TRIPS protects ‘trade secrets’ linked to pharma, agri-chemical products
Undisclosed information includes all technical, technological information, knowledge and secrets related to a commodity or a particular product, including innovations, formulations, components, elements or industrial methods, methods or means maintained by the producer or manufacturer
The WTO Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) contributes to the protection of undisclosed information (trade secrets) related to pharmaceutical and agricultural chemicals, according to the Ministry of Commerce, Industry and Investment Promotion. Article 39 of the TRIPS agreement, terms it “Protection of undisclosed information”, and includes it within the intellectual property, which is similar to trade secrets protection system in US law.
Amina bint Sulaiman al Balushi, a pharmaceutical patent specialist in the National Intellectual Property Office at the ministry, said: Article 39.1 of TRIPS agreement stipulates that undisclosed information includes all technical, technological information, knowledge and secrets related to a commodity or a particular product, including innovations, formulations, components, elements or industrial methods, methods or means maintained by the producer or manufacturer, and not disclosed.
In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3, she noted.
Accordingly, the protection prescribed for undisclosed information is focused on two types of information: the first type includes the confidential information and data that belong to natural and legal persons who shall have the possibility of preventing information lawfully within their control from being disclosed in accordance with Article 39, paragraph 2, while the second type includes the data and information submitted to the government agencies when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products in accordance with Article 39, paragraph 3. So the agreement has obligated member states to protect both types of information with the rules that are stipulated in Article (10) bis of Paris Convention, while it considered the infringement of this information is an unfair competition.
Significantly, the right of ownership of confidential information is not limited to its owner, as others can, if they obtain this information or develop it independently on their own through researches that they are conducting or through reverse engineering or to any other lawful way.
The agreement also prohibits third parties from using and obtaining it illegally, as indicated in Article (65), paragraph 1, of the Omani Industrial Property Rights Law 67/2008, stressing that certain conditions, including general and special conditions must be met in the information so that it can be legally protected.
Amina also pointed out that the required general conditions for protection of the such information includes that the information must be confidential, and of commercial and economic value, while the holder of the information shall seriously take measures to preserve the confidentiality of the information. This is as indicated in Article (65), paragraph 2, of the Omani Industrial Property Rights Law 67/2008.
The special conditions are related to the second type of information and data submitted to the competent government agencies to obtain a licence to market pharmaceutical products and agricultural chemical products, where the submission of data and information to the government entity must be a necessary condition for obtaining a licence to market medicines or agricultural chemical products.
For example, it is known that pharmaceutical companies shall not launch any medicine in the market until after conducting a lot of experiments, tests and clinical trials that are financially costly and go through stages, which may take a long time to ensure the safety and effectiveness of the drug.