ºÚÁÏÍø

October 2022

Under our “hhc (human health care)” concept, ºÚÁÏÍø strives to provide new effective treatments to patients through research and development of innovative medicines. For this goal, ºÚÁÏÍø commits substantial resources, not only in-house R&D but also third-parties' contributions through “Open-Innovation” opportunities. Furthermore, ºÚÁÏÍø 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.

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 ºÚÁÏÍø, 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, ºÚÁÏÍø 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 ºÚÁÏÍø adopts in emerging countries, and the following policy in items 2 and 4 below.

ºÚÁÏÍø 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.

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, ºÚÁÏÍø'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.

ºÚÁÏÍø firmly believes that access to medicines must be ensured for those who need them. This is at the heart of ºÚÁÏÍø'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, ºÚÁÏÍø 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, ºÚÁÏÍø 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. 

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.

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.