Dey, L.P. v. Sunovion Pharma., Inc.

Clinical trial was not "public use" under 102(b), therefore summary judgment of invalidity was reversed.

July 15, 2013

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Dey, L.P. v. Sunovion Pharma., Inc., Case No. 2012-1428, 2013 U.S. App. LEXIS 10010 (Fed. Cir. May 20, 2013) (Circuit Judges Newman, Bryson, and O’Malley presiding; Opinion by Bryson; Dissent by Newman) (Appeal from S.D.N.Y., Koeltl, J.)

Drug Product and Patent(s)-in-Suit:Brovana® (formoterol);  U.S. Patent Nos. 7,348,362, 7,462,645, 7,465,756, 7,473,710, and 7,541,385

Nature of the Case and Issue(s) Presented: The issue before the Federal Circuit was whether third-party clinical trials could constitute public use under 35 U.S.C. §102(b). Sunovion argued that its clinical trials, which were done under confidentiality agreements, constituted public use of the claimed invention in Dey’s asserted patents. The district court granted summary judgment of invalidity based on public use because Sunovion’s clinical trials were open and free, which is to say, the participants could take the drugs home and there were no repercussions for failing to return them. The district court also found that the confidentiality requirements were so “loose” that they did not preclude a finding of public use. In particular, the district court relied on the fact that (i) the participant was given the identity of the active ingredient in the study; and (ii) the participant was permitted to discuss the trial, including the drug that was the subject of that trial, with his/her regular doctor.

The Federal Circuit reversed the district court’s summary judgment ruling. It held that there existed genuine issues of fact, which precluded entry of summary judgment of invalidity.

Why Dey Prevailed: The Federal Circuit disagreed that the clinical trial participants had unfettered use of the trial drug. In particular, the Federal Circuit focused on the facts that the subjects agreed to take the medication, keep usage logs, and return any unused drugs at the end of the trial. Likewise, the test administrators could only dispense the drugs to trial participants, were held accountable for storage of the drugs, and knew that all unused drugs were to be returned. Therefore, the Federal Circuit held that there were genuine issues of fact that precluded summary judgment.

The Federal Circuit also disagreed with the district court’s finding concerning the lack of confidentiality associated with the clinical trial. The subjects were given incomplete descriptions of the treatment formulation; while they were informed about the active chemical compound and the range of possible dosages being investigated, they were not told the identity of the particular drug or formulation they were receiving. Thus, the subjects could not tell the inventive formulation to someone else. Further, that the participants did not sign confidentiality agreements did not render the trial a public use because participants routinely do not sign confidentiality agreements.  Rather, the investigators were the most knowledgeable persons involved in the study, and they were required to sign a pledge of confidentiality. Thus, as to this issue too, Dey raised genuine issues of fact that precluded entry of summary judgment.

In her dissent, Judge Newman agreed with the majority’s opinion to reverse the district court, but disagreed with the decision to remand. “There are no disputed facts, and no facts requiring finding or that could be found to show that these trials were a public use. The issue requires resolution, not perpetuation.”

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