Tuesday, August 16, 2016

Apotex loses appeal at CAFC; Senju Pharm. Co. v. Lupin Ltd., 780 F.3d 1337, 1346 (Fed. Cir. 2015) explained

Apotex tried IPR to invalidate a Wyeth patent.

In March 2013, Apotex filed a petition to institute inter
partes review of the ’828 patent [of Wyeth]. The Board instituted
review based on one ground: that claims 1–23 would have
been obvious over the combination of Chinese Patent
Publication No. 1390550A (“CN ’550”); V. Naggar et al.,
Effect of Solubilizers on the Stability of Tetracycline, 29
PHARMAZIE 126 (1974) (“Naggar”); and E. Pawelczyk et
al., Kinetics of Drug Decomposition: Part 74: Kinetics of
Degradation of Minocycline in Aqueous Solution, 34 POL.
J. PHARMACOL. PHARM. 409 (1982) (“Pawelczyk”).

From the decision:

Apotex Inc. appeals from the U.S. Patent and Trademark
Office Patent Trial and Appeal Board (“the Board”)
final written decision in an inter partes review concluding
that claims 1–23 of U.S. Patent 7,879,828 (“the ’828
patent”) are not unpatentable as obvious. See Apotex Inc.
v. Wyeth LLC, No. 2014-00115, 2015 WL 1848261, at *14
(P.T.A.B. Apr. 20, 2015). For the reasons that follow, we

Note that there was an "incorrect translation" issue:

In its decision to institute, the Board relied on an
incorrect translation of CN ’550. See Apotex, 2015 WL
1848261, at *3–4. Apotex submitted a corrected translation
in response to Wyeth’s objections, and the Board
relied on that corrected translation in its final written
decision. See id. at *4. Discrepancies between the two
translations are not relevant to this appeal. See Appellant’s
Br. 11 n.4.

Apotex had two arguments:

Apotex challenges the Board’s conclusion regarding
obviousness in two respects. First, it contends that the
Board imported an epimeric stability limitation into the
claims, and thereby wrongly relied on the failure of CN
’550 to teach the epimeric stability of its composition.
Second, Apotex argues that the Board failed to consider
any motivation to combine the prior art of record beyond
the problem the patentee was trying to solve, in contravention
of KSR International Co. v. Teleflex Inc., 550 U.S.
398 (2007), and cases from this court. We address and
reject each challenge in turn.

As to the first, the CAFC observed:

To the extent the Board considered epimeric stability
during its obviousness analysis generally, it did so in the
context of assessing whether a skilled artisan would have
been motivated to combine references. That is not the
same as importing a limitation into the claims.

Of the second, as to the Senju case:

We further find Apotex’s invocation of Senju unpersuasive.
As an initial matter, Senju does not stand for the
general proposition that a skilled artisan would always be
motivated to try later generation compounds in an old
composition. Rather, the conclusion of obviousness in
Senju turned on the very specific factual findings made by
the district court about the teachings of the prior art and
the similarities across the quinolone family of compounds.
See, e.g., Senju, 780 F.3d at 1343 (“The ’470 patent also
teaches that each of the disclosed quinolones have ‘similar
substituents,’ and that pharmaceutical formulations of
gatifloxacin follow ‘the routes well known’ with respect to
‘oral[] and parenteral[]’ administration.” (internal citation


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