As we have written previously, the PTAB is very active in defining what is and is not a printed publication, and what the PTAB decides can make or break the IPR. A recent decision illustrates yet again the pitfalls that petitioners can face when attempting to prove that a reference is a printed publication. In IPR2016-01614, the petitioner cited a drug label as a printed publication, and though it had a copyright date, the PTAB wanted to see more than just what was on the face of the label.
To be considered a printed publication, a document must be publicly accessible. For example, the document may be accessible because it was indexed and searchable on a website. In IPR, the burden falls on the petitioner to show accessibility.
The technology claimed in this patent relates to the use of rituximab (a.k.a. Rituxan) and methotrexate to treat rheumatoid arthritis. The patent claims priority to 1999. The petitioners sought to establish the drug label of rituximab as a printed publication, arguing that the label had a copyright date of 1997, that FDA rules required that the label be provided with the drug beginning in 1997, and that the label was on the patent owner's website at that time.
The problem for the petitioner, as the PTAB saw it, was proof. The patent owner asserted that the petitioners did not establish that the drug label was accessible to the public at the time of the invention. Specifically, the patent owner denied that that particular label was the one used before 1999. The PTAB concluded that the petitioners did not provide sufficient proof to establish the drug label as a printed publication.
Takeaways
This case illustrates that printed publications are not limited to what many might think of as publications, such as journal articles and books, and may include drug labels. However, articles and books can be better for IPRs because their date of publication (i.e., public accessibility) is often well documented.
This case is also a reminder that the petitioner's burden to establish that its cited references are actually prior art is not one that can be overlooked. As the PTAB pointed out, the petitioner here did not submit sufficient testimony supporting the publication date, which is something that petitioners should consider in challenging cases. And of course, whenever the petitioner strives to meet its burden on an issue, the patent owner should seek to prove otherwise.
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