NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE 1 Guideline Familial hypercholesterolaemia: the identification and management of patients 1.1 Short title 2 Background The National Institute for Health and Clinical Excellence (‘NICE’ or ‘the Institute’) has commissioned the National Collaborating Centre for Primary Care to develop a clinical guideline on fam
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Bakermckenzie.co.jpClient Alert The IP High Court Clarifies the Scope of The interpretation of the scope of “product-by-process” claims under Japanese patent law has been quite controversial. A particularly difficult issue is whether the inclusion of the details of the process of how the patented product is manufactured actually limits the scope of the patent. In this regard, the Grand Panel of the Intellectual Property High Court (the "IP High Court") recently issued an important judgment which clarifies the determination of the scope of product-by-process claims (IP High Court: Heisei 22 (Ne) No. 10043; the “Pravastatin” case). This judgment, issued on 27 January 2012, held that product-by-process claims are to be interpreted in accordance with the process terms in claims unless it is established that the product-by-process claims at issue fall under a “authentic product-by-process claim” (as described below). The recent IP High Court judgment in the Pravastatin case raises the following key points: Recommended approach to patent applications In terms of an application for a patent, if an invention can be identified and patentable without any description of its production process, the scope of the claim should not involve a description of the process. The unnecessary description of the process in a claim is likely to limit the scope of the patent. In terms of the enforcement of a patent, if an important patent consists of a product-by-process claim, the owner of such a patent should preserve evidence relating to why the claim contains a process term in case there is future litigation concerning the patent. The owner may be required to prove that it was impossible or difficult to directly specify a product by the structure or features of the product at the time of filing the patent application. In the Pravastatin case, a pharmaceutical company (the "Appellant") filed an injunction against another pharmaceutical company (the "Appellee") on the grounds that the Appellee's sales of the medicinal products infringed on the Appellant's patent. Since the invention subject to the Appellant's patent was described in terms of the process of manufacture, it was argued that the patent should be interpreted as a product-by-process claim. The IP High Court clarified the criterion with respect to the interpretation of a product-by-process claim. The scope of a patent claim should be determined by the terms stated in a claim. Therefore, if a process of production is stated in a claim, the scope of the claim should, in principle, be limited by such process of production. However, the IP High Court further noted that in terms of product-by-process claims, there are two categories: An Authentic Product-by-Process Claim: which is a claim that specifies or identifies a product by its process of production because it is impossible or difficult to directly specify or identify the product by its structure or feature at the time of filing the patent application; and An Unauthentic Product-by-Process Claim: which is a claim that describes the process of producing a product despite the fact that it is not impossible or difficult to directly specify or identify the product based on its structure or feature at the time of filing the patent application. When a product-by-process claim falls within the scope of an Authentic Product-by-Process Claim, the claim should be interpreted to cover the products which are identical to a product produced by the process described in the claim, regardless of the process by which they are produced. On the other hand, the scope of an Unauthentic Product-by-Process Claim is limited to the product produced by the process described in the claim. Furthermore, the IP High Court clearly states that, in terms of the burden of proof in patent infringement cases, a person who claims that the claim falls the scope of an Authentic Product-by-Process Claim bears the burden of proof as to whether it was impossible or difficult to directly specify or identify a product by its structure or feature at the time of the filing of the patent application. In this case, the IP High Court concluded that the scope of the Appellant's patent should be limited by the process terms in the claim because the patent consisted of an Unauthentic Product-by-Process Claim and consequently, the Appellee's products did not fall within the scope of the Appellant's patent. In addition, the IP High Court also responded to the issue of the invalidation defense raised by the Appellee, stating that the classifications above also apply to the case where the scope of an invention needs to be determined to examine whether it is patentable or not. 2 The IP High Court Clarifies the Scope of the Product-by-Process Claims ⎜April 2012 www.bakermckenzie.com
This recent landmark case has pronounced a clear interpretation of “product- by-process” claims in Japan. This IP High Court judgment clearly stated that the description of a process in a claim limits its scope in the absence of proof that a definition of the product without a description of its production process was impossible or difficult at the time of filing the patent application. In this regard, the situation in Japan is now aligned more closely to the position in the United States where the CAFC clearly stated in a high profile 2009 case based on a similar scenario that "process terms in product-by- process claims serve as limitations in determining infringement" (see Abbott Laboratories v. Sandoz Inc. 90 U.S.P.Q. 2d 1769(Fed. Cir. 2009) (en banc) Additionally, the IP High Court has clearly stated that the same rule applies to cases where the invention is defined in relation to invalidation. This case has been appealed to the Supreme Court and the appeal is still Baker & McKenzie GJBJ Tokyo Aoyama Aoki Koma Law pending. It is anticipated that the appeal judgment of the Supreme Court, when announced, will also attract attention. The Prudential Tower 2-13-10, Nagatacho Chiyoda-ku, Tokyo 100-0014 Japan Tel + 81 3 5157 2700 Fax + 81 3 5157 2900 www.taalo-bakernet.com www.bakermckenzie.com 2012 Baker & McKenzie. All rights reserved. Baker & McKenzie GJBJ Tokyo Aoyama Aoki Koma Law Office (Gaikokuho Joint Enterprise) is a member firm of Baker & McKenzie International, a Swiss Verein. In accordance with the common terminology used in professional service organizations, reference to a "partner" means a person who is a partner, or equivalent, in such a law firm. Similarly, reference to an "office" means an office of any such law firm. This Publication has been prepared for clients and professional associates of Baker & McKenzie. Whilst every effort has been made to ensure accuracy, this Publication is not an exhaustive treatment of the area of law discussed and no responsibility for any loss occasioned to any person acting or refraining from action as a result of material in this Publication is accepted by Baker & McKenzie. This may qualify as “Attorney Advertising” requiring notice in some jurisdictions. Prior results do not guarantee a similar outcome. 3 The IP High Court Clarifies the Scope of the Product-by-Process Claims ⎜April 2012
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