On February 1 2011, in its decision in Novartis Pharma AG v Monte Verde SA, the Federal Court of Appeals in Civil and Commercial Matters, Division III, confirmed the rejection of the plaintiff's request for the protection of test data. The plaintiff had requested that test data submitted abroad for the approval of an original pharmaceutical product be protected in Argentina in accordance with Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs).
This article establishes that the test data that is required for marketing approval of pharmaceutical or agricultural chemical products which use new chemical entities will be protected against unfair commercial use, where the origination of that data involves considerable effort.
The Confidentiality Act (24,766) regulating the protection of test data does not offer effective data protection and, in this sense, its literal interpretation is inconsistent with TRIPs.
The most distressing situation with respect to pharmaceutical products concerns the sanitary authorities, which have established a similarity-based approval system through Article 5 of the act and Articles 3 and 4 of Executive Order 150/92, dealing with abridged approval of similar medicines already registered in Argentina or in the countries listed in Appendix 1 of the act.
The principle governing this situation should be that every company which requested marketing authorisation must perform its own clinical trials, thus evidencing the efficacy and safety of the product for which approval is sought. However, the abovementioned similarity-based approval mechanism (by means of a summary proceeding) does not require the performance of their own trials or tests.
The information required by Article 5 of the act, which must be filed with the sanitary authorities in order to obtain approval by similarity, can be easily accessed by copying the information of the original drug used as reference.
Novartis Pharma AG started legal action against Monte Verde SA, requesting the court to order Monte Verde to cease using confidential information related to any product containing the active principle imatinib mesilate. Monte Verde had requested and obtained marketing approval for its Leucimat pharmaceutical product, which also contained imatinib mesilate. Novartis also requested that Articles 5 and 6 of the Confidentiality Act and Articles 3 and 4 of the executive order be declared unconstitutional, as they establish a similarity-based approval mechanism by means of a summary proceeding that does not require own trials or tests.
In order to support the petition, Novartis Pharma emphasised the following:
- It had undertaken research (pre-clinical and clinical studies) and invested funds in order to obtain marketing approval for its Glivec product in the United States and Europe;
- The confidential information that it had obtained is protected under Article 39.3 of TRIPs; and
- Although Glivec is not patented in Argentina, Articles 14 and 17 of the Argentine Constitution protect Novartis' property rights and Article 39.3 of TRIPs also protects such data against unfair competition carried out through disclosure or unfair commercial use.
The court considered that Novartis could not request that Articles 5 and 6 of the act and Articles 3 and 4 of the executive order be declared unconstitutional, as Novartis had previously obtained marketing approval for several original pharmaceutical products in Argentina based on the same rules that establish the abridged registration procedure to which it objected on this occasion.
Likewise, the court held that a strict requirement that every company must perform its own trials of active principles already researched and authorised would obstruct public access to pharmaceutical products, which is an essential aspect of the right to health, and would make such products more expensive, mainly in those countries that have adopted the generic-drug policy.
The court also stated that Article 39.3 of TRIPs may be implemented by TRIPs members either:
- through the rules on unfair competition, in which case marketing approval in favour of a third party based on the similarity registration process does not entail non-compliance with Argentina's obligation to protect data from unfair commercial use; or
- through a system of exclusive rights on the undisclosed data during a specific term, which does not exist in Argentina.
Based on these reasons, among others, the court rejected Novartis' petition. This decision confirms the lack of protection of test data in Argentina.
For further information on this topic please contact Daniel R Zuccherino at Obligado & Cia by telephone (+54 11 4114 1100), fax (+54 11 4311 5675) or email ([email protected]).