BILLUPS-ROTHENBERG loses at CAFC over written description, anticipation

In the BILLUPS-ROTHENBERG, INC. case,
a summary judgment of invalidity based on lack
of written description and anticipation was affirmed by the
CAFC. At issue as a genetic test for Type I hereditary hemochro-
matosis.

**Ariad was cited to give background to the written
description requirement:

Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1351 (Fed. Cir. 2010) (en banc) (internal quotations
omitted). “Requiring a written description of the inven-
tion limits patent protection to those who actually per-
form the difficult work of ‘invention’—that is, conceive of
and complete the final invention.” Id.

**The written description requirement keeps a patent
applicant from preempting the future:

The written de-
scription requirement exists to ensure that inventors do
not “attempt to preempt the future before it has arrived.”
Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993). In
Fiers, a party’s priority application failed to provide an
adequate written description as it purported to cover all
DNAs coding for a specific protein but did not describe the
DNA. The party only provided a generic reference that
the DNA could be obtained by reverse transcription and
this court held that “[c]laiming all DNA’s that achieve a
result without defining what means will do so is not in
compliance with the description requirement.” Id.


**University of California v. Lilly arises:


The “level of detail required to satisfy the written de-
scription requirement varies depending on the nature and
scope of the claims and on the complexity and predictabil-
ity of the relevant technology.” Ariad, 598 F.3d at 1351
(citing Capon v. Eshhar, 418 F.3d 1349, 1357-58 (Fed. Cir.
2005)). “[A]n adequate description of a DNA requires
more than a mere statement that it is part of the inven-
tion and reference to a potential method for isolating it;
what is required is a description of the DNA itself.”
Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d
1559, 1566-67 (Fed. Cir. 1997) (internal quotations omit-
ted). Complementary DNA (“cDNA”) is a form of DNA
that only contains exons, stretches of DNA that code for
genes. In Regents, a claim to a cDNA invention was held
invalid as lacking written description because such a
claim “requires a specificity usually achieved by means of
the recitation of the sequence of nucleotides that make up
the cDNA.” Id. at 1569.

**Later-acquired knowledge not helpful:

Given the lack of knowledge of
sequences for the hemochromatosis gene and its muta-
tions in the field, the limited extent and content of the
prior art, and the immaturity and unpredictability of the
science when the ’681 patent was filed, Billups cannot
satisfy the written description requirement merely
through references to later-acquired knowledge. This
case is like Regents and Fiers, in which the DNA se-
quences at issue were unknown in the art. Regents, 119
F.3d at 1567-69; Fiers, 984 F.2d at 1171.


**One species is not enough to support a genus:

Under Ariad, a patent
must set forth “either a representative number of species
falling within the scope of the genus or structural features
common to the members of the genus.” Id. at 1350. The
’681 patent does not identify even a single species that
satisfies the claims. In this case, the eventual discovery
of only one species—the C282Y mutation—within the
claimed genus does not constitute adequate written
description of that genus.


**Failure to disclose structure/function relation:

The district court, however, found that the art did not
establish a correlation between structure and function
because the “[p]atentee’s general location disclosure is too
imprecise to constitute structural features necessary to
meet the written description requirement.” Summ. J.
Order 6-9. As explained in the district court’s order, the
“specification for the ’681 patent contains only functional,
not structural, characteristics of the predicted mutations.”

***As to anticipation:

A patent claim is anticipated if each and every limita-
tion is found either expressly or inherently in a single
prior art reference. 35 U.S.C. § 102. The asserted claims
of the ’425 patent are invalid because they are anticipated
by the ’130 patent. The ’130 patent was filed nearly three
years be§ 102(e).

Celeritas came up:

Although the ’130 patent discounts the utility of the
S65C mutation in diagnosing hemochromatosis, we have
held that a “reference is no less anticipatory if, after
disclosing the invention, the reference then disparages it.”
Celeritas Techs., Ltd. v. Rockwell Int’l Corp., 150 F.3d
1354, 1361 (Fed. Cir. 1998). Indeed, in Celeritas, this
court explained that “whether a reference ‘teaches away’
from the invention is inapplicable to an anticipation
analysis.” Id. (quoting Kalman v. Kimberly-Clark Corp.,
713 F.2d 760, 772 (Fed. Cir. 1983)). In Celeritas, this
court considered prior art stating that “de-emphasis
would cause severe inter-symbol interference in a single-
carrier data signal; it may be feasible only for multicarrier
signals.” Id. (emphasis added). This court held that the
disclosure was sufficient to anticipate and invalidate the
claims of the asserted patent, as “[t]he fact that a modem
with a single carrier data signal is shown to be less than
optimal does not vitiate the fact that it is disclosed. The
modem in the article is not disclosed to be inoperative.”
ld.

Oral argument is cited:

At oral argument, Billups conceded that it waived its
argument that the ’130 patent cannot be used to antici-
pate because the relevant teachings were not enabled.
Oral Arg. at 25:23-25:50; 29:23-29:56, available at
http://www.cafc.uscourts.gov/oral-argument-
recordings/all/billups.html. Even if this argument had
not been waived, the district court presumes the enable-
ment of the material in a prior art patent, and Billups
failed to present evidence of nonenablement that the
district court found persuasive.