Things You Should Know
1. Patents can be challenged
Patents can look pretty daunting. They are granted through an official application process, protected by law, and backed by the might of powerful pharmaceutical corporations. But it is always worth doing more research. For all the legal processes they go through, patents are not always valid.
Patents are a social tool, so in many countries, anyone may question whether the claims of a patent are factually true, and whether the patent was granted in error. And it’s not a hopeless task: many groups and individuals have already been successful by following the steps described in this tutorial.
2. What makes a patent valid?
Generally, across the world, for a patent to be valid, there are three requirements: novelty (the product was not previously known by the public); inventiveness (the product is not simply an obvious solution that anyone could have thought of) and industrial application (the product can be demonstrably used in some kind of industry).
All national laws allow for a patent to be revoked if it is found to be invalid. But the particular way that the validity of a patent can be challenged is determined by national law, so checking them will be a fundamental part of your research — see Step 1. Fundamentals, for more information.
3. Routes to oppose patents
You may challenge the validity of a patent or application:
After it has been granted (a "post-grant opposition")
In some countries, during the period when a patent application is being reviewed (known as a "pre-grant opposition" or a "pre-grant observation").
Patent oppositions highlight information and evidence showing that the patent application does not meet a country’s patentability standards. This reduces the possibility of unmerited and invalid patents being granted on these drugs.
Generic manufacturers have already filed a number of pre-grant oppositions. The Lawyers’ Collective and patient groups (cancer and networks of people living with HIV/AIDS) are also working to oppose patent applications on important drugs. The procedure of challenging patents and applications may differ between countries. You may need to pursue it via:
- an administrative route (e.g. through a patent office),
- a judicial route (e.g. in the courts), or
4. One drug may have multiple patents
To decide if an opposition is possible on a specific medicine, it is important to first identify which patents cover it, and then assess whether any of them block generic competitors from producing, marketing or supplying the medicine in your country.
Successful challenges can prevent the patent from being granted in the first place, or can completely or partly revoke patents.
Example: Tenofovir disoproxil fumarate (TDF) is an essential antireteroviral that is a backbone of first- line HIV treatment. In India, Gilead had filed number of patent applications for TDF, including applications covering the pro-drug, fumarate salt, intermediates and fixed-dose combinations. These applications were successfully opposed by networks of people living with HIV/AIDS and civil society. As a result, both the patent grant for TDF and a 28-year patent monopoly were avoided in India.