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Filed concurrently with the petitions at issue in IPR2015-00417 and IPR2015-00418, Boehringer Ingelheim filed the petition at issue in IPR2015-00415 seeking review of U.S. Patent No. 7,820,161 owned by Genentech and Biogen Idec.  The Board’s institution decision steadily whittled down Boehringer’s varied attacks on the patent.  Ultimately, IPR was granted on 2 of the 36 obviousness grounds in the petition (additional grounds were summarily denied for failure to identify the ground with particularity), with the two surviving grounds implicating half of the 12 claims of the ‘161 patent.  This outcome at the institution phase might be seen as a reason to avoid the scorched-earth comprehensive approach to attacking a patent in an IPR, and as we’ll see, oftentimes that is the lesson.  The most surprising aspect of the PTAB’s institution decision, however, cautions against dropping a colorable ground of unpatentability.

The ‘161 patent is drawn to methods of treating rheumatoid arthritis with a combination therapy involving multiple doses of rituximab and a dose of methotrexate.  Much of this information was contained in a letter written by Dr. Gryn that was sent to IDEC Pharmaceuticals, a commercial entity, more than one year prior to the earliest effective filing date associated with the ‘161 patent.  Notably, Dr. Gryn sent the letter without any restriction on subsequent use of that information.  Boehringer relied on Dr. Gryn’s letter as primary reference in half of its 36 obviousness grounds attacking the ‘161 patent.  The PTAB concluded that petitioner failed to show that the letter was accessible to the public, qualifying the letter as a printed publication available as prior art under the statute (pre-AIA 35 U.S.C. § 102(b)).  Petitioner had relied on Garrett Corp.’s statement that, “[w]hile distribution to government agencies and personnel alone may not constitute publication . . . distribution to commercial companies without restriction on use clearly does.”  The PTAB distinguished Garrett Corp. as involving multiple communications to commercial entities without restriction.  In particular, the PTAB relied on factors disclosed in Garrett Corp. useful in assessing whether a printed document had been published.  Those factors include the number of copies made, availability, accessibility, dissemination, and even intent of the communication.  The PTAB found that petitioner had not provided evidence establishing that the Gryn letter was a printed publication, and on that basis denied half of petitioner’s grounds, although some of those grounds were also denied as redundant.

This reliance is misplaced as Petitioner does not assert that Dr. Gryn distributed his letter to commercial companies.  Rather, Petitioner asserts only that Dr. Gryn mailed his letter to a single commercial entity. . . .  Petitioner has not established persuasively that the Gryn letter was publicly accessible so as to render it a printed publication . . . .

The petition was also found to suffer from other weaknesses.  Six obviousness grounds were denied on the basis of redundancy, including grounds based on the Gryn letter and all grounds reliant on the Pincus reference.  The petition also included grounds trained on dependent claims that neglected to show that the limitations of the parent claims were disclosed or suggested in the prior art and grounds based on misinterpretations of the art as disclosing escalating dosages when the references disclosed escalating rates of administration or varied dosages in different patients.

Although the petition suffered major losses in having 34 of 36 obviousness grounds denied, the two surviving grounds supported grant of an IPR addressing half of the ‘161 patent claims, which also meant that half of the claims remain unchallenged.  It is difficult to fault Petitioner for not realizing that the disclosure of the invention in a printed communication sent to a commercial entity more than one year before the earliest effective filing date associated with a patent would not suffice to establish a reference as prior art under § 102(b).  In fact, it appears that the Patent Owner is getting what might be considered a mulligan for unrestricted disclosure to a single commercial entity.  The decision highlights the need to proceed carefully and methodically in building grounds for attacking a patent in an IPR proceeding.  Emphasizing that lesson is the loss of grounds based on redundancy, which creates a risk that the most robust ground will be denied as redundant over a weaker ground, a problem noted in summarizing the recent Federal Circuit decision in Harmonic Inc. v. Avid Technology, Inc.  Further emphasizing the lesson was the failure to address all limitations of dependent claims and the failure to understand the technology sufficiently to distinguish escalating dosages from escalating rates of administration and varied dosages in different patients.  In view of the potential commercial impact of an IPR decision and the cost of mounting an IPR attack, exacting attention to detail and thoroughness should be coupled to a careful consideration of the legal underpinnings of any patent challenge.