CAFC affirms PTAB in Storer v. Clark

The CAFC affirmed the Board in the Storer case:


We conclude that substantial evidence supports the
Board’s finding that “a high amount of experimentation is
necessary to synthesize” the target compound. The record
before the Board showed sufficient variability and unpredictability
to support the Board’s conclusion that Storer’s
provisional application did not enable the interference
subject matter. The Board’s decision is affirmed.



The opinion, written by Judge Newman, involved a patent interference
in the pharma area:


This patent interference contest involves methods of
treating hepatitis C by administering compounds having
a specific chemical and stereochemical structure



Of note:


To establish priority, Storer relied on the disclosure in
the provisional specification from which priority was
claimed for conception and constructive reduction to
practice. In its joint decision on Clark’s motion to deny
Storer the benefit of the provisional application and on
Clark’s motion to invalidate Storer’s claims on the
grounds of lack of enablement and written description,1
the Patent Trial and Appeal Board (PTAB or “Board”)
held that Storer’s provisional application was not enabling
for the count of the interference, and on that ground
the PTAB entered judgment granting priority to Clark.2
Storer appeals that judgment and the underlying decision
on Clark’s motions.

We take note that Storer initially filed in the District
of Delaware, seeking review of the Board’s decision under
35 U.S.C. § 146. The district court dismissed the case,
Idenix Pharmaceuticals. LLC v. Gilead Pharmasset LLC,
2016 WL 6804915, at *1 (D. Del. Nov. 16, 2016), based on
this court’s ruling in Biogen MA, Inc. v. Japanese Foundation
for Cancer Research, 785 F.3d 648 (Fed. Cir. 2015),
that the America Invents Act eliminated the option of
district court review under Section 146 for interferences
declared after September 15, 2012. Although Storer says
that Biogen was incorrectly decided, that decision is
binding on this panel.




Of undue experimentation:


The Board agreed with Clark’s position, and held that
the S1 provisional’s description of the 2´-keto precursor, in
combination with the Matsuda reference, was insufficient
to enable and thereby to establish possession of the
2´F(down) methyl(up) compound of claim 1 before Clark’s
priority date. The Board stated, correctly, that for new
chemical compounds the specification must provide sufficient
guidance that undue experimentation is not required
to obtain the new compounds.

(...)

The boundary between a teaching sufficient to enable
a person of ordinary skill in the field, and the need for
undue experimentation, varies with the complexity of the
science. Knowledge of the prior art is presumed, as well
as skill in the field of the invention. The specification
need not recite textbook science, but it must be more than
an invitation for further research. Genentech, Inc. v. Novo
Nordisk A/S, 108 F.3d 1361, 1366 (Fed. Cir. 1997).
In Genentech the patentee argued that the prior art
taught a method that could be used to produce a claimed
human growth hormone product, compensating for lack of
detail in the specification. The patentee argued that it
did not need to include information in the prior art. This
court agreed, but stressed the need to assure enablement
of the novel aspects of the invention:
It is true . . . that a specification need not disclose
what is well known in the art. See, e.g., Hybritech
Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367,
1385 (Fed. Cir. 1986). However, . . . . [i]t is the
specification, not the knowledge of one skilled in
the art, that must supply the novel aspects of an
invention in order to constitute adequate enablement.
Genentech, 108 F.3d at 1366.
The Storer provisional specification does not describe
synthesis of the 2´F(down) target compounds.

(...)

On review, we conclude that substantial evidence
supports the Board’s findings that the synthetic schemes
in Storer’s provisional application do not teach or suggest
conversion of any precursor into the 2´F(down) structure,
and that the Matsuda synthesis of a corresponding 2´-
methyl (down), 2´-hydroxyl (up) structure does not enable
a person of ordinary skill to produce the target compounds
without undue experimentation.
Wands factor 7, the predictability or unpredictability
of the art, appears to be particularly relevant. Although
Storer states that this is predictable chemistry, and
therefore that detailed specific examples are not necessary,
the Board’s findings are in accord with the record.