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Avoiding the On-Sale Bar: Invention Not ‘Ready for Patenting’

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The Supreme Court’s recent decision, Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., No. 17-1229, 586 U.S. ­___ (2019), underscores the importance of filing for patent protection early. In Helsinn, the Supreme Court confirmed that under both the Leahy-Smith America Invents Act (AIA) and pre-AIA law, a prior sale of an invention may bar the inventor from receiving later patent protection if the inventor does not apply for this protection within one year of the sale, even if the sale does not actually disclose any of the inventive elements to the public.  However, not all sales will start the one-year clock.  The invention must be “ready for patenting” at the time of the sale and not in a stage of “experimental use.”  Polara Eng’g Inc. v. Campbell Co., 894 F.3d 1339, 1348 (Fed. Cir. 2018).  Accordingly, two days after the Helsinn decision, the Federal Circuit held in Barry v. Medtronic, Inc., No. 914 F.3d 1310 (Fed. Cir. 2019) that three surgeries using a method to correct spinal column anomalies did not invalidate a patent on the method, even though the surgeries were performed by the inventor/doctor for his standard fee outside the one-year grace period, because at the time of the surgeries the method was still in the experimental stage and thus not ready for patenting. 

The patents at issue in Barry concerned methods developed by Dr. Mark Barry to correct spinal anomalies (such as those arising due to scoliosis), using a tool to manipulate multiple vertebrae simultaneously.  Id. at 1317.  After developing the method, Dr. Barry used it to perform three surgeries in August and October of 2003 on patients with the most common types of scoliosis-related spinal conditions.  He conducted follow-up examinations with each of these patients after a three-month convalescence period, the last examination occurring in January 2004.  Id. at 1319.  According to Dr. Barry’s trial testimony, it was only after this last follow-up examination that Dr. Barry felt confident that his method functioned properly.  Dr. Barry then filed a patent application on December 30, 2004, from which his first patent issued in 2010.  Id.

Dr. Barry sued Medtronic, Inc., a company that produced kits for use in performing spinal manipulations, alleging that the company had induced surgeons to infringe his patents based on the training and instructions Medtronic provided on how to use its kits.  At the district court stage, a jury found for Dr. Barry, and awarded him over fifteen million dollars in damages for Medtronic’s infringement.  Id. at 1320.  In post-trial rulings, the district court upheld the verdict despite numerous challenges by Medtronic, including a challenge to the validity of the first patent under both the on-sale and public use bars of 35 U.S.C. § 102.1  Id.  Medtronic claimed that because the three initial surgeries all took place prior to December 30, 2003 (the critical date for the one-year grace period), Dr. Barry’s method was in public use and/or on sale before this date and his resulting patent was therefore invalid.  Id.

On appeal, a divided panel of the Federal Circuit affirmed, with Chief Judge Prost providing a strong dissent.  While the majority discussed its decision primarily in terms of the public use bar, it also explained that its reasoning applied equally to the on-sale bar, citing to Helsinn, of all things, for the on-sale bar requirements.  Id. at 1331.  The majority first found that Dr. Barry’s invention was not in public use prior to the critical date, because it was not yet “ready for patenting” prior to this date.  Specifically, the majority stated that in order to show “readiness for patenting,” Medtronic had to show that the invention had been reduced to practice, requiring a showing that “the inventor (1) constructed an embodiment or performed a process that met all the limitations and (2) determined that the invention would work for its intended purpose.”  Id. at 1322 (citing In re Omeprazole Patent Litig., 536 F.3d 1361, 1373 (Fed. Cir. 2008)).  The majority found that, because the three surgeries performed by Dr. Barry involved the three most common types of scoliosis-related spinal anomalies, the evidence permitted a reasonable finding that “Dr. Barry did not know that his invention would work for its intended purpose until January 2004, when he completed the follow-ups on the[se] three surgeries, which were on three patients who fairly reflected the real-world range of application of the inventive method.”  Id. at 1323.  The majority further rejected Medtronic’s contention (which the dissent embraced) that the patent claims themselves compelled a narrower reading of the “intended purpose” of the invention, which would have been satisfied upon the completion of at least the second surgery.  Id. at 1325 (“intended purpose need not be stated in claim limitations, given that one typical way of claiming is simply to define the physical steps of the process, or the physical elements of a product, without building functional or purpose language into the claim limitations at all,” citing In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997)). 

The majority additionally found that not only had Medtronic not met its burden of proving that the invention was “ready for patenting” prior to the critical date, Medtronic had also not met its burden of proving that the method was even in public use prior to the critical date, given that the jury could have reasonably found that those present in the operating room with Dr. Barry when he performed the procedures were under an implied duty of confidentiality.  Id. at 1327.  Furthermore, the majority found that even if the method was in public use prior to the critical date, this use fell within the experimental use exception of 35 U.S.C. § 102, even though Dr. Barry received payment for the surgeries, and the patients did not know that they were part of any experimentation.  Id. at 1328-29.  Here, the majority distinguished similar cases which had ruled against experimental use, on the ground that Dr. Barry had not relinquished control over his invention prior to the critical date (given that the patent was for a method and it was Dr. Barry who performed the method).  Id. at 1329.  Furthermore, even though Dr. Barry had received payment for the method, the majority felt it important that he had not received more than his standard rate, and he did not attract any of the patients because of the new method.  Id.

The majority opinion generated a 23-page dissent from Chief Judge Prost.  Judge Prost felt that the facts of the case were simple:

More than one year before filing for the ’358 patent, Dr. Barry successfully performed his claimed surgical method on three different patients, charging each his normal fee.  Dr. Barry’s method was thus prima facie “on sale” or in “public use” before the critical date under 35 U.S.C. § 102(b).

Id. (Prost, C.J., dissenting) at 1336. 

Judge Prost criticized the majority for what she considered a misapplication of the law concerning both the on-sale and public use statutory bars.  For Judge Prost, whether an invention is “ready for patenting” amounts to a determination of whether the inventor “could have obtained a patent.”  Id. at 1339.  Judge Prost believed the record was clear that Dr. Barry could have received a patent on his method upon completion of the second surgery.  Id. (“There was at least some amelioration of [two different types of aberrant spinal column deviation conditions] by the end of the [two] surgeries.  At this point, Dr. Barry could have satisfied the enablement and written description requirements of § 112 and credibly claimed utility under § 101.”).  In her view, by both requiring a reduction to practice, which the majority reasoned did not occur until Dr. Barry knew that his method would work for its intended purpose, and broadening the intended purpose beyond what was required by the claims and specification, the majority had committed error.

Furthermore, Judge Prost believed that the three uses of the method prior to the critical date did not satisfy the requirements for the experimental use exception.  Id. at 1347.  She felt that the only actual evidence of an experimental use was Dr. Barry’s own self-serving testimony at trial that the surgeries were experimental.  Judge Prost criticized the majority for finding experimental use, given that all of the factors present for the three surgeries—"the lack of records indicating experimentation, the normal fee charged, the control exercised, and the failure to inform customers of experimental purpose”— also would have been present for surgeries performed for purely commercial purposes.  Id.

Barry illustrates the fact-intensive nature of the experimental use inquiry.  While the majority did find that Dr. Barry’s early surgeries were performed for experimental purposes, Chief Judge Prost’s strong dissent illustrates the importance for inventors of keeping detailed records of their development efforts, including any evidence of experimentation.  Furthermore, it may be advisable for inventors to include details articulating the “intended purpose” of their inventions within the claims, or at least the specification, to improve their chances of success on a subsequent “not ready for patenting” argument.  Additionally, the circumstances of further illustrates the importance of filing for patent protection early.  According to Dr. Barry’s own testimony, he had determined that his method was ready for patenting in January of 2004; however, Dr. Barry did not file his patent application until December 30, 2004.  Had Dr. Barry not waited almost twelve months to file for protection, the three surgeries at issue in this case would have easily fallen within the one-year grace period.   


1 As the parties in Barry agreed, pre-AIA provisions of Title 35 applied to the case.

 

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