August 8, 2017

Millennium Pharmaceuticals, Inc. v. Sandoz Inc. (Fed. Cir. 2017)

A Court of Appeals for the Federal Circuit (CAFC) panel reversed the district court’s holding that Millennium’s licensed patent, U.S. Patent No. 6,713,446 (“the ‘446 Patent”) was invalid for being obvious. The ‘446 Patent claimed a lyophilized mannitol ester prodrug of Bortezomib (See Claim 20). Claim 20 was not obvious according to the panel because, among other reasons, the inventors unexpectedly “discovered that the reason for the dramatic improvement in dissolution and stability for this formulation was the formation of a new chemical compound during lyophilization: the claimed ester of bortezomib and mannitol.”

• Claim 20:  The lyophilized compound D-mannitol N-(2-pyrazine)carbonyl-L-phenylalanine-L-leucine boronate.

Earlier, the district court concluded that the new compound was obvious reasoning that Bortezomib was already known (U.S. Patent No. 5,780,454), Lyophilization is already known known, and that the claimed compound is “the inherent result of an allegedly obvious process” of  lyophilizing bortezomib and mannitol together.

• There was no evidence that anyone “foresaw, or expected, or would have intended, the reaction between bortezomib and mannitol, or that the resulting ester would have the long-sought properties and advantages”
• “The district court did not find that the prior art taught or suggested that the claimed new compound would be formed, or taught or suggested making the claimed new compound by any method, or taught or suggested that this new compound would have the properties of stability, solubility, and dissociability that it exhibited.”
• “No reference taught or suggested reacting bortezomib with mannitol, and no reference hinted that such an esterification reaction might occur during lyophilization.”
• “No reference taught or suggested that the product of such lyophilization would be a new chemical compound that would solve the problems that had inhibited development of bortezomib in oncology.”

IP Watchdog Post by Jay Pattumudi:

http://www.ipwatchdog.com/2017/08/10/inherent-obviousness-motivation-modify-lead-compound-surprising-unexpected-results/id=86661/

Patent Docs Post:

http://www.patentdocs.org/2017/07/millennium-pharmaceuticals-inc-v-sandoz-inc-fed-cir-2017.html

Dilworth IP Post:

http://www.dilworthip.com/nonobviousness-push-back-millennium-pharma-v-sandoz/

VELCADE® Prescribing Information:

http://www.velcade.com/Files/PDFs/VELCADE_PRESCRIBING_INFORMATION.pdf

VELCADE® (bortezomib) Official Website:

http://www.velcade.com/