International Research Journal of Biotechnology (ISSN: 2141-5153) Vol. 2(5) pp.078-084, April, 2011
Available online http://www.interesjournals.org/IRJOB
Copyright © 2011 International Research Journals
Full Length Research Paper
Technological prospecting for patents on herbal
medicines in Brazil
Ana Claudia Dias de Oliveira *1, Simone Milezi de Miranda Reis 2, Alexandre Guimarães
Vasconcellos 3, Celso Luis Salgueiro Lage 4
1
PhD Student – Plant Biotechnology Program – CCS – Universidade Federal do Rio de Janeiro, 21941-590, Rio de
Janeiro, RJ, Brazil
2
Patent Analyst - ANVISA
3
Researcher and Permanent Professor - INPI
4
Senior Specialist - INPI.
Accepted 10 May, 2011
This study analyzes patent documents of phytotherapeutic agents filed by Brazilian investigators. The
main phytotherapeutic agents protected by the patents system have been diagnosed, and their
respective therapeutic indications have been identified. Additionally, the course of every patent
application has been verified, in order to measure the percentage of granted patents in the area. The
most important goal of this study is to demonstrate the patenting evolution of herbal medicines agents
by Brazilian investigators, in order to identify the real situation of the legal protection of this kind of
medication. The results indicate that the few patent applications for herbal agents have been granted;
which shows the need for technical skills as well as prospection studies, research and development.
Keywords: Phytotherapeutic agent, patent, intellectual property, Brazil, prospection, herbal medicine.
INTRODUCTION
The use of herbal medicine as a resource is growing
every year. In the nineties, about 80% of medications
were natural products, or analogues inspired by them (Li
& Vederas, 2009).
The benefits derived from treatment of herbal
compounds are undeniable and their excellent
cost/benefit ratio, id est, the effective biological action
with low toxicity and few or no side effect, should be
assessed, since this therapy is already recognized by
World Health Organization (WHO, 2003).
Currently, the herbal compounds are prescribed in
human medicine and veterinary medicine. The Euphrasia
sp. is used against eye diseases, Echinacea sp. has
been shown to restore the immune system, Aloe vera has
antibacterial, fungicidal properties and wound healing,
moisturizing, and nourishing characteristics (Blazics et
al., 2008; Zhai et al., 2007; Norris, 2007). The cascara
*Corresponding author Email: anaclaudia_dias@hotmail.com
buckthorn (Rhamnus purshiana) is used in veterinary
medicine for the treatment of constipation (Wynn &
Fougere, 2007). The Centella asiatica is known as “brain
food”, and it has being used in the treatment of cerebral
vascular accident (CVA) (Subathra et al., 2005).
The development of new drugs, mainly the synthesis of
new active principles, requires much time, between 10
and 15 years to reach the stage of commercialization,
high investment, and the safest way to guarantee the
return of these funds is through patent system (Oliveira,
2004).
The System of Patents of Brazil neither considers the
natural plants per se as inventions, nor the products
extracted from them, as compounds and extracts [Art.
10th, clause IX, of the Law of Industrial Property (Lei de
Propriedade Industrial – LPI) nº 9279/96] (Brazil, 1996).
However,
the
processes
for
obtainment
of
phytotherapeutic extracts or active chemical compounds,
as well as the compositions containing extracts or
isolated molecules of phytotherapeutic compounds can
be patented. Genetically modified plants cannot be
Oliveira et al. 079
patented according to brazilian law (Article 18 th of
9.279/1996 law). In Brazil, the only living beings
susceptible to be protected by patents are the transgenic
microorganisms. In the case of extracts and chemical
compounds originating from genetically modified plants,
they will be susceptible to patent protection only, if the
molecules of interest are proven to be different from the
ones commonly found in nature.
Vasconcellos et al. have analyzed the patent
application of phytotherapeutic products done in Brazil
over the nineties, and verified an already existent great
interest of the national segment in the area, being
achieved the second place in number of applications by
the national inventors, considering the more than 67,000
technological fields present in the International Patent
Classification (IPC) (Vasconcellos et al., 2004).
Vasconcellos et al. emphasized yet the need of continuity
for that study, with the purpose to determine which
percentage of patents application in the area were,
effectively, transformed into granted patents.
This way, it is necessary to lift all documents of patents
of phytotherapeutic agents filed by Brazilian investigators,
to evaluate what is being patented, which apply for a
patent are being granted, which are the most applied new
technologies, and how is Brazil placed in this specific
scenery.
The objectives of this article are: to analyze the
documents of patent of phytotherapeutic agents filed by
Brazilian investigators worldwide, to diagnose the main
phytotherapeutic agents protected by the system of
patents, determining their respective therapeutic
indications, to identify the effectively granted patents,
analyzing this way the patenting evolution of
phytotherapeutic agents by Brazilian investigators.
MATERIALS AND METHODS
The research about documents of patent of
phytotherapeutic agents had already been done in the
databases of the European Patent Office (EPO)
(http://www.ep.espacenet.com); the Derwent Innovations
Index, accessed by means of CAPES (Coordenação de
Aperfeiçoamento de Pessoal de Nível Superior or
Coordination of Improvement of Higher Education Staff)
portal (http://www.periodicos.capes.gov.br); and the
National Institute of Industrial Property (Instituto Nacional
de Propriedade Industrial – INPI) (http://www.inpi.gov.br).
These databases were chosen because they
contemplate a higher number of documents of patents,
being also frequently updated.
The search has been done without determine a specific
period of applications. So, the first document of patent
presented in the search results is dated of 1966. The
search of patent documents was held in November 2010.
However, as the Brazilian Legislation of Intellectual
Property has passed to grant patents for pharmaceutical
products only in year of 1995, the documents we have
analyzed were only those filed from that year forth.
The search methodology was developed entering the
applicant country acronym between square brackets
(‘[BR]’ for Brazil) in the ‘Applicant’ field; and in the field for
‘International
Patent
Classification’
(IPC),
the
classification referring to phytotherapeutic agents, that is,
the classifications A61K 35/78 or A61K 36. The
International Classifications A61K 35/78 and A61K 36 are
referred to “Medicinal preparations containing materials
of undetermined constitution, derived from algae, lichens,
fungi, or plants, or their derivatives; for example,
traditional medications based on herbs”. From the 8th
edition of IPC, the Classification A61K 35/78 was
substituted and subdivided into several classifications
within the subclass A61K 36. Due to this subdivision,
both codes were typed in the IPC search field,
A61K35/78 and A61K 36, in order to enable the search
for all results of interest.
The documents of patent have been analyzed and
classified according to the species of utilized plants and
respective therapeutic indications. The therapeutic
indications were classified according to International
Classification of Diseases (ICD) below:
I (A00-B99) - Certain infectious and parasitic diseases
II (C00-D48) - Neoplasms
III (D50-D89) - Diseases of the blood and blood-forming
organs and certain disorders involving the immune
mechanism
IV (E00-E90) - Endocrine, nutritional and metabolic
diseases
V (F00-F99) - Mental and behavioural disorders
VI (G00-G99) - Diseases of the nervous system
VII (H00-H59) - Diseases of the eye and adnexa
VIII (H60-H95) - Diseases of the ear and mastoid process
IX (I00-I99) - Diseases of the circulatory system
X (J00-J99) - Diseases of the respiratory system
XI (K00-K93) - Diseases of the digestive system
XII (L00-L99) - Diseases of the skin and subcutaneous
tissue
XIII (M00-M99) - Diseases of the musculoskeletal system
and connective tissue
XIV (N00-N99) - Diseases of the genitourinary system
XV (O00-O99) - Pregnancy, childbirth and the
puerperium
XVI (P00-P96) - Certain conditions originating in the
perinatal period
XVII (Q00-Q99) - Congenital malformations, deformations
and chromosomal abnormalities
XVIII (R00-R99) - Symptoms, signs and abnormal clinical
and laboratory findings, not elsewhere classified
XIX (S00-T98) - Injury, poisoning and certain other
consequences of external causes
XX (V01-Y98) - External causes of morbidity and
mortality
XXI (Z00-Z99) - Factors influencing health status and
contact with health services
41
41
38
29
23
5
09
20
08
20
07
20
06
20
05
20
04
20
03
20
20
02
01
20
00
20
99
19
98
19
97
19
19
96
8
24
27
35
37
60
50
40
30
20
10
0
44
50
53
Int. Res. J. Biotechnol.
Number of Patent
Documents
080
Year
Phytotherapic Patents deposited by Brazilians
Figure 1. Documents of patent of phytotherapeutic agents filed by Brazilian investigators, in the period between
1995 and 2010.
XXII (U00-U99) - Codes for special purposes
It was done a comparison of results found in the
databases of the European Patent Office (EPO) and
Derwent Innovations Index. Then, it was developed the
identification of Brazilian apply for a patent, and the
corresponding apply for a patent in Brazil, in the cases of
apply for a patent registered also in other countries.
Divergent results were analyzed and added, and
duplicate results were removed.
After the lift of documents of interest, it was developed a
verification of the course of that documents in the INPI
database, aiming to identify which were the effectively
granted apply for a patent, the rejected ones, and the
ones still in phase of examination.
RESULTS AND DISCUSSION
Four hundred eighty-two (482) documents related to
Classifications A61K35/78 and/or A61K 36 have been
found, filed within the period between 1966 and 2010.
Eighteen (18) documents were referred to medicinal
preparations containing materials derived from bacteria,
fungi, and algae, being not included in the
phytotherapeutic agents. Three documents have been
added, and 7 duplicate documents and 23 documents
earlier than 1995 have been removed.
So, 437 documents of patent of phytotherapeutic
agents filed by Brazilian investigators, in the period
between 1995 and 2010, have been analyzed in this
article (Figure 1).
In the application documents, only 177 Public or Private
Institutions have been identified, including Public and
Private Universities, Research Centers, and Private
Laboratories; as well as 260 independent inventors.
The more prominent Brazilian states were São Paulo,
Minas Gerais, Rio de Janeiro, Santa Catarina e Paraná.
The Southeastern Region has obtained the higher
number of applications, followed by Southern Region;
which demonstrates that the knowledge about the system
of protection by patents is linked to the development of
the large urban centers, where are placed the most
important Institutes of Research & Development and the
great pharmaceutical companies.
Two hundred sixty-two plant genders have been found.
Between them, some are detached by the number of
applications, such as the Genera Aloe sp. (11
documents), Calendula sp. (12 documents), Ginkgo sp.
(9 documents), Glycine sp. (10 documents), Malus sp. (8
documentos), Matricaria sp. (8 documentos), Mentha sp.
(10 documents), Paullinia sp. (8 documents), Piper sp. (9
documents), Solanum sp. (9 documents), Trichilia sp. (8
documents) and Vitis sp. (10 documents).
The category of the International Classification of
Diseases (ICD) more detached by the number of
applications was the one referred to ‘Diseases of the Skin
and Subcutaneous Tissue (XII)’ (190 documents), and
included, among others, vitiligo, psoriasis, and acne.
Other detached classification was the one referring to
‘Infectious and Parasitic Diseases (I)’ (114 documents),
including the viroses in general (dengue, camp fever,
hepatitis, HIV infection), the bacterial infections, and the
parasitic diseases.
The found plant genera with the respective therapeutic
indications are listed at Table 1.
Out of the 437 documents of patent, the majority are
still in phase of examination at the INPI. Two hundred
fifty-five applies for a patent are still in phase of
examination, 155 were filed, 25 were rejected, and only 2
were effectively granted. The patents granted to date
were BR9703727 (Applicant: José Eduardo Pereira
(BR/RJ)) which claims jambul’s extracts and BR9804730
(Applicant: UNICAMP) which claims a process for
Oliveira et al. 081
Table 1. Plant genera with the respective therapeutic indications
Aleurites sp.
Allium sp.
Aloe sp.
Alpinia sp.
Alternanthera sp.
Anacardium sp.
Anadenanthera sp.
Anchietea sp.
Annona sp.
Araucaria sp.
Arctium sp.
Argyrovernonia sp.
Arnica sp.
Arrabidaea sp.
Artemisia sp.
Astragalus sp.
Astrocaryum sp.
Atropa sp.
Attalea sp.
Avena sp.
Azadirachta sp.
Baccharis sp.
Baptisia sp.
Bauhinia sp.
Berberis sp.
Bertholletia sp.
Bidens sp.
Bignonia sp.
Bixa sp.
Boerhavia sp.
Boswellia sp.
Brassica sp.
Bryonia sp.
Butia sp.
Cacalia sp.
2
1
1
1
1
1
1
2
1
1
2
1
3
2
1
1
1
1
1
1
1
1
1 4
2
1
1
1
5
1
1
1
4
1
1
1
3
1
2
1
1
1
2
1
1
1
1
1
1
1
1
1 1
1
1
2
3
1
1
1
1
1
1
1
1
2
1 1
2
1
2
1
1
1
1
2
1
3
1
XXII
XXI
XX
IXX
XVIII
XVII
XVI
XV
XIV
XIII
INTERNATIONAL CLASSIFICATION OF
XII
XI
X
IX
VIII
VII
VI
V
IV
III
II
GENUS
Acacia sp.
Acanthospermum sp.
Achillea sp.
Achyrocline sp.
Acmella sp.
Aconitum sp.
Acrocomia sp.
Adiantum sp.
Aesculus sp.
I
NUMBER OF PATENT DOCUMENTS /
DISEASES
082
Int. Res. J. Biotechnol.
Table 1. Continue
Caesalpinia sp.
Calendula sp.
Calophyllum sp.
Calotropis sp.
Camellia sp.
Capsicum sp.
1
1
1
1
1
1
7
1
1
1
1
1
1
1
1
Casearia sp.
Cassia sp.
Caulophyllum sp.
Cayaponia sp.
Cecropia sp.
Ceiba sp.
Centella sp.
Cereus sp.
1
1
Chaptalia sp.
Chelidonium sp.
Chenopodium sp.
Cichorium sp.
Chionanthus sp.
Cinnamomum sp.
Citrullus sp.
Citrus sp.
Clinopodium sp.
Coccoloba sp.
Cocos sp.
Coffea sp.
1
Cyphomandra sp.
Cyrtopodium sp.
Datura sp.
Dendrobium sp.
Dicksonia sp.
3
1
1
2
Carapa sp.
Carica sp.
Caryocar sp.
Caryophyllus sp.
Copaifera sp.
Cecropia sp.
Commiphora sp.
Convolvulus sp.
Conyza sp.
Coutarea sp.
Crataegus sp
Croton sp.
Cuphea sp.
Curcuma sp.
Cymbopogon sp.
Cynara sp.
1
1
1
1
1
1
1
1
1
1
1
1
3
1
1
1
1
2
1
1
1
1
1
2
3
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
3
1
2
1
3
1
1
1
1
1
1
1
1
Oliveira et al. 083
Table 1. Continue
1
Enterolobium sp.
Equisetum sp.
Erigeron sp.
Eriodendron sp.
Erythrina sp.
Erythroxylum sp.
Eucalyptus sp.
Eucommia sp.
Eupatorium sp.
Euphorbia sp.
Euterpe sp.
Ferula sp.
Ficus sp.
Furcraea sp.
Gentiana sp.
Ginkgo sp.
Glycine sp.
Gossypium sp.
1
1
2
1
Ignatia sp.
Ilex sp.
Indigofera sp.
Iris sp.
Jasminum sp.
Jatropha sp.
Kalanchoe sp.
Kielmeyera sp.
Lavandula sp.
Lawsonia sp.
Leonotis sp.
Lilium sp.
Lippia sp.
Luffa sp.
Macadamia sp.
Malpighia sp.
Malus sp.
1
2
4
1
1
1
1
3
1
1
1
1
1
3
1
2
1
5
3
3
1
1
1
Hamamelis sp.
Hancornia sp.
Helianthus sp.
Helleborus sp.
Heteropteris sp.
Hevea sp.
Hibiscus sp.
Himatanthus sp.
Hordeum sp.
Hymenaea sp.
Hypericum sp.
Hyptis sp.
5
1
1
1
3
1
2
1
1
4
1
1
1
1
1
2
1
1
1
1
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
2
1
1
1
1
1
1
1
1
2
2
1
2
obtaining artemisinin from Artemisia annua L. (Pereira,
1997; Rehder et al., 1998).
2
2
2
It was verified that the documents with already finished
examination were filed up to 2002. Those application
084
Int. Res. J. Biotechnol.
afterwards are still in phase of examination or were filed,
in the majority of cases, due to lack of annuity payment or
because the application for examination was not done
within the established term.
From the obtained results, it is noticed that the
procedure for granting of patent by INPI, in the
pharmaceutical area, continues delaying around 8 years
as previously reported by Vasconcellos et al. (2004).
The very low number of patents granted in the area in
relation to the decision already made applies for a patent
to the INPI (2/180 or 1.1%) shows that although Brazil
has the highest plant biodiversity on the planet and
intense scientific production in the area of Pharmacology
and Toxicology (Vasconcellos & Rodrigues, 2008), yet
has managed to turn this potential inventions protected
by patents, so as to take innovative phytoproducts to
market and leverage the comparative advantage offered
by its rich biodiversity.
Regarding the legal aspects, it should be noted that, as
of June 30, 2000, the whole question of access to genetic
heritage, as well as protection and access to associated
traditional knowledge has been regulated by Provisional
published in 2052 under federal (currently MP 2.18616/2001). Based on MP 2.186-16/2001, through
Resolution 207 of 24/04/2009 of the INPI, the patent
applicants shall declare to the INPI if the object of the
patent application was obtained as a result of access to
samples of Brazilian genetic heritage component, held
from June 30, 2000. If so, you must declare the origin of
the genetic material and the number of authorized access
provided by the Board of Management of Genetic
Heritage (CGEN). These new legal rules may create
more difficulty in obtaining patents to inventors who make
use of Brazilian biodiversity, especially individuals who,
by virtue of article 16 of MP 2186-16/2001, has no right to
obtain the term access of CGEN and therefore able to
patent protection.
Thus, it is necessary a great effort in the area of
educational training for investigators and the Brazilian
institutions involved with research in the herbal industry
can meet fully the statutory requirements and have, in
fact, research based medicinal plants can be transformed
into new medicines reaching the market.
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