Launched in October 2016, MPP’s Medicines Patents and Licences (MedsPaL) database is a free resource that provides information on the intellectual property status of medicines, vaccines and health technologies. It initially focused on medicines for HIV, hepatitis C and tuberculosis but was expanded in December 2017 to cover all patented medicines on WHO’s Model List of Essential Medicines. It was further expanded in March 2020 to provide patent information on treatments being tested for COVID-19.

Sébastien Morin, a Senior Manager with MPP’s Policy, Strategy and Market Access team

Sébastien Morin, a Senior Manager with MPP’s Policy, Strategy and Market Access team tells us about the unique benefits of MedsPaL and how it helps the wider MPP team – and several external users – to more easily navigate the global access landscape.

I began my career as a biomedical researcher, working in laboratories for my PhD and postdoc, before turning to public health. I was a member of the International AIDS Society’s (IAS) HIV Programmes team for several years, running the Industry Liaison Forum. We focused on paediatric drug formulations, HIV pre-exposure prophylaxis (PrEP), and regulatory affairs, and in so doing, created a bridge with the pharmaceutical industry to address challenges at the intersection of our shared goals.

But I never really used patent information at the IAS. Frankly, I didn’t know about MedsPaL at all. My knowledge of the challenges and opportunities of access to medicines was limited.

That all changed in 2019 when I joined the MPP Policy team. MedsPaL’s first iteration was a Microsoft Excel spreadsheet created in 2011, and was essentially a list of patents and their mapping across low- and middle-income countries (LMICs) for products for which MPP was hoping to secure – or had already secured – a licence. These lists became popular with other organisations, particularly procurement agencies seeking to procure medicines on behalf of certain LMICs, so MPP started to publish the spreadsheet on its website. It should be remembered that the fundamental purpose of patents is to protect an invention, in exchange for transparency on the invention, so patent information needs to be transparent and publicly accessible. The problem is that it’s often very difficult for non-patent experts to locate and understand this information. This is where MedsPaL makes a great difference.

Building targeted use-cases

By the time I joined MPP it had been relaunched as a specialised database, but I had no ‘use-case’ when I first went on to MedsPaL. I was arbitrarily checking information, but not knowing how best to use it. As we needed to understand and map the patent status of the products we were licensing to help guide our negotiations, we therefore began to build targeted use-cases that established which products could be accessed in generic format in which countries, through both MPP licences and other licensing agreements.

As a tool MedsPaL had already proved effective and it was soon expanded to include all medicines on WHO’s Model List of Essential Medicines (EML) as well as those with a high likelihood of being included, often including medicines for which an application to the EML has been submitted.

An invaluable way of understanding the mechanics behind access

I now use MedsPaL on an almost daily basis. Many access questions boil down to which products can be accessed in which country, and MedsPaL can almost always answer this. It’s an invaluable way of understanding the mechanics behind access.

There are a number of ways in which MedsPaL helps us in our work at MPP. Firstly, we may want to inform national decision-makers and community advocates about which products could be made available in their country. The database helps inform our strategy for expanding this access.

Patent landscape varies from country-to-country

At present, for instance, we are focusing on new products that have recently been recommended by WHO for HIV treatment as alternatives to TLD. But as the patent landscape varies from country to country, the detail behind that information is often not immediately obvious, especially for combination products.

Sometimes governments approach us about whether they can access particular generic products, and what the cost would be if they could. If there’s no patent filed or it’s been withdrawn or revoked or rejected, the product can often be accessed as a generic, if a generic version exists. Assessing the patent status of the medicines judged to be of fundamental importance is facilitated in MedsPaL.

Especially valuable for combination medicines

MedsPaL is especially valuable for establishing the patent landscape for combination medicines, such as recently WHO-recommended TAF-based HIV treatment regimens. These are combination products that include two patented medicines (TAF and DTG), which by their nature mean the overall patent landscape is more complex.

That makes unpicking this landscape more of a challenge, but one that is much easier to approach with MedsPaL, in which the MPP licences that exist for both of these products are also mapped. This provides clear indications on where the products can be accessed in generic forms.

Uniquely, MedsPaL also shows where any given patent has not been filed, which is not the same as not knowing whether the patent has been filed. This is a crucial distinction. By accessing MedsPaL, users know that this information has been checked, and that the patent was never filed – and never will be. This adds simplicity and clarity as to how best to navigate the landscape. It’s equally beneficial to be able to show products that are not MPP-licensed, because in the public health sphere, MPP is seen as an expert on access, and patents and licences, and is why MedsPaL includes so many products beyond those covered by MPP licences alone.

User-friendly with visual clarity

MedsPaL is also very user-friendly. It can show the patent landscape as a series of maps. At the granular level, one significant advantage is its visual clarity. It’s a digest that’s easy to understand. There’s a one-line description – much like a bullet point description of the reach of each patent – that’s not even a full line.

Contrast this, for example, to other repositories of patents for medicines, which have the full patent application title and documents. These become very technical very quickly. The application title and documents can of course also be found as hyperlinks in MedsPaL entries, but MedsPaL also has the one-line digest. Users therefore don’t need to access a separate webpage for every single application, which means the information can be accessed more quickly. And MedsPaL is also a curated tool, displaying patents that are judged to be only the most relevant, removing noise created by large numbers of inconsequential patents, thereby enhancing clarity.

We – and when I say we, I am talking about our amazing team of Patent Information Experts: Amina Larbi, Zongyuan Tang and Dana Mozaffari –  have carefully designed, expanded, and maintained MedsPaL so that it’s easy to understand and use, especially as we’d like external users to deploy it to inform their planning, procurement, advocacy and other efforts to provide the best possible medicines to populations in LMICs. That’s why we’re always happy to show people how MedsPaL – and our other access to medicines’ tools (below) – can be most effective, so do please contact us at: medspal@medicinespatentpool.org

 

MPP’s access to medicines’ tools:

MedsPaL

Access to Medicines Tracker

LaPaL