Curing the Drug Label as Prior Art Malady at the PTAB

By Aziz Burgy & Christopher Gallo
November 13, 2019

“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.”

https://depositphotos.com/21871179/stock-photo-closeup-of-prescription-drugs.htmlPetitioners 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.

Outlook

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.

 

The Author

Aziz Burgy

Aziz Burgy a registered patent attorney at Axinn, has nearly two decades of patent litigation experience, serving as lead counsel to clients in a multitude of venues including U.S. district courts, Patent Trial and Appeal Board (PTAB), U.S. Court of Appeals for the Federal Circuit (CAFC), and the U.S. International Trade Commission. Aziz’s practice focuses on the Hatch-Waxman Act, having litigated over seventy such cases in the last ten years. Although many of his cases have focused on pharmaceuticals, he has also represented clients in the banking, medical device, Internet security, robotics, software, and GPS technology industries and has handled other matters beyond patent disputes, including trademark and copyright cases.

For more information or to contact Aziz, please visit his Firm Profile Page.

Aziz Burgy

Christopher Gallo holds a PhD in Biochemistry and Molecular Genetics. His practice at Axinn is focused on patent litigation. Christopher's experience includes matters before federal district courts and the United States International Trade Commission in which he has been heavily involved in all aspects of litigation, from pre-filing investigation, through fact and expert-witness discovery, claim-construction, and trial. Christopher also has experience in patent reexaminations and in inter partes review proceedings before the Patent Trial and Appeal Board at the USPTO. Prior to joining the firm, Christopher worked as a postdoctoral fellow at the Johns Hopkins University School of Medicine.

For more information or to contact Christopher, please visit his Firm Profile Page.

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Discuss this

There are currently 6 Comments comments. Join the discussion.

  1. TFCFM November 14, 2019 9:48 am

    An interesting article, and I’m sorry to comment about a tangential issue:

    Authors: “…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.

    I’ve used the Wayback Machine in the past, and it can have its uses. There’s one thing I’ve never figured out, and I hope someone here knows the answer:

    When you examine a website using the Wayback Machine, it typically offers essentially a “snapshot” of the website on various past dates. The dates often look ‘random’ to me. Is there any rhyme or reason to the dates on which “snapshots” of websites are recorded on the Wayback Machine or similar archives? (For example, does the archive strive to record every date on which a change is made to a website?)

  2. Anon November 14, 2019 12:41 pm

    TFCFM,

    I too have interacted with the use of the Wayback Machine.

    The dates are arbitrary, and there is no rhyme or reason.

  3. mike November 14, 2019 1:53 pm

    Back in the day, my understanding was that the Wayback Machine was an early crowd-sourced repository of images. Users downloaded the wayback machine which would then take snapshots when they visited a site and upload them to the archive. I believe there was also a web-crawler system that would visit sites autonomously and uploaded snapshots as it found them. But no, there was no systematic effort to update the archive as the sites changed.

  4. Pro Say November 14, 2019 7:02 pm

    For at least this fundamental reason, the Wayback Machine should not be relied on by anyone:

    It’s alleged content is, including the alleged dates of the alleged content — as is most content on the internet — human and/or “machine” modifiable.

    Making it nothing at all equivalent to a patent, a book . . . or even a catalogued student thesis tucked away in some library in Iceland.

    At most, the WM is useful only as — and should only be relied on for — a guide to potential sources of trusted, usable prior art. Which can then be — at least potentially — tracked down from there.

  5. TFCFM November 15, 2019 10:09 am

    PS: “At most, the WM is useful only as — and should only be relied on for — a guide to potential sources of trusted, usable prior art. Which can then be — at least potentially — tracked down from there.

    I’d second that. I’ve never tried to introduce its output as evidence in any sort of proceeding (although I think I’ve responded to USPTO trademark examining attorneys’ comments about the output a few times).

    However, I’ve several times found it to be a great way of discovering the existence of information that I previously hadn’t realized existed, and which I thereafter knew to go and track down.

  6. Anon November 15, 2019 5:30 pm

    I am in agreement with the exchange here, and will add that I know of a colleague that had an item from the Wayback Machine successfully used against him. In that case, the item did survive a challenge as technical evidence (the opposing side did have the WM results attested to by an employee of WM).

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