July 26, 2018
Earlier this month, the Federal Circuit issued an opinion in Jazz Pharmaceuticals v. Amneal Pharmaceuticals, upholding the PTAB’s finding that certain materials related to the FDA regulatory review process for Xyrem® were sufficiently accessible to the public to constitute prior art to seven Jazz patents. These materials (the “ACA materials”) were accessible via a link on the FDA website “where background material would be posted before the meeting, and the meeting minutes, transcript, and slides would be posted after the meeting.” In finding that the ACA materials constituted publicly accessible prior art, the Federal Circuit noted:
1. The breadth of dissemination of the ACA materials: “(T)he Notice in the Federal Register widely disseminated the ACA materials through a hyperlink to a public FDA website where the ACA materials could be accessed. The Notice explained what materials were located on the FDA website, approximately when they would be available, and how to navigate to them.”
2. That a person of ordinary skill in the art “would have been familiar with the Federal Register and motivated to look for notices related to drug distribution, safety, or abuse prevention,” which was important because “[w]hether the disseminated material is addressed to or of interest to persons of ordinary skill is also relevant to the public accessibility inquiry.”
3. That the ACA materials were available online for a substantial period of time (at least two months) before the patents’ priority dates (“The longer a reference is displayed, the more likely it is to be considered a ‘printed publication.’)”
4. That the ACA materials were distributed via public domain sources with no possible expectation that the materials would remain confidential or not be copied.
5. That a reference can be a "printed publication" without indexing or searchability.
It's interesting that the Federal Circuit stated that “[w]e do not interpret the [PTAB’s] decision as applying a per se rule that every notice in the Federal Register satisfies the requirements for prior art, nor do we endorse such a rule that would supplant the case-by-case inquiry consistently applied throughout our case law.” So, no per se rule exists in this context.
And “whether the disseminated material is addressed to or of interest to persons of ordinary skill” (point 2 above) superficially might sound like part of the test for determining whether a prior art reference constitutes analogous art.** Determining whether a prior art reference is analogous art involves considering “(1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor's endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Clay, 966 F.2d 656, 658 (Fed. Cir. 1992). “A reference is reasonably pertinent if, even though it may be in a different field from that of the inventor’s endeavor, it is one which, because of the matter with which it deals, logically would have commended itself to an inventor’s attention in considering his problem.” Id. at 659. These legal concepts (“public accessibility” and “reasonably pertinent”) appear to be connected through the level of interest in a reference by those in the relevant art .
But are the two concepts really so similar?
In my February 2018 post, “Apotex v. OSI Pharmaceuticals: Beware What You Say To The SEC,” I noted that the PTAB found that OSI’s SEC filing (10-K) could be relied upon as a prior art reference, stating that “competitor pharmaceutical companies working in the same area as [OSI] at the time of invention, which would have employed medical oncologists who met the requirements of an ordinary artisan, would have been aware of company filings such as OSI’s 10-K” and that such competitors would have looked to OSI’s 10-K to determine which drugs and treatments pharmaceutical companies were pursuing. Surely, 10-Ks are publicly accessible, so it makes sense that 10-Ks theoretically could be available as a source of prior art.
But are such corporate filings “analogous”? Would such a filing “logically have commended itself to an inventor’s attention in considering his problem”? Would an inventor really look to SEC filings to attempt to solve a problem he/she is working on? Perhaps not.
** For prior art to be available as a basis for a rejection, it must be publicly accessible and “analogous” to the claimed invention.