When is an invention “ready for patenting”? And when should an inventor recognize that it is? Finally, should the standard for deciding when an invention is ready for patenting (in contrast to needing additional experimentation) be solely a legal question or depend on objective or subjective (i.e., an inventor’s) belief that the invention works for its intended purpose? All these questions arose in the Barry v. Medtronic case decided by the Federal Circuit recently, and while the inventor prevailed the Chief Judge of the Court penned a strong dissent that could change how these questions are answered in a future case.
These issues arose in patent infringement litigation by Dr. Mark Barry, a sole inventor, for infringement by Medtronic of his invention as claimed in U.S. Patent Nos. 7,760,358 and 8,361,121. The invention was directed to a system or device and methods for correcting spinal column deviation conditions. Named inventor Barry, an orthopedic surgeon, began development of his invention while working with a sales representative for DePuy, a medical device company. After developing the tool, Dr. Barry used it in three back surgeries performed over a three-month period on patients having "the three most common types of scoliosis-caused spinal deviation conditions that surgeons typically see." Within one year after a three-month post-operative convalescence for the last of these patients, Dr. Barry filed a patent application that eventually matured into the patents-in-suit. These activities were thus within the one-year grace period applied under 35 U.S.C. § 102(b) prior to amendment of the Patent Act under the Leahy-Smith America Invents Act.
Following introduction of an infringing product by Medtronic, Barry sued and a jury found in his favor and awarded damages. The jury rejected Medtronic's defenses of that the invention had been in public use and on-sale more than one year before Barry’s patent application was filed, based on the three surgeries performed in testing the claimed device and methods.
The Federal Circuit affirmed over a strong dissent by Chief Judge Prost. The Court found that the device and accompanying methods were not in public use by these surgeries because the inventor (Dr. Barry) performed the surgeries to determine whether the devices could be used for their intended purposes and thus the use was experimental. (Similar reasoning applied to the on-sale bar, where the experimental use of the device and methods negated any contrary conclusion that could (and for Chief Judge Prost) did, arise because Dr. Barry charged the patients his customary surgical fee.) In particular the district court and the Federal Circuit credited Dr. Barry's testimony that he did not know that the claimed method and device had worked for three months after the last of the three surgeries. The panel majority expressly held that the claimed invention was not "ready for patenting" prior to the critical date because "there is substantial evidence that Dr. Barry's invention was not ready for patenting until January 2004 because the final follow-up from the October surgery was reasonably needed for the determination that the invention worked for its intended purpose.”
Chief Judge Prost's dissent was predicated on her view that the panel majority had misapplied the law regarding both the public use and on-sale bars under pre-AIA § 102(b). For Chief Judge Prost "the facts are simple":
More than one year before filing for the patent[-in-suit], 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).
The crux of Chief Judge Prost's argument is that Dr. Barry's self-serving testimony (that he did not appreciate that his claimed method worked as intended until three months after the last of the three surgeries) was inconsistent with his appreciation, as a surgeon, that "his method worked as of a surgery's completion." She focuses her argument on whether the invention was "ready for patenting" at any time prior to the end of the convalescence period of the last surgery. Chief Judge Prost was convinced that the invention was reduced to practice by at least the completion date of the second surgery, which was prior to the critical date. The basis for her disagreement with her brethren ultimately rested on her belief that the claimed method was reduced to practice as soon as Dr. Barry achieved correction of the spinal abnormalities on the surgical table and her rejection of the evidence that he could only appreciate reduction to practice after sufficient patient convalescence had occurred for him to conclude that the surgical adjustment had sufficient permanence to satisfy the criterion of "ameliorating" the abnormality as recited in the asserted claims.
The Chief Judge's determination that Dr. Barry's invention was "ready for patenting" after the second surgery was because he had shown that the spinal deformity could be surgically corrected in two patients (and thus established that the method was of general utility). While she acknowledged that the majority identified a "common-sense approach to identifying the intended purpose [that] is rooted in the preamble claim language as well as the specification," she asserts that she was "unpersuaded" because concepts like follow-up time were not found in the claims or specification of the patent-in-suit.
The question of whether an invention is reduced to practice would appear to be one fraught with an understanding of how that phrase would be interpreted by one having ordinary skill in the art. And while the ultimate question of reduction to practice is a legal one, it is based on such significant underlying factual determinations that the substantial evidence standard would in most cases make it difficult for a court (on post-trial motions) or reviewing court on appeal to overturn a jury's fact findings. But this is the root of what Chief Judge Prost seems to be arguing in setting out her position. And at least some of her criticism of this testimony and evidence has a "damned if you do damned if you don't" flavor:
I cannot see how charging one's normal fee makes the sale look like anything other than a normal sale. Had Dr. Barry charged a premium, a claim of experimental purpose would be difficult to maintain. Had he charged less, it might suggest experimental purpose—or it might not [citations omitted].
The case has the usual amount of sniping, in footnotes, between the majority and the dissent. One such statement, however, encapsulates the basic grounds for disagreement between the two opinions (or at least the reasoning underlying them):
The dissent proposes several changes to the legal standards stated in governing case law, such as a change to impose a (high) burden of persuasion on the patent owner to establish experimental use. Medtronic has not argued for such changes. We follow existing case law.
Kevin Noonan is a partner with the law firm McDonnell Boehnen Hulbert & Berghoff LLP and represents biotechnology and pharmaceutical companies on a myriad of issues. A former molecular biologist, he is also the founding author of the Patent Docs weblog, http://patentdocs.typepad.com/.