New limited substitution rules for medicinal products protected by second medical use patents
By
Mikkel Vittrup
28 October 2015
On the basis of the ruling by the Danish Maritime and Commercial High Court of 25 June 2015 in the Lyrica case the Danish Health Authority has now presented a proposal to change the substi-tution rules with the result that in future they will take into account the patent protection of certain indications in connection with the pharmacies' dispensing of medicinal products.
Specifically, it is proposed that a new provision (section 38a) be incorporated into the Danish Prescription Order with the following wording:
§ 38a. When processing a prescription for a medicinal product that due to a patented indication is not included in a substitution group with medicinal products synonymous with the medicinal product, the pharmacy shall dispense the cheapest synonymous medicinal product in compliance with the rules laid down in section 38, but see (2).
(2) If a prescription for a medicinal product specified in (1) above has been issued for the treatment of the patented indication, the pharmacy shall dispense the medicinal product with the patented indication.
(3) The Danish Health Authority notifies the phar-macies when a medicinal product has a patented indication, see (1) and (2) above.
The new provision is proposed as a consequence of the Danish Maritime and Commercial High Court's ruling in the Lyrica case which resulted in it being impossible to include generic versions of the medicinal product Lyrica® in the same substitution group. The new provision entails that the pharmacies are not to substitute the medicinal product if the medicinal product has been prescribed for the treatment of a patented indication. The pharmacies must also dispense the patented medicinal product if the doctor has decided to prescribe a generic medicinal product for the treatment of the patented indication (off-label). But the pharmacies are to substitute the medicinal product if the medicinal product has been prescribed for the treatment of a non-patented indication.
Pharmaceutical companies that have patented a specific indication are urged to notify the Danish Medicines Agency of such fact by writing an email to the following address: godtjur@dkma.dk.
Moreover, no distinction is made between the different types of patent claims for the treatment of certain indications (the so-called Swiss-type claims and EPO 2000 claims).
It is expected that the new rules on limited sub-stitution will enter into force on 1 November 2015.
The ruling can be read here (in Danish only).
The proposed amendment to the Danish Statutory Order on Prescriptions can be read here (in Danish only).
§ 38a. When processing a prescription for a medicinal product that due to a patented indication is not included in a substitution group with medicinal products synonymous with the medicinal product, the pharmacy shall dispense the cheapest synonymous medicinal product in compliance with the rules laid down in section 38, but see (2).
(2) If a prescription for a medicinal product specified in (1) above has been issued for the treatment of the patented indication, the pharmacy shall dispense the medicinal product with the patented indication.
(3) The Danish Health Authority notifies the phar-macies when a medicinal product has a patented indication, see (1) and (2) above.
The new provision is proposed as a consequence of the Danish Maritime and Commercial High Court's ruling in the Lyrica case which resulted in it being impossible to include generic versions of the medicinal product Lyrica® in the same substitution group. The new provision entails that the pharmacies are not to substitute the medicinal product if the medicinal product has been prescribed for the treatment of a patented indication. The pharmacies must also dispense the patented medicinal product if the doctor has decided to prescribe a generic medicinal product for the treatment of the patented indication (off-label). But the pharmacies are to substitute the medicinal product if the medicinal product has been prescribed for the treatment of a non-patented indication.
Pharmaceutical companies that have patented a specific indication are urged to notify the Danish Medicines Agency of such fact by writing an email to the following address: godtjur@dkma.dk.
Moreover, no distinction is made between the different types of patent claims for the treatment of certain indications (the so-called Swiss-type claims and EPO 2000 claims).
It is expected that the new rules on limited sub-stitution will enter into force on 1 November 2015.
The ruling can be read here (in Danish only).
The proposed amendment to the Danish Statutory Order on Prescriptions can be read here (in Danish only).
