Intellectual Property Philippines (IP Philippines) recently held a public consultation on the crafting of the Implementing Rules and Regulations (IRR) of provisions under the Cheaper and Quality Medicine Bill (RA 9502) amending 10 Sections of the Intellectual Property Code (RA 8293).

IP Philippines Director General Adrian S. Cristobal, Jr., together with the IP Philippines Taskforce, presented the amended provisions to various sectors for comments and clarification. “This session is limited to the provisions under the RA 9502 which amended the IP Code. Other bureaus or agencies attached to the Department of Trade and Industry (DTI) and Department of Health (DOH) will be undertaking its own process,” Cristobal said. “Eventually, all agencies concerned will coordinate, compare and reconcile, if needed, the different rules, until the final IRR are completed,” he added.

Provisions for granting compulsory licenses (Section 93) drew the most comments during the consultation, with the provisions on government’s use of invention (Section 74) a close second.  

Under Sec. 93 of the Intellectual Property Code (RA 8293), as amended, IP Philippines’ Director General may grant compulsory license on a patented invention if: (1) there is national emergency; (2) the public interest is at stake particularly in the field of national security, nutrition, or health; (3) the manner of exploitation by the patent owner has been determined as anti-competitive; (4) there is public non-commercial use of the patent by the patentee; (5) the patented invention is not promoted in the country on a commercial scale; and (6) the Department of Health Secretary determines that the demand for the patented drug is not being met. 

Under Section 93A, the Director General may issue a special compulsory license for the importation of patented drugs and medicines under the TRIPS Agreement upon the filing of a petition and written recommendation of the Secretary of the Department of Health.

Under the same section, no court, except the Supreme Court of the Philippines, shall issue any temporary restraining order or preliminary injunction or such other provisional remedies that will prevent the grant of a special compulsory license.

Section 74 enumerates instances and qualifications where a Government agency or third person authorized by the Government may exploit an invention even without agreement of the patent owner.

Aside from Sections 74 and 93, RA 9502 amended the IP Code provisions on: non-patentable inventions (Section 22), inventive step (Section 26), limitations of patent rights (Section 72), civil action for infringement (Section 76), period for filing a petition for a compulsory license, requirement to obtain a license on reasonable commercial terms (Section 95), rights conferred (Section 147), and limitation to action for infringement (Section 159).

RA 9502 mandates the IP Philippines, in coordination with DOH and the Bureau of Food and Drugs (BFAD), to issue and promulgate the IRR within 120 days after its enactment to effectively implement the provisions of RA 9502 that relate to RA 8293.

“We shall put flesh to the letter and spirit of the Cheaper and Quality Medicines Act to ensure the objectives of the law are earnestly pursued and achieved within the framework of the Constitution, State policies, existing laws, and international treaties and agreements,” Cristobal said.

Cristobal informed the participants that after the consultation and after receiving all written position papers in the days to come, IP Philippines shall immediately craft the IRR pertaining to amendments to the IP Code. IP Philippines will post them on its website for further or additional comments. IP Philippines shall also coordinate with other agencies identified by the law as responsible for crafting the IRR. After it has finished the review and reconciliation, IP Philippines may call for another public hearing, depending on what the DTI and DOH determine.

Over seventy participants from Congress, government agencies, consumer organizations, NGOs, pharmaceutical companies, university/research institutions, private associations and law firms attended the consultation.

The crafting of whole IRR of RA 9502 is spearheaded by the Department of Health and the Department of Trade and Industry.

Media that featured the story:

• Philippine Daily Inquirer (8/22/2008)
• Philippine Star (8/1/2008)