Considering that patent cases are infrequently heard by the House of Lords, it is noteworthy that the UK's highest court has recently released two decisions in this area of the law: Kirin Amgen Inc v Hoechst Marion Roussel Limited and TKT (the Amgen case) relating to a biotechnology patent for the erythropoietin protein (EPO) used to treat anemia and Sabaf SpA v MFI and Menegetti (the Sabaf case), relating to a patent for gas hob burners. Each case involved fundamental patent issues such as claim construction, obviousness, anticipation and sufficiency. In both cases, the House of Lords found that the disputed patents were invalid. In the first case, the Amgen case, at issue was whether TKT's process of producing EPO by gene activation infringed the relevant claims of Amgen's patent. The patent is directed to EPO manufactured by an exogenous DNA sequence coding for EPO which has been introduced into a host cell. By contrast, TKT's EPO is manufactured by an endogenous DNA sequence coding for EPO in a human cell into which an exogenous control sequence has been inserted. As the Court held that Amgen's invention was a method of manufacturing EPO, it was necessary to consider whether TKT's process was a variant falling within the scope of the claims. Following the approach espoused earlier in Catnic Components Ltd v Hill & Smith Ltd, [1982] RPC 183, the House of Lords found that TKT did not infringe the claims of the patent. In particular, the Court held that a person skilled in the art would not have understood the claims as sufficiently general to include gene activation. In doing so, the Court stated that the three-step test traditionally used to construe claims to assess whether a variant falls within their scope (see Improver Corporation v Remington Consumer Products Ltd, [1990] FSR 181), was only a "guideline" which was not necessarily useful in all cases. Although this may be seen as broadening the scope of patents, the Court expressly refused to adopt the US doctrine of equivalents which arguably would have provided a broader scope of protection. The House of Lords also found the two relevant claims at issue were invalid – the first on the basis of anticipation and the second for insufficiency. According to the Court, "Amgen have got themselves into difficulties because, having invented a perfectly good and ground-breaking process for making EPO and its analogues, they were determined to try to patent the protein itself, notwithstanding that, even when isolated, it was not new." In the second case, the Sabaf case, the House of Lords considered the issue of obviousness. There, the patent related to a gas hob burner with two features which were said to constitute the invention. According to the Court, before applying the test for obviousness set out in the Patents Act, 1977, it must be determined what the invention is and whether, in law, there is more than one invention. Once that determination is made, the four-step test for obviousness (the Windsurfing test) is applied to each purported invention (see Windsurfing International Inc v Tabur Marine (Great Britain) Ltd, [1985] RPC 59, 73-74):
There are, we think, four steps which require to be taken in answering the jury question. The first is to identify the inventive concept embodied in the patent in suit. Thereafter, the court has to assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and to impute to him what was, at that date, common general knowledge in the art in question. The third step is to identify what, if any, differences exist between the matter cited as being 'known or used' and the alleged invention. Finally, the court has to ask itself whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they require any degree of invention.
The House of Lords found that the two features comprising the Sabaf's patent were for two separate purported inventions since neither feature had an effect on the other. Applying the Windsurfing test, each alleged invention was obvious in light of the prior art. As the legal reasoning set out in decisions of the House of Lords is often considered and applied by Canadian Courts in patent cases, each of these decisions will be of considerable interest in Canada. To read the House of Lords' decision in Kirin Amgen v Hoechst Marion Roussel Limited and TKT, visit: http://makeashorterlink.com/?S36824E99. The House of Lords' decision in Sabaf SpA v MFI and Menegetti, can be found at: http://makeashorterlink.com/?P27832E99. Summary by: Lenni Carreiro

E-TIPS® ISSUE

04 10 27

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