“Recent PTAB decisions make clear that just a date printed on a drug label with no other evidence supporting that date will not be sufficient to demonstrate that the label was publicly available as of the printed date; but petitioners can employ the following best practices to aid in proving a drug label’s prior art status.”
Petitioners challenging patents covering pharmaceuticals and biologics often use drug product labels as prior art in the Patent Trial and Appeal Board (PTAB). To effectively use a label as prior art, a petitioner must show that it is a “printed publication” under 35 U.S.C. §§ 102 and 311(b). Past PTAB cases demonstrate, however, that proving drug product labels as prior art can be fraught with danger. But practitioners can employ best practices to guard against this.
In Celltrion, Inc. v. Biogen, Inc., IPR2016-01614, Paper 65 (Feb. 21, 2018), the Petitioners relied on a copyrighted label for Rituxan that was published on the internet and available on the Food and Drug Administration’s (FDA’s) and on Biogen’s website all before the critical date. The Board held that the Petitioners did not provide sufficient evidence establishing that the drug label was indeed the one disseminated with Rituxan at the time it was proposed to be publicly available or that “persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence, can locate it.” Id. at 15-20.
Similarly, the Board held in Mylan Pharmaceuticals Inc. v. Boehringer Ingelheim International GMBH, IPR2016-01563, Paper 16 (Feb. 3, 2017), that a relied-upon Glucophage label had no source identifying information or indicia of when it became publicly available and the declaration attesting to its publication was not based on personal knowledge, but was merely conclusory. Id. at 12-14.
Employing Best Practices in Light of Celltrion and Mylan
The above PTAB decisions make clear that just a date printed on a drug label with no other evidence supporting that date will not be sufficient to demonstrate that the label was publicly available as of the printed date. Nevertheless, petitioners can employ the following best practices to aid in proving a drug label’s prior art status.
First, petitioners should check noted publications such as a pharmacopeia or the Physicians’ Desk Reference for a prior art entry for the drug label of interest. But, because a drug label can sometimes become available between the time of those publications’ dates and a challenged patent’s priority date, those publications may not always be helpful sources.
Therefore, second, petitioners should look for archived versions of the drug label of interest using internet archiving websites. One example is the Internet Archive’s Wayback Machine. In short, these websites crawl the internet and archive a web page’s content as it is on the day the page is crawled by the archiving service. And these archives can then be used to show what a web page disclosed on its archiving date. Notably, the authenticity and date of public availability of an archived version of the drug label can be supported by an affidavit obtained from the archiving service itself. And the PTAB has accepted entries from archived FDA pages with supporting affidavits in the past. See, e.g., Amneal Pharms., LLC v. Jazz Pharms., Inc., IPR2015-00545, Paper 69 (July 27, 2016), at 24-31.
Lastly, should none of the above be available, affidavits or declarations from those with personal knowledge of the drug label’s existence and accessibility can be provided. See, e.g., Sandoz, Inc. v. AbbVie Biotechnology Ltd., IPR2018-00156, Paper 11 (June 5, 2018), at 9-13. The person providing the affidavit or declaration, though, will likely have to appear for a deposition to support the authenticity of the proffered information.
But even after employing the best practices outlined above, petitioners should also evaluate any facts specific to their case that might require further providing indicia of a drug label’s public availability as of a specific date. Indeed, “whether a reference is a ‘printed publication’ is a ‘case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.’” Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018) (quoting In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)). For example, the issue of whether a person of ordinary skill in the art exercising reasonable diligence could have located the drug label of interest before the challenged patent’s priority date may be subject to dispute and require shoring up by providing testimony related to how and why one of ordinary skill would have found the prior art drug label.
On April 3, 2019, the PTAB’s Precedential Opinion Panel (POP) issued an order in Hulu, LLC v. Soundview Innovations LLC, IPR2018-01039, Paper 15 (Apr. 3, 2019) that asked the question of what is required for a petitioner to show that a reference qualifies as a “printed publication” at the institution stage. In the underlying case, Hulu’s petition had been denied because the PTAB panel found that there were several differences between a prior art reference that was relied upon in its petition and a librarian’s declaration regarding the same prior art. These differences resulted in the PTAB panel finding that the petitioner, Hulu, had not proven that the reference was a printed publication. During the POP hearing, Hulu’s counsel advocated for “conventional markers” of publication such as the copyright date, ISBN number, and publisher information. Id., Paper 28 (Sept. 23, 2019). It will be interesting to see if the POP decides on a set of factors that petitioners can follow to demonstrate that a reference qualifies as a prior art printed publication.