In July 2019 the National Institute of Industrial Property (INPI) issued an official statistic report on the priority examination of patent applications requested by the Ministry of Health in relation to a number of drugs of interest to the public health policy. The report demonstrates the results of one of the measures adopted by INPI to speed up the examination of patent applications.
Legal basis for priority examination requests
Under Resolutions INPI/PR 80/2013, 217/2018 and 239/2019, the Ministry of Health can request the priority examination of patent applications related to pharmaceutical processes, products, equipment or health use materials for diagnosis, prophylaxis and the treatment of AIDS, cancer and rare or neglected diseases.
A rare disease is considered to affect up to 65 people per 100,000 individuals (ie, 1.3 people per 2,000 individuals), as defined by the World Health Organisation (WHO).
The following are neglected diseases listed by the Ministry of Health and the WHO:
- chagas disease;
- buruli ulcer;
- helminthiasis; and
- manifestations resulting from poisoning or poisoning due to poisonous or venomous animals.
Priority examination is allowed for patent applications related to the Ministry of Health’s assistance policies and considered strategic to the scope of the Brazilian healthcare system (SUS).
In order to be eligible for priority examination, a patent application:
- must have been filed before INPI within the last 18 months or must have had earlier publication requested;
- must have had substantive examination requested; and
- must have not been voluntarily divided or amended by the applicant between the request and the decision regarding priority examination.
In 2016 the Ministry of Health requested the priority examination of five drugs (Sofosbuvir, Simeprevir, Daclatasvir, Ledipasvir and synthetic phosphoethanolamine). In 2017 the number of requests increased to 15 drugs (eg, Adalimumab, Bevacizumab, Pramipexol, Trastuzumab, Atazanavir, Infliximab, FazaClo) and in 2018 the Ministry of Health also requested the priority examination of Nusinersena (Spunraza)-related patent applications.
Table 1 shows a summary of the results of the INPI’s analysis for some of the drugs for which the Ministry of Health requested priority examination.
|Drug||Number of requests||
Number of granted patents
|Number of rejected applications||Number of applications waiting examination||Number of shelved applications||Number of applications with substantial examination||Number of applications with ANVISA’s prior consent|
|Sofosbuvir||16||PI0410846-9 (which is now sub-judice)||10 (2 under analysis at appellate level)||2||1|
|Daclatasvir||9||3 granted patents (PI0716483-1 is under administrative nullity proceeding)||2||3||1|
|Simeprevir||11||5 granted patents||2||1||3|
|Ledipasvir||4||2 granted patents (PI1010795-9 and BR112014006324-9)||2|
|Adalimumab||8||1 granted patent (PI0512554-5)||1 (PI0415373-1 under analysis at appellate level)||5||1|
|Bevacizumab||9||1 granted patent (PI0307702-0)||2 (PI0817182-3) under ana8lysis at appellate level)||1||3||2|
|Everolimus||2||1 granted patent (PI0212922-1)||1 (PI0618808-7)|
By adopting priority examination measures for pharmaceutical-related patent applications, INPI has demonstrated not only its intent to reduce the patent backlog, but also its willingness to support the launch of drugs related to public health issues. Further, faster decisions will direct public policies towards partnerships for the local production of strategic generics favouring the SUS’s supply (in case of definitively rejected applications).