A recent decision by the European Patent Office (“EPO”) will affect patent applicants seeking protection of pharmaceutical compounds since Swisstype claims will no longer be permitted. There are also numerous important EPC rule changes coming into effect on April 1st, 2010.
Swiss-type claims and Second medical use claims
In the 1983 decision in EISAI (G5/83), the Enlarged Board of Appeal of the EPO held that the so-called “Swiss form” of claims for second medical uses, that is claims to the use of a compound for preparing a medicament for a new therapeutic indication, were legitimate in principle. Essentially, this was on the reasoning that, as first novel uses were allowable under the European Patent Convention, then subsequent novel uses should be as well. This decision led in due course to two subsidiary issues: was the convoluted Swiss form of claim necessary and would new dosage regimes for a drug be patentable as new medical uses?
The first point was specifically addressed by the EPC 2000 amendments to the European Patent Convention which entered into force on 13 December 2007 and were intended to codify EPO case law allowing second medical use claims but without need for the Swiss form wording. The second point on dosage regimes was considered in a number of Board of Appeal decisions, some allowing claims to new dosage regimes (particularly T 1020/03) but others doubting this approach considering that dosage regimes were excluded from patentability as methods of treatment. By decision T 1319/08, the Board of Appeal sought clarity on both points from the Enlarged Board of Appeal. On 19 February 2010, the Enlarged Board gave its decision (G2/08) holding that:
1. claims should no longer use the Swiss format; and
2. T 1020/03 was correct that new therapeutic treatments of a known drug for a known illness were patentable, including new dosage regimes.
While the decision brings welcome clarity to the scope of second medical use claims, there is a concern that allowing claims for new dosage regimes could give unduly prolonged patent protection for drugs. The Enlarged Board noted this concern stating that the claimed regime must be not only “verbally different” from the prior art but also “reflect a different technical teaching”.
How the prohibition on Swiss form claims will take effect is less clear. The Enlarged Board said that its decision should not be retroactive instead setting a timeframe of 3 months from publication of its decision in the EPO Official Journal for compliance by “future applications” (publication is expected to be at the end of March 2010). “Future applications” is defined by reference to their filing or priority dates. Thus, it seems that applications currently pending, or filed over the next 3 months, can still use Swiss-form claims and arguably should use them in parallel with claims in EPC 2000 compliant format. As the Enlarged Board’s decision indicates, there may be a difference in scope between the two forms of claims1. Furthermore, Swiss form claims remain permissible in various countries outside Europe, including Canada, Australia, New Zealand, Israel, and Japan. But what is clear is that very shortly Swiss claims will no longer be permitted by the EPO in new applications.
EPC rule changes
In addition to the fact that Swiss-type claims will no longer be accepted, the EPO has announced various important EPC rule changes that will have a major impact for patent Applicants and practitioners. Most of these changes will come into effect on April 1st, 2010.
First, the EPO is setting new time limits for filing divisional applications. In the past, it was possible to file divisionals at any time until the day before grant of a parent application, which could itself be a divisional. As of April 1st, 2010, not only will it still be necessary for the parent application to be pending upon the filing of the divisional, but the divisional will also have to be filed (i) within a period of 24 months from the date of a first communication issued by the Examining Division on the parent application, or (ii) 24 months from the date of any communication in which an objection of lack of unity was raised for the first time by the Examining Division against the parent application. These provisions not only apply to new European applications, but also to already pending applications. However, there is a six-month transitional period (i.e. until October 1st, 2010) for filing divisionals in cases where the 24-month deadline has already expired, or will expire during this six-month period.
Fortunately for Applicants, informal Opinions (e.g. in a PCT) and the Extended European Search Report (EESR) are not considered to be a first communication triggering the 24-month deadline since they are issued by the Search Division and not the Examining Division.
Therefore, Applicants should review their patent portfolios and consider how this change may affect their future protection. Particular care is needed where a series of applications have been filed and where a divisional has already been filed.
Multiple independent claims
On April 1st last year, the EPO introduced escalating punitive fees for applications with large numbers of claims (200 € for each claim between the 16th and the 50th and 500 € for the 51st and each subsequent claim). Under the new rules coming into force on April 1st this year, the EPO is given more power to require Applicants to restrict their claims to only one independent claim per category (method, apparatus, composition, etc.). Apart from some exceptions, if an application has more than one independent claim, the EPO will set a non-extendable 2-month time limit in which an Applicant will have to either indicate on which claims the search is to be carried out or pay additional search fees. If the Applicant does not respond, only the first independent claim in each category will be searched. Since during examination the EPO will most likely require the Applicant to restrict the claims to the subject matter searched, claims relating to non-searched matter will have to be removed without the possibility of being reintroduced. Such claims will have to be the subject of a divisional application. Accordingly, Applicants should consider reducing their claim set to one independent claim per category or craft their application such that a full justification can be provided as to why the claims fall within one or more of the statutory exceptions.
Claim amendments and early response
The EPO has also introduced various rule changes to speed up patent prosecution. Among the changes coming into force on April 1st, 2010 is a new obligation on the Applicants to provide a full statement of basis for any amendment in the application as filed. There are also responses to Opinions which, optional in the past, will now become mandatory. The changes have different effects and set different deadlines depending on the particular circumstances (e.g. regular EPO application, an Euro-PCT application where the EPO is or is not the International Searching Authority). Overall, Applicants will have less opportunities to file voluntary amendments and will need to be better prepared to formulate responses and strategies than under the current system.
In summary, patent Applicants should be aware of these significant rule changes and consider them at an early stage in the filing process as the new rules may have serious implications on their future patent protection.
1 Swiss-type claims are in the form "Use of substance X in the manufacture of a medicament for the treatment of condition Y" whereas EPC 2000 claims can be phrased as just "Substance X for use in treatment of condition Y".