Guidance Note by Tim Laurens
A patent approaching expiry can immediately attract commercial interest, particularly in the generic medicines sector. However, the expiry of one patent does not necessarily mean that the way is clear for a competing product to enter the market.
Consider a company planning to introduce a generic controlled-release tablet containing “Compound X” in South Africa. The original patent protecting Compound X expires in 2027, and the company is considering a launch in 2028.
At first sight, the opportunity may appear straightforward. But later patents may still protect a particular crystalline form of Compound X, the controlled-release formulation, a manufacturing process, a dosage regimen, a therapeutic use or a combination with another medicine.
Instructions of this kind illustrate an important point: asking someone to “check the patents” can involve several different enquiries, each answering a different commercial question.
Patentability: Can the new development itself be protected?
If the company has developed a new, more stable formulation of Compound X, a patentability search considers whether that development is new and inventive in light of the prior art.
The prior art is not limited to patents that are currently enforceable. Expired patents, scientific publications and other public disclosures may all be relevant. An expired patent can therefore prevent a new invention from being patented even though that patent can no longer be enforced.
Equally, obtaining a patent does not automatically mean that the invention can be commercially exploited. An improvement may be patentable while still falling within the scope of an earlier, enforceable patent.
Infringement: Does the proposed product fall within a particular patent?
The enquiry is different where a specific South African patent has been identified as a possible obstacle.
An infringement analysis compares the claims of that patent with the proposed product or process. The question is not simply whether the products appear similar, but whether all essential features or requirements of the relevant claim are present in the proposed product or process.
That enquiry is directed to the identified patent. It does not, by itself, determine whether other patents may also affect the proposed launch.
Patent landscaping: What does the broader field look like?
A patent landscape provides a broader view of the commercial and technical field.
For Compound X, this could include patents and applications relating to different forms, formulations, combinations, manufacturing processes and therapeutic uses. A landscape can also identify patent owners, patent families, filing activity, jurisdictions, legal status and expected expiry dates.
This can reveal competitor activity, areas of concentrated patent protection, possible gaps and patents approaching expiry.
A landscape is useful for understanding the terrain. It is not, however, a clearance exercise and does not establish that a proposed product is free to launch.
Freedom to operate: Can the proposed launch proceed?
For a company considering an actual market launch, this is usually the critical question.
A freedom-to-operate assessment starts with the intended commercial activity: what will be made or sold, how it will be produced, where it will be marketed and when the launch is planned.
Relevant enforceable patents in that market can then be identified and their claims assessed against the proposed product, process and activities.
In the Compound X example, expiry of the original compound patent is only the starting point. Other patents covering the formulation, manufacturing process, therapeutic use or combination may still be in force and affect the launch.
The assessment may show that the company can proceed, should delay launch, redesign the product or process, consider a licence, or investigate the validity of a potentially blocking patent.
The practical lesson is that a patent search should begin with the commercial question to be answered. Patentability, infringement, landscaping and freedom-to-operate assessments are related, but they are not interchangeable.
An expiring patent may create an opening. Whether there is a clear route through it depends on what other rights remain in force, what their claims cover and exactly what the company intends to bring to market.
KISCH IP assists clients in navigating these questions by providing targeted patentability, infringement, patent landscape and freedom-to-operate assessments. By identifying the right question at the outset, we can help businesses understand the relevant patent landscape, assess potential risks and make informed commercial decisions before committing to a product launch or market entry.
If you are considering the launch of a new product, particularly following the expiry of a key patent, our patent team can assist in determining whether the way is genuinely clear.
