Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc.

• Decision Date: 01 May 2017
• Docket Number: 2016-1284, 2016-1787
• Citation: 855 F.3d 1356
• Parties: HELSINN HEALTHCARE S.A., Plaintiff–Appellee v. TEVA PHARMACEUTICALS USA, INC., Teva Pharmaceutical Industries, Ltd., Defendants–Appellants
• Court: U.S. Court of Appeals — Federal Circuit

855 F.3d 1356

HELSINN HEALTHCARE S.A., Plaintiff–Appellee

v.TEVA PHARMACEUTICALS USA, INC., Teva Pharmaceutical Industries, Ltd., Defendants–Appellants

2016-1284, 2016-1787

United States Court of Appeals, Federal Circuit.

Decided: May 1, 2017

Joseph 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.

George 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, Alexandria, VA.

Mark A. Lemley, Durie Tangri LLP, San Francisco, CA, for amicus curiae 42 Intellectual Property Professors. Also represented by Robert P. Merges, Davis, CA.

Ron D. Katznelson, Encinitas, CA, amicus curiae.

Robert Allen Armitage, Marco Island, FL, for amicus curiae Congressman Lamar Smith.

Andrew Baluch, Strain PLLC, Washington, DC, for amicus curiae The Naples Roundtable, Inc. Also represented by Larry L. Shatzer.

Lynn 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.

Jamie 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 Saunders.

Before Dyk, Mayer, and O'Malley, Circuit Judges.

Dyk, Circuit Judge.

Helsinn 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").

Helsinn 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.

We 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.

Background

Helsinn 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 chemotherapy

treatment.

The use 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 invalidating.¹

Helsinn 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.

2. A pharmaceutically stable solution for reducing emesis or reducing the likelihood of emesis comprising:

a) 0.05 mg/mL palonosetron

hydrochloride, 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 80 mg/ml

'725 patent, col. 10 ll. 11–19.

Claim 1 is representative of the asserted claims of the '219 patent.

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 mannitol,

wherein said formulation is stable at 24 months when stored at room temperature.

'219 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 dose.

In 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.

On 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 Purchase Agreement].

Under 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.

Under 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").

The 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...