October 29, 2019
On October 16, the Patent Trial and Appeal Board (PTAB) provided its first-ever preliminary guidance in response to a motion to amend filed under the new pilot program that began in March 2019. Under that program, patent owners may request preliminary guidance from the PTAB in a motion to amend, which the PTAB is to provide after the petitioner files its opposition to the motion. This nonbinding guidance includes whether the motion meets formal requirements and whether the petitioner has established a reasonable likelihood that the substitute claims presented in the motion are unpatentable.
Petitioner Mylan Pharmaceuticals Inc. filed a number of inter partes review (IPR) petitions challenging various Sanofi-Aventis patents covering Sanofi’s Lantus® insulin pen. In three of the instituted proceedings (one involving U.S. Patent No. 8,992,486 and two involving U.S. Patent No. 9,526,844), Sanofi sought preliminary guidance from the PTAB regarding proposed substitute claims.
In its guidance, the PTAB found that Sanofi’s motions to amend satisfied the relevant statutory and regulatory requirements in that the proposed substitute claims were reasonable in number, responded to the petitioner’s unpatentability grounds, properly narrowed the scope of the claims, and did not add new matter. However, the PTAB ultimately found there was a reasonable likelihood that each of the proposed substitute claims were unpatentable over the combinations of prior art asserted by the petitioner in its opposition to the motions.
Notably, in some instances the parties attempted to rely on arguments from the petition and the patent owner response with respect to prior art already of record in the proceeding. The PTAB repeatedly advised the parties that such incorporation of arguments by reference is not permitted, which should be noted by practitioners when preparing and responding to motions to amend.
In addition, the PTAB acknowledged that Sanofi was without the opportunity to address new prior art references and an expert declaration filed by the petitioner in response to the motions to amend, which highlights a downside of the timing of the PTAB’s preliminary guidance for patent owners. In response to the PTAB’s nonbinding guidance, Sanofi will have an opportunity in each proceeding to file a revised motion to amend, file a reply with additional argument and evidence, or withdraw the motion to amend. However, if a revised motion to amend is filed, the PTAB will not provide further preliminary guidance.
This guidance is particularly relevant to patent owners and their counsel who may wish to file a motion to amend in an AIA proceeding, as well as petitioners facing such motions. In addition to demonstrating the potential benefits (and drawbacks) of requesting preliminary guidance, patent owners may also use Sanofi’s motions as examples of motions that satisfy the relevant statutory and regulatory requirements. However, practitioners should be careful to include all relevant arguments within their briefing, rather than referring to arguments already of record.
For the full text of the guidance, please see IPR2018-01679 Guidance, IPR2018-01682 Guidance, and IPR2018-01680 Guidance.
For more information on this program, please contact Fitch Even partner Paul B. Henkelmann, author of this alert.
Fitch Even associate Evan Kline-Wedeen contributed to this alert.
Fitch Even IP Alert®