Shionogi Group Intellectual Property Policy

  Based on the Shionogi Group’s purpose to "supply the best possible medicine to protect the health and wellbeing of the patients we serve," we research and develop new medicines with the aim of making a positive contribution to all stakeholders.

 

  To deliver on this purpose at a global level, we will increase the Company's value by making sure to appropriately protect the various innovations produced in the course of our research and development as our intellectual property. Moreover, we will promote intellectual property measures that improve access to medicines.

 

 

1. Ensuring appropriate intellectual property protection

 

  The patent system aims to reward inventors by granting them exclusive rights for a limited period of time to foster new intellectual creations. This provides incentives to advance technology, and thereby advance the economy of society as a whole.

    The Shionogi Group establishes a framework to protect our inventions with patents, utilize our patent rights, monitor potential infringement by third parties, and take appropriate legal action, if necessary. In addition, we manage our business activities so that they do not infringe the valid patent rights of third parties. 

  The circumstances surrounding the research and development of medicines are quite unique, given the low success rate, the long span of time involved in research and development from when the basic research starts until the medicines go on the market, and the tremendously high expenses involved. As such, contributing to society through continuously providing groundbreaking products and technologies means, we must make sure to recover our investments in research and development as well as invest in innovative research and development to achieve future growth. The Shionogi Group believes that properly and securely protecting the fruits of our research and development by means of patents is profoundly important.

  On the other hand, in exchange for granting an exclusive right, the patent system requires that we fully disclose the invention, discovered by spending our money, time, and labor, for public use. As a result, an invention protected by a patent is made well-known to people worldwide, including those in developing countries. This enables them to actually use the invention, and provides opportunities for even further progress and added improvements, thereby contributing to the continuous development of society as a whole.

  As described above, it is our belief that appropriate and reliable patent protection of medicines stimulates their continuous creation and manufacture, and that building partnerships where needed can lead to the development of distribution infrastructure for the global supply of medicines as well as to new employment opportunities. We will proactively contribute to improving access to medicines by supplying the medicines that we create and manufacture, as well as information about these medicines, to patients worldwide.

  As for intellectual property other than patents, we will promote brand design activities as well as protection of trademarks, designs, copyrights, and trade secrets, with the aim of ensuring the credibility of our brands and preventing imitations.

 

 

2. Promoting intellectual property measures aimed at improving access to medicines

 

  Today, people in developing countries have limited access to necessary medicines due to economic reasons and problems with the supply chain. Under these circumstances, we recognize the enormous importance of supplying medicines that can help treat infectious diseases to those in need, given that those diseases are closely related to the medicines we manufacture and can directly lead to death.

  In this regard, we consider improving access to medicines to be a source of our competitiveness in line with our Company Policy, and we will appropriately promote the following measures on intellectual property with the aim of improving access to medicines.

 

a) We will not apply for patents, and will not exercise patent rights, in any of the least developed countries ("LDCs" as defined by the United Nations) or any of the low-income countries ("LICs" as defined by the World Bank), or in most of the lower middle-income countries ("LMICs" as defined by the World Bank).

 

b) If we are requested by an appropriate third party to supply medicines that we have developed to all of the LDCs and LICs, or to most of LMICs, in order to improve access to medicines in accordance with the spirit of international agreements and treaties*, we will consider granting licenses for our patents under appropriate terms and conditions. If the licensing is restricted by an agreement with a different party, we will sincerely negotiate the matter with the different party. In addition, we will also consider granting voluntary licenses for our patents through existing patent pools and the like, to supply our products for which there is high medical need, such as anti-infectives, to patients in need in the aforementioned countries.

 

c) The Shionogi Group has participated in the Patent Information Initiative for Medicines (Pat-INFORMED), which helps to facilitate access to basic patent information on approved medicines, ever since its foundation. We create opportunities for communication with third parties interested in bringing our products to patients who need them and promote appropriate licensing activities.

 

(Established on July 1, 2020)

 

*) The Doha Declaration on the TRIPS Agreement and Public Health was adopted in November 2001. In August 2003, it was decided that exemptions from performance obligations according to Article 31 (f) of the TRIPS Agreement shall be given, under certain terms and conditions, in countries lacking sufficient production capacities in order to supply medicines that are produced under compulsory licenses and which are essential for handling public health issues. The TRIPS Agreement was revised in January 2017. Furthermore, the TRIPS Council has extended the exemption on performance obligations by LDCs with regard to medicine patents until 2033.

 

 

 

Note) Our specific engagements, aimed at directly supplying our medicines in order to improve access to medicines, are described in the Shionogi Global Health Access Policy Statement as follows.

 

1) Shionogi considers the value and affordability of a medicine carefully and tailors the pricing strategy for each product to the dynamics of each country and its healthcare system.

 

2) Dolutegravir, an integrase inhibitor for the treatment of HIV discovered and developed jointly by Shionogi and ViiV, is included in the Medicines Patent Pool. The license permits generic manufacturers to manufacture dolutegravir, as a standalone or in combination with other HIV therapies, and distribute it to more than 130 low-income and lower middle-income countries.