Establishing Drug Labels as Printed Publications

This article is a summary of material presented in Post-Grant for Practitioners: BioPharma Patents at the PTAB, hosted by Dorothy Whelan and Tasha Francis.

A major question facing the PTAB recently concerns the evidentiary requirements petitioners must meet to show that drug labels are sufficiently publicly accessible so as to be considered printed publications. Generally, 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. In re Lister, 583 F.3d 1307, 1311 (Fed. Cir. 2009); Kyocera Wireless Corp. v. ITC, 545 F.3d 1340, 1350 (Fed. Cir. 2008). But how does the petitioner meet this standard in the context of drug labels? The PTAB addressed this question in detail in the two recent cases of Sandoz, Inc. v. Abbvie Biotechnology, Ltd., IPR2017-01824 (PTAB Feb. 9, 2018), and Celltrion, Inc. v. Biogen, Inc., IPR2016-01614 (PTAB Feb. 21, 2018).

In Sandoz v. Abbvie, the patent at issue covered a method of treating psoriasis by administering the drug HUMIRA. The petitioner relied on the HUMIRA package insert as one of its references in its IPR challenge. The PTAB denied institution, claiming that the petitioner failed to prove that the package insert was "publicly accessible to the extent required to establish it as a 'printed publication.'" The petitioner's evidence consisted solely of the package insert itself and an FDA approval letter stating that HUMIRA was approved in December 2002 to treat psoriasis and that the package insert was a "prior art FDA approved label" disclosing the psoriasis dosing regimen. In response, the board stated that the package insert and the FDA approval letter alone were not enough to establish that either was sufficiently publicly accessible for the purposes of institution. Rather, the board held that the petitioner would need to present additional evidence, such as the availability of the package insert or FDA letter on the FDA's website prior to the critical date, for the reference to be considered "publicly accessible."

The board took up this issue again in Celltrion v. Biogen. In that case, the patent covered a method of treating rheumatoid arthritis by administering rituximab (Rituxan) and methotrexate. In their IPR petition, the petitioners relied on the Rituxan label as part of its obviousness challenge, offering several reasons why the label qualified as a printed publication as of the critical date of 1998. First, petitioners noted that the label bore a copyright date of 1997. Second, petitioners submitted the associated FDA approval letter for Rituxan and argued that both it and the label were available on the FDA's website as part of the November 26, 1997 approval package for Rituxan.

The board found that the copyright date alone was not evidence that the label was publicly accessible on that date, and that the petitioners had also failed to prove that the Rituxan label it retrieved from the FDA website in 2016 was available on the website prior to the critical date in a manner that a person of ordinary skill in the art could have located it. In response, petitioners argued that even if the patent owner Genentech did not market Rituxan with the label allegedly available on the FDA's website, it was also available on Genentech's website prior to the critical date. To support this assertion, petitioners submitted a webpage copy of the full prescribing information for Rituxan with a "" footer bearing a date of January 23, 1998 from the Internet Archives. Although this exhibit was persuasive, the board found that it could not be considered a printed publication because the petitioners failed to submit evidence supporting their assertion that Genetech's website would have permitted a person of ordinary skill in the art to locate the label.

The key takeaway from these two cases is that it is quite difficult to establish that drug labels are printed publications, as the existence of the documents themselves is not enough to show public accessibility. Rather, to show public accessibility, the petitioner must submit additional evidence that the label or package insert at issue was available on the internet (either the FDA's website or a non-governmental website) before the critical date. The petitioner must then show, likely with an expert declaration, that a person of ordinary skill in the art would have looked to the website in question and have been able to find the reference.