Barry v. Medtronic: Physician Experimental Use
Last week, the Federal Circuit rendered an opinion in Barry v. Medtronic, in which Dr. Barry alleged that Medtronic induced surgeons to infringe U.S. Patent Nos. 7,670,358 and 8,361,121 both for "System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions."
The patents relates to systems for correcting spinal column anomalies by applying force to multiple vertebrae at once. The decision is an interesting one because of its detailed analysis of Dr. Barry's activities prior to applying for patent.
Briefly, the timeline of Dr. Barry's activities is as follows:
Late 2002 - Dr. Barry begins working on trying to link certain components of a device.
Early 2003 - Dr. Barry works with a salesperson for DePuy to revise standard equipment to achieve his goals.
July 2003 - Dr. Barry develops a prototype of the tool.
August 4, 2003 - Dr. Barry perform a first surgery with the tool.
August 5, 2003 - Dr. Barry perform a second surgery with the tool.
October 14, 2003- Dr. Barry perform a third surgery with the tool.
August 2003-January 2004 - Dr. Barry follows up with the patients from the three surgeries to review the results.
December 30, 2004 - Dr. Barry files his patent application.
The three surgeries were chosen because they represented the three most common types of scoliosis-caused spinal deviation conditions.
Under 35 U.S.C. § 102(b), there is a statutory bar on patenting inventions that were in public use in the United States more than one year before the application for a patent. Thus, activities prior to December 30, 2003 (one year earlier than the filing date) are potentially invalidating. Moreover, this public use bar is triggered where, before the critical date, the invention is in public use and ready for patenting.
In the instant case, the Court concluded that Dr. Barry's tool was not ready for patenting one year prior to filing, and that there was no public use except for an experimental use, which serves to negate statutory bars.
Specifically, it held that (1) Dr. Barry's tool was not ready for patenting until he had performed the surgeries, and followed-up with his patients to see that the surgeries were successful as intended, noting that the follow-up visits were necessary for determining whether the tool operated as intended, and (2) that the surgeries themselves were within the experimental-use exception, even though other people were present within the operating room at the time of the surgeries, and even though Dr. Barry received compensation.
The decision in this case is quite fact-sensitive, and is worth reading at the link provided. However, a few general lessons may be learned.
First, though Dr. Barry ultimately prevailed, it would be prudent of physicians to file a provisional application as early as possible, or to at least carefully discuss their timeline with an attorney. Relying on experimental use exceptions, especially when others may see the inventive device or method is taking an unnecessary gamble. Additionally, there is an 11-month window between the January 2004 follow-up and the December 2004 filing. That delay may have been through the fault of the inventor or their attorney. Regardless, it could have been costly, and in this case quite unnecessary.
Second, the Federal Circuit was quite lenient in examining "ready for patenting" in favor of the inventor in this case, but it creates a tension with the doctrine of reduction to practice. After reading the dissent, it is quite easy to see how this case could have been decided otherwise. Thus, it is imperative on patentees to be diligent in filing at the earliest opportunity.