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European IP Bulletin, Issue 29, February - Patents
Patents
5. The EPO Clarifies the Concept of Diagnostic Methods
On 29 December 2003, the President of the European Patent Office (EPO) made use of his power under Article 112(1)(b) EPC and referred a question to the Enlarged Board of Appeal. The referral was mainly based on the conflicting interpretation contained in decisions T 385/86 and T 964/99 of the term “diagnostic methods practiced on the human or animal bodies” within the meaning of Article 52(4) EPC.
The question referred concerned the following points of law:
- Are diagnostic methods practised on the human or animal body excluded under Article 52(4) of the European Patent Convention (EPC) only those methods containing all the steps needed to carry out a medical diagnosis (namely, the collection of data, the comparison of the said data with standard values, the discovery and attribution of a significant deviation) ? ; or
- Does the exclusion also preclude those methods containing one step or more that can be used for diagnostic purposes?
Further, the President asked whether a claimed method is a diagnostic method if it contains at least one essential procedural step and requires the presence of a physician; or it does not require the presence of a physician but the latter bears the responsibility for the method; or all procedural steps can be carried out by non-technical staff. Additionally, he questioned whether the presence of the physician is necessary; what are the procedural steps he/she has to undertake; and how to construe the phrase “practised on the human and animal body”.
The Enlarged Board of Appeal said that, according to the well established jurisprudence of the EPO, a diagnostic method practised on the human or animal body for making a diagnosis for curative purposes has to include the four steps and therefore a narrow interpretation has to be given to Article 52(4) EPC and to the cases of exclusion from patentability since the very wording of the provision which indicates the narrow construction is appropriate. In fact, a member of the Enlarged Board of Appeal held that steps are required to bring a diagnostic method within the meaning of Article 52(4) due to the inescapable multi-step nature of such method.
Furthermore, the Board regarded the qualification of a method as having diagnostic character does not necessarily depend on who is involved because it is unequivocal that the exclusion relates to the method and not to the person carrying out the method.
Finally, the Board found that the criterion “practised on the human or animal body” is to be considered only in relation to the method steps of technical nature and not to the diagnosis stricto sensu, i.e. the deductive decision phase which cannot be practised on the human or animal body. As far as the other technical steps are concerned, the Board stated that the performance of all method steps of technical nature should imply an interaction with the human or animal body.
In summary, the Enlarged Board of Appeal, on 16 December 2005, answered the referred point of law by delivering its opinion stating that the subject matter of a claim relating to diagnostic methods practised on the human or animal body falls under the prohibition of Article 52(4) EPC when the claims include features relating to all the above mentioned procedural steps necessary to make a diagnosis. Thus, whether or not a method is a diagnostic method does not depend on a medical or veterinary practitioner being present or bearing the responsibility. Essentially, all the procedural steps of technical nature that are involved in making the diagnosis for curative purposes must satisfy the criterion “practised on the human or animal body”, and this criterion is met when their performance implies some type of interaction with the human or animal body.
6. Tamglass v Luoyang North Glass
Tamglass v Luoyang North Glass & Anr [2006] EWHC 65 Ch was a patent action in which the claimants alleged infringement of a European Patent (UK) relating to a glass bending and tempering process. The claimants argued that the first defendant company Luoyang North Glass (LNG) was the manufacturer, importer and seller of the infringing machine to the second defendant company “Novaglaze”, and Novaglaze had been guilty of keeping and using the machine. LNG counterclaimed for revocation of the patent on the grounds of novelty and obviousness, while Novaglaze expressed its intention to abide by the court’s decision in respect of infringement and validity, but sought an opportunity to be heard on remedies.
Before examining the legal issues involved, the Court had to wade through complicated procedural issues due to certain particularities of the case. Firstly, LNG was representing itself through its employee, Mr. Wang, who had little understanding of the English procedure, rather than through English solicitors and counsel. Secondly, the expert evidence submitted on behalf of LNG was not made in accordance with the Ikarian Reefer requirements. The expert, Mr. Gao, was a shareholder in the company. The court gave due regard to these circumstances in evaluating the expert evidence and the allegations advanced by the defendant. The court rejected the anticipation and obviousness attacks against the patent because the defendant had failed to prove them.
On the issue of infringement, LNG denied that they had made an offer to sell the machine or that they had any knowledge that the machines would infringe. They stated that the fax from their agent was merely a list of machines with their identification number and a description in general terms, and that such a fax could not amount to a formal contractual offer. However, the court relied on the judgment of Justice Jacob in the case of Gerber Garment Technology Inc v Lectra Systems Ltd [1995] RPC 383. In that case Jacob J had held that an advertisement or negotiations demonstrating a willingness on the part of the person to supply an infringing machine is an “offer to dispose” within S 60 of the Patent Act, 1977. Therefore, Justice Mann similarly concluded that the fax from the LNG’s agent could amount to an “offer” for the purposes of S 60 of the Patent Act, 1977, even though it is not a formal offer.
On the second requirement, as to whether or not LNG knew that the use of the machine without the consent of patentee would infringe, the court held that such knowledge could be imputed to LNG through inference. LNG’s position in the glass market, its patent portfolio and the evidence that they had participated in the trade fairs where the claimants were present were held as important factors for making such an inference against LNG. Hence, the Court found the defendants guilty of infringing the patent.
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