Intellectual Property and Access to Medicines

Eisai's position regarding Intellectual Property and Access to Medicines

January 5, 2018

Under our “hhc (human health care)” philosophy, 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 item 2 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 philosophy, 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. Compulsory Licensing

Eisai firmly believes that medicine must be made available to those who need them. This is at the heart of Eisai's hhc philosophy. Eisai fully recognizes that there are circumstances where it is both appropriate and right not to enforce our patent rights in certain countries where the pharmaceutical market is still at a very early stage1) to promote “Access to Medicine.”
Eisai implements patient assistance programs such as affordable pricing and tiered pricing, and also seriously considers granting non-exclusive licenses in order to promote “Access to Medicine.” As such, we believe that compulsory licensing is unnecessary in these circumstances.

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.TRIPS 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.

  • 1)
    “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.
  • 2)
    LDC, LHDC, LIC and Sub-Saharan African countries (excluding South Africa) identified by the World Bank as “Lower-middle-income Countries”(LMIC) and “Upper-Middle-Income Countries”(UMIC) are examples of the countries where the pharmaceutical market is still at a very early stage or lacks the infrastructure to manufacture medicines themselves.
  • 3)
    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 December 2016).
  • 4)
    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 art31(f) with conditions.
  • 5)
    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.