Friday, July 13, 2018

CUSTOPHARM INC. loses its appeal against Endo

The CAFC affirmed the "not invalid" determination of Judge Robinson of D. Delaware:

After a four-day bench trial on invalidity, the
district court concluded that Custopharm had not proven
that the claims were invalid under 35 U.S.C. § 103.
Custopharm appealed. For the reasons below, we find no
reversible errors in the district court’s conclusion and
accordingly, we affirm

Of review standards:

“Obviousness is a question of law based on underlying
findings of fact.” In re Kubin, 561 F.3d 1351, 1355 (Fed.
Cir. 2009). We review the district court’s conclusions of
law de novo. Eli Lilly & Co. v. Teva Parenteral Meds.,
Inc., 845 F.3d 1357, 1372 (Fed. Cir. 2017). And we review
the district court’s factual findings for clear error. Par
Pharm., 773 F.3d at 1194.

There was an issue of "which guidelines":

First, Custopharm’s overdose argument is predicated
on the assumption that a skilled artisan would have
applied the AACE Guidelines to the exclusion of other
guidelines that existed at the time, including the FDA
Guidelines. Under the FDA Guidelines, the range of
normal testosterone is 300 to 1000 ng/dl or 10 to
35 nmol/l. The record evidence sufficiently demonstrates
that the most prevalently applied guidelines in clinical
practice were the FDA Guidelines, not the AACE Guidelines.
The studies underlying the Articles all employed
the FDA Guidelines.

Of motivation

Second, Custopharm argues that the obviousness of
an invention does not require using the “best” motivation8;
only a “suitable” motivation is required. Par
Pharm., 773 F.3d at 1197–98. But this is a misunderstanding
of Custopharm’s burden. While the FDA Guidelines
do not teach away from using the AACE Guidelines,
the district court found that Custopharm had not shown,
by clear and convincing evidence, that a skilled artisan
would have recognized that patients injected with
1000 mg TU were being overdosed. To meet its burden,
Custopharm needed to do more than merely show that the
prior art does not preclude lowering the dose of TU.
Custopharm needed to affirmatively demonstrate that a
skilled artisan would have been motivated to lower the
dose of TU despite no clear evidence of overdosing under
the FDA Guidelines. See Pfizer, Inc. v. Apotex, Inc., 480
F.3d 1348, 1361 (Fed. Cir. 2007) (“[T]he burden falls on
the challenger of the patent to show by clear and convincing
evidence that a skilled artisan would have been
motivated to combine the teachings of the prior art references
to achieve the claimed invention . . . .”).

Of inherency:

To establish that a prior art reference inherently—
rather than expressly—discloses a claim limitation, “the
limitation at issue necessarily must be present, or [is] the
natural result of the combination of elements explicitly
disclosed by the prior art.” Par Pharm., 773 F.3d at 1196.
Here, Custopharm argues that the vehicle formulation
was “necessarily present” in the Articles because it was
later revealed to be the actual formulation the authors of
the Articles used in their reported clinical studies. We
An inherent characteristic of a formulation can be
part of the prior art in an obviousness analysis even if the
inherent characteristic was unrecognized or unappreciated
by a skilled artisan. See In re Kao, 639 F.3d 1057,
1070 (Fed. Cir. 2011). But, inherency “may not be established
by probabilities or possibilities.” Par Pharm., 773
F.3d at 1195 (quoting In re Oelrich, 666 F.2d 578, 581
(CCPA 1981)). “The mere fact that a certain thing may
result from a given set of circumstances is not sufficient.”
Id. (citing In re Rijckaert, 9 F.3d 1531, 1533–34 (Fed. Cir.
1993); Oelrich, 666 F.2d at 581 (“[M]ere recitation of a
newly discovered function or property, inherently possessed
by things in the prior art, does not distinguish a
claim drawn to those things from the prior art.”); In re
Shetty, 566 F.2d 81, 86 (CCPA 1977) (“[T]he inherency of
an advantage and its obviousness are entirely different
questions. . . . Obviousness cannot be predicated on what
is unknown.” (quoting In re Spormann, 363 F.2d 444, 448
(CCPA 1966))).

Footnote 9 delves into waiver:

Custopharm, however, did not respond to Endo’s contention
that Custopharm waived this argument by failing to
raise it before the district court. We agree with Endo. In
its reply brief, Custopharm argued that Helsinn
Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., is a
pertinent intervening case, but did not explain how it is
an intervening change in law to the inherency doctrine,
especially given that it is an on-sale bar case. 855 F.3d
1356 (Fed. Cir. 2017).


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