Cross-appeal by Hospira clobbers The Medicines Company on bivalirudin/Angiomax ®
The Medicines Company appeals the U.S. District
Court for the District of Delaware’s claim construction
and non-infringement findings. Hospira, Inc. cross-
appeals the district court’s determination that the assert-
ed claims are not invalid under the on-sale bar, obvious-
ness, or indefiniteness.
We conclude that the district court clearly
erred in finding that the bivalirudin batches
prepared by Ben Venue Laboratories before the critical
date were not sold to The Medicines Company and
were prepared primarily
for an experimental purpose. Accord-
ingly, we reverse the district court’s
tion and hold the asserted claims invalid under the on-
As to standards of review:
On appeal from a bench trial, we review a district
court’s legal determinations de novo and factual findings
for clear error. Braintree Labs., Inc. v. Novel Labs., Inc.,
749 F.3d 1349, 1358 (Fed. Cir. 2014).
Of the on-sale bar:
As we have explained, “the intent of
[invalidating claims under the on-sale bar] is to preclude
attempts by the inventor or his assignee to profit from
commercial use of an invention for more than a year
before an application for patent is filed.”
D.L. Auld Co. v. Chroma Graphics Corp., 714 F.2d 1144,
1147 (Fed. Cir. 1983).
To ensure the
doctrine is not easily circumvented,
we have found the on-sale bar to apply
where the evidence clearly demonstrated that the inventor commercially
exploited the invention
before the critical date,
even if the inventor
did not transfer title to
the commercial embodi-
ment of the invention.
We find no principled distinction between
mercial sale of products prepared by
the patented method at issue
in D.L. Auld Co. and
the commercial sale of services
that result in the patented product-by-
The Medicines Company paid Ben Venue for per-
that resulted in the patented product - by-process,
and thus a “sale” of services occurred.
cial Devices, Inc. v. OEA, Inc.
, 270 F.3d 1353, 1355 (Fed. Cir. 2001)
(“A ‘sale’ under th[e on-sale bar] occurs when
the parties offer or agree to reach‘
a contract. ..
to give and pass rights of property for consideration which the
buyer pays or promises to pay the seller for the thing
bought or sold.’”
(quoting Zacharin v. United States , 213
F.3d 1366, 1370 (Fed. Cir. 2000))).
Of inherency issues:
Moreover, “[i]f a product that is offered for sale inher-
ently possesses each of the limitations of the claims, then
the invention is on sale, whether or not the parties to the
transaction recognize that the product possesses the
Abbott Labs. v. Geneva Pharm.,
182 F.3d 1315, 1319 (Fed. Cir. 1999).
There is no dispute that the batches had the levels of Asp9-
quired by the claims.
is irrelevant whether The Medicines Company
knew that the process limitations of
the asserted claims reliably and consistently produced
levels of Asp9-bivalirudin below 0.6%.
Of experimental use:
However, we have held that where an invention is on
sale, conception is not required to establish reduction to practice.”
Scaltech, Inc. v. Retec/Tetra, LLC, 269 F.3d
1321, 1331 (Fed. Cir. 2001) (citation omitted).
In other words, “[t]he sale of the [invention] in question obviates
any need for inquiry into conception.”
Abbott Labs., 182 F.3d at 1318–19.
To be sure, Abbott and Scaltech did not
involve experimental use, and the experimental use
defense may be available even if the invention had been
reduced to practice if the inventor was unaware that the
invention had been reduced to practice (i.e.,
worked for its intended purpose) and continued to experiment.
See New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290,
1297 (Fed. Cir. 2002) (“‘When an evaluation period is
reasonably needed to determine if the invention will serve
its intended purpose, the § 102(b) bar does not start to
accrue while such determination is being made.’
Once an inventor realizes that the invention as later
claimed works for its intended purpose, further ‘experi-
mentation’ may constitute a barring public use.”
(quoting Seal-Flex, Inc. v. Athletic Track & Court Constr., 98 F.3d
1318, 1324 (Fed. Cir. 1996))).