The Court of Appeals for the Federal Circuit presented an interesting paradox in patent validity challenges, especially when the same parties bring forth essentially the same issues, but have different results in different federal agency or judicial reviews, as was seen in Nobel Biocare Services AG v. Instradent USA, Inc.,[1] decided on September 13, 2018.
The facts are as follows.
Nobel owns U.S. Patent No. 8,714,977 (‘977), entitled “Condensing skeletal implant that facilitate insertions,” and directed to dental implants. It has a critical date, for purposes of 35 U.S.C. §102(b) (pre-AIA), of May 23, 2003. The specification discloses a preferred embodiment with a “height of the coronally tapered region 85 is 0.5 – 4 mm.” The issue revolved around this coronal region of the claimed implant, and specifically its frustoconical shape.
Claim 1 was deemed representative.
A dental implant comprising:
a body;
a coronal region of the body, the coronal region having a frustoconical shape wherein a diameter of an apical end of the coronal region is larger than a diameter of a coronal end of the coronal region;
an apical region of the body, the apical region having a core with a tapered region wherein a diameter of an apical end of the core is smaller than a diameter of a coronal end of the core and the apical end of the core is substantially flat; and
a pair of helical threads extending from the body along at least a portion of the apical region, each of the threads comprising an apical side, a coronal side, and a lateral edge connecting the apical side and the coronal side, a base connecting the threads to the core, a thread height defined between the lateral edge and the base, and the lateral edge having a variable width that is expanded along a segment in the direction of the coronal end along a segment in the direction of the coronal end along a segment int eh direction of the coronal end of the apical region, so that a least width of the lateral edge of the threads is adjacent the apical end of the apical region and a greatest width of the lateral edge of the threads is adjacent the coronal end of the apical region, and the threads having a variable height that is expanded substantially along the segment of the implant in the direction of the apical end of the apical region, so that a least height of the threads is adjacent the coronal end of the apical region and a greatest height at apical end of the apical region; and
a bone tap, wherein the helical threads starts at said bone tap and said substantially flat apical end of the core;
wherein each of the helical threads have a thread step that is defined as a distance along a longitudinal axis of the dental implant covered by a complete rotation of the dental implant, the threat step is between 1.5 – 2.5 mm.
(Emphasis added.)
The PTAB found claims 1-5 and 19 of the ‘977 patent invalid as anticipated. The key issue was the critical date of May 23, 2003, and a prior art reference, from the Product Catalog belonging to Alpha-Bio Tech Ltd. (ABT) which was presented at the IDS Conference in March 2003. ABT was subsequently acquired by Nobel in 2008.
In October 2014, the US ITC instituted an investigation of Instradent dental implants based on a complaint filed by Nobel in violation of 19 U.S.C. §1337, alleging import of dental implants which infringed the ‘977 patent. Instradent argued that the ‘977 patent claims 1-5 and 19 were invalid as anticipated based on the ABT reference. The ITC issued an opinion that Instradent had failed by clear and convincing evidence that the ABT reference qualified as §102(b) art, construing “conical region having a frustoconical shape” as a “the coronal region has partly or entirely, a frustoconical shape.” It held claims 1-5 and 19 were infringed, but not anticipated. The decision was upheld by the Fed Circuit.[2]
In August 2015, Instradent petitioned for IPR of claims 1-7, 9, and 13-20 of the ‘977 patent. The PTAB instituted review of claims 1-5, 19 and 20 on the grounds of unpatentability under §102, among others. The PTAB adopted the same construction as the ITC for the frustoconical limitation. The PTAB considered the same evidence as the ITC, as well as additional evidence as to the public accessibility of the ABT reference. In its final decision, the PTAB determined that a preponderance of the evidence the ABT reference qualified as §102(b) art.
The Fed Circuit panel was composed of Chief Judge Prost, and Judges Lourie and Chen, with Judge Lourie writing for a unanimous court. He noted that:
‘Public accessibility’ has been called the touchstone in determining whether a reference constitutes a ‘printed publication.’ “A reference will be considered publicly accessible if it was disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art exercising reasonable diligence can locate it.”[3]
He further underscored that review of the PTAB’s fact-finding decisions is reversed only if the findings were not supported by substantial evidence. Continuing, he stated:
We first note that we are not bound by our prior affirmance of the ITC’s holding that there was insufficient evidence to find pre-critical date public accessibility. The parties agree that our prior decision is not binding on this factual issue. The Board correctly observed, the evidentiary standard in its proceedings, preponderance of the evidence, is different from the higher standard applicable in ITC proceedings, clear and convincing evidence . . . . Moreover, we apply a substantial evidence standard of review to both ITC and Board factual findings, “and the possibility of drawing two inconsistent conclusions from the evidence does not prevent an administrative agency’s finding from being supported by substantial evidence.”[4]
Judge Lourie agreed with Instradent that substantial evidence supported the PTAB’s finding that the ABT reference was §102(b) art, which was fully supported by the factual testimonies presented to the PTAB. He further noted that Nobel never presented evidence that the ABT catalog, when disseminated to the public, would be kept confidential.[5] He further observed that corroboration is required of testimony presented to invalidate a patent, which could be presented based on the following factors:
1) relationship between the corroborating witness and the alleged prior user;
2) time period between the event and trial;
3) interest of the corroborating witness in the subject matter of the lawsuit;
4) contradiction or impeachment of the witness’ testimony;
5) extent and details of the corroborating testimony;
6) witness’ familiarity with the subject matter of the patented invention and the prior use;
7) probability that a prior use could occur considering the state of the art at the time; and
8) impact of the invention on the industry, and the commercial value of its practice.[6]
While there are not black letter rules to determine what is sufficient corroboration, ultimately, each case is determined by the facts. Here, Judge Lourie noted, the case involved a document’s date to be corroborated by multiple witnesses. By substantial evidence, the date of the document matched the date which the witnesses testified it was publicly accessible; therefore, it constituted sufficient corroboration under the case’s facts.
The Fed Circuit panel rejected Nobel’s claim construction objections, and affirmed the anticipation finding.
[1] ___F.3d___ (Fed. Cir. 2018) (slip op.), aff’g Instradent USA, Inc. v. Nobel Biocare Servs. AG, Case No. IPR2015-01786, (P.T.A.B. Feb. 15, 2017).
[2] See Instradent USA, Inc. v. Int’l Trade Comm’n, 693 F. App’x 908, 909 (Fed. Cir. 2017).
[3] See Nobel, supra (slip op. at 12), citing Medtronic, Inc. v. Barry, 891 F.3d 1368, 1380 (Fed. Cir. 2018).
[4] Id. (slip op. at 13), citing Consolo v. Fed. Mar. Comm’n, 383 U.S. 607, 620 (1966).
[5] See, e.g., Cordis Corp. v. Boston Sci. Corp., 561 F.3d 1319, 1333-34 (Fed. Cir. 2009).
[6] See Nobel, supra (slip op. at 17-18), citing Woodland Tr. v. Flowertree Nursery, Inc., 148 F.3d 1368, 1371 (Fed. Cir. 1998).