Patent Challenges in Brazil
Observations from the 2015 AIPPI World Congress

10/22/2015| Elizabeth Lee D’Amore and Michael N. Mercanti

The 2015 World Congress of the International Association for the Protection of Intellectual Property (AIPPI) was held last week in Rio de Janeiro. One topic that was widely discussed is the huge patent application backlog in Brazil. We heard from a number of sources that it takes more than 10 years for a decision on the granting of a patent in Brazil. The newly edited Industrial Property Law even provides a mandatory minimum validity term of 10 years counted from the issuance date for those patent whose examination takes more than 10 years to be completed. By contrast, patent applications submitted to the USPTO receive a first office action within an average of 17.3 months. (Source: USPTO website patents dashboard at http://www.uspto.gov/dashboards/patents/main.dashxml.)

In July, Luiz Otávio Pimentel became President of Brazil’s National Institute of Industrial Property, Ministry of Development and Foreign Trade (INPI), the equivalent of the USPTO, and he has begun implementing practical, low cost process and technology changes, such as using non-examiners for some tasks, to reduce the backlog. Hiring additional examiners is not an option since the INPI is among the governmental agencies impacted by a hiring freeze announced by the country in September. Moreover, examiners are required to undergo extensive training before meeting the qualifications to officially examine the patent applications, thereby further limiting the number of currently available examiners. Until Pimentel’s changes get traction, patent applicants and their advisors need to be proactive to keep the process moving.

For example, when a third party is using an invention without authorization from the applicant, the applicant can send a cease and desist letter, sending a copy to the INPI with a request for an accelerated examination. The good news is that because proof of infringement is not required or the requirements are lenient, a copy of the letter is likely to suffice. However, it is advisable to carefully plan such request, because if the request gets rejected it may affect future litigation and could be considered as bad faith evidence. The request might also trigger the alleged infringer to oppose the patent application.

The following cases are examples of patents granted through the accelerated proceedings:

• PI 0412219-4 (BAYER HEALTHCARE LLC): the application was filed July 22, 2004 and the accelerated examination requested at June 21, 2011. On July 30, 2013 the application entered in the accelerated examination and issued on August 5, 2014.
• PI 0502833-7 (BDF NIVEA LTDA): the application was filed on July 13,2005 and entered accelerated examination on April 3, 2007, which received a first Office Action on September 11, 2007 and was finally rejected on May 26, 2009.
• PI 9915927-9 (ROCHE DIAGNOSTICS GMBH): the application was filed on November 29, 1999 and entered accelerated examination on February 19, 2008, receiving a final rejection on May 6, 2008.
• PI 0417941-2 (BALANCED BODY): the application was filed on December 9, 2004 and entered accelerated examination on July 13, 2010. It then received an Office Action on December 7, 2010, which led to a lengthy process until granting on December 26, 2012.

Caution: Pharmaceutical Patent Applications are Handled Differently

Pharmaceutical patent applications are examined by the equivalent of the U.S. Food and Drug Administration in Brazil, the National Sanitary Vigilance Agency (ANVISA), instead of by patent examiners at the patent office. Article 229-C of Brazil’s Patent Statute provides that ANVISA shall have the right to provide approval of patent applications claiming pharmaceutical inventions, often referred to as “prior approval” or “prior consent.” What this does is further delay the grant of a patent because the Brazilian FDA (government) basically wants to provide these drugs to the public without having the public pay for expensive “prescription drug” medicines. The quid pro quo is that pharma companies are able to get an additional 10 years of protection from the patent grant date.

So, to accelerate the examination process, pharmaceutical companies need to consider filing a writ of mandamus against ANVISA.

Other examples for accelerating examination of patent applications claiming pharmaceutical inventions include:

• • The Ministry of Health can request the accelerated examination of patent applications that are consistent with health care public policies, i.e., the application claims a product or process that is considered to be strategic to the public healthcare system (SUS).
  • Interested third parties can also request the accelerated examination for applications referred to the diagnosis, prevention and treatment of Acquired Immune Deficiency Syndrome, cancer or neglected diseases as defined by the World Health Organization (WHO), which include chagas, dengue, schistosomiasis, hanseniase, leishmaniasis, malaria, tuberculosis, buruli ulcer, neurocysticercosis, echinocccosis, yaws, fascioliasis, paragonimiasis, filariasis, rabies, Helminthiasis or manifestations that result from poisonous or venomous animals. It is believed that a competitor would qualify as an interested third party. However, whether a non-government organization (NGO) or an HIV patient group would qualify is unclear.

Please contact us for any additional information.

Elizabeth Lee, an associate at Lucas & Mercanti, LLP, focuses on the preparation and prosecution of patent applications in the biological, chemical, pharmaceutical, biochemical and biotechnological arts as well as on portfolio development and management. She can be reached at +1 (212) 661-8000 ext. 135 or at eld@lmiplaw.com.

Michael N. Mercanti, co-founder of Lucas & Mercanti, LLP and chair of its Biotechnology and Life Sciences practice, represents pharmaceutical, life sciences and biotech companies, helping them to maximize their exclusivity and product revenue streams. Reach him at +1 (212) 661-8000 or at mnm@lmiplaw.com.

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About Lucas & Mercanti, LLP: The firm provides comprehensive intellectual property legal services to clients in various fields, including pharmaceuticals, chemicals, electronics, medical devices, telecommunications, manufacturing, and life sciences. We represent start-ups, mid-size companies, multi-national conglomerates, and academic and research institutions, contributing to their success by understanding the science behind their innovations, by representing them proactively, and by being efficient and easy to work with.