Yeda Research & Development Co. v. Abbott GmbH & Co. KG

United States Court of Appeals
for the Federal Circuit
______________________
YEDA RESEARCH AND DEVELOPMENT CO., LTD.,
Plaintiff-Appellant
v.
ABBOTT GMBH & CO. KG,
Defendant-Appellee
______________________
2015-1662
______________________
Appeal from the United States District Court for the
District of Columbia in No. 1:10-cv-01836-RMC, Judge
Rosemary M. Collyer.
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ABBOTT GMBH & CO. KG,
Plaintiff-Appellee
v.
YEDA RESEARCH AND DEVELOPMENT CO., LTD.,
Defendant-Appellant
______________________
2015-1663
______________________
2 YEDA RESEARCH AND DEVELOPMENT v. ABBOTT GMBH
& CO. KG
Appeal from the United States District Court for the
District of Columbia in No. 1:00-cv-01720-RMU, Judge
Ricardo M. Urbina.
______________________
Decided: September 20, 2016
______________________
MATTHEW NIELSEN, Marshall, Gerstein & Borun LLP,
Chicago, IL, argued for plaintiff-appellant/defendant-
appellant. Also represented by KEVIN M. FLOWERS,
AMANDA ANTONS; ROGER L. BROWDY, RONNI JILLIONS,
Browdy and Neimark PLLC, Washington, DC.
JAMES RICHARD FERGUSON, Mayer Brown, LLP, Chi-
cago, IL, argued for defendant-appellee/plaintiff-appellee.
Also represented by TODD RAY WALTERS, Buchanan
Ingersoll & Rooney P.C., Alexandria, VA.
______________________
Before REYNA, WALLACH, and HUGHES, Circuit Judges.
REYNA, Circuit Judge.
Yeda Research and Development Co., Ltd. (“Yeda”)
appeals two decisions by the United States District Court
for the District of Columbia—one decided in 2008 (No.
2015-1663) and the other in 2015 (No. 2015-1662). Both
district court decisions reviewed determinations by the
Board of Patent Appeals and Interferences regarding
Yeda’s assertion that Abbott GmbH & Co. KG’s (“Abbott”)
U.S. Patent No. 5,344,915 (the “’915 patent”) is invalid as
anticipated.
The ’915 patent’s invalidity turns on whether it bene-
fits from the filing dates from either of two German
patent applications—P39 15 072 (the “’072 application”)
and P39 22 089 (the “’089 application”). J.A. 5006. If it
does, then the field of prior art narrows to exclude the
YEDA RESEARCH AND DEVELOPMENT V. ABBOTT GMBH 3
& CO. KG
anticipating reference. Whether the ’915 patent is enti-
tled to benefit from the ’072 application’s filing date
depends on whether the ’072 application provides ade-
quate written description support for the invention
claimed in the ’915 patent.
We affirm the district court’s 2015 decision that Ab-
bott’s ’915 patent is supported by the written description
of the ’072 application. As this renders moot Yeda’s
appeal No. 2015-1663 concerning the district court’s 2008
decision, we dismiss that appeal for want of jurisdiction.
BACKGROUND
A. Patented Technology
Abbott’s ’915 patent discloses a protein referred to as
TBP-II. TBP-II binds to and neutralizes a protein called
Tumor Necrosis Factor α (“TNFα”), which is associated
with various immunological diseases. The ’915 patent has
three claims. ’915 patent col. 6 ll. 37−60. Claim 1 is
representative:
1. A purified and isolated TNFα-binding protein
which has a molecular weight of about 42,000 dal-
tons and has at the N terminus the amino acid se-
quence
Xaa Thr Pro Tyr Ala Pro Glu Pro Gly Set
Thr Cys Arg Leu Arg Glu
where Xaa is hydrogen, a phenylalanine residue
(Phe), or the amino acid sequences Ala Phe, Val
Ala Phe, Gln Val Ala Phe, Ala Gln Val Ala Phe,
Pro Ala Gln Val Ala Phe or Leu Pro Ala Gln Val
Ala Phe.
The U.S. application that resulted in the ’915 patent
was filed May 4, 1990. It claimed priority to two applica-
tions for a “novel protein”—the ’072 application, filed May
9, 1989, and the ’089 application, filed July 5, 1989. J.A.
5006.
4 YEDA RESEARCH AND DEVELOPMENT v. ABBOTT GMBH
& CO. KG
The prior art in question is the Engelmann reference,
which is an article published in January 1990 that de-
scribes and distinguishes the TBP-I and TBP-II proteins. 1
The parties do not dispute that Engelmann constitutes
applicable prior art if the priority date for the ’915 patent
is May 1990, but not if the ’915 patent benefits from the
filing date of either the ’072 or the ’089 application. The
parties do not dispute that the Engelmann reference
anticipates the ’915 patent if the priority date is May
1990.
Neither the ’072 nor the ’089 application discloses the
full N-terminus sequence claimed in the ’915 patent.
Instead, they disclose a partial N-terminus sequence, a
protocol for obtaining the protein from its biological
source, and additional properties of the protein, such as
molecular weight, biological activity, and degradation
characteristics when exposed to trypsin. The parties
agree that the only protein containing the N-terminus
sequence set forth in the ’072 application is TBP-II—i.e.,
the same protein claimed in the ’915 patent. J.A. 5024.
B. Procedural History
In 1996, the Board declared Interference No. 103,625
between Abbott’s ’915 patent and Yeda’s Application No.
07/930,443. The Board assigned Abbott the May 1990
filing date of the application that became the ’915 patent
and held that the ’915 patent was invalid as anticipated
by Engelmann. Abbott filed suit in federal district court
seeking review of the Board’s final decision. In 2008, the
district court granted summary judgment for Abbott,
holding that the ’089 patent inherently discloses the
1 Dr. Hartmut Engelmann et al. published “Two
Tumor Necrosis Factor-Binding Proteins Purified from
Human Urine” in the Journal of Biological Chemistry on
January 16, 1990. J.A. 5009.
YEDA RESEARCH AND DEVELOPMENT V. ABBOTT GMBH 5
& CO. KG
TBP-II protein and provides an adequate written descrip-
tion of the invention claimed in the ’915 application. The
district court vacated the Board’s decision and remanded
for further proceedings.
On remand, the Board reversed course. In 2010, the
Board held that the ’072 application sufficiently disclosed
TBP-II for the ’915 patent to benefit from the ’072 appli-
cation’s May 1989 filing date. Yeda filed a district court
action seeking review of the Board’s 2010 determination.
In 2015, the district court affirmed the Board’s decision
and granted Abbott summary judgment.
Yeda appeals the district court’s 2008 and 2015 deci-
sions. We have jurisdiction over these appeals pursuant
to 28 U.S.C. § 1295(a)(4)(C).
STANDARD OF REVIEW
This court reviews de novo a district court’s grant of
summary judgment in an interference action. Boston Sci.
Scimed, Inc. v. Medtronic Vascular, Inc., 497 F.3d 1293,
1296 (Fed. Cir. 2007). We review de novo the district
court’s legal determinations. See Rolls-Royce, PLC v.
United Techs. Corp., 603 F.3d 1325, 1330 (Fed. Cir. 2010).
The Board’s factual findings, including those relied on by
the district court, are reviewed for substantial evidence.
In re Gartside, 203 F.3d 1305, 1311−15 (Fed. Cir. 2000).
Substantial evidence exists where a reasonable mind
could accept it as adequate support for a conclusion. Id.
at 1312 (citing Consol. Edison Co. v. NLRB, 305 U.S. 197,
229−30 (1938)).
DISCUSSION
Yeda raises three arguments on appeal. First, Yeda
challenges the legal standard applied by the district court
to determine whether there was adequate written de-
scription support for the ’915 patent in the ’072 applica-
tion. Second, Yeda argues that the prosecution history
precludes Abbott from relying on inherent disclosure.
6 YEDA RESEARCH AND DEVELOPMENT v. ABBOTT GMBH
& CO. KG
Third, Yeda asserts that the district court erred in hold-
ing that the Board’s finding of adequate written descrip-
tion was supported by substantial evidence.
We first address the legal standard for written de-
scription support. In order for the claims of the ’915
patent to benefit from the ’072 application’s filing date,
the claimed invention must be disclosed by the ’072
application. 35 U.S.C. §§ 112, 120; see Kennecott Corp. v.
Kyocera Int’l, Inc., 835 F.2d 1419, 1421 (Fed. Cir. 1987).
The invention must be disclosed in a way that clearly
allows a person of ordinary skill to recognize that the
inventor invented what is claimed and possessed the
claimed subject matter at the date of filing. Ariad Phar-
maceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351
(Fed. Cir. 2010) (en banc).
Yeda argues that the district court failed to apply the
correct test for determining the sufficiency of the written
description. According to Yeda, Abbott must show that at
the time the ’072 application was filed, a person of ordi-
nary skill in the art would have understood that the
partial N-terminus sequence in the ’072 application
included the additional amino acids identified in the ’915
patent claims at issue. Abbott responds that the district
court correctly held that the ’072 application need only
describe and enable the TBP-II protein, and that a protein
can be adequately described when a partial amino acid
sequence is disclosed along with other biological charac-
teristics.
Under the doctrine of inherent disclosure, when a
specification describes an invention that has certain
undisclosed yet inherent properties, that specification
serves as adequate written description to support a sub-
sequent patent application that explicitly recites the
invention’s inherent properties. See Kennecott, 835 F.2d
at 1423. In this case, it is undisputed that TBP-II is the
only protein with the same partial N-terminus sequence
YEDA RESEARCH AND DEVELOPMENT V. ABBOTT GMBH 7
& CO. KG
and additional traits disclosed in the ’072 applica-
tion. J.A. 5024. Therefore, the ’072 application inherent-
ly discloses the remaining amino acids in the N-terminus
sequence of TBP-II and serves as adequate written de-
scription support for the patent claiming TBP-II. It is not
necessary for an application to disclose a protein’s com-
plete N-terminus sequence in order to provide an ade-
quate written description of that protein. Yeda relies on
two cases where we declined to find inherent disclosure to
argue that the doctrine of inherent disclosure does not
extend to this case: Hyatt v. Boone, 146 F.3d 1348 (Fed.
Cir. 1998) and In re Wallach, 378 F.3d 1330 (Fed. Cir.
2004). We disagree. Neither Hyatt nor Wallach involved
the situation present in this case, where it is undisputed
that the invention described in an earlier application was
the exact invention claimed by the later patent.
Yeda also argues that prosecution history belies Ab-
bott’s reliance on inherent disclosure. Yeda notes that in
“the context of priority determinations, the allegedly
inherent limitation cannot be material to the patentabil-
ity of the invention.” Yeda asserts that the amino acids
missing from the ’072 application are material because
Abbott relied upon their absence to distinguish the prior
art during prosecution of the ’915 patent. See Hitzeman v.
Rutter, 243 F.3d 1345, 1355 (Fed. Cir. 2001). The prose-
cution history, however, does not support Yeda’s argu-
ment.
During prosecution of the ’915 patent, the examiner
rejected claims based on prior art that disclosed a protein
with the same source, weight, and function as the protein
claimed in the ’915 patent. J.A. 9251. Abbott relied on
the Engelmann article to argue that the cited art con-
cerned only TBP-I, and that TBP-II includes a sequence of
five amino acids not present in TBP-I that match the
chain recited in the ’915 patent claims. J.A. 9268,
9276−77. Abbott’s response did not solely rely on amino
acids missing from the priority applications; three of the
8 YEDA RESEARCH AND DEVELOPMENT v. ABBOTT GMBH
& CO. KG
five amino acids disclosed in Engelmann were disclosed in
the ’072 application and were themselves sufficient to
distinguish TBP-I from TBP-II.
Finally, we reject Yeda’s argument that the district
court erred in finding that the Board’s conclusion that the
’072 application provides written description for the ’915
patent is supported by substantial evidence. As the
district court noted, the Board’s decision rested on the
facts that the ’072 application identified nine of the fifteen
amino acids of the N-terminus sequences recited in the
relevant claim, as well as several biological characteristics
of the protein. J.A. 5028. The parties do not dispute that
no known protein other than TBP-II matches these char-
acteristics. The district court correctly found that the
Board’s decision was supported by substantial evidence.
CONCLUSION
Because the ’072 application provides an adequate
written description of the protein claimed in Abbott’s ’915
patent, the ’915 patent benefits from the priority date of
the ’072 application. We affirm the district court’s 2015
decision. We dismiss Yeda’s appeal No. 2015-1663 from
the district court’s 2008 decision for lack of jurisdiction, as
it is now moot.
AFFIRMED
COSTS
No costs.