Helsinn Healthcare S. A. v. Teva Pharmaceuticals Usa, Inc.

139 S.Ct. 628 (2019)

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Nature of the Case

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Facts

P is a Swiss pharmaceutical company that makes Aloxi, a drug that treats chemotherapy-induced nausea and vomiting. In early 2000, it submitted protocols for Phase III clinical trials to the FDA, proposing to study a 0.25 mg and a 0.75 mg dose of palonosetron, the active ingredient. In September 2000, P announced that it was beginning Phase III clinical trials and was seeking marketing partners for its palonosetron product. P 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. MGI agreed to make up-front payments to P and to pay future royalties on the distribution of those doses. MGI agreed to purchase exclusively from Helsinn any palonosetron product approved by the FDA. P, in turn, agreed to supply MGI however much of the approved doses it required. Both agreements required MGI to keep confidential any proprietary information received under the agreements. P and MGI announced the agreements in a joint press release, and MGI also reported the agreements in its Form 8-K filing with the SEC. Neither the 8-K filing nor the press releases disclosed the specific dosage formulations covered by the agreements. On January 30, 2003, almost two years after the agreements, P filed a provisional patent application covering the 0.25 mg and 0.75 mg doses of palonosetron. P filed four patent applications that claimed priority to the January 30, 2003, date of the provisional application. The fourth patent application was filed in May 2013. It issued as the ’219 patent. The ’219 patent covers a fixed dose of 0.25 mg of palonosetron in a 5 ml solution. The ’219 patent is governed by the AIA. Teva (D), an Israeli company and its American affiliate, sought approval from the FDA to market a generic 0.25 mg palonosetron product. sued D for infringing its patents, D asserted that the ’219 patent was invalid because the 0.25 mg dose was “on-sale” more than one year before P filed the provisional patent application covering that dose in January 2003. The AIA states: “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.” §102(a)(1) The patent statute in effect before the passage of the AIA included a similar proscription, known as the “on-sale bar.” The Court determined that the “on-sale” provision did not apply. It held that, under the AIA, an invention is not “on-sale” unless the sale or offer in question made the claimed invention available to the public. P and MGI did not disclose the 0.25 mg dose and the court determined that the invention was not “on-sale” before the critical date. The Federal Circuit reversed. If the existence of the sale is public, the details of the invention need not be publicly disclosed in the terms of sale” to fall within the AIA’s on-sale bar. The Supreme Court granted certiorari.