## Facts

- Three Kenyan citizens living with HIV challenged provisions of the Anti-Counterfeit Act, 2008, fearing it would be used to block or seize lawful generic antiretroviral and other essential medicines.
- They depended on continuous access to affordable generic medicines, which they alleged were widely used in Kenya for HIV treatment.
- The Act created an Anti-Counterfeit Agency with enforcement powers and defined “counterfeit” and “counterfeit goods” broadly in a way that, according to the petitioners, could include legitimate generic medicines produced or imported lawfully under intellectual-property exceptions.
- The petition sought declarations that the constitutional rights to life, human dignity, and the highest attainable standard of health include access to affordable and essential medicines, including generics, and that the Act infringed those rights to the extent it restricted such access.
- The court issued conservatory orders staying enforcement of specified provisions as they related to importation of generic medicines pending final determination.

## Issues

1. Whether the Anti-Counterfeit Act’s definition of “counterfeit” and “counterfeit goods” was so broad and vague that it could encompass legitimate generic medicines, thereby threatening or violating constitutional rights to life, human dignity, and health.
2. Whether statutory measures aimed at intellectual-property enforcement and anti-counterfeiting may be applied in a manner that restricts access to essential medicines for people living with HIV, consistent with constitutional and related international obligations.

## Decision

- The court held that the statutory definition of “counterfeit” was vague and overbroad and could be applied to lawful generic medicines.
- The court found that this ambiguity created a credible risk of seizure or restriction of essential HIV medicines, which would threaten the petitioners’ lives and health.
- The court declared that the rights to life, human dignity, and health include access to affordable and essential medicines, including generic drugs.
- The court declared the Act unconstitutional to the extent it could be used to limit access to lawful generic medicines.
- The court directed that Parliament should review and amend the Act to remove ambiguities and prevent arbitrary enforcement against legitimate generics; the interim protection against enforcement as to generics was effectively confirmed by the merits ruling.

## Legal Principles

- Constitutional rights to life, human dignity, and health include meaningful access to affordable and essential medicines.
- A statute affecting fundamental rights may be unconstitutional where vague drafting confers broad discretion that foreseeably risks arbitrary enforcement and rights deprivations.
- Where application of intellectual-property enforcement would restrict access to life-saving medicines, constitutional rights to life and health prevail over expansive enforcement claims.
- The state bears obligations to respect, protect, and fulfill the right to health, including by maintaining legal frameworks that do not obstruct lawful access to essential medicines.

## Conclusion

The court concluded that the Anti-Counterfeit Act’s ambiguous definition of “counterfeit” unlawfully threatened access to lawful generic HIV medicines, violating constitutional protections of life, dignity, and health, and required legislative clarification to prevent enforcement against legitimate generics.


Ochieng v. Attorney Gen., Pet. No. 409 of 2009 (Kenya High Ct. 2012)