In IPRs, Section 112 Can Play a Critical Role—Even Late in the Game

Posted by Joseph Bowler on May 1, 2017

As we’ve written before, notwithstanding statutory limits restricting IPR challenges to novelty and obviousness, Section 112 challenges are possible in an IPR. In several proceedings, petitioners have asserted references that have required the Board to determine whether an earlier filing supports the challenged patent’s claims. The Board generally has addressed these issues at the institution stage. However, a recent decision involving Kyle Bass and his Coalition for Affordable Drugs demonstrates the Section 112 analysis may not be fully resolved until the trial stage, where it can play a determinative role.

The patents at issue in Coalition for Affordable Drugs (ADROCA) LLC v. Acorda Therapeutics, Inc. (IPR2015-01858) claim methods of treating multiple sclerosis by administering an aminopyridine composition in a specified dosing regimen. All instituted grounds of unpatentability relied on Acorda’s SEC S-1 registration statement, which the petitioner alleged described clinical trials in detail sufficient to render all claims obvious. The Board determined that the S-1 did not qualify as prior art and upheld the validity of all patents.

At the institution stage, the Board did not substantively evaluate the prior art status of the asserted reference. The registration statement had printed months before the priority application was filed, and its authorship listed the names of the inventors among several non-inventors. Thus, for the purposes of its decision to institute these proceedings, the Board viewed the statement as statutory prior art under at least Section 102(a) (pre-AIA).

The petitioner argued that the provisional application to which all of the patents claimed priority failed to provide adequate written description support for the dosing regimen the claims required. If true, the claims would not be entitled to the priority filing date, and the S-1 statement would be prior art under 102(a) and 102(b). The patent owner disagreed that it should even qualify as prior art, arguing that the provisional application contained a figure that adequately described the claimed dosing regimen and the statement was solely the work of the inventors.

The Board first determined that the statement did not qualify as prior art under 102(b) because the provisional application adequately described the claimed invention. Both sides presented expert testimony that provided competing interpretations of a graphically depicted design of a treatment program shown in the provisional. The Board ultimately agreed with the patent owner that one of skill in the art would interpret the figure in a manner consistent with the claimed dosage regimen.

Next, the Board determined that the statement did not qualify as prior art under 102(a) because its pertinent portions were solely the work of the inventors. Crediting declarations from the inventors and non-inventors listed as authors of S-1, the Board found ample evidence that the disclosure relied upon by the petitioner was not the work of others. Accordingly, the statement falls into the pre-AIA grace period and does not qualify as prior art.


This case presents another example of how a petitioner can use a Section 112 analysis in an IPR. Other petitioners have accomplished this by asserting intervening art, where the Board’s assessment proceeded only to the level of determining whether it qualified under 102(a). Here, a non-intervening reference was asserted, and 112 support guided the specific parameters under 102 to be applied. This issue proved critical to the outcome for both parties at trial. Had the Board decided not to preserve the chain of priority, the patent owner would have lost the opportunity to present evidence that disqualified the cited reference as prior art. Nonetheless, this case illustrates the extent to which 112 can play a role in IPR proceedings.

Topics: Kyle Bass, BioPharma

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This blog is intended to promote thought and debate on developing areas of the law. The opinions, commentary and characterizations of cases provided on this blog are not legal advice and do not represent the opinions of Wolf Greenfield or its clients.