Understanding Brazil’s Service Guideline #37 for the Examination of Patent Applications Claiming Pharmaceutical Products and Processes

On September 25, 2017, the Director of the National Sanitary Surveillance Agency (ANVISA) issued internal guidelines (Orientação de Serviço #37/2017) regarding the procedures to be used by the agency when examining patent applications claiming pharmaceutical products and processes in light of public health (in accordance with Article 229-C of Patent Statute #9,279/96, Resolution RDC #168, of 2017, the Joint Ordinance ANVISA/INPI #001, of 2017, and Ordinance GM/MS #736, of 2014).  According to these guidelines, ANVISA will follow the following procedures when reviewing applications claiming pharmaceutical products and processes.

  1. Upon receipt of a patent application from the Brazilian Patent Office (Instituto National da Propriedade Industrial (INPI)), ANVISA will assess the subject matter of the application to verify compliance with the provisions of Article 229-C of IP Law #9,279/96. Article 229-C provides that pharmaceutical patent applications shall receive a prior approval by ANVISA (often referred to as “prior approval” or “prior consent”). Specifically, Article 229-C provides that: “The grant of patents for pharmaceutical products and processes shall depend upon the prior approval from the National Sanitary Vigilance Agency.” 
  1. Once it is determined that prior approval or prior consent by ANVISA is required, an application is assessed with respect to its (1) health risk; and (2) interest under the drug or pharmaceutical assistance policies within the Brazilian Unified Health System (SUS). 
  1. The health risk of the application is assessed by determining whether the pharmaceutical product or process claimed comprises or results in substances included in List E (which is a list of prohibited plants which may give rise to narcotic and/or psychotropic substances) or List F (a list of substances banned in Brazil) based on Ordinance SVS/MS #344, of 12 May 1998, which relates to plants and substances (including salts and isomers thereof) that are prohibited for use in the country. Applications which do not claim a pharmaceutical product or process that comprise or result in substances included in Lists E or F are not considered to present a health risk.  If the application is considered to present a health risk, ANVISA will deny prior consent or prior approval and return the application to INPI, which will dismiss the application. 
  1. After determination of the absence of health risk, the application is reviewed to determine whether or not the pharmaceutical product or process is of interest to the drug or pharmaceutical assistance policies under SUS. An application is determined to be of interest to the drug policy or pharmaceutical assistance policy under SUS when:
    • The subject matter is related to one of therapeutic applications defined by Ordinance MS/GM #736, of 2014 as listed in Annex I (provided below); or
    • It is related to a product incorporated into SUS (except for drugs that are part of the Basic Component of Pharmaceutical Assistance (CBAF), which is guided by the National List of Essential Medicines (RENAME) in force); or
    • It is related to a product of potential interest to the SUS according to Annex II (provided below).

If the application is of no interest to the healthcare policy, ANVISA will grant prior consent or prior approval and send the application back to INPI for further processing.  However, if an application is determined to be of interest to the drug or pharmaceutical policies under SUS, ANVISA will send the application back to INPI for further processing along with a report providing an analysis of the patentability requirements to be used by INPI during examination.

An important take away is that according to the service guidelines, ANVISA is able to provide an opinion addressing the patentability requirements of applications claiming pharmaceutical products or processes.  Regrettably, this is a continued attempt by ANVISA to try and  work around case law that has clearly established that the agency is not allowed to evaluate the patentability requirements of such applications under Article 229-C.

Annex I 

Viral Diseases (antiviral and antiretroviral diseases)

Neglected diseases:

Dengue

Chagas Disease

Schistosomiasis

Rocky Mountain spotted fever

Filariosis

Leprosy

Leishmaniasis

Malaria

Systemic mycoses

Tuberculosis

Neurodegenerative diseases

Alzheimer’s

Parkinson’s

Immunosuppressants

Rheumatoid arthritis

Transplant rejection

Mental diseases (antipsychotics/anticonvulsants)

Epilepsy

Psychosis / Schizophrenia

Neoplasias / Cancer (Oncology products)

Products obtained by biological routes

Provided that the therapeutic application is included in ordinance GM/MS 736/14

Vaccines and sera

Vaccines of the National Immunization Program

BCG vaccine

Hepatitis B vaccine

Diphtheria, tetanus, pertussis, hepatitis B and Haemophilus Influenza B vaccine

Diphtheria, tetanus and pertussis vaccine

Polio vaccine (VIP / VOP)

Pneumococcal vaccine (Pneumo 10, PN 23)

Human rotavirus vaccine

Meningococcal C vaccine

Yellow Fever vaccine

Hepatitis A vaccine

Measles, mumps and rubella vaccine

Measles, mumps, rubella, and varicella vaccine

Diphtheria and tetanus vaccine

HPV vaccine

Influenza vaccine

Rabies vaccine

Vaccines for sexually transmitted diseases

Vaccines for neglected diseases

Vaccines for cancer

Hemoderivatives

Plasma concentration of factor VIII

Von Willebrand factor

Prothrombin complex (partially activated or human)

Recombinant activated factor VII concentrate

Plasma and recombinant factor concentrate

Plasma concentration of factor IX

Factor XIII concentrate

Excluded:  Fibrinogen, Tranexamic Acid and Desmopressin Acetate

Annex II

            Roadmap to identify patent applications of potential interest for SUS

  1. The patent application, to be identified as of potential interest to SUS, in addition to complying with Article 6 herein, should also comply with at least one of the following criteria:
    • Be related to a product registered with a sanitary authority of any country or region;
    • Be related to a substance under an active phase II clinical trial or higher, in any country or region, for a therapeutic application of interest to SUS;
    • Be related to high-cost drug that is part of the Specialized Component of Pharmaceutical Assistance (CEAF);
    • Be related to the drug provided in Partnership for Productive Development (PDP) or equivalent;
    • Be related to a request for priority examination made by the Ministry to Health to the INPI;
    • Has been filed with INPI less than six years ago.
  2. The patent application included in item A above may be exempted from a patentability examination for the purposes of supportive data if the application satisfies any of the below:
    • The product has its incorporation into SUS denied by the National Commission for the Incorporation of Technologies (CONITEC); or
    • The product is excluded from SUS; or
    • The invention is unlikely to be incorporated into SUS after conducting a prospective analysis.

Please continue to watch the BRIC Wall Blog for further updates on ANVISA and prior approval or consent in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues of Licks Attorneys.

 

New guidelines in Brazil give more power to ANVISA in the examination of pharmaceutical patent applications

On March 13, 2017, the board of directors of Agencia Nacional De Vigilancia Sanitari’s (ANVISA) announced that they had reached a new agreement with the Brazilian Patent Office, namely, the Instituto Nacional da Propriedade Industrial (INPI), concerning the prior approval provision under Article 229-C of the Brazilian Patent Statute (For more information about the 229-C article, please see our posts here, here, and here).  On April 12, 2017, after an event with several authorities and President Michel Temer, ANVISA and INPI published a written version of the new joint guidelines #1/2017 (translation enclosed here:  INTERAGENCY ORDINANCE). These guidelines describe the new workflow between ANVISA and INPI involving the examination of pharmaceutical patent applications.

Article 4 of the guidelines establishes that ANVISA will analyze whether a patent application is contrary to public health.  According to Article 4, a patent application claiming a product or process is considered to be contrary to public health when the product or process presents a “health risk”.  The article further states that the “health risk” will be characterized when the pharmaceutical product comprises, or the pharmaceutical process results in a substance that has been prohibited in the country”.    

If a product or process is found to pose a “health risk” (as defined in the Annex I of the Ministry of Health’s Ordinance #344 of 1998), ANVISA will deny prior approval and will send the application back to INPI for further handling. At this point, INPI will publish the definitive dismissal of the application. In other words, the application is denied.

The guidelines contain a new approach in the examination of patent applications claiming pharmaceutical products and processes of interest under the Brazilian government’s drug policies and pharmaceutical assistance of the National Healthcare System (SUS). Under Article 5, ANVISA will examine these applications of interest and prepare a “technical” opinion as to whether the claims meet the patentability requirements under Brazilian law.  This opinion will be sent to INPI for use as a third-party observation under Article 31 of the Patent Statute of 1996.  Once INPI receives ANVISA’s opinion, it is “free” to decide whether or not to agree with it.  In the event INPI disagrees with ANVISA’s opinion and grants the patent application, it will send ANVISA a list containing all granted patents and will continue to make this list available to ANVISA (Article 7 of the guidelines).  

The guidelines do not contain any information as to what ANVISA can or should do with the list of granted patents received from INPI.  Actions that ANVISA could take include filing a post-grant opposition or seeking invalidity of the patent before Federal Courts. 

Article 9 of the guidelines creates an Interagency Group between the two agencies. The purpose of this group is to seek to “harmonize” the understanding between the ANVISA and INPI regarding the application of patent law in “polemic” topics such as Markush claiming, selection inventions, the patentability of new uses, salts, polymorphs and antibodies, as well as other issues relevant to the pharmaceutical industry.  One concern is that such “harmonization” could result in an unlawful administrative ban of claims that are currently being allowed INPI. As such, Article 9 gives ANVISA power to influence the INPI in a multitude of ways. 

Additionally, it is important to note that the new guidelines come after several decisions were obtained against ANVISA by various pharmaceutical companies (See our post here) holding that that the agency lacked the statutory authorization to examine patentability requirements under Brazilian law.  After these early decisions were rendered (which held that ANVISA’s prior approval review was restricted solely to the analysis of potential public health issues and not patentability requirements), ANVISA amended its guidelines to include a provision stating that “the granting of patents that do not fulfil the patentability requirements violates public health”. This change was interpreted by the courts as an attempt by the agency to escape the unfavorable case law and avoid the new guidelines.  

As a whole, the guidelines read like an attempt by ANVISA to revive its ability to participate in the examination of pharmaceutical patent applications.  Interestingly, many the associations representing generic companies in Brazil such as ABIFINA and Pro Generics are celebrating the guidelines as a victory for the local industry. 

Continue to watch the BRIC Wall Blog for continuing updates on these new guidelines in Brazil.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho from Licks Attorneys.

 

 

 

Two Important Decisions Addressing ANVISA’s Prior Approval of Pharmaceutical Patents in Brazil

In the second half of 2016, two very interesting decisions were issued by the federal courts in Brazil against the Brazilian Food and Drug Agency (ANVISA) involving the prior approval of patent applications claiming pharmaceutical products.  These decisions bring some very good news to pharmaceutical patent owners who have struggled for years with ANVISA while trying to protect their pharmaceutical patents in this country. 

In the decisions, Genentech and Novartis each obtained preliminary injunctions against ANVISA in cases of prior approval of their patent applications under Article 229-C of the Brazilian Patent Statute (Additional information about each of the decisions can be found here:  novartisdecision genentechdecision).  Specifically, Novartis’ patent application claims fingolimod (Gilenya) and Genentech’s application claims bevacizumab (Avastin). 

Two different trial judges affirmed that ANVISA did not have the authority to examine patentability requirements under Article 229-C of the Patent Statute.  In the decision involving Genentech’s application, the judge, the Honorable Diana Silva, limited ANVISA’s role during the prior approval process to only aspects involving public health. The decision also stated that the Brazilian Patent and Trademark Office, namely, the Instituto Nacional da Propriedade Industrial (INPI) is the sole legitimate agency to examine the patentability requirements of patent applications directed to pharmaceutical products. 

The decision involving Novartis’ application is an important case for pharmaceutical companies facing the issues of backlog and pendency of their patent applications in Brazil.  Specifically, in this case, Novartis sought a preliminary injunction against ANVISA, claiming that the agency was taking an unreasonable amount of time to issue a decision regarding prior approval.  Additionally, Novartis also requested preventive measures against the agency to prevent it from examining the application for compliance with patentability requirements under the Brazilian Patent Statute (which is the function of INPI).   The judge, the Honorable Iolete Oliveira, accepted  Novartis’ arguments and granted a preliminary injunction ordering ANVISA to:  (1) analyze the prior approval of the patent application within 15 days; and (2) abstain from examining the application for compliance with any patentability requirements but focus instead only on aspects of public health. 

Both of these decisions highlight that the Brazilian federal courts are willing to limit ANVISA’s role under the prior approval analysis.  The Novartis case establishes important precedent that can be used by other companies currently waiting ANVISA’s decision on prior approval analysis. 

Please continue to watch the BRIC Wall Blog for continuing updates on Brazil’s prior approval of pharmaceutical patent applications.

This post was written by Lisa Mueller and Roberto Rodrigues Pinho, LLM candidate at Stanford University.

Updates to the Brazilian Food and Drug Administration OTC Drug Guidelines

It has been 13 years since the Brazilian Food and Drug Administration (ANVISA) updated the guidelines regulating which drugs can receive over-the-counter (OTC) status. The much-anticipated guidelines, which issued on August 3, 2016 as Rule #98, revoke the previous Rule #138, which was established in 2003. Rule #138 established which drugs could be sold as OTC medications, according to their therapeutic indications. Drugs currently recognized as safe for over-the-counter use under Rule #138 will continue to be categorized as such until a reassessment can be completed and compliance with Rule #98 evaluated; however the new guidelines allow ANVISA to simultaneously reassess the status of currently available OTC drugs while expanding the number of new products available to consumers.

Rule #98 was previously submitted to Public Inquiry #27 on April 8, 2015. According to ANVISA’s report on the public inquiry, the general feedback was that the new rule will have a positive impact on the market, especially with regards to increasing patient’s access to drugs and the recognition of pharmacists’ roles in healthcare. It is expected that Rule #98 will expand the number of OTC drugs in the Brazilian market, which will increase price competition and marketing efforts towards consumers, rather than physicians.

In order to be compliant with Rule #98, drugs must comply with the following seven criteria:

  1. The drug must have been commercially available for a minimum of 10 years (five years in Brazil), as a prescription drug, or five years, as an OTC drug, in countries where regulations are similar to ANVISA.
  2. The drug must exhibit a high level of safety: the causes of the adverse reactions must be well known and easily reversed, the drug must have a low level of toxicity, a safe therapeutic window, and a low level of interactions with other drugs and food.
  3. The clinical condition treated by the drug cannot evolve rapidly, and its symptoms must be easily identifiable by the consumer.
  4. The drug must pose a low risk when used off label or in overdose scenarios.
  5. The drug cannot be indicated for continuous use; rather, it can only be used for a short period of time or a fixed period of time, which must be identified in the drug’s label (except for drugs labeled for prevention).
  6. The consumer must be capable of using the drug without any physical assistance from a healthcare professional.
  7. The drug cannot cause chemical dependency in consumers.

Companies looking to obtain OTC status for a particular drug can do so at any time; status can be applied for with the Marketing Approval Application, or after the drug has already been approved. The OTC status request must be supported by the required documents listed in Rule #98, ensuring compliance with the above-identified criteria. The company must also support its request with a risk reduction plan, which will inform the ANVISA how it will monitor occasional risks arising from the commercialization of the drug as an OTC product. Once the OTC status is approved, the decision will be published by ANVISA in the Official Gazette and be made available online. The publication will include the active pharmaceutical ingredients (API) in the drug. Once published, companies will have 180 days to make appropriate amendments to the drug packaging and label, as well as have the product sales status changed to OTC.

Importantly, Rule #98 defines which products are not entitled to receive OTC status, which includes drugs that require parenteral administration, or drugs that are commercially packaged, as the quantity of the API per package exceeds the maximum limits established by ANVISA.

The enforcement of Rule #98 will begin 30 days after its publication on September 3, 2016.  Please continue to check the BRIC Wall Blog for additional updates on the enforcement of these new guidelines in Brazil.

This blog post was written by Lisa L. Mueller, Caitlin E. Mac Nair of Michael Best, Ricardo Campello and Roberto Rodrigues of Licks Attorneys.

An Overview of the USTR’s 2016 Special 301 Report on the State of IPR in Brazil

In this post, the BRIC Wall Blog continues to examine the Office of the United States Trade Representative (USTR) 2016 Special 301 report (Report) reviewing the state of intellectual property rights (IPR) protection and enforcement in U.S. trading partners around the world. The Report details the results of extensive research and analysis, which led to placing eleven countries on the priority watch list and twenty-three on the watch list. Brazil remains on the Watch List in 2016.   

Despite efforts to protect against online piracy, significant concerns remain over the high levels of piracy and counterfeiting in Brazil. In order to create public awareness and enact enforcement campaigns, the National Council on Combating Piracy and International Property Crimes (CNCP) was identified in past years as an effective entity for carrying out public awareness and enforcement campaigns. Unfortunately, the CNCP was underutilized and overall ineffective in 2015. In the Report, the United States urges Brazil to provide resources for intellectual property (IP) enforcement and seeks further commitments from the country on the strengthening of its IPR protection and enforcement measures. 

The Report also addresses the continued problem of significant delays in the examination of patents and trademarks, which, on average, take about eleven and three years, respectively. In early 2016, the United States-Brazil Patent Prosecution Highway pilot program was enacted to expedite the patent examination process in Brazil, specifically for inventions related to the oil and gas sector. Despite this positive step forward, there is still a duplicative review of pharmaceutical patent applications by the National Sanitary Regulatory Agency (ANVISA) which lacks transparency, exacerbates delays of patent registrations for innovative medications, and prevents patent examination by the National Institute of Intellectual Property (INPI).  

Furthermore, although there are laws and regulations in Brazil to protect veterinary and agricultural chemical products against unfair commercial use of undisclosed test data and other data generated to maintain marketing approval, these same laws and regulations do not apply to pharmaceutical products. Additionally, the Report notes that actions are being taken by INPI to invalidate or shorten the term of certain “mailbox” patents for pharmaceutical and agricultural chemical products. The Report concludes that the strengthening of IPR enforcement and protection for foreign and domestic right holders as well as expediting the examination of trademarks and patents is essential for continued innovation and investment in Brazil.  

This post was written by Lisa Mueller and Kate Merath.

 

 

 

 

 

 

Seminar: Brazilian High-Tech Litigation: Law, Business & Policy

George Washington University Law School, Licks Attorneys, the Ministry of Foreign Affairs Department of Trade and Investment Promotion and the Embassy of Brazil in Washington D.C. are hosting a one day seminar on Thursday, May 12, 2016, in Washington D.C. entitled “Brazilian High-Tech Litigation: Law, Business & Policy”. Interesting topics to be covered include:

  • Brazilian PTO Examination Guidelines for Biotechnology Inventions
  • The role of Brazilian Courts in ensuring Compliance with TRIPS
  • Policy Making by Judicial Activism and the Judiciary’s Practice
  • Litigation in Brazil against the Government on behalf of foreign companies
  • The role of specialized IP Courts in the business environment
  • Litigating Standard Essential Patents
  • Pharmaceutical Litigation: BRPTO, ANVISA and infringers
  • Opportunities Created by Regulatory Developments for pharma, telecom and the internet
  • Brazilian Model of Internet Governance and Regulation
  • Antitrust litigation in Brazil

For more information and to register, please click here: http://www.lickslegal.com/dcseminar/

AstraZeneca’s Crestor® Patent is Invalidated by the Brazilian Federal Courts

On June 5, 2015, the 13th Federal District Court of Rio de Janeiro invalidated Astrazeneca’s patent BR PI0003364-2 covering Crestor® (rosuvastatin). The Judge, the Honorable Marcia Nunes Barros, agreed with the arguments submitted by the Brazilian Patent Office and National Sanitary Vigilance Agency (ANVISA) that the patent was obvious over the prior art. The Honorable Barros is the same Judge that recently issued a decision holding that ANVISA was allowed to examine patentability requirements during prior approval/consent analysis under Article 229-C of the Patent Statute.

According to the decision, the use of the tribasic calcium phosphate to stabilize statins was expressly recommended in the prior art document PT 547 000E. Even though the use of the term “potentially” in the prior art did not denote certainty regarding stabilization, according to the Court, this meant that tribasic calcium phosphate was “probably useful for stabilizing statins”.

Additionally, although the prior art document recited a pH value of at least 8, preferably 9, for the stabilization of statins, the Court held that this pH value related to the stabilization of fluvastatin and not rosuvastatin. The Court referred to the Handbook of Pharmaceutical Excipients, which stated that tribasic calcium phosphate had a pH value of 6.8 at 20% solubility.

The Court held that a person of ordinary skill in the art (POSITA) would have known from PT 547 000E that tribasic calcium phosphate could be used to stabilize statins. Therefore, because the pH of a stabilizing agent varies based on concentration, a POSITA would have been motivated to investigate using tribasic calcium phosphate to stabilize a statin (in other words, it was “obvious to try”). The Court found this to be true because the pH value of 8 recited in PT 547 000E referred to the stabilization of a different statin (fluvastatin) and not rosuvastatin. Other prior art, such as WO 97/23200, described using a pH value of between 7.0 to 8.0 to stabilize the HMG-CoA inhibitor, E)-3,5-dihydroxy-7-[4′-4″-fluorophenyl-2′-cyclopropyl-quinolin-3′-yl]-6-heptenoic acid.

Therefore, according to the Court, a PHOSITA at the time of the invention would have understood that different statins required different pH values for stabilization. Even though tribasic calcium phosphate only had a pH value of 6.8 based on its solubility data, the Court held that a PHOSITA would have been motivated to test tribasic calcium phosphate as a stabilizing agent for rosuvastatin.

Interestingly, despite the fact that the court-appointed expert issued a report concluding that the patent was valid, the Judge mentioned international standards for assessing inventive step, including the U.S. Supreme Court’s decision in KSR Int’l Co. v. Teleflex, Inc., in concluding that the technical solution presented in the patent was obvious to try and that there was a reasonable expectation of success.

This post was written by Lisa Mueller and Roberto Rodrigues and Luiza Cotia of Licks Attorneys.