This blog has previously reported on several PTAB and Federal Circuit decisions concerning what does and does not qualify as prior art:

  • See here for an example of where the PTAB concluded that a product catalog was not publically accessible because the relevant tradeshow was not announced to the public, but where the CAFC found that the catalog was prior art;
  • See here for an example of where the PTAB concluded that a tradeshow catalog qualified as prior art because the catalog was available to the public;
  • See here for an example of where the PTAB concluded that a video stored on a CD is not a publication but see where the CAFC found that the PTAB failed to properly apply the test for a printed publication;
  • See here for an example of where the petitioner failed to show that a patent owner’s drug product package insert was a printed publication;
  • See here for an example of where the PTAB concluded that a product label was not disseminated or otherwise publically available to a person of skill exercising reasonable diligence;
  • See here for an example of where the PTAB concluded that a slide presentation at an investor event was not a printed publication because the audience lacked expertise;
  • See here for an example of where the PTAB concluded a document stored on an electronic repository at a university was not publically accessible;
  • See here for an example of where the PTAB concluded that a Russian doctoral thesis was prior art.

Another decision can be added to the growing list of cases where the PTAB and CAFC have considered the issue of what qualifies as prior art – Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC (Fed. Cir. Jul. 13, 2018). Here, the CAFC affirmed a PTAB decision finding that materials generated in association with a FDA advisory meeting qualify as prior art. The claimed invention of the patents in suit involves tracking prescriptions of a sensitive drug (i.e., drugs with a potential for abuse, such as Jazz’s Xyrem®) through a database. During the regulatory review process for Xyrem®, the FDA held an advisory committee meeting and provided a hyperlink to an FDA website where background material as well as meeting minutes, transcript, and slides (“the ACA materials”) would be made available. The PTAB’s obviousness determinations relied on the ACA materials as prior art.

In considering whether a person of ordinary skill exercising reasonable diligence would have been able to locate the ACA materials, the PTAB agreed with Amneal that a person of ordinary skill would have been familiar with the Federal Register and motivated to look for notices related to drug distribution, safety, or abuse prevention and, as a result, this provided a person of ordinary skill with “sufficient motivation to have located the Federal Register Notice and FDA website for Xyrem.” The PTAB further found that a person of ordinary skill would have been capable of locating the ACA materials, and thus held all instituted claims of the patents in suit unpatentable as obvious over the ACA materials alone or in combination with another reference.

The primary issue before the CAFC was whether the ACA materials were sufficiently accessible to the public to qualify as prior art. On appeal, Jazz emphasized the substantial length of the annual Federal Register, and argued that the PTAB failed to make the requisite finding that a person of ordinary skill exercising reasonable diligence could have located the ACA materials.

The CAFC agreed with Amneal and noted that wide dissemination of a reference through a publication like the Federal Register that those of ordinary skill would be motivated to examine is a factor strongly favoring public accessibility. The CAFC further noted that the ACA materials were available online for a substantial time and were distributed via public domain sources with no possible expectation that the materials would remain confidential or not be copied.

The CAFC finally noted that indexing or searchability is unnecessary for a reference to be a printed publication under § 102(b). Thus, considering the multiple factors discussed above favoring public accessibility, the Court held that Jazz’s emphasis that the Federal Register was a lengthy 67,702 pages does not demonstrate the PTAB erred in finding that the ACA materials were publicly accessible.

While several of the past decisions noted above highlight the difficulty petitioners have had convincing the PTAB that materials are prior art, this case demonstrates that factors such as the motivation of the interested person and the duration of availability can contribute to a finding of public availability and thus qualify materials as prior art.