Genzyme Corporation v. Pentech Pharmaceuticals, Inc. and Cobrek, Inc.

Genzyme Corporation v. Pentech Pharmaceuticals, Inc. and Cobrek, Inc.

N.D. Ill. (2012)

Fitzpatrick Secures Victory For Genzyme In Patent Suit Over Genzyme's Kidney Disease Drug Hectorol®.

On March 22, 2012, Judge Robert M. Dow, Jr., of the United States District Court for the Northern District of Illinois issued a decision in favor of Fitzpatrick’s client, Genzyme Corporation, upholding the validity and enforceability of Genzyme’s United States Patent No. 5,602,116. The ‘116 patent claims a method of using the vitamin D analog doxercalciferol to treat hyperparathyroidism in patients on dialysis. Genzyme markets doxercalciferol for such use under the trade name Hectorol®. In this suit, defendants Pentech Pharmaceuticals, Inc. and Cobrek, Inc. sought FDA approval to market generic versions of Hectorol®, and had challenged the validity and enforceability of the ‘116 patent on the grounds that the patented method of use was inoperable, obvious or unenforceable due to inequitable conduct.

Judge Dow’s opinion was issued following a 12-day bench trial held in October and November of 2010. In the opinion, Judge Dow first found that the ‘116 patent was entitled to a priority date of 1988, because the patented method of use was adequately described and enabled in an earlier related patent application filed on that date. Judge Dow then ruled that the claimed method of use was operable, noting that Defendants faced a “high bar” in asserting otherwise, and that Defendants’ evidence failed to meet that bar. Next, Judge Dow found that the patented method of use would not have been obvious as of 1988, noting that Defendants had failed to show that a person of ordinary skill would have selected doxercalciferol over other vitamin D analogs to treat end-stage renal disease, or that a person of ordinary skill could have “anticipated success” using it. In holding the ‘116 patent not obvious, Judge Dow observed that the “circumstances here are not like KSR Int’l, Inc. v. Teleflex, Inc., 550 U.S. 398, 421 (2007), in which the Supreme Court held that a product that was one of ‘a finite number of identified, predictable solutions’ that led to ‘anticipated success’ may have constituted an instance where the product simultaneously was obvious to try and obvious under [35 U.S.C.] § 103.” Finally, Judge Dow held that, because the ‘116 patent was entitled to a priority date of 1988, the alleged nondisclosure of certain post-1988 scientific references to the Patent Office was immaterial to patentability, and thus did not constitute inequitable conduct.

The Fitzpatrick team was led by partners Scott Reed, Donald Curry, Christopher Loh and Robert Baechtold, and included associates Daniel Minion, John Kirkland, Fiona Darkin, Christina Schwarz and Susanne Flanders.