Amgen v TKT : Assessment of inventive concept is crucial for assessing infringement of biotechnology patents
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Amgen v TKT: Assessment of inventive concept is crucial for assessing infringement of biotechnology patents William Cook Date received (in revised form): 5th January, 2005
Abstract In a landmark decision, the House of Lords in Kirin Amgen v Hoechst & TKT has confirmed the correct approach of proper construction of patent claims, as interpreted in the full light of the invention, to assess infringement. There is no ‘doctrine of equivalence’ under English law: variants falling outside a patent claim cannot infringe that claim, even if they are somehow ‘equivalent’ to the claimed invention.
INTRODUCTION Keywords: patent, construction, infringement, Amgen, equivalents, protocol
William Cook Simmons & Simmons, One Ropemaker Street, London EC2Y 9SS, UK Tel: +44 (0) 207 825 4288 Fax: +44 (0) 207 628 2070 Email: [email protected]
On 21st October, 2004, the House of Lords gave its judgment in the biotechnology case of Kirin-Amgen Inc and others v Hoechst Marion Roussel Limited and others 2004 WL 2330204, which contains a careful restatement of the correct approach to the assessment of patent infringement in UK courts. In construing a patent claim, much more emphasis must be placed upon what the skilled person would have understood a patentee to mean by the language of the claims, especially of ‘new technology’ patents, than the traditional sole reliance on the three ‘Protocol’ or ‘Improver’ questions. Patent practitioners, who have been wedded to the Improver questions as structured guidelines in assessing infringement for the past 15 years, will need to address the substantive nature of the invention as claimed more carefully in the future. The judgment also clarifies the correct approach in the UK to the novelty of ‘product-by process’ claims. Such claims will be novel only if the product itself is new: a product-byprocess claim may only be used where the product cannot in practice be defined by reference to its composition (for example, where novelty of the
product arises from the process of manufacture and the product is defined by that process). Finally, the judgment gives some further guidance on when a patent is ‘sufficient’ for the purposes of patent law, especially in the context of biotechnology inventions. Lord Hoffman gave the leading judgment of the Court, unanimously approved by the other four Law Lords who heard the case. His clarification of the patent infringement test that he himself propounded 15 years ago in Improver Corporation and others v Remington Consumer Products Limited and others [1990] FSR 181 is particularly interesting, especially his critical comments as to when that test may be of use. The judgment’s emphasis upon the primary importance of the claims, as interpreted in accordance with Article 69 of the European Patent Convention, using the Protocol on Interpretation of Article 69, brings the UK’s approach to claim construction closer to that in Germany, the Netherlands and other continental European jurisdictions. At a time when the proposals for a European Community-wide pa
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