from the United States District Court for the District of New
Jersey in Nos. 3:11-cv-03962-MLC-DEA, 3:11-cv-05579-MLC-DEA,
3:13-cv-05815-MLC-DEA, Judge Mary L. Cooper.
M. O'Malley, Jr., Paul Hastings LLP, New York, NY, argued
for plaintiff-appellee. Also represented by Isaac S.
Ashkenazi, Eric William Dittmann, Young Jin Park; Stephen
Blake Kinnaird, Anand Bipin Patel, Washington, DC; Charles M.
Lizza, Saul Ewing LLP, Newark, NJ.
C. Lombardi, Winston & Strawn LLP, Chicago, IL, argued
for defendants-appellants. Also represented by Tyler
Johannes, Julia Mano Johnson; Steffen Nathanael Johnson,
Andrew Curtis Nichols, Jovial Wong, Washington, DC; Karl
Leonard, The Exoneration Project, Chicago, IL.
William Ernest Havemann, Appellate Staff, Civil Division,
United States Department of Justice, Washington, DC, argued
for amicus curiae United States. Also represented by Mark R.
Freeman, Benjamin C. Mizer; Thomas W. Krause, Scott
Weidenfeller, Joseph Matal, Joseph Gerard Piccolo, Office of
the Solicitor, United States Patent and Trademark Office,
A. Lemley, Durie Tangri LLP, San Francisco, CA, for amicus
curiae 42 Intellectual Property Professors. Also represented
by Robert P. Merges, Davis, CA.
Katznelson, Encinitas, CA, amicus curiae. Robert Allen
Armitage, Marco Island, FL, for ami-cus curiae Congressman
Baluch, Strain PLLC, Washington, DC, for amicus curiae The
Naples Roundtable, Inc. Also represented by Larry L. Shatzer.
Campbell Tyler, Barnes & Thornburg LLP, Indianapolis, IN,
for amicus curiae American Intellectual Property Law
Association. Also represented by Mark L. Whitaker, Morrison
& Foerster LLP, Washington, DC.
Wisz, Wilmer Cutler Pickering Hale and Dorr LLP, Washington,
DC, for amici curiae Pharmaceutical Research and
Manufacturers of America, Biotechnology Innovation
Organization. Also represented by Robert Manhas, Thomas
Dyk, Mayer, and O'Malley, Circuit Judges.
Healthcare S.A. ("Helsinn") is the owner of the
four patents-in-suit directed to intravenous formulations of
palonosetron for reducing or reducing the likelihood of
chemotherapy-induced nausea and vomiting ("CINV").
brought suit against Teva Pharmaceuticals USA, Inc. and Teva
Pharmaceutical Industries, Ltd. (collectively,
"Teva") alleging that the filing of Teva's
Abbreviated New Drug Application ("ANDA")
constituted an infringement of various claims of those
patents. Teva defended, inter alia, on the ground
that the asserted claims were invalid under the on-sale bar
provision of 35 U.S.C. § 102. The district court found
that the patents-in-suit were not invalid. With respect to
three of the patents, which are governed by the
pre-Leahy-Smith America Invents Act ("pre-AIA")
version of § 102, the district court concluded that
there was a commercial offer for sale before the critical
date, but that the invention was not ready for patenting
before the critical date. With respect to the fourth patent,
which is governed by the AIA version of § 102, Pub. L.
No. 112-29, § 3(b), 125 Stat. 284, 285-86 (2011), the
district court concluded that there was no commercial offer
for sale because the AIA changed the relevant standard and
that, in any event, the invention was not ready for patenting
before the critical date.
reverse. The asserted claims of the patents-in-suit were
subject to an invalidating contract for sale prior to the
critical date of January 30, 2002, and the AIA did not change
the statutory meaning of "on sale" in the
circumstances involved here. The asserted claims were also
ready for patenting prior to the critical date.
owns four patents, U.S. Patent Nos. 7, 947, 724
("'724 patent"), 7, 947, 725 ("'725
patent"), 7, 960, 424 ("'424 patent"), and
8, 598, 219 ("'219 patent") (collectively,
"the patents-in-suit"), directed to reducing the
likelihood of CINV. CINV is a serious side effect of
of palonosetron to treat CINV was not new. Indeed, U.S.
Patent No. 5, 202, 333 ("'333 patent") taught
that an intravenous formulation of palonosetron is
"useful in the prevention and treatment of emesis,
" '333 patent, col. 9 ll. 56-57, including
"emesis induced by . . . treatment for cancer with . . .
chemotherapy, " id. col. 10 ll. 7-9. The
'333 patent is now expired. The patents-in-suit purport
to disclose novel intravenous formulations using unexpectedly
low concentrations of palonosetron that were not taught by
the prior art. All four of the patents-in-suit claim priority
to a provisional patent application filed on January 30,
2003. The critical date for the on-sale bar is one year
earlier, January 30, 2002. The significance of the critical
date is that a sale of the invention before that date can be
alleged infringement of claims 2 and 9 of the '724
patent, claim 2 of the '725 patent, claim 6 of the
'424 patent, and claims 1, 2, and 6 of the '219
patent (collectively, "the asserted claims"). Claim
2 of the '725 patent is representative of the asserted
claims of the '724, '725, and '424 patents.
pharmaceutically stable solution for reducing emesis or
reducing the likelihood of emesis comprising:
a) 0.05 mg/mL palonosetron hydrochlo-ride, based on the
weight of the free base, in a sterile injectable aqueous
carrier at a pH of from 4.5 to 5.5;
b) from 0.005 mg/mL to 1.0 mg/mL EDTA; and
c) mannitol in an amount sufficient to tonicify said
solution, in a concentration of from about 10 mg/ml to about
'725 patent, col. 10 ll. 11-19.
is representative of the asserted claims of the '219
1. A pharmaceutical single-use, unit-dose formulation for
intravenous administration to a human to reduce the
likelihood of cancer chemotherapy-induced nausea and
vomiting, comprising a 5 mL sterile aqueous isotonic
solution, said solution comprising:
palonosetron hydrochloride in an amount of 0.25 mg based on
the weight of its free base;
from 0.005 mg/mL to 1.0 mg/mL EDTA; and
from 10 mg/mL to about 80 mg/mL manni-tol,
wherein said formulation is stable at 24 months when stored
at room temperature.
patent, col. 10 ll. 2-12. The claims of the patents-in-suit
to some extent all express the same concepts in different
terms. For instance, the '724, '725, and '424
patents claim a 0.05 mg/ml concentration of palonosetron,
which equates to a total dose of 0.25 mg when administered in
a 5 ml solution. The '219 patent expressly claims a fixed
dose of 0.25 mg of palonosetron in a 5 ml solution. It is
undisputed that each asserted claim covers the 0.25 mg dose
of palonosetron. In order to simplify the relevant
discussion, we refer to the patents as covering the 0.25 mg
1998, Helsinn acquired a license under the '333 patent
from Roche Palo Alto LLC ("Roche") to palonosetron
and all intellectual property resulting from ongoing
palonosetron research. Roche and its predecessor, Syntex
(U.S.A.) Inc. ("Syntex"), had already conducted
Phase I and Phase II clinical trials. A Phase II trial-Study
2330-found that the 0.25 mg dose "was effective in
suppressing chemotherapy-induced emesis for 24 hours."
J.A. 32, 1636. Helsinn then submitted safety and efficacy
protocols for Phase III clinical trials to FDA in early 2000,
proposing to study two dosages-0.25 mg and 0.75 mg. By early
2001 the Phase III trials were ongoing but not yet completed.
April 6, 2001, almost two years before applying for a patent,
Helsinn and MGI Pharma, Inc. ("MGI"), an
oncology-focused pharmaceutical company that markets and
distributes in the United States, entered into two
agreements: (1) a License Agreement and (2) a Supply and
Purchase Agreement. These agreements were announced in a
joint press release of the two corporations and in MGI's
Form 8-K filing with the Securities and Exchange Commission
("SEC"), which included partially-redacted copies
of both agreements. See MGI Pharma Inc., Current
Report (Form 8-K) Ex. 99.1 (Apr. 25, 2001) [hereinafter
License Agreement]; MGI Pharma Inc., Current Report (Form
8-K) Ex. 99.2 (Apr. 25, 2001) [hereinafter Supply and
the terms of the License Agreement, MGI agreed to pay $11
million in initial payments to Helsinn, plus additional
future royalties on distribution of "products" in
the United States. The parties agree that the
"products" covered by the License Agreement were
0.25 mg and 0.75 mg doses of palonosetron.
the Supply and Purchase Agreement, MGI agreed to purchase
exclusively from Helsinn, and Helsinn agreed to supply
MGI's requirements of the 0.25 mg and 0.75 mg
palonosetron products, or whichever of the two dosages were
approved for sale by FDA. The agreement required MGI to
submit purchase forecasts to Helsinn and to place firm orders
at least 90 days before delivery. It also specified that such
orders would be "subject to written acceptance and
confirmation by [Helsinn] before becoming binding."
Supply and Purchase Agreement, supra, art. 4.2. But,
in the event that Helsinn were unable to meet MGI's firm
orders and to the extent they fell within the previously
forecasted amount, Helsinn would then be obligated to
designate a third party manufacturer to supply MGI with the
product. The agreement specified price (29% of the gross
sales price by MGI with a minimum of $28.50 per vial), method
of payment (wire transfer within 30 days of receipt of an
invoice), and method of delivery (DDU-which means delivery
duty unpaid). See Black's Law Dictionary 481,
521 (10th ed. 2014) (defining "DDU" and
"delivery duty unpaid").
License Agreement made reference to the ongoing clinical
trials and stated that in the event that the results were
unfavorable and FDA did not approve the sale of either dosage
of the product, Helsinn could terminate the agreement. If the
License Agreement were terminated, the Supply and Purchase
Agreement would "terminate automatically." Supply
and Purchase Agreement, supra, art. 11.1.
the above information about the transaction was publicly
disclosed with two exceptions. The two features of the
agreements that were not publicly disclosed were the price
terms and the specific dosage ...