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01 October 2009

Your guide to IP issues in Germany

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Effective management of pharmaceutical and biotechnology inventions involves considering issues such as patentability, data protection, enforcement, experimental use and branding. Christine Kanz and Anja Lunze of Reimann Osterrieth Köhler Haft explain how these issues are addressed in Germany

Ownership of IP – how does ownership arise? (including inventors rights)

In Europe, for example in Germany, unlike the United States, the first-to-file principle applies. That means that patent authorities do not examine whether the applicant is the first and true inventor, but any applicant is considered to be entitled to request the grant of the patent according to Section 7 paragraph 1 of the German Patent Act (GPA) if he is the first to file. However, if the applicant is not entitled to obtain patent protection because he is not the first and true inventor, the first and true inventor may respectively request transfer of title of the application or the patent.

An important change in German employee's invention law will enter into force on October 1 2009 that will simplify the transfer of the employee's ownership of the invention to the employer: any invention of which the employer will be notified after that date will belong to the employer if the employer does not waive its right with respect to the invention within four months of the respective notification. This is to the contrary of the present provision, under which the employer has to explicitly claim the invention in written form within four months after he has been notified of the invention. This has been a major source of legal disputes in employee invention law in the past.

Patentability of pharmaceutical and biotech inventions – what claims are permissible?

In the past, the European Patent Office (EPO) granted claims for second medical indications only when directed to the use of a substance or composition for the manufacture or preparation of a medicament for a specified new and inventive therapeutic application (so-called Swiss-type claims). Due to the amendment of Article 54 paragraph 5 EPC by EPC 2000, it is now provided that Article 54 paragraphs 2 and 3 shall not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in any method for treatment of the human or animal body by surgery or therapy and diagnostic methods, provided that such use is not comprised in the state of the art. That means that it is now permissible to claim "pharmaceutical composition for treating disease x comprising substance y" or "substance y for the treatment of disease x". Such a claim formulation has always been admissible in Germany (Schulte/Moufang, Section 1, number 262).

Regarding patentability of pharmaceutical and biotech inventions, there are two cases of particular importance pending before the Enlarged Board of Appeal at the EP. In the first case (G1/07), the first question is whether an imaging method for diagnostic purpose containing a step of physical intervention is a method for treatment by surgery according to Article 53 (c) EPC, if it does not per se aim at curing; the second question is whether this method is a constitutive step of surgical treatment, if the data obtained can be used immediately during a surgical intervention; and the third question is whether exclusion from patent protection can be avoided by a certain wording of the claim, for example by using disclaimers. The oral proceedings in this case are scheduled for November 11 2009.


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