Consider Confidentially Measures When Using Inventions in Clinical Trials

May 20, 2013

Heather J. DiPietrantonio PhD

What This Means To You

  • Obtain a confidentiality agreement, or at the very least maintain a showing of confidentiality, when participating in clinical trials.

Overview

In Dey, L.P. v. Sunovion Pharmaceuticals, Inc., the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) found that an invention disclosed during clinical trials raised issues relating to the public use doctrine and confidentiality.

Case Background

Dey and Sunovion simultaneously developed pharmaceutical formulations of formoterol, used to treat chronic obstructive pulmonary disease COPD. Both Dey and Sunovion filed for and obtained patents and also conducted clinical trials. Dey’s patent applications were filed after Sunovion’s applications, and Dey’s patents issued after consideration of Sunovion’s patent.

When Dey sued Sunovion for patent infringement, Sunovion argued that Dey’s patents were invalid because Sunovion’s clinical trials of its own product constituted prior public use of Dey’s invention. The district court granted summary judgment for Sunovion, holding that a clinical trial is public use and that Dey’s patents were invalid. Dey appealed.

Decision Analysis

The Federal Circuit focused on whether or not sufficient precautions were taken during Sunovion’s Phase III clinical trials to exclude members of the public from obtaining information about the potentially invalidating prior art.

Prior to the trials, several confidentiality measures were taken. Test subjects agreed that (1) only they would take the medication, (2) they would keep accurate usage logs, and (3) return all unused medication. Also, test administers (1) agreed to dispense drugs only to trial subjects, (2) were accountable for secure storage and records of drug use, and (3) knew that unused supplies had to be returned. Test subjects were given the drug to take home and self-administer but were unaware of the specifics of the inventive drug formulation. Throughout the trial, only a couple of vials of the drug were not returned.

The Federal Circuit reversed the district court’s grant of summary judgment and remanded the case based on its ruling that a reasonable jury could conclude that the use of the experimental drug was “sufficiently controlled and restricted.”

In reversing the district court, the Federal Circuit determined there was an issue of fact regarding the sufficiency of precautions taken to exclude members of the public from obtaining information about the drug formulation.

Takeaways

This case highlights the importance of carefully considering confidentiality measures when using an invention in a clinical trial or in other product development platforms.