Yesterday, a new global medicines patent database, the Patent Information Initiative for Medicines (Pat-INFORMED), was launched by WIPO and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA).
Pat-INFORMED is designed to help procurement agencies better understand the global patent status of medicines, for example to anticipate generic launch and to design tenders. It includes a free open access database of patent information, and a platform where procurement agencies can make direct enquiries to companies. This is already happening in many countries. For example, in the UK, the Commercial Medicines Unit asks brand owners about the patents that cover their products, and uses this to determine when to publish competitive tenders or to design tenders to take these patents into account. The patient access schemes liaison unit (PASLU), set up by NICE, also asks companies for information on expiry dates of relevant UK/ EU patents and Supplementary Protection Certificates (SPC) as part of the documentation required to negotiate patient access schemes.
Pat-INFORMED intends to assist such discussions and expand them to countries where these questions are not asked as a matter of course. As IFPMA’s press release explains:
“While information about patent applications and grants reside in the public domain, resources that directly link patents to medicines already on the market are scarce and limited. Tools that directly link granted patents to medicines are only available publicly in certain countries (e.g. the USA's 'Orange Book') or through private third-party databases. Pat-INFORMED aims to help close these gaps and make patent research easier, faster and more accessible to a wider array of health workers.”
The database currently includes patent information on small molecule drugs in certain therapy areas (oncology, hepatitis C, cardiovascular, HIV, diabetes, and respiratory), together with any products on the WHO Essential Medicines List that are not within these therapy areas. It covers a total of 169 INNs. However, it is likely that procurement bodies will still need to carry out further checks, for example for information on SPCs or pending applications. In its second phase, the initiative will extend to all therapeutic areas and explore the inclusion of complex therapeutics.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.