## Facts

- Helsinn Healthcare S.A. makes Aloxi, a drug used to treat chemotherapy-induced nausea and vomiting, containing the active ingredient palonosetron.
- While conducting clinical trials for intravenous palonosetron at 0.25 mg and 0.75 mg doses, Helsinn entered into two agreements in 2001 with MGI Pharma, Inc., a U.S. company.
- Under the agreements, Helsinn granted MGI rights in the United States to distribute, market, and sell any FDA-approved palonosetron product, and Helsinn agreed to supply product to MGI.
- The agreements contained confidentiality provisions requiring MGI to keep Helsinn’s proprietary information confidential, including details tied to the formulations and dosages.
- Although the existence of the agreements and some business terms became public (including through an SEC filing), the specific 0.25 mg formulation later claimed in the patent was not publicly disclosed in those documents.
- Helsinn filed a provisional patent application on January 30, 2003, describing the 0.25 mg and 0.75 mg dosages, and later filed four patent applications claiming priority to that provisional filing date.
- The fourth application, filed in 2013 and governed by the America Invents Act (AIA), issued as U.S. Patent No. 8,598,219 (the ’219 patent) and claimed a “fixed dose of 0.25 mg of palonosetron in a 5 ml solution.”
- In 2011, Teva Pharmaceuticals USA, Inc. sought FDA approval (via an ANDA) to market a generic version of the 0.25 mg palonosetron product.
- Helsinn sued Teva for infringement; Teva responded that the ’219 patent was invalid because Helsinn’s 2001 agreements placed the invention “on sale” more than one year before the January 30, 2003 effective filing date.
- The district court held the AIA on-sale bar did not apply because the sale did not make the invention’s details available to the public; the Federal Circuit reversed; the Supreme Court granted certiorari.

## Issues

1. Did the AIA change the meaning of “on sale” in 35 U.S.C. § 102(a)(1) so that a sale counts only if it makes the invention available to the public?
2. Does a commercial sale to a third party under a confidentiality obligation qualify as an invalidating “on sale” event under the AIA?

## Decision

- The Supreme Court affirmed the Federal Circuit.
- The Court held that the AIA did not alter the settled meaning of “on sale.”
- A commercial sale or offer for sale can trigger § 102(a)(1) even if the buyer is bound to keep the invention confidential and the invention’s details are not publicly disclosed by the transaction.
- The Court treated the pre-AIA framework (including the requirement that the invention be the subject of a commercial offer for sale and “ready for patenting”) as continuing to govern the on-sale bar analysis.

## Legal Principles

- When Congress reenacts statutory language that has an established judicial meaning, courts generally presume Congress adopted that meaning absent a clear indication of change.
- The AIA’s addition of the phrase “or otherwise available to the public” does not, by itself, narrow the separate categories listed in § 102(a)(1), including “on sale.”
- A sale can be an invalidating prior-art event even if it does not publicly reveal the invention’s details; the on-sale bar focuses on the fact of a commercial sale or offer for sale (and readiness for patenting), not public disclosure.
- Confidentiality obligations in a commercial deal do not prevent that deal from qualifying as “on sale” for purposes of § 102(a)(1).

## Conclusion

Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. held that the AIA did not narrow the patent on-sale bar: a commercial sale made before the critical date can invalidate a patent under § 102(a)(1) even when the transaction requires confidentiality and does not publicly disclose the invention’s details.


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