[Update from the author: Brazil announced on 19 December adoption of the resolution against the extension of patent rights to second-use drugs and polymorphs. Such patents were seen as subterfuges from the pharmaceutical companies to expand their patent rights. The inter-ministry intellectual property group met on 1 December, but only announced the result on 19 December. The group is formed by the ministries of: Development, Industry and Commerce; Agriculture; Health; Science & Technology; Culture; Justice; Environment; and others. The Office of the Brazilian President, the Brazilian Office of Intellectual Property and Brazilian National Health Surveillance Agency also participated in discussions.]

By Claudia Jurberg for Intellectual Property Watch
RIO DE JANEIRO - Brazil’s lower house of Congress held a recent hearing to discuss proposed changes to rules on pharmaceutical patents that would limit patents on two types of pharmaceuticals.

Under proposed legislation, patent rights would not be permitted in two modalities: second-use drugs and polymorphs. A second-use drug patent refers to when another function is discovered in a drug for which the pharmaceutical industry holds the patent on a substance. The situation could be explained as a positive side effect.

In the case of polymorph patents, the substance is made with the same material and shows the same effects as the medicines protected by a patent, according to legislation author Deputy Paulo Teixeira. It is like a substance with the same crystalline forms.

The authors of the legislation are congressional deputies Teixeira and Dr. Rosinha (Florisvaldo Fier) of the Workers Party, the same political party as the Brazilian president.

According to Luis Carlos Wanderley Lima, coordinator of intellectual property at the Brazilian National Health Surveillance Agency (Anvisa), both cases lack novelty - one of the principles required to issue a patent.

Wanderley Lima said that applying patents to polymorphs has been identified as a pharmaceutical industry strategy to expand patents and gain a monopoly on some substances important to the commercial market. In his view, it could be valid to developed countries but it could prejudice developing countries such as Brazil because it causes a delay of generic drugs’ entrance in the market.

The president of the Brazil Patent Office (INPI), Jorge Avila, said during the 31 October hearing that in his view “there is space for an [positive] environment for business initiatives in the country while at the same time it is possible to promote the strengthening of production of generics and encourage Brazilian research in the pharmaceutical area.”

Researcher Claudia Chamas, representative of the Health Ministry, said “there is a profound difference in understanding between the INPI’s guidelines and the opinion of the deputies.” According to her, the project of the deputies is better, because it incentivises the innovation and curb the excesses.

In general, the acceptance of pharmaceutical patents in Brazil should be very carefully done, said Wanderley Lima, as patents can limit the access to drugs.

The attention to protection of drug patents is significant because it could have implications for public health. Access to medications by governments and consumers can be restricted to a single producer who monopolises production and could choose to charge high prices, thereby causing a problem to the public health system, according to Wanderly Lima.

Every nation has the right to define patent concession criteria for pharmaceutical companies, he said, adding that public health can be adversely affected by broad application of patent rights, such as in the case of second-use drugs.

According to him, “It is important that the INPI discusses the organisational guidelines and the examination of patents, but it is fundamental that they do not forget the interests of society.”

This subject should be resolved quickly by an Intellectual Property Interministerial Group, Chamas said. For her, patents such as on second-use drugs and polymorphs do not have support in Brazilian law, which provides rights only for patents on products and processes with novelty, inventive activity and industrial application.

”These undue monopolies could cause an increase in medicine prices and bring obstacles to development assistance programmes and to the pharmaceutical industry in general,” Chamas told Intellectual Property Watch. “It is a barrier to free competition, plus an unjustified monopoly.”

Prior Informed Consent

A further discussion regarding patents is occurring between Anvisa and INPI on prior informed consent. For approval of the right of a drug patent in Brazil, both Anvisa and INPI give their opinion.

Anvisa has established stiff rules on obtaining this kind of privilege and the agency showed this position to INPI. The agency says it understands the importance of the patent system to pharmaceutical companies, but believes that this protection of patent could be given only to drugs that meet the basic requirements and not just for any kind of patent. The concern is that there are a lot of made-up situations that do not bring any benefit to the country and prejudice the public interest.

On the other hand, there are many critics of prior informed consent, many arguing that the mechanism delays the patent processing system. For this reason, at the lower house of Congress there is proposed legislation from Deputy Rafael Guerra that would eliminate the prior informed consent mechanism realised by Anvisa. If the legislation were approved, the agency would no longer analyse all patent requirements.

Wanderly Lima said that the Anvisa had created a special coordination with professionals to perform this task, and the period of analysis is about 120 days. After this period, if the patent is granted, the holder shall have the exclusive rights to exploit the object protected by the period of 20 years. Therefore, he said there is a need for a careful review because they are giving a monopoly, and must take into account that this implies a lack of competition and, consequently, the final price of the product to the public and for Health Ministry programs.

According to him, 1002 applications were sent for analysis by Anvisa from 2001 to 2007, and 752, or 68 percent, were approved. Around 30 percent stumbled on requirements before being granted permission, which he said proves the accuracy of the mechanism.

About 5 percent of the applications were denied permission due to purely legal aspects, such as the lack of novelty or inventive activity. This shows that the prior informed consent process is aimed at granting the patent according to Brazilian law while preventing the suffering of society by undue restrictions on drugs, such as high prices.

If this initiative of the Deputy Guerra advances, it will change one of the most important articles of the patent system and weaken the Brazilian system, said Wanderley Lima. If approved, he added, it could cause a serious drop in the quality of the examination of pharmaceuticals patents, generating worrisome economic and social consequences to society.

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