[Ip-health] German Court invalidates drug dosage patent

[James Packard Love]

*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.

http://ipgeek.blogspot.com/2007/03/german-court-invalidates-drug-
dosage.html

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 K=F6kl=FC, Simmons & Simmons, D=FCsseldorf

----------------------------------------------
James Packard Love
Knowledge Ecology International
http://www.keionline.org
james.love@keionline.org
Washington, DC +1.202.332.2670

"If everyone thinks the same: No one thinks." Bill Walton"