Accord Healthcare v. Helsinn (PGR2014-00010): An Early Post-Grant Review Petition

Post-grant review became available on September 16, 2012, but for well over a year almost nobody filed one. Accord Healthcare, Inc. v. Helsinn Healthcare S.A., PGR2014-00010, was one of the first petitions to reach the Board. Looking at what it challenged, and on what grounds, shows what made PGR different from inter partes review and why it started so slowly. This page describes the petition itself, which is a party’s filing; it does not describe the Board’s handling of the case.

The petition

The petitioner was Accord Healthcare, Inc. The patent owners named were Helsinn Healthcare S.A. and Roche Palo Alto LLC. The challenged patent was U.S. Patent No. 8,598,219, issued December 3, 2013, and titled “Liquid Pharmaceutical Formulations of Palonosetron.” Palonosetron is an antiemetic drug, used to prevent nausea and vomiting associated with chemotherapy. The patent issued from a continuation-in-part application filed in 2013, and the petition was dated September 2014.

The petition challenged claims 1–5 and 8. Its grounds fell into three categories under 35 U.S.C. § 112:

• lack of written description under § 112(a);
• lack of enablement under § 112(a); and
• indefiniteness under § 112(b).

None of the grounds in the petition’s statement of challenges relied on prior art.

Why early PGRs were rare

PGR applies only to patents subject to the first-inventor-to-file provisions of the America Invents Act. In practice that means patents containing at least one claim with an effective filing date on or after March 16, 2013. A petition must also be filed within nine months of the patent’s grant or reissue (35 U.S.C. § 321(c)).

Those two limits explain the slow start. An application filed in or after March 2013 typically took years to issue, so very few PGR-eligible patents existed in 2013 and 2014. Patents that did qualify early often came from continuation-in-part or other applications that added new claims after the effective date, which is why eligibility itself could be disputed. Every early petitioner had to explain why the patent was eligible, a showing an IPR petitioner does not need to make in the same way. The first petition, LaRose Industries v. Choon’s Design, was not filed until 2014.

What the petition shows about PGR

Accord illustrates the main attraction of PGR: breadth of grounds. Under 35 U.S.C. § 321(b), a PGR petitioner may raise any ground of invalidity that could be raised under § 282(b)(2) or (3), including § 101 eligibility and § 112 written description, enablement and definiteness (the best-mode requirement aside). An inter partes review is limited to anticipation and obviousness based on patents and printed publications (§ 311(b)). A challenge built entirely on § 112, like this one, could only be brought at the Board through PGR.

The threshold is also different. The Board may institute PGR only if it is more likely than not that at least one challenged claim is unpatentable, or if the petition raises a novel or unsettled legal question important to other patents (§ 324). For drug formulations, where disclosure and claim scope questions are often central, those grounds can be significant. For a fuller comparison, see PGR vs. IPR.

Related history

Helsinn’s palonosetron patents were later at the center of Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. (2019). There the Supreme Court held that a sale to a third party obligated to keep the invention confidential can still place the invention “on sale” under the AIA version of § 102(a)(1). That case arose from district court litigation, not from this petition.

Key takeaways

• Accord v. Helsinn, PGR2014-00010, was among the first post-grant review petitions, filed in 2014.
• It challenged a palonosetron formulation patent solely on § 112 grounds, which IPR cannot raise.
• PGR reaches only first-inventor-to-file patents and must be sought within nine months of grant, so few patents were eligible at first.
• Helsinn’s palonosetron patents later produced the Supreme Court’s 2019 on-sale bar decision.