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Pharma companies query LatAm policies

“You might not know it from my talk, but I love the region,” warned Manisha Desai of Eli Lilly at the beginning of her AIPLA presentation yesterday morning. Her preface was a good summary of both the opportunities and challenges that pharmaceutical companies face in Latin America.

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Developments in Mexico highlight some of the challenges. According to Juan Luis Serrano of AstraZeneca (pictured), the changes there are driven by a combination of the unintended consequences of policies and litigation over these policies.

One prime example of this is the patent linkage system. Created back in 2003, the system was supposed to be similar to the Orange Book system in the US, that is, for Mexico’s patent office (IMPI) to create a list of patented drugs and relevant patent information in order to allow regulators to deny market approval for drugs that would infringe a patent. However, as Serrano notes, it has been much different in practice.

One big point of contention in the system was that it initially only included drugs covered by compound patents. Formulation, use or polymorph patents were excluded.

Not surprisingly, patent holders were unhappy with this setup. Several brought suit against IMPI on constitutional grounds, arguing that their non-compound patents were being discriminated against. After several contradictory lower court decisions, the Supreme Court handed down a 3-2 decision that held that formulation patents should be included in the gazette. However, strangely enough, IMPI argued that it wasn’t bound by the Supreme Court’s ruling and that it will include a specific formulation patent after it is sued by the patent holder in court. Eventually, IMPI agreed to include formulations without being subject to litigation, though use patents are still an outstanding issue.

“If your patent is not in the gazette, it will most likely not be reviewed by the regulatory agency and the patent office when a generic submits an application for market approval,” he warns.

Other countries in the region also pose challenges, with patentability being a key issue. For example, members of the Andean Community (Colombia, Ecuador, Peru and Bolivia) do not allow for methods of treatment patents even if the claims are written as Swiss-type claims.

Argentina, one of the region’s largest economies, also raised similar concerns. In 2012, the government propagated new guidelines on pharmaceutical patents. Under these guidelines, method of use patents were not allowable.

“They wrote in the guidelines that it’s considered equivalent to therapeutic treatment and therefore it lacks industrial applicability,” Desai explained.

Along the same lines, polymorphs, salts and esters are not patentable in Argentina.

These guidelines have not been well received by rights holders. Several groups brought an administrative action challenging the guidelines on the grounds that they were implemented improperly. The administrative case failed, and a court challenge to the guidelines is still pending.

Ecuador also has similarly controversial patentability issues. Polymorphs are not patentable in the country. However, neither Ecuador’s national law nor Andean Community law, which Ecuador is bound by, specifically disallows the patenting of polymorphs. Desai notes that this policy is being challenged, but the matter is still pending.

Despite these concerns, both Desai and Serrano say that there are positive developments in the region, as well as things rights holders can do to get better protection. In Costa Rica, Desai explained that despite some implementation problems initially, it is now possible to get data protection and, in fact, Eli Lilly was able to secure the protection for one of its products.

Meanwhile, Serrano encouraged rights holders to engage IMPI examiners when applying for a patent.

Desai and Serrano were two of the speakers presenting at yesterday’s panel: Never a Boring Day – the IP and Regulatory Roller Coaster in Latin America and the European Litigation Landscape.

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