COMPULSORY LICENSING Usually a multiplex owner asks Disney to please be allowed screen the movie. But here, there is a gun put to someones head and said you HAVE to. Compulsory licensing happens when a fee is reduced. Important in India because of the health requirement. TRIPS and Public Health: TRIPS ProvisionsComment by MADAN: Need to know, Paris, DOHA and know NATCO v BAYER and BAYER v UOI. A- 7 (Objectives): promotion of technological innovationadvantage to producers and users of technological knowledge and in a manner conducive to social and economic welfare and to the balance of rights and obligations. IP owners dont fear this because it is just a blanket statement. A-8 (Principles) : members may, in formulating/amending their laws and regulations, adopt measures necessary to protect public health and nutritionprovided that such measures are consistent with the provisions of this AgreementA-8 is narrowing down social welfare to health. The reason it is more forceful is because it points the finger specifically to drug manufacture. Its like naming and shaming. Appropriate measures, provided that they are consistent wuth the provisions of this Agreement, may be needed to prevent the abuse of IPR by right holders. A-31: Allows certain uses without the authorisation of right holders, subject to conditions. (Fundamentally in opposition to what IP is really about. (national emergency) Paris Convention The root of this is Paris Convention. The framers acknowledged that IP rights can be abused (overpricing of patents). A-30 and 31 of TRIPS and Public Health. 31 allows you to contravene 30. Even if something unreasonably conflicts with the use of patent, you can still sue that. something unlawful being made lawful. But this is subject to conditions. TRIPS again A-31: Individual merits. First has to enter into negotiations with the right owner and those negotiations have to have failed. However, in case of national emergency, no requirement if there is a state of national emergency- epidemic, or case of extreme urgency or in cases of public non-commerical use. Scope and duration only authorized Shall be non-exclusive- if you only give Cipla the license then all can be given that. Non-assignable. (f) Any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use. Essentially means that they cant export. But there are certain countries which dont have the capacity to make drugs etc. so, if there is an epidemic in Africa of yellow fever (g) When the health crisis ends, it shall cease to exist. (h) The rights holder shall be paid adequate remuneration, but taking into account the economic value of the authorization. (i) Subject to judicial review or other independent review by a district higher authority in that Member state. TRIPS: Doha Declaration Concerns expressed by developing countries and LDCs about implications of TRIPS on access to medicines, some confusion about scope of TRIPS flexibilities (the ability to circumvent) November, 2001: Declaration on TRIPS and Public Health adopted by the Fourth Ministerial Conference of the WTO in Doha. Para 1: We recognize the gravity of public health problems afflicting many developing and LDCs especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. (Nobody cares, its like a Fundamental Duty) Para 2: We stress the need for the WTO Agreement on TRIPS Agreement to be part of the wider national and international action to address these problems. Para 3: we recognize that IP protection is important for the development of new medicines. We also recognize the conerns about its effects on prices. Tell me something I didnt know! Para 4: We agree that TRI{S doesnt and shouldnt prevent members from taking measures to protect public health. Accordingly, while reiterating out commitment to the TRIPS Agreement, we affirm that the Para 5: Include the grant to give compulsory licensingits actually clarifies saying that its a right that a member state has. So WE will determine whether there is a health problem. (HIV, malaria- it is recognized as national emergency). It interprets TRIPS in a manner favouring the poorer countries. Why? Because China, Brazil, India (richer Developing countries) and campaigning from Nelson Mandela etc. Para 6: why will countries face a disadvantage? Because if you dont have enough factories please find a solution by 2002. In 2003, waived 31(f), the Govt. of India can now issue compulsory licensing for yellow fever in Africa. So, the check here is judicial reviewit can now be solely for export. It is known as the paragraph 6 system. (Canada issued a compulsory licensing to Rwanda). Using Paragraph 6 system Ecuador: for local manufacture of anti-AIDS medicine Indonesia: for local manufacture of anti-AIDS medicine Mozambique: for local manufacture of Anti-AIDS medicines Taiwan: for Tamiflu- even rich countries can because when there is an outbreak, it needs this. Import Ghana: for import of anti-AIDS medicines from India Thailand: for import of anti-AIDS medicines from India Malaysia: for import of anti-AIDS medicines from India. Amendment of TRIPS December, 6th, 2005: Permanently trying to waive (f) but hasnt come into force yet. Can happen when ratified by 2/3rd of WTO members. Compulsory Licensing in India 9 sections dealing with it. S-84- 3 years from the date of the grant of the patent (takes time to see whether it is unaffordable or something)- also when you get the patent, many companies dont start producing of it. Ground: Reasonable requirements of the public Patentee refuses the grant on reasonable terms Demand supply problem Development of any trade or industry is prejudiced Not worked in the territory of India Pricing problems. Not peculiar only to medicine. S-90- Reasonable royalty to the patentee That CL is non-exclusive, non-assignable. S-92A Allows CL for manufacture of export licensing. Natco v. Bayer N is a generic company based in Hyderabad, applied for a compulsory license to sell Nexavar to treat cancer. (reg in 2008). Natco was waiting for 3 years to get over. They get into negotiations, nothing happens- applies for compulsory licensing. Held by Controller of Patents: Reasonable requirements of the public: not satisfied: Not enough medicines being sold. Price of Nexavar was not reasonably affordable (2.85 lakhs a month)has to be construed predominantly with reference to public rather than R&D costs. Worked in the territory of India- means- manufactured to a reasonable extent in India, Bayer was only exporting a few medicines in India, doesnt constitute working of the patent. Controller fixes royalty at the 6% of the royalty with Bayer. There was an appeal to the IPAB (IP Office, IPAB, HC, SC) Raised this to 7%. Natco is currently selling Sorafenib Tosylate at Rs. 8,800 per month. Referred to the Doha Declarationaccess to medicines- facet of Right to Life Bayer says that it will endanger pharma research. Its not a long term solution to resolving any problems. More than 50% of Cancer patients still cant afford. BDR Pharma v Bristol Myers You cant come to us without negotiating. Patent Controller rejected plea by BDR Pharma to grant CL for manufacture of Dasatinib (anti-cancer drug made by Bristol) BDR argued that drug is unaffordable (Rs. 1 lakh), they can make for Rs 8000 a moth. Refused because no negotiations. Controversial?