18th July, 2018
The Standing Committee on the Law of Patents (SCP) of the World Intellectual Property Organization was created in 1998 and is composed by all member states of WIPO and/or of the Paris Union. Its main task is to discuss, coordinate and provide guidelines for the progressive international development of patent law.
The topic of Patents and Health is one of the five substantive topics currently under discussion by the SCP. The discussion was triggered by the presentation of a study prepared by external experts on exclusions from patentable subject matter and exceptions and limitations to the rights, which had been prepared and coordinated by Prof. Lionel Bently.
Discussions at the SCP on the topic of Patents and Health seem to be aimed at striking, and first finding, a balance between incentive and access within the patent system. When dealing with this topic, the main issues discussed by the SCP include the following:
- TRIPS Flexibilities: several proposals seek to enhance the capacities of Member States to adapt their patent regimes to make full use of the so-called “flexibilities” available in the TRIPS Agreement to promote public policy priorities related to public health. Discussions also focus on the desire of developing countries and least developed countries (LDCs) of making full use of these “flexibilities”, which would arguably impact on the access to affordable essential medicines.
- Patent Eligibility: the SCP analyzes how different countries limit the kind of subject matter that would qualify for patent protection. These exclusions can be broadly divided into three classes: (i) exclusions based on policy considerations (e.g., public order, methods of treatment, animals and plant varieties), (ii) exclusions derived from the meaning of the term “invention” (e.g., discoveries); and (iii) exclusions derived from a heightened patentability standard (e.g., the so-called “evergreening”, second medical uses).
- Compulsory Licenses: discussions focus on the right of each member to grant compulsory licenses and their freedom to determine the grounds upon which such licenses are granted. These grounds include lack or insufficiency of working, refusal to deal, anti-competitive practices, emergency, government use and public interest. Discussions also include the implementation of Art. 31bis of the TRIPS Agreement.
- Exhaustion of Patent Rights and Parallel Importation: in view of the right of each member state to freely decide its exhaustion regime, the SCP analyzes the capability of parallel importation to reduce the price of pharmaceuticals by introducing competition.
- Bolar and other exemptions: discussions focus on the right of member states under Art. 30 of the TRIPS Agreement to introduce exemptions to patent rights in cases of experimental or research uses, non-commercial uses, prior uses and uses for regulatory approval (i.e., Bolar exemption).
- INN disclosure: it has been discussed whether it would be desirable to introduce a mandatory disclosure requirement of INN (International Nonproprietary Name, also known as a generic name) in patent applications and patents as a way to find out all relevant patents relating to a particular medicine.
- Admissibility of Markush claims (broad patent claims that may apply to a broad range of compounds): discussions focus on whether Markush claims based on theoretical inference can be considered to satisfy the criteria for patentability.
- Patent quality: although this issue is not specifically limited to the topic of Patents and Health, the SCP analyzes the difficulties experienced by the IP offices in meeting the increasing demand for patents and reducing existing backlogs.
There is no underestimating the importance of these discussions, the result of which may determine whether in future patent rights will be upheld or eroded.