PTAB Seeks to Nip Abusive IPRs in the Bud

Biosimilar News  •  BPCIA and Related U.S. Statutes  •  PTAB + IPR

The PTAB is asking for briefing on whether IPRs filed by the Coalition for Affordable Drugs against Shire PLC should be dismissed for abuse of the IPR process. The petitions (Nos. IPR2015-00990 and IPR2015-01093) concern U.S. Patent No. 7,056,886, directed to GLP-2 peptides and analogs thereof, which may be used to treat short bowel syndrome and Crohn’s disease, among other things.

The Coalition for Affordable Drugs has come under fire before for filing IPRs to manipulate drug stock prices. The PTAB seems to be concerned with ensuring that IPRs are not misused in this fashion.

The PTAB issued two identical orders asking for briefing on four questions:

1) the standing requirement for challenging the validity of that patent in an inter partes review under 35 U.S.C. § 311(a);

2) to what extent, if any, the business objective or intent of the Petitioner should be considered in reaching a determination of abuse of process;

3) the intent of Congress to provide an alternative to litigation and to provide a mechanism to increase patent quality by allowing expedited administrative patent challenges; and

4) the resulting social costs/benefits associated with a decision to address the merits of the Petitions versus a decision to dismiss the Petitions for abuse of process without reaching the merits of the Petitions.

Briefing is due in one week. We will continue to monitor this issue, and update as new developments come in.

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