A bad idea: settlement proposal for the Pfizer-Philippines Litigation
There are changes in the Pfizer litigation I reported some months ago. The Philippine court dealing with the case released a settlement order (available here and here). At CPtech we have studied the settlement proposal and I would like to share with you our analysis.
The paragraph 2 of the order, aims to introduce linkage of patent and health registration in the Philippines, although a 2005 Department of Health Administrative Order, clearly stated the Government of the Philippines intentions not to accept linkage.
What is linkage? Patent-Registration Linkage is the practice of linking drug marketing approval to the patent status of the originator’s product and not allowing the grant of marketing approval to any third party prior to the expiration of the patent term unless by consent of the patent owner. This practice requires that "second applicants" for marketing approval (usually generics) demonstrate that the pharmaceutical product for which they are applying is not protected by a valid patent. Under this kind of regulation, national regulatory authorities have the obligation to prevent the registration and marketing of a generic pharmaceutical when a patent covers the product.
The use of linkage is subject to several critiques, the most important is that linkage creates many problems if the national patent office grants low quality patents. If linkage is introduced in the Philippines through this settlement, Pfizer is the clear winner in this litigation and will force the Philippine health administration to act as a patent police.
The paragraph 2 of the order, aims to introduce linkage of patent and health registration in the Philippines, although a 2005 Department of Health Administrative Order, clearly stated the Government of the Philippines intentions not to accept linkage.
What is linkage? Patent-Registration Linkage is the practice of linking drug marketing approval to the patent status of the originator’s product and not allowing the grant of marketing approval to any third party prior to the expiration of the patent term unless by consent of the patent owner. This practice requires that "second applicants" for marketing approval (usually generics) demonstrate that the pharmaceutical product for which they are applying is not protected by a valid patent. Under this kind of regulation, national regulatory authorities have the obligation to prevent the registration and marketing of a generic pharmaceutical when a patent covers the product.
The use of linkage is subject to several critiques, the most important is that linkage creates many problems if the national patent office grants low quality patents. If linkage is introduced in the Philippines through this settlement, Pfizer is the clear winner in this litigation and will force the Philippine health administration to act as a patent police.
posted by ju at 12:08 PM
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