By Donald Zuhn —

On Monday, the U.S. Supreme Court denied a motion to expedite consideration of a petition for a writ of certiorari filed by Pfizer Inc. in Pfizer Inc. v. Apotex, Inc. (2007).  The Chief Justice took no part in the consideration or decision of Pfizer’s motion.

As previously reported by Patent Docs, on March 22, 2007 the Federal Circuit reversed a District Court finding of validity with respect to U.S. Patent No. 4,879,303, holding that the ‘303 patent was rendered obvious by, inter alia, U.S. Patent No. 4,572,909 and Berge, 1977, "Pharmaceutical Salts," J. Pharm. Sci. 66:1-19.  Pfizer’s ‘303 patent relates to amlodipine besylate (sold by Pfizer under the trademark Norvasc®), an acid addition salt of amlodipine that does not exhibit the instability and stickiness in tablet form of amlodipine maleate (an acid addition salt of amlodipine disclosed in Pfizer’s ‘909 patent).

At trial, the District Court had determined that amlodipine besylate was nonobvious, concluding that "[t]here is no reliable way of predicting the influence of a particular salt species on the behavior of a parent compound," and further, that amlodipine besylate "clearly and unexpectedly illustrates a superior combination of properties when compared to [amlodipine maleate]."  However, on appeal, a panel consisting of Chief Judge Michel and Judges Mayer and Linn reversed, stating that "[a]t most . . . Pfizer engaged in routine, verification testing to optimize selection of one of several known and clearly suggested pharmaceutically-acceptable salts to ease its commercial manufacturing and marketing of the tablet form of the therapeutic amlodipine."

As also reported by Patent Docs, on May 21, 2007 the Federal Circuit denied a combined petition for panel rehearing and rehearing en banc filed by Pfizer.  Following the denial of its combined petition, Pfizer appealed the Federal Circuit’s determination to the Supreme Court, filing a petition for writ of certiorari and a motion to expedite consideration of the petition for a writ of certiorari on May 30, 2007.

As reported on IP LAW360, Robert Breisblatt of Welsh & Katz Ltd. (counsel for Apotex) explained that the Supreme Court’s denial likely means that the case will not be heard until the fall term, as the Court’s current term ends in June and Apotex’ response is not due until June 29, 2007 (see docket for Case No. 06-1582).

Neither Pfizer nor Apotex released a statement regarding the denial of Pfizer’s motion to expedite.