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e, even if something similar has been previously disclosed, provided it is not close with the degree of inevitability that is required, the patent application will not necessarily fail on the basis of not being novel.

A general disclosure of a possible process does not impact on the novelty of an invention; however, where there is a series of processes, each individual process could be the reason for a future patent application failing, due to lack of novelty.

Secondly, there is the element of enablement. This means that whatever has been disclosed must be sufficient for a person, skilled in the relevant art, to copy or replicate the process or invention. This enablement provision should be thought of separately to the disclosure, as in the case of disclosure the information must be sufficient for a skilled individual to understand the disclosure. For the purpose of enablement, the skilled person must be capable of actually utilising or at least trying to utilise the relevant invention.

When it comes to determining whether or not the invention is novel, therefore, several issues need to be considered. It is not simply a matter of determining if something similar has ever been made public. It must have been made public with sufficient clarity as to allow the invention to have been understood and put into effect by another third party. The patent, therefore, in order to gain protection, must offer a solution to a situation that has not been possible to achieve before and not simply a fanciful possibility of a solution given enough further experimentation. As stated in the case of General Tire & Rubber Co. v Firestone Tyre & Rubber Co. Ltd, the disclosure 'must contain clear and unmistakable directions to do what the patentee claims to have invented'.

Pharmaceutical Application 在制药中的应用

The pharmaceutical industry as a whole has been one of the most litigated and dynamic areas in relation to the test of novelty. The recent case of Actavis UK Limited v Merck & Co. Inc changed the way in which UK courts look at the test of novelty in relation to medical products. Prior to the Actavis case, it was thought that a new dosage or way of taking a particular drug could not be seen as novel; this has now been reversed by the Court of Appeal.

In this case, it was held that a new regime for taking medicine could constitute a novel invention for the purpose of obtaining a valid patent. Furthermore, the court dealt with the issue of obviousness, stating that it had to be obvious at the date of priority, not before or after, to defeat the patent, on this basis.

The leading case of Merrell Dow v. Norton and Penn, commonly referred to as the Terfenadine decision, held that when looking at a pharmaceutical process the definition of new had to be applied to the actual processes and not to a new result or outcome. In this case, it was held that although Merrell had discovered a new reaction from Terfenadine, it was not novel as the composition had previously been disclosed to the public (albeit not for that specific purpose). This produces an interesting position. Based on this judgment, it would seem that whether or not the process or invention produces a solution for a previously unsolvable issue is irrelevant; the issue is whether the actual matter itself has been disclosed. The focus of the test is on the physical items and not on the result