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.

Expediting Patent Prosecution in Brazil

Although it was encouraging when Brazil implemented new laws in the mid-1990s that expanded the scope of patentability to include pharmaceutical and biotechnology inventions, the Brazilian Patent Office (INPI) has not been able to accommodate the dramatic influx of patent applications that followed. At present, a serious backlog in patent prosecution delays the examination of applications by an average of 10 years, weakening the intellectual property infrastructure in Brazil. In an attempt to address the backlog and expedite patent prosecution, several pilot programs have been introduced. These programs include the Green Patent pilot program, the implementation of Rules #151/2015 and #80/2013 and the Patent Prosecution Highway (PPH) pilot program.

Green Patent Pilot Program

The goal of this program, coined the “green” patent program, is to examine applications related to alternative energy, transportation, energy conservation, waste management, and agriculture (other qualifying technologies are listed here), in two years or less. Launched in 2012, Brazil was the first country to implement such a program. The program is currently in its 4th phase and is accepting applications filed under the Patent Cooperation Treaty (PCT).

In order to participate in the program, an applicant must submit an application that contains no more than 15 total claims (of which three are independent), and has not previously undergone technical examination. A submission of the form specific to the pilot program must be completed, and examination and publication must be requested. According to the INPI, the progress of applications in the program can be tracked online. However a limited period of time remains to participate in the Green Patent pilot program.

INPI Rule #151/2015

Rule #151/2015 of November 10, 2015, revised the conditions for requesting priority examination of a patent application. Specifically, Rule #151/2015 allows expedited patent prosecution for elderly (above 60 years of age) or ill applicants, or applicants that can show a third party is reproducing the subject matter of their patent application. Rule #151/2015 revoked the specific provision which allowed the Ministry of Health to request prioritized examination of applications involving drugs regularly purchased by the Brazilian Public Health System. However the Ministry of Health can still request priority examination of strategic drugs for the Public Health System pursuant to Rule #80/2013 (discussed below), and the Brazilian government has retained the right to prioritize the examination of applications relevant to national emergency or public interest.

For more information, an English translation of Rule #154/2015, which implements the PPH pilot program, is available: Rule154.

INPI Rule #80/2013

Rule #80/2013 of April 9, 2013, establishes the possibility of expedited examination of applications relating to the diagnosis, prophylaxis and treatment of Acquired Immunodeficiency Syndrome (AIDS), cancer or other neglected diseases.  Neglected diseases include:

  • Chagas Disease;
  • Dengue / Dengue hemorrhagic fever;
  • Schistosomiasis;
  • Leprosy;
  • Leishmaniasis;
  • Malaria;
  • Tuberculosis;
  • Buruli ulcer;
  • Neurocysticercosis;
  • Echinococcosis;
  • Bouba;
  • Fascioliasis;
  • Paragonimiasis;
  • Filariasis;
  • Rabies;
  • Helminthiasis;
  • Manifestations from intoxications or poisonings due to poisonous and venomous animals.

There is no limitation on the use of Rule #80/2013 and any applications expedited become the responsibility of the Board of Patent – DIRPA.    Determination of whether or not an application would qualify for expedited examination under Rule #80/2013 and whether or not there would be any disadvantage associated with requesting such expedited examination must be done on a case-by-case basis. Interestingly, since 2013, Rule #80/2013 has only been used 28 times.

Judicially Induced Fast-Track Examination of Patent Applications

In addition, applicants can request the Federal Courts issue an order imposing a “judicially induced fast-track” examination of a pending application.  Specifically, during the last few years, several applicants have filed lawsuits in the Federal Courts requesting expedited examination of a patent application.  Several applicants have been successful in obtaining injunctive relief with the Courts ordering INPI to complete examination of a pending application within 60 days. The 60 day period to conclude examination takes into consideration sections 48 and 49 of Statute #9,784/99, which provides general rules governing federal proceedings. The attached graphic summarizes the decisions issued by each of the four intellectual property (IP) specialized courts as well as by the appellate courts.  Both the 1st and 2nd Panels from the Court of Appeals for the 2nd Federal District, which are in charge of hearing appeals against decisions from the four IP specialized courts, have affirmed the decisions from the lower courts ordering INPI to expedite examination of pending applications.

Patent Prosecution Highway (PPH) Pilot Program

Implemented on January 11, 2016, the PPH pilot program is an agreement that exists between the United States Patent and Trademark Office (USPTO) and the INPI. Limited to oil and gas inventions (e.g. extraction, refining, and transportation) filed after January 1, 2013, the PPH allows expedited examination of a Brazilian application for which a corresponding U.S. application has received a Notice of Allowance from the USPTO. In order to participate, an Applicant must submit a copy of the Notice of Allowance issued by the USPTO for the related U.S. application, and pursuant to Rule #154/2015, the Applicant must also file a request using service code 277, and pay the requisite fee of R$1,775 (approximately US$420). While the PPH pilot program is an important step by the INPI in addressing the patent application backlog, the subject matter limitation to oil and gas technologies may result in future legal challenges before the Federal Courts.

Will there be any improvement in the backlog anytime soon?

Given the current political and economic crisis in Brazil, it is unlikely that applicants will see an improvement in the backlog any time soon.  Moreover, the Ministry of Health will likely support launches at risk in order to have copies of lower cost drugs available in the Brazilian market.  While not the best news for applicants, the worst case scenario is that pending applications will remain in the same place in INPI’s queue.


Please continue to watch the BRIC Wall Blog for updates on patent examination in Brazil.

This post was written by Lisa Mueller and Caitlin Mac Nair of Michael Best and Roberto Rodrigues of Licks Attorneys.