Archive | 2010, February | (5) posts

New dosage regimen may be patented, but no more Swiss-type claims

The Enlarged Board of Appeal of the EPO clarifies, in decision G 2/08 of 19 February 2010, that it is possible to obtain a patent for a medicament known to treat a specific illness for use in a different method for treatment of the same illness. However, such inventions may not be claimed in the format of so-called Swiss-type claims.

The European Patent Convention, EPC, specifies that European patents shall not be granted in respect of methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body (hereafter referred to as methods for treatment). However, the patentability of any known substance or composition shall not be excluded for use in such a method. These provisions in combination with case law, in particular the earlier decision from the Enlarged Board of Appeal G 5/83, have led to the rather complicated way of protecting the second medical indication called the Swiss-type claim: Use of a substance or composition X for the manufacture of a medicament for treatment of disease or condition Y.

Since December 2007, the EPC specifies that any known substance or composition can be patentable for any specific use in methods for treatment. The intent is to eliminate any legal uncertainty regarding the patentability of further medical uses and to permit purpose-related product protection for each further medical use of a substance or composition already known as a medicine. Thus, it is now possible to formulate claims on a second medical indication as: Substance or composition X for use in the treatment of disease or condition Y. However, the EPC does not define the nature of such further therapeutic use of a known substance or composition other than by saying that it must be “specific”. It does not give any definition of the degree of distinctiveness required from the new use in order for it to be “specific”, and in particular whether a new method for treatment of the same disease or condition could constitute such a ”specific” use.

Decision G 2/08 relates to a European patent application with Swiss-type claims directed to a known substance for use in treatment of the same condition as disclosed in prior art. The patent application was refused on the grounds of lack of novelty and because it related to a method for treatment. The only novel claim feature resided in a specific dosage regimen. The remaining issue was whether a dosage regimen feature can be recognized as a further medical indication within the meaning of the EPC.

The Enlarged Board of Appeal confirms the previous liberal decision T 1020/03 and comes to the conclusion that the new use does not need to be the treatment of another disease. The “specific” use may thus reside in something else than treatment of a different illness, and there is therefore no reason to treat a feature consisting of a new dosage regime of a known medicament in any other way than one would treat any other specific use acknowledged in prior case law. It is stressed that the claimed definition of the dosage regime must not only be verbally different from what is described in the art but must also reflect a different technical teaching.

During the revision of the EPC, it was considered that this purpose-related product protection should give an equivalent protection to that of Swiss-type claims. It is therefore very interesting to note that the Enlarged Board of Appeal in the present decision concludes that “It appears that the rights conferred on the patentee by [purpose-related product claims] … are likely broader [than Swiss type claims] …”.

What might be most noteworthy and surprising in this decision is that the Enlarged Board of Appeal states that for a claim with subject-matter rendered novel only by a new specific use of a medicament, such claim may no longer have the format of a so called Swiss-type claim. The Enlarged Board of Appeal notes that patents have been granted and many applications are still pending seeking patent protection for Swiss type claims. Therefore, in order to ensure legal certainty, the abolition of this possibility shall have no retroactive effect. It appears that the prohibition on Swiss-type claims will only apply to applications having a date of filing or priority more than three months after publication of the present decision in the Official Journal of the EPO. As soon as this time limit is fixed, this information will be provided on our website.

Inga-Lill Andersson, European Patent Attorney
Maria Stenbäck, European Patent Attorney
Mikael Henriksson, European Patent Attorney

Controversy over Benelux decision on what constitutes “genuine use” of a Community Trademark

What constitutes genuine use of a Community Trademark (CTM) has recently been subject for discussions within the European Union. Although, there is still no precedent case, the general opinion has been that use in only one member state is sufficient to fulfill the requirement of genuine use in the Community as stipulated in the CTMR (Council Regulation (EC)) No. 207/2009 dated 26 February 2009 on the Community Trade Mark). Therefore, when the Benelux Office for Intellectual Property (BOIP) issued a ruling indicating the exact opposite – that use in one member state could not constitute genuine use – several voices were raised.According to article 15 CTMR, to be able to avoid sanctions, a proprietor shall within a period of five years following the registration put the Community trade mark to “genuine use in the Community”. When the CTMR was established the Council and the Commission expressed their opinion and interpretation in the so-called Joint Statements, which states that use which is genuine within the meaning of article 15 in one member state constitutes genuine use in the whole Community.

The background is as follows. The holder of the Community trademark ONEL, filed an opposition against a company that had filed a Benelux trademark application for the mark OMEL. During the proceedings it was admitted between the parties that the opponent had made genuine use of their mark ONEL, in the Netherlands, for the services for which it was registered. The BOIP considered itself to be bound by the parties opinion in this respect. Therefore, the question the parties disagreed upon and for BOIP to decide, was whether use in one member state of the EU was enough to constitute genuine use in the Community according to article 15 CTMR.

In the absence of case law the BOIP questioned whether the opinion presented in the Joint Statements was legally binding or not. In its findings, the BOIP comes to the conclusion that the view presented in the Joint Statements cannot be maintained. To support its conclusion the BOIP refers to e.g. the principle of free movement of goods and freedom to provide services. It says that in order to justify the monopoly given by a trademark and to fulfil its essential function, a mark must be used. “A monopoly that goes (much) further than the territory in which the mark is used, will indeed form an obstacle for the free movement of goods as well as the freedom to provide services within the internal market”.

Following the decision several organizations have expressed their opinions on the matter, i.e. OHIM (the office responsible for registering trademarks and designs that are valid in all 27 member states of the EU) and MARQUES (a European organisation which represents brand owners in Europe).

The OHIM refers to the principle of the unitary character of the CTM and considers that boundaries of Member States should not play a part in assessing genuine use within the EU Single Market (Press release on the OHIM homepage dated 27 January 2010). Further, in a recently published contribution to the study on the overall functioning of the trade mark system in Europe the OHIM maintains this view, and says that proving genuine use is not an easy matter – there must be real evidence that is open to challenge from the other party to the proceedings – and adding the uncertainty of what might constitute the proper territorial coverage would place a severe and unwarranted burden on CTM proprietors. MARQUES takes it one step further and asserts that the decision seriously jeopardizes the concept of the unitary character of the CTM (statement of MARQUES dated 28 January 2010 published on its homepage).

We are of the opinion that BOIP was mistaken in its interpretation of article 15 CTMR. Should the interpretation presented in the decision turn out to be correct, one question would be how many member states a CTM would have to be used in to fulfill the requirement of genuine use. It is our opinion that setting up such quantitative measures regarding what constitutes genuine use, would be unreasonable. Whether a mark has been put in genuine use in the Community or not should not be based merely on territorial provisions. Rather, it shall be based on qualitative measures, i.e. real evidence. We believe that another interpretation would not only be contrary to the principle of the unitary character of the CTM but also to the purpose of the CTM system as a whole. Further, it would create an unjustified uncertainty among trademark owners as to whether the use of their mark is in fact genuine or not.

According to a press release, dated 11 February 2010, on the homepage of Onel, an appeal has been filed with the Appeal Court of the Hague. Thus, to bring clarity to the issue, we hope that the question will be refered to the ECJ. We will continue to watch the case.

Maria Nyrell, European Trademark Attorney

The language of proceedings used before the EPO can never be changed

The language of proceedings used before the EPO can never be changed – this includes the language used before the international receiving office if that language is English, French or German

The Enlarged Board of Appeal of the European Patent Office (EPO) has for the second time this week issued a decision. This latest decision, G 4/08 of 16 February 2010, relates to the language of proceedings, and it clarifies that it is never possible to change the language of the proceedings. According to Article 14(3) of the European Patent Convention, the official language of the EPO in which the European patent application is filed or into which it is translated shall be used as the language of the proceedings in all proceedings before the EPO, unless the Implementing Regulations provide otherwise. The three official languages of the EPO are English, French and German.

The European patent application in question, EP 02759818.4, relates to a vaccine against the Nile Fever virus. It is the European regional phase application of an International application, which was filed and published in French. When the regional stage before the EPO was entered in November 2003 it was requested that the language of the proceedings should be English, and an English translation of the application was filed at the same time. If the EPO would not allow the language to be English, an appealable decision on this was also requested. The applicant further made two auxiliary requests in case the EPO would not allow the change of language. Thus they requested that if English was not allowed as language of the proceedings, the EPO should use English in all written proceedings and decisions, and finally, if this was not allowed, the prosecution of the application should proceed in French. In December 2006, the EPO issued a decision to reject the request for a change of the language and also the first auxiliary request. This decision was appealed by the applicant, and after oral proceedings held in April 2008, the following three questions were referred to the Enlarged Board of Appeal in December 2008:

Question 1
If an international patent application has been filed and published under the Patent Cooperation Treaty (PCT) in an official language of the European Patent Office (EPO), can the applicant, on entry into the regional phase before the EPO, file a translation of the application into one of the other EPO official languages with the effect that the language of this translation must then be considered as language of the proceedings to be used in all proceedings before the EPO?

Question 2
If the answer to that question is no, can EPO departments use, in written proceedings on a European patent application (or an international application in the regional phase), an EPO official language other than the language of proceedings used for the application?

Question 3
If the answer to question 2 is yes, what are the criteria to be applied in determining the official language to be used? In particular, must EPO departments accede to such a request from a party or parties?

In its decision the Enlarged Board of Appeal explains that the EPC (neither in the form of the current EPC, EPC 2000 or the earlier EPC 1973) does not allow replacement of a euro-PCT application published in an official language with a translation into another official language. Thus the response to Question 1 is that when an international patent application has been filed and published under PCT in an official language of the EPO, it is not possible, on entry into the European regional phase, to file a translation of the application into one of the two other languages with the effect that the language of this translation is considered as language of the proceedings to be used in all proceedings before the EPO. In this context the Enlarged Board of Appeal refers both to Article 14(3) EPC, discussed above, and to Article 158 EPC 1973 corresponding essentially to parts of Article 153 of the current EPC, respectively. The Enlarged Board of Appeal in particular refers to Article 158(2) EPC 1973. The same Article is not explicitly found in the current EPC, however, it has become part of Article 153(4). The latter in combination with Rule 159(1)a) specify that a translation of an international application shall be supplied upon entry into the European phase if the Euro-PCT application is published in another language than English, French or German, and that this translation shall be published. Article 153(3) further specifies that the international publication of a Euro-PCT application in an official language of the EPO shall take the place of the publication of the European patent application. The term Euro-PCT is explained in Article 153(2) as an international application for which the EPO is a designated or elected office, and it is further stated that if an international date of filing has been accorded, it shall be equivalent to a regular European application. They further conclude that there is no conflict between these regulations and the regulations of the PCT.

The Enlarged Board of Appeals goes on to clarify that the only applicable law to Question 2 is the current EPC, and that it does not allow the EPO departments to use, in written proceedings on a European patent application or an international application in the regional phase, an EPO official language other than the language of proceedings used for the application in accordance with Article 14(3). The decision is thus stricter than similar decisions issued prior to EPC2000, including J 18/90.

Since the response to Question 2 thus is no, the Enlarged Board of Appeal does not respond to Question 3.

The complete text of the decision can be here. It is only available in French – the language of proceedings.

Maria Stenbäck, European Patent Attorney

New EPO practice on the patentability of surgical methods

The Enlarged Board of Appeal of the European Patent Office has in its latest decision G 1/07 of 15 February 2010 provided guidelines on the exception to patentability on methods for treatment of the body by surgery. The purpose of this exclusion is to free the medical profession from constraints by patents. The context of this decision relates to methods for MRI imaging of lung and heart vasculature, involving as one of many steps the administration of an imaging agent to a patient’s body. One embodiment involves injection of the imaging agent into the heart.

It has been questioned whether the current practice that the presence of a single surgical step in a multi-step method excludes this method from patentability is appropriate. The present decision makes it clear that a method is excluded from patentability if it involves at least one method step for treatment of a body by surgery or therapy.

Until now, the lower instances have developed two different lines of interpreting the exception to patentability on methods for treatment of the body by surgery. The first, and dominating, interpretation has been that it is the nature of the intervention that is decisive, i.e. what actual operations are performed on the body. The second, dissenting interpretation has been that it is the purpose of the intervention that is relevant, or more precisely whether or not the method is intended to, or suitable for maintaining or restoring health, physical integrity or physical well-being.

The present decision emphasizes that it is the nature of the intervention that is decisive, but it is also recognized that this should not be so broadly interpreted so as to exclude safe routine techniques, such as hair removal by optical radiation, from patentability. When determining its nature, a guiding factor may be the complexity of the invasive step, including the required medical expertise and the health risks involved. In this particular case, however, the invasive step represents a substantial physical intervention on the body, which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise. This step is therefore of a surgical nature regardless of its purpose, and methods comprising this step are as a consequence excluded from patentability as methods for treatment of the body by surgery.

Although some remedies, such as disclaimers, may be available if a claimed method is held to be a method for treatment of the body by surgery, this decision reinforces the rather strict European view on the patentability of inventions involving a step that is surgical in its nature. It therefore remains of key importance to word the specification and the claims carefully when setting out to protect such inventions by a European patent.

Please read the questions referred to the Enlarged Board of Appeal in Case G 1/07, and the answers given here.

Mikael Henriksson, European Patent Attorney

How to protect your IP rights in Hong Kong

Many people are aware of the important role that Hong Kong plays for trade in Asia, not least as a gateway to the Chinese market, yet few know much about how to go about protecting their intellectual property rights there.

Since 1997 Hong Kong has had its own patent law under which a British or Chinese patent does not automatically guarantee protection. The region’s links to China and the United Kingdom have not been totally severed, however. Hong Kong patent law does make provisions for what are called “standard patents” registered on a quid pro quo basis when a corresponding application has been filed for one of these other areas. In practice, this means that an application must first be filed with the Chinese Patent Office, the UK Patent Office, or the European Patent Office (provided that the application to the EPO designates the UK).

There are two further provisos to granting a Hong Kong standard patent: the request to record must be filed in Hong Kong within 6 months from the publication of the initial patent application, and the request for registration and grant must be filed within six months from the date of grant of the initial patent. There are no problems as regards the language requirements, as it is not necessary to translate the full text of the application. The only requirement is that the title and abstract are available in both English and Chinese at the time the application is filed. It is not necessary to file a translation of a European patent application that has been published in French or German.

A standard patent that provides protection for 20 years may only be granted after the patentee has first applied for patent protection in China or the UK as described above. There is, however, another option; namely what is called a “short-term patent” that can be obtained by filing directly with the Hong Kong Intellectual Property Department. A short-term patent provides protection for just eight years but, on the other hand, it may be granted without the formality of a substantive examination. In this sense, it corresponds more or less to the unexamined utility models known from many European countries.

As a rule, a Hong Kong patent is granted relatively quickly as soon as the formal criteria have been met.

Vibeke Warberg Rohde. European Patent Attorney