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Helsinn Healthcare S.A. v. Teva Pharm. USA, Inc. - 139 S. Ct. 628 (2019)

Rule:

More than 20 years ago, the United States Supreme Court determined that an invention was “on sale” within the meaning of an earlier version of 35 U.S.C.S. § 102(a) when it was “the subject of a commercial offer for sale” and “ready for patenting.” The Court did not further require that the sale make the details of the invention available to the public. In light of this earlier construction, the reenactment of the phrase “on sale” in the Leahy-Smith America Invents Act ("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. 

Facts:

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.

Issue:

Was Helsinn prohibited by the "on sale" bar in 35 U.S.C.S. § 102(a)(1) from obtaining a U.S. patent on a drug that treated chemotherapy-induced nausea and vomiting?

Answer:

Yes

Conclusion:

The Court held that the U.S. Court of Appeals for the Federal Circuit properly found that  Helsinn was prohibited by the "on sale" bar in 35 U.S.C.S. § 102(a)(1) from obtaining a U.S. patent on a drug that treated chemotherapy-induced nausea and vomiting because it entered into a license agreement and a supply and purchase agreement with MGI Pharma, Inc. (MGI) to sell the drug in the United States more than a year before it applied for a U.S. patent. Although Helsinn and MGI did not disclose the dosage of the active ingredient that was in the drug, they disclosed the existence of both agreements, and that disclosure qualified as "prior art" under § 102(a)(1) for purposes of determining the patentability of the drug.

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