Persion Pharma loses at the CAFC; district court's analysis of obviousness/written description not inconsistent

At the district court for Delaware:


The district court next determined that the asserted
claims are invalid as obvious over Devane in view of Jain,
the state of the prior art at the time of invention, and the
Vicodin and Lortab labels. Id. at 595–96, 610. Specifically,
the district court found that in light of the teachings of Jain
and the Vicodin and Lortab labels, a person of ordinary
skill in the art would have been motivated to administer
the extended-release hydrocodone bitartrate formulation
disclosed in Devane to patients with mild or moderate hepatic
impairment at an unadjusted dose and would have
had a reasonable expectation of success in so doing. Id. at
609–10, 615. The district court further found that the
pharmacokinetic limitations in the pharmacokinetic claims
are “inherent in any obviousness combination that contains
the Devane formulation” because the recited pharmacokinetic parameters
were “necessarily present” in the Zohydro
ER formulation described in both Devane and the asserted
patents. Id. at 607. Finally, the district court found that
the objective factors of unexpected results, long-felt but unmet need,
and failure of others did not weigh in favor of
finding nonobviousness.



Of procedure:


In an appeal from a bench trial, we review the district
court’s factual findings for clear error and the district
court’s legal conclusion on obviousness de novo. Novo
Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d 1346,
1354 (Fed. Cir. 2013). Under the clearly erroneous standard of review,
we defer to the district court’s factual findings unless, considering
the totality of the evidence, we are
“left with the definite and firm conviction that a mistake
has been committed.” Zenith Radio Corp. v. Hazeltine Research, Inc.,
395 U.S. 100, 123 (1969) (quoting United
States v. U.S. Gypsum Co., 333 U.S. 364, 395 (1948)).



As to inherency in an obviousness context:


It is long
settled that in the context of obviousness, the “mere 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 Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981). The Supreme
Court explained long ago that “[i]t is not invention to perceive that the product which others had discovered had
qualities they failed to detect.” Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249 (1945).
(...)
Our predecessor court similarly concluded
that it “is not the law” that “a structure suggested by the
prior art, and, hence, potentially in the possession of the
public, is patentable . . . because it also possesses an
[i]nherent, but hitherto unknown, function which [the patentees] claim to have discovered.” In re Wiseman, 596
F.2d 1019, 1023 (C.C.P.A. 1979).




Of motivation:


However, as the district court explained, “[t]he standard to find a motivation to combine is far below what is sufficient to prove
safety and efficacy to the FDA,” and therefore, “[t]he fact
that the FDA found the comparison [between Vicoprofen
and Zohydro ER] insufficient to satisfy its safety and efficacy standards does not speak to the issue of obviousness.”
Pernix, 323 F. Supp. 3d at 611. We find no clear error in
the district court’s conclusion that the FDA’s approval requirements do not undermine the force of the evidence as
to obviousness. Id. In light of the record as a whole, we
find no clear error in the district court’s findings on the relevance of combination product data to a person of ordinary
skill considering the administration of a hydrocodone-only
product.



As to the factual findings:



In sum, after reviewing the entire evidentiary record,
we are not left with any conviction that the district court
has made a mistake. See Zenith, 395 U.S. at 123. We
therefore reject Persion’s challenge to the district court’s
factual findings, which are not clearly erroneous.



Of the tension between obviousness and written description:



Lastly, Persion argues that the district court’s obviousness decision must be reversed because its obviousness
findings are at odds with its findings concerning the written description issue. Persion states that, for example, in
finding a lack of written description support for the asserted claims, the district court “found [that] ‘nothing in
the state of the art as of July 2012 . . . would have provided
guidance as to which [ER hydrocodone-only] formulations
would [achieve the claimed PK profile] and which would
not[.]’” Appellant’s Br. 22 (quoting Pernix, 323 F. Supp. 3d
at 627) (emphasis omitted). Persion asserts this statement
contradicts the district court’s finding that a person of ordinary skill in the art “would ‘look to Jain and to the Vicodin and Lortab labels for [] guidance as to the
appropriate dosing levels of Devane’s formulation for patients with mild or moderate [hepatic impairment].’” Id.
(quoting Pernix, 323 F. Supp. 3d at 612) (emphasis omitted). We reject this argument as we see no inconsistency
in the district court’s findings.



The CAFC pointed to a problem of incomplete quotations:


Persion’s entire argument with respect to this issue is
based on incomplete quotations from the district court’s
opinion. For example, a complete reading of the district
court’s statement above belies Persion’s assertion that the
district court’s findings are inconsistent. The district court
stated that “there was nothing in the state of the art as of
July 2012 that would have provided guidance as to which
of the broadly claimed formulations would work and which
would not, with the exception of the single embodiment described in Example 8.” Pernix, 323 F. Supp. 3d at 627 (emphasis added). The embodiment described in Example 8 of
the common written description of the ’760 and ’499 patents is the Devane formulation, which formed the basis for
the district court’s obviousness findings. Id. at 575, 619.
In contrast to the “essentially limitless number of formulation species” covered by the claims of the ’760 and ’499 patents, the district court found that the prior art provided adequate guidance with respect to the sole formulation described in Example 8: the Devane formulation. Id. at 618–19, 622–23. Thus, there is no inconsistency between the
statement Persion quotes and the district court’s conclusion that a person of ordinary skill in the art would have
been motivated to combine Devane with Jain and the Vicodin and Lortab labels to arrive at the claimed invention.

For the same reason, we reject Persion’s argument that
the district court’s findings with respect to reasonable expectation of success are inconsistent with its findings concerning the lack of written description. Persion asserts
that the district court “found that there was no ‘way of predicting which formulations would work and which would
not[,]’ stating that ‘testing results would be fundamental to
determining which formulations would satisfy the asserted
claims[.]’” Appellant’s Br. 20 (quoting Pernix, 323 F. Supp.
3d at 624, 628). According to Persion, this necessity for experimentation contradicts the district court’s finding that
a person of ordinary skill would have had a reasonable expectation of success in combining Devane with Jain and the
Vicodin and Lortab labels. Id. at 20–21. Once again, however, Persion omits critical context from its quote that
demonstrates the district court was addressing formulations other than the one described in Example 8. See
Pernix, 323 F. Supp. 3d at 623 (declining to credit expert
testimony that “the specification would provide guidance to
a person of skill in the art regarding how to make a formulation that would satisfy the limitations of the asserted
claims, except for the Devane formulation set forth in Example 8 or compositions closely similar to that one”) (emphasis added). In context, there is no inconsistency
between the district court’s findings underlying its obviousness and lack of written description determinations, and
we will not reverse the district court on this basis.