Drug product labels (also known as prescribing information) are often asserted as prior art by patent challengers, both in front of the PTAB and in district court ANDA litigation. Before the PTAB, using such prior art requires showing that it qualifies as a “printed publication” under 35 U.S.C. §§ 102 and 311(b). Recently, the PTAB appears to be applying greater scrutiny to the use of such prior art when cited in invalidity grounds. The Board’s analysis in such situations “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.” Sandoz Inc. v. AbbVie Biotechnology Ltd., IPR2018-00156, Paper 11 at *9 (June 5, 2018) (citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). A pair of recent rulings identify some of the evidentiary issues catching the eyes of PTAB panels as they consider invalidity arguments that rely on product-label prior art.
Incyte Corp. v. Concert Pharms., Inc., IPR2017-01256, Paper 14 (Apr. 9, 2018). The Board considered the public availability of two product-related documents: the Jakafi label and the Concert Backgrounder. The Petitioner’s arguments in support of public accessibility of the Jakafi label included a bare statement that the product label was first published in 2011. Id. at *13. Notably, Petitioner’s declarant also testified that FDA approved the underlying drug product in 2011, so its product label would have been accessible to the public as of that date of approval, but the Petitioner did not cite that testimony in its petition. Id. Even if considered, a majority of the Board found the declaration unpersuasive because the approval date does not say anything about public dissemination or availability of the label. Id. at *13-14. The majority also held that the declarant lacked any personal knowledge of the label, failed to describe its dissemination, and provided no documentation from the FDA website confirming availability. Id. at *14. The majority of the Board therefore held that the Petitioner failed to make a threshold showing of availability. Id. at *15.
On this issue, Judge Fitzpatrick dissented. He felt that the evidence showed approval of the Jakafi product in 2011, and publication of the prescribing information. Dissent at *2. Based on his “understanding of the FDA drug approval process,” concurrent publication of the approved label occurred with approval of the drug. Id. at *3 (noting 2011 “Initial U.S. Approval” and “Revised” dates in the prescribing information). Judge Fitzpatrick asserted that the evidence sufficed as a threshold showing of availability, and that any questions of accuracy or authenticity could have been addressed during trial. Id.
Interestingly, the Board reached the opposite conclusion regarding the Concert Backgrounder, a primer on Concert’s product platform, holding that this document was publicly available. Id. at *16. The Board found persuasive: 1) a cached WebCite page, which WebCite described in its description of services as publicly available, 2) use of the Backgrounder in a law review article, which cited the WebCite page, and 3) citation of the Backgrounder in an International Search Report on a patent application related to the Concert product. Id. at *16-17.
Sandoz Inc. v. AbbVie Biotechnology Ltd., IPR2018-00156, Paper 11 (June 5, 2018) (decision denying institution). The PTAB noted that, for purposes of institution, the Petitioner bears the burden to show that there is a reasonable likelihood that it will prevail on the merits. Id. at *8. Here, the question was whether a 2003 Humira Package Insert is a printed publication. The Board stated:
“Petitioner is not required at this stage of the proceeding to establish by a preponderance of the evidence that 2003 Humira Package Insert was publicly accessible before the effective filing date of the ’559 patent and, therefore, qualifies as a printed publication. To meet the initial burden of production under Dynamic Drinkware, however, the Petition must include argument and direct us to evidence sufficient to show that Petitioner would establish such public accessibility by a preponderance of the evidence during the course of the trial.”
Id. at *9.
The Petitioner provided the following evidence of availability, which the Board found persuasive:
- Public availability on the FDA website “as demonstrated by the Internet Archive and the Wayback Machine service which it provides,” including a supporting affidavit from the Office Manager of the Archive; and
- An expert’s testimony, from the perspective of a person of ordinary skill in the art, regarding the accessibility of drug product inserts (or labels) on the FDA website.
Id. at *10. The Patent Owner challenged the evidence by suggesting that there was no suggestion that the FDA website was indexed, and other alleged weaknesses in the ability to search for the prior art in question. Id. at *11. The Board held that such evidence was not necessarily required, in all cases, to make the threshold showing of accessibility for purposes of institution. Here, for example, the archived webpages and the expert testimony indicated public accessibility, on their own. Id. at *11-12. The Board denied institution on other grounds. Id. at *19.
These two decisions confirm that a Petitioner must provide proof of public accessibility of label-based prior art, and cannot rely on assumptions about availability, or descriptions of practices and expectations. Such proof can include testimony of one with personal knowledge of the document’s accessibility, and proof of hosting on a public website that is available to those interested in finding such prior art. These proofs were available in Sandoz, but not Incyte.
Additional recent decisions addressing label-based prior art include:
- Pfizer, Inc. v. Biogen, Inc., IPR2017-01166, Paper 9 at *10-17 (Nov. 13, 2017) (majority holding, over a dissent by Judge Snedden, that Petitioner failed to show that a label was publicly accessible to the extent required to establish it as a “printed publication” for purposes of an institution decision; Judge Snedden considered the evidence, viewed as a whole, a sufficient threshold showing of availability);
- Watson Labs., Inc. v. United Therapeutics Corp., IPR2017-01621, Paper 10 at *19-22 (Jan. 11, 2018) (Board holding that Petitioner failed sufficiently to demonstrate that a label, annexed to the records of a European Community commission, was publicly accessible for purposes of institution); and
- Celltrion, Inc. v. Biogen, Inc., IPR2016-01614, Paper 65 (Feb. 21, 2018) (holding, in final written decision, that label was not public prior art where the “evidence merely demonstrat[ed] publication to the internet,” which did not show that the label 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”).