A good idea: amending Philippines’s Patent Law

Not all are bad news in the Philippines fight for affordable medicines. There is currently an excellent initiative to amend the Philippine Patent Law and incorporate public health flexibilities to promote greater competitiveness in the Philippine pharmaceutical industry and made medicines more affordable and accessible.

At CPTech we are following with great interest the work of the Philippine’s Senate Committees on Trade & Commerce and Health & Demography, chaired by Senator Roxas and Senator Cayetano, respectively.

On June 7, these two senators filed Committee Report No. 79 containing Senate Bill no. 2263, substituting Senate Bill no. 2139 and which would amend the Intellectual Property Code of the Philippines. On August, 16 2006, Senator Mar Roxas presented a sponsorship Speech.

The proposed bill has a title that is worthy to read: “An act to make the laws on patents, tradenames and trademarks more responsive to the health care needs of the Filipino people by clarifying non-patentable inventions, allowing the importation and early development of patented medicines, and modifying government use provisions for drugs or medicines, to lower prices and increase access to and supply of quality drugs or medicines, amending for this purpose certain provisions of Republic Act no. 8293 otherwise known as the Intellectual Property Code of the Philippines".

Some of the most important public health flexibilities included in the proposed legislation are:

a) Following on the example of the Indian Patent Act, exclude from patentability new indications/uses of existing substances that have already been patented.

b) Express recognition of the early working of a patent (Bolar Amendment in the U.S.)

c) Adopting the doctrine of international exhaustion of intellectual property rights that will allow for the parallel importation of patented medicines from third countries. And in order to make the process more easily operationalize, the proposal includes an exception to the application of trademarks and tradename restrictions when applied to parallel imports.

d) Amends the conditions for the use of a patented invention by the Government (or third person authorized by the Government) without agreement of the patent owner, to make the process simple and fast.

But not everybody is happy with this new turn of the Philippines, as Inside US Trade reported last 4/8/2006, the Pharmaceutical Research and Manufacturers of America (PhRMA) opposes proposed Filipino patent law amendments and in that sense is pressuring Adrian Cristobal, Director General of the Intellectual Property Office of the Philippines.

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.