Earlier this month, the Patent Trial and Appeal Board (“PTAB” or “the Board”) denied institution of Sandoz’s petition for inter partes review of Abbvie’s patent, U.S. Patent No. 9,512,216 (“the ’216 patent”), directed to methods for treating moderate to severe chronic plaque psoriasis with a human anti-tumor necrosis factor α (TNFα) antibody.[1] The petition, filed on October 2, 2017, asserted that claims 1-16 of the ’216 patent were unpatentable under 35 U.S.C. § 103(a) as obvious over a Humira 2003 Label and a Humira 2002 Label, in combination with other references. The institution decision ultimately hinged on whether the labels constituted prior art “printed publications” under 35 U.S.C. § 102(b).

As the Board explained in its decision, the petitioner has the burden to establish a reasonable likelihood that it will prevail on the merits, which, inter alia, includes putting forth sufficient arguments and evidence to show that the petitioner would establish public accessibility of the reference by a preponderance of the evidence over the course of the trial.[2] Whether a reference qualifies as a “printed publication” is a case-specific inquiry, with the key factor being a satisfactory showing that the reference was “sufficiently accessible to the public interested in the art” before the filing date.[3] A reference is considered “publicly accessible” if it was “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it.”[4]

In its petition, Sandoz identified the Humira 2002 Label and Humira 2003 Label as prior art under § 102(b), asserting merely that the labels were “prior art FDA-approval label[s]” and that the drugs were approved by the FDA in December 2002 and January 2003, respectively.[5] In the preliminary patent owner response, Abbvie argued that this showing was insufficient. Specifically, Abbvie pointed out that the issue dates on the face of the labels do not establish “public accessibility,” and although Sandoz attached exhibits which could support an argument that the labels were publicly accessible, including a screenshot of the Humira 2003 label from the WayBack Machine and affidavit from the Office Manager at the Internet Archive, neither was cited or discussed in the petition itself.

In response to the preliminary patent owner response, Sandoz sent an email to the Board requesting, in part, authorization to file a reply to address Abbvie’s arguments regarding the public availability of the Humira labels. The PTAB denied this request, explaining that Petitioner could have reasonably foreseen arguments regarding whether the Humira labels were publicly available before the priority date of the ʼ216 patent, given that a petitioner bears the initial burden of production to establish the existence of prior art that renders the claims unpatentable. The Board did, however, grant Sandoz’s request to file a reply in response to the Patent Owner’s arguments regarding §§ 314(a) and 325(d).

Despite the Board’s limited authorization regarding the scope of the reply, the background section of Sandoz’s reply included arguments addressing the public availability and “printed publication” status of the Humira labels, citing to the WayBack Machines screenshot and the affidavit of Christopher Butler, Office Manager at the Internet Archive, affirming that the 2003 Humira Label was publicly accessible and archived from www.fda.gov on March 31, 2003. This appears to have rubbed the Board the wrong way. In the decision denying institution, the PTAB noted that “Petitioner’s attempt in the Reply to meet its threshold showing that Humira 2003 Label is a printed publication is not only untimely, but also appears to circumvent our Order (Paper 11) denying Petitioner’s request to file a reply on that very issue.”[6]

The PTAB ultimately agreed with Abbvie’s arguments that the Humira labels were insufficient to establish public availability, such that the labels did not qualify as prior art under § 102(b), and the petition was thus denied. While this decision illustrates a hard lesson learned under the old adage “don’t bite the hand that feeds you,” it is also a testament to the need for petitioners to put forth sufficient evidence to establish that a reference relied upon is indeed a prior art “printed publication” in the petition itself. Merely including supporting evidence as an exhibit, without a citation or explanation in the petition, just won’t cut it for meeting the threshold showing of prior art status.