As we previously reported, Celltrion filed three petitions seeking inter partes review (“IPR”) of two patents related to Genentech and Biogen’s Rituxan® (rituximab). Celltrion filed two petitions seeking review of U.S. Patent No. 7,682,612 (“the ʼ612 patent”) and one petition seeking review of U.S. Patent No. 8,206,711 (“the ʼ711 patent”). The PTAB has now reached institution decisions on those petitions.

IPR2017-01230 and IPR2017-01227 both concern the ʼ661 patent. Every Ground asserted in both petitions relied upon either a newsletter from the MD Anderson Cancer Center (“Newsletter”), or the transcript from an FDA public hearing that took place July 25, 1997 (“FDA Transcript”). But, the PTAB determined that Celltrion failed to establish that either reference was sufficiently available to the public to constitute a printed publication. Consequently, the PTAB denied institution on all grounds.

In attempting to establish the public availability of the FDA Transcript, Celltrion submitted a letter from the FDA establishing that (1) the FDA Transcript would have been received on August 8, 1997 based on a date stamp on the document, (2) the FDA would have made the document publicly available in a reading room, and (3) access to the document would have required filling out a reading room request form. However, the PTAB noted that even taking those facts as true, “[p]etitioner has not explained how such persons may have known that this particular transcript existed and was available, upon request, in the [reading room].” Without such an explanation, the PTAB determined that the FDA Transcript is not a prior art printed publication.

With respect to the Newsletter, the PTAB accepted Celltrion’s evidence that the Newsletter was posted on a website before the actual filing date of the ʼ612 patent, but did not accept Celltrion’s evidence that the Newsletter was sufficiently available to the public. Celltrion submitted a declaration from a doctor involved in the clinical study discussed in the Newsletter that stated that it “was disseminated to referring physicians, and they were free to share the information with their prospective patients.” The declaration also noted that physicians involved in the studies were “especially motivated to spread the word about the Newsletter[]” so that more patients could be enrolled in the study. But, the PTAB concluded that the declarant did not provide “any indication that he, or anyone else, in fact accessed or distributed the [Newsletter].” Nor was there any indication that the declarant “did in fact discuss the [Newsletter] relied upon in this proceeding with another physician, or direct anyone to that newsletter.” The PTAB thus concluded that there is not sufficient evidence to show that a person of ordinary skill would have been independently aware of the Newsletter.

Celltrion also attempted to establish that a print version of the Newsletter was publicly available prior to the claimed 1998 priority date and had been disseminated to several thousand physicians in the United States. However, the PTAB found that the declarant had no firsthand knowledge of this, and based these statements on conversations with another person who had not submitted a declaration supporting the public availability of the Newsletter. Moreover, the PTAB found that even assuming the Newsletter had been printed and published, there was not testimony showing that “the newsletter was then available to members of the interested public.”

The ʼ711 patent is involved in IPR2017-01229. All but one of the Grounds asserted against the ʼ711 patent also relied on either the Newsletter or FDA Transcript. Consequently, the PTAB denied institution on those Grounds for the same reasons as in the ʼ612 patent IPRs. The remaining Ground relied on a reference published in 2005 coupled with an assertion that certain claims were entitled only to the 2009 actual filing date of the ʼ711 patent. However, the PTAB concluded that the claims are entitled to either the 1998 provisional application filing date or the 1999 parent application filing date. For this reason, the PTAB found the 2005 reference was not prior art to the ʼ711 patent, and denied institution on that remaining Ground.

These IPRs are the latest examples of the PTAB denying institution based on a finding that the cited prior art is not publicly available. The PTAB is clearly taking a hard look at any non-patent literature asserted in an IPR petition to ensure that it meets the “public accessibility” standard required to qualify as a prior art printed publication. Although such determinations are made on a case-by-case basis, decisions such as these can provide helpful guidance to a Petitioner seeking to establish the public availability of a cited reference. Similarly, a Patent Owner would be well advised to take advantage of such decisions to develop potential arguments for challenging the availability of a given reference as prior art.