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Ortho gets mixed decision in appeal of D NJ case

By Lawrence B. Ebert, Esq.

ORTHO-MCNEIL PHARMACEUTICAL v. TEVA is a patent law appeal from a D NJ order granting summary
judgment of invalidity based on anticipation and obviousness.

Part of the case turns on unexpected results:

Ortho-McNeil can rebut the prima facie case if it can show that the prior art
teaches away from the claimed range, or the claimed range produces new and
unexpected results over the prior art range. See Iron Grip Barbell Co. v. USA Sports,
Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004). Before the United States Patent and
Trademark Office, the district court, and now us, Ortho-McNeil principally relies on
unexpected results in the form of synergy between tramadol and acetaminophen. As
described in RE?221, the observed analgesic effect of tramadol-acetaminophen
combinations exceeds what one would predict from merely adding the effects observed
upon administering each drug individually. See, e.g., RE?221 fig. 1. Ortho-McNeil?s
problem, however, is that its own evidence indicates no perceptible difference in
synergy between a weight ratio of 1:7.1 and 1:10?and indeed over a much broader
range of ratios. Id. Ortho-McNeil does not dispute this. Thus, Ortho-McNeil has failed
to create a material dispute of fact regarding whether ?the claimed range achieves
unexpected results relative to the prior art range.? In re Woodruff, 919 F.2d 1575, 1578
(Fed. Cir. 1990) (emphasis added); cf. Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299,
1311-12 (Fed. Cir. 2006) (?Evidence of commercial success, or other secondary
considerations, is only significant if there is a nexus between the claimed invention and
the commercial success.?).

** An expert went down the tubes:

Dr. Stanski did not opine on that option, and therefore did not create a
material issue of fact regarding whether the prior art teaches away from the claimed
invention. We have considered Ortho?s other arguments and find them to be without
merit.

Ortho did better on OTHER claims:

Ortho?s proffered reading of Flick and the German references, as well as expert
testimony regarding the understanding of one skilled in the art, raises material questions
of fact as to whether a skilled artisan would have found the claimed combination of
tramadol and acetaminophen to be obvious. We therefore vacate the district court?s
summary judgment invalidating RE?221 claims 43-48, 51, 54, 67, 69, 72, and 74 based
on obviousness and remand the case for a trial on the merits.

Full post as published by IPBiz on August 26, 2009 (boomark / email).