Under the Law on Patents in force in Cambodia, pharmaceutical products now stand excluded from patent protection [Article 4(iv) and Article 136 of the amended Law on Patents (Royal Kram Nº NS/RKM/1117/016)].
Article 136 - The pharmaceutical products mentioned in the Article 4 of this Law shall be excluded from patent protection until January 01, 2016, according to the Declaration on Agreement on Trade-Related Aspects of Intellectual Property Rights and Public Health of the Ministerial Conference of World Trade Organization dated November 14, 2001 in Doha of Qatar."
Under the Law on Management of Pharmaceutical promulgated by Kram No. ChS/RKM/0696/02 dated on June 17, 1996 and amendment adopted by the National Assembly of the Kingdom of Cambodia on November 8, 2007, a pharmaceutical is one or many kinds of substances which are primarily from chemicals, bio-products, microbes, plants combined in order to use in the prevention or treatment of human or animal diseases, or to use in the medical or pharmaceutical research or diagnosis, or change or support the functioning of the organs.
Accordingly, the following products shall be considered as pharmaceutical products and excluded from protection in Cambodia:
• Serum and vaccines,
• Blood or blood products,
• Traditional medicines,
• Products which are composed of poisonous substances, which are included in a list determined by Sub-Decree.
This waiver would also apply to European, Singapore and Chinese patents providing protection for pharmaceutical products, for which validation is sought in Cambodia. Furthermore, Cambodia currently benefits from the World Trade Organization waiver allowing Least Developed Countries (LDCs) to avoid granting and enforcing IP rights on pharmaceutical products until 2033.
Position in India
The establishment of the World Trade Organization (WTO) has led to a paradigm shift in world trade. The agreement on Trade-Related (Aspects of) Intellectual Property Rights (TRIPS) was negotiated during the round trade negotiations of the General Agreement on Tariffs and Trade (GATT) in Uruguay and the pharmaceutical industry was one of the primary reasons for incorporating intellectual property issues into the framework of GATT. India became a signatory to the GATT on April 15, 1994, which mandated to comply with the requirements of GATT, including the agreement on TRIPS.
Hence, India is required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. Patents are to be granted for a minimum term of 20 years to any invention of a pharmaceutical product or process that fulfils established criteria.
