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ANVISA


waiving of tests by the producers of generic and similar drugs.


“ THE REGULATION MAY LEAD TO DPE INFRINGEMENT AND VIOLATION OF THE CONSUMER LAW, AS THE CONSUMER IS NOW VULNERABLE TO PRODUCTS THAT HAVE NO UNEQUIVOCAL PROOF OF EFFICACY AND SAFETY FOR ALL THE APPROVED THERAPEUTIC INDICATIONS.”


Te semantic analysis of the verb ‘to use’ also rejects the conclusion made by ANVISA. Tis word has the following meanings: employ, usefully take, enjoy, exploit, be useful or helpful, take advantage.


All of these meanings converge with ANVISA’s conduct, because it is undeniable that ANVISA used, employed and exploited the results of the tests previously presented in order to grant generic and similar marketing approvals.


Te law only authorises disclosure by the government of


this confidential information “when necessary to protect the public”.


It must be stressed that what is discussed here is not the simple prohibition of physical access or consultation by third parties to the data package submitted by the plaintiffs and under ANVISA’s responsibility, and therefore the use of such information to produce and obtain a marketing approval for the generic version of the reference drug produced by the plaintiffs.


Initially, it is necessary to underline that the right to protection of trials and data submitted to the governmental agencies to obtain marketing approval is set forth in Section 7, Article 39 of the TRIPS Agreement.


ANVISA argues in its defence that it “did use the data package provided by the owner of the reference drug, be it in [an] analytic, comparative, interpretative or exploratory meaning. At most, there was a presumption (based on logical inference) that it would be unnecessary and unjustifiable to require such data to be submitted once again”.


Tis argument, however, does not withstand a logical analysis.


If the owner of the marketing approval to the reference drug had not submitted its tests, there would be no possibility to exempt the producers of generic and similar drugs from the presentation of their own tests to evidence the safety, effectiveness and quality of the drug.


Tus, the data package of the reference drug is an indivisible part of the causal chain that allows the


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In this case, the use of the results of the tests presented to grant marketing approval for the reference drug is not intended to protect the public, but only exempt laboratories that want to register generic and similar drugs from presenting tests that would demonstrate the safety, effectiveness and quality normally required for everybody who wants the marketing approval for a new drug. Terefore, there is no doubt that ANVISA used the results of the tests performed by the plaintiffs to grant the marketing approvals to the defendants.


Te necessary tests to have a marketing approval granted for a reference drug are the result of considerable effort and investment of economic resources, besides years of research, to ensure compliance with the requirements for marketing approval of the reference drug—effort that is not required from the laboratories that want generic or similar marketing approval.


Rules for marketing approval of biosimilar medicines in Brazil next to reach courts


On December 17, 2010, ANVISA issued regulation no. 55/2010, establishing the requirements for granting marketing approval to new biological products and existing biological products, opening a new chapter regarding Brazil’s lack of enforcement of DPE.


A request for marketing approval of biological products (not new) can be made in two different ways: individual development and development by comparability. When


applicants opt to


develop by comparability, they must submit a comparative dossier containing non-clinical and clinical studies used to demonstrate comparability between the biological product to be approved and the biological product used as a comparator.


Anderson Nascimento was recently an associate at Momsen, Leonardos & Cia. He has an LLM in competition law and regulation from Lisbon University. He specialises in complex litigation involving pharmaceutical and IP law, food and drug law, competition law and administrative matters.


Te regulation may lead to DPE infringement and violation of the consumer law, as the consumer is now vulnerable to products that have no unequivocal proof of efficacy and safety for all the approved therapeutic indications.


Bearing in mind all the recent developments cited above, one can see that Brazil’s deficient IP rights enforcement is on the verge of change. IPR owners who consider investing in Brazil should realise that its future will be set by these decisions and should not hesitate to seek enforcement.


Otto Licks is a partner at Momsen, Leonardos & Cia. He can be contacted at: oblicks@leonardos.com.br


Anderson Nascimento was recently an associate at Momsen, Leonardos & Cia. He can be contacted at: arnvancouver@gmail.com


Otto Licks is a partner and leads the firm’s life sciences group. He advises and practises trial and appellate litigation in the intersection of food and drug and intellectual property laws, including government procurement, patent and Orange Book-related issues, biogenerics, nanotechnology, linkage, data package exclusivity, regulatory compliance, unfair competition and policy making.


Life Sciences Intellectual Property Review 2011


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