Mark A. Barry v. Medtronic, Inc.

Docket No. 2017-2463

January 24, 2019

Brief summary: DC and jury conclusions of no invalidity and infringement affirmed (e.g., the invention was not in “public use” as the use was experimental, no § 102(b) on-sale bar, no § 102(g) prior invention, no inequitable conduct, “underlying direct infringement by surgeons”).

Summary: Dr. Barry alleged Medtronic induced surgeons to infringe his US 7,670,358 and 8,361,121 claiming “methods and systems for correcting spinal column anomalies, such as those due to scoliosis, by applying force to multiple vertebrae at once”, and the jury found infringement, rejected Medtronic’s invalidity challenges, and awarded damages. The DC upheld the jury’s verdict and rejected Medtronic’s inequitable conduct challenge. Medtronic appealed “on numerous grounds, principally concerning the public-use and on-sale statutory bars, but also concerning prior invention, inequitable conduct, and induced infringement and associated damages.” The FC panel explained that “[t]he public use bar is triggered where, before the critical date, the invention is in public use and ready for patenting” (Polara Eng’g, FC 2018; Pfaff, US 1998; Invitrogen, FC 2005). And it disagreed with Medtronic’s public use arguments because “the invention was not ready for patenting before the critical date” and “there was no public use except for an experimental use”. The FC panel addressed “both readiness for patenting and experimental use because they are related”, and to address points raised in the dissent. The FC panel explained “that ‘evidence of experimental use may negate either the ‘ready for patenting’ or ‘public use’ prong [of the public-use-bar standard]’”, and that it has “recogniz[ed] an overlap of the experimental use negation and the ready for patenting standard” (“[p]roof of experimental use serves as a negation of the statutory bars” (Polara Eng’g)). Here, the FC panel found that Dr. Barry did not know “that the surgical technique worked for its intended purpose” as of the date the surgery was carried out alleged by Medtronic since, e.g., expert testimony showed that “[f]ollow up is absolutely required” after surgery “to determine that it lasts” and the preamble language of the claim “here, is not a limiting” (In re Omeprazole, FC 2008; Honeywell, FC 2007 (“an invention might not be ready for patenting until the inventor ascertains how that invention will function in practical circumstances”); TP Labs., FC 1984 (“for medical procedures, follow-up appointments can be necessary to determine whether an invention is performing its intended purpose”); the “intended purpose need not be stated in claim limitations”, citing In re Schreiber, FC 1997)). The FC panel also found that the invention was not in “public use” since, e.g., the ‘358 patent invention was not accessible to the public before the critical date” (“accessibility determination may be rejected where the evidence establishes a sufficient obligation of confidentiality, which can be implied”, citing Dey, FC 2013; “sometimes (as in Egbert) even a limited disclosure can make an invention accessible to the public” (Egbert, US 1881)) and “the asserted acts of commercial exploitation…come within the experimental-use exception” (“An inventor’s use, while public in one sense, will not be considered a statutory public use if the use was experimental.” Electromotive, FC 2005; however, “an inventor’s own prior commercial use, albeit kept secret, may constitute a public use or sale under § 102(b)” (Woodland Tr., FC 1998 and TP Labs.; “A use may be experimental if its purpose is: ‘(1) [to] test claimed features of the invention or (2) to determine whether an invention will work for its intended purpose-itself a requirement of patentability” (Polara; Clock Spring, FC 2009 (13 factors to assess whether a use is experimental, several reviewed here)). Medtronic also argued for invalidity under § 102(b) (on-sale bar) but the FC panel found no abuse of discretion in the DC’s jury instruction that “there is a difference between ‘experimental use’ in the context of patent law and the way that the word ‘experiment’ is used in the context of medicine” since “what the court said on the subject was both modest and consistent with our holdings” (Penwalt, FC 1984 (“The fact that a sale or use occurs under a regulatory testing procedure…does not make such uses or sales per se experimental for purposes of 35 U.S.C. § 102(b)); Clock Spring). The FC panel also upheld “the jury’s rejection of Medtronic’s § 102(g) challenge” because substantial evidence showed Medtronic’s alleged inventor “did not reduce the claimed inventions to practice” until “after Dr. Barry did so.” Medtronic also alleged inequitable conduct based on Dr. Barry’s incorrect initial description of “Figure 6 of both patents” (“contrary to the description, the subject of the submitted x-rays actually was not a patient treated with the inventive methods”), which was corrected by Certificate of Correction after litigation began. The DC found “no intent to deceive the PTO”, and the FC panel found no clear error in this conclusion (Therasense, FC 2011), since, e.g., “Dr. Barry and his counsel were credible in explaining why the errors occurred”. The FC panel also found that substantial evidence supported “the jury’s finding of underlying direct infringement by surgeons” since, e.g., “[t]he steps recited in” Medtronic’s survey of surgeouns “track the claim language in the patent” (§ 271(b); Limelight, US 2014; Eli Lilly, FC 2017; Vanda, FC 2018), and “that Medtronic induced infringement after issuance of Dr. Barry’s two patents”. The FC panel also found no abuse of discretion in the jury’s damage award. Judge Prost’s dissent argued that “Dr. Barry successfully performed his claimed surgical method on three different patients, charging his normal fee” and was “thus prima facie ‘on sale’ or in ‘public use’ before the critical date under” § 102(b).

This entry was posted in Anticipation (35 USC 102), Conception and Reduction to Practice, Experimental Use, Inducement to Infringe, Inequitable Conduct, Infringement, Preamble, Public Use and tagged . Bookmark the permalink.

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