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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
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 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
French Authors * Hayley French View author publications You can also search for this author inPubMed Google Scholar RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE
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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