Regulatory Exclusivity is a form of Intellectual Property (IP) protection available for pharmaceutical compounds, which is provided by numerous jurisdictions across the globe.
Recently, we published an article considering the types of Regulatory Exclusivity available for newly developed pharmaceutical compounds (see IP Rights in the Pharmaceutical sector: Not exclusively the domain of patents). The focus of this article will be on an additional form of Exclusivity which exists, that applicable for Orphan Diseases.
The term Orphan Disease can be considered synonymous to that of a “Rare Disease”. In practice this refers to a disease where the number of people affected comprises only a small proportion of the overall population. What constitutes an Orphan Disease varies jurisdictionally, with some jurisdictions applying a definition based on a fixed ratio of the population, while others apply a definition based on the overall number affected within the population. This can result in some diseases being designated Orphan within certain jurisdictions, while not being considered as such in others.
A result of this low population prevalence, as well as the high cost of developing new pharmaceuticals, is that pharmaceutical companies have historically invested fewer resources to discovering treatment options for Orphan Diseases. To compensate for the perceived economic “unattractiveness”, some jurisdictional authorities offer incentives to induce research into Orphan Disease treatments. One such incentive is providing additional Exclusivity term for pharmaceutical compounds which receive approval to treat Orphan Diseases. This is known as Orphan Exclusivity.
In our previous article we discussed the types of Regulatory Exclusivity applicable for newly approved pharmaceutical compounds. Orphan Exclusivity relies on a similar set of principles, and can be considered functionally similar to that of Market Exclusivity. Several facets unique to Orphan Exclusivity are noted below:
A list of provisions available in selected jurisdictions can be found in the table below:
Orphan Exclusivity provisions
|Australia||No Orphan Exclusivity provisions currently exist.|
(European Medicines Agency)
|10 years Orphan Exclusivity from initial approval of that Orphan Disease indication.|
10 years Post Marketing Surveillance (PMS) from initial approval of that Orphan Disease indication.
|New Zealand||No Orphan Exclusivity provisions currently exist.|
|United States||7 years Orphan Exclusivity from initial approval of that Orphan Disease indication.|
As set out above, some jurisdictions offer significant periods of Orphan Exclusivity as an incentive for pharmaceutical companies to develop therapies for Orphan Diseases. These incentives apply irrespective of whether the compound is specifically developed for that condition, or if a previously known compound is subsequently approved for an Orphan Disease. The additional Exclusivity term is linked to the regulatory approval date for the treatment of the Orphan Disease, meaning it is possible for a pharmaceutical compound to obtain protection for an Orphan Disease which exceeds the Exclusivity term it received at its first approval. This additional Exclusivity can be crucial as it may prevent a rival company from marketing their generic version of a reference pharmaceutical compound for the treatment of that Orphan Disease. Hence, a pharmaceutical company can maintain a monopoly for treating an Orphan Disease with its pharmaceutical compound, allowing it to attempt to obtain a desired economic return of investment without fear of competition.
John Kotsanas is a technical specialist from AthenaIP, associated with FB Rice. AthenaIP is a specialist searching and watching service, providing searching skills in all areas of intellectual property.