A patent relating to a method of treating rheumatoid arthritis using rituximab recently survived its fourth IPR challenge. Celltrion, Inc. v. Biogen, Inc., IPR2016-01614 (PTAB Feb. 21, 2018). The PTAB determined that the Petitioners failed to establish that the challenged claims of the patent were obvious over prior art, in part, because of the Petitioners’ failure to establish the prior art status of the product label for RITUXIN®, which contains rituximab. Petitioners bears the burden of establishing that a printed publication was available to the public before the patent’s filing date and that persons interested and ordinarily skilled in the art could locate it using reasonable diligence. Challenges associated with establishing prior art status of, e.g., product catalogs and videos, were detailed in this blog previously. Here, Petitioners asserted that the proffered product label was prior art based on:

(1) the copyright date on the label,

(2) the label’s alleged availability on the FDA website as part of rituximab’s approval package,

(3) FDA regulations requiring Patent Owner to include the label with sales of RITUXAN®, and

(4) alleged availability of the label on Patent Owner’s website,

all of which allegedly occurred more than one year before the effective filing date of the challenged patent (“the critical date”). The Petitioners’ evidence was not, however,  sufficient to establish that the label was publicly accessible before the critical date.

First, the PTAB agreed with Patent Owner that a copyright date does not establish the date on which the document became publicly accessible. While the copyright date may establish when a publication was generated, the Petitioners cited no authority  supporting its proposition that the copyright date is evidence the label’s public accessibility.

Second, the PTAB seemed to again agree with the Patent Owner that Petitioners failed to establish that the label was, indeed, part of the FDA approval package prior to the critical date.

Third, the Petitioner failed to establish that the proffered label was, in fact, the label that accompanied the prior sales of RITUXIN®. The Petitioners cited an FDA regulation requiring a drug product label accompany the sale of the drug product. But the PTAB determined that regulation was insufficient. According to the PTAB, without “documentary or testimony evidence establishing that [the proffered label] is, in fact, the drug label disseminated with Rituximab at any time,“ the Petitioner is merely “inviting us to speculate as to whether [the proffered label] is a copy of that disseminated label.”

Finally, Petitioners asserted that a copy of the label was posted on Patent Owner’s website. In support, the Petitioners submitted as an exhibit a copy of a webpage of the “Full Prescribing Information” including a footer listing a date before the critical date. The Petitioners also submitted an authenticating declaration from the Office Manager from Internet Archives explaining that the copy was a true and accurate copy of printouts on the date specified in the footer. The Petitioners also asserted that the website “was organized such that the label could be easily located.”

In this case, we determine that evidence merely demonstrating publication to the internet is
not “a satisfactory showing that such 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.”

Notably, the authenticating declaration did not reference the webpage exhibit number, and the separate copy of the webpage that accompanied the declaration was different than the webpage exhibit submitted by the Petitioner. Despite that discrepancy, the PTAB focused on Petitioner’s failure to cite any evidence regarding the Patent Owner’s website, stating “Petitioners …have not submitted any supporting evidence for us to consider regarding the issue of whether [the webpage exhibit] would have been, for example, ‘indexed and thereby findable by an internet search engine.’” Merely offering that a website is “organized” does not satisfy the burden of establishing unpatentability of claims by a preponderance of the evidence.

Product labels are convenient sources of prior art for obviousness challenges of second generation or follow-on patents, as the FDA requires drug manufacturers to set forth detailed information about the active ingredient, formulation, side effects, and administration regimen. To be successful, petitioners must provide sufficient factual evidence to establish the printed publication status of a product label as a matter of law, or risk having the PTAB never reach the substance of the challenge.