Novelty: new products processes

07 June 2004

Hayley French

It is a central tenet of patent law that anything that is not new is unpatentable. This follows from the principle that patents cannot be extended to material that is already in the public domain. In the first of two pieces on novelty, this article looks at what novelty means with respect to new products and processes.

Patents are the lynchpins of the pharmaceutical and biotechnology sectors, and there are significant differences between the laws governing patentability in the US and Europe that need to be understood to obtain effective patent coverage in these product markets. The concept of novelty is fundamental to patentability all over the world, but Europe and the US operate different tests for novelty, so if you wish to obtain patent protection in both regions it is important to understand the differences that exist.

The European position

Europe operates an ‘absolute novelty system’ that addresses the question of novelty by reference to disclosure worldwide before the date of filing a patent application. The concept of novelty is enshrined in the European Patent Convention (EPC), which provides that an invention shall be considered to be novel if it does not form part of the state of the art. 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” in any country of the world. If an examination of the state of the art reveals that the invention has been anticipated in whole or in part before the filing of the patent application then no patent will be granted.

In Europe, the first person to file an application is entitled to grant of a patent, providing that they satisfy the requirements of patentability. In such a system it is important to obtain the earliest possible filing date for an invention and to keep all details of the invention secret until the patent application has been filed, otherwise the invention could slip into the prior art and will not be considered novel. Publishing scientific results, presenting them at a conference or simply revealing them to an investor, collaborator or customer without a confidentiality agreement could invalidate subsequent patent protection.

All patents are assigned a priority date, which denotes the date on which it is assessed against competing patent applications or against information that might make it invalid owing to lack of novelty. In a first-to-file system the priority date establishes the time from which the invention’s novelty is determined.

The US position

The US does not operate a first-to-file system, but instead operates a unique first-to-invent system, and as a result the novelty requirements in the US are more complex than the rest of the world, where the filing date is crucial. The operation of such a system inevitably leads to conflict when two or more parties claim patent rights to the same invention. Determination of priority in such conflicts is resolved using interference proceedings. For the purposes of US interference proceedings, any party seeking to prove priority of invention must prove they invented first and reduced the invention to practice. There is therefore an essential practical need for rigorous objective record keeping if patent protection in the US is required.

The US also differs from Europe in that it operates a ‘mixed novelty system’. Publication of an invention anywhere in the world can destroy novelty but prior use of an invention (provided there is no written description) would only undermine the novelty of the patent in the country in which it is used.

Grace periods

In the US (and Japan and Canada) an invention can be disclosed and this will not prevent a patent application from being made, so long as an application is filed within a specified period of the earliest disclosure. This ‘grace period’ allows the applicant’s own research to be published, and products and processes to be developed and tested without prejudicing the subsequent domestic patent application. (See the box below for a discussion of the Cohen–Boyer patents, which were only possible because of the 12-month US grace period.)

Patent strategy

Although the US has the first-to-invent principle, any US inventor wishing to extend patent protection beyond a domestic patent essentially needs to act as if the US were a first-to-file country and file as early as possible. Otherwise the US publication will be part of the state of the art and undermine the ability to patent elsewhere. Although it is the ‘date of invention’ that is of vital importance in the US, it is of no importance in the rest of the world where all that matters is the inventor’s US filing date.

In Europe the temptation to file an application as early as possible must be balanced against possessing adequate experimental data to draft a patent that clearly defines the scope of the invention. European inventors should also not be under the impression that a grace period is a window for disseminating results by publication before filing a patent application. Once the results are published, deft competitors can be hot on their heels. Many are aware of the practical need for detailed record keeping for the purposes of interference proceedings, but the unwary can be faced with great legal uncertainty.

The Cohen and Boyer Patents

The basic technique of gene splicing which marked the beginning of genetic engineering and launched the biotechnology industry was invented by Stanley Cohen at Stanford University and Herbert Boyer at the University of California. Stanford University could only obtain a US patent (US 4,237,224: process for producing biologically functional molecular chimeras) because some elements of the invention had been disclosed in a journal1 and in the New York Times. Stanford University was able to file the US application because there was time available within the grace period. However, no patent cover could be obtained in the rest of the world.

The Cohen and Boyer patents protected enabling technology which became the core of the biotechnology industry and the patents realized about US $300 million in revenues. However, today’s biotechnology industry is a different proposition and global patent coverage is imperative in order to realise maximum revenues. Europe accounts for over a third of the global market for drugs and there is huge competition against generic products in countries where no patent protection exists.

1. Cohen, S. N., Chang, A. C., Boyer, H. W. & Helling, R. B. Construction of biologically functional bacterial plasmids in vitro. Proc. Natl Acad. Sci. USA 70, 3240–3244 (1973).

First published in Nature Reviews Drug Discovery June 2004, Vol 3