The bicameral version also adopted Section 93-A that was introduced in the House bill, which provides an alternative procedure for the issuance of a special compulsory license under the framework of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

The IPO itself has declared that these amendments are a legitimate exercise of the flexibilities accorded to developing countries like the Philippines in the Doha Declaration on the TRIPS and Public Health.

The World Trade Organization (WTO) had adopted the TRIPS Agreement in November 2001. More than six years later, however, such flexibilities have yet to be incorporated in Philippine intellectual property law that would have made it more responsive to the problem of inaccessible medicines and expensive drug prices.

HOLE-RIDDEN AMENDMENTS?
Lawyer Peria says he is happy that the IP amendments made it to the final draft of the bill. But he echoes other experts in pointing out some of these are likely to face challenges from pharmaceutical companies in court. Congress should have strengthened these so they could withstand such challenges, he says.

In fact, from the outset, multinational drug companies, particularly those represented by the Pharmaceutical and Healthcare Association of the Philippines (PHAP), had opposed the proposed amendments to the intellectual property law. As the drug companies see it, these would weaken the country’s patent system.

In PHAP's 27-page position paper submitted to Congress during deliberations on the bill, 17 pages were devoted to the changes in the IP Code, arguing that these are discriminatory and violative of the due process and equal protection clauses of the Constitution. It also said that these were inconsistent with the country’s international treaty obligations of the Philippines.

These days, Peria’s organization, TWN, has made known its concerns over the final draft’s Section 72, which is on the international exhaustion of patent rights. Peria says this provision was weakened when the bicameral panel opted to retain the national exhaustion principle by inserting the phrase “in the Philippines.” He says this provides patent owners with additional ammunition for litigation as they can argue that the national exhaustion rule still applies in specific circumstances when there is a patent existing in the Philippines for the drug in question.

Section 72.4 on the “early working” or Bolar provision adopted from the House bill, meanwhile, is also weak since it copied the data protection provisions of Article 39.3 of the TRIPS Agreement without its key provisos, says Peria.

These provisos, he explains, stipulate that data protection applies only to new chemical entities and that it should involve data generated through a considerable effort and investment. Without these, the section practically imposes higher levels of intellectual property protection — also known as TRIPS-plus rules — that tend to undermine or weaken the public-health safeguards allowed under TRIPS.

The same is true of Section 74 in regard to government's use of an invention, says Peria, as it qualifies the public non-commercial use of the patent by the government with the phrase “without satisfactory reason.” This, the lawyer says, is an additional requirement that is not found in the TRIPS Agreement.

And while Peria says that a stipulation allowing government use in case demand for the patented medicines is not met is good, it could be subjected to litigation by the patent-holder because of the phrase “to an adequate extent and on reasonable terms.”