When we feel patents do not comply with the law, we intervene.
We usually intervene when bad patents are also being used to keep prices artificially high for the public.
What does it mean to say a patent does not comply with the law?
To get a patent, a company has to show the drug is new, inventive, useful, and in some countries more therapeutically effective than older drugs. If drug patents are not meeting these standards, that is when we get involved.
How do you get involved?
There are different types of patent interventions. The main type we do is by submitting evidence to patent offices across the world.
What kind of evidence?
All of our evidence is on strictly scientific and legal grounds to show that the patent wasn't lawful. We don't argue on grounds of health or equity, and don't mention how companies are pricing the drugs out of reach for patients. We stick to the science and the evidence, since these are technical determinations.
What and where are patent offices?
Each country has its own patent law, though there are a lot of similarities for most countries. The patent offices are administrative bodies (not courts). They are government entities, much like the US FDA (Food and Drug Administration) is for drug safety. The patent offices (like the US PTO- patent and trademark office) deal with patents in a similar way.
What is the purpose of challenging patents?
Challenging invalid patents is a way to expose system failures while increasing access to specific medicines. If you can show a patent does not comply with the law, it opens the door for generic versions of the drug, which are often cheaper. In the developing world, this can make a huge difference for access. And studies show that after generics come on the market, prices come down even further due to competition.
Is it hard to challenge a patent?
It is not easy, and requires significant technical expertise and a lot of resources. Its tough for the public to take on. Usually, determining whether a patent is deserved is left to patent offices (run by the governments, which are usually underresourced) or commercial drug companies (competitors, wanting to enter the market who may have different priorities than the public).
How much does it cost?
The good news is, intervening is free in most countries. We incur costs along the way, for scientific and legal research, and other admin costs, but governments usually let the public participate in the system for free.
Why does this issue matter?
Undeserved patents can cause a lot of harm to the public. The person/company holding the patent has a monopoly which means they are in a strong position to charge whatever they want for 20 years. The implications? That patients in resource-poor settings cannot afford essential medicines. And that true scientific progress and innovation could be blocked - if a company can keep getting undeserved patents and maintain control of a drug for a long time, why would it invest in serious R&D?
What is being done about this problem?
A growing number of people are giving voice to this problem, and a small group of public-interest lawyers, scientists and others are challenging these questionable patents. They are "taking back the public domain from private interests". This is happening in India (Read More!), the United States (Read More!), Europe, and many other countries.
What is the process to intervene on a patent?
It differs from country to country. In Europe, any person can present an observation at the patent office to offer their opinion on whether a patent should be granted. In India, it is the same thing, except in India the public has a right to a hearing. In the United States, the public can only challenge the patent after it has been granted, not before