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What is a patent?

Below are four key concepts to help understand drug patents.
1. The rationale for patents
Patents came about as a way to stimulate innovation. In order to encourage inventors to disclose their invention by publishing the patent, instead of keeping it a secret, they are offered time-limited monopoly rights to exploit the invention commercially. For drugs, patents are usually granted for a period of 20 years. After this period of time, the monopoly rights are lifted and the invention can be copied for free.
The theory is that it’s a win-win situation: society learns relatively quickly from any invention, and eventually gets free access to the knowledge behind it. The patent holder profits from the patent by selling the invention at a higher price than would have been the case without a patent - since the patent monopoly prevents competitors from making a similar product.  But when it comes to medicines, where patents may result in life-saving drugs priced out of the reach of many patients, the reality is quite different from the theory. 
2. One pill, many patents
Many people assume that a patented medicine is protected by one particular patent. Unfortunately, it is not as straightforward as that.
Patents are intended to protect “inventions,” not medicines as such.  In the pharmaceutical sector, an invention may for example relate to a product (e.g. a specific molecule), a process (e.g. the way the molecule is manufactured), a medical indication (e.g. the effect of this molecule on a human body), or a combination of products (e.g. a fixed-dose combination combining two molecules into a single pill). Formulations (including e.g. powders, tablets and capsules) can also be patented, as can the active pharmaceutical ingredients that are used to make a drug.  Even a “new use” of an old molecule can sometimes be patented, if scientists subsequently discover that it works against another disease than the one for which it originally was granted a patent.
In other words, a single medicine can be protected by a large number of separate patents.  This makes assessing which drugs are patented in which countries a complex task.  It also means that the 20-year patent monopoly in practice can last much longer, as pharmaceutical companies usually extend that monopoly by filing for consecutive 20-year patents.  This well-known process is known as ‘ever-greening’.
3. Patents are a matter of national and not international policy
There is, as yet, no such thing as a global patent. When a company is said to have patented a medicine worldwide, it really means that they have a whole collection of different patents, one for each country (or region, when countries decide to pool their patenting offices such as in francophone Africa). 
Far from being international, the granting of patents is a matter of national sovereignty, and governments can take steps to design their patent laws in a way that takes into account their national interests, and their social or economic needs.    As an example, India in 2005 designed a patent law that is very restrictive on which medical inventions should be patented.  This decision was taken in the interest of public health, as fewer patents mean increased access to affordable medicines. 
Nevertheless, one of the most significant trends in pharmaceutical patenting today is the move towards harmonising patent laws across different countries.   For several decades now, the pharmaceutical industry has been pushing for the stricter patent standards of Europe and North America to be extended to the developing world. This to a large extent has been done through the World Trade Organization’s TRIPS Agreement.
4. Existing patents may be invalid
When a patent constitutes a barrier to access to essential medicines, it is important to investigate whether the patent is indeed valid - it is crucial that a patent office’s decision to grant a patent is not seen as final. 
Patent applications must meet a number of tests before a patent is granted on a specific product or process. The conditions of patentability are laid down in the national or regional patent law.  In a number of cases, patents that had been granted on drugs have turned out to be invalid, because on closer inspection, the patent fails one or more of the tests it was supposed to pass when it was granted. 
The right to challenge a patent is therefore important.  Often this occurs after the patent has been granted – this is known as a ‘post-grant opposition’.  But in some countries, such as in India or Brazil, the challenge can actually be done before the patent office makes a decision whether to grant a patent or not – this is known as ‘pre-grant opposition’ and is a key way to protect public health interests.  Patents on several key AIDS medicines have been rejected in India thanks to pre-grant oppositions filed by civil society.
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