The registration data protection enables competitors in the field of medical preparations to ensure for a certain limited period of time exclusive rights to data gathered for testing the safety and effectiveness of a medical preparation, namely with respect to results of pharmacological and toxicological tests and clinical tests. This data generally must be filed with the administrative Office competent to register medical preparations for the purpose of approving the medical preparation for its launching on the market.
This data or its part may be and generally are protected through intellectually property rights, including patents, industrial designs, copy right, as well as protection of trade secret, respectively know how. This is complemented by the special protection provided pursuant to the respective regulations of pharmaceutical law. The respective regulations of the pharmaceutical law stipulate whether and under what conditions another applicant for registration of a medical preparation, other than the one, who has filed this data with the registration Office, may use this data in the registration proceedings relating to its own medical preparation.
In the Czech Republic, results of pharmacological and toxicological test and results of clinical trials of another owner of a decision on registration may be referred to provided that the medical preparation is essentially similar to the preparation that is already registered in the Czech Republic and that the owner of the decision on the registration of the original medical preparation has granted consent with the use of this data. If no such consent has been granted this data can be referred to only if the medical preparation is essentially similar to a medical preparation, which is registered in the Czech Republic, possibly in another state of the EU for at least the period of six years.
The interpretation of the EU directive setting out the protection for the registration data protection is a relatively common subject of decisions of the European Court of Justice. The European Court of Justice dealt apart from others with the question of how to interpret the term of essentially similar medical preparation and it defined it as a preparation that has identical qualitative and quantitative composition of the active substance, an identical pharmaceutical form and that is bio-equivalent, provided that it does not follow from the scientific knowledge that it differed from the original medical preparation as to its safety and effectiveness.
The European Court of Justice in the decision Generix (UK) Ltd. No. C-368/96 expressed a principle that if a medical preparation was essentially similar to an already registered medical preparation it was possible if other legal requirements were met to use the registration procedure with the reference to the data of the original preparation with respect to all therapeutic indications already authorized for the given preparation. The same applies to the dosage forms, doses and ways of dosage. In the decision Novartis Pharmaceutical UK Ltd. No. C-106/01 the ECS said that if so called hybrid administration abridged proceedings had been used for the registration of a medical preparation B, it was possible without a consent from the owner of the registration of this product and even though the six respectively ten year period of registration data protection had not lapsed yet, to refer to the registration data of this preparation when reviewing the application for registration of a medical preparation C, which referred to the medical preparation A, which had been approved for the period of more than six respectively ten years if the registration data of the medical preparation B lied in clinical tests that were to prove the safety of the product B even though this product had a higher degree of bioavailability than the product A if it was given in the same dosage. In the newest decision Approved Prescription Services Ltd. No. C-36/03 the European Court of Justice came to the conclusion that it was possible to refer to the preparation B, which was basically similar to the newly applied medical preparation if the product B was a new pharmaceutical form of the product A even though product A, not the product B had been approved in the EU for at least the period of six respectively 10 years.
A new system of registration data protection that will introduce the formula 8 + 2 + 1 will become effective next year. An application for registration of a generic medical preparation using the abridged procedure shall not be admissible before the expiration of the period of eight years from the registration of the original medical preparation in the EU or in another member state. However, the launching of a generic medical preparation on the market will be possible after the expiration of the period of ten years from the first registration of the original medical preparation. This ten-year period will be extended for a one more year provided that the owner of the registration receives during the first eights years from the ten-year period of protection an authorization for one or more new therapeutic indications that bring an important clinical benefit compared to the present ways of treatment.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.