ABSTRACT 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. MAIN 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

(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 Box 1 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. BOX 1: 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, 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 global market for drugs and there is huge competition against generic products in countries where no patent protection

exists. REFERENCES * 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). Article  CAS  Google Scholar  Download references AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Solicitor, Bird & Bird, 90 Fetter Lane, London, EC4A 1JP, UK Hayley

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THIS ARTICLE French, H. Novelty: new products and processes. _Nat Rev Drug Discov_ 3, 469 (2004). https://doi.org/10.1038/nrd1421 Download citation * Issue Date: 01 June 2004 * DOI:

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