Journal of Cancer Therapy, 2013, 4, 56-64 Published Online August 2013 (
Copyright © 2013 SciRes. JCT
R&D Landscape for Breast Cancer through Patent
Adelaide M. S. Antunes1,2*, Iolanda M. Fierro1, Rafaela Di Sabato Guerrante1,
Priscila Rohem dos Santos1, Flavia Maria Lins Mendes2
1National Institute of Industrial Property, Rio de Janeiro, Brazil; 2Federal University of Rio de Janeiro, Postgraduate Program in
Technology of Chemical & Biochemical Processes, Rio de Janeiro, Brazil.
Email: *
Received June 12th, 2013; revised July 10th, 2013; accepted July 18th, 2013
Copyright © 2013 Adelaide M. S. Antunes et al. This is an open access article distributed under the Creative Commons Attribution
License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Cancer is a leading cause of death worldwide, and is estimated to be the cause of 13.1 million deaths in 2030. Breast
cancer is the second cancer in the global mo rtality ranking, considering both sexes. Due to the burden of breast cancer
worldwide, this paper aims to present an overview of th e main R&D ef fo r ts fo c us i ng on breast cancer treatment. Patents
were retrieved from the Derwent Innovations Index®, which has a specific code for pharmaceuticals related to breast
cancer. A total of 423 patent documents filed in recent years were identified, of which 126 are exclusively for breast
cancer, 169 for breast cancer and other cancers, and 128 are inventions related to the treatment of cancer and other dis-
eases. The patent documents were classified into two large groups, the first of which had a predominance of claims for
antibodies, proteins and polypeptides for use in medication production, while the second focuses on gene therapy, nu-
cleotides and RNA. The country with the majority of priority patent applications was found to be the United States, fol-
lowed by China and Japan.
Keywords: Patent; Breast Cancer; Treatment; R&D Trends
1. Introduction
The aim of this work is to use the technological infor-
mation contained in patents as a way of identifying re-
search and development (R&D) trends in biotechnolo-
gical pharmaceuticals for breast cancer treatment.
One of the most reliable tools for appraising tech-
nology development in a given sector is patent mining,
because thousands of new patent applications are filed
every year around the world. The scope and level of
detail required for protection to be conferred on a given
innovation means that 70% of all technical documen-
tation produced in the world is only contained in patents
and is not published in any other form. Each patent do-
cument should describe the state-of-the-art in a given
area, report on existing problems, and suggest novel
solutions to be gra nt e d protection by patent [ 1] .
According to the Frascati Manual, patents and scien-
tific publications serve as first-generation indicators of
the outputs of innovation activity. In this paper we con-
sidered the Organization for Economic Co-Operation and
Development (OECD, 1963) definition for R&D ac-
tivities. This definition states R&D as all creative work
undertaken on a systematic basis to increase the stock of
scientific and technical knowledge, including knowledge
of man, culture and society and the use of this knowledge
to devise new applications [2]. Patent documents are
valuable and unique source of data on technological ef-
fort, which is an aspect of innov ative activity.
The analysis of patents from a given sector can serve
different purposes, including: 1) to demonstrate growth
prospects, if the number of patent applications filed over
a particular time series is examined; 2) to identify patent
assignees, thereby demonstrating market concentration
patterns; 3) to identify what kinds of technology are
being developed b y making qualitative evaluatio ns of the
claims made in the patent documents; and 4) to identify
technology trends [3 ].
It is well known that in the pharmaceuticals sector
potentially important technologies tend to be protected
by patents.
The importance of this kind of analysis resides in the
fact that decisions about government investments in the
*Corresponding a uthor.
R&D Landscape for Breast Cancer through Patent Documents
Copyright © 2013 SciRes. JCT
development of new products and/or processes, the crea-
tion of partnerships for joint R&D activities, and tech-
nology transfer agreements are in many cases related to
the existence of patents.
Breast Cancer
According to World Health Organization data, breast
cancer is the main form of cancer in women, but it can
also affect men. In 2010, it is estimated that 1.5 million
people were diagnosed with breast cancer [4]. If com-
pared with all cancers that affect both sexes, it comes
second for mortality, accounting for 458,000 deaths in
2008, as can be seen from Figure 1.
Considering the USA and Brazil as two representative
countries from the Americas, it can be observed that in
the United States it is estimated that 232,340 women will
be diagnosed with breast cancer and 39,620 women will die
of the disease in 2013. In Brazil, the estimated number of
new cases in 2012 was 52,680, while 2010 data show that
breast cancer was responsible for 12,852 deaths, of which
147 were of men and 12,705 of women [5].
Breast cancer is the form of cancer that most afflicts
females, accounting for 22% of all new cancer cases each
year. Its prognosis is relatively good provided it is diag-
nosed early. Worldwide, average survival after five years
is 61%. In Brazil, the mortality rate for breast cancer is
still high, but probably because the disease still tends to
be diagnosed at an advanced stage [5]. This is consistent
with international data, which report that about 70% of
all cancer deaths occur in low- and middle-income coun-
tries [6].
According to the National Cancer Institute in the
United States, the most common type of breast cancer is
ductal carcinoma, which begins in the cells of the ducts.
Cancer that begins in the lobes or lobules is called lobu-
lar carcinoma and is more often found in both breasts
than are other types of breast cancer. Inflammatory breast
cancer is an uncommon type of breast cancer in which
the breast is warm, red, and swollen [7].
Biotechnology is a powerful presence in healthcare. In
its report entitled “Genomics and Global Health”, the
World Health Organization highlights genomics and pro-
teomics as promising sources of breakthroughs for the
treatment, diagnosis and prevention of several diseases
Biotechnology refers to a set of enabling technologies
whose common denominator is the use of biotech cells or
molecules. It would also be fair to say that this area has
three conceptual hallmarks which could arguably be ex-
pressed as generations, especially the advances that have
led from fermentation processes to the most advanced
cloning, enzyme and genome engineering techniques.
Meanwhile, biotechnology R&D is geared towards pro-
ducts, such as monoclonal antibodies, or technologies,
such as gene therapy.
The aim of this study is to present the current global
R&D landscape for biotechnological medications for
breast cancer treatment by investigating patent docu-
ments filed in recent years.
2. Methodology
The Derwent Innovations Index® was selected as the
source of patents to this study. It is an internationally
recognized database that facilitates the retrival of patent
applications for future analysis, and has its own classi-
fications, or manual codes, which classify technology
knowledge into different areas. Since 2005, it has had a
specific code for pharmaceuticals related to breast cancer
treatment, B14-H01D1. As such, this is the year that was
adopted as the starting point for the patent document
search in this study, also bearing in mind that the main
medical applications of modern biotechnology started to
appear in the new millennium.
This search was combined with a search using the In-
ternational Patent Classification (IPC) so as to ensure
that no patent documents were overlooked. Providing a
classification of industrial property, this system is the
outcome of international agreements between different
countries. Its main goal is to supply an effective means of
retrieving documents so that the criterion of novelty can
be appraised and the status of technology in different
fields can be assessed. It also serves as a basis for the
preparation of industrial property statistics, which in
Figure 1. Mortality for different types of cancer in both sexes, according to WHO data [4].
R&D Landscape for Breast Cancer through Patent Documents
Copyright © 2013 SciRes. JCT
turn permit the evaluation of technology developments in
different areas. As such, for this study, a search was made
of patent applications filed for medications (A61K),
therapeutic activity (A61P) and biotechnology (C12N).
The result of the combined survey of the Derwent In-
novations Index® Classification (Manual Code) and the
IPC yielded 423 patent documents filed and published in
the world about biotech medications for use in breast
cancer treatment. The next stage was to conduct a quali-
tative analysis of the uses, claims, novelty, activity and
mechanism of action described in the documents to iden-
tify technology trends.
3. Results and Discussion
Having read all 423 patent documents, it became clear
that not all of them dealt exclusively with technologies
for breast cancer treatment. As such, the documents were
divided into three categories: 1) patents exclusively for
breast cancer (126 patent documents, or 30%); 2) patents
for breast cancer and other cancers, particularly lung
cancer, colon cancer and prostate cancer (169 patent
documents, or 40%); and 3) patents for breast cancer,
other cancers and other diseases, including diabetes, rheu-
matoid arthritis, Alzheimer’s disease, Huntington’s dis-
ease, Parkinson’s disease, multi-infarct dementia, mixed
Alzheimer/multi-infarct dementia and hypothyroidism (128
patent documents , o r 30%) (Figure 2).
Another observation made from the perusal of the
documents was that amongst the claims for breast cancer
treatment, there were many that were also for its preven-
tion and/or diagnosis. This led to another classification of
the 423 patent documents: 241 were just for treatment;
29 were just for diagnosis, nine were just for prevention,
65 were for treatment and prevention, 63 were for treat-
ment and diagnosis, and 16 were for treatment, diagnosis
and prevention. This is shown in Figure 2. One ex ample
is the use of monoclonal antibodies to make diagnosis
kits of tumors or pre-cancerous stem cells. When looking
at the diagnosis-related technologies, it was found that
some of the patent documents also made mention of
prognosis, such as the possibility of predicting the con-
tinuation of treatment by d etecting expression levels of a
set of genes or of a particular gene (estrogen receptor)
Patent assignees, which are the holders of the rights to
the patented technology, may choose to patent their in-
vention in different countries. In this study, the break-
down of the patents by country only considered the pri-
ority patent applications, i.e. the first country in which
the patent applications were filed (see Figure 3).
In Figure 3, it can be seen that most of the priority
patent applications were made in the United States (251).
This country is followed by China and Japan, with 46
and 45 priority applications each, respectively, while
Figure 2. Graphic representation of patent documents. Do-
cuments divided by categories; Documents divided by uti-
Europe has a total of 58 priority applications, with the
top country in the bl oc bei n g the UK, wi t h 2 1.
By analyzing the “claims”, “novelty”, “activity” and
“mechanism of action” fields from the patent applica-
tions, it was possible to divide the R&D trends they con-
tain into two major groups of biotechnology entities, as
shown in Table 1.
There were a few documents (7% of the total) which
did not fit into either of these two groups. These patents
applications are for active ingredients extracted from
plants, agents acting in gene transfer (polymers) and cell
therapy (using chemical compoun ds or stem cells).
The patents identified were then divided by their ap-
plication (for breast cancer, for breast cancer and other
cancers, or for breast cancer, other cancers and other dis-
eases) into the two groups o f biotech entities. Th e results of
this breakdown can be seen in the following figures.
R&D Landscape for Breast Cancer through Patent Documents
Copyright © 2013 SciRes. JCT
Figure 3. Distribution of patent applications over time by country.
Table 1. Main biotechnological entities in patents for breast
Group 1 Group 2
Antibodies (Monoclonal or
Proteins (Fusion or
Peptides and Polypeptides—57
Amino acids—3
Recombinant Albumin—1
Recombinant Toxin—1
Nucleotides, Oligonucleotides and
Genes and Fusion Genes—28
RNA, RNAi, siRNA, Recombinant
RNA and miRNA—42
DNA, DNA Microarray and
Recombinant DNA—19
Nucleic Acid—18
Recombinant Vector—12
Transgenic Mic roorganism—4
Gene Promoter—1
The entities from Group 1 cited in the patent applica-
tions exclusively for breast cancer treatment involve
primarily protein-based medications, followed by pep-
tides and monoclonal antibodies, while from Group 2
there is a broader array of biotech entities, made up pri-
marily of Genes and Fusion Genes, RNA, Nucleotides
(oligonucleotides and polynucleotides) and DNA.
Around 85% of these 126 patent applications relating
specifically to breast cancer were filed first in the United
States or Asia. The 64 priority patent applications filed in
the USA were mostly filed by residents: 52% by uni-
versities and/or research centers, 38% by companies, and
10% by individuals. The leading assignee is the Univer-
sity of California, with nine patent applications.
Turning to the biotech entities, 58% of the patent ap-
plications made in the USA fit into Group 2, and are
primarily for genes, fusion genes, RNAi and oligonucleo-
tides. The 42% from Group 1 are primarily for proteins,
peptides and monoclonal antibodies. This indicates a
potential trend for future medications to include onco-
gene blocking and/or the replacement of altered tumor
suppressor genes.
Gene therapy is one of the main mechanisms used in
the new technologies to optimize breast cancer treatment.
R&D Landscape for Breast Cancer through Patent Documents
Copyright © 2013 SciRes. JCT
What RNAi does is to silence the expression of genes
that encode proteins implicated in carcinogenesis. One
example is patent application US2012004278, which
comprises administering to a subject with metastatic
cancer an amount of a RNA interference inhibitor of
HOTAIR long non-coding RNAs (lincRNA) levels or
function, or an amount of an RNAi inhibitor to inhibit
HOTAIR LincRNA expression from the HOTAIR gene.
Basically, through this technology it is p ossible to silen ce
any kind of gene, including genes that are not yet treata-
ble using conventional drugs [11].
RNAi technology can also be used to identify cancer
more quickly than other technologies. Patent application
US2012010090 is for an siRNA composition which re-
duces the expressio n of the nucleic acid sequen ce A5657,
B9769, or C7965, in view of the fact that diagnosing
breast cancer or a predisposition to developing breast
cancer in a subject comprises determining a level of ex-
pression of a breast cancer-associated gene in a pa-
tient-derived biological sample selected from A5657,
B9769, and C7965, where an increase in the sample ex-
pression level as compared to a normal control level of
the gene indicates that the subject suffers from or is at
risk of deve loping breast canc e r [ 12].
As oligonucleotides are complementary to mRNA,
they are used to inhibit the translation of a target protein
that could be expressed defectively. In patent app lication
US2010331390, for instance, the aim is to modulate the
level of a target gene mRNA, with an antisense oligo-
nucleotide containing 15 - 30 nucleobases, where the anti-
sense oligonucleotide reduces the level of apolipopro-
tein B mRNA [13].
Different proteins and peptides have been tested with
the aim of manipulating the expression of specific genes
in cancer cells without the transfer of genetic material.
Most of the patent applications encountered involve poly-
peptides, one example being patent application US2009-
202587, which shows a recombinant polypeptide com-
prising a polypeptide (P1) encoded by a defined se-
quence of 294 base pairs (SEQ ID NO: 23) given in the
specification, linked to a non-high molecular weight me-
lanoma-associated antigen (HMW-MAA) polypeptide
[14]. Another important target of cancer therapy is vas-
cular endothelial growth factor and its receivers, which
play an essential role in tumor-induced angiogenesis.
Patent application US2008214465 claims protection for a
breast cancer treatment by administering a vascular en-
dothelial growth factor (VEGF) antagonist VEGFR1R2-
Fc Delta C1 comprising a sequence of fully defined 458
amino acids (SEQ ID NO: 2) [15].
Antibodies with specificity for tumor antigens could
provide efficient immunomodulation and selective cyto-
toxicity for neoplastic cel ls, as i s th e case o f pa tent app lica-
tion US2012201752, which claims an isolated antibody or
functional fragment which binds an antigenic peptide se-
quence corresponding to the N-terminal transactivation
domain of human forkhead box C1 (FOXC1) [16].
Turning to diagnosis, patent applications US200923-
2818 and US2010330075 mention antibodies capable of
binding to the variable part of an antibody (CDR) or to
measure the expression level of S14 [17,18]. Meanwhile,
patent documents US2008193938 and US2008305959
refer to predicting the continuation of patient treatment
by detecting expression levels of a set of genes or one
particular gene (estrogen receptor) [9,10].
In Asia there are 43 patent application s specifically for
breast cancer. The priority applications of 30 of these
were filed in China, mostly by universities and/or re-
search centers (25), followed by individual assignees (4)
and one company. As for the 11 patent applications filed
in Japan specifically for breast cancer technologies,
which account for 25% of the patents filed in this country,
most of them are held by private Japanese companies,
but all the assignees have just one patent. Just two prior-
ity patent application s specifically for breast cancer were
filed in South Korea, one by a company and the other by
a university [49,50].
Unlike the trend seen in the USA, Japan and South
Korea, in China 75% of the patent applications are spe-
cifically for breast cancer treatments, and five are also
for technologies used in the diagnosis of breast cancer,
while another five are for technologies for preventing the
disease. There are only two patent applications which
target not just breast cancer treatment, but also its pre-
vention and diagnosis. Additionally, it is worth noting
that only one of these 30 documents was filed outside
China [19]. This means that the technologies described in
the 29 other patent documents will only be protected in
China, if their patents are granted.
Amongst the 30 priority patent documents filed in
China for technologies specifically for breast cancer,
60% are from Group 1 and make claims for new fusion
or other kinds of proteins, toxins [20-25], recombinant
peptides (e.g. biosensors [26]) and monoclonal antibod-
ies [27,28], most of them to be used in the production of
drugs to treat breast cancer. The remaining 40%, from
Group 2, contain patent applications for oligonucleotides
[29,30], RNA interference [31], fusion genes [32-33] and
vectors [34-36], many to be used in the production of vac-
cines [32,33,36] and drugs for breast cancer treatment
All 11 Japanese patent applications are for breast can-
cer treatment, and four of them [41-44] also address the
diagnosis of the disease using monoclonal antibodies,
while one is for a drug to prevent breast cancer [42]. The
breast cancer treatments that are the subject of the patent
claims are: (a) monoclonal antibodies that identify and
inhibit the proliferation of cancer cells [45-47], some
R&D Landscape for Breast Cancer through Patent Documents
Copyright © 2013 SciRes. JCT
acting in the identification of pre-cancerous stem cells
and also the inhibition of genes from these cells [42], and
compounds with estrogen ic effect, their analogs and their
antagonistic inhibitors [48].
One of the two breast cancer-specific patents with pri-
ority applications in South Korea claims protection for a
drug with RNAi which acts on cancer stem cells [49],
while the other is for a specific DNA molecule used in
the composition of a drug for breast can cer treatment and
diagnostic kits [50].
Amongst the 169 patent applications categorized as
relating to breast cancer and other cancers, the highest
proportions were for monoclonal antibodies, followed by
proteins (see Figure 4, Group 1) and oligonucleotides
(see Figure 5, Group 2). One representative example is
an US patent application for a new anti-cancer cytotoxic
monoclonal antibody, useful for reducing and treating
human breast or lung tumor burden [51]. Meanwhile, a
Chinese patent application (CN102061285) claims pro-
tection for using a nicotinamide adenine dinucleotide
(NAD) and NAD hydrogenase (NADH) based drug for
killing malignant cells, e.g. kidney cancer cells,
Figure 4. Number of patent documents for Group 1 biotech entities according to the intended application of the technology.
Figure 5. Number of patent documents for Group 2 biotech entities according to the intended application of the technology.
R&D Landscape for Breast Cancer through Patent Documents
Copyright © 2013 SciRes. JCT
in a process that involves mixing NAD and NADH
powders, and adding the obtained drug to cultured ma-
lignant cells [52].
The majority of the 128 patent documents for breast
cancer and other diseases were from Group 1, principally
proteins and antibodies, while a smaller proportion were
for oligonucleotides, nucleic acids, recombinant RNA
and microRNA (Group 2). The patent documents are
often related to immune system modulation, as they ad-
dress the treatment of chronic autoimmune diseases or
are sometimes related to homeostatic (hor monal) control.
Two examples worth citing are: US2012231006 (from
Group 1), which involves a new anti-calcium release-
activated calcium modulator 1 antigen binding protein,
useful for treating an immune disorder, a disorder related
to venous or arterial thrombus formation, and breast
cancer; and CN102307997 (from Group 2), for the mo-
dulating function and expression of sirtuin 1 polynucleo-
tide, useful to prev ent or trea t, e.g. breast cancer, diabetes,
obesity, cataract and osteoporosis, and which comprises
contacting the cells or tissues with an antisense oligonu-
cleotide [53,54].
4. Conclusions
The number of cancer cases around the world continues
to rise, especially because of increased life expectancy.
Different studies have put forward new treatment tech-
niques, but as cancer is a multifactorial disease, such
procedures are not always effective and major research
and development effort is required to discover safer and
more effective novel treatments for patients. By mining
patents in databases, this study was able to highlight
R&D trends in biotechnology for breast cancer treatment,
meaning the use of biotech tools to replace chemical en-
tities, such as gene therapy, the use of RNAi and anti-
bodies, fusion or recombinant protein- and peptide-
based drugs to target cells more specifically and effi-
It is important to stress that many of the findings from
recent R&D of drugs for breast cancer treatment can also
be applied to the treatment of other cancers, especially
lung cancer, colon cancer and prostate cancer, and also
for the treatment of other diseases including diabetes,
rheumatoid arthritis, Alzheimer’s disease, Hunting-
ton’s disease, Parkinson’s disease, multi-infarct de-
mentia, mixed Alzheimer/multi-infarct dementia and
There are clear signs from the patent landscape ana-
lyzed here that it is in the United States that the greatest
R&D effort is being put into developing biotech drugs
for breast cancer treatment. However, there is also im-
portant work being done in Asia, especially China and
Japan, where the majority of patent applications are filed
by universities and research centers.
5. Acknowledgements
The authors thank CAPES (Coordenação de Aperfeiçoa-
mento de Pessoal de Nível Superior) for access to the
Derwent database, available at th e CAPES Journal Portal
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