Monday, April 21, 2014

Glenmark loses appeal at CAFC

The CAFC affirmed DNJ in Sanofi-Aventis v. Glenmark

We conclude that jurisdiction is proper,
and affirm the district court’s judgment and related rulings.

Glenmark's unsuccessful argument

Glenmark argues that the verdict cannot stand, as
a matter of law, on the premise that if a combination of classes of compo-
nents is already known, all selections within such classes
are obvious to try, as a matter of law. (...)

Glenmark argued at trial, and repeats on this appeal,
that the Tarka® product simply substituted one known
ACE inhibitor for another. The Plaintiffs responded that
there were hundreds if not thousands of potential combi-
nations of ACE inhibitors and calcium antagonists in
1986, and that none of the available information pointed
directly at the combinations claimed.

The CAFC noted:

This court has elaborated that the identified path
must “present a finite (and small in the context of the art)
number of options easily traversed to show obviousness.”
Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
520 F. 3d 1358, 1364 (Fed. Cir. 2008). As illustrated in
In re O’Farrell, 85 3 F.2d 894, 903 (Fed. Cir. 1988), it would not
be “obvious to try” when “the prior art gave either no
indication of which parameters were critical or no direc-
tion as to which of many possible choices is likely to be


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