There is, as yet, no such thing as an international or 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 of interest to them.
Most people know that patents confer a monopoly on their owner. It is probably less clear how the patent owner's monopoly rights relate to, for example, the TRIPS Agreement.
The TRIPS Agreement is an agreement between WTO Member States. It requires WTO Member States to enact or modify their own patent legislation to regulate the granting and enforcement of patents in accordance with some minimum international rules that it defines. If a WTO Member fails to include such TRIPS rules in their national/regional legislation or includes them in a way which another WTO member does not agree with, then that and/or other WTO Members could file a complaint before the WTO. Private companies or individuals cannot sue a WTO Member at the WTO for failing to have a TRIPS compliant patent law, although it is perhaps true to say that if they can get their government involved on their behalf, it can amount to much the same thing.
The TRIPS Agreement only provides a general framework with minimum standards for national patent laws. It obliges WTO Members, for example, to grant patents in any field of technology and specifies what minimum exclusive rights a patent should confer. It is then up to the national or regional legislation to implement or complement the general rules contained in the TRIPS Agreement. It is the national or regional rules that make up the basis for the granting and enforcement of patents, not the TRIPS Agreement itself.
At the national level, according to TRIPS
Article 28, patents shall confer on their owner the exclusive right to prevent others from "making, using, offering for sale, selling, or importing for these purposes" the invention without the owner's consent. Given that all these rights should be included in the national patent law, if someone makes, uses, offers for sale, sells, or imports for these purposes a patented product, or a product made with a patented process, without the patent owner's permission, then (s)he is likely to be infringing the patent - subject to possible exceptions in accordance with the national law.
However, because these rights are only private rights, i.e. the state does not police patents for a patent holder, it is up to patent owners to take action before the competent judicial or administrative authorities to stop any infringement. In practice, only after a patent holder has brought a legal action before this competent authority can it be proved that patent infringement has happened. If a patent holder decides, for one reason or another, not to sue a potential infringer, then the matter will go no further.
Although the state authorities (e.g. the customs authorities) may assist a patent holder, a far more dangerous development from the perspective of access to medicines is the appearance of proposed or actual provisions to make "deliberate" patent infringement a crime, even if carried out for non-commercial purposes. Instead of the patent holder having to sue, state prosecutors would deal with the matter as a criminal offence. Instead of the patent holder risking looking bad in front of the world (including their shareholders) for suing public health organizations using generic versions of patented medicines, the state would do the job for them. There is absolutely no requirement in the TRIPS Agreement to make any sort of patent infringement a crime. The fight against counterfeiting and piracy (which is required to be criminalized under the TRIPS Agreement) is a completely different matter than the use of generic versions of patented medicines and patent infringement.
Do imports of generic medicines constitute an infringement in Kenya?
In Kenya, MSF and another local NGO, MEDS, import generic versions of antiretroviral medicines protected by the African Regional Industrial Property Organization (ARIPO) patents. The NGOs are doing this on the basis of section 58(2) of the Kenyan Industrial Property Act 2001, according to which "The rights under the patent shall not extend to acts in respect of articles which have been put on the market in Kenya or in any other country or imported into Kenya". Regulation 37 of the Industrial Property Regulations 2002 further clarifies that "the limitation on the rights under a patent in section 58(2) of the Act extends to acts in respect of articles that are imported from a country where the articles were legitimately put on the market".
In accordance with the TRIPS Agreement and as confirmed by the Doha Declaration on TRIPS and Public Health, Kenya - like any other WTO Member - is allowed to provide for such limitations and exceptions to the rights conferred by patents. Such a limitation/exception is to be regarded as TRIPS-compliant as long as (following another WTO Member contradicting it and filing a WTO complaint thereon) the WTO has not ruled that it is not compliant.
The particular generic versions of medicines were imported from India where they had been legitimately put on the market and therefore fall into the limitation category as provided under section 58(2) and Regulation 37. In addition, the medicines have been duly authorised for use by the Ministry of Health with regard to their quality, safety and efficacy. Should the patent owners disagree with the legitimacy of the importation, it is their responsibility to file an infringement action before the Kenyan Industrial Property Tribunal to claim for damages and/or compensation. Only the Tribunal can assess whether the activities of the NGOs fall under the exception to patent rights.
Thanks to the imported medicines, the local treatment programmes supplied by MEDS are now providing ARVs to up to four times as many patients as before.
The Nyumbani orphanage in Kenya celebrates a donation of 2000 vials of a generic version of the AIDS drug zidovudine from the Brazilian government; the 2001 event was covered by media (Father D'Agostino, the director of the orphanage, interviewed by the press, left) and the Kenyan Minister of State and the Brazilian Ambassador to Kenya participated (second photo from left). As at May 2003, over 30 children living in the orphanage and another 3200 Kenyans living with HIV/AIDS benefit from generic ARVs imported by MSF and MEDS and distributed through local hospitals and treatment programmes, including those run by MSF.
Photos: © MSF