The Supreme Court of the United States granted a petition for writ of certiorari in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA Inc. This will be one of the first cases to address the rewriting of on-sale bar language, of 35 U.S.C. §102.
The question presented before the Supreme Court was:
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.
On-sale bar refers to a patent that is deemed invalid because the invention was on sale a year or more prior to the date the patent application was filed.
In 2001, Helsinn entered into a Supply and Purchase agreement with MGI Pharma, Inc. A press release was made in regard to the agreements and MGI supplied a redacted copy of the agreements omitting the price and dosage formulation for Helsinn’s anti-nausea drug, Aloxi.
In 2011, Teva sought FDA approval for a generic version of Aloxi and Helsinn sued claiming patent infringement. Due to the Supply and Purchase agreements, Teva argued Helsinn’s patents were invalid under the on-sale bar. The District Court disagreed, found in favor of Helsinn, and concluded the agreements were for future sales and the drug was not ready for patenting at the time the companies entered into the agreements. As for the post AIA patent, the Court found that yes, the agreement was made public, but, the dosage information was not.
Teva appealed the District Court’s ruling and in May 2017, the United States Court of Appeals for the Federal Circuit (CAFC) heard the case. The CAFC held that certain patents for Helsinn’s anti-nausea drug, Aloxi, were invalid. The CAFC further held that Helsinn’s patented claims “were subject to an invalidating contract for sale prior to the critical date,” and, “the AIA did not change the statutory meaning of ‘on sale’ in the circumstances involved here.” The Court also concluded that Helsinn’s “invention was reduced to practice and therefore was ready for patenting before the critical date” of January 30, 2002.
The CAFC’s final conclusion stated:
We hold that the asserted claims, claims 2 and 9 of the ’724 patent, claim 2 of the ’725 patent, claim 6 of the ’424 patent, and claims 1, 2, and 6 of the ’219 patent, are invalid under the on-sale bar.
Under revised 35 U.S.C. 102(a)(1), a person is entitled to a patent unless “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.” Helsinn believes the Congress added the phrase “or otherwise available to the public” to eradicate “secret sales” as prior art and to require that the sale(s) make the “claimed invention” “available to the public.”
In its petition, Helsinn referenced the definition of prior art and stated it is “critically important” and “goes to the heart of patentability.” They feel the AIA has narrowed the scope of on-sale bars to sales that are “publicly available.” Helsinn further stated “[t]he Federal Circuit’s decision threatens to upend that carefully constructed system…[it] casts doubt on the validity of countless patents issued since the AIA took effect and will chill valuable collaborations by smaller innovators.”
The Supreme Court is expected to hear this case in the fall with a decision to follow in early 2019.
Helsinn attorney Joseph O’Malley said: “We are pleased that the Supreme Court will consider the validity of the patent covering our client’s Aloxi drug franchise and clarify the AIA’s on-sale bar provision.”
A spokesperson for Teva said: “We acknowledge that the Supreme Court granted further review, but we remain confident in our position on the merits.”
Many hope this case will clarify discrepancies that have led to increased confusion for patentees and lower courts in regard to past on-sale bar rulings.