Eisai's position regarding Intellectual Property and Access to Medicines
October 2022
Under our “hhc (human health care)” concept, Eisai strives to provide new effective treatments to patients through research and development of innovative medicines. For this goal, Eisai commits substantial resources, not only in-house R&D but also third-parties' contributions through “Open-Innovation” opportunities. Furthermore, Eisai also strives to contribute to research and development based pharmaceutical industry as a whole through the earliest publication of technical aspects of outcomes using the patent system.
Launching innovative new medicines requires enormous amounts of time, effort and expenses. Aiming to ensure that critical inventions are made public and protected properly, the patent system encourages such commitment of resources to deliver medicines to patients and their families as soon as possible.
1. Relationship between Patent System and Access to Medicine
Some critics have alleged that the patent system per se is detrimental to patients in terms of “Access to Medicine.” On the contrary, development of innovative medicines would be discouraged if technical aspects of inventions are not disclosed earlier via the patent system. Without appropriate patent protection for inventions, research-based pharmaceutical companies, including Eisai, could not invest vast resources in research and development for pharmaceuticals, which would stall the development of innovative medicines and hinder access to them. At the same time, Eisai believes that the problem of “Access to Medicine” for low income patients can be improved via affordable pricing, patient assistance programs such as tiered pricing which Eisai adopts in emerging countries, and the following policy in items 2 and 4 below.
2. Improvement of Access to Medicine
Eisai will sincerely consider granting non-exclusive licenses to qualified third parties wishing to manufacture our patented products to supply to patients in countries where the pharmaceutical market is still at a very early stage1) or countries which lack the infrastructure to manufacture medicines themselves2) within the disease scope covering communicable diseases, Neglected Tropical Diseases as well as maternal and neonatal diseases.
3. Ever-greening
Research-based pharmaceutical companies have sometimes been criticized for establishing an unwarranted patent portfolio in order to extend lifetime of medicinal products (“ever-greening”). We disapprove of obtaining patents simply to extend the lifetime of medicines. In order to realize our hhc concept, Eisai's patents, including patents expiring after a basic composition of matter (COM) patent, will be maintained only when they serve public interests such as innovative formulations, innovative medical uses or other innovations that provide patients more value.
4. Patent Enforcement in the Countries and Areas that have difficulty in Accessing Medicines
Eisai firmly believes that access to medicines must be ensured for those who need them. This is at the heart of Eisai's hhc Concept. In certain countries where the pharmaceutical market is still at a very early stage1), it is important to promote “Access to Medicine”, and therefore, Eisai does not intend to enforce our patent rights within the scope of infectious diseases, Neglected Tropical Diseases as well as maternal and neonatal diseases. In “Lower-middle-income Country” (LMIC) and “Upper-Middle-Income Country” (UMIC) as identified by the World Bank, Eisai will consider not enforcing our patent rights within the aforementioned disease scope, taking into consideration situations surrounding the countries such as access to medicine and economic conditions.
5. Amendment of TRIPS Art. 31bis
We believe that the amendment of TRIPS3) reflected in Art. 31bis4) to provide medicines to countries which lack the infrastructure to manufacture medicines themselves presents a reasonable and rational balance between intellectual property protection and the need for protection of public health under appropriate circumstances.
6锛嶵RIPS plus5)
Some TRIPS clauses basically clarify minimal standards for Intellectual Property (IP) protection and do not prohibit World Trade Organization (WTO) member states from strengthening IP protection as one of their public policies. Each WTO member country should enact such laws and regulations that are WTO-consistent, are in the best interests of their citizens' health, and promote the free flow of medicines to all those in need.
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1锛�“Least Developed Countries”(LDC) and “Low Human Development Countries”(LHDC) as identified by the United Nations, and “Low-income Countries”(LIC) as identified by the World Bank, are examples of the countries where the pharmaceutical medical market is still at a very early stage.
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2锛�LDC, LHDC, LIC and Sub-Saharan African countries (excluding South Africa) in “Lower-middle-income Countries”(LMIC) and “Upper-Middle-Income Countries”(UMIC) as identified by the World Bank, are examples of the countries where the pharmaceutical market is still at a very early stage or lacks the infrastructure to manufacture medicines themselves.
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3锛�TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights): Multilateral agreement of general intellectual property rights. It is validated in all the WTO member states (164 states/regions as of September 2022).
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4锛�TRIPS art31bis: The draft amendment decided by the general council of TRIPS on December 6, 2005. It allows export of certain pharmaceutical products manufactured under the compulsory license by exempting art 31(f) with conditions.
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5锛�TRIPS plus: It is commonly understood that WTO member states can conduct their policy to protect broader IP than required by TRIPS. TRIPS per se allows such protection in Art1.