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PTAB Grants Rare Motion to Amend

| Daniel A. KamkarNathanael Luman, Ph.D.

The PTAB issued a Final Written Decision in Amerigen Pharm. Ltd. v. Shire LLC, IPR2015-02009, Paper 38 (P.T.A.B. March 31, 2017) granting a rare motion to amend. The motion canceled all instituted claims and amended a multiple dependent claim to depend only from non-instituted claims.

Amerigen filed an IPR petition against several claims of Shire’s U.S. Patent No. RE42,096. The PTAB instituted the IPR proceeding on a subset of challenged claims. Shire filed a motion to amend canceling all the instituted claims and proposing one substitute claim. The substitute claim (below) was identical to instituted multiple dependent claim 25, except that it removed dependencies to instituted (and canceled) claims as follows:

[[25]]26. The pharmaceutical composition of any one of claims 2[[,]] or 13 or 18 to 20 wherein the pharmaceutically active amphetamine salt in (a) and (b) comprises mixed amphetamine salts.

Amerigen argued that the motion should be denied because Shire had not met its burden of showing the substitute claim is patentably distinct over the prior art of record under Idle Free Sys. v. Berstrom, Inc., IPR2012-00027, Paper 26 (P.T.A.B. June 11, 2013). The PTAB distinguished Idle Free and adopted Shire’s explanation that “effectively, no claim is being amended, and claims are only being cancelled” and that “there is no requirement for Shire to prove . . . that original non-amended claims are patentable over all potential prior art, especially non-instituted claims.” The PTAB therefore granted Shire’s motion to amend.

The PTAB rarely grants motions to amend—granting only 6 out of 118 motions in whole or in part according to published statistics. This case provides a potential roadmap for patent owners to amend claims in an IPR by deleting dependencies such that the amended claim depends only from non-instituted claims.