Kenya's new Anti-Counterfeit Act will be challenged on March 8 in the country's Constitutional Court on the basis that it violates the right to health.
The petitioners, three people living with HIV, argue that the law confuses generics with fake medicine.
This could cause a health crisis as generics constitute 90 per cent of medicines used in Kenya.
The petitioners want the Constitutional Court to declare the law, which was enacted in the middle of this year, unconstitutional on grounds that it will deny them access to affordable life-saving generic medicines and therefore rob them off their right to life, says Mr Peter Munyi, an intellectual property rights lawyer working with Health Action International (HAI) Africa.
HAI Africa is part of a global network working to increase access to life-saving medicines.
Generics, which are between 70 and 90 per cent cheaper than their brand-name counterparts, have enabled poor people in developing countries to get the necessary treatment.
Donors who fund drug distribution, including the US President's Emergency Plan for AIDS Relief (Pepfar) and the Global Fund to Fight Aids, Tuberculosis and Malaria, also source the drugs from generics manufacturers.
Mr James Kamau, the co-ordinator of the Kenya Treatment Access Movement, an organisation advocating access to anti-retrovirals, has previously pointed out that the Anti-Counterfeiting Act of 2008 contains ambiguities which could lead to misinterpretation, undermining the government's efforts to ensure access to essential medicines for all Kenyans.
HAI Africa director of programmes, Christa Cepuch, adds that the act, which is aimed at cracking down on fake batteries, pens, drugs and cosmetics, "contains a vague definition of counterfeiting which could be read to include generic drugs".
She describes generic medicines as legitimate, effective and exact copies of brand-name products.
The law makes the manufacturing, importation or sale of "counterfeit goods" a criminal offence rather than a civil matter, which is the usual way in which disputes over intellectual property rights are resolved.
The onus to verify whether goods are fakes or not has been put on customs officials and police officers.
"We'll have Kenya Revenue Authority officials trying to figure out if drugs are fakes or not. This increases the risk of products being labelled fakes," Ms Cepuch says.
"The law further gives these officials excessive powers, making the process difficult and expensive. Moreover, the onus to prove the products are not fakes lies with the accused, a price many will not be willing to pay."
Activists argue that the existing Pharmacy and Poisons Board should be in charge of combating counterfeit medicines as it has the necessary technical expertise to deal with such issues -- which customs officials don't.
The idea that essential medicines could be delayed for months at ports of entry is not far-fetched, based on what has happened in Europe where 22 seizures of legitimate generic drugs destined for developing countries have taken place in the recent past.
"The risk is simply too high and will potentially keep away generics manufacturers and importers. This is also because the cost of the whole process, should the products be confused for counterfeits, will be too high," Mr Munyi cautions.
The Kenyan law seems to be serving as a template for similar policies at the regional level.
Health advocates fear an "anti-counterfeiting" agenda is being pushed by actors who do not have interests of the poor at heart.
Suspicion has also been raised by the speed at which the Kenyan bill was passed and acceded to.
"Parliament was under immense pressure to pass bills that would change Kenya's political dispensation (after the election violence in 2008). However, they somehow found time to deal with this less urgent bill at the time. And no sooner had it been passed than the commencement notice was published -- despite earlier indications that there was no budget allocated to effect the bill," Mr Munyi says.
He is referring to the Industrialisation ministry's publishing of a notice in the government gazette on July 24 that backdated commencement of the legislation to July 7, a day before the suit was launched in the Constitutional Court.
"We believe the government should combat counterfeiters and counterfeit goods, including medicines, some of which have been seized in the Kenyan market. However, this should not be done at the expense of the health of millions of Kenyans and their right of life," according to Ms Cepuch