Wednesday, August 29, 2012

Patent linkages

IP Komodo has reported on Data Exclusivity in Health Department procedures for approving generic drugs. Another area that remains slightly unclear in some Asian markets is the the conflict between a regulatory approval and a patent. In theory you cannot market a drug which has a patent on it, but in practice sometimes there is a conflict of laws between the regulatory approval and the patent grant.

As a result regulatory authorities are supposed to have patent linkage systems whereby the Health Authority should not grant regulatory approval to drugs which have patents on them. The problem is that they do not have the expertise to assess the patents so some slip through the net.

Indonesia adopts a self-assessment approach. The Health agency (BPOM) requires an applicant to produce the results of patent search from the Patent Office for the drug in question showing it is not covered. They will not inquire into the basis of the self-assessment report so long as it covers a series of criteria such as :

a.   No omission from the self-assessment of any patent that is apparently relevant on its face – e.g. patent referring to the key compound;
 b.  It provides reasoned contention why the drug under review is not covered by the patents identified.

This system should capture and applications which would otherwise infringe a patent, however concerns remain that occasionally cases can slip through.
In the Philippines, the Food and Drug Administration (FDA) does not look into whether or not a drug is covered by a patent. The FDA issues a Certificate of Product Registration (CPR), which is a prima facie evidence that the registrant has the authority to market the product. 

In the mid 2000s there was a fight between generic drug companies and pharma companies in which the latter were accused of delaying the approval of generics by raising issues through FDA over patents that supposedly covered the generic drugs that were being introduced. As a result a Department of Health Administrative Order 2005-0001 concerning the Revised Policies and Guidelines Governing Patent and Trade Secret Rights in relation to the Registration of Pharmaceutical Products was enacted which expressly states that IP matters are beyond the legal mandate of the FDA. Any IP matters should be raised before the IPO or the courts. This means there is no patent lineage system and a pharma company objecting to an approval must file a patent litigation suit.


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