Takeaway: Congress did not limit inter partes reviews to parties having a competitive interest in the technology covered by the challenged patents, and an economic motive for challenging a patent claim alone does not raise abuse of process issues.

In its Decision, the Board did not institute inter partes review of any challenged claim of the ‘059 patent. The ‘059 patent “is directed to a method for controlling access to a sensitive prescription drug prone to potential abuse or diversion, by utilizing a central pharmacy and database to track all prescriptions for the sensitive drug.”

As an initial matter, the Board addressed Patent Owner’s argument that Petitioner failed to “identify individuals or entities who have invested in the Hayman funds allegedly responsible for filing the Petition.” When assessing real parties in interest, “we inquire into the ‘relationship between a party and a proceeding,’ and consider ‘the degree of control the nonparty could exert over the inter partes review, not the petitioner.’” The Board, however, was “not persuaded that Patent Owner has provided sufficient evidence to show that Petitioner’s disclosure of real parties-in-interest is inadequate” because the “record before us does not persuade us sufficiently that any individual or entity who has invested in the listed RPIs has or could have exerted control over the filing of the Petition in this case” and the “record presents little or no information as to how any unnamed investor relates to, or could have participated in, this proceeding in particular.”

The Board next addressed Patent Owner’s contention that the Board “should exercise our discretion under 35 U.S.C. §§ 314(a) and 315(b) to deny the Petitioner because it is presented for an improper purpose contrary to the purpose of the AIA.” The Board, however, declined to exercise its discretion to deny the Petition on this basis. The Board held “that Congress did not limit inter partes reviews to parties having a specific competitive interest in the technology covered by the patents” and that “Patent Owner’s assertion that the profit motive behind the filing of this Petition is an improper purpose is [] unavailing.” The Board explained:

Profit is at the heart of seeking patent protection in almost all inter partes reviews. As such, an economic motive for challenging a patent claim alone does not raise abuse of process issues. We take no position on the merits of short-selling as an investment strategy other than it is legal and regulated.

The Board next addressed the public accessibility of the DAC Transcript and the CSR, finding that “Petitioner has not shown that the DAC Transcript was publicly available.” According to the Board, a 2001 Federal Register Notice that identified a website for providing “[b]ackground material from the sponsor and FDA” and stated that “the minutes, transcript, and slides from the meeting” are “generally posted about 3 weeks after the meeting” is “not sufficient under the circumstances to show that the DAC Transcriptactually was made available to the extent that interested, ordinarily skilled persons, exercising reasonable diligence, could have located it as of June 27, 2001, three weeks after the date of the Advisory Committee meeting.” Further, an exhibit from the Wayback Machine “indicates that the DAC Transcript was not publicly available as of the Wayback Machine archive date.”

Even though Petitioner did not meet its burden to show that the DAC Transcript is a prior art printed publication, the Board still addressed both asserted grounds to challenge the patentability of the claims, which were found lacking. “Petitioner glosses over the differences between the DAC Transcript and Lilly or Camarda, and does not address the specific language of the steps in the independent claims, in context, to explain why it would have been obvious for one of ordinary skill to combine the prior art references in the manner recited.” In sum, the Board agreed with Patent Owner that “Petitioner does not offer reasons why a POSA would ‘cobble together disclosures from the[se] disparate references’ that are not related to the same endeavor.”

Thus, the Petition for inter partes review was denied.

Coalition For Affordable Drugs III LLC v. Jazz Pharms., Inc., IPR2015-01018

Paper 17: Decision Denying Institution of Inter Partes Review

Dated: October 15, 2015

Patent: 7,895,059 B2

Before: Jacqueline Wright Bonilla, Susan L. C. Mitchell, and Brian P. Murphy

Written by: Mitchell

Related Proceedings: Jazz Pharms, Inc. v. Par Pharm., Inc., 2:13-cv-07884 (D.N.J. Dec. 27, 2013); Jazz Pharms, Inc. v. Amneal Pharms., LLC, 2:13-cv-00391 (consolidated) (D.N.J. Jan. 18, 2013); Jazz Pharms, Inc. v. Roxane Labs., Inc., 2:10-cv-06108 (consolidated) (D.N.J. Nov. 22, 2010); Jazz Pharms., Inc. v. Ranbaxy Labs. Ltd., 2:14-cv-4467 (D.N.J. July 15, 2014); Jazz Pharms., Inc. v. Watson Labs., Inc.,2:14-cv-7757 (D.N.J); CBM2014-00149 (not instituted); and IPR2015-00548 (instituted).