diligence. A petitioner seeking to rely on a document should therefore produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned with the art to which the document relates.
In GoPro, Inc., v. Contour IP Holding LLC, the PTAB concluded that a product catalog was not publically accessible because the relevant tradeshow was not announced to the public and therefore a person interested and ordinarily skilled in the art would not and could not have known about it and could have obtained a copy of the product catalog. On appeal, however, the Court of Appeals for the Federal Circuit (CAFC) found that the catalog was prior art, noting that tradeshows are similar to conferences in that the meeting is geared towards individuals interested in a specific topic.
In Medtronic, Inc., v. Mark A. Barry, the PTAB concluded that a video stored on a CD was not a publication. On appeal, however, the CAFC found that the PTAB failed to properly apply the test for a printed publication, noting that a publication need not be easily searchable after publication if it was sufficiently disseminated at the time of its publication.
In Sandoz Inc., v. Abbvie Biotechnology Ltd., the PTAB concluded that the petitioner failed to show, based solely on the date present in the header of each page, that a patent owner’s drug product package insert was a printed publication.
In Celltrion, Inc., v. Biogen, Inc., the petitioners asserted that the product label was prior art based on the copyright date on the label and the label’s alleged availability on the FDA’s website, among other reasons. The PTAB, however, concluded that a product label was not prior art because it was not disseminated or otherwise publically available to a person of skill exercising reasonable diligence.
In Trustees of the University of Pennsylvania v. Coalition for Affordable Drugs VIII, LLC, the petitioner asserted that a slide presentation at an investor event was prior art, but the PTAB concluded that the presentation was not a printed publication because the audience lacked expertise.
More recently, in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, the CAFC affirmed a PTAB decision finding that materials generated in association with an FDA advisory meeting qualify as prior art. Here, the CAFC noted that 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. The CAFC further noted that the materials were available online for a substantial time and were distributed via public domain sources with no possible expectation that the materials would remain confidential or not be copied.
These decisions highlight the important requirement for a petitioner to include sufficient evidence to demonstrate that a reference is a printed publication under 35 U.S.C. § 102. To be successful, particularly with respect to “non-traditional” prior art, petitioners should provide sufficient factual evidence to establish the prior art status of the printed publication. Petitioners must often look beyond the face of the publication in order to convince the PTAB that a publication was publicly accessible and available to persons interested and ordinarily skilled in the art.
Eric M. Brusca is a partner at Marshall, Gerstein & Borun LLP. He secures patents internationally through prosecution and related proceedings for clients producing biotech advancements in biologics and vaccines. He may be reached at [email protected]