Sandoz Inc. v. AbbVie Biotechnology Ltd. (§ III.C.1)

Informative decision only: persuasive authority, not binding precedent. When a petitioner relies on a web-posted reference as a "printed publication" under 35 U.S.C. § 311(b), it need not prove public accessibility by a preponderance at institution, but the petition must include argument and direct the Board to evidence sufficient to show it would establish public accessibility by a preponderance during trial. Absent evidence of indexing, unrebutted testimony that the website was well known to those interested in the art and that they would have found the reference using the site's own search functions can satisfy that threshold showing. No prior precedent directly addressed this issue in the text; the Board follows Federal Circuit printed-publication law and cites Symantec Corp. v. Trs. of Columbia Univ., IPR2015-00371 (Paper 13), as a decision denying institution for a failed showing. It clarifies that indexing evidence is probative but not required in every case, and it declines to treat mere existence on an FDA website as the end of the inquiry, as Patent Owner urged citing Celltrion, LLC v. Biogen, Inc., IPR2017-01230 (Paper 10). Petitioners can meet the threshold with Wayback Machine evidence, an Internet Archive affidavit, and expert testimony on how skilled artisans found such documents. Patent owners can still challenge accessibility at institution, but unrebutted, experience-based testimony will likely carry the day, and actual dissemination is not required. The Board relied on Klopfenstein, Lister, Kyocera, Voter Verified, and Dynamic Drinkware (Fed. Cir.), and In re Wyer (CCPA). Here institution was nonetheless denied on obviousness. LEGAL TEST OR STANDARD: Petitioner has the initial burden of production under Dynamic Drinkware and, for institution, must make a sufficient showing under 35 U.S.C. § 314(a) and 37 C.F.R. § 42.108(c) that the reference is a printed publication. The petition need not establish public accessibility by a preponderance, but must include argument and direct the Board to evidence sufficient to show that Petitioner would establish public accessibility by a preponderance during trial. The inquiry is case-by-case. The key question is whether the reference was sufficiently accessible to the public interested in the art before the effective filing date, i.e., disseminated or otherwise made available so that interested persons ordinarily skilled in the art, exercising reasonable diligence, can locate it. TRIGGERING FACTS: The 2003 Humira Package Insert was challenged as a printed publication. Petitioner offered a Wayback Machine screenshot (Ex. 1031) and the Butler Affidavit (Ex. 1032) showing the label on an FDA website on March 31, 2003. Petitioner also offered Dr. Bjarnason's testimony that physicians knew labels were available from the FDA website, that he personally accessed them many times, and that a skilled person would easily have found the insert using the site's own search capabilities. Patent Owner argued that existence on an FDA website is insufficient and that Petitioner showed no indexing or search evidence. Patent Owner did not rebut the testimony. KEY QUOTE: "Rather, absent evidence of indexing, testimony indicating that the particular online publication or website on which the reference was published was well-known to the community interested in the subject matter of the reference, and that, upon accessing the website, those interested would have found the reference using the website's own search" (Paper 11, p. 11) PRIOR PRECEDENT AFFECTED: No prior precedential or informative decision is directly affected. The Board cites Symantec Corp. v. Trs. of Columbia Univ., Case IPR2015-00371 (PTAB June 17, 2015) (Paper 13), and the ServiceNow, Inc. v. Hewlett-Packard Co., Case IPR2015-00707 (PTAB Aug. 26, 2015) (Paper 12) (Crumbley, APJ, dissenting) passage on the reasonable likelihood standard. It does not follow Patent Owner's reliance on Celltrion, LLC v. Biogen, Inc., Case IPR2017-01230 (PTAB Oct. 12, 2017) (Paper 10). PRACTICE TIP: In the petition, do not rest on a Wayback Machine or archive date alone. Add declaration testimony tied to the specific website, covering its reputation in the relevant community, how interested artisans searched it, and that the reference was findable by reasonable diligence. Patent owners should rebut that testimony with evidence at the preliminary response stage, since unrebutted testimony was credited.