In its judgment dated October 20, 2005 in a patent dispute between Synthon BV (Synthon) and Smithkline Beecham plc (SkB) regarding the invention of paroxetine methanosulfate, the House of Lords found that Synthon's earlier unpublished application did anticipate SkB's patent, making the latter invalid. The decision restored the original trial decision by the High Court, later reversed by the Court of Appeal. The House of Lords clarified two aspects of the concept of prior art. First, an unpublished prior filed application is prior art for the purposes of novelty but not for obviousness. Second, disclosure and enablement are distinct elements, and in order to demonstrate anticipation, both elements must be present in a single reference. An important distinction between disclosure and enablement lies in the scope of knowledge which may be assumed when assessing adequate disclosure or enablement. Disclosure relates to a statement of the invention, and it must be a clear indication of the same purported invention claimed in the patent at issue, without resort to experimentation on the part of a skilled reader. Enablement, however, is the extent to which the disclosure allows someone of skill in the art to practise the disclosed invention, and does allow for some possible experimentation by a person of skill in the art to get the invention to work. In the case at hand, Synthon disclosed paroxetine methanosulfate, but incorrectly stated the method by which the crystalline form would be created. Since paroxetine methanosulfate has only one crystalline form, a skilled reader would be expected to use reasonable alternative methods available to make the desired compound. This clarification of what is meant by the phrase "enabling disclosure" could also find acceptance in Canada. For the House of Lords judgment in Synthon BV v Smithkline Beecham plc [2005] UK 59, see: http://makeashorterlink.com/?P5B514B0C For other commentary, visit: http://makeashorterlink.com/?N1C521B0C Summary by: Nicholas J. Whalen

E-TIPS® ISSUE

05 10 26

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