Publishing comprehensive and transparent patent information

The transparent management of intellectual property, including information about where patents are filed and enforced, can facilitate the affordable supply of medicines by supporting market entry by generic medicine manufacturers and informing decision-making by international procurers. For example, clear and reliable information that a pharmaceutical company will not enforce its patents in a particular country can provide a signal to generic medicine manufacturers in that country that they can begin the process of making a generic version of the product.

Companies demonstrate best practice when they publish the status of all their patents, including biological products. Although disclosure of information on biological products is often complex as multiple patents may be attached, it is also an important step in addressing barriers to access.

Many companies use Pat-INFORMED (Patent Information Initiative for Medicines), a World Intellectual Property Organization (WIPO) database. Of the 20 companies in scope of the Index, 19 publish information about their patents. Boehringer Ingelheim is the only company in scope that does not disclose patent status anywhere. Many companies use the database on Pat-INFORMED to share information about the status of their patents, which is an encouraging first step but does not represent full disclosure. On their own websites, companies can provide more product-specific details, for example disclosing the numbers and expiry dates of each of their patents.

The Index looks at different sources for disclosure of patent status (whether a product is on- or off-patent), including the FDA (US), Health Canada, CIPC (South Africa) and MedsPaL (see appendix). Of all companies in scope, AstraZeneca demonstrates best practice. It is the only one to publish patent status and information on its website for all of its 32 products in scope for analysis. This includes biological products, such as the two vaccines in scope. Following quality standards for transparency, AstraZeneca publishes annual information including numbers, brand names and nature, expiry dates (including the platform technology expiry date for vaccines) and jurisdiction. On its website, it discloses patent status in the US, China, EU and Japan.

Increased access through a decrease of patent enforcement

AstraZeneca’s transparency, particularly about biological products such as vaccines, sets a benchmark. If more companies increase the quantity and quality of patent disclosures, this will facilitate opportunities for manufacturers to launch generic versions of the products, expand the market and ultimately increase the availability of products.

To improve access, companies can combine transparency in disclosure with a commitment not to enforce patents in LMICs. AstraZeneca commits not to file for patents in 80 countries, and three other companies disclose a list of countries where they do not file for or enforce patents (Boehringer Ingelheim in 61, Merck in 90 and Sanofi in 71). Companies can also consider how to measure outcomes and develop metrics to track, for example, how patent disclosures for specific products can increase patient reach.