Brazil: Prosecution Of Pharmaceutical Patents In Brazil: Tensions Between The Brazilian Patent Office And ANVISA

Introduction

Current Intellectual Property Law No. 9,279 of May 14, 1996 and the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement allow for patenting of pharmaceuticals in Brazil. Notwithstanding, in 2001, the Brazilian IP Law was amended and the prosecution of pharmaceutical patent applications changed substantially.

In this regard, instead of being exclusively prosecuted at the Brazilian Patent Office, called Instituto Nacional da Propriedade Industrial-INPI, the pharmaceutical patent applications must also be approved by Agência Nacional de Vigilância Sanitária- ANVISA, which is the local agency responsible for determining whether products or services may potentially be harmful to public health, and for granting market approval for products, including pharmaceuticals.

In view of this change in the law, pharmaceutical patent applications started being reviewed not only by the INPI, but also by ANVISA. And ANVISA, instead of issuing opinions on public health, which is its legal attribution, when reviewing these patent application also examined patentability requisites, which is the competence of the INPI. The purpose of this article is to review the current situation involving the specific prosecution for pharmaceutical patent applications through the INPI and ANVISA and the respective violations of Brazilian legal principles and legislations.

A Brief History of Pharmaceutical Patents in Brazil

Before the present IP Law came into force in 1997, pharmaceuticals could not be patented in Brazil. Article 9, "c", of former Brazilian IP Law No. 5,772/71, which had been in force until May 14, 1997, stated that substances, matters, mixtures or food products, pharmaceutical-chemicals and pharmaceuticals of any type, as well as their respective modification or obtainment processes were not patentable in this country.

The reason behind that prohibition was a policy adopted by the Brazilian government aimed at developing the domestic industry to supply the internal market. However, this policy did not produce the desired effects. The result was an undeveloped local industry, and, furthermore, there were retaliations from the international market. At the end of 1993, the World Trade Organization (WTO) was created, and, consequently, the TRIPS- Trade-Related Aspects of Intellectual Property Rights Agreement, which was one of the sections of the WTO.

This occurred during the Uruguay Round, the multilateral trade negotiations conducted within the framework of the General Agreement on Tariffs and Trade (GATT). At that time, Brazil signed TRIPS and introduced the Agreement into the domestic legal system by means of Decree No. 1,355 of December 30, 1994. The assignment of the TRIPS Agreement in Brazil provided a positive perspective for the development of the country, as the rules allowed for patent protection for all technological fields, including pharmaceuticals, among others:

Article 27 Patentable Subject Matter:

1. Subject to the provisions of paragraphs 2 and 3, patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced." (emphasis added). Based on these new rules of the TRIPS Agreement, the present IP Law, No. 9,279/96, came into force in Brazil on May 15, 1997.

The new IP Law confirmed most provisions in the TRIPS Agreement, including the patentability for pharmaceuticals. In view of this, the legal requisites for patentability in Brazil for all these technologies, including pharmaceuticals, were to be novel, inventive and capable of being exploited industrially, as provided in Article 8 of the IP Law. Also, these inventions could not contain the unpatentable matters indicated in Articles 10 and 18:

Article 8 - To be patentable an invention must meet the requirements of novelty, inventive activity and industrial application.

Article 10-The following are not considered to be inventions or utility models:

I - discoveries, scientific theories and mathematical methods;

II - purely abstract concepts;

III - schemes, plans, principles or methods of a commercial, accounting, financial, educational, publishing, lottery or fiscal nature;

IV - literary, architectural, artistic and scientific works or any aesthetic creation;

V - computer programmes per se;

VI - the presentation of information;

VII - rules of games;

VIII - operating or surgical techniques and therapeutic or diagnostic methods, for use on the human or animal body; and

IX - natural living beings, in whole or in part, and biological material, including the genome or germ plasma of any natural living being, when found in nature or isolated therefrom, and natural biological processes.

Article 18-The following are not patentable :

I - that which is contrary to morals, good customs and public security, order and health;

II - substances, matter, mixtures, elements or products of any kind, as well as the modification of their physical-chemical properties and the respective processes of obtaining or modifying them, when they result from the transformation of the atomic nucleus; and

III - living beings, in whole or in part, except transgenic micro-organisms meeting the three patentability requirements-novelty, inventive activity and industrial application-provided for in article 8 and which are not mere discoveries.

As a result of the enactment of the present IP Law, a new scenario arose in the Brazilian patent system, since many other technologies, (especially those related to pharmaceuticals) could be patented, guaranteeing local protection for their owners in this country.

Amendment in the IP Law Subjecting Patent Applications for Pharmaceuticals to the ANVISA's Prior Consent

A few years after the present IP Law took effect in Brazil, the Law was amended to include additional steps specifically for the prosecution of pharmaceutical patent applications.

Accordingly, Law No. 10,196 of February 14, 2001, introduced Article 229-C in the Brazilian IP Law, stating that any patent application related to the pharmaceutical must be submitted to the prior consent of the Agência Nacional de Vigilância Sanitária (National Agency for Sanitary Surveillance), or simply ANVISA, before being allowed, and, subsequently, granted by the Brazilian Patent Office (Instituto Nacional da Propriedade Industrial-INPI).

On this subject, it is important to clarify that ANVISA is the public entity in charge of addressing public health issues in Brazil, according to the Law that had created this Agency, i.e. , Law No. 9,782 of January 26, 1999 (this Brazilian Agency corresponds to the U.S. Food and Drug Administration/FDA):

Article 6. The Agency has an institutional purpose of promoting a public health protection by carrying out a sanitary control of the production and commercialization of products and services submitted to the sanitary surveillance, including related environments, processes, inputs, and technologies, as well as the control of ports, airports and boarders. (emphasis added).

The Law that created ANIVSA never made any reference to the analysis of patent applications, however. Now, ANVISA would be directly involved in the prosecution of pharmaceutical patent applications, and most importantly, would have the power to either allow or deny the grant of patents for pharmaceuticals in Brazil.

At that time, a justification for this amendment in the Law, which allowed ANVISA to intervene in patent prosecutions, was a supposed lack of expertise in the patent examiners of the INPI to examine patent applications in the pharmaceutical area, provided that the former IP Law had forbidden pharmaceutical patents. However, a contradiction appeared soon afterwards in this justification, as ANVISA started contracting former examiners from the INPI to carry out their analysis in the patent applications for pharmaceuticals.

The real reason for this change in the IP Law, in fact, was political. The Brazilian government wanted to control the granting of patents in the sensitive field of pharmaceuticals. Even though ANVISA has denied finally (after the administrative appeal stage) less than 4% of the applications submitted to their approval, the inclusion of ANVISA in this patent system has certainly amounted to an additional governmental means to control, and, ultimately, an obstruction to obtaining pharmaceutical patents in Brazil.

Prosecution Adopted by the Patent Office and ANVISA to Comply with IP Law

After the amendment in the IP Law, the INPI has adopted the procedure of carrying out formal and substantive examination in the patent applications, where office actions and technical opinions were issued as necessary. If, at the end of this examination, the application for a pharmaceutical subject matter was considered allowable, i.e. , fulfilling all legal requirements in the IP Law, the application was then submitted to the ANVISA's prior consent. The INPI has sent patent applications to ANVISA, after analyzing them and concluding that they had fulfilled all conditions to be allowed. Although ANVISA had been created with "the purpose of promoting a public health protection by carrying out a sanitary control of the production and commercialization of products and services submitted to the sanitary surveillance, including related environments, processes, inputs, and technologies, as well as the control of ports, airports and boarders," the Agency's analysis actually included reviewing patentability requisites in those patent applications received from the INPI.

In other words, even though the INPI had previously carried out a patentability examination for those pharmaceutical patent applications, added analysis by ANVISA of the patentability requisites is carried out without any statutory ground or competence. Notwithstanding, ANVISA issued a resolution on June 24, 2008, known as RDC No. 45, for regulating the manner in which it would examine pharmaceutical patent applications providing a view of the process for giving its prior consent (or not) for the granting of a patent, as determined by Article 229-C in the IP Law.

Resolution No. 45 (RDC) Made by ANVISA to Prosecute Patent Applications

As demonstrated below, this Resolution (RDC) No. 45 of ANVISA is not in accord with the principles and rules of the public administration.

Lack of Legality in the Public Administration

The principle of legality is a constitutional matter and must comply with the public administration, as defined by Article 37 of the Brazilian Federal Constitution:

Article 37. The direct and indirect public administration for any of Union, States, Federal District and Cities will comply with the principles of legality, impersonality, morality, publicity and efficiency (.). (Constitutional Amendment No. 19 of 1998)

In this regard, Law No. 9,784 of January 29, 1999, which regulates the administrative process for the federal public administration, provides that:

Article 2 nd . The public administration will follow, among others, principles of legality, finality, motivation, reasonability, proportionality, morality, right to defence, contradictory, guarantee that the law will be complied with, public interest and efficiency.

The above provisions are grounded on the general legal principle in Article 5 th , II, of the Federal Constitution: "Article 5. (.) II-No one will be obliged to do or not to do something that is not provided in the law." The Brazilian Supreme Court has already decided (ADI-MC 1668) that:

a) regarding sections IV and X of Article 19, without summarizing the text, interpreting based on the Federal Constitution, having a purpose of clarifying that the competence of Telecommunication National Agency for creating rules must comply with the legal and regulatory precepts, which ground the granting, supply and realization of telecommunication services in the public and private regimes.

In view of this, acts carried out by the public administration must follow the laws made by the Brazilian Legislative Power.

Resolution (RDC) No. 45 Dated June 23, 2008

As the IP Law has not provided any specific rules for ANVISA examining patent applications, the Brazilian Intellectual Property Association (ABPI) has reviewed this matter and concluded that "the participation of ANVISA in the granting of patents for pharmaceutical processes or products is limited to the rules provided in the final part of Article 18, I, of the IP Law 5 , and the Article 27.2 of TRIPS 6, i.e. , to check whether the patent application for an invention or an utility model might cause any harm to the public health." In other words, according to the Brazilian Intellectual Property Association (ABPI), the analysis of patent applications by ANVISA should be limited to public health issues.

It was clear that ANVISA was overreaching its statutory mandate of addressing public health issues, and was executing a second examination on patentability requisites of patent applications, which had already been approved by the Brazilian INPI.

ANVISA created Resolution (RDC) No. 45, which, instead of targeting public health issues, defined a prosecution process aimed at analyzing patentability requisites and, basically, reproduced the very same steps executed by the INPI during the substantive examination for patent applications, provided in the IP Law:

Article 3 - The procedure for prior consent will be carried out as follows: INPI will submit the cases to ANVISA for the latter to acknowledge and issue an opinion on them, giving or withholding its consent, based on a well-grounded decision.

Article 4 - After having received the patent applications submitted by INPI, ANVISA will carry out its analysis with respect to the prior consent thereto, assessing whether said applications meet the patentability requirements and other criteria set forth by the legislation in force, by means of a decision substantiated by a technical opinion issued by the proper unit within the Agency.

§1 During the examination, the applicant shall provide ANVISA, upon request, with the following:

I - documents required to regularize the proceedings and the examination of the application;

II - objections, prior art searches and the results of the examination for the granting of corresponding applications in other countries, when priority is claimed; and

III - other documents required to clarify any doubts which may arise during the examination.

§2 Until the end of the analysis referred to in this Resolution, the interested parties may submit documents and information to be considered in the examination by ANVISA.

Article 5 - When the Office Action expresses a preliminary opinion for the withholding of the prior consent or formulates any requirement, the applicant or its attorney will be notified by registered mail, and will be required to submit a reply within ninety days of official notification or of the date the interested party is notified thereof.

§1 Once a reply to the requirement is submitted, even if the requirement is not met, or if the formulation of the requirement is challenged, whether or not any comment is made regarding patentability or compliance, ANVISA will continue with the analysis.

§2 Prior consent will not be given to applications regarding which requirement has been formulated if no reply to said requirement is submitted.

Article 6 - When the analysis carried out by ANVISA concludes in favor of the prior consent, the application shall return to INPI for the patent granting procedure to be concluded.

The Articles of RDC quoted above are copies of Articles Nos. 31, 34, 36 and 37 in the IP Law for the prosecution carried out by the INPI.

This additional examination of patentability requisites in patent applications by ANVISA lacks legal basis; as neither Law No. 9,782 (which defines the competences for ANVISA, as indicated above), nor the IP Law (which merely indicates that "the grant of patents for pharmaceutical products and processes shall depend on previous approval by the [ANVISA]") provide grounds for this examination carried out by ANVISA on patent matters.

The Brazilian IP Association (ABPI) has concluded that the analysis done by ANVISA should take into account its statutory competence, i.e. , the surveillance and control of sanitary issues. In this regard, ABPI pointed out that there is no legal basis for this patentability examination executed by ANVISA:

2) Under any hypothesis, ANVISA cannot examine or even review patentability requisites provided in Article 8 of the IP Law No. 9,279/96, i.e., novelty, inventive activity and industrial utilization. ANVISA also cannot examine compliance of formalities related to patent applications. There is no provision in Law No. 10,196 or Law No. 9,782/99, which would attribute these tasks that have always been executed by the INPI;

3) Articles 6 and 8, §1, I, in Law No. 9,782/99 attribute to ANVISA the sanitary control of pharmaceutical products, including the production process and the related technologies. Accordingly, the participation of ANVISA in the grant of patents related to pharmaceutical products and processes only concern to the final part of Article 18, I, in the IP Law No. 9,279/96 and Article 27.2 in TRIPS, in order to check if the invention or utility model patent application per se causes any harm to the public health;

4) The invention or utility model patent application that may provide any benefic effect, even in the case it eventually provides collateral effects (to be clearly informed to the consumer during the commercialization of the product) or noxious effects caused by improper utilization, should not be considered a threat to the public health. For instance, the improper shot from a gun should not prevent the granting of a patent for innovative techniques applied to it;

Therefore, Resolution (RDC) No. 45 of ANVISA does not fulfill the legality principle in the Federal Constitution and in Law No. 9,784, which regulates the administrative activities for Federal Public Entities.

The Patent Office does have the legal competence and attribution to review the merits of patent applications, including the patentability requisites, as determined by Law No. 5,648 of December 11, 1970:

Article 2-The Institute has a main purpose of executing the norms that regulate the industrial property in the national ambit, taking into account the social, economic, legal and technical functions, such as pronouncing on assignment, ratification and presentment of conventions, treaties, accords and agreements on industrial property.

In view of this, while the Prosecutions carried out by the Patent Office are granted by statute, grounded in the IP Law, among other laws, prosecutions by ANVISA are merely based on a Resolution ((RDC) No. 45) that does not have any legal basis.

The Opinion Issued by the Attorney General's Office (AGU)

The interference of ANVISA in patent prosecutions has been reviewed by the Attorney General's Office (AGU). In view of the this conflict between ANVISA and the INPI on the prosecution of patent applications, an administrative proceeding driven by the INPI, was opened before the Attorney General's Office and the Opinion (No. 210/PGF/AE/2009) issued in 2009 and approved by the Attorney General, declared that ANVISA, in the exercise of its statutory duty to assess pharmaceutical patent applications for prior consent ends, should be limited to examining the issues closely related to its institutional purposes, i.e. , issues related to public health:

a) It is not the responsibility of ANVISA to promote examinations (assessment/reassessment) of its own technical criteria of patentability (novelty, inventive activity and industrial application) when there is an action of prior informed consent (Article 229-C of Law No. 9279 of 1996 plus the Provisional Measure No. 2006 of 12.15.1999, later converted into the Law No. 10,196, 2001), for it is INPI´s own attribution, as established by statute (Article 2 of Law No. 5.648/70);

b) ANVISA, for purposes of art. 229-C of Law No. 9.279/96 must act in accordance with its institutional mandate (Article 6 of Law No. 9.782/99): prevent by a health control, the production and marketing of products and services potentially harmful to human health; (...).

The opinion of AGU has spelled out that ANVISA should stick to public health issues, leaving the INPI to play the role of examining the requirements for patentability.

Unhappy with this opinion, ANVISA filed a request The opinion of AGU has spelled out that ANVISA should stick to public health issues, leaving the INPI to play the role of examining the requirements for patentability. Unhappy with this opinion, ANVISA filed a request for reconsideration with the AGU, with support from the Ministry of Health and some segments of society notoriously against the current patent system in Brazil. Fortunately, the AGU refused to be intimidated by political pressure and confirmed its earlier opinion, by issuing the Opinion No. 337/PGF/EA/2010, approved by Attorney General on July 1, 2011, ratifying the determination that ANVISA shall limit its examination of patent applications to the perspective of public health, for purposes of prior consent.

For reconsideration with the AGU, with support from the Ministry of Health and some segments of society notoriously against the current patent system in Brazil. Fortunately, the AGU refused to be intimidated by political pressure and confirmed its earlier opinion, by issuing the Opinion No. 337/PGF/EA/2010, approved by Attorney General on July 1, 2011, ratifying the determination that ANVISA shall limit its examination of patent applications to the perspective of public health, for purposes of prior consent.

How the Brazilian Courts Are Reacting to this Issue?

On the judicial front, decisions have been issued recognizing the excesses of ANVISA in the alleged exercise of its statutory duty in connection with the procedure for granting patents. They have also declared, incidentally, the very unconstitutionality of Article 229-C of the IP Law, thus determining that the INPI should conclude the administrative process relating to a patent application, although ANVISA had denied its prior consent. The Federal Court of Appeals has expressed the same view, determining that ANVISA should only assess whether there are any risks to public health present:

I - It is contrary to good sense to think that the requirements of a pharmaceutical patent require double analysis and from two separate public bodies, which translates into unnecessary bureaucratic procedures, with conceptual, economic and human losses.

II - If the understanding prevails that Article 229-C confers ANVISA the authority to assess the patentability requirements, this would mean that the INPI would be deprived of its independence and autonomy, being subordinated to ANVISA, thus resulting in a true absurd.

III - It is clear that the only possible interpretation of Article 299-C does not involve any new assignment to ANVISA (analysis of patentability requirements), but rather the opportunity given by the legislature to anticipate its health surveillance administration, by identifying any possible health risks before the grant of the letters patent; before such provision, this risk was only identified at the time the product was effectively traded in the market. (Civil Appeal No. 2005.51.01.5004279)

1. ANVISA has started to examine pharmaceutical applications after Provisional Presidential Decree Nº 2006/1999 was issued, which created the legal procedure of prior consent, later consolidated by Law 10196/2001, including it in the Industrial Property Law as Article 229-C. 2. The laws must be interpreted and enforced within the limits that comprise the legal framework of the nation as a whole, and not separately, being reconciled, so as to effectively ensure the accomplishment of the common good without compromising the guarantees of the Rule of Law.

In this sense, it does not seem reasonable or efficient that the legislature intended that two government agencies-the INPI and ANVISA- concurrently analyzed the patentability requirements set forth in the Brazilian Industrial Property Law, because this would create situations of extreme mismatch, in the cases of insurmountable divergent opinions between these agencies, such as happened in the second patent.

Thus, a reasonable interpretation of the law would understand that, at the time of prior consent, ANSIVA should inform if there is any obstacle in the area of public health to the grant of the patent, based on the provisions of Law no. 9782/99 and according to its jurisdiction. 3. The recognition of the constitutionality and applicability of Article 229-C of the IP Law is essential, considering that the Constitution establishes in its Article 5 (XXIII) that the property shall fulfill its social function and that the economic order shall abide by the social function of property [Article 170 (III)]. In this vein, the supremacy of the common good over individual rights of property is highlighted, legitimizing the role of ANVISA in the granting of pharmaceutical patents, provided it is within the strict limits of the mission for which it was created. (Civil Appeal No. 2004.51.01.5170540)

51 - In view of the foregoing, for the reasons above, we suggest that:

a) It is not ANVISA's duty to carry out examinations (assessment/reassessment) of technical criteria specific of patentability (novelty, inventive step and industrial use) when working for prior consent (article 229-C of Law No. 9279 of 1996, added by Provisional Measure No. 2006, of December 15, 1999, later converted into Law No. 10196, of 2001), once this is an attribution of the INPI, as established in the very law (article 2 of Law 5,648/70);

b) ANVISA, for purposes of article 229-C of Law 9279/96, shall act in accordance with its institutional attributions (article 6 of Law No. 9782/99): prevent, by means of sanitary control, the production and commercialization of products and services potentially harmful to human health; (Civil Appeal No. 2009.34.00.037368-5)

The Circuit Courts have also handed down rulings negating the intervention of ANVISA in the assessment of patentability, including, the decision rendered by the 8 th Federal Court of Brasília, which, in addition to recognizing the ANVISA excesses in alleged compliance with its legal duty in the scope of the patent granting procedure, has incidentally declared the unconstitutionality of Article 229-C of the IP Law, thus directly determining that the INPI should conclude the administrative proceeding referring to the patent application, although prior consent was denied by ANVISA (Record No. 29724-10.2010.4.01.3400):

Based on the foregoing, I hereby DECLARE

incidenter tantum the unconstitutionality of Article 229-C of Law No. 9279/96 and, therefore, GRANT the claim, ruling that the administrative proceeding referring to the pharmaceutical product indicated in the complaint must be immediately forwarded to the INPI, within 48 (forty eight) hours of the judgment rendered, for due conclusion of the patent granting procedure; I hereby also GRANT the interlocutory relief requested and, therefore, disallow any writ to stay the proceedings of an eventual appeal filed against the decision by ANVISA.

In view of these decisions, the Courts are cancelling the analysis on patentability requisites carried out by ANVISA, and subsequently determining that the INPI grants the patents (even those previously denied by ANVISA). It is necessary to file a court action in the Federal Court to cancel a decision issued by ANVISA that has previously denied approval of a patent application.

Position Adopted by ANVISA When Reviewing Brazilian Patent Applications

As indicated, ANVISA has denied (after the administrative appeal stage) less than 4% of the applications submitted to their approval, according to information obtained from their website.

When carrying out the examination of patent applications, ANVISA has issued opinions on patentability and formal issues that diverge from the opinions previously issued by the INPI. Consequently, applications previously approved by the PTO have been denied by ANVISA. The graphic above demonstrates the grounds for ANVISA rejecting patent applications.

As indicated above, the reasons for ANVISA denying approval for patent applications relate exclusively to patentability requisites and/or to formalities related to prosecutions of patent applications. None of these rejections are based on public health issues.

These are opinions which, by law, may only be manifested by the INPI. Accordingly, ANVISA is clearly overstepping its bounds as a public health regulatory agency to supplement the examination of patent applications in such a way.

The Recent Change in the Prosecution of Pharmaceutical Patents of the INPI

Notwithstanding the above, a recent Administrative Ordinance issued by an Inter-ministerial Group composed of the INPI, ANVISA, the Ministry of Health, the Ministry of Development, Industry and Foreign Commerce, and the Federal Attorney General's Office agreed that pharmaceutical patent applications should first be forwarded to ANVISA for its preliminary analysis and only upon ANVISA's prior consent may the application then be examined on the merits by the INPI.

According to these new rules, patent applications will follow the steps depicted below, during their prosecutions at the INPI and ANVISA: In other words, these applications will take the following steps:

Step 1: The INPI will perform the first formal examination of the documentation submitted by the applicant of the patent application;

Step 2: After the application is approved in the formal examination, the INPI will identify the type of product and process and forward to ANVISA applications related to pharmaceutical products and processes;

Step 3: ANVISA will perform the technical examination of applications sent by the INPI and will publish the opinion in the Federal Official Gazette either granting prior consent or not for each patent application;

Step 4: Once its opinion is published, the ANVISA will return the applications to the INPI; and,

Step 5a: If the application is approved by ANVISA, the INPI will examine the technical application and will publish the granting of the patent or the shelving of the application, according to its assessment, in the Brazilian Industrial Property Journal.

Step 5b: If the application is not approved by ANVISA, the INPI will shelve the application and will publish such shelving in the Brazilian Industrial Property Journal.

The aforementioned Ordinance specifically required the issuance of Normative Acts regulating the procedure for obtaining ANVISA's prior consent. Despite not having published any such Normative Acts, the Brazilian INPI has already begun forwarding pharmaceutical patent applications to ANVISA for its prior consent before any examination of the application by the INPI, as indicated below.

As depicted above, the INPI is sending pharmaceutical patent applications to ANVISA, before carrying out the formal and substantive examinations, even though no Normative Acts have been issued in this regard to date.
This act of the INPI might generate a new round of discussions that will certainly be reviewed by the Brazilian Courts.

Conclusion

The legal attribution to ANVISA embraces only the surveillance and determination of whether products or services may potentially be harmful to public health. Accordingly, the analysis and decisions issued by ANVISA on pharmaceutical patent applications must be limited to public health issues. In spite of that, ANVISA's prior consent opinions have been taken into account on patentability matters, for instance, denying applications on grounds that they lack novelty or inventive activity.

These are opinions which, by law, may only be manifested by the INPI. It seems that the reason for ANVISA to adjudge patentability matters is that the granting of certain patents would inhibit and deter the entry of generics into the Brazilian market, making access to medicine much more difficult. In any event, ANVISA is clearly overstepping its bounds as a public health regulatory agency to supplement the examination of patent applications in such a way.

As mentioned, ANVISA's prior consent is not legal, particularly in the circumstance where ANVISA rejects an application resulting in the permanent shelving of the patent application procedure, and effectively bypassing outright any examination of the merits of the patent application by the INPI.

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