In a rare case where the Patent Trial and Appeal Board (PTAB) granted a motion to amend the claims in an inter partes review (IPR), the patent owner successfully canceled all claims subject to review by changing the dependency of one of the claims at issue. Amerigen Pharms. Ltd. v. Shire LLC, Case No. IPR2015-02009 (PTAB, Mar. 31, 2017) (Scheiner, APJ).
Shire owns a patent related to dosage forms for the delivery of drugs that treat attention-deficit hyperactivity disorder in an immediate dose and at least one delayed, enteric dose with a rapid release (marketed as Adderall XR®). Amerigen filed a petition requesting IPR of Shire’s patent, which the PTAB instituted. After institution, Shire filed a motion to amend, cancelling all of the claims on which trial had been instituted and proposing one substitute claim. Specifically, Shire’s motion sought to replace instituted claim 25 with the following substitute claim 26:
Claim 25. The pharmaceutical composition of any one of claims 2, 13 or 18 to 20 wherein the pharmaceutically active amphetamine salt in (a) and (b) comprises mixed amphetamine salts.
Claim 26. The pharmaceutical composition of any one of claims 2[[,]] or 13
or 18 to 20wherein the pharmaceutically active amphetamine salt in (a) and (b) comprises mixed amphetamine salts.
The proposed substitute claim 26 was identical to multiple dependent claim 25, except that dependencies from instituted claims 18–20 were deleted.
The PTAB noted that claim 25 was part of the trial only to the extent it depended from claims 18–20, and that “the practical effect of substituting proposed claim 26 (which depends from claim 2 or claim 13) for claim 25 would be to leave no instituted claim remaining in the trial.” Notably, in instituting IPR on claims 18–21, 23 and 25, the PTAB differentiated claim 25 as having limitations that were dependent from claim 2 and limitations that were dependent from claims 18–20. The PTAB did not institute the IPR with respect to claim 2, and Amerigen did not challenge the patentability of claim 13.
Amerigen argued that Shire’s motion should be denied because Shire failed to demonstrate the patentability of proposed substitute claim 26, as required by the PTAB’s Idle Free decision (IP Update, Vol. 17, No. 1). According to Idle Free, the burden is on the patent owner to show “the substitute claim’s patentable distinction over not only the prior art asserted in the petition, but also all prior art of record in the initial patent prosecution, reissue proceeding, prior litigations and other prior art known to [the] patent owner.”
The PTAB disagreed, explaining that Idle Free only applies where a feature “is added to each substitute claim, as compared to the challenged claim it replaces.” In this case, the substitute claim merely cancelled the three claims dependent on instituted claims 18–20 while preserving the two claims dependent on non-instituted claims 2 and 13, and “[e]ffectively, no claim [was] amended” because no other changes to the claims were being made. In granting Shire’s motion to amend, the PTAB held that a patent owner is not required to prove “that original non-amended claims are patentable over all potential prior art, especially non-instituted claims.”