Addressing whether an alleged infringer’s clinical trial was an invalidating public use, the U.S. Court of Appeals for the Federal Circuit reversed a lower court’s summary judgment ruling, finding that whether a clinical trials constitutes “public use” depends on the extend of confidentiality controls and restrictions imposed by the party conducting the clinical trial.  Dey, L.P. v. Sunovion Pharmaceuticals, Inc., Case No. 12-1428 (Fed. Cir., May 20, 2013) (Bryson, J.) (Newman, J., dissenting).

Both the alleged infringer, Sunovion, and the patentee, Dey, developed pharmaceutical products for treating chronic obstructive pulmonary disease.  Dey owned two families of patents claiming the priority date of July 10, 2003.  Sunovion conducted a clinical trial (Study 50) in February 2002.  The parties stipulated that one of the formulations tested in Study 50, Batch 3501A, was identical to Sunovion’s eventual product, Brovana. The participants in Study 50 were given some information about the study and were subject to certain restrictions.  However, they were not provided with any specific information about the medicine.  They signed a consent form stating that participants must keep dosage logs and return unused medicines.  They were allowed to discuss this study with their doctors and were not prohibited from speaking with others about the study.  The clinical trial administrators were also subject to certain restrictions.  They had to sign a formal confidentiality agreement and were forbidden from disclosing the study protocols or dispensing the medicine to any person who was not a trial subject.  They were instructed to return unused medicines.  Nonetheless, a small fraction of Batch 3501A was lost and never returned.

The district court held that Sunovion was entitled to summary judgment of invalidity because Sunovion’s clinical trial constituted clear and convincing evidence of public use.  In particular, the district court found that confidentiality obligations imposed in Study 50 were so loose that use of Batch 3501A by Study 50 participants was essentially open and free.

On Dey’s appeal, the Federal Circuit reserved.  The Federal Circuit found that the use of Batch 3501A during Sunovion’s clinical trial was not “open and free” and the restrictions imposed by Sunovion rendered the use anything but “unfettered.”  The Court explained that the fact that some small fraction of the medicine was lost, or that participants were allowed to self-administer at home, would not preclude a reasonable jury from concluding that the use of Batch 3501A was sufficiently controlled and restricted.

The Federal Circuit found that confidentiality obligations imposed in Study 50 were not so loose to justify a summary judgment.  Although participants were under no obligation of confidentiality, they did not have sufficient information to reveal the composition of the medication they received.  In contrast, clinical trial investigators, who did have knowledge of the nature of the medication, were under a confidentiality obligation.

The Federal Circuit concluded that, in view of the confidentiality controls imposed by Sunovion, a reasonable jury could conclude that Study 50 was conducted with “a reasonable expectation of confidentiality” as to the nature of the formulations being tested and thus, summary judgment on the issue of public use was inappropriate.

In dissent, Judge Newman, while agreeing with the majority that Sunovion’s clinical trial did not constitute an invalidating “public use,” found that there were no pertinent facts remaining in dispute and would have entered judgment in favor of Dey on the existing record.