German Court invalidates drug dosage patent

Germany's highest court, the Bundesgerichtshof rendered its decision in the Carvedilol II case. Subject of the decision of the Federal Court of Justice was the validity of a patent claim containing a specific dosage instruction for Carvedilol, a beta blocker indicated in the treatment of congestive heart failure. The patent claim contained detailed instructions regarding the use of carvedilol as follows:

"[...]
4.1.1. administering a pharmaceutical formulation which contains either 3.125 or 6.25 mg carvedilol per day,
4.1.2. for a period of 7-28 days,
4.2.1. followed by an increase of the dosage
4.2.2. each with an interval of 14 days
4.3. administering finally a maximum dosage of 2 x 25.0 mg carvedilol per day."

The Federal Court of Justice revoked the claim and underlined that a specific dosage instruction for the use of drugs should be seen as a non-patentable method for treatment of the human body. According to the reasons of the decision the non-patentability results from the spirit and purpose of Art. 52 (4) EPC. The provision reflects the will of the legislator to protect a doctor's freedom to determine an individual therapy plan for patients, in particular to determine the dosage of drugs individually, without being restricted by opposing patent claims. Further, the court concluded from the non-patentability of such dosage instructions that these isntructions should not be considered for the question of novelty and inventiveness regarding the remaining part of the claim. Unfortunately, the court has made no clear statements regarding the question, whether claims containing such non-patentable dosage instructions are entirely invalid even though the remaining part of the claims may still be novel and inventive. While the European Patent Office assessed in several cases that such claims are invalid as a whole, the Federal Court of Justice left this question explicitly unanswered.

Nonetheless, this decision restricts the possibilities for life science companies to expand protection for their patents by simply formulating dosage instructions in their patent claims. Since it cannot be excluded that the use of specific dosage instructions may lead to the revocation of a whole claim, applicants have to draft new patent applications very carefully and should refrain from any reference to dosage instructions for the use of medicines within the claims. They should focus more on the ingredients and substance of the medicine itself.

Dr. Kaya Köklü, Simmons & Simmons, Düsseldorf