Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc.
| Citation | 139 S.Ct. 628,202 L.Ed.2d 551 |
| Decision Date | 22 January 2019 |
| Docket Number | No. 17–1229.,17–1229. |
| Parties | HELSINN HEALTHCARE S.A., Petitioner v. TEVA PHARMACEUTICALS USA, INC., et al. |
| Court | United States Supreme Court |
139 S.Ct. 628
202 L.Ed.2d 551
HELSINN HEALTHCARE S.A., Petitioner
v.
TEVA PHARMACEUTICALS USA, INC., et al.
No. 17–1229.
Supreme Court of the United States
Argued Dec. 4, 2018.
Decided Jan. 22, 2019.
Kannon Shanmugam, Washington, DC, for Petitioner.
Malcolm L. Stewart, for the United States as amicus curiae, by special leave of the Court, supporting the petitioner.
William M. Jay, Washington, DC, for Respondents.
Joseph M. O'Malley, Jr., Eric W. Dittmann, Young J. Park, Isaac S. Ashkenazi, Paul Hastings LLP, New York, NY, Kannon K. Shanmugam, David M. Krinsky, Amy Mason Saharia, A. Joshua Podoll, Kathryn S. Kayali, Meng Jia Yang, Williams & Connolly LLP, Stephen B. Kinnaird, Anand B. Patel, Paul Hastings LLP, Washington, DC, Charles M. Lizza, Saul Ewing Arnstein, & Lehr LLP, Newark, NJ, for Petitioner.
Steffen N. Johnson, Andrew C. Nichols, Winston & Strawn LLP, William M. Jay, Stephen R. Shaw, Goodwin Procter LLP, Washington, DC, David J. Zimmer, Joshua J. Bone, Goodwin Procter LLP, Boston, MA, for Respondents.
Justice THOMAS delivered the opinion of the Court.
The Leahy–Smith America Invents Act (AIA) bars a person from receiving a patent on an invention that was "in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention." 35 U.S.C. § 102(a)(1). This case requires us to decide whether the sale of an invention to a third party who is contractually obligated to keep the invention confidential places the invention "on sale" within the meaning of § 102(a).
More than 20 years ago, this Court determined that an invention was "on sale" within the meaning of an earlier version of § 102(a) when it was "the subject of a commercial offer for sale" and "ready for patenting." Pfaff v. Wells Electronics, Inc ., 525 U.S. 55, 67, 119 S.Ct. 304, 142 L.Ed.2d 261 (1998). We did not further require that the sale make the details of the invention available to the public. In light of this earlier construction, we determine that the reenactment of the phrase "on sale" in the AIA did not alter this meaning. Accordingly, a commercial sale to a third party who is required to keep the invention confidential may place the invention "on sale" under the AIA.
I
Petitioner Helsinn Healthcare S.A. (Helsinn) is a Swiss pharmaceutical company that makes Aloxi, a drug that treats chemotherapy-induced nausea and vomiting.
Helsinn acquired the right to develop palonosetron, the active ingredient in Aloxi, in 1998. In early 2000, it submitted protocols for Phase III clinical trials to the Food and Drug Administration (FDA), proposing to study a 0.25 mg and a 0.75 mg dose of palonosetron. In September 2000, Helsinn announced that it was beginning Phase III clinical trials and was seeking marketing partners for its palonosetron product.
Helsinn found its marketing partner in MGI Pharma, Inc. (MGI), a Minnesota pharmaceutical company that markets and distributes drugs in the United States. Helsinn and MGI entered into two agreements: a license agreement and a supply and purchase agreement. The license agreement granted MGI the right to distribute, promote, market, and sell the 0.25 mg and 0.75 mg doses of palonosetron in the United States. In return, MGI agreed to make upfront payments to Helsinn and to pay future royalties on distribution of those doses. Under the supply and purchase agreement, MGI agreed to purchase exclusively from Helsinn any palonosetron product approved by the FDA. Helsinn in turn agreed to supply MGI however much of the approved doses it required. Both agreements included dosage information and required MGI to keep confidential any proprietary information received under the agreements.
Helsinn and MGI announced the agreements in a joint press release, and MGI also reported the agreements in its Form 8–K filing with the Securities and Exchange Commission. Although the 8–K filing included redacted copies of the agreements, neither the 8–K filing nor the press releases disclosed the specific dosage formulations covered by the agreements.
On January 30, 2003, nearly two years after Helsinn and MGI entered into the agreements, Helsinn filed a provisional patent application covering the 0.25 mg and 0.75 mg doses of palonosetron. Over the next 10 years, Helsinn filed four patent applications that claimed priority to the January 30, 2003, date of the provisional application. Helsinn filed its fourth patent application—the one relevant here—in May 2013, and it issued as U.S. Patent No. 8,598,219 ('219 patent). The '219 patent covers a fixed dose of 0.25 mg of palonosetron in a 5 ml solution. By virtue of its effective date, the '219 patent is governed by the AIA. See § 101(i).
Respondents Teva Pharmaceutical Industries, Ltd., and Teva Pharmaceuticals USA, Inc. (Teva), are, respectively, an Israeli company that manufactures generic drugs and its American affiliate. In 2011, Teva sought approval from the FDA to market a generic 0.25 mg palonosetron product. Helsinn then sued Teva for infringing its patents, including the '219 patent. In defense, Teva asserted that the '219 patent was invalid because the 0.25 mg dose was "on sale" more than one year before Helsinn filed the provisional patent application covering that dose in January 2003.
The AIA precludes a person from obtaining a patent on an invention that was "on sale" before the effective filing date of the patent application:
"A person shall be entitled to a patent unless ... the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention." 35 U.S.C. § 102(a)(1) (emphasis added).
See also § 102(b)(1) (exception for certain disclosures made within a year before the effective filing date). Disclosures described in § 102(a)(1) are often referred to as "prior art."
The patent statute in effect before the passage of the AIA included a similar proscription, known as the "on-sale bar":
"A person shall be entitled to a patent unless—...
"(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign
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