In its Decision, the Board denied institution of inter partes review of the challenged claims of the ‘612 patent. The ‘612 patent “discloses parenteral administration of iron carbohydrate complexes ‘at relatively high single unit dosages for the therapeutic treatment of a variety of iron-associated diseases, disorders, or conditions’ . . . , e.g., iron deficiency anemia, anemia of chronic disease, and dysfunctional iron metabolism.”
The Board first addressed claim construction under the broadest reasonable construction standard. The Board determined “that no claim term requires express construction for purposes of this Decision, except to the extent the term ‘iron polyisomaltose complex’ is discussed below in the context of the challenge to claim 20 based on Marchasin.”
The Board turned next to the alleged grounds of unpatentability set forth in the Petition. Regarding anticipation by Groman, the Board found that Petitioner’s expert Dr. Linhardt’s analysis “rests on a series of assumptions in order to arrive at the claimed administration rate of fifteen minutes or less.” The Board went on to state that, “[a] best, Dr. Linhardt’s testimony establishes that it is possible to arrive at the requisite amount and rate by selecting a particular combination of variables disclosed by Groman” and that “[s]uch picking and choosing, however, is improper in the context of an anticipation challenge.” The Board cited In re Arkley, 455 F.2d 586, 587 (CCPA 1972), in connection with this position. The Board determined “that Petitioner has not established that Groman discloses administering a single dosage unit of at least about 0.6 grams of elemental iron in about 15 minutes or less, as required by claim 1, and therefore, has not demonstrated a reasonable likelihood of establishing that Groman anticipates claim 1” (and by dependency claims 2-5, 15, 16, and 20).
As for anticipation by Marchasin, the Board agreed with Patent Owner that “the evidence of record, . . . has not established adequately that the claim term ‘iron polyisomaltose’ would be understood by one of ordinary skill in the art in the context of the entire disclosure of the ’612 patent to encompass Marchasin’s ‘iron-dextran.’” As such, the Board indicated that “Petitioner has not demonstrated a reasonable likelihood of showing that claims 1 and 20 are anticipated by Marchasin.”
Regarding obviousness over Geisser and Groman, the Board agreed with Patent Owner “that Petitioner has not established that one of ordinary skill in the art would have had a reason to combine the teachings of Geisser and Groman in the manner required by the challenged claims.” Specifically, the Board indicated that “Petitioner has not established that Groman discloses administering a single dosage unit of at least about 0.6 grams of elemental iron in about 15 minutes or less, as required by claim 1.” The Board further found that Petitioner had not “explained why it would have been obvious for one of ordinary skill in the art to choose, from all the variables disclosed in Groman, those parameters that would result in administering at least about 0.6 grams of elemental iron in less than fifteen minutes, much less an even larger dose of at least about 1.0 gram.” As such, the Board was not persuaded “that Petitioner has demonstrated a reasonable likelihood that it would prevail in showing that challenged claims 7, 11, and 12 are unpatentable over Geisser and Groman.”
With respect to obviousness over Groman and van Zyl-Smit, the Board again agreed with Patent Owner “that Petitioner has not established that one of ordinary skill in the art would have had a reason to combine the teachings of Groman and van Zyl-Smit in the manner required by the challenged claims.” Specifically, the Board indicated that “Petitioner has not established that Groman discloses administering a single dosage unit of at least about 0.6 grams of elemental iron in about 15 minutes or less, as required by claim 1.” Further, the Board indicated that “Petitioner [had not] explained why it would have been obvious for one of ordinary skill in the art to choose, from all the variables disclosed in Groman, those parameters that would result in administering at least about 0.6 grams of elemental iron in less than fifteen minutes, much less an even larger dose of at least about 1.5 grams.” As such, the Board was not persuaded “that Petitioner has demonstrated a reasonable likelihood that it would prevail in showing that challenged claims 8 and 17 are unpatentable over Groman and van Zyl-Smit.”
Thus, the Petition was denied and no inter partes review was instituted.
Pharmacosmos A/S v. Luitpold Parms., Inc., IPR2015-01495
Paper 11: Decision Denying Institution of Inter Partes Review
Dated: January 8, 2016
Patent: 8,895,612
Before: Toni R. Scheiner, Lora M. Green, and Christopher G. Paulraj
Written by: Scheiner
Related Proceedings: Petitions for inter partes review challenging the claims of related U.S. Patent Nos. 7,754,702 B2 and 8,431,549 B2 (IPR2015-01490, IPR2015-01493, respectively)