On February 9, 2018, the PTAB denied Sandoz Inc.’s petition for inter partes review of U.S. Patent No. 9,512,216, a patent owned by AbbVie Biotechnology Ltd. The patent recites methods for treating moderate-to-severe chronic plaque psoriasis with adalimumab, a human anti-tumor necrosis factor α (TNFα) antibody. The methods of the claimed invention involve subcutaneously administering to a patient an initial dose of 80 mg of adalimumab, followed by 40 mg of adalimumab every other week starting one week after the initial dose. The patent is one of several patents AbbVie owns that relate to its blockbuster autoimmune drug Humira. In its petition, Sandoz asserted that the claims of the patent would have been obvious in view of several references including the Humira Package Insert. In denying the petition, the PTAB first focused on whether Sandoz made an adequate showing (for purposes of institution) that the Humira Package Insert was prior art (i.e., that the Humira Package Insert was a “printed publication” within the meaning of 35 U.S.C. §§ 102 and 311(b)). The PTAB noted that “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 subject matter or art exercising reasonable diligence can locate it’ and that ‘a party seeking to introduce a reference … should 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 ….’” (Decision, p. 6).

In support of its assertion, Sandoz argued that the Humira Package Insert was prior art as of the product’s approval date in December 2002. AbbVie argued that the Humira Package Insert did not qualify as a printed publication because Sandoz’s petition did not sufficiently establish that the insert was publicly accessible in December of 2002. The PTAB agreed with AbbVie, concluding that the product’s December 2002 approval and the December 20, 2002, date present in the header of each page of the label “are insufficient on their own to show a reasonable likelihood that [the] Humira Package Insert was publicly available in 2002.” Id.

On March 9, 2018, Sandoz filed a Motion for Rehearing. Sandoz argues that, for purposes of institution, its showing is sufficient. Sandoz cited numerous prior Board decisions supporting this argument. Sandoz also argued that AbbVie cited the product label in an information disclosure statement during prosecution of the challenged patent, suggesting AbbVie therefore conceded that the label may be material to patentability. Sandoz further argued that AbbVie offered neither information that disputes nor a denial that the label was publicly distributed in 2002. (Motion, pp. 6–8).

This blog has previously discussed the difficulties in establishing that an alleged printed publication was “publically accessible.” It will be interesting to see how the Board decides the Motion for Rehearing. Regardless, this decision highlights the important requirement for a petitioner to include sufficient evidence to demonstrate that a document is a printed publication under 35 U.S.C. § 102, even for a threshold showing for institution purposes.