Tuesday, April 25, 2017

Duke University v. Biomarin. Duke saves two claims on appeal.

In Duke University v. Biomarin (2016-1106), one has a pharma company bringing an
IPR against a university, and the university appealing an unfavorable result to the CAFC.

Duke was able to save two claims:

Duke University (“Duke”) appeals from the decision of
the U.S. Patent and Trademark Office (“PTO”) Patent
Trial and Appeal Board (“Board”) in an inter partes review
(“IPR”) holding claims 1–9, 11, 12, 15, and 18–21 of U.S.
Patent 7,056,712 (the “’712 patent”) unpatentable. See
BioMarin Pharm. Inc. v. Duke Univ., No. IPR2013-00535,
2015 WL 1009196 (P.T.A.B. Feb. 23, 2015) (“Board Decision”),
aff’d on reh’g, 2015 WL 4467381 (P.T.A.B. July 14,
2015) (“Rehearing Decision”). Because the Board erred in
holding claims 9 and 19 unpatentable, but did not otherwise
err, we affirm in part, reverse in part, vacate in part,
and remand.

Of claim 9:

We begin with Duke’s argument relating to the proper
construction of the term “precursor” in claim 9. In an
IPR, a patent claim is given “its broadest reasonable
construction in light of the specification of the patent in
which it appears.” Cuozzo Speed Techs., LLC v. Lee, 136
S. Ct. 2131, 2142 (2016) (quoting 37 C.F.R. § 42.100(b)).
“[W]e review the Board’s ultimate claim constructions de
novo and its underlying factual determinations involving
extrinsic evidence for substantial evidence.” Microsoft
Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1297 (Fed. Cir.
2015) (citing Teva Pharm. USA Inc. v. Sandoz, Inc., 135 S.
Ct. 831, 841–42 (2015)). Here, because the intrinsic
record alone determines the proper construction of “precursor,”
we review the Board’s construction de novo. See
Shire Dev., LLC v. Watson Pharm., Inc., 787 F.3d 1359,
1364, 1368 (Fed. Cir. 2015) (citing Teva, 135 S. Ct. at


However, our agreement with BioMarin as to what
the Board held is not the same as agreeing with the
Board’s holding. On this point, we disagree with the
Board’s construction and agree with Duke that the proper
construction of “precursor” in claim 9 is “exclusively a
precursor of recombinant hGAA that has been produced
in CHO cell cultures.” Claim 9 requires that “the [hGAA]
is a precursor” and refers to claim 1 for the antecedent
basis of “the [hGAA].” ’712 patent col. 13 ll. 9–12 (emphases
added). That sentence structure makes clear that the
“is a precursor” phrase limits the form of hGAA to a
precursor form. The claim language and structure thus
support the conclusion that “the [hGAA]” in claim 9 is
exclusively a precursor of hGAA.


Applying the correct construction, we agree with Duke
that van Bree does not disclose a “precursor.” The Board
did not find that van Bree discloses administering exclusively
a precursor of rhGAA produced in CHO cell cultures.
See Board Decision, 2015 WL 1009196, at *12.
And BioMarin does not argue on appeal that van Bree’s
disclosure teaches the “precursor” limitation of claim 9
under the correct construction. Thus, we reverse the
Board’s finding that claim 9 was anticipated.

Of claim 19:

Duke argues that the Board’s claim 19 obviousness
determination is legally deficient and the underlying factfinding
is not supported by substantial evidence because
it rests on cursory and conclusory expert testimony.
We agree with Duke that the Board erred in concluding
that claim 19 was unpatentable as obvious. Substantial
evidence does not support the Board’s finding that
“the prophylactic administration of an immunosuppressant
would have been a predictable variation of the use of
immunosuppressant disclosed in Brady.” Id. at *8. It is
undisputed that the Board correctly found that “Brady
does not disclose administering immunosuppressant prior
to any and all administration of hGAA, as required by
claim 19.” Rehearing Decision, 2015 WL 4467381, at *4.
The expert testimony relied on by the Board to bridge the
gap between the disclosure in Brady and claim 19 falls
short of what would have rendered the subject matter of
claim 9 obvious.
Thus, the
evidence of record does not establish the conditions precedent
(a high incidence of patients with high antibody
titers to the enzyme) to the prophylactic administration of
immunosuppressants according to the expert’s testimony.
Such conclusory expert testimony cannot support an
obviousness conclusion. See In re Magnum Oil Tools, 829
F.3d at 1380 (“To satisfy its burden of proving obviousness,
a petitioner cannot employ mere conclusory statements.
The petitioner must instead articulate specific
reasoning, based on evidence of record, to support the
legal conclusion of obviousness.”). The evidence thus fails
to render claim 19 obvious.

Of the presumption of nexus

Notably, Duke’s objections to the Board’s treatment
of its evidence of objective indicia of non-obviousness—
including its failure to apply a presumption of nexus—
appear well taken.

Some legal points:

Expert testimony was not necessary to support the
Board’s anticipation determination. Here, the disclosures
of van Bree alone were sufficiently clear and on point to
constitute substantial evidence to support the Board’s
anticipation findings. Thus, the Board “could permissibly
‘rely on its own reading of [van Bree]—supported by the
Petition’s observations about it’—to find that the [limitations]
were disclosed.” In re NuVasive, Inc., 841 F.3d 966,
973 (Fed. Cir. 2016) (quoting Belden Inc. v. Berk-Tek LLC,
805 F.3d 1064, 1074 (Fed. Cir. 2015)).

Duke also argues that the Board “acted outside its
statutory authority in instituting an IPR and in its Final
Decision by adopting anticipation theories that BioMarin
never raised.” Appellant’s Br. 46. We reject this argument
on its merits insofar as it challenges the Board’s
final decision.

Footnote 1 of the Duke case:

We note that Duke has not raised an enablement
challenge to van Bree and that, in any event, proof of
efficacy or an actual reduction to practice using CHO cell
cultures is not required for a reference to be an anticipation
of the challenged method of treatment claims. In re
Gleave, 560 F.3d at 1334; Rasmusson v. SmithKline
Beecham Corp., 413 F.3d 1318, 1326 (Fed. Cir. 2005)
(explaining “proof of efficacy is not required in order for a
reference to be enabled for purposes of anticipation”).


Post a Comment

<< Home