TRIPPING ON TRIPS
Another problematic amendment is Section 93-A regarding the grant of a “special” compulsory license. The provision, he says, “operationalizes” Paragraph 6 of the Doha Declaration on TRIPS and Public Health that calls for making effective use of compulsory licensing by countries with insufficient or no drug manufacturing capacity.

Peria says that legislators may not have realized the international implication of their action when they “unwittingly” grafted to this section Article 31 bis. He says this is an amendment to the TRIPS Agreement that was meant as a "permanent solution" to the issues raised in relation to Paragraph 6 of the Doha Declaration.

In an August 30, 2003 decision, the WTO General Council proposed a “temporary solution” by waiving the limitation that compulsory licenses should be predominantly for the supply of the domestic market. But patent experts and public-interest health groups criticized the decision, noting that it also imposed several conditions and procedures for generics exporters and importers that were largely seen as hindering access to medicines.

Essentially, what Article 31 bis does is to remove this limitation on the grant of compulsory licenses. But Peria says that by calling it “special,” Section 93-A is a “misapprehension” of Paragraph 6 of the Doha Declaration.

“(Paragraph 6) doesn't refer to the license, but to the process that may be undergone by a country that accepts the Article 31 bis amendment to the TRIPS Agreement,” he explains. “What does that make of the other compulsory licenses in the other provisions of the IP Code? Is there basis for that distinction? Without any basis, the provision can be easily questioned in court.”

Besides, the amendment has yet to come into force, with less than two-thirds of WTO member-nations ratifying it.

Other potentially litigious amendments, says TWN, are the anti-evergreening provisions found in Sections 22 (on Non-Patentable Inventions from HB 2844) and 26 (on Inventive Step from SB 1658).  Patterned after amendments in the India Patents Law, both sections exclude from patent protection “new uses” of a previously patented product or process. This addresses the phenomenon of “evergreening,” which consists of the patenting of minor changes to existing products (e.g., formulations, dosage forms, polymorphs, salts, etc.) thereby artificially extending the protection conferred by the original patent over a drug.

Peria says that what legislators might have thought of as double protection against the proliferation of frivolous patents on just about any demonstrable “new use” could be construed as a case of double standards. PHAP, which has insisted that the current IP Code has sufficient safeguards against double patenting and evergreening, may well question these provisions for making it doubly difficult for drug firms to comply, he says.

A VEILED U.S. WARNING?
Heightening worries of public-health advocates regarding the IP amendments is the release last month — just as the bicameral debates on the bill were winding up — of the annual IP report of the U.S. Trade Representative (USTR).

The report highlights, among others, the need for proper implementation of the TRIPS Agreement by developed and developing country-members of the WTO. According to the United States, it will consider all options, including (but not limited to) initiation of dispute settlement consultations in cases where countries do not appear to have implemented fully their obligations under the agreement.

Yet while the Philippines is on its Watch List, the USTR’s concern is more on the apparent increase in piracy cases, particularly concerning books, as well as illegal downloads using mobile devices and the Internet, and illegal camcording of films in cinemas.

Still, the report’s comments on Thailand, which remains on the USTR’s Priority Watch List, could be a veiled warning to the Philippines. After all, the report cites the “overall deterioration” in Thailand of IP rights protection, which includes the use of compulsory licenses to produce cheaper versions of patented medicines.

The USTR has urged Thailand to respect the viability of the existing patent system. It sides with the developed-nation pharmaceutical industry that has expressed concern that “the use of such licenses in mid-size economies such as Thailand could inflict economic harm on the industry and its ability to carry out research and development.”

The Office of the U.S. Trade Representative was suspected of attempting to modify some of the provisions in House Bill 2844 during the deliberations prior to its passage on third and final reading last year. An unsigned position paper circulated among members of the Lower House’s trade and industry committee was traced to the USTR based on references in the paper to U.S. “modern free trade agreements.”

The paper had called the legislators’ attention to the strict definition of patentability and the provision on the government’s use of compulsory licensing in the House bill.