Monday, April 07, 2008

CAFC addresses obviousness in Ortho-McNeil v. Mylan

The CAFC addressed obviousness in Ortho-McNeil v Mylan (topomax case):

Mylan cites KSR International Co. v. Teleflex Inc., for the
proposition that "[w]hen there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a person of ordinary
skill has good reason to pursue the known options within his or her technical grasp."
127 S. Ct. 1727, 1742 (2007). The record, however, shows that even if an ordinarily
skilled artisan sought an FBPase inhibitor, that person would not have chosen
topiramate. Moreover this invention, contrary to Mylan's characterization, does not
present a finite (and small in the context of the art) number of options easily traversed to
show obviousness. The passage above in KSR posits a situation with a finite, and in
the context of the art, small or easily traversed, number of options that would convince
an ordinarily skilled artisan of obviousness.

In this case, the record shows that a person
of ordinary skill would not even be likely to start with 2,3:4,5 di-isopropylidene fructose
(DPF), as Dr. Maryanoff did. Beyond that step, however, the ordinarily skilled artisan
would have to have some reason to select (among several unpredictable alternatives)
the exact route that produced topiramate as an intermediate. Even beyond that, the
ordinary artisan in this field would have had to (at the time of invention without any clue
of potential utility of topiramate) stop at that intermediate and test it for properties far
afield from the purpose for the development in the first place (epilepsy rather than

[IPBiz note: recall "the selection of anions" case decided by the CAFC (PRIOR TO KSR);
Pfizer v. Apotex (on norvasc), discussed in Obviousness: knowing it when you see it?

Of the experts on obviousness:

In other words, Mylan's expert, Dr. Anderson, simply retraced the path of the
inventor with hindsight, discounted the number and complexity of the alternatives, and
concluded that the invention of topiramate was obvious. Of course, this reasoning is
always inappropriate for an obviousness test based on the language of Title 35 that
requires the analysis to examine "the subject matter as a whole" to ascertain if it "would
have been obvious at the time the invention was made." 35 U.S.C. § 103(a) (emphasis
added). In retrospect, Dr. Maryanoff's pathway to the invention, of course, seems to
follow the logical steps to produce these properties, but at the time of invention, the
inventor's insights, willingness to confront and overcome obstacles, and yes, even
serendipity, cannot be discounted.

[IPBiz note: Anderson reminds one of Loring and Trounson in the WARF case!]

The CAFC signaled that TSM still exists:

As this court has explained, however, a flexible TSM test remains the primary
guarantor against a non-statutory hindsight analysis such as occurred in this case. In re
Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) ("[A]s the Supreme Court
suggests, a flexible approach to the TSM test prevents hindsight and focuses on
evidence before the time of invention."). The TSM test, flexibly applied, merely assures
that the obviousness test proceeds on the basis of evidence – teachings, suggestions (a
tellingly broad term), or motivations (an equally broad term) – that arise before the time
of invention as the statute requires.

See also

A decision from ED Texas was vacated and remanded in O2 Micro v. Beyond Innovation.

Separately, note the CAFC issued corrections to the Monsanto v. Bayer Biosciences case of January 25, including the deletion of footnote 14.


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