Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc.
Issues
Under the Leahy-Smith America Invents Act, does the sale by an inventor of a claimed invention trigger the “on sale” bar to patentability if the sale does not disclose details of the claimed invention to the public?
Helsinn Healthcare S.A. (“Helsinn”) sought and received four patents, beginning in 2003, for a drug developed pursuant to a licensing agreement with another pharmaceutical company. Though the drug’s formula remained confidential, the news of the deal was made public. In 2011, Teva Pharmaceuticals USA, Inc. (“Teva”) applied to the Food and Drug Administration for approval of a generic version of the drug, and—within that application—certified that Helsinn’s patents were invalid. Helsinn sued for patent infringement, arguing that the on-sale bar provision of the America Invents Act (“AIA”) does not apply to licensing agreements like the one Helsinn entered, because the confidentiality agreement in place meant that the invention was not publicly available. Helsinn then argues that adopting a different interpretation would conflict with the AIA’s two goals of aligning U.S. patent law with international standards and incentivizing prompt filing under the first-to-file standard. On the other hand, Teva asserts that the AIA’s on-sale bar provision does apply based on the plain meaning of “on sale” as illustrated by two-hundred years’ worth of statutory interpretation. Teva additionally counters that Helsinn’s interpretation would invite the secret-commercialization tactics that extend a company’s monopoly over inventions and that the AIA sought to eliminate. The Supreme Court’s decision has vast implications for patent-holders in the United States, may chill biotechnological innovation, and may adversely affect the public by extending monopolies over certain drugs and thus undermine the development of competition in the biotechnical market.
Questions as Framed for the Court by the Parties
Whether, under the Leahy-Smith America Invents Act, an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.
Petitioner Helsinn Healthcare S.A. (“Helsinn”) owns four patents: U.S. Patent No(s). 7,947,724 (“724 patent”), 7,947,725 (“725 patent”), 7,960,424 (“424 patent”), and 8,598,219 (“219 patent”), which relate to the drug palonosetron used in the treatment of chemotherapy-induced nausea and vomiting (“CINV”). Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. at 4.
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Additional Resources
- Robert L. Maier, Supreme Court Set to Tackle ‘Secret’ Patented Sales Under AIA, New York Law Journal (Aug. 7, 2018).
- Gene Quinn, Supreme Court to hear Helsinn v. Teva, decide AIA Secret Sales, IPWatchdog (June 26, 2018).