Sodium oxybate - USA

On Jul 13, 2018, Federal Circuit upheld PTAB’s decision & found 7 REMS patents covering Xyrem® invalid as obvious.

Background:

Jazz Pharmaceuticals, Inc. appealed from the IPR decisions of the PTAB which held certain claims of Jazz’s U.S. Patents 7,668,730 7,765,106, 7,765,107, 7,895,059, 8,589,182, 8,457,988 and 8,731,963 invalid as obvious. The patents in suit are members of a family of patents owned by Jazz relating to a drug distribution system for tracking prescriptions of a Xyrem® through database. On May 14, 2001, the FDA announced a meeting through the Notice in the Federal Register & and that main focus of the deliberations was on risk management issues associated with Xyrem. The meeting was “open to the public,” and permitted interested persons to “present data, information, or views, orally or in writing, on issues pending before the committee.” The Notice also included a hyperlink to an FDA website where background material from the drug sponsor and the FDA would be posted & furthermore, the Notice provided specific instructions on how to access the meeting materials on the FDA website. The Board determined that the Advisory Committee Art (ACA) materials were publicly accessible on an FDA website listed in the Notice no later than October 4, 2001, over two months prior to the critical date of December 17, 2001. Thus, the Board found that a person of ordinary skill would have been motivated to combine the ACA materials, and that the ACA materials collectively taught or suggested all limitations of the claims. Jazz appealed.

Appeal:

The primary issue on appeal was whether the ACA materials available on FDA website during regulatory review of Xyrem® were sufficiently accessible to the public to constitute prior art.

During appeal Jazz principally argued that the ACA materials are not prior art, so all of the Board’s decisions relying on the ACA materials should be reversed. Emphasizing the substantial length of the annual Federal Register, Jazz asserted that the Board failed to make the requisite finding that a person of ordinary skill exercising reasonable diligence could have located the ACA materials and also argued that Amneal failed to submit any evidence of searchability or indexing of that material. Whether a reference qualifies as a “printed publication” under § 102(b) is a legal conclusion based on underlying factual findings. ‘Public accessibility’ has been called the touchstone in determining whether a reference constitutes a ‘printed publication’ . . . .”[ In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)]. Federal circuit said that comparing the facts of this case to those in MIT, Klopfenstein, and Medtronic confirms that the ACA materials were disseminated more broadly and for a longer duration to persons of ordinary skill than the materials disclosed at individual meetings in those cases. First, the breadth of the dissemination here to persons of ordinary skill is significant. The 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. Second, the ACA materials were available online for a substantial time before the critical date of the patents in suit. “[T]he longer a reference is displayed, the more likely it is to be considered a ‘printed publication.’” [Klopfenstein, 380 F.3d at 1351]. Third, the ACA materials were distributed via public domain sources with no possible expectation that the materials would remain confidential or not be copied. In sum, after considering the relevant factors identified in our public accessibility cases, the record here demonstrates that the ACA materials were widely disseminated to persons of ordinary skill for a substantial time with no reasonable expectation of confidentiality. They were “in the possession of the public,” [Wyer, 655 F.2d at 226].

Jazz next asserted that the Board’s finding of public accessibility must be reversed because evidence of “searchability or indexing is required to conclude that the ACA materials are prior art” and Amneal did not submit such evidence. But federal circuit held that neither indexing nor searchability was required for a reference to be a printed publication under § 102(b). Specifically, printed publication ‘need not be easily searchable after publication if it was sufficiently disseminated at the time of its publication.’ Moreover, even assuming that indexing is relevant to this case, the Federal Register was meaningfully indexed.

Jazz also argued that the Board erred by “equating the constructive notice provided by the Federal Register with the legal standard for prior art”. Federal circuit said that….. “we do not interpret the Board’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. Nor do we discern any error in the Board’s sensible observation that the purpose of the Federal Register is to provide notice of government action such as the advisory committee meeting here. However, we do reiterate that [i]f accessibility is proved, there is no requirement to show that particular members of the public actually received the information.” Thus, the ACA materials were publicly accessible because they were broadly disseminated to interested persons of ordinary skill for a substantial time with no expectations of confidentiality. Hence, they qualify as printed publications under § 102(b).

Next with respect to obviousness Jazz argued that the Board’s finding that a person of ordinary skill would have been motivated to modify the ACA materials. Federal circuit, however, agreed with Amneal & held that the Board’s decisions on this matter are consistent. The Board made the same essential finding in both decisions that a person of ordinary skill would have been motivated to run the ACA materials’ distribution system over multiple computers, as taught in Korfhage. Court also agreed with Amneal that Jazz misinterprets both the Supreme Court’s decision in KSR and this court’s obviousness precedent. KSR did not impose a rigid requirement to identify both a problem to be solved in the art and a finite universe of potential options. Thus, the Board did not err in concluding that implementing the ACA materials’ centralized database system on multiple computers “would have been a predictable use of a known distributed data system according to its established function.” For these reasons, Federal Circuit affirmed the Board’s decisions & found these REMS patents invalid as obvious.