from the United States District Court for the District of
Delaware in No. 09-CV-750-RGA, Richard G. Andrews, Judge.
Haug, Haug Partners LLP, New York, NY, argued for
plaintiff-appellant. Also represented by Porter F. Fleming,
Angus Chen, Jason Ari Kanter, Laura Krawczyk, Catalin
Sebastian Zonte, Damon Marcus Lewis.
Bradford Peter Lyerla, Jenner & Block LLP, Chicago, IL,
argued for defendant-cross-appellant. Also represented by
Aaron A. Barlow, Sara Tonnies Horton.
Dyk, Wallach, and Hughes, Circuit Judges.
HUGHES, CIRCUIT JUDGE.
Medicines Company appeals findings of no infringement made by
the United States District Court for the District of
Delaware. Hospira cross-appeals the district court's
finding that a distribution agreement did not constitute an
invalidating "offer for sale" under 35 U.S.C.
§ 102(b). We affirm the district court's
noninfringement findings and remand the case for the district
court to determine whether the on-sale bar applies.
Medicines Company owns U.S. Patent Nos. 7, 582, 727 and 7,
598, 343. Both patent applications were filed on July 27,
2008. The patents cover an improved process for manufacturing
a drug product of bivalirudin, a synthetic peptide used as an
anti-coagulant. For almost twenty years, The Medicines
Company has marketed its bivalirudin product under the brand
name Angiomax. Sales of Angiomax represent over 90% of The
Medicines Company's revenues. J.A. 16050 at 70:15-22.
Medicines Company's original manufacturing process
occasionally produced batches of Angiomax with unacceptably
high levels of the impurity Asp9-bivalirudin. To solve this
problem, The Medicines Company developed a new mixing method,
which it incorporated in the master batch record on October
25, 2006. The Medicines Company's contract manufacturer,
Ben Venue Laboratories, used this patented mixing method for
all Angiomax batches manufactured since October 31, 2006. By
using this process, Ben Venue consistently manufactures
Angiomax batches with a maximum Asp9-bivalirudin impurity
level of 0.6%. The overriding majority of Angiomax batches
produced using The Medicines Company's original
manufacturing method had impurity levels below 0.6%.
February 27, 2007, The Medicines Company entered into a
Distribution Agreement with Integrated Commercialization
Solutions, Inc. (ICS). That agreement stated that The
Medicines Company "now desire[d] to sell the
Product" to ICS and ICS "desire[d] to purchase and
distribute the Product." J.A. 14674. Accordingly, title
passed to ICS "upon receipt of Product at the
distribution center." J.A. 14678 ¶ 4.1. The
Distribution Agreement forbade The Medicines Company from
selling Angiomax to any other party in the United States for
the three-year duration of the contract. Notably, ICS had
been providing distribution for The Medicines Company since
September 2002, but ICS did not take title to the product
under the previous distribution agreement.
Distribution Agreement included a "Commercial Price
List" dictating the price of the product, J.A. 14697,
and required ICS to place weekly orders "for such
quantities of Product as are necessary to maintain an
appropriate level of inventory based on customers'
historical purchase volumes." J.A. 14676 ¶ 3.1. The
Medicines Company agreed to "use its commercially
reasonable efforts" to fill ICS's product orders
within two days of order receipt. J.A. 14678 ¶ 4.2.
ICS's orders were deemed accepted unless The Medicines
Company rejected the order within two business days. ICS
first received batches of Angiomax produced by the improved
process in August 2007.
to market a generic version of Angiomax, Hospira submitted an
Abbreviated New Drug Application to the Food and Drug
Administration. In Hospira's mixing process, the
pH-adjusting solution is added to the bivalirudin solution in
three equivalent portions. The first two portions are
"added rapidly with about 2-minute mixing time, "
and the third portion is "added gradually over a period
of approximately 10 minutes." J.A. 13958. Hospira mixes
the batches using a paddle mixer at 560 rpm.
Medicines Company filed suit in the District of Delaware
alleging infringement of the '727 and '343 patents
under 35 U.S.C. § 271(e)(2). In response, Hospira
asserted that the patents are invalid. After a bench trial,
the district court concluded that the patents were neither
infringed nor invalid. The district court found that the
invention was ready for patenting but was not sold or offered
for sale before the critical date of July 27, 2008. The court
concluded that the Distribution Agreement was only an
agreement for ICS to be the U.S. distributor of Angiomax and
was not an offer to sell Angiomax. Based on the holding that
"there was no offer to sell, " the court did not
reach "whether the Distribution Agreement concerned
Angiomax made by the new method as opposed to Angiomax made
by the original method." J.A. 26 n.14.
parties appealed. This case is on remand from Medicines
Co. v. Hospira, Inc. (Medicines I), 827 F.3d
1363 (Fed. Cir. 2016) (en banc). We have ...