SOUTH AFRICA Law and Practice Contributed by: Russell Bagnall, Danie Dohmen, Sophia Smallbones and Ramon Pereira, Adams & Adams Attorneys
2.2 Regulatory Data and Market Exclusivity There is no data package exclusivity of any kind available in South Africa. 2.3 Acceptable Pre-Launch Preparations In terms of the South African Bolar provision, it shall not be an act of infringement to make, use, exercise, offer to dispose of, or dispose of, or import a patented invention on a non-commer - cial scale and solely for the purposes reasonably related to obtaining, development and submis - sion required under any law that regulates the manufacture, production distribution, use or sale of any product. However, stockpiling with a com - mercial intent is not permissible. 2.4 Publicly Available Drug and Patent Information No Orange Book or patent linkage system is used in South Africa. The fact of the registration, including the holder and basic product details, becomes available on grant of the MA. However, no notification is provided. Underlying documents are not freely available and must be obtained through access to infor - mation legislation (which is subject to certain defences including trade secrets defences) or through the discovery proceedings in trial pro - ceedings. 2.5 Reimbursement and Pricing/Linkage Markets As noted in 2.4 Publicly Available Drug and Pat- ent Information , no Orange Book or patent link - age system is used in South Africa. There has been no skinny labelling litigation in South Africa. However, it is well settled law
that contributory infringement is actionable (for example, by way of inducement). Tender supply is limited to the public sector. The most relevant sector in patent disputes is usually the private sector. Best practice in the private sec - tor is to put in an indication code on the script, but that rarely takes place. In practice, the pharmacy will look to fill the script for the drug (even under a general reimbursement code). So, the drug gets prescribed for off-label use and there is no practi - cal prevention measure based on an indication specific code at prescription level. Generic sub - stitution takes place at pharmacy level unless the clinician indicates no generic substitution. If the drug is being prescribed for an approved chronic condition, the clinician will need to submit the prescribed chronic application to the scheme where the indication and justification is set out. However, if chronic approval is denied (because it does not fit within the chronic diseases) then the drug can still be dispensed against the patient’s savings portion on the scheme (depending on the level the patient is on). There is generally no notification made of any listing or reimbursement application, although the MA holder becomes aware when the reim - bursement price is lowered to the generic price. Generally, administration suits to force delisting or listing of products are not filed.
3. Biosimilar Market Entry 3.1 Infringing Acts
There are no differences for infringing acts in biosimilar market entry when compared with the same in 2.1 Infringing Acts .
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