Sanofi believes that patents are a fundamental incentive for driving innovation in the pharmaceutical sector.
The development of new medicines and vaccines is a risky, costly, and lengthy process. Patents are an essential incentive for pharmaceutical companies to invest in research & development to address unmet medical needs. IP policies therefore need to be safeguarded. While patents by themselves should not be considered a barrier for access, Sanofi believes that being transparent and flexible with our patents can help address pressing health challenges in developing countries. In order to enable access to our medicines and vaccines:
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Sanofi makes patent status of their Essential Medicines and Vaccines in developing countries publicly available (see Annex I of the R&D for Unmet Needs and Patent Management Factsheet);
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Sanofi does not file patent applications or enforce patent rights in all Least Developed Countries (LDCs) and Low-Income Countries (LICs);
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Sanofi does not file or enforce patents in several Lower-Middle-Income Countries (LMICs) and Upper Middle-Income Countries (UMICs). See Annex II of the R&D for Unmet Needs and Patent Management Factsheet for the complete list of countries;
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Sanofi supports the implementation of the 2001 WTO Doha Declaration on Trade Relate Aspects of Intellectual Property Rights (TRIPS Agreement) and Public Health and the appropriate use of the flexibilities therein intended to protect public health;
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Sanofi supports the transition period that LDCs are exempted from obligations under the TRIPS Agreement regarding pharmaceutical patents until January 1, 2033. We support this exemption of LDCs and an extension of the exemption beyond 2033;
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Sanofi acknowledges the value of voluntary licensing agreements and patent pools for access to medicines in developing countries. We would consider joining patent pools and engaging in voluntary licensing if relevant to our portfolio, and aimed at accelerating access to medicines and vaccines in low- and middle- income countries;
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Sanofi respects compulsory licensing as a short-term and targeted measure where urgent access to patented medicines is critical to maintaining public health, and no appropriate alternative is available. We believe that compulsory licenses should only be used in extraordinary and very limited circumstances, such as meeting a health crisis or emergency; and
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Sanofi respects a formal exemption from patent infringement for activities which are undertaken as part of the regulatory review process: “conducting the necessary studies and trials with a view to the application of paragraphs 1 to 4 [i.e. bioequivalents and biosimilars] and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.” (Bolar exemption, Directive 2004/27/EC. Article 10(6)).