The Committee on Social Security and Family approved on Wednesday (27), a bill forbidding the concession of patents of therapeutic indication for pharmaceutical products and of polymorphic substances.

That therapeutic indication is the so-called second use of medicines, and happens when researches discover, for instance, that some medicine for headache has effects against kidney stones. Polymorphic substances are those which have the same chemical formula, but a different morphologic structure, which generates physical-chemical variations – such as different pHs and fusion points.

The approved text by the committee was a substitution bill by Deputy Rita Camata (PMDB-ES) to the bill 2511/07, by Deputy Fernando Coruja (PPS-SC), and 3995/08, by Deputy Paulo Teixeira (PT-SP).

According to Coruja, although the Patents’ Law (9.279/96) forbids the patenting of surgical techniques and therapeutic methods, or of methods of diagnosis, it does not define what “therapeutic methods” are. That imprecision, according to that congressman, has been leading to the granting of patents of second use and to the prorogation of already-existing patents for discoveries on new therapeutic indications.

"That protection has been tried by the pharmaceutical and chemical industry, as a means of extending the deadline of patents and of preventing competition by other producers”, said Rita Camata. “But the exertion of rights coming from that patent cannot harm public interest”, she stressed.

Prerequisites
According to that rapporteur, for the State to recognize and protect and invention, three prerequisites are necessary: novelty, inventive activity and industrial application. In that sense, the polymorphs are not patentable, since they do not present any inventive activity. There are also challenges on the inventive activity regarding patents of second use. “In most of the cases, the new usage is found out by the very user, or by physicians. That discovery can be even accidental, and does not come from expensive researches”, affirms Rita Camata.

For this rapporteur, though, that discussion should not focus on the existence or non-existence of innovation and inventive activity. “The essential becomes the social interest and the technological and economic development of this country”.

Rita Camata reminded that the committee held two public hearings to discuss that subject. In the debates, government’s bodies disagreed on that prohibition. The National Sanitation Agency (Anvisa) is against patents on polymorphs and on medications of second use, but the National Institute on Intellectual Property (INPI), defends the concession of those patents.

According to Camata’s evaluation, Brazil needs to adopt clear mechanisms to avoid the perpetuation of monopoles, by means of patent protection, which would harm the broadening of pharmaceutical assistance and of the access to medicines. “That is not good for public health”, she said.

Procedure
The Project, which is subject to analysis in conclusive character, will still be reviewed by the Committees on Economic Development, Industry and Commerce; and on the Constitution and Justice and Citizenship.

From the newsroom/ ND
Translation - Positive Idiomas Ltda