J&J loses at CAFC for lack of written description

In summary:

Johnson & Johnson, Inc. (J&J), Cordis Corp. (Cordis)
and Wyeth (collectively, Appellants) appeal the decision of
the United States District Court for the District of Dela-
ware granting summary judgment that certain claims of
U.S. Patent Nos. 7,217,286 (the ’7286 patent), 7,223,286
(the ’3286 patent), 7,229,473 (the ’473 patent), and
7,300,662 (the ’662 patent) (collectively, the patents-in-
suit) are invalid for failure to comply with
35 U.S.C. § 112, ¶ 1. Boston Scientific Corp. v. Johnson &
Johnson, Inc., 679 F. Supp. 2d 539 (D. Del. 2010). The
district court determined that the asserted claims of the
’7286 patent, the ’3286 patent, and the ’473 patent (collec-
tively, the 1997 patents) are invalid for lack of adequate
written description and lack of enablement, and that the
asserted claims of the ’662 patent are invalid for lack of
adequate written description. Because no finder of fact
could reasonably determine that the asserted claims of
the patents-in-suit contained an adequate written de-
scription, we affirm.

At district court:

The district court also determined that the specifica-
tion fails to disclose any formulae or structures of any
specific analog or provide any “definitions, examples, or
experimental models . . . for determining whether a
compound is a structurally similar analog as contem-
plated by the patentees.” Boston Scientific Corp., 679 F.
Supp. 2d at 554. The district court acknowledged that at
the time of filing, a small number of macrocyclic lactone
analogs of rapamycin were known. Id. However, the
district court, without finding a specific quantity, noted
that there is “a general agreement among the parties that
there are numerous potential analogs of rapamycin.” Id.
at n.23.

AND

The district court noted that the inventors testified
they did not work with or test any analogs of rapamycin
prior to filing, and “no evidence contradicts the inventors’
deposition testimony or otherwise indicates that the
inventors had possession of the full scope of the invention
as claimed.” Id. The court concluded that “[l]ogically, the
inventors could not have described a knowledge that they
did not possess.” Id.

The CAFC discussed the requirements of written
description:

Section 112, paragraph 1, requires that the specifica-
tion contain a written description of the invention.
35 U.S.C. § 112, ¶ 1. “[T]he hallmark of written descrip-
tion is disclosure.” Ariad Pharm., Inc. v. Eli Lilly & Co.,
598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). A specifi-
cation adequately describes an invention when it “rea-
sonably conveys to those skilled in the art that the
inventor had possession of the claimed subject matter as
of the filing date.” Id. at 1351. “A ‘mere wish or plan’ for
obtaining the claimed invention is not adequate written
description.” Centocor Ortho Biotech, Inc. v. Abbott Labs,
636 F.3d 1341, 1348 (Fed. Cir. 2011).

Of Appellants' argument:

Instead, Appellants argue that the
specification combined with the knowledge of one skilled
in the art “provided a template for those of ordinary skill
to use for identifying analogs falling within the scope of
the claims.” Appellants’ Br. 45-46. Appellants, relying
upon In re Herschler, 591 F.2d 693, 702 (CCPA 1979) and
In re Fuetterer, 319 F.2d 259 (CCPA 1963),4 argue that
when claiming a combination of known elements, as
opposed to a novel compound, the specification “need not
list examples” nor is any “comprehensive description”
required. Appellants’ Br. 32-34. Appellants argue that
the claimed macrocyclic lactone analogs were sufficiently
well known such that “the written description need be
‘only so specific as to lead one having ordinary skill in the
art to that class of compounds.’” Id. at 34 (quoting
Herschler).

The CAFC did NOT accept the argument:

We agree with BSC that no reasonable jury could con-
clude that there is sufficient written description support
for the asserted claims of the 1997 patents. “A written
description of an invention involving a chemical genus,
like a description of a chemical species, ‘requires a precise
definition, such as by structure, formula, [or] chemical
name,’ of the claimed subject matter sufficient to distin-
guish it from other materials.” Eli Lilly, 199 F.3d at 1568
(quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir.
1993)).
We have “held that a sufficient description of a genus
requires the disclosure of either a representative number
of species falling within the scope of the genus or struc-
tural features common to the members of the genus so
that one of skill in the art can ‘visualize or recognize’ the
members of the genus.” Ariad, 598 F.3d at 1350. Because
each individual invention “has a novel relationship with
the state of the art from which it emerges” we have de-
clined to “set out any bright-line rules governing, for
example, the number of species that must be disclosed to
describe a genus claim . . . .” Id. at 1351. The appropriate
number of species that one must disclose when claiming a
genus “necessarily changes with each invention, and it
changes with progress in a field.” Id.

Of examples:

Although examples are not always required to satisfy
the written description requirement, the lack of any
disclosure of examples may be considered when determin-
ing whether the claimed invention is adequately de-
scribed.

AND

It is true that some species of this vast genus were
known in the art. For example, both the Cottens publica-
tion and the Skotnicki patent disclosed specific species of
the claimed genus of macrocyclic lactone analogs. Any
suggestion that these references represented existing
knowledge in the art so well known as to excuse including
a more detailed disclosure of the macrocyclic lactone
analogs genus in the specification is belied by the state of
the art at the time of the invention. Cf. Ariad, 598 F.3d
at 1354-55 (inventor has obligation to disclose molecules
when the art is unpredictable and existing knowledge
scant).
At the effective filing date, very little knowledge ex-
isted regarding the use of drug-eluting stents to inhibit
restenosis.

Carnegie Mellon was cited:

This case, in many respects, parallels our decision in
Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541
F.3d. 1115, 1126 (Fed. Cir. 2008). In Carnegie Mellon, the
court held that our case law regarding generic claims is
applicable to both inventions claiming novel genera of
chemical and biological compounds as well as inventions
claiming combinations of prior art compounds with other
elements. 541 F.3d at 1124. In Carnegie Mellon, the
patentee argued that our holding in “Eli Lilly is distin-
guishable from the present case because the invention in
Eli Lilly was tied to a specific cDNA sequence, whereas
the invention here involves a combination of well known
elements that create a generic biotechnological tool.” Id.
at 1122-23. The patentee argued that species of the
claimed genus “were well known in the art” and that the
district court in granting summary judgment of no writ-
ten description “failed to draw inferences in [the pat-
entee’s] favor.” Id. at 1123. We rejected these arguments
in Carnegie Mellon and likewise find them unavailing
here.

AND

We conclude that in this case, like Carnegie Mellon,
summary judgment was appropriately granted. In Car-
negie Mellon, the court noted that only three bacterial
genes out of thousands of species had been cloned, and
only one was disclosed in the specification.

Aro was cited:

Aro
Mfg. Co. v. Convertible Top Replacement Co., 365 U.S.
336, 345 (1961) (“[T]here is no legally recognizable or
protected ‘essential’ element, ‘gist’ or ‘heart’ of the inven-
tion in a combination patent.”).

Of functional claim language:

Although it is true that functional claim language can
meet the written description requirement when there is
an established correlation between structure and func-
tion, Appellants fail to establish any such correlation.
See, e.g., Univ. of Rochester, 358 F.3d at 925 (explaining
that “functional descriptions of genetic material can, in
some cases, meet the written description requirement if
the functional characteristics are coupled with a known or
disclosed correlation between function and structure”)
(citations and internal quotations omitted).

Of shooting oneself in the foot:

Here, the specification of the 1997 patents
itself refutes any conclusion that “the structural elements
of rapamycin and its mechanism of action and biological
activity was known.” See Univ. of Rochester, 358 F.3d at
930 (“Although section 282 places the burden of proof on
the party seeking to invalidate a patent, it does not fore-
close the possibility of that party demonstrating that the
patent in suit proves its own invalidity.”).

Of sub-genus claiming:

We held
that in the absence of blaze marks “as to what compounds
other than those disclosed as preferred, might be of spe-
cial interest . . . simply describing a large genus of com-
pounds is not sufficient to satisfy the written description
requirement as to particular species or sub-genuses.” Id.
at 1570-71.

[citing Fujikawa v. Wattanasin, 93 F.3d 1559, 1570 (Fed.
Cir. 1996)]


***link to J&J case:
http://www.cafc.uscourts.gov/images/stories/opinions-orders/10-1230.pdf