Thursday, May 24, 2018

CAFC affirms D. Delaware in UCB case by 2-1 vote


The CAFC affirmed D. Delaware in the UCB case:


Following a bench trial, the district court made exhaustive
fact findings based on the trial evidence and
concluded that the asserted claims of the ’551 patent are
not invalid. Appellants appeal that decision, arguing that
the district court misapplied the legal standards for
obviousness-type double patenting, obviousness, and
anticipation, and that the prior art anticipates and/or
renders the ’551 patent obvious.
As explained more fully below, we hold that the district
court applied the correct legal standards in its obviousness-type
double patenting, obviousness, and
anticipation analyses. And because we discern no clear
error in its underlying fact findings, we affirm the district
court’s ultimate conclusion that the asserted claims are
not invalid.



Of obviousness-type double patenting:


By statute, only a single patent may issue for the
same invention. See 35 U.S.C. § 101 (“Whoever invents or
discovers any new and useful process, machine, manufacture,
or composition of matter, or any new and useful
improvement thereof, may obtain a patent therefor . . . .”)
(emphasis added); In re Lonardo, 119 F.3d 960, 965
(Fed. Cir. 1997) (“[Section 101] thus permits only one
patent to be obtained for a single invention, and the
phrase ‘same invention’ refers to an invention drawn to
substantially identical subject matter.”).
Nonstatutory double patenting, however, is a judicially-created
doctrine, which “prohibits an inventor from
obtaining a second patent for claims that are not patentably
distinct from the claims of the first patent.” Id. at
965. It “prevent[s] the extension of the term of a patent,
even where an express statutory basis for the rejection is
missing, by prohibiting the issuance of the claims in a
second patent not patentably distinct from the claims of
the first patent.” Otsuka Pharm. Co. v. Sandoz, Inc.,
678 F.3d 1280, 1297 (Fed. Cir. 2012) (quoting In re Longi,
759 F.2d 887, 892 (Fed. Cir. 1985)) (alteration in original).
The obviousness-type double patenting analysis involves
two steps: “First, the court ‘construes the claim[s]
in the earlier patent and the claim[s] in the later patent
and determines the differences.’ Second, the court ‘determines
whether those differences render the claims
patentably distinct.’” AbbVie Inc. v. Mathilda & Terence
Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1374
(Fed. Cir. 2014) (quoting Sun Pharm. Indus., Ltd. v. Eli
Lilly & Co., 611 F.3d 1381, 1385 (Fed. Cir. 2010)). The
second part of this analysis is analogous to the obviousness
inquiry under 35 U.S.C. § 103 in the sense that if an
earlier claim renders obvious or anticipates a later claim,
the later claim is not patentably distinct and is thus
invalid for obviousness-type double patenting. Id.
at 1378–79. In chemical cases, the double patenting
inquiry is not whether a person of ordinary skill in the art
would select the earlier compound as a lead compound,
but rather whether the later compound would have been
an obvious or anticipated modification of the earlier
compound. Otsuka, 678 F.3d at 1297. Unlike in an
obviousness analysis, the underlying patent in the double
patenting analysis need not be prior art to the later claim.
See id.

(...)

We agree with Appellants that the obviousness-type
double patenting inquiry requires consideration of the
differences between the claims in the reference
’301 patent and the ’551 patent. As we stated above, the
focus of the double patenting analysis entails determining
the differences between the compounds claimed in the
reference and asserted patents and then “determin[ing]
whether those differences render the claims patentably
distinct.” AbbVie, 764 F.3d at 1374 (emphasis added). In
this case, both claims recite a methoxymethyl group at R3.
Thus, the double patenting analysis requires determining
whether the claims’ differences, i.e., unsubstituted benzyl
and methyl at R and R1, would have been obvious to one
of skill in the art.

(...)

We turn next to the district court’s double patenting
analysis. Appellants assert that claims 9, 10, and 13 of
the ’551 patent are not patentably distinct from claims
44–47 of the ’301 patent and are thus invalid for obviousness-type
double patenting. Because these claims only
have a common methoxymethyl group at the R3 position,
the question before us is whether a person of ordinary
skill in the art, starting with claim 45 of the ’301 patent,
would have been motivated to place an unsubstituted
benzyl at R and an unsubstituted methyl at R1 in combination
with the methoxymethyl group at R3 with a reasonable
expectation of success. We acknowledge that this
is a close case, but because we discern no clear error in
the district court’s underlying fact finding that there
would have been no reasonable expectation of success in
placing an unsubstituted benzyl and methyl in the
claimed combination, we agree with the district court that
the asserted claims of the ’551 patent are patentably
distinct from the ’301 patent.

(...)

Here, the district court, relying on the prior
art and expert evidence, found no reasonable expectation
of success. That is a fact finding that we review for clear
error following a bench trial. Par Pharm., Inc. v. TWI
Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014).


Of enantiomers:


We hold that the district court did not clearly err in
finding that LeGall does not anticipate claim 9 of the
’551 patent. As the district court recognized, we have
held that “[t]he knowledge that enantiomers may be
separated is not ‘anticipation’ of a specific enantiomer
that has not been separated, identified, and characterized.”
Id. at 1084.



In her dissent, CJ Prost writes


An obviousness
determination requires that a skilled artisan would have
perceived a reasonable expectation of success in making
the invention in light of the prior art. Id. at 1362. This is
a question of fact, which we review for clear error following
a bench trial. Par Pharm., Inc. v. TWI Pharm., Inc.,
773 F.3d 1186, 1198 (Fed. Cir. 2014). “A factual finding is
clearly erroneous if, despite some supporting evidence,
‘the reviewing court on the entire evidence is left with the
definite and firm conviction that a mistake has been
committed.’” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348,
1359 (Fed. Cir. 2007) (quoting United States v. U.S.
Gypsum Co., 333 U.S. 364, 395 (1948)).

(...)

While it is true that there may be some evidence
supporting the district court’s view, given the overwhelming
evidence to the contrary, I am “left with the definite
and firm conviction that a mistake has been committed.”
Pfizer, 480 F.3d at 1359 (quoting U.S. Gypsum, 333 U.S.
at 395).

(...)

It was clear error for the district court to require testing
to provide “insight into the effectiveness of benzyl and
methyl relative to other structures that could be placed at
R and R1.” Id. Where the prior art teaches that the
selected substituent will work, even when it is selected
from thousands of compounds, an inability to predict how
any one substituent will work in the composition and a
need for testing will not render that selection nonobvious.
See In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985)
(“Although [the inventor] declared that it cannot be
predicted how any candidate will work in a detergent
composition, but that it must be tested, this does not
overcome [the prior art’s] teaching that hydrated zeolites
will work.”); Pfizer, 480 F.3d at 1364.


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