SCOTUS to Consider Certiorari in Proposed Clinical Trial Case - Fordham Intellectual Property, Media & Entertainment Law Journal
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SCOTUS to Consider Certiorari in Proposed Clinical Trial Case

SCOTUS to Consider Certiorari in Proposed Clinical Trial Case

On December 7, 2012, the Supreme Court considered whether to grant certiorari in the case Montgomery v. Kappos. At issue in the case, from the Federal Circuit, is whether a research proposal that was never performed can anticipate a patent claim under Tilghman v. Proctor, as a matter of law. The Federal Circuit opinion and briefs discussed in this article can be found here: http://www.scotusblog.com/case-files/cases/montgomery-v-kappos/

The petitioners are a team of professors from University College London Medical School who sought to patent the use of Renin-Angiotensin System Inhibitors (“RASIs”) for the treatment or prevention of stroke. The patent examiner rejected three of the petitioners’ claims because they were anticipated by four prior art references. The petitioners appealed to the Board of Patent Appeals and Interferences, arguing that one of the references, the research project HOPE (Heart Outcomes Prevention Evaluation) was merely a proposal for future research and did not anticipate the petitioners’ findings. The Board rejected this argument and affirmed the examiner’s rejection. Likewise, a Federal Circuit panel affirmed the Board’s rejection after concluding that the HOPE study described a clinical trial protocol that inherently anticipated the petitioners’ claims.

The majority found that the prior art, which included protocols for administering RASIs to patients at risk for stroke anticipated the petitioners’ claims because doing so would necessarily treat or prevent stroke. The majority agreed with the dissent that mere “invitation to investigate is not an inherent disclosure” but found that HOPE’s protocol was sufficiently concrete and specific to constitute inherent disclosure. The dissent would have found that the HOPE study failed to inherently anticipate the petitioners’ claims because the protocol, even if followed, may not have achieved the same results as were found by the petitioners – that RASIs can be used to treat or prevent stroke. In the dissent’s view, “[a] process that, if it had been carried out might yield a particular undisclosed result is not an inherent anticipation of that result.” [Emphasis in original]. In their petition for a writ of certiorari, Montgomery et al argue, citing Judge Learned Hand, that the HOPE protocol is “no more than a starting point for future experiments…[which] has not correspondingly enriched the store of common knowledge, and it not an anticipation.”

It’s interesting that without the petitioners’ research, the majority would not know whether RASIs would inevitably treat or prevent strokes until the HOPE study was completed, if then. The issue hinges on whether the HOPE proposal was too abstract to constitute anticipation and the petitioners seem to suggest a bright line rule where, as a matter of law, research proposals that have not yet begun cannot anticipate patent claims. While the current fact-intensive inquiry by the examiner may yield inconsistent results, the effects of that bright line rule would likely do damage the way that the scientific research community functions.

In any case, the Supreme Court’s decision, or lack thereof, should be interesting. Orders are expected following the Court’s winter recess.

Federal Circuit Opinion:
http://www2.bloomberglaw.com/public/document/In_re_Montgomery_677_F3d_1375_102_USPQ2d_1881_Fed_Cir_2012_Court_

Petition:
http://sblog.s3.amazonaws.com/wp-content/uploads/2012/09/12-182-Montgomery-v-Kappos-2012.pdf

Respondent’s Brief:
http://sblog.s3.amazonaws.com/wp-content/uploads/2012/11/12-182-Montgomery-BIO.pdf

Petitioner’s Reply Brief:
http://sblog.s3.amazonaws.com/wp-content/uploads/2012/11/12-182-Reply-Brief.pdf

Alexander Simpson

Alexander Simpson is a second year student at Fordham Law. He holds a degree in economics from the University of Maryland. His interest in intellectual property law began when close friends began managing a peer-to-peer file sharing network, for which no wrongdoing is admitted.