IP Law Daily Surgeon’s spinal derotation device was not reduced to practice before patent’s critical date
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Thursday, January 24, 2019

Surgeon’s spinal derotation device was not reduced to practice before patent’s critical date

By Cheryl Beise, J.D.

Medical device maker Medtronic failed to prove that three surgeries performed using a spinal derotation device amounted to reductions to practice showing that the claimed invention worked for its intended purpose

Medical device maker Medtronic failed to show no reasonable jury could find that a patent claiming a spinal derotation device owned by spinal surgeon David Barry was invalid under the on-sale or public use bars under 35 U.S.C. § 102(b), the U.S. Court of Appeals for the Federal Circuit has held in a split decision. The federal district court in Beaumont, Texas, did not err in finding that there was sufficient evidence at trial for the jury to find that Dr. Barry’s use of the device in three spinal surgeries performed before the patent’s critical date were experimental in nature and, therefore, did not amount to a reduction to practice. The evidence also supported the jury’s finding that Medtronic was liable for direct and induced infringement of both patents asserted at trial. In an opinion dissenting in part, Chief Judge Sharon Prost wrote that she would find that the earlier filed patent was invalid under Section 102(b) (Barry v. Medtronic, Inc., January 24, 2019, Taranto, R.).

Spinal surgeon and inventor Mark Berry is the owner of two patents at issue—U.S. Patent Nos. 7,670,358 (the ’358 Patent) and 7,776,072 (the ’072 Patent)—both entitled "System and Method for Aligning Vertebrae in the Amelioration of Aberrant Spinal Column Deviation Conditions" and directed to methods and systems for correcting spinal column anomalies, such as those due to scoliosis, by applying force to multiple vertebrae at once. The ’358 patent issued in 2010 from an application Dr. Barry filed on December 30, 2004. The ’121 patent issued in 2013 from an application—a continuation of an August 2005 application that was a continuation-in-part of the December 30, 2004 application—that Dr. Barry filed in 2010.

In 2014, Dr. Barry filed suit against medical device manufacturer Medtronic, Inc., in the Eastern District of Texas. Medtronic asserted method claims 4 and 5 of the ’358 patent and system claims 2-4 of the ’121 patent. Medtronic contended that Dr. Lawrence Lenke, a surgeon who worked with Medtronic, was a prior inventor of a spinal derotation tool and that Dr. Barry ’s patents were invalid under 35 U.S.C. § 102(g). A jury rejected Medtronic’s arguments and awarded Dr. Barry $15,095,970 for domestic infringement of the ’358 patent and $2,625,210 for domestic infringement of the ’121 patent. The district court enhanced the domestic damages award by 20 percent and rejected Medtronic’s post-trial motions. Medtronic appealed.

On appeal, Medtronic raised issues involving the on-sale and public use bars under 35 U.S.C. § 102 (Pre-AIA version) as to the ’358 patent, inequitable conduct as to both patents, prior invention as to both patents, and induced infringement and associated damages as to both patents.

Section 102 statutory bar. Medtronic argued that the ’358 patent’s asserted claims are invalid under Section 102(b)’s statutory bar on patenting of inventions in "public use" in the United States more than one year before the application for the patent was filed. The critical date for an invalidating domestic public use was December 30, 2003, one year after the patent application was filed. Medtronic did not dispute that in order to show readiness for patenting, it had to show (a) a reduction to practice or (b) drawings or descriptions enabling an ordinarily skilled artisan to practice the invention. Medtronic focused on the reduction-to-practice alternative.

Reduction to practice element. Under the test for a reduction to practice, the challenger must show 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." In re Omeprazole Patent Litig., 536 F.3d 1361, 1373 (Fed. Cir. 2008).

The evidence showed that Dr. Barry began working in late 2002 or early 2003 on trying to link derotation components (which grab screws in vertebrae to move the vertebrae) of devices for ameliorating spinal column deviation conditions. On August 4, August 5, and October 14, 2003, Dr. Barry performed surgeries using a tool that allowed him to link the screw-grabbing, vertebrae-moving wrenches together. Dr. Barry charged his normal fee for performing the surgeries. Between August 2003 and January 2004, the patients in those surgeries returned to Dr. Barry several times for follow-up appointments. Dr. Barry testified that it was only after the January 2004 follow-up (three months after the last surgery) that he felt confident that his invention functioned for its intended purpose and could be reported for publication in a professional forum. In February 2014, Dr. Barry submitted the surgical results in an abstract to a professional organization for a meeting that took place in July and he filed the relevant patent application in December 2004.

Medtronic argued that the August and October 2003 surgeries were reductions to practice that proved that the claimed invention of the ’358 patent would work for its intended purpose. The Federal Circuit, however, found that there was sufficient evidence for a jury to find that Dr. Barry’s invention was not ready for patenting before December 30, 2003, and that that there was no public use of the invention. According to the court, the three surgeries Dr. Barry performed constituted "experimental use." The court agreed with Dr. Barry that his 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." In addition, evidence from several sources confirmed that, to evaluate the success of a spinal-deviation correction, it was important for the surgeon to evaluate the patient after some time had elapsed following the surgery, particularly once the patient could stand.

The court was not persuaded by Medtronic’s argument one or two surgeries and follow-up appointments would have sufficed for Dr. Barry to determine that the device functioned for its intended purpose. The jury could have credited Dr. Barry’s testimony that he preferred to evaluate his invention on a range of "deviation conditions" surgeons would regularly encounter.

Public use element. Although the court found that that Dr. Barry’s invention was not reduced to practice, it nevertheless decided to address Medtronic’s argument that the claimed invention was "in public use" because it was accessible to the public and commercially exploited before the critical date. Medtronic relied on the three surgeries to support both points.

The Federal Circuit disagreed. First, there was substantial evidence that Dr. Barry’s surgeries were not exposed or accessible to the public. The jury reasonably found that those in the operating room were under an implied duty of confidentiality covering at least the tools and techniques used. Second, the court found that the surgeries qualified for the experimental use exception to both the ready for patenting and the public use prongs. Dr. Barry earned no more from the surgeries than he would have earned had he used prior-art methods; and there was no basis for finding that he attracted the three customers because of the new technique. In addition, Dr. Barry did not surrender control of his invention because "[n]o person left the operating room with the (method) invention, and no person learned the method without an obligation of confidentiality." That Dr. Barry did not inform the patients of the experimentation was not significant in the court’s view. The jury could properly find that the surgeries fell within the experimental-use exception.

On-sale bar. To be rendered invalid under the on-sale bar under Section 102(b), an invention "must be the subject of a commercial offer for sale" in the United States and it "must be ready for patenting" before the critical date. Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67 (1998). As with the public use bar, experimental use negated applicability of the on-sale bar in this case. Medtronic also argued that the district court erred by instructing the jury 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." The Federal Circuit declined to find that the district court’s instruction was an abuse of discretion.

Priority of invention. Medtronic contended that Dr. Lenke invented the claimed matter before Dr. Barry, rendering the asserted claims invalid under 35 U.S.C. § 102(g). The Federal Circuit found that there was substantial evidence to support a finding that Dr. Lenke did not reduce the claimed inventions to practice before February 2006, after Dr. Barry did so (for both patents at issue).

Inequitable conduct. Medtronic asserted that the district court erred in finding that both patents were not unenforceable due to Dr. Barry’s alleged inequitable conduct during prosecution. Medtronic claimed that Dr. Barry misrepresented Figure 6 in both patents. In March 2016, Dr. Barry sought to correct the description during this litigation. The USPTO allowed the correction for the ’121 patent, issuing a Certificate of Correction in August 2016. However, because the ’358 patent was subject to inter partes review, the Certificate of Correction was not issued until June 2017. The district court did not abuse its discretion in finding that both Dr. Barry and his counsel were credible in explaining why the errors occurred, without any intent to deceive, and why the errors were not discovered until the litigation.

Infringement. Sufficient evidence supported the jury’s finding that Medtronic directly infringed the patents and that it induced others to infringe. Dr. Barry presented the results of a survey of spinal surgeons (the Neal Survey) showing that the doctors used steps outlines in the patents’ claims in performing the surgeries. The survey asked not only about specific steps but also about surgeons’ use of Medtronic’s Horizon System and that any use of the Horizon System to derotate a spine necessarily would have used the accused VCM kit. The jury also could have found that Dr. Lenke himself used the accused VCM kit. Finally, from the evidence in the record, the jury could permissibly find inducement in the period after patenting. Medtronic’s challenge to the amount of the jury’s award depended on rejection of the Neal Survey.

Dissenting opinion. Chief Judge Sharon Prost filed an opinion dissenting-in-part. She agreed with the majority’s opinion regarding the ’121 patent, but would find that the asserted claims of the ’358 patent were invalid under Section 102(b) as a matter of law. According to Chief Judge Prost, the evidence did not show that the three pre-critical-date surgeries were for experimental purposes, negating application of a Section 102(b) bar. Rather, Medtronic established that the inventions were reduced to practice no later than the second surgery’s completion, and therefore were ready for patenting by then. The only evidence that affirmatively suggested the surgeries were experimental was Dr. Barry’s own testimony after the fact, during litigation. "As a matter of law, that is insufficient to show experimental purpose," Chief Judge Prost said.

The case is No. 2017-2463.

Attorneys: David Clay Holloway (Kilpatrick Townsend & Stockton LLP) for Mark A. Barry. Seth P. Waxman (Wilmer Cutler Pickering Hale and Dorr LLP) for Medtronic, Inc.

Companies: Medtronic, Inc.

MainStory: TopStory Patent FedCirNews

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