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Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc.

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Supreme Court of the United States
Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc.
Term: 2018
Important Dates
Argument: December 4, 2018
Decided: January 22, 2019
Outcome
United States Court of Appeals for the Federal Circuit affirmed
Vote
9-0
Majority
Chief Justice John G. Roberts • Clarence Thomas • Ruth Bader Ginsburg • Stephen Breyer • Samuel Alito • Sonia Sotomayor • Elena Kagan • Neil Gorsuch • Brett Kavanaugh

Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. is a patent law case that was argued before the Supreme Court of the United States on December 4, 2018, during the court's 2018-2019 term. The court affirmed the ruling of the United States Court of Appeals for the Federal Circuit, holding that "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 Leahy-Smith America Invents Act included an on-sale bar." The case came on a writ of certiorari to the Federal Circuit Court.[1][2]

HIGHLIGHTS
  • The case: Helsinn Healthcare S.A. was the owner of four patents related to the use of palonosetron to treat chemotherapy-induced nausea and vomiting. Prior to the critical date for the on-sale bar, Helsinn signed a supply and purchase contract with MGI Pharma, which was made public but was partly redacted. Helsinn sued Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. for allegedly infringing on the patents. Teva claimed that the patents were invalid under the on-sale bar provision of 35 U.S.C. § 102. Helsinn argued that the patents were valid because the actual invention was kept secret although the sale agreement was public.
  • The issue: 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.[3]
  • The outcome: The court affirmed the ruling of the United States Court of Appeals for the Federal Circuit, holding that "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 [Leahy-Smith America Invents Act] included an on-sale bar."


    • You can review the lower court's opinion here.[4]

    Timeline

    The following timeline details key events in this case:

    • January 22, 2019: U.S. Supreme Court affirmed the ruling of the Federal Circuit Court
    • December 4, 2018: Oral argument
    • June 25, 2018: U.S. Supreme Court agreed to hear case
    • February 28, 2018: Petition filed with U.S. Supreme Court
    • May 1, 2017: The Federal Circuit Court reversed the lower court's decision, ruling that the patents were invalid.

    Background

    Helsinn Healthcare S.A. was the owner of four patents related to the use of palonosetron to treat chemotherapy-induced nausea and vomiting. Prior to the critical date for the on-sale bar, Helsinn signed a supply and purchase contract with MGI Pharma, which was made public but was partly redacted.[5]

    Helsinn sued Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd. for allegedly infringing on the patents. Teva claimed that the patents were invalid under the on-sale bar provision of 35 U.S.C. § 102. Helsinn argued that the patents were valid because the actual invention was kept secret although the sale agreement was public.

    A district court ruled in favor of Helsinn. On appeal, the Federal Circuit Court reversed the district court's decision, ruling "The asserted claims of the patents-in-suit were subject to an invalidating contract for sale prior to the critical date of January 30, 2002, and the AIA did not change the statutory meaning of 'on sale' in the circumstances involved here. The asserted claims were also ready for patenting prior to the critical date."[4]

    Question presented

    The petitioner presented the following question to the court:[3]

    Question presented:
    • 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.

    Audio

    • Audio of oral argument:[6]

    Transcript

    • Read the oral argument transcript here.

    Outcome

    Decision

    Justice Clarence Thomas delivered the unanimous opinion of the court. The court affirmed the ruling of the United States Court of Appeals for the Federal Circuit, holding that "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 [Leahy-Smith America Invents Act] included an on-sale bar."[2]

    Opinion

    In his opinion for the court, Justice Thomas wrote,

    “ Helsinn does not ask us to revisit our pre-AIA interpretation of the on-sale bar. Nor does it dispute the Federal Circuit’s determination that the invention claimed in the ’219 patent was “on sale” within the meaning of the preAIA statute. Because we determine that Congress did not alter the meaning of “on sale” when it enacted the AIA, we Cite as: 586 U. S. ____ (2019) 9 Opinion of the Court hold that an inventor’s sale of an invention to a third party who is obligated to keep the invention confidential can qualify as prior art under §102(a). We therefore affirm the judgment of the Federal Circuit.[7] ”

    Text of the opinion

    • Read the full opinion here.

    See also

    External links

    Footnotes

    1. ↑ Supreme Court of the United States, "17-1229 Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc.," accessed November 2, 2018
    2. ↑ 2.0 2.1 2.2 United States Supreme Court, "Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc." Opinion, January 22, 2019
    3. ↑ 3.0 3.1 Supreme Court of the United States, "QPReport 17-1229 Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc.," accessed November 2, 2018
    4. ↑ 4.0 4.1 SCOTUSblog, "Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc.," accessed November 2, 2018
    5. ↑ Oyez, "Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc.," accessed November 2, 2018
    6. ↑ Supreme Court of the United States, Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. argued December 4, 2018
    7. ↑ Note: This text is quoted verbatim from the original source. Any inconsistencies are attributable to the original source.
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