Drug Patents Under the Spotlight. Sharing practical knowledge about pharmaceutical patents
(2003; 40 pages) View the PDF document
Table of Contents
View the document1. Introduction
Open this folder and view contents2. Four key concepts to understanding drug patents
Close this folder3. The patent system should respond to countries' public interest
View the document3.1. The subject matter of a patent must be new
View the document3.2. The subject matter of a patent must be inventive
View the document3.3. Patentability is a matter of national policy: example of new use inventions
View the document3.4. The invention should be clearly disclosed to benefit society as a whole
View the document3.5. An invalid patent may be revoked
View the document4. How to read and use the patent table
View the document5. Conclusions
View the document6. References
View the documentAnnex A - Patent Table
View the documentAnnex B - The anatomy of a patent

3.1. The subject matter of a patent must be new

The first fundamental requirement for a valid patent is that the invention is novel. As mentioned earlier, the TRIPS Agreement does not dictate any particular approach to novelty. It is therefore for each WTO Member to determine what is new and what is old.

A typical example of a definition of novelty can be seen in Article 54(1) of the European Patent Convention (EPC)[31]. It provides that "an invention shall be considered to be new if it does not form part of the state of the art". The "state of the art" is defined in EPC Art 54(2) to comprise "everything made available to the public by means of written or oral description, by use, or in any other way, before the date of the filing of the European patent application"[32]. Although this may sound complicated, it is really just the common sense idea that nobody should be allowed to get a patent for something that the public already knew about.

A written description is the most commonly encountered form of disclosure and can include papers published in journals, articles in magazines and patent applications that have been published. An example of oral disclosure might be a researcher describing the invention in a presentation to a conference. Other categories of disclosure include using or demonstrating the product in public, or selling the product[33].

One important choice still left to WTO Members is whether they define state of the art nationally or internationally. Most countries have chosen to assess it on a global basis rather than just for their own country, thereby allowing their patent examiners to refuse a patent application if the invention has already been revealed to the public in any previous publication or communication worldwide[34]. On the one hand this gives countries the advantage of considering what the global public rather than the local public already knew[35]. On the other hand, exhaustive bibliographic searches are no easy task for IP examiners in developing countries without routine access to international databases. In practice this means that patents might be erroneously granted for inventions that are not novel.

Priority rights are an important concept relating to novelty. In the late 19th century, an earlier era of globalisation, the country-by-country novelty requirement made it difficult for inventors to have their invention protected by patents in several countries. If the invention was made public after a patent application had been filed in one country but not yet in a second country, then when the patent application was eventually filed in the second country, the invention would already be known there and so it could no longer be considered new. Problems like this made it impossible for inventors to obtain patent protection in as many countries as they wanted to. What was needed was a way for each similar patent application filed in a different country to be treated in the same way, as if it was being filed for the first time. This is exactly what the Paris Convention for the Protection of Industrial Property, originally signed in 1883, solved by inventing the "right of priority".

Why patents cannot be filed in Brazil or Thailand to protect existing medicines

The novelty requirement implies that pharmaceutical companies have to file patent applications to protect their inventions at the earliest stage of the development of a medicine, i.e. between basic research and pre-clinical research, without even knowing whether the invention will end up on the market or not.

The novelty requirement helps to explain the availability of generic medicines in some countries, such as Brazil, India or Thailand, as compared to South Africa where many medicines and all ARVs are only available from the patent holder.

The pharmaceutical company Boehringer Ingelheim first applied for a patent protecting the basic molecule of nevirapine, an antiretroviral medicine used to prevent mother-to-childtransmission of HIV/AIDS, in Germany on November 17th 1989. In accordance with the rules of the Paris Convention on the right of priority, the company had until November 17th 1990 to file similar patent applications in any other country. After this date, the novelty of Boehringer Ingelheim's invention was no longer ensured. The company filed a patent application related to nevirapine in South Africa but could not file an application in Brazil or Thailand because the patent laws of these countries did not offer such a possibility at that time. Although both Brazil and Thailand have now revised their patent laws to enable patent protection of pharmaceutical products, the basic molecule of nevirapine cannot be patented any more in these countries because the novelty of the invention has since been destroyed by the publication of the patent application in South Africa and elsewhere, and by the subsequent marketing of the drug.

Thai activists protesting against patent protection of ddI, a key AIDS drug (see p. 20 for more details on the 2001-2002 court case). Bangkok, December 2000.

Photo: © MSF

Under the Paris Convention, the first regular filing of a patent application in a country gives a right of priority to the applicant for the filing of similar patent applications in the vast majority of other countries for a period of 12 months[36]. The novelty of the invention is thus artificially maintained during those 12 months. The practical consequences of this are important: it is the priority date that a patent office looks at when examining novelty, although the patent term will start running from the filing date. Considerations of novelty are particularly relevant for the class of inventions known as "new uses", discussed in section 3.3.

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