The recent US Supreme Court decision Helsinn Healthcare S.A v. Teva Pharmaceuticals USA Inc. gives an insight into the definition of prior art under the Leahy-Smith America Invents Act (AIA), in particular, whether a 'secret sale' can deprive a claimed invention of novelty in a US patent application.
Background
In 2000, Helsinn entered clinical trials relating to the dosage of a drug named palonosetron for treating chemotherapy induced nausea. Shortly thereafter, under a series of confidential agreements, Helsinn agreed a licensing agreement with MGI Partners Inc. who acquired the rights to distribute and market the product. While the cooperation between parties was publicly known, the technical details of the invention were not disclosed.
On January 30th 2003, Helsinn filed a provisional patent detailing the specific dosage of palonosetron. A series of patents were filed claiming priority from this application, the fourth of which, US 8,598,219 (US '219), was granted by the USPTO in May 2013.
In 2011, Teva Pharmaceuticals sought approval from the FDA to create a generic version of Helsinn's product. When Helsinn sued for infringement of their patent, Teva counterclaimed that the patent was invalid.
The amended AIA 35 U.S.C § 102 conditions for patentability stipulate that "a person shall be entitled to a patent unless (1) 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" [emphasis added] (see here). An exception to this rule includes anything disclosed by the inventor 12 months before filing a relevant patent application (known as the "grace period").
Pre-AIA, Pfaff v. Well Electronics (1998) had previously established that a 'secret sale' in the US could invalidate a US patent. However, changes to the conditions for patentability raised questions about whether this interpretation was still valid. In particular, did the inclusion of the term 'or otherwise available to the public,' not present in the previous statute, change the on-sale bar?
Decision
The Supreme Court held that the AIA rewording of this provision did not change the established case law with respect to "secret sales" as explained in Pfaff. Two conditions had to be met for there to be a sale: first, the product must be the subject of a commercial offer for sale and second the invention must be ready for patenting. The Supreme Court affirmed the Federal Circuit's ruling that "if the existence of the sale is public, the details of the invention need not be publicly disclosed in terms of sale in order to fall under the AIA 'on sale' bar."
The Courts found that there was overwhelming evidence that Helsinn's dosing invention was ready for patenting and reduced to practice before the critical date (i.e. January 30th 2002, one year before filing the provisional patent application). Since Helsinn had sold this invention before the critical date, the sale to MGI Partners Inc. was deemed to deprive the US '219 patent claims of novelty.
It is important to note that the AIA definition of novelty now has no geographic restriction. It is therefore important to be aware that a confidential sale of a product anywhere in the world, more than one year before filing the relevant patent application, is likely to deprive a US patent application directed to that product of novelty.
A comparison with Europe
At the European Patent Office (EPO), under Article 54(2) EPC, the state of the art comprises everything made available to the public by means of a written or oral description, by use, or in any other way, before the filing or priority date of the European patent application. Unlike the US, there is no grace period for inventor disclosures 12 months before filing a European patent application.
The situation regarding 'secret sales' is also quite different at the EPO. According to the EPO's Case Law of the Boards of Appeal a single sale of a prototype was sufficient to render the article available to the public, but only because the buyer was not bound by an obligation to maintain secrecy (see here). While a secret sale does not deprive a claimed invention of novelty, the patentee is required to provide suitable evidence to prove that the sale was bound by confidentiality.
Furthermore, a product sold to the public is only deemed to be
part of the art if it can be analysed and reproduced by the skilled
person (see G 1/92). For example, the EPO Board of Appeal in
T 1833/14 held that the opponent could not
sufficiently prove that the skilled person had enough information
to prepare a claimed polymer without knowing, among other things,
which catalyst system was used to prepare said polymer product,
despite the product being sold before the priority date.
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