NEWS & ANALYSIS

PATENT PRIMER Novelty: new products and processes Hayley French

It is a central tenet of law that anything to lack of novelty. In a first-to-file system the developed and tested without prejudicing the that is not new is unpatentable. This follows priority date establishes the time from which subsequent domestic . (See from the principle that cannot be the ’s novelty is determined. BOX 1 for a discussion of the Cohen–Boyer extended to material that is already in the patents, which were only possible because of public domain. In the first of two pieces on The US position the 12-month US grace period.) novelty, this article looks at what novelty means The US does not operate a first-to-file system, with respect to new products and processes. but instead operates a unique first-to-invent Patent strategy system, and as a result the novelty requirements Although the US has the first-to-invent principle, Patents are the lynchpins of the pharmaceutical in the US are more complex than the rest of the any US wishing to extend patent pro- and biotechnology sectors, and there are signifi- world, where the filing date is crucial. The opera- tection beyond a domestic patent essentially cant differences between the laws governing tion of such a system inevitably leads to conflict needs to act as if the US were a first-to-file in the US and Europe that need to when two or more parties claim patent rights to country and file as early as possible. Otherwise be understood to obtain effective patent cover- the same invention. Determination of priority the US publication will be part of the state of age in these product markets. The concept of in such conflicts is resolved using interference the art and undermine the ability to patent else- novelty is fundamental to patentability all over proceedings. For the purposes of US interference where. Although it is the ‘date of invention’ that the world, but Europe and the US operate dif- proceedings, any party seeking to prove priority is of vital importance in the US, it is of no ferent tests for novelty, so if you wish to obtain of invention must prove they invented first and importance in the rest of the world where all patent protection in both regions it is important reduced the invention to practice. There is that matters is the inventor’s US filing date. to understand the differences that exist. therefore an essential practical need for rigorous In Europe the temptation to file an applica- objective record keeping if patent protection in tion as early as possible must be balanced against The European position the US is required. possessing adequate experimental data to draft a Europe operates an ‘absolute novelty system’ that The US also differs from Europe in that it patent that clearly defines the scope of the inven- addresses the question of novelty by reference to operates a ‘mixed novelty system’.Publication of tion. European inventors should also not be disclosure worldwide before the date of filing a an invention anywhere in the world can destroy under the impression that a grace period is a patent application. The concept of novelty is novelty but prior use of an invention (provided window for disseminating results by publication enshrined in the European Patent Convention there is no written description) would only before filing a patent application. Once the (EPC), which provides that an invention shall be undermine the novelty of the patent in the results are published, deft competitors can be considered to be novel if it does not form part of country in which it is used. hot on their heels. Many are aware of the practi- the state of the art. The state of the art comprises cal need for detailed record keeping for the pur- “everything made available to the public by Grace periods poses of interference proceedings, but the means of a written or oral description, by use, or In the US (and Japan and Canada) an invention unwary can be faced with great legal uncertainty. in any other way”in any country of the world. If can be disclosed and this will not prevent a 1. Cohen, S. N., Chang, A. C., Boyer, H. W. & Helling, R. B. an examination of the state of the art reveals that patent application from being made, so long as Construction of biologically functional bacterial plasmids in vitro. Proc. Natl Acad. Sci. USA 70, 3240–3244 (1973). the invention has been anticipated in whole or in an application is filed within a specified period of Dr Hayley French, Solicitor, Bird & Bird, part before the filing of the patent application the earliest disclosure. This ‘grace period’ 90 Fetter Lane, London, EC4A 1JP,UK. then no patent will be granted. allows the applicant’s own research to be pub- e-mail: [email protected] In Europe, the first person to file an applica- lished, and products and processes to be doi:10.1038/nrd1421 tion is entitled to grant of a patent, providing that they satisfy the requirements of patentability. THE COHEN AND BOYER PATENTS In such a system it is important to obtain the earliest possible filing date for an invention and The basic technique of gene splicing which marked the beginning of genetic engineering and to keep all details of the invention secret until the launched the biotechnology industry was invented by Stanley Cohen at Stanford University patent application has been filed, otherwise and Herbert Boyer at the University of California. Stanford University could only obtain a US the invention could slip into the and patent (US 4,237,224: process for producing biologically functional molecular chimeras) will not be considered novel. Publishing scientific because some elements of the invention had been disclosed in a journal1 and in the New York results, presenting them at a conference or simply Times. Stanford University was able to file the US application because there was time available revealing them to an investor, collaborator or within the grace period. However, no patent cover could be obtained in the rest of the world. customer without a confidentiality agreement The Cohen and Boyer patents protected enabling technology which became the core of the could invalidate subsequent patent protection. biotechnology industry and the patents realized about US $300 million in revenues. However, All patents are assigned a priority date, todays biotechnology industry is a different proposition and global patent coverage is imperative in order to realize maximum revenues. Europe accounts for over a third of the which denotes the date on which it is assessed global market for drugs and there is huge competition against generic products in countries against competing patent applications or against where no patent protection exists. information that might make it invalid owing

NATURE REVIEWS | DRUG DISCOVERY VOLUME 3 | JUNE 2004 | 469