Posts by: Jakob Leffland Reimers | (3) posts

Claiming a non-therapeutic use with inseparably associated therapeutic effect

A use of a substance or composition for the treatment of humans by therapy is excluded from patentability according to the EPC Article 53(c). However, claiming a non-therapeutic use of a substance or composition may still fall under this same exclusion if the non-therapeutic use is inseparably associated with a therapeutic use.

This was confirmed by the Technical Board of Appeal in a case against a decision from the Opposition Division (T1635/09). The case in suit related to the use of a contraceptive composition with reduced concentrations of the active substances, wherein the use had the further effect of preventing or reducing pathological side-effects (i.e. a therapeutic effect).

In the Board’s assessment of the subject-matter of the patent as a whole it was found that the reduced concentrations served solely to prevent or reduce the side-effects. Thus, the contraceptive effect was inseparably associated with the therapeutic effect.

Provisions in the EPC exist for claiming the substance or composition for use in the treatment; previously in the form of Swiss-type claims, i.e. a claim directed at the use of a substance or composition for the manufacture of a product for the treatment in question. However, the Board finds that the wording “manufacture of a product” according to the Swiss-type claim inherently provides an additional protection of the product per se. Hence, in T1635/09 it was further confirmed that a use claim (as excluded under EPC) cannot readily be converted into a corresponding Swiss-type claim (or the equivalent new format) without also extending the protection of the patent.

Consequently, owing to the facts of this case, applicants (in particular from the U.S., where the similar use claims are not excluded from patentability) should carefully consider the form and wording of use claims directed at protecting treatments by therapy as well as claims related to non-therapeutic uses, wherein the use may be associated with a therapeutic effect.

Jakob Leffland Reimers, Associate

Supplementary protection certificates for plant protection products

Supplementary protection certificates for plant protection products

11 November 2010 the Court of Justice of the European Union issued a preliminary ruling in the case C-229/09 that Supplementary protection certificates for plant protection products may validly be obtained based on provisional marketing authorisations

In this recent decision by the Court of Justice (CJ) it was ruled that a supplementary protection certificate (SPC) may also be validly issued based on a provisional MA granted by a competent national authority of a Member State. That is a MA which has been granted pursuant to Article 8(1) of European Council Directive 91/414/EEC.

The case in question, C-229/09, was referred to CJ during the course of proceedings between Hogan Lovells International LLP and Bayer CropScience AG by the Bundespatentgericht (German Federal Patent Court).
Lovells petitioned for invalidation of a SPC granted to Bayer in Germany on the product ‘iodosulfuron’. Lovells disputed that the certificate was valid since it was issued based on a provisional MA granted by the Bundespatentgericht and not a definitive MA. Lovells stated that according to Article 3(1)(b) of the Regulation relating to SPC (Regulation No 1610/96) a SPC can only be granted after a definitive MA has been issued under the conditions laid down in Article 4 of Directive 91/414/EEC – thus, it cannot be based on a provisional MA under Article 8(1) of the same directive.

However, the CJ based their decision on that Article 8(1) stipulates that the provisional MA is to be granted only if the product is expected to satisfy the same requirements as provided in Article 4. Thus, they found the criteria of both the provisional and the definitive MA to be equivalent and thereby found no reason to exclude provisional MAs from forming the basis in respect to granting a SPC on a plant protection product.

Jakob Leffland Reimers, Associate, Awapatent

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Changes to the German Intellectual Property Laws

A series of changes to the German intellectual property laws was recently passed by the German parliament. The reforms enter into force on 1 October 2009.

Of greatest importance are the changes to the patent law regarding patent invalidity proceedings. The changes aim at speeding up the process by limiting the possibility of making changes to the patent at a late stage and filing other submissions, which could delay the proceedings.

The changes also affect the Employees’ Invention Act, thus providing that employee inventions belong to the employer unless the employer declares otherwise within four months from the notification of the invention. Presently, the employer is required to actively claim exclusive or non-exclusive right over the invention whereas with the new reform no action is required by the employer.

The new patent law also entails changes to the costs of filing new patent applications. The fee for filing a patent application electronically will be reduced. However, at the same time claim fees will be introduced and filing more than ten claims will result in an additional fee for each claim exceeding ten claims.

The EU Paediatric Regulation will also be implemented. The regulation provides an addition to the regulation on Supplementary Protection Certificates, which allow for extensions of the term of Patents relating to medicinal products. The Paediatric Regulation provides the possibility of an extra six months extension of the Supplementary Protection Certificates if a paediatric investigation plan for the medicinal product in question is approved.

Jakob Leffland Reimers, Associate