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PTAB Determines That Medical Journal Article Qualifies as a Publicly Available Printed Publication

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Grunenthal GmbH v. Antecip Bioventures II LLC, PGR2018-00092 (Feb. 25, 2020)

In a recent decision invalidating certain claims of a pain treatment patent, the PTAB held that a 2012 article published in the scientific journal Rheumatology was a publicly available printed publication that qualified as prior art.

Antecip Bioventures is the owner of U.S. Patent No. 9,820,999 B2 (“Neridronic Acid for Treating Complex Regional Pain Syndrome”). The ‘999 patent is directed to a method of treating pain, through the administration of neridronic acid, in people suffering from complex regional pain syndrome (CRPS). The patent has a priority date of May 14, 2013.

Grunenthal petitioned for IPR of the ‘999 patent, and challenged seventeen of the thirty claims as unpatentable over an article by M. Varenna et al. in Rheumatology journal titled “Treatment of complex regional pain syndrome type I with neridronate: a randomized, double-blind, placebo-controlled study.” Rheumatology is published by Oxford University Press on behalf of the British Society for Rheumatology.

To qualify as a “printed publication,” a reference “must have been sufficiently accessible to the public interested in the art before the critical date.”[1] A reference is considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.

Antecip argued that the Varenna reference was not publicly accessible before the effective filing date of the invention and was therefore not prior art.  Antecip contended that the only evidence of public accessibility offered by Grunenthal was a PDF file downloaded from the internet on December 6, 2017, four years after the ‘999 patent’s 2013 priority date. Antecip further argued that a 2012 copyright notice standing alone failed to demonstrate that the reference was publicly accessible before the priority date.

The PTAB, however, sided with Grunenthal, which claimed that it provided ample evidence demonstrating that the reference was a prior art printed publication. According to the PTAB, the face of the reference bore “several hallmarks suggesting it was published in 2012 as part of a regularly distributed medical journal.” These hallmarks included the name of the journal; citation information reflecting the journal’s date, volume number, and pertinent page numbers; the dates the article was available to the public; a link to the journal’s website; the publisher of the journal; and a mailing address where readers could make inquiries.

Although the PTAB determined that these indicia alone were sufficient, it also cited the testimony of a doctor who stated that he accessed, reviewed, and posted about the Varenna reference on Twitter in February 2013—before the ‘999 patent’s priority date of May 14, 2013.

By contrast, the PTAB noted the absence of evidence put forth by Antecip in support of its position: Antecip countered neither the indicia on the face of the reference nor the doctor’s testimony. Instead, Antecip offered only “bare attorney arguments,” which “[could] not take the place of evidence lacking in the record.”

Implications for Patent Law Litigation

The existence of evidence/quality of evidence demonstrating that a publication was publicly accessible before a patent’s priority date (or, in the case of a patent owner, not publicly available before a patent’s priority date) is an important consideration when a non-patent publication is asserted as prior art in an IPR.

[1] See In re Cronyn, 890 F.2d 1158, 1160 (Fed. Cir. 1989). An IPR may be requested only “on a ground that could be raised under section 102 or 103 and only on the basis of prior art consisting of patents or printed publications.” 35 U.S.C. § 311(b).