The case originated in a request from the Secretary of State for Health, through which the Portugues Competition Authority (AdC) was sent a letter/circular, dated 25.02.2013, in which TEVA apparently informed its distributors of the conclusion of a contract with ASTRAZENECA regarding the product Rosuvastatin Ratiopharm.
In order to ascertain the facts necessary to discover the truth, several evidentiary diligences were carried out, including the search, examination, collection and seizure of documents, pursuant to the provisions of article 18, no. 1, paragraph c), of Law no. 19/2012, at the premises of 9 companies.
Both the product Rosuvastatin Ratiopharm, marketed by the companies TEVA/RATIOPHARM, and the branded medicines Crestor and Visacor, marketed by Astrazeneca, fall within the category of MSRM, belonging to a group of medicines called hmg-coa reductase inhibitors or statins.
All three contain the same active ingredient, rosuvastatin, and their therapeutic purpose is to reduce cholesterol and fatty substances called triglycerides.
The main distinction between, on the one hand, the products Crestor and Visacor and, on the other hand, the product Rosuvastatin Ratiopharm, is that the former are originator products and the latter is a generic product.
The State may grant protection to inventions and to its holder over the result of its creation by granting a patent. A national patent may relate to a product or a process, conferring on its holder the exclusive right to exploit the invention anywhere in Portuguese territory. The exploitation in question includes the production and commercialisation of products based on the invention as well as the granting of licences to third parties to use the invention against payment of royalties. The patent also gives its holder the right to prevent third parties, without his consent, from manufacturing, offering, stocking, introducing into commerce or using a product covered by the patent, or importing or possessing it.
The originating company can also choose to protect its invention with a European Patent through a single, centralised procedure at the European Patent Office (EPO). The scope of the patent granted by the EPO is the same in all designated countries, but only takes effect after the respective validation. Validation is understood as the delivery, to the Office of each country, of a translation of the granted patent, in the official language of that country
The Complementary Protection Certificate is an Industrial Property right that extends, for up to a maximum of 5 years, the protection conferred by a basic patent, for a given product, medicine or plant protection product, provided that the product is protected by the said basic patent and confers the same protection as the patent but only for the product identified in the AIM.
Competition Law does not affect the existence of industrial property rights, e.g. patents, however, their exercise through an agreement between undertakings may fall under the prohibition of Article 9 of Law 19/2012 and Article 101 TFEU.
If the infringement of the patent is established by the court, the means used to remove the competitor is based on the strength of the patent. In cases where, by agreements between the parties, the generic company gives up challenging the patent due to a transfer of value (of any nature) by the originator company, the exclusion from the market is not based on the strength of the patent but, possibly, on the existence of an anti-competitive agreement.
It is necessary, from a competition law perspective, to analyse agreements based on alleged infringements of industrial property rights in order to understand if their scope goes beyond the resolution of the dispute in question and, in particular, if the generic company was "compensated" for the non-entry or exit of the market.
In the present case, there is no evidence that the agreement entered into between ASTRAZENECA and TEVA/RATIOPHARM went beyond the resolution of the dispute, and there is no evidence that TEVA/RATIOPHARM received any advantage from the withdrawal of the product Rosuvastatin Ratiopharm from the market.