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About prostate enlargement and hair loss

July 2011 - Intellectual Property. Legal Developments by Norrbom Vinding Law Firm, member of ius laboris.

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0.05-1.0 mg ”finasteride” against hair loss. The UK and French courts could not agree if this dose was patentable.

In Europe, deciding how a sick person should be treated is the doctor’s prerogative. Therefore, businesses will only be able to patent substances that have a therapeutic effect – not methods for therapeutic treatment. But which rules apply to an invention which is a substance that has a therapeutic effect at a particular dose?
A global pharmaceutical company was granted a patent in 1978 on the substance finasteride against prostate enlargement. In 1993, the company applied to have the substance patented again – this time, for treatment of hair loss. The application claimed a dose of 0.05-1.0 mg. As the competition had already disclosed that the substance could be used against hair loss, the invention consisted of the dosage itself.
Disagreement about doctor’s prerogative
A competitor sued in France, the UK and Germany to have the patent invalidated.
The UK courts dismissed the competitor’s claim, referring to the fact that businesses can patent the use of an already known substance for the treatment of a ‘new’ disease. The UK courts therefore held that the use of a substance is also patentable even if the only thing novel is a change in dosage. The European Patent Office took the same view.
The German and French courts, however, reached the opposite conclusion. They held that a patent on a substance at a particular dosage must be seen as concerning therapeutic treatment – which is the doctor’s prerogative.
Norrbom Vinding notes:
  • that the patentability of dosage is an issue that has been raised a number of times during the past 10 years, without having led to agreement between the courts of the various European countries; and

  • that there is a strong case for arguing that a product at a particular new dosage should be considered a new product, which may raise suspicions that the reluctance of some countries may be rooted in the fact that these patents are often described as a method to extend the patent term of the substance itself.
The above does not constitute legal advice and should not be relied upon as such

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