In my last post, I discussed the Supreme Court’s opinion in Helsinn Healthcare v. Teva Pharms., holding Helsinn’s patent on a drug was invalid on the basis that Helsinn’s semi-secret sale of the drug to a marketing partner triggered the AIA s. 102 on-sale bar. I use the term, semi-secret, because Helsinn issued a press release announcing the deal more than a year before they filed their patent application, but the press release did not disclose the dose of the drug that was sold, and the deal involved an NDA between Helsinn and the marketer. The Supreme Court considered this to be a “secret sale” that violated the policy against an inventor’s commercializing the invention for an indefinite period, while keeping features of the invention secret, and then filing an application to protect it after competition was threatened.

Barry v. Medtronic, Inc., Appeal no. 2017-2463 (Fed. Cir., January 24, 2019), in a split decision that addressed both the “public use” and “on-sale” bars of s. 102(b) in a case involving much more factual detail than Helsinn. Dr. Barry is a surgeon who obtained patents on methods and systems for correcting spinal column anomalies, such as those due to scoliosis, by conducting a surgical procedure with a surgical device that applied force to multiple vertebrae at once. He based his applications on the results of three surgeries that he conducted outside the one-year grace period of s. 102 (the “critical date”). The patients all had follow-up visits – two were outside the grace period, but the third was within it. After the third follow-up showed the procedure had been successful, Barry submitted an abstract to a professional meeting.

Multiple personnel were present in the operating room, and Dr. Barry charged his usual fee for performing the operation. The patients were not told that they were test subjects for the new device. He testified that all three follow-ups were necessary to determine whether or not the surgery was successful, but apparently testified that he could determine the likely outcome while the patient was still undergoing the procedure. Medtronic began its alleged infringement in 2004.

While most of the lengthy majority opinion focused on whether or not there was an invalidating “public use” of the invention, the requirements for an invalidating “public sale” were also discussed. The Fed. Cir. cited Pfaff v. Wells Electronics, Inc. as requiring, for a finding of “public use”, that the invention be in public use and ready for patenting before the critical date. Importantly, the Fed. Cir. cited to Pfaff v. Wells as requiring both that there had been a commercial sale of the invention and that the invention be ready for patenting before the on-sale bar can be established (citing Helsinn, of all things).
First the majority found that Medtronic’s public use defense “fails on two grounds, which are substantially related”:

“First, the invention was not ready for patenting before the critical date. Second, there was no public use except for an experimental use, and ‘[p]roof of experimental use serves as a negation of the statutory bars’… We place out discussion our experimental use within our discussion of the ‘public use’ elements. This placement fits the facts that commercial exploitation may sometimes satisfy [the public use] element…and ‘[t]he law has long recognized the distinction between inventions put to experimental use and products sold commercially [citing Pfaff and the truly hoary decision, Elizabeth v American Nicholson Pavement Co., 97 U.S. 126 (1877)(Roadway pavement can be tested in public view while retaining experimental use defense)… but this placement is not inevitable; we have observed that ‘evidence of experimental use may negate either the ‘ready for patenting’ or ‘public use’ prong [of the public use bar standard].’”

By now, you can probably see how the next eleven pages of the opinion are going to conclude. The majority spends pages of the opinion rebutting Medtronic’s assertions that the invention was “ready for patenting” prior to the critical date, because the majority credited evidence that it had not been “shown or known to work for its intended purpose.” This reading of the evidence as supported a finding that the invention was not ready for patenting in this case, where it was used in a real-world context prior to the critical date, require rigorous but forgiving findings that all of Barry’s activities that fell outside of the grace period were within the experimental use exception to the public use bar.
This is also true of the section affirming the lower court’s finding that the invention was not “in public use” as required by the public use bar, because the invention was not accessible to the public before the critical date: “We also conclude that the asserted acts of commercial exploitation, namely, the August and October 2003 surgeries come within the experimental use exception.” Page 26 of the slip opinion lists 13 factors relevant to assessing whether or not a use is experimental. While the majority concludes that the evidence supporting “not ready for patenting” also shows that “many of the above recited factors point toward a conclusion of experimental use.”

I am not going to walk through the majority’s analysis of the 13 factors, except to note that its tone is forgiving. I think that many of the factors could be read to favor the defense. For example, although there were a number of other medical personnel in the operating room, including a technician from the company that made parts of the device, the majority finds that everyone was under an implied duty of confidentiality. I also feel that the majority struggled to distinguish Sinskey v. Pharm. Ophthal., 982 f .2d 494 (Fed Cir 1992), a case that involved an intraocular lens, but I will leave that for your review, along with the strength of the minority opinion. In any case, this opinion should be added to your reference libraries for its exhaustive analysis of the on sale and public use bars either pre- or post- AIA.

This article was originally published on Patents4Life.com.

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