Read all about it! Printed publication bars patents on drug tracking system

February 15, 2019
Patterson Thuente IP

How often do you browse the Federal Register? For most people, the answer probably is never. But if you want to patent an invention that falls within the regulations of a federal agency like the U.S. Food and Drug Administration (FDA), the Federal Register might trip you up. For one patent applicant, it did just that.

PTAB invalidates patents

Jazz Pharmaceuticals, Inc., holds several patents on a distribution system for tracking prescriptions of “sensitive” drugs (for example, drugs that can be abused or are addictive). It also exclusively markets Xyrem®, a narcolepsy drug. Xyrem’s active ingredient is gamma-hydroxybutyrate (GHB), which can be illicitly used as a “date rape drug.”

During the regulatory review process for the drug, the FDA scheduled an advisory committee meeting and announced the meeting in a notice published in the Federal Register. The notice included a publicly available link to an FDA webpage where a visitor could access background materials from Jazz and the FDA, as well as eventual meeting minutes, transcripts and slides from the meeting.

Amneal Pharmaceuticals, LLC, requested inter partes review (IPR) of seven of Jazz’s patents for the drug distribution system. Under IPR, the U.S. Patent and Trademark Office Patent Trial and Appeal Board (PTAB) can reconsider and cancel an already-issued patent based on certain types of “prior art.” This includes printed publications showing that the invention wasn’t nonobvious before the relevant date.

The PTAB found six of the challenged patents invalid as obvious, relying on the materials on the FDA webpage. Jazz appealed, arguing that the materials didn’t constitute prior art.

Federal Circuit affirms

On review, the U.S. Court of Appeals for the Federal Circuit explained that public accessibility generally is considered the touchstone in determining whether a reference constitutes a printed publication. A reference is considered publicly accessible if it has been disseminated or otherwise made available so that “persons interested and ordinarily skilled” in the topic can locate it by exercising reasonable diligence. Only accessibility need be shown — it’s not necessary to establish that particular people actually received the information.

The Federal Circuit found that the webpage materials indeed were publicly accessible for several reasons. First, the notice in the Federal Register widely disseminated the materials through a link to the public FDA website where they could be accessed. It explained which materials could be found there, when they would be available and how to navigate them.

The court also considered whether the materials were addressed to or of interest to “persons of ordinary skill” in the relevant field. The PTAB found — and Jazz didn’t appeal the finding — that such persons would be familiar with the Federal Register and motivated to look for notices related to drug distribution, safety or abuse prevention. According to the Federal Circuit, wide dissemination of a reference through a publication that those of ordinary skill would be motivated to examine strongly favors a finding of public accessibility.

In addition, the materials were available online for a substantial time (two months) before the critical date of the patents at issue. (The critical date under the applicable law for this case was one year before the date of application filing; under current law, a patent is barred if printed publication occurred anytime before the application date.) The longer a reference is displayed, the court noted, the more likely it is to be considered a printed publication.

Finally, the materials were distributed through public domain sources with no possible expectation that they would remain confidential or not be copied. The court has repeatedly emphasized the importance of such expectations when determining whether a reference is publicly accessible.

The implications

The court’s ruling could affect the patentability of a wide range of inventions that are subject to government oversight. Patent applicants beware: Materials submitted to agencies that are made publicly available could trigger the printed publication bar. •

Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, No. 17-1671, July 13, 2018, Fed. Cir.

“Printed publication” doesn’t require indexing

The U.S. Court of Appeals for the Federal Circuit also considered the role of indexing or searchability in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC. Jazz argued the materials at issue couldn’t qualify as prior art because there wasn’t evidence of indexing or searchability.

The court pointed out that it has consistently held that indexing or searchability is unnecessary for a reference to be a printed publication for prior art purposes. Regardless, the court said, the Federal Register (where the notice about the materials was published) was “meaningfully indexed.” The issue where it appeared included a five-page table of contents organized alphabetically by agency. Each agency’s rules, proposed rules and notices were then listed in that order.

The court declined to endorse a rule that every notice in the Federal Register satisfies the prior art requirements. But it accepted the finding of the Patent Trial and Appeal Board that a person of ordinary skill for these circumstances had a degree in pharmacy or computer science, was interested in drug distribution, safety and abuse, and would have reason to look at the register and FDA notices.

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