To request cancellation of one or more claims of a patent in an inter partes review (IPR), a petitioner must challenge the claim on the basis that the claim is unpatentable under 35 U.S.C §102 or 103, in view of prior art patents or printed publications. 35 U.S.C. § 311(b).
Two ways a patent owner can disqualify references relied upon by the petitioner for unpatentability are by (i) asserting that the petitioner did not set forth sufficient evidence showing that the reference qualifies as a printed publication, or (ii) antedating the reference to show that the date of invention is prior to the critical date of the reference.
Is the Reference a Prior Art Printed Publication?
Regarding the patent owner’s first option, the statutory phrase “printed publication” is flexibly interpreted to include technological advances for references that are not necessarily physically printed, (e.g., an electronic publication or a video recorded on a CD) but otherwise satisfy the requirements of being a printed publication. In re Wyer, 655 F.2d 221, 226 (CCPA 1981); and Medtronic, Inc. v. Barry, IPR2015-00780, Paper 51 at 9 (PTAB Sept. 7, 2016) (Final Written Decision). A reference qualifies as a printed publication if it was “sufficiently accessible to the public interested in the art” before the critical date of the challenged patent. In re Cronyn, 890 F.2d 24 1158, 1160 (Fed. Cir. 1989). A reference “is ‘publicly accessible’ upon a satisfactory showing that [the reference] has been 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.” Bruckelmyer v. Ground Heaters, Inc., 445 F.3d 1374, 1378 (Fed. Cir. 2006).
Several factors may support a finding that the reference is accessible to one of ordinary skill in the art. Factors weighing in favor of supporting public accessibility may include “intent to make public, activity in disseminating information, production of a certain number of copies, and production by a method allowing production of a large number of copies.” In re Wyer, 655 F. 2d at 227. Additional factors, establishing an approximate time a reference was public accessible, may include showing competent evidence of routine business practices indicating that the reference was publicly accessible prior to the critical date of the challenged claim. In re Bayer, 568 F.2d 1357 (CCPA 1978); and Seabery North America Inc., v. Lincoln Global, Inc., IPR2016-00840, Paper 60 at 13-17 (PTAB October 2, 2017)(Final Written Decision).
In the Seabery IPR, the reference at issue was a doctoral thesis. The petitioner submitted declaration testimony from an advisor of the student who wrote the thesis to proffer that, based on general routine practices at the advisor’s library, the reference was available to the public well before the critical March 2010 filing date of the challenged patent. Seabery, IPR2016-00840, Paper 60 at 15 and 17. The Board noted several points in the advisor’s testimony that weighed in favor of establishing an approximate time that the thesis was publicly available, for example:
- According to the rules of the University around the alleged time the reference was publicly accessible, the University required the student to deposit the dissertation at the University’s library for the student to receive his Ph.D. at 15. The advisor testified that the student would not have been able to receive his degree if he did not follow this procedure. Id. at 16. Further, he testified that when the dissertation is formally published, it is assigned an ISBN identifier so that it may be sold. Id. To support his testimony, he showed where an electronic copy of the dissertation is available for sale. Id.
- The advisor “confirmed the dissertation was deposited and available for retrieval by the public on March 3, 2006.” at 15.
- He indicated where the work was indexed in the national library system. at 16. As an aside, the Board indicated that “neither cataloging nor indexing is a necessary condition for a reference to be publicly accessible.” Seabery, IPR2016-00840, Paper 60 at 15 quoting In re Lister, 583 F.3d 1307 (Fed. Cir. 2009).
- He testified “that a reprint of the dissertation  bears a copyright and publication date and portions and excerpts based on the dissertation were published elsewhere.” Seabery, IPR2016-00840, Paper 60 at 16.
- Further, he explained why the title in the library shelving record was different from the published book format which included a subtitle, noting that the subtitle relates to the book series from the publisher and not the dissertation.
- Additionally, the advisor testified that three copies of the thesis are available in the University’s library; “provided a screen shot of the library’s online catalog . . . [showing] the three copies of the thesis and a date of 2006;” and “reviewed the library check-out history and determined one of the copies was first checked out in May 2006.”
However, in certain situations, the availability of a reference does not automatically mean the ordinarily skilled artisan would be able to locate the reference in order to be considered a prior art printed publication. Medtronic, IPR2015-00780, Paper 51 at 9.
For instance, to support an argument of public accessibility, the petitioner may be required to submit additional evidence to corroborate that a date printed on a reference is in fact the date the reference was publicly accessible. Sandoz Inc. v. Abbvie Biotechnology LTD., IPR2017-01824, Paper 14 at 7 and 8 (PTAB February 9, 2018) (Decision, Denying Institution of Inter Partes Review). In Sandoz, the petitioner asserted that the FDA gave regulatory approval for a drug product on December 20, 2002; this date was displayed on the drug package insert; and the package insert qualified as a printed publication as of this date. Id. at 6 and 7. To disqualify the insert from being used in the IPR, the patent owner asserted that the petitioner did not set forth sufficient evidence to establish that the insert was publicly accessible on the alleged date, where the Board quickly agreed and noted several deficiencies with the petitioner’s argument. Id. at 7.
In light of the petitioner’s mere assertions, the Board indicated that the petitioner did “not direct [the Board] to any source-identifying information from the FDA (e.g., a copy of the insert on the FDA’s website), a publication date, or other indicia indicating when the relied upon Humira Package Insert, or the information contained therein, became publicly available.” Id. Further, the Board noted that the language of the regulatory approval letter indicated that the “drug product ‘will be marketed in . . .’ vials and syringes . . . , [and therefore, the] drug product was not yet marketed or available to the public [on December 20, 2012].” Id. at 8.
Other factors may depend on the type of reference being used by the petitioner.
For instance, in Electronic Frontier Foundation, the Board determined that when a reference was only temporarily publicly available via a URL but no longer exists at that URL, the petitioner must show that the reference can be found through another source not including the URL. Electronic Frontier Foundation v. Personal Audio, LLC, IPR2014-00070, Paper 21 at 22 (PTAB Apr. 18, 2014) (Decision, Institution of Inter Partes Review).
In another example, the Board determined that confidential submissions later published by the FDA are publicly accessible not on the date the patent pertaining to the submission was filed, but rather, on the date the FDA published the submission. Medtronic, Inc. v. NuVasive, Inc., IPR2014-00074, Paper 15 at 13 (PTAB Apr. 8, 2014) (Decision, Institution of Inter Partes Review).
Further, a reference can be disqualified as a printed publication if the petitioner is unable to prove that the reference is a true and accurate copy as it appeared when published. C&D Zodiac, Inc. v. B/E Aerospace, Inc., IPR2014-00727, Paper 65 at 26-30 (PTAB Oct. 26, 2015) (Final Written Decision). In C&D Zodiac, the petitioner submitted a reference that was a three-ringed binder of loose-leaf pages; however, the patent owner argued that the pages in this binder can be inserted and removed to update the reference. IPR2014-00727, Paper 65 at 27. Additionally, the petitioner’s witness, who testified that the reference was a true and accurate copy of the reference as it appeared at the alleged publication date, subsequently admitted that he lacked personal knowledge of whether the [reference] submitted . . . was actually published” at the alleged date. Id.
Can the Reference be Antedated?
Turning to the patent owner’s second option, a patent owner may disqualify a reference as being prior art if the patent owner can produce evidence antedating the reference. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378–80 (Fed. Cir. 2015).
In an IPR, the petitioner bears the burden of establishing a reference as being prior art under 35 U.S.C §102 or 103. However, if a patent owner chooses to remove the petitioner’s reference by antedating the reference, the patent owner bears the burden of production showing that (a) the inventor of the challenged claim(s) reduced the invention to practice before the critical date of the reference (Green Cross Corp., v. Shire Human Genetic Therapies, Inc., IPR 2016-00258, Paper No. 89 at 11 (PTAB March 22, 2017) (Final Written Decision); or (b) the inventor conceived the idea for the invention before the critical date of the reference and exercised reasonably continuous diligence following conception to reduce the invention to practice (See REG Synthetic Fuels v. Neste Oil OYJ, Appeal No. 2015-1773 at 13-14 (Fed. Cir. Nov. 8, 2016), and Perfect Surgical Technical, Inc. v. Olympus America, Inc., 841 F.3d 1004, 1009 (Fed.Cir. 2016)).
The Board will “review the record as a whole and determine the sufficiency of a patent owner’s antedating effort after evaluating all relevant admissible evidence and argument.” Corning Inc. v. DSM IP Assets B.V., IPR2013-00053, Paper 66 at 7 (PTAB May 1, 2014) (Final Written Decision). Once the patent owner shows either (a) or (b), the burden shifts to the petitioner to show that the reference is entitled to an earlier date than the date the invention was reduced to practice or to show that the challenged claims were not actually reduced to practice at the alleged date. Green Cross Corp., at 11. The remainder of this article focuses on reduction to practice.
A patent owner may establish reduction to practice either by showing “constructive” reduction to practice, which occurs when a patent application is filed, or by showing “actual” reduction to practice. ABB Inc. v. Roy-G-BIV Corp., IPR 2013-00062, Paper 84 (PTAB Apr. 11, 2014) (Final Written Decision). “In order to establish an inventor’s actual reduction to practice, Patent Owner must show: (1) construction of an embodiment meeting all limitations of the challenged claims; (2) that the invention would work for its intended purpose, and (3) sufficient evidence to corroborate the inventor’s testimony. Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1169 (Fed. Cir. 2006).” Green Cross Corp., at 11. Supporting a finding of sufficient evidence to corroborate the inventor’s testimony is determined using a rule of reason analysis by examining the evidence as a whole and is based on the facts of each case. Id. at 11-12.
In Green Cross Corp., the challenged claim related to a composition of a purified recombinant I2S protein having a specific amino acid sequence and having less than a certain amount of a host cell protein. Id. at 5. To support the burden of production in antedating the challenged reference, the patent owner submitted evidence of several laboratory tests with different dates before the critical date of the reference and declarations from the inventor and co-workers of the inventor to corroborate the inventor’s testimony. Id. at 12, 16, and 19-21. The Board determined that these tests were “within the scope of the invention to show that the reduction to practice of the claimed invention was ‘consistent and reliable.'” Id., see footnote 11. Subsequent to shifting the burden of persuasion back to the petitioner, the petitioner was unable to persuade the Board that the patent owner’s evidence was insufficient in showing that the purported embodiments met all the limitations of the challenged claim. Id. at 13 and 21.
The above discussion demonstrates the wide range of factual matters considered by the Board in assessing whether a patent owner has successfully disqualified a prior art publication relied upon by the petitioner. Patent owners seeking to defeat a challenge to its claims in this manner would be well-advised to question both the sufficiency and admissibility of the petitioner’s reference as a viable basis for an inter partes challenge. Conversely, if patent owner seeks to antedate petitioner’s reference, it must make sure that its own evidence is sufficient in its weight and properly corroborated.