Review of patent expiry dates of HIV/AIDS drugs

The following table provides indication on expiry dates of the basic substance patent protecting some HIV/AIDS related drugs, as well as countries in which this patent has been applied for and granted. However, some caveats apply.

In the pharmaceutical sector, patents may be granted for different kinds of inventions. The invention may concern a new pharmaceutical substance, or a new manufacturing process for a known pharmaceutical substance, or a new use or indication of a known pharmaceutical substance, or a new formulation. Therefore, looking for patents related to a specific drug is a huge task since a drug may be protected by dozens of patents in different countries. A pharmaceutical company which owns an invention, either through its own R&D or in-licensing of patents from other inventors (i.e. other companies, public institutions, etc) will file or enforce patent protection in countries where there is a market for such invention or where potential competitors could use the invention for their product development.

To get an approximate idea of the date on which generic competition can start for a specific drug, the most useful approach is to locate the date of application for the first patent, usually protecting the basic substance of the drug. Then, if one adds 20 years to this date, taking into account the one-year period of priority ("20 + 1"), one gets an approximate idea of when the same patent granted for the same drug in other countries will expire - since those patents for the same invention should have been filed within the one-year priority period. As from this expiry date of the substance patent, copies of the basic substance of this drug may be produced, although other patents may protect a manufacturing process, a formulation or an indication. But the basic substance at least is in the public domain. This applies only to countries where a patent has been granted and where the patentee regularly pays the maintenance fees to keep the patent "alive". Depending on the specific patent and country, patent owners may not file or maintain all patents.

Finally, with regard to the patent expiry date provided in the table, it is possible to obtain patent extension beyond 20 years in some countries, to compensate for time spent in R&D or the registration process to obtain marketing authorization.

In the table, the patent priority date column corresponds to the date of the first patent application for the drug in question, and which was referred to as the priority date by the company seeking for the same patent protection in other countries.

The 20-year patent protection column gives an idea of the latest date around which the same patent should expire in other countries. Note that this date may not be valid in countries where patent extensions are possible (such as Australia, EU, Japan, Korea, Mexico and the US).

The next two columns provide for the expiry date of the first patent in the US and in Europe (as a regional patent) or France.

The last column gives some of the countries where a similar patent has been applied for or granted (with reference to the priority date), whether for the protection of a product or process. Data mainly originates from the European Patent Office website, which provides patent data originating from about 64 patent offices, including regional patent offices (Argentina, ARIPO¹, Australia, Brazil, Bulgaria, Canada, China, Croatia, Cuba, Cyprus, Czech Republic, Egypt, EPO², Eurasian Patent Office³, Hong Kong, Hungary, India, Israel, Japan, Korea, Latvia, Lithuania, Mexico, Moldova, Mongolia, New Zealand, Norway, OAPI⁴, Philippines, Poland, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, Turkey, Vietnam, Yugoslavia). However, the European Patent Office warns that the information provided is not exhaustive, often refers to published patent applications only and that this service cannot be considered as a complete and official source of patent information.

¹ The ARIPO patents granted by the Office of the African Regional Industrial Property Organization (ARIPO, Harare) may have effect in 14 African countries (Botswana, Gambia, Ghana, Kenya, Lesotho, Malawi, Sierra Leone, Somalia, Sudan, Swaziland, Uganda, United Republic of Tanzania, Zambia, Zimbabwe).

² European patents, granted by the European Patent Office (Munich) may have effect in up to 18 European countries (Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, Netherlands, Portugal, Spain, Sweden, Switzerland, United Kingdom).

³ Eurasian patents granted by the Eurasian Patent Office (Moscow), which have effect in 9 countries (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Republic of Moldova, Russian Federation, Tajikistan, Turkmenistan).

⁴ Patents granted by the African Intellectual Property Organization (OAPI, Yaoundé) have effect in 14 African countries (Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Congo, Côte d'Ivoire, Gabon, Guinea, Mali, Mauritania, Niger, Senegal, Togo).

Recourse was also made to Derwent database which provides data on whether a patent has indeed been granted following the application, but only covers 40 countries (Argentina, Australia, Brazil, Canada, China, Czech Republic, EPO, Hungary, Israel, Japan, Korea, Mexico, Norway, New Zealand, Philippines, Romania, Russia, Singapore, South Africa, Slovakia, Taiwan, and the USA).

Thus, the data presented here cover only approximately 80 countries. No reliable patent information is available from the others. Taking into account the caveats of this study, it is therefore strongly advised to check the patent status at the national patent office before planning drug procurement or manufacture in a specific country.