Tuesday, May 14, 2019

Appellants lose in BTG v. Amneal: the epitome of a decision that must be sustained upon review for substantial evidence.

From the decision of the CAFC:

Appellants appeal the PTAB’s Final Written Decisions
and the District Court’s Final Judgment. We consolidated
the appeals. We have jurisdiction pursuant to 28 U.S.C.
§ 1295(a)(1) and 1295(a)(4)(A) (2012). We affirm the
PTAB’s Final Written Decision in Wockhardt. Because our
affirmance renders the remaining issues on appeal moot,
we dismiss the appeals of Amerigen, Mylan, and BTG.

Footnote 2 states:

When a party challenging the actions taken by an
agency in separate appeals and “the decision [in one case]
resolves the substantive issues appealed” in the other
cases, the other cases are moot. See Dep’t of Commerce v.
U.S. House of Representatives, 525 U.S. 316, 344 (1999)
(explaining that by “affirm[ing] the judgment of the District
Court . . . this decision also resolves the substantive issues
presented by” the other companion case and, therefore, the
“appeal in that case is therefore dismissed”); see also Synopsys, Inc. v. Lee,
812 F.3d 1076, 1077 (Fed. Cir. 2016) (dismissing an appeal
of a district court opinion as “moot”
because “[o]ur decision in the companion [PTAB appeal] resolves
all of the substantive issues presented in this [district court appeal];
nothing remains to be decided” and
“this [district court appeal] no longer presents a ‘sufficient
prospect that the decision will have an impact on the parties’” (citation omitted)).

Of the meaning of the word "or":

The specification states that a “therapeutic agent” may
be either “an anti-cancer agent or a steroid.” Id. col. 10
ll. 54–55 (emphasis added). As such, the use of “or” in
between “anti-cancer agent” and “steroid” suggests that a
steroid is not necessarily the same thing as an anti-cancer
agent. See Housey Pharm., Inc. v. Astrazeneca UK Ltd.,
366 F.3d 1348, 1353–54 (Fed. Cir. 2004) (explaining the
claim term “inhibitor or activator of a protein” was “not limited”
to the narrow meaning because “the specification and
prosecution history affirmatively demonstrate that [the
appellant] intended the broader meaning”). Importantly,
the specification identifies prednisone as a glucocorticoid,
see ’438 patent col. 3 ll. 9–11 (“[A] glucocorticoid includ[es],
but [is] not limited to, hydrocortisone, prednisone[,] or dexamethasone”),
and glucocorticoid as a steroid, see id. col. 5
ll. 9–11 (explaining that “one therapeutic agent, such as an
anti-cancer agent or steroid, particularly [is] a glucocorticoid”).
Prednisone is similarly listed as an example of an
antibiotic agent. See id. col. 9 ll. 30–44 (“Suitable antibiotic
agents . . . [include] prednisone.”). The specification states
that antibiotic agents are one example of anti-cancer
agents. Id. col. 7 l. 46 (providing that “anti-cancer agent[s]
include . . . antibiotic agents”). Therefore, the specification
explains that prednisone may be used as both a steroid and
an anti-cancer agent.

Of "substantial evidence":

“We review the PTAB’s factual findings for substantial
evidence and its legal conclusions de novo.” Redline Detection, LLC
v. Star Envirotech, Inc., 811 F.3d 435, 449 (Fed.
Cir. 2015) (citation omitted). Substantial evidence “is such
relevant evidence as a reasonable mind might accept as adequate to support a conclusion.”
In re NuVasive, Inc., 842
F.3d 1376, 1380 (Fed. Cir. 2016) (internal quotation marks
and citations omitted). “If two inconsistent conclusions
may reasonably be drawn from the evidence in record, the
PTAB’s decision to favor one conclusion over the other is
the epitome of a decision that must be sustained upon review for substantial evidence.”
Elbit Sys. of Am., LLC v.
Thales Visionix, Inc., 881 F.3d 1354, 1356 (Fed. Cir. 2018)
(internal quotation marks, brackets, and citation omitted).

Footnote 11:

Because Appellants predicate their obviousness arguments upon
their assertion that the “PTAB’s erroneous
construction infected its analysis of obviousness,” Appellants’ Br. 35,
we need not separately address Appellants’
conditional invalidity arguments, see Knowles, 886 F.3d at
1373 n.3 (“Because we conclude that the PTAB did not err
in its construction of the disputed limitation, we need not
address the appellants’ conditional arguments as to the
PTAB’s unpatentability determinations.”(internal quotation marks and citation omitted)). However, for purposes
of this appeal, we address these arguments as an independent basis for affirming the PTAB’s findings.


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