Cancellation of market authorization of a pharmaceutical product proved to be more effective remedy against patent infringements in pharmaceutical industry than just a termination of patent infringements every time they are revealed on the market. Main advantage of the cancellation of market authorization of an infringing product is that a patent holder should prove the infringement just once to protect its rights from a certain infringement for the whole patent validity period. When market authorization cancellation instrument is unavailable, patent holders have normally to file patent infringement action each time they reveal the infringement which is very time and resource consuming and sometimes not feasible at all.
Patent linkage mechanism is normally implemented within the process of registration of pharmaceuticals to secure the above remedy. The said mechanism is successfully exploited, inter alia, in the US.
Enforcement of pharmaceutical patents has a big room for improvement in Ukraine. Under the law, a patent holder who seeks for market authorization of its original product in Ukraine (through filing thereof for the state registration) should provide the regulator with a copy of the patent regarding the product applied or a license/ license agreement confirming authorization to manufacture and/or sell the respective product protected by the patent as well as the official confirmation that the respective patent is valid. In turn, generic applicants whose products refer to the respective original pharmaceuticals registered in Ukraine should file the guarantee that patent rights of any third parties would not be infringed by the generic product applied thereby for the state registration. In addition, an application for a generic product may be rejected if such product would infringe effective patents, inter alia, by its manufacture, use, sale etc.
The described legal environment still allows unfair market players obtaining market authorization for the products infringing patents and introduce those into commercial turnover, and quite frequently patent holders have no ultimate means to prevent such infringements.
In view of the above, it appears reasonable to introduce the patent linkage requirement in Ukraine. The above linkage mechanism envisages the following main stages:
(1) any applicant for a generic or biosimilar product referring within the state registration process to an original pharmaceutical shall indicate a respective patent involved (if any). The applicant should provide either a license regarding the relevant patent or undertaking not to use its product until the respective patent expires.
(2) in addition to the above, the applicant encloses a patent attorney opinion explaining a linkage of the generic to any patent or absence of the said linkage.
(3) the regulator makes available all the information regarding pharma applications database and patent linkages to allow patent searches and timely responses by patent holders to the applicants.
(4) notification (along with all necessary files) by the regulator of a patent holder that the generic/ biosimilar product application is filed.
(5) upon the above, patent holder may file a court action against a generic/biosimilar applicant.
(6) upon motion by the patent holder, the state registration is suspended until the above court case is resolved.
(7) if patent holder fails to prove the infringement in court, generic product obtains market authorization.
As a result of the said patent linkage mechanism, generic/biosimilar applicants and patent holders would receive a number of benefits:
- applicant will have the possibility to use its product right upon the respective patent has expired (having the respective generic registered and not used until the patent expiry), and to recover damages from the patent holder abusing its rights (in case of failure by the patent holder in court);
- patent holder would receive the effective instrument to prevent unfair products from the state registration, and thus from introduction of those into commercial turnover.