Brazilian Generic Drug Registration Sets Standard For ‘Pipeline’ Patents

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The first Brazilian generic drug against erectile dysfunction recently received registration at the National Surveillance Agency – a unit of the Health Ministry. The Viagra generic’s registration was only possible because of a decision of the Superior Court that will terminate the drug patent next month, said Odnir Finotti, president of the Pro-Generics Association.

The decision of Superior Court was announced on 28 April. From 20 June, generic Viagra production will be allowed and competition promises to benefit Brazilian consumers.

According to Jorge Ávila, president of National Institute of Industrial Property (in Portuguese, Instituto Nacional de Propriedade Industrial), “pharmaceutical generic laboratories announced the launch of Viagra generics with the price up to 50 percent lower than today.” Viagra has been sold in Brazil since 1998. These days, a box with four tablets of 50 mg costs US$77.

In a press release, Viagra brand owner Pfizer took issue with the decision, stating, “We respect, but disagree with the Superior Court decision.” The pharmaceutical company argues that the period of patent exclusivity until mid-2011 was a way to guarantee the investment in development of Viagra.

The guarantee of investment ensured in the research and development of new drugs ensures the enabling of innovation, it said. Under Brazilian law, the pharmaceutical company may appeal the decision.

Pipeline to Debate

The polemic is over Brazilian “pipeline” patents. In 1996, Brazilian Industrial Property Law number 9.279 created the mechanism known as the pipeline, which allowed patent claims to be accepted and approved for technological fields that had not been recognised previously, such as pharmaceutical and food products, based on the date of first foreign filing. The rule effectively created monopoly situations in some cases where items had already entered the public domain, sources said. For more on this debate, see (IPW, Public Health, 22 January 2008).

In Brazil, the maximum period for a foreign patent is 20 years.

In June 1990, Viagra received a registration in England. However, Pfizer says that request was not concluded and the registration was only finished in 1991, in the European Union. As a result, the laboratory demands an extension of one more year, until 2011.

Ávila disagreed and said Pfizer’s argument “was based on an inappropriate idea, in our view, that whatever reason for the extension of a patent term of protection in the origin country, a similar extension should be granted a pipeline patent in Brazil.”

He explained that patent applications at the national level in European countries may lead to applications to the European Patent Office up to 12 months after the first request, keeping the original date, and if the patent application is given, the protection across the entire continent is for 20 years from the second application. Thus, the protection in the origin country is extended by up to 12 months.

The National Institute of Industrial Property, said Ávila, respects the European liberality, but for him it is obvious in Brazil the patent extension cannot be affected by European particularities. Some countries give an extension because of delays during the proceedings of the patent applications. It is evident to Ávila, however, that the patent in the Brazil has not been extended due to delays in the origin country.

This decision is expected to have a major impact. “We hope that the decision represents the understanding of pipeline patents,” said Ávila. He said the Superior Court of Justice confirmed INPI’s view on the debate. The time of a patent begins counting from the date of the first deposit, which is called the date of “Union priority,” regardless of what will occur later with this patent anywhere in the world.

Odnir Finotti, from Pro-Generics, agrees that the decision is very important because it defines the term of a patent in Brazil and thus prevents other actions in the Brazilian courts. “Now it is clear, we can plan a generic drug launched at the market in an advance and we know the rules of the market.”

There are at least 30 other drugs in the same situation and whose laboratories are requesting an extension in Brazil. There are drugs for cholesterol, stroke, hypertension, obesity, hepatitis, cancer, diabetes and other. According to Finotti, today there are 91 pharmaceutical companies that produce generic drugs. These laboratories are responsible for some 3,000 different drugs for 90 percent of diseases.

The Brazilian Viagra market is estimated at US$114 million per year. If all Brazilians used only generic Viagra, explained Finotti, the savings would be US$40 million. Since generic drugs were introduced in the country in 2001 up to now, Brazilians have saved US$10.28 billion with the consumption of all generic medicine.[Note: paragraph clarified]

Regarding retaliation from multinational pharmaceutical companies, INPI’s Ávila said he does not think it possible. He praised the fact that in many countries there is no patent on Viagra because it predates the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and most countries did not adopt the “pipeline” mechanism.

Claudia Jurberg may be reached at info@ip-watch.ch.

Attribution-Noncommercial-No Derivative Works 3.0 Unported

Comments

  1. ks says

    as a point of clarification, this appears to be a different conflict than the one over pipeline patents per se (which the article links to, from a January 2008 story). There are two issues. The first is whether Brazil should grant pipeline patents (it is one of the few countries in the world to do so, and as the 2008 article explains the costs of this decision are quite high). The second issue is, given that Brazil does grant pipeline patents, whether Brazil then automatically adjusts expiration dates as these are adjusted abroad. The “viagra” case discussed in this article appears to be about this latter point.

  2. Nuno Pires de Carvalho says

    In Brazil there are two other issues pending that are related to this matter, besides the constitutionality (or not) of pipeline patents (hence, of their outright invalidity (or not)), and the extension of pipeline patent terms to correspond to the term of subsequent patents obatined abroad (the Brazilian statute says that the 20-year term of pipeline patents should be counted from the date of the original application). Those two additional issues are: the possible extension of the terms of pipeline patents so as to correspond to the extended terms of patents in Europe, as per the concession of SPCs (supplementary protection certificates) in order to compensate for the delay in obtaining marketing approval; and the possibility of the Brazilian sanitary agency (ANVISA) to hold the marketing approval of bioequivalent pharmaceutical entities pending the existence of a patent (the so-called linkage). The vote of one of the Superior Curt of Justice judges on the Viagra case clearly spoke against extending the terms of pipeline patents to compensate for delays in obtaining marketing approval in Europe.

  3. wackes seppi says

    Something really wrong with the math, or with the knowledge of the market… or both.

  4. says

    Thanks for pointing that out Wackes. The paragraph has been clarified as follows: The Brazilian Viagra market is estimated at US$114 million per year. If all Brazilians used only generic Viagra, explained Finotti, the savings would be US$40 million. Since generic drugs were introduced in the country in 2001 up to now, Brazilians have saved US$10.28 billion with the consumption of all generic medicine.

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