Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc., 586 U.S. ___ (2019)
Helsinn makes a treatment for chemotherapy-induced nausea using the chemical palonosetron. While developing that product, Helsinn granted another company the right to market a 0.25 mg dose of palonosetron in the United States; that company was required to keep proprietary information confidential. Nearly two years later, in 2003, Helsinn filed a provisional patent application covering a 0.25 mg dose of palonosetron. Helsinn filed four patent applications that claimed priority to the 2003 date. Helsinn’s fourth application, filed in 2013 (the 219 patent), is covered by the Leahy-Smith America Invents Act (AIA). In 2011, Teva sought approval to market a generic 0.25 mg palonosetron product. Helsinn sued for infringement. Teva countered that the 219 patent was invalid under the “on sale” provision of the AIA, which precludes a person from obtaining 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), arguing the 0.25 mg dose was “on sale” more than one year before Helsinn filed the 2003 application.
The Federal Circuit held, and the Supreme Court unanimously agreed, that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the agreements. A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under section 102(a). The patent statute in force immediately before the AIA included an on-sale bar. Supreme Court and Federal Circuit precedent interpreting that provision indicated that a sale or offer of sale need not make an invention available to the public to constitute invalidating prior art. The Court applied the presumption that when Congress reenacted the “on sale” language in the AIA, it adopted earlier judicial constructions.
Under the Leahy-Smith America Invents Act's "on sale" bar, a commercial sale to a third party who is required to keep the invention confidential can constitute invalidating prior art for subsequently-issued patents.
SUPREME COURT OF THE UNITED STATES
Syllabus
Helsinn Healthcare S. A. v. Teva Pharmaceuticals USA, Inc., et al.
certiorari to the united states court of appeals for the federal circuit
No. 17–1229. Argued December 4, 2018—Decided January 22, 2019
Petitioner Helsinn Healthcare S. A. makes a treatment for chemotherapy-induced nausea and vomiting using the chemical palonosetron. While Helsinn was developing its palonosetron product, it entered into two agreements with another company granting that company the right to distribute, promote, market, and sell a 0.25 mg dose of palonosetron in the United States. The agreements required that the company keep confidential any proprietary information received under the agreements. Nearly two years later, in January 2003, Helsinn filed a provisional patent application covering a 0.25 mg dose of palonosetron. Over the next 10 years, Helsinn filed four patent applications that claimed priority to the January 2003 date. Relevant here, Helsinn filed its fourth patent application in 2013. That patent (the ’219 patent) covers a fixed dose of 0.25 mg of palonosetron in a 5 ml solution and is covered by the Leahy-Smith America Invents Act (AIA).
In 2011, respondents Teva Pharmaceutical Industries, Ltd., and Teva Pharmaceuticals USA, Inc. (collectively Teva), sought approval to market a generic 0.25 mg palonosetron product. Helsinn sued Teva for infringing its patents, including the ’219 patent. Teva countered that the ’219 patent was invalid under the “on sale” provision of the AIA—which precludes a person from obtaining 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)—because the 0.25 mg dose was “on sale” more than one year before Helsinn filed the provisional patent application in 2003. The District Court held that the AIA’s “on sale” provision did not apply because the public disclosure of the agreements did not disclose the 0.25 mg dose. The Federal Circuit reversed, holding that the sale was publicly disclosed, regardless of whether the details of the invention were publicly disclosed in the terms of the sale agreements.
Held: A commercial sale to a third party who is required to keep the invention confidential may place the invention “on sale” under §102(a). The patent statute in force immediately before the AIA included an on-sale bar. This Court’s precedent interpreting that provision supports the view that a sale or offer of sale need not make an invention available to the public to constitute invalidating prior art. See, e.g., Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 67. The Federal Circuit had made explicit what was implicit in this Court’s pre-AIA precedent, holding that “secret sales” could invalidate a patent. Special Devices, Inc. v. OEA, Inc., 270 F.3d 1353, 1357. Given this settled pre-AIA precedent, the Court applies the presumption that when Congress reenacted the same “on sale” language in the AIA, it adopted the earlier judicial construction of that phrase. The addition of the catchall phrase “or otherwise available to the public” is not enough of a change for the Court to conclude that Congress intended to alter the meaning of “on sale.” Paroline v. United States, 572 U.S. 434, and Federal Maritime Comm’n v. Seatrain Lines, Inc., 411 U.S. 726, distinguished. Pp. 5–9.
855 F.3d 1356, affirmed.
Thomas, J., delivered the opinion for a unanimous Court.
Amicus brief of The Biotechnology Innovation Organization (BIO) submitted. |
Amicus brief of Houston Intellectual Property Law Association submitted. |
Amicus brief of The Naples Roundtable submitted. |
Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed. |
Amicus brief of Austin Intellectual Property Law Association submitted. |
Amicus brief of Bar Association of the District of Columbia submitted. |
Amicus brief of The Massachusetts Biotechnology Council submitted. |
Brief amicus curiae of United States of America filed. |
Amicus brief of Pharmaceutical Research and Manufacturers of America submitted. |
Amicus brief of American Intellectual Property Law Association submitted. |
Amicus brief of THE INTELLECTUAL PROPERTY LAW ASSOCIATION OF CHICAGO submitted. |
Brief amicus curiae of Houston Intellectual Property Law Association in support of neither party filed. |
Brief amicus curiae of The Naples Roundtable in support of neither party filed. |
Amicus brief of US Inventor, Inc. submitted. |
Brief amicus curiae of The Biotechnology Innovation Organization (BIO) filed. |
Brief amicus curiae of US Inventor, Inc. filed. |
Brief amicus curiae of The Intellectual Property Law Association of Chicago in support of neither party filed. |
Brief amicus curiae of The Massachusetts Biotechnology Council filed. |
Brief amicus curiae of Austin Intellectual Property Law Association in support of neither party filed. |
Brief amicus curiae of American Intellectual Property Law Association in support of neither party filed. |
Brief amicus curiae of Bar Association of the District of Columbia filed. |
Joint Appendix submitted. |
Amicus brief of Intellectual Property Owners Association submitted. |
Brief of Helsinn Healthcare S.A. submitted. |
Brief of petitioner Helsinn Healthcare S.A. filed. |
Amicus brief of Congressman Lamar Smith submitted. |
Brief amicus curiae of Intellectual Property Owners Association filed. |
Brief amicus curiae of Intellectual Property Owners Association in support of neither party filed. |
Brief amicus curiae of Congressman Lamar Smith filed. |
Joint appendix filed. |
Blanket Consent filed by Petitioner, Helsinn Healthcare S.A.. |
Motion to extend the time to file the briefs on the merits granted. The time to file the joint appendix and petitioner's brief on the merits is extended to and including August 23, 2018. The time to file respondents' brief on the merits is extended to and including October 9, 2018. |
Motion for an extension of time to file the briefs on the merits filed. |
Petition GRANTED. |
DISTRIBUTED for Conference of 6/21/2018. |
Reply of petitioner Helsinn Healthcare S.A. filed. (Distributed) |
DISTRIBUTED for Conference of 6/14/2018. |
Brief of respondents Teva Pharmaceuticals USA, Inc., et al. in opposition filed. |
Brief amicus curiae of The Naples Roundtable filed. |
Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed. |
Brief amicus curiae of Bar Association of the District of Columbia filed. |
Brief amicus curiae of The Biotechnology Innovation Organization (BIO) filed. |
Brief amicus curiae of US Inventor, Inc. filed. |
Brief amicus curiae of Boston Patent Law Association in support of neither party filed. |
Brief amicus curiae of The Massachusetts Biotechnology Council filed. |
Brief amicus curiae of Intellectual Property Owners Association filed. |
Brief amicus curiae of American Intellectual Property Law Association filed. |
Brief amicus curiae of Congressman Lamar Smith filed. |
Blanket Consent filed by Respondents, Teva Pharmaceuticals USA, Inc., et al.. |
Motion to extend the time to file a response is granted in part and the time is extended to and including May 11, 2018. |
Blanket Consent filed by Petitioner, Helsinn Healthcare S.A.. |
Motion to extend the time to file a response from April 2, 2018 to May 17, 2018, submitted to The Clerk. |
Petition for a writ of certiorari filed. (Response due April 2, 2018) |