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Access to Medicines

Our Approach

Eisai's position regarding Intellectual Property and Access to Medicines

April 20, 2016

Under our “hhc (human health care)” philosophy, Eisai strives to provide new effective treatments to patients through research and development of innovative medicinal products. For this goal, Eisai commits substantial resources, not only in-house R&D but also third-parties' contributions through ‘Open-Innovation’ opportunities. Furthermore, Eisai promotes research and development of medicines by earliest publication of the outcome and technical details through the patent system.
Launching innovative medicinal product requires enormous resources of time, effort and expense. The patent system encourages such commitment of resources to bring the innovative product at the earliest time to patients and their families by assuring that critical inventions are made public and be properly and appropriately protected.

1. Relation of Patent System and Access to Medicine

Some critics have alleged that the patent system per se could be detrimental for patients in terms of “Access to Medicine.” On the contrary, development of innovative medicines would be discouraged if technical aspects of inventions were not disclosed earlier via the patent system. Furthermore, without appropriate patent protection for inventions, research-based pharmaceutical companies, including Eisai, could not invest vast resources in research and development for pharmaceuticals, thereby stalling development of innovative medicinal products and hindering access to such medicines. Eisai believes that problem of “Access to Medicine” for low income patients can be resolved by such other approaches as affordable pricing and tiered pricing that Eisai adopts in emerging countries.

2. 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 lifetime of medicinal products. In keeping with our hhc mission, 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 values.

3. Compulsory Licensing

Eisai firmly believes that necessary medicine must be made available to those who need them. This is at the heart of Eisai's hhc mission. Eisai fully recognizes that there are circumstances where it is both appropriate and right not to enforce our patent rights but to promote “Access to Medicine”, in certain countries where medicinal market is still at very early stage1). Compulsory licensing would be unnecessary in certain circumstance, where affordable pricing and tiered pricing, as Eisai practices, are adopted in order to promote “Access to Medicine.”

4. Amendment of TRIPS Art. 31bis

We believe that the amendment of TRIPS2) reflected in Art. 31bis3) to provide medicinal products to countries without their own medicinal products presents a reasonable and rational balance between intellectual property protection and the need for protection of public health under appropriate circumstances.

5. TRIPS plus4)

Some TRIPS clauses basically clarify minimal standards for IP protection and do not prohibit 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 are promotive of the free flow of medicines to each all those in need.

“Least Developed Countries”(LDC) and “Low Human Development Country”(LHDC) as identified by the United Nations, and “Low-income Country”(LIC) as identified by the World Bank, are examples of the countries where medical market is still at very early stage.

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 (162 states/regions as of January 2016).

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.

TRIPS plus: It is commonly understood that WTO member states conducting their policy to protect broader IP than required by TRIPS. TRIPS per se allows such a protection in Art1.

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