The process of bringing a pharmaceutical product comprising a new active ingredient to market is an expensive and lengthy venture. It often takes numerous years, as well as a considerable amount of capital, to navigate through the R&D stages, clinical environment and regulatory agencies to finally release the new pharmaceutical onto the market. The pharmaceutical sector relies on Intellectual Property (IP) rights, such as patents, as an incentive for this investment.
Another IP protection right available for new pharmaceutical products is Regulatory Exclusivity. This is a distinct form of IP protection, which functions in its own unique way. The effect of Regulatory Exclusivity should be carefully considered by those in the sector attempting to launch a new pharmaceutical product, as well as by those aiming to launch their own generic copy.
What is Regulatory Exclusivity?
Regulatory Exclusivity is a right that is granted by a government to a sponsor of a pharmaceutical, which provides a period of time in which third parties cannot copy their product. Regulatory Exclusivity encompasses two main components, each with its own effect. This includes:
Data Exclusivity: Data Exclusivity constitutes a period of time where clinical data, submitted by the original sponsor to a national regulatory authority, concerning a pharmaceutical compound, cannot be accessed by a third party for their own regulatory submission for the same compound. In effect, this provision prevents others from relying on pre-existing clinical data in order to obtain regulatory approval for their generic copy.
Market Exclusivity: Market Exclusivity constitutes a period of time where the regulatory authority prevents the marketing and sale of a third party generic copy of the pharmaceutical product within that jurisdiction. When applied to the pharmaceutical product this prevents the launch of a generic copy, irrespective of whether the copy has received authorisation to be marketed. Therefore, this provision acts as an effective block against generic companies aiming to launch a copy of the pharmaceutical.
Regulatory Exclusivity considerations:
The following aspects also require consideration when accounting for the effects of Regulatory Exclusivity.
One important consideration is that the Exclusivity provisions provided can often vary substantially between jurisdictions. For instance, some jurisdictions may only provide Data Exclusivity, while others may only provide Market Exclusivity. Additionally, certain jurisdictions contain provisions for both forms of Exclusivity, while others lack provisions of any sort.
Furthermore, Exclusivity provisions can also vary within the jurisdiction itself. This often occurs when provisions are amended or updated, resulting in an “Old” and a “New” system co-existing. This duality can impact how Exclusivity term is determined, depending on when the transition occurred.
Finally, further Exclusivity could also be provided, which is dependent on whether additional studies or regulatory approval were undertaken on the product. This can include:
- Approval of additional, new, therapeutic indications for the product.
- Approval of new dosages regimes or routes of administration for the product.
- Approval of new pharmaceutical combinations inclusive of the product.
- Approval of Orphan Disease status.
- Undertaking studies in Paediatric populations.
The availability of these criteria for obtaining further Exclusivity also differs between jurisdictions.
The Table below provides a brief summation of Exclusivity provisions within several key jurisdictions. This table does not discuss orphan drug exclusivity, which will be the subject of a future article.
Regulatory Exclusivity Provision(s)
|Australia||5 years Data Exclusivity from Market Authorisation|
Pre-17th June 2006: 5 years Data Exclusivity from Market Authorisation
Post-17th June 2006: 6 years of Data Exclusivity followed by 2 years of Market Exclusivity from Market Authorisation*In September 2018 Canada signed a trade agreement to extend its Data Exclusivity provision to 10 years. Currently, this has not yet been put into place.
Pre-November 2005: 10 years Data Exclusivity from Market Authorisation
Post-November 2005: 8 years of Data Exclusivity followed by 2 years of Market Exclusivity from Market Authorisation*Potential for 1 additional year if certain criteria are met
|India||No Exclusivity provisions exist|
|New Zealand||Five years Data Exclusivity from Market Authorisation|
|United States|| |
New Chemical Entities: 5 years Market Exclusivity from Market Authorisation.Biologics: 12 years Market Exclusivity from Market Authorisation.
In many cases, the IP protection provided by Regulatory Exclusivity is shorter in duration than that provided by a patent. However, Regulatory Exclusivity rights are more difficult to challenge than a patent. There are also examples where the Regulatory Exclusivity period is longer than the patent term. For example, for the biological product Eylea® (Aflibercept), the US patent to the compound itself is due to expire in June 2023, however the Regulatory Exclusivity period for this product expires in November 2023. Accordingly, the Regulatory Exclusivity provisions provide an additional 3 months of protection for Eylea®, over that of the patent. For a drug as successful as Eylea®, this additional time could mean significant revenue for the brand company.
As discussed, Regulatory Exclusivity is an important form of IP right for those working in the pharmaceutical sector. The overall period of Exclusivity attached to a product can form an additional barrier for innovator companies against generic competition. In some instances, the term of this Exclusivity can extend beyond patent protection. Generic companies must consider the loss of Exclusivity period when considering their approach to launching a copy. Since provisions can differ both within and between jurisdictions, determining the full impact of Regulatory Exclusivity is often not a straightforward task. We recommend consulting with IP specialists first to ensure that the effect of any Regulatory Exclusivity provisions are properly accounted for.