GLATIRAMER ACETATE |
II |
100 |
FURP |
Cristália Produtos Químicos Farmacêuticos Ltda. |
- |
Cristália Produtos Químicos Farmacêuticos Ltda. |
No |
There is a mailbox patent whose termination is being challenged in court. As of December 31, 2020, the analysis of PI 0515033-7 had not been completed. |
The analysis of PI 0515033-7 had not been completed even after prioritized examination was granted in 2017. In 2015, Cristália submitted a subsidy for the examination, indicating its interest in the request to carry out local production. If the rejection were reversed and a patent was granted, it would be in force until 2025, six years less than before ADI 5529. |
ADALIMUMAB |
II |
40 |
Bio-manguinhos |
Bionovis S.A - Companhia Brasileira de Biotecnologia Farmacêutica |
- |
Bionovis S.A - Companhia Brasileira de Biotecnologia Farmacêutica |
No |
There are two terminated mailbox product patents. But there are two patents, apparently process patents, in force until 2031. |
The mailbox patents were originally to run until 2019 and 2020, but the INPI questioned their extension under the sole paragraph of article 40 on the grounds that it was not a regular patent. Even at an early stage, the announcement of the adalimumab PDP resulted in extrajudicial notices being sent by Abbvie in 2015 and 2016 to those involved in the PDP. One of the patents in force had its application refusal by ANVISA reversed by a court order. |
II (suspended) |
10 |
Butantan |
Libbs Farmacêutica Ltda. |
- |
Libbs Farmacêutica Ltda. |
No |
II |
20 |
Butantan |
Libbs Farmacêutica Ltda. |
- |
Libbs Farmacêutica Ltda. |
No |
II (suspended) |
30 |
TECPAR |
Orygen Biotecnologia S/A |
Pfizer Incorporated |
Orygen Biotecnologia S/A |
No |
BEVACIZUMAB |
II (suspended) |
25 |
Bio-manguinhos |
Bionovis S.A - Companhia Brasileira de Biotecnologia Farmacêutica |
- |
Bionovis S.A - Companhia Brasileira de Biotecnologia Farmacêutica |
No |
Two patents that apparently protect the drug were immediately terminated after the judgment of ADI 5529/DF. There are two other patents in force, apparently process patents, which had their validity period reduced by almost 5 years each, but remain in force until 2023 and 2025. There is also an unfinished application. |
The terminated product patents would have been in force until 2026 and 2031 if ADI 5529/DF had not been judged. Patent 9809387-8 had its application refusal by ANVISA reversed by a court order, and its granting was being challenged in court by Libbs, which requested for the patent to be invalidated. The unfinished application, apparently in process, was granted prioritized examination in 2019 and is awaiting analysis of the appeal against the rejection. |
II |
25 |
Butantan |
Libbs Farmacêutica Ltda. |
- |
Libbs Farmacêutica Ltda. |
No |
II (suspended) |
50 |
TECPAR |
Orygen Biotecnologia S/A |
Pfizer Incorporated |
Orygen Biotecnologia S/A |
No |
SEVELAMER HYDROCHLORIDE |
III |
50 |
Farmanguinhos |
Cristália Produtos Químicos Farmacêuticos Ltda. |
- |
ITF Chemical Ltda. |
Yes |
There seems to be no patent protecting the drug in Brazil. A process patent was terminated by ADI 5529/DF. |
The process patent would have been in force for 25 years and 5 months if ADI 5529/DF had not been judged. |
IV (suspended) |
50 |
Bahiafarma |
Cristália Produtos Químicos Farmacêuticos Ltda. |
- |
ITF Chemical Ltda. |
Yes |
CLOZAPINE |
IV |
100 |
LAFEPE |
Cristália Produtos Químicos Farmacêuticos Ltda. |
- |
Cristália Produtos Químicos Farmacêuticos Ltda. |
Yes |
There seems to be no patent protecting the drug. A patent, apparently a process patent, was terminatedby ADI 5529/DF. |
The process patent was granted by reversing a previous rejection by the INPI and was meant to be in force for 28 years and 11 months, prior to the judgment of ADI 5529/DF. |
PRAMIPEXOLE DIHYDROCHLORIDE |
III |
50 |
Farmanguinhos |
Nortec Química S/A |
Boehringer Ingelheim do Brasil Química e Farmacêutica Ltda. |
Nortec Química S/A |
Yes |
There seems to be no patent protecting the drug. A pipeline product patent was terminated in 2004. Other applications were rejected or archived. |
The holder of the pipeline patent tried to extend its term in court. All the other applications received an opinion from ANVISA against the granting of the patent. Eurofarma submitted a subsidy for the examination of several applications. |
EVEROLIMUS |
II (suspended) |
50 |
Farmanguinhos |
- |
- |
- |
No |
There seems to be no patent in force protecting the drug. Pipeline product patent terminated in 2013. Process patent terminated in 2019. |
The rejection of another patent application was challenged in court, but Novartis lost. The company was a partner in the PDP, whose term of commitment was signed in 2012, but went out of business in 2015. The terms of commitment of the PDPs with Farmanguinhos and NUPLAM are from 2018. |
II |
50 |
NUPLAM |
EMS S/A |
|
Nortec Química S/A |
No |
INFLIXIMAB |
II (suspended) |
50 |
TECPAR |
Orygen Biotecnologia S/A |
Pfizer Incorporated |
Orygen Biotecnologia S/A |
No |
There seems to be no patent protecting the drug. A patent lost 6 years and 7 months of validity after the judgment of ADI 5529/DF and was terminated in August 2021. |
The patent was granted contrary to the subsidy for examination by ANVISA. EMS submitted various subsidies for the technical examination of the patent application. |
III |
50 |
Bio-manguinhos |
Bionovis S.A. - Companhia Brasileira de Biotecnologia Farmacêutica |
Janssen-Cilag Farmacêutica Ltda. |
Bionovis S.A. - Companhia Brasileira de Biotecnologia Farmacêutica |
Yes |
IMATINIB MESYLATE |
IV |
50 |
Farmanguinhos |
Cristália Produtos Químicos Farmacêuticos Ltda. |
- |
Cristália Produtos Químicos Farmacêuticos Ltda. |
Yes |
Pipeline patent PP 1100739-7 (not included in the study), which protects the drug, terminated since 2012. A patent that could apparently affect the production of generics had its validity reduced by 8 years and 7 months after the judgment of ADI 5529/DF and was terminated in October 2021. |
The patent that was terminated in October 2021 was “sub judice,” and its nullity was demanded in court by several generic pharmaceutical companies. An opinion from ANVISA was submitted as a subsidy to the examination by the INPI and went against the granting of the patent. |
IV |
50 |
IVB |
Laborvida EMS S/A |
- |
Globe Química S/A |
Yes |
ATATAZANAVIR SULFATE |
III |
100 |
Farmanguinhos |
Nortec Química S/A |
Bristol-Myers Squibb Company (BMS) |
Nortec Química S/A |
Yes |
The patent protecting the product was terminated in 2017. A granted process patent had its validity reduced by 4 years by ADI 5529/DF, but will remain in force until 2025. |
The process patent was granted contrary to the subsidy for examination by ANVISA. The terminated product patent belonged to Novartis and was licensed to Bristol-Myers Squibb, which holds the current process patent. To establish the PDP, a voluntary license agreement was signed with BMS in 2011. |
TRASTUZUMAB |
II |
40 |
Bio-manguinhos |
Bionovis S.A. - Companhia Brasileira de Biotecnologia Farmacêutica |
- |
Bionovis S.A. - Companhia Brasileira de Biotecnologia Farmacêutica |
Yes |
There seems to be no patent protecting the drug. A pipeline patent (PP1101137-8, not included in the technical note) was terminated in 2014. |
The applications were rejected, in accordance with the examination subsidy presented by ANVISA. Several other applications were mentioned in other studies, but there is no clarity on the main patent that protected the product. Roche has been a partner in the PDP since 2017, which may indicate the use of the PDP as a monopoly extension. Moreover, there was an investigation by the TCU and the MPF into the overpricing of the generic produced by TECPAR. |
II (suspended) |
20 |
Butantan |
Libbs Farmacêutica Ltda. |
- |
Libbs Farmacêutica Ltda. |
No |
III (suspended) |
40 |
TECPAR |
Axis Biotec Empreendimentos e Participações Ltda |
F. Hoffmann-La Roche Ltd. |
Axis Biotec Empreendimentos e Participações Ltda |
Yes |