AIDS Access Foundation, et al.. v. Bristol Myers-Squibb, et al.

The Plaintiffs were the AIDS Access Foundation, a non-governmental organization committed to protecting the rights and welfare of people living with HIV, and two persons living with HIV. The Defendant, Bristol Myers-Squibb, is a multinational pharmaceutical company based in the United States. The Court also summoned the Department of Intellectual Property as co-defendant.

Defendant Bristol Myers-Squibb applied for a patent for didanosine, a reverse transcriptase inhibitor effective against HIV and used in combination with other antiretroviral drug therapy. The patent claim stated that it was a “better formula for oral use” and stipulated the dosage “from about 5 to 100 mg per dose.” Defendant later amended the patent claim to delete the dosage stipulation.

The Plaintiffs claimed the amendment to the patent was unlawful and requested the Court to amend the patent to include the dosage stipulation. They contended that without the stipulation Defendant’s patent protection would be so broad as to severely restrict access to HIV medicines in Thailand by reducing access to affordable drugs, in violation of the rights of people living with HIV. They noted that didanosine was unaffordable for many people living with HIV and could not be replaced by other medicines. The Plaintiffs claimed that the Thai Pharmaceutical Authority (the Authority) had attempted to manufacture didanosine tablets of more than 100 mg per dose to market at an affordable price. However, the Authority decided not to manufacture the drug because the Defendant’s representative claimed the scope of its patent prohibited them from doing so.

The Defendant claimed the Plaintiffs did not have standing to challenge its patent, as they were not manufacturers or sellers of the medicine protected by the patent. The Co-defendant Department of Intellectual Property argued that the Plaintiffs were not injured or interested parties and were not entitled under the Patent Act to assert the invalidity or request the revocation of the patent. The Co-defendant also contended that the patent amendment was not a material amendment and that the Defendant was not permitted to manufacture any dosage of the patented drug simply because the dosage stipulation had been removed. Rather, according to the Patent Act, the “scope of invention shall be determined by the Patent claim, taking into account the nature of invention from the details of the invention.”

The Court granted standing to the Plaintiffs. It  held that injured parties were not limited to the manufacturers or sellers of the medicine protected by the patent. Rather, patients and those in need of the medicine, as well as organizations that help people living with HIV to access the medicine, were also interested parties entitled to bring suit.

The Court  also held that the deletion of the dosage stipulation from the patent claim was unlawful and that the claim must be amended to include the stipulation as requested by the Plaintiffs. It stated that medicines were fundamental to the well-being of human beings and were thus distinct from other patented inventions that people may or may not choose for consumption. It stressed that treatment for the life and health of human beings was “[more] important than other property.” It noted that the Doha Declaration on the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and Public Health, adopted by the World Trade Organization in 2001, declared that the TRIPS Agreement was to be interpreted and implemented so as to promote the rights of Member States to protect public health, particularly in regard to access to medicines.

The Court held that deletion of the phrase “from about 5 to 100 mg per dose” from the patent claim was a material amendment that granted the Defendant protection for all dosage amounts of the medicine. The Court held that the phrase “material to the invention” includes both details of the invention and the patent claim itself. The Defendant’s amended patent claim went beyond the scope stipulated in the original claim and the scope of invention was thus extended beyond what was disclosed in the details of the invention.

The Court held that the Defendant must register the amendment of the patent, to reintroduce the dosage stipulation, or the Department of Intellectual Property would amend the claim pursuant to the Court’s ruling.

"Since the medicine is one of the fundamental factors necessary for human being, as distinct from other products or other invention that the consumers may or may not choose for consumption. The treatment of life and health of the human is of the most important than any other property. This was recognized internationally in the 4th Ministerial Meeting of the World Trade Organization at Doha, Quatar from 9 to 14 November 2001, in which it was confirmed of the importance of the Treaty on the Rights on Intellectual Property (TRIPS) in relation to the public health. It was insisted that the TPIPS be interpreted and implemented so as to promote the rights of the members to protect the countries’ public health, especially, the promotion and support of the access to medicine of the people as a whole. Therefore, the injured parties from the grant of Patent are not limited to the manufacturers or the sellers of medicine protected by the Patent. The patients or those in need of the medicine are also interested parties to the grant of the Patent." Translation page 7.

"The words “adding of materiality” mean by themselves that the material parts are changed. Therefore, the deletion of phrase may be the adding of materiality. The deletion of the phrase “from about 5 to 100 m.g. per dose” from the original Patent claim changed materiality of the Patent claim. As a result the patent holder received more protection for the unlimited portion of dosage, which is beyond the scope stipulated in the original Patent claim, and the scope of invention is extended beyond those disclosed in the details of invention. The deletion of phrase “from about 5 to 100 m.g. per dose” is therefore prohibited by law." Translation page 9.