The evolution of new Pharmaceuticals requires a huge investment of time, resource, human efforts. Usually, Research & Development of a new pharmaceutical molecule prescribes for 10- 15 years and one of every thousand entities reached to market as it has pass-through stringent pre-clinical, clinical and regulatory approval process.
To protect rights of Innovator and to avert unfair competition by generic players, IP Rights and Exclusivity came into existence in course of series of Trade convention and Agreements.
Thought sometimes overlapping, both Patent rights, as well as Exclusivity, differ on many fronts.
Patent:
A patent is the territorial property right issued by the Nation to an inventor “to keep out others from producing, using, offering, selling or importing the innovation for a specified time period, in return publishes the invention when the patent is granted. Patent rights are for a fixed period, that is 20 years.
Particularly in the Pharmaceutical Industry, there exists a number of patent covering different aspects of the product. Namely, Primary Patent covers Active Pharmaceutical Ingredient and secondary patents cover formulation, dosage, Method of treatment, the process of manufacturing.
Primary patents are filed during the development stage of the product. If the duration between the filing of patent and Market Approval of product is less than 15 years, in many countries provision of patent term extension is available.
Patent rights are the bar to producing, using, offering, selling or importing of pharmaceutical, not to obtaining marketing authorization of Generic. Moreover, such rights can be questionable as well as refutable by a competitor.
Exclusivity:
“Exclusivity is absolute marketing & manufacturing rights accorded by the regulatory body of the country upon the approval of any drug.”
As Article 39(3) of TRIPS says:
“Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use.”
Exclusivity can be of different matters namely new chemical entity, Orphan drug status, New clinical trials or use, Paediatric trials. Term of exclusivity rights varies from country to country.
Exclusivity can run simultaneously with a patent. If the patent period has expired or lapsed or invalidated or there is no patent on a product, exclusivity acts independently.
Though for shorter duration compared to patent, Exclusivity right is much-consolidated right than a patent. Unlike a patent, Exclusivity rights cannot be challenged or invalidated. Also, Exclusivity rights are not compromised in case of national circumstances like compulsory license in India. Unlike a patent, Exclusivity is indigenous in nature, i.e. no filing or fees are required.
Patent and Exclusivity rights, when strategized, are marketing exclusive rights that recognize, protect and reward time, resources and economical investment and supplement competitive environment for innovation and development.
In summary, in the course of product identification or extension of the line of products or market extension, one needs to evaluate patent as well as regulatory exclusiveness of the target country to have profit-making products in the portfolio. We will provide more detailed information on regulatory exclusiveness in USA and Europe in our upcoming blogs. So stay tuned for more information.
