Fed Circuit Watch: Helsinn and the On-Sale Bar

By Brent T. Yonehara

On May 1, 2017, the Federal Circuit Court of Appeals decided Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 2016-1284, 2016-1787 (Fed. Cir. 2017), holding that the on-sale bar of pre-AIA 35 U.S.C. § 102(b) invalidated four patents held by Helsinn, for treatment of chemotherapy-induced nausea and vomiting (CINV).

The patents at issue were, 7,947,724, 7,947,725, 7,960,424, and 8,598,219.  All of these patents shared a priority date of January 30, 2003, and a critical date of January 30, 2002 for purposes of pre-AIA 35 U.S.C. § 102(b).  Helsinn and MGI Pharma, Inc. entered into a sales agreement which was signed on April 6, 2001.  This agreement was then announced in a press release and in an SEC filing with a copy of the agreement, albeit in redacted form, on April 25, 2001.  This April 25, 2001 date would, therefore, represent a public disclosure of the invention’s subject matter prior to the critical date of January 30, 2002.

Claim 2 of the ‘724 patent and Claim 1 of the ‘219 patent were deemed representative of the asserted claims:

2.  A pharmaceutically stable solution for reducing emesis or reducing the likelihood of emesis comprising:

a) 5 mg/mL palonosetron hydrochloride, based on the weight of the free base, in a sterile injectable aqueous carrier at a pH of from 4.5 to 5.5;

b) from 0.005 mg/mL to 1.0 mg/mL EDTA; and

c) mannitol in an amount sufficient to tonicify said solution, in a concentration of from about 10 mg/ml to about 80 mg/ml.

  1. A pharmaceutical single-use, unit-dose formulation for intravenous administration to a human to reduce the likelihood of cancer chemotherapy-induced nausea and vomiting, comprising a 5 mL sterile aqueous isotonic solution, said solution comprising:

palonosetron hydrochloride in an amount of 0.25 mg based on the weight of its free base;

from 0.005 mg/mL EDTA; and

from 10 mg/mL to about 80 mg/mL mannitol,

wherein said formulation is stable at 24 months when stored at room temperature.[1]

The on-sale bar invalidates a patent if the patented subject matter is (i) subject of a commercial sael or offer for sale prior to the critical date of the patent, and (ii) ready for patenting.[2]  Both pre-AIA and post-AIA treatments of § 102 utilize the Pfaff steps of  the on-sale bar.

Pre-AIA 35 U.S.C. § 102(b) barred a patent if: “…(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.”[3]

AIA 35 U.S.C. § 102(a)(1) barred a patent if: “…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.”[4]

(Emphasis added.)

The Federal Circuit held that sale agreement between Helsinn and MGI constituted a commercial sale for purposes of 35 U.S.C. § 102(b) on-sale bar because the facts met the definition of the on-sales bar of § 102(b).  As noted by the Federal Circuit, Helsinn did not require confidentiality with its execution of the sales agreement, and was an unambiguous contemplation of a sale between Helsinn and MGI.[5]

The Federal Circuit also held that, for purposes of an on-sale bar under AIA 35 U.S.C. § 102(a)(1), “ after AIA, if the existence of the sale is public, the details of the invention need not be publicly diclosed in the term of sale.”[6]  Helsinn had argued that for AIA purposes, the on-sale bar did not apply until the sale disclosed the subject matter of the invention to the public.  The Federal Circuit disagreed, rationalizing that preventing such a bar would be “a foundational change in the theory of the statutory on-sale bar.”[7]  Rather, all that is required is if there is a sale or offer to sell which embodies the invention, and that sale is then made public.[8]

As for whether the claims were “ready for patenting,” the Federal Circuit found that the 0.25 mg of palonosetron formulation met the burden, and that evidence was “overwhelming” that the formulation was properly reduced to practice work for its intended purposes for limiting the likelihood of emesis.[9]

The implications of this case could be quite profound.  For purposes of the AIA 35 U.S.C. § 102(a)(1) on-sale bar, public disclosure of a sale of a patented invention could effectively invalidate that patent even though the invention’s specifics were not disclosed in the public disclosure of that sale.

[1] Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., 2016-1284, 2016-1787 (Fed. Cir. 2017), slip op. at 5.

[2] Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 67 (1998).

[3] 35 U.S.C. § 102(b) (pre-AIA); MPEP 2133.

[4] 35 U.S.C. § 102(a)(1) (AIA); MPEP 2152.

[5] Helsinn, slip op. at 16-17.

[6] Id. at 27.

[7] Id. at 22.

[8] Id. at 23.

[9] Id. at 30.