Cozen O’Connor: Experimental-Use Exception [Alert]

Experimental-Use Exception 

April 2, 2019

On March 27, 2019, Medtronic, Inc. petitioned for panel rehearing and rehearing en banc of the January 24, 2019, Federal Circuit split decision in Barry v. Medtronic, Inc., where the panel majority affirmed the District Court’s denial of a post-verdict motion for judgment as a matter of law of patent invalidity because substantial evidence supported findings of experimental use and that the “on-sale” and “public-use” statutory bars to patentability did not apply.

The patent-at-issue concerns methods and systems for correcting spinal column anomalies, such as scoliosis, through use of a derotation tool, which engages screws inserted in the vertebrae to move the vertebrae into a corrected position. The inventor used the derotation tool in three surgeries in August and October 2003, more than one year prior to filing his patent application. The inventor claimed these surgeries were an experimental use and an exception to the on-sale and public-use statutory bars to patentability. The inventor testified that it was only in January 2004, after the three-month follow-up to the last of the three surgeries, that he determined that his invention functioned for its intended purpose and, on December 30, 2004, filed his application for a patent. The inventor admitted that straightening of the spine is normally seen at the time of surgery, but he and his expert explained that a three-month post-surgical follow-up is standard medical practice for confirming that a new surgical technique performed as intended.

In its petition, Medtronic argues that Barry’s after-the-fact testimony of experimental use is insufficient as a matter of law to establish an experimental use. Medtronic argues that the August and October 2003 surgeries were not experimental uses because the inventor charged his normal surgical fee to his patients and did not advise his patients that the surgeries were experimental. Medtronic argues that the panel majority incorrectly allowed “post hoc testimony, unsupported by contemporaneous objective evidence” to evidence an experimental use.

Medtronic also argues that the panel majority incorrectly placed the burden of proof on the alleged infringer to disprove the patentee’s assertion of experimental use. Medtronic argues that after it established a prima facie showing that the claimed invention was on sale and/or in public use before the critical date, that the burden should have shifted to the patentee to prove the experimental use.

Medtronic also argues that the panel majority incorrectly concluded that the invention was not ready for patenting before the critical date, based on its finding that Barry needed the third follow-up assessment to determine that the invention worked for its intended purpose of ameliorating aberrant spinal column deviation conditions. In contrast to the analysis of the panel majority, Medtronic argues that the August and October 2003 surgeries were reductions to practice that immediately proved that the invention worked for its intended purpose.

Medtronic’s petition essentially tracks the arguments made in Chief Judge Prost’s dissenting opinion. It will be interesting to see if the petition is granted.


Martin B. Pavane

Vice Chair, Intellectual Property Department
Co-Chair, Hatch-Waxman & Biologics Litigation

(212) 883-4994

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