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ANVISA Non-obviousness

On October 26, 2010, the Federal Court of Appeals for the 2nd Circuit upheld a lower court decision, which nullified INPI’s decision reconsidering the grant of a patent alleging its obviousness and declared the patent valid. Te core of the litigation was whether the simple reduction of the molecule in question would impair non-obviousness (since merely reducing the size of the molecule would be a procedure that is known in the state of art) and whether the judges would have to rely on the court-appointed expert’s opinion or could challenge it.

Te panel established by majority that the non- obviousness was not related to the reduction of the molecule per se, but to its unexpected result. One of the appellate judges said that although the molecule was known and successfully marketed, there was a technical problem to be addressed concerning the adverse reactions of some patients. Tis problem, then, made the company seek to improve its safety and efficacy, which was achieved by an unpredictable reduction of the molecule.

Furthermore, Judge Roriz said that, in her opinion, INPI should not reconsider its own opinion on the non-obviousness requirement in light of the same set of prior art documents. According to her, unless there is new evidence or a clear error, the administrative authority should not have to change its opinion.

ANVISA prior approval

For the last 12 years, a controversy has developed concerning the role of ANVISA in the patent examining procedure of pharmaceutical products. Back in 1999, ANVISA’ s prior approval requirement was established for patent applications claiming “drugs of any kind, and the respective process for obtaining or modifying them”.

Since then, there have been controversies about: (i) for which kinds of patent applications (ordinary, pipeline or both) prior approval is mandatory; (ii) from when it is mandatory; (iii) the objective standards that should guide ANVISA’s examination; (iv) possible overlaps between ANVISA’s and INPI’s examination; (v) the procedure to be adopted when those agencies’ opinions conflict; and (vi) whether ANVISA’s role should be limited to public health concerns, among others.

In the past 12 months, relevant case law has clarified a few points. On April 27, 2010, the Federal Court of Appeals for the 2nd Circuit rendered a landmark ruling on an appeal challenging ANVISA’s opinion analysing patent requirements. In that decision, the panel decided

that despite ANVISA’s mandatory participation in pharmaceutical patent examination, it would be unreasonable or inefficient to believe that the legislator would have established that ANVISA should assess the existence of patent requirements already examined by INPI, as set forth in the IP law. It also states that the reasonable interpretation of the provision suggests that ANVISA should render its opinion concerning public health concerns. Nonetheless, according to the decision, ANVISA should be able to provide INPI with relevant information related to the patent requirements of an application. In general, the decision concluded that the agencies’ roles are complementary, since they must focus on different aspects.

On June 21, 2010, the Federal Court of Appeals for the 1st Circuit issued a decision on this matter. At the lower level, the federal judge denied the injunction requested against ANVISA’s opinion analysing patent requirements, which prevented the granting of the patent in spite of INPI’s favourable decision. In its decision, the court panel ordered ANVISA to re-examine the application, restricted to its legal responsibilities, i.e. public health concerns.

It is also worth mentioning three favourable rulings of federal courts in Brasilia concerning the issue. Te first, issued on August 26, 2010, ordered ANVISA to grant its prior approval to a patent application if it has no public health concerns to raise on that case. Te second, issued on January 12, 2011, went further and declared the unconstitutionality of the prior approval

provision, since it establishes an

unnecessary re-examination of pharmaceutical patent applications, breaching Article 4 of the Paris Convention. Te third, related to the first, declared ANVISA in contempt of court and established a fine of approximately $125,000.

Data package exclusivity (DPE) enforcement

Brazil explicitly infringes DPE rights, in spite of the legal framework providing protection by Article 195, XIV of the IP Law and Article 39.3 of the TRIPs Agreement. Although the first provision established that the disclosure, use and exploitation of a human drugs data package presented to ANVISA by the originator company by unauthorised third parties is an act of unfair competition, it does not indicate a term for such an exclusivity.

Law 10,603/2002 limits protection afforded by the statutes approved in the 1990s that established a term of data package protection for veterinarian drugs and agrochemicals of

62 Life Sciences Intellectual Property Review 2011

10 years for active ingredients never approved before the authorities and five years for data packages of active ingredients previously approved in Brazil entailing data concerning new therapeutic indications. Te same law established compulsory licences and antitrust defences.

On May 9, 2011, Brazil had its first final

decision on the merits in a litigation seeking the enforcement of DPE rights concerning an originator’s drug for human use. In this decision, the Federal Court recognised that in the marketing approval proceeding based on bioequivalence and other comparative tests, there was an undisputable reliance on the originator’s data package. However, considering the lack of a specific provision fixing a term for DPE for human drugs, the federal judge observed that it would be unreasonable to establish the exclusivity for good. Terefore, he decided by analogy, that the term applicable to veterinarian drugs should be applicable to the current case and granted 10 years of DPE for the originator company.

Te relevant parts of the decision reads as follows: “ANVISA denies, above all, the breach of confidentiality of the [non-disclosure agreements’] data package and the utilization of such data, stating that such information is not necessary to grant the generic drugs’ marketing approvals, because the bioequivalence and bioavailability tests would be sufficient to that end, as the security, efficacy and quality of the substances contained in the generic and similar drugs have been already proved by the reference drug.”

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