BiotechnologyReport 2005
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 2
Stem cells . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 3
The market
The legal position
The investment
The patent landscape
The first filings
The key players
Conclusions
Bionanotechnology. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 7
The market
The patent landscape
The first filings
The key players
Conclusions
Cancer therapeutics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 11
The market
The patent landscape
The key players
Other factors
Conclusions
The future . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 15
Marks & Clerk contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 16
CONTENTS
Over the years the innovation and hard work of researchers in the pharmaceutical and biotechnology
sectors have helped to tackle disease and create healthier, longer lives. In the 20th century, the
discovery of penicillin and other antibiotics provided a classic example of a groundbreaking advance
that improved life expectancy and quality for millions worldwide. In the 21st century, research in fast-
advancing areas of biotech research such as stem cell technology, bionanotech and cancer therapeutics
could help to eliminate or relieve diseases and illnesses that blight many people today.
However, research must reach beyond the laboratory in order to be transformed into life changing medicines, a hugely costly
process. This won’t happen without investment; investment from Government, and from private foundations, such as the one I
have set up in the UK, as well as the ability to access venture and market capital.
Pioneering companies rely heavily upon the security of the patent system in order to protect their huge R&D investment and make
drug development commercially viable. Patents, therefore, can be a determinant of investment levels. This report examines
worldwide patent activity in these three exciting areas – stem cell research, bionanotech and cancer therapeutics – providing
enlightening statistics and predictions that I’m sure will be of use to Government, patent authorities, NGOs and industry alike.
The first conclusion that can be drawn is that the growth in patent filings since the turn of the century in all three areas indicates
increasing commercial confidence. Yet 2004 saw a decrease in activity. It remains to be seen whether this represents a natural
plateau or if there are serious investment gaps, particularly outside the US. It will come as a surprise to no one that the US leads
in patent activity in all three areas. For a non-American, these statistics promote feelings of both admiration and concern. These
gaps need to be closed; particularly as this report highlights China’s entry into the cancer therapeutic market, indicating that
Europe will soon encounter more than just one competitive threat. Regulation alone can’t be blamed. Nonetheless it is clear that
European patent offices are struggling with a lack of clarity of the regulations governing the scope of patent claims in the newer
or more controversial areas.
One of the most interesting conclusions of the report is that in stem cell technology, research is continuing apace, despite some
of the ethical concerns and subsequent legal and regulatory restraints in some localities. It seems clear that in the face of such
barriers investment is still coming through. Companies perhaps realise that once people see what a contribution stem cell research
has to offer the world of drug discovery, the concerns will diminish and the resulting commercial gains will be huge.
Another issue that comes out of the report is the rapid growth in the bionanotech sector. There are real prospects of drug
companies delivering more effective treatments through use of breakthroughs in this area largely made by young, dynamic
bionanotech companies.
For these advances to become a reality, the biotech industry will need all the support it can get, both financial and regulatory.
Professor Sir Christopher EvansChairman of Merlin Biosciences
FOREWORD
page 1
Patent filing trends and analysis in biotechnologyIn the past twenty years there has been an explosion in patent applications in the field of biotechnology. As the technology has
matured, and the Patent Office Examiners have come to grips with it, so the nature of the applications has changed. Where
patents for DNA sequences used to be granted almost without question, now the case for a sound utility must be established.
But with the race to sequence the human genome now passed into the annals of history, biotechnology has moved on, and
applicants are now focussing on more specialist areas. Stem cells and nanotechnology are the emerging areas of interest although
the old favourite, cancer therapies, continues to be as topical as ever.
This report looks at global patent activity in these areas of interest, asking how many applications are being filed, by whom,
and where?
MethodologyThree biotechnology fields were selected by Marks & Clerk for analysis – stem cells, bionanotechnology, and cancer therapeutics
– and patent databases searched for relevant publications and granted patents from 1 January 2000. The definitions of these
fields, particularly bionanotechnology, are clearly somewhat fluid, and a combination of keyword searching and international
patent classification was initially used, followed by manual review of selected results to ensure the results were accurate. The
search for stem cells was intended to identify technologies relating to stem cells – for example, culture methods and derived
therapies – as well as stem cells per se and differentiated cells derived from stem cells. Cancer therapeutics covered conventional
therapeutic compounds and genomic-based therapies, as well as diagnostic tools. Bionanotechnology was identified using
keyword searching directed to nanotechnology combined with keywords and classifications covering therapeutics, life sciences,
diagnostics, and biological compounds and materials.
This report was compiled using, in part, patent searching performed on our behalf by CPA Analytics.
page 2
INTRODUCTION
The marketThe world market value for stem cell derived therapies in
2001 was $2.7 billion (source: ITI Life Sciences), and this is
expected to grow significantly over the next few years.
Potential uses of stem cell technology include, for example,
therapeutic cloning for replacing damaged tissues, and cell
replacement, to treat degenerative and other disorders. Stem
cells also show promise in the drug development cycle for
target identification, and for screening of candidate drugs
against differentiated cell lines.
The legal positionThere is a distinction between adult stem cells, which
typically are only capable of differentiation into a restricted
number of cell types and embryonic stem cells, which are
capable of differentiation into essentially any cell type of the
body. The controversy arises over the provenance of
embryonic stem cells, as it is necessary to derive these from
an early-stage embryo.
Thus, while it is generally possible to obtain patent
protection for stem cell related inventions, some jurisdictions
place restrictions on the patentability of embryonic stem
cells as such, or treatments using such cells. For example, in
Europe, a recent decision has held that embryonic stem cells
as such are unpatentable, although an appeal against this
decision is currently pending, thereby only serving to foster
uncertainty in the industry. It is worthy of note that, despite
the stance of the EPO, the UK Patent Office has ruled that it
will grant patents to pluripotent (but not totipotent) cells
derived from embryos. However, it remains to be seen
whether this will be endorsed by the courts in the UK, which
are increasingly following the EPO line in recent decisions.
The investmentLevels and areas of funding for research differ substantially
between countries. In the US, federal funding is currently
only available for research on embryonic stem cell lines
created before August 2001, although there are no such
restrictions on other stem cell lines. In practice, few of these
existing embryonic stem cell lines are likely to be of use in
the clinic. State funding and attitudes to research also differ:
with California and New Jersey encouraging stem cell
research, while Michigan and North Dakota have banned
research on cloned embryos. As a result, the main source of
research funding in the US is private funds. Attempts are
currently being made to loosen restrictions on the federal
funding of stem cell research in a bill which appears to have
a good chance of being approved. However, President Bush
has pledged to veto it, which can only be overridden if there
is a two-thirds majority in both Houses. In short, the situation
remains very uncertain.
Many therapies currently being investigated are based on the
use of adult stem cells, such as hematopoietic or
mesenchymal stem cells, and are not therefore subject to the
same controversies as embryonic stem cell therapies.
However, it is possible that the controversy surrounding
embryonic stem cells may have a detrimental effect on other
stem cell research, for example purely by reducing the overall
amount of research carried out in a particular country.
In Europe the research field is regulated at a national, rather
than European, level. Germany, France, and Ireland have
banned interventions with human embryos which are not for
the embryo’s benefit while the creation of human embryos
for research is permitted in the UK. Indeed, in May 2005 a UK
team reported the creation of the country’s first cloned
human embryo.
In Asia, there are large investments in stem cell research by
the governments of China, South Korea, and Singapore. A
recent UK government report (Stem Cell Mission to China,
Singapore and South Korea, from http://www.oti.globalwatch
online.com/online_pdfs/36206MR.pdf) praised the quality of
research being carried out in these countries, and recognised
a drive towards clinical uses, particularly in China.
Extraordinary advances have been made in South Korea, with
the team led by Hwang Woo-Suk announcing in May 2005
the first cloning of patient-specific stem cells, opening the
prospect of therapeutic cloning sooner than many analysts
had predicted.
STEM CELLS
page 3
The patent landscapeSo is this difference in attitudes and funding reflected in the
patenting landscape? Worldwide, over 3000 applications
have been published in the field of stem cell technology since
2000, more than 50% of which have been filed in the US.
There has been a steady increase in the number of
applications published since 2000, as shown in Figure 1.
However, by far the majority of patents have been granted in
the US (more than 1300, compared with 64 in Europe). While
one has to take into account a slightly less liberal patenting
regime in Europe, the discrepancy is probably more a
reflection of the delays currently present in the EPO system,
which will remain until the uncertainty over patentability is
resolved.
As shown in Figure 1, the number of published applications
worldwide saw a significant decrease in 2004 compared to
previous years. Closer analysis shows that the decrease in
filings is almost entirely due to a 50% reduction in the
numbers of international applications published (359 in 2003
versus 171 in 2004). Numbers of US published applications
(279 versus 243) and US granted patents (277 versus 265)
remained generally constant, while there was a significant
increase in the number of EP published filings, up from 68 in
2003 to 130 in 2004. Note that, in considering this and
other figures, US patent applications were not routinely
published until 2001, while ‘international applications’ refers
to published applications outside the US and the EPO,
including PCT publications.
The first filingsThe main country in which priority applications are filed, even
for non-US applicants is overwhelmingly the United States,
reflecting the importance of the US market and the
significance of the US as a source of innovation (3188
priority filings in the period under consideration, and 1250
granted patents). As shown in Figure 2, the next largest
amount of filings is made in Japan, although the number of
first filings is some 85% lower than in the US. Within Europe
the highest number of first filings is made in the UK, which is
Fig. 1 Patenting activity : Published applications and granted patents.
Source: Computer Patent Annuities Limited Partnership/Marks & Clerk ©2005.
page 4
likely to be the result of a combination of the amount of
research performed there, the permissive legislation on stem
cell research and the generous patenting regime of the UK
Patent Office. The number of first filings is almost as great
in Germany as in the UK, indicating that the restrictive laws
governing research into and patenting of stem cells in that
country have not prevented advances being made in their
laboratories.
Of the total number of patent families filed worldwide in this
period, around one quarter relate to embryonic stem cell
technology. The split between embryonic and other stem cell
technology varies by country, from 15% embryonic stem cell
related filings in the US, to nearly 40% in the UK, reflecting
the more liberal research regime in the UK.
The key playersThe key applicants for stem cell related patents are shown in
Figure 3. Not surprisingly, US companies or multinationals
dominate. The University of California has filed 40 stem cell
patent families since 2000, primarily specialising in cancer
treatments. The pre-eminence of the University may reflect
the encouragement given by the Californian state
government to stem cell research. The US Government is
represented by the Department of Health and Human
Services, while the Japanese Science and Technology Corp is
another government agency. Other top players include:
Bayer AG; the Danish company Novo Nordisk, which
specialises in treatment of diabetes; and the US based
companies Johnson & Johnson, Osiris Therapeutics, and
Pfizer. Within the top five, Osiris is the only company
specialising solely in stem cells.
The technologies being patented reflect the whole range of
research. There is no restriction to either adult or embryonic
stem cells in the filings, while other applications cover cell
selection and cultivation (particularly those of Olympus
Optical Co); uses of stem cells; and differentiated stem cells.
Most applications relate to stem cells per se, and their
cultivation.
ConclusionsThere seems to be little evidence that the controversial
nature of the topic, in particular the hostile research
environment in some jurisdictions, is acting as a deterrent to
research and investment (as shown by the number of patent
applications filed) in this field. Restrictions on research into
embryonic stem cells do not appear to have affected
Fig.2 Geographical distribution of patents and first filings (US figures not shown)
Source: Computer Patent Annuities Limited Partnership/Marks & Clerk ©2005.
page 5
investment into other stem cell therapies. Even in Europe,
where some countries have banned all human cloning
research, the number of patent applications published has
almost doubled from 2003 to 2004, while the US remains the
dominant player despite controversy regarding funding of
research. This emphasises the huge potential of stem cell
research, and it is clear that investment will continue, despite
the legal and regulatory uncertainties surrounding the topic.
Indeed, despite the complex and uncertain regulatory and
legal situations, with controversy in the US over federal
funding of research opening up the prospect of a head-on
confrontation between the President and Congress,
companies clearly recognise the huge potential of the market
in the US and in Europe and wish to protect their position.
This reinforces the message that patenting is a long-term
investment, and that companies are willing to file in the
expectation that the uncertainty will be resolved in the
future, or that legislation will become more liberal as the
technology matures and becomes accepted. This optimism
pervades the sector, and companies still seek to protect their
position in markets where the position on research and
exploitation is still far from clear.
Thus, the industry is still exceedingly positive on stem cells,
with increasingly large amounts of money being invested in
research and development. The downturn in international
patent applications does not reflect the position vis-à-vis the
EPO and USPTO, and it is likely that this downturn reflected
the brief period where the EPO declined to examine
international applications in the field of biotechnology. We
would conclude, therefore, that applications will proceed at
least at the rate seen in 2002/2004, but probably
approaching or even exceeding that seen in 2003.
We predict that the recent filing trends combined with the
maturation of the technology and acceleration of advances
made will lead to an increase in the number of patent
applications relating to therapeutic uses of stem cells rather
than to cell lines per se. The advances recently made in
South Korea show the amazing potential in this field.
However, the hostile reaction to the announcement of these
advances in some sections of the media is a reflection of the
continued ethical minefield within which this research is
conducted.
page 6
Fig.3 Key applicants
Source: Computer Patent Annuities Limited Partnership/Marks & Clerk ©2005.
Fig.4 Patenting activity
Source: Computer Patent Annuities Limited Partnership/Marks & Clerk ©2005.
“Just as in biotechnology, intellectual property will be a
critical battleground in bionanotechnology. We have already
witnessed growth in key materials science patents and a
subsequent rise in corporate licensing. It is vital for
entrepreneurs, researchers, and corporate executives to
understand this very dynamic landscape. This report
demonstrates a clear understanding of the present IP climate
and offers insight into future trends.”
Michael Sinkula, co-founder Molecular ID Systems, and co-author LUX
Nanotechnology Report 2003
The marketDespite the existence of a fervent "anti" lobby,
nanotechnology has attracted the attention of stock markets,
governments and venture capitalists, in equal measure, as
well as, of course, interested companies and institutions. The
global market for this discipline is currently estimated as
US$1-2 trillion.
Government investment has been promised to organisations
developing the technology on both sides of the Atlantic: the
EU has set aside approximately €1.4 billion under its "sixth
framework" programme, while the US House of
Representatives recently endorsed the Nano Research and
Development Act, authorising a budget of US$3.7 billion for
the initiative. Similar sums are also being spent in the Far
East. Is this significant amount of finance being translated
into innovative ideas and patenting activity?
The patent landscapeThe Lux Research Nano-technology Report 2004 found that
88,546 nanotechnology patents were granted by the US
Patent and Trademark Office during the period 1976 to 2002
inclusive. The Report also presents data suggesting a near
exponential growth in patent and scientific paper publication
growth from 1980 through to 2004. Of course, the Lux
Report relates to all areas of nanotechnology, and is not
concerned solely with the bionanotechnology field. Our
analysis narrows this investigation further, in order to
BIONANOTECHNOLOGY
page 7
Fig.5 Geographical distribution of patents and first filings (without US)
Source: Computer Patent Annuities Limited Partnership/Marks & Clerk ©2005.
establish what proportion of nanotechnology patent filings
relate to bionanotechnology, as previously defined, and
whether there has been an increasing trend in filings and
grant of patents. The results are shown in Figure 4.
Compared to the figures for nanotechnology patents in the
Lux Report, bionanotechnology filings only form a small
proportion of total nanotech patent applications. There is
perhaps no a real surprise here, given that
bionanotechnology is an area which is still in the early stages
of development. Although the US, as expected, is in the lead
position (accounting for around 40% of all filings) in terms of
published and granted applications, the gap between Europe
and the US is nothing like as large as in the areas of stem cell
technology and cancer therapeutics, and is fast closing.
However, the trend established with regard to stem cell
filings also pertains in the field of bionanotechnology, and
while the total numbers steadily increased over the years
2000 – 2003, the number of filings actually decreased in
2004. The biggest decrease, once again, was in international
applications published/granted and, also in line with the stem
cell position, the US position was substantially unchanged,
while there was an increase in EP grants/patent publications.
The first filingsAny form of analysis readily shows that the US has the
greatest number of applications and grants in the field of
bionanotechnology (1723 applications; 405 granted patents
in the period under consideration). Nevertheless, a
significant number of priority applications is filed elsewhere,
including Germany, the UK, France, China, and Japan, as
shown in Figure 5.
In a turnaround on the stem cell position, Germany exceeds
both the UK and Japan. In fact, Japan trails in behind both
France and Canada, perhaps reflecting greater investment in
bionanotechnology in the West, as well as there currently
being little or no significant regulatory issues concerning
page 8
nanotechnology innovation (although it should be noted that
the EU has recently announced that it will be looking at
safety issues concerning nanoparticles used in vivo).
The key playersThe key players, as shown in Figure 6, come from a diverse
background, ranging from universities, to biotech companies,
to large pharmaceutical companies. However, perhaps not
surprisingly, it is generally the universities and small /
medium-sized enterprises that appear to be seeking to obtain
broad-based platform technology patents, whereas the big
pharmaceutical companies often file much narrower specific
formulation-type applications. One explanation is that the
large pharmaceutical companies are forming wholly/partly
owned subsidiaries to carry out research and development
into general drug delivery, or outsourcing/collaborating with
specialist smaller companies, rather than conducting the
work in-house.
As can be seen, Elan is top of the list of patent filers. Elan
was in fact one of the earliest players in the
bionanotechnology field and through its patent filings, the
Irish company is looking to strengthen its hold in the drug
delivery field using their nanocrystal technology. Indeed,
Elan has successfully licensed their technology to a number
of other pharmaceutical companies and Wyeth's
immunosuppressant Rapamune was granted FDA approval in
the US in 2000. SkyePharma, the second largest filer, is also
concerned with developing new technologies for improving
oral, injectable, inhalable and topical drug delivery.
ConclusionsFrom the patent publications investigated, several general
trends are developing in the drug field, with nanotechnology
techniques being at the forefront of inventions pertaining to
drug delivery, particularly using nanoparticles, dendrimers,
nanoemulsions, and the like, and also in increasing/improving
drug solubility/bioavailability.
Fig.6 Key applicants
Source: Computer Patent Annuities Limited Partnership/Marks & Clerk ©2005.
page 9
It appears that the use of nanotechnology in relation to
biologicals is in a rapid growth phase, with applications,
particularly in the drug delivery/formulation area, set to
continue on this steep upward curve. There is already an
indication that drug companies are going through their back
catalogues to take another look at compounds which in the
past failed for one reason or another, to see if they can be
made more efficacious using nanotechnological techniques.
Michael Sinkula of Molecular ID Systems suggests that
“Bionanotechnology will most likely evolve in a manner
similar to biotechnology where Big Pharma will essentially
use small companies to fuel their R&D. As a result, you
currently see young bionanotechnology companies going
after very disruptive and broad technologies.”
Whilst it is difficult to be certain why there should be such a
drop in published patent applications at the international
stage in 2004, it is possible that this may have been a
reflection of the difficult financial times the biotech sector
was facing in 2003 (international patent applications filed in
the latter half of 2003 being published in 2004, if the
international application was not a first filing). However,
there is also another explanation. The dip correlates to a
short period when the EPO refused to examine biotech PCT
applications – reaction to an influx of US based PCT
applications. If this is factored in to the graphs, then it is clear
that numbers are actually increasing, and we expect this to
be borne out over the next couple of years.
page 10
The marketAccording to the latest statistics from Cancer Research UK,
each year nearly 11 million people worldwide are diagnosed
with cancer and there are nearly 7 million deaths from the
disease. It is estimated that there are around 25 million
people alive who received a diagnosis of cancer in the last
five years. Worldwide, breast and lung cancer cases have
doubled since 1975, a reflection of the worldwide growth in
population as well as increased life expectancy. The
proportion of the world’s population aged 60 or over
currently stands at 10%, but is expected to more than
double by 2050.
Most forms of cancer are linked to age. As the world’s
population gets older, the number of people diagnosed with
cancer can be expected to rise. Although some types of
cancer are showing a decline in developed countries, most
notably stomach cancer and cervical cancer, this is not
universal. Moreover, the evidence from the developed world
is that lung cancer rates mirror smoking rates. Hence, while
there are beginning to be notable falls in the number of
people being diagnosed with lung cancer in some developed
countries, in other parts of the world, where smoking remains
prevalent, it is expected that there will be big increases in the
number of people diagnosed with lung cancer over the next
twenty years.
Such figures explain why cancer therapeutics have, over the
last 5 years, been a very active area of research, attracting
much funding, with it being anticipated that this situation
will continue for the foreseeable future.
Fig.7 Patenting activity
Source: Computer Patent Annuities Limited Partnership/Marks & Clerk ©2005.
CANCER THERAPEUTICS
page 11
The patent landscapeSome feared that the patenting of isolated human DNA
would stifle research in such areas as cancer therapeutics,
but such fears appear, increasingly, to be unfounded. As
shown in the various Figures, the demand for cancer
therapies is driving research in many companies and
institutions, with the the US leading the field in
patent activity.
It can be seen that Figure 7 tells a similar story to both that
for stem cell applications and for nanotechnology. Once
again, publications peaked in 2003, and fell back nearly to
2002 levels in 2004. Again, as with stem cells and
bionanotechnology, the main contributing cause was a
reduced amount of international (that is, outside the US and
EPO) publications.
Priority applications are, again, overwhelmingly filed in the
United States (5305 priority filings in the period under
consideration, with 3818 granted patents). Filings in other
countries are shown in Figure 8, which shows that a
significant number of priority applications are made in China
(462) and Japan (188), although within Europe priority filings
are split nearly evenly between the United Kingdom (282
filings) and EPC filings (235). Other national European
priority filings are less significant. Interestingly, relatively
few patents appear to have been granted outside the United
States other than EPC filings (82 granted patents); this is also
illustrated in Figure 7.
page 12
Fig.8: Geographical distribution of patents and first filings (without US)
Source: Computer Patent Annuities Limited Partnership/Marks & Clerk ©2005.
The key playersBayer Healthcare is just one of many pharmaceutical
companies which has been pumping a major part of its
research budget into developing cancer therapeutics, as
mirrored by a surge of patenting activity becoming apparent
in 2004 (93 published patent families relating to cancer
therapeutics). As a result Bayer Healthcare is the leading
patenting company in the Western World. In 2004, €1,044
million, or 50% of Bayer Group’s research and development
budget, was spent by Bayer Healthcare (source: Bayer Group
Annual Report). This level of funding has enabled Bayer to
forge forward with research and consequent patenting
activity on a number of fronts. Bayer is in the top three
applicants for published patent families over the last five
years in relation to all of cancer therapeutics,
nanotechnology and stem cell research. Furthermore, the
high spend of Bayer Healthcare in relation to cancer
therapeutics has brought results in terms of products
showing clinical promise, notably, for example, the Raf kinase
inhibitor, BAY 43-9006, which has been in Phase III clinical
trial for advanced kidney tumours and is also undergoing trial
for other tumour types.
However, with the explosion of genetic information from the
human genome project, other players became, for a time,
prominent in the area of patenting cancer therapeutics. As
can be seen from Figure 9, leading the explosion of patent
publications on postulated or proven cancer related genes
was, surprisingly, a Chinese company, Shanghai Biowindow
Gene Development Inc. Within a short time of coming into
being, this company filed patent applications on over 2700
human genes and, by 2003, had 204 published patent
families relating to cancer. In 2002, it was third in WIPO’s
table of PCT Applicants from developing countries, with 136
International patent application filings (only 48 behind CSIR
India and Samsung Electronics). While Shanghai Biowindow
used its DNA information to build DNA microarray chips,
including the Bio Door™ liver and lung cancer microarray
Fig.9: Key applicants
Source: Computer Patent Annuities Limited Partnership/Marks & Clerk ©2005.
page 13
chips, the focus of research and patenting activity in relation
to cancer therapeutics has now returned to identifying
means of interfering with cellular processes thought to
contribute to cancer development, and improvement of
targeting of drugs to tumours.
Unsurprisingly, Bayer is not the only major pharmaceutical
company in the top ten filers, as determined by the number
of published patent applications concerning cancer
therapeutics between 2000 and 2005. Others in the list
include: Pfizer (fourth); Johnson and Johnson; Roche; Sanofi-
Aventis; GSK and Novo Nordisk. These companies are joined
in the same list by the University of California (fifth), the
University of Texas and the US Department of Health and
Human Services.
Advances in genomics have affirmed that cancer is not a
single disease. As the new science of genomics has built
catalogues of the molecular errors that result in cells turning
cancerous, so researchers have increasingly turned away
from seeing cancers as diseases of particular organs and,
instead, are tending to classify cancers in terms of the
underlying genetic defects. The very diversity of such
defects means that there is room for many, both big and
small, to contribute to research, and consequent patenting
activity, in the field of cancer therapeutics, so that a slow
down in filings is not expected any time soon.
Other factorsThe parallel growth in patenting activity in relation to genetic
testing has not met with universal praise. Notably, in Europe,
controversy continues to surround the patents relating to
genetic diagnosis of breast cancer susceptibility arising
through defects in the BRCA 1 gene. These patents remain
under opposition at the EPO by a number of parties, with the
leading patent, EP-B 0699754, now being before an EPO
Appeal Board. However, much of the controversy surrounding
these patents in Europe is clearly related to factors other
than patenting as such and, indeed, it seems likely that the
oppositions to the BRCA 1 gene patents will be decided on a
technicality concerning claiming priority, rather than on any
point of opposition under the general heading of being
contrary to morality or “ordre public”. Such controversy does
not appear to have spilled over into the field of cancer
therapeutics, except in relation to the much publicised
Oncomouse patents. The saga in relation to the European
Oncomouse patent has now ended with restriction of the
claims to genetically-engineered mice for which there is clear
evidence of their use as test animals capable of bringing
likely substantial medical benefit to the cancer field.
It has been stated by Edward Benz, President of the Dana-
Farber Cancer Institute, “My guess is that we’re going to end-
up with a few hundred genes accounting for 90% of what
goes wrong in cancer” (‘New Scientist’ 9th April 2005).
However, the dividends arising from tackling the underlying
genetic defects may well depend on more than a few key
patents with a few large companies given that finding of a
genetic defect is only the start of a long research road to
effective therapeutic treatment.
ConclusionsClearly, then, cancer researchers still have many avenues to
explore, and the predominance of cancer related applications
in the field of biotechnology is likely to continue for some
time to come. Although there was an apparent downturn in
publications during 2004, it is entirely likely that this is for
similar reasons to those affecting stem cells and
bionanotechnology and that, at the worst, the number of
filings has plateaued out. Indeed, any reduction in filings is
exceedingly unlikely, given the substantial revenue streams
involved.
The clear trend towards increased filings relating to
interference with cellular processes that are involved in
cancer development and improved targeting of drugs to
tumours is, we believe, sure to continue over the next few
years. We also confidently predict that the huge sums of
money invested in this field and the potential revenues that
could result will lead to a substantial increase in the numbers
of patents involved in opposition and revocation proceedings.
The stakes are high and this is sure to lead to some fierce
battles in coming years.
page 14
As the different technologies mature, so their part in an integrated whole becomes more apparent, and there are increasing
numbers of crossover applications being filed. The drivers for research and patenting in relation to cancer therapeutics are
spilling over into other technology areas, notably nanotechnology. In September 2004, the US National Cancer Institute
announced a five year, $144 million programme to develop nanotechnology applications for the detection and treatment
of cancer. A few nanotech products are already in cancer clinics as drug- delivery vehicles. In addition, there is now cross
over with the field of stem cell research, with the finding that, for at least a few tumour types, only a tiny fraction of cells
within the tumour (tumour stem cells) forms the foundation for tumour growth.
The temporary downturn in overall numbers of patent applications in 2004 seems at least partly attributable to the
temporary refusal of the EPO to examine foreign-originating biotechnological PCT applications. Large numbers of PCT
applications are filed by US companies designating the EPO as the International Preliminary Examination Authority, in order
to obtain a non-US search, in addition to the search that the USPTO provides for the corresponding domestic patent
application. If the EPO refuses to act as the IPEA, then the benefit to US applicants is substantially reduced, and the fall
in published PCT applications bears out this situation.
Thus, despite the figures for 2004, we predict that numbers of applications will continue, and likely increase, at levels
similar to that of 2003 and that, with the EPO having restored its position as IPEA, international applications are also likely
to pick up again.
As already noted, there can be little doubt that in the cancer therapeutics field the high stakes will lead to the validity of
many patents being challenged, with some major clashes between significant players leading to a possible shake up in the
field. Substantial drops in share prices have already been seen in some biotech companies as a result of adverse decisions
on key patents. In a couple of years this is sure to be repeated in the stem cell and bionanotechnology sectors. There could
also be some difficulties in commercialising technologies as a result of dominant patents on core technologies, particularly
in the stem cell and bionanotechnology sectors.
Substantial returns will be made by some investors in these sectors, and certainly the signs are that more money is being
invested after the downturn earlier in the decade. However, some investors may continue to be deterred by the fact that
the value of many firms is tied to just one or two key patents, the legal backdrop against which the strength of those
patents must be assessed is relatively undeveloped, and there is continued legislative and ethical uncertainty. They may
prefer to sit and wait until these issues have been clarified. Could this hold back the development of many exciting
technologies that offer real hope of treating some of the world’s most intractable diseases?
THE FUTURE
page 15
If you have any questions about this report or would like more information, contact one of the authors from our
Bioscience Group:
Stem CellsDr. Gareth Williams
UK & European Patent Attorney
66-68 Hills Road,
Cambridge, CB2 1LA, UK
T: +44 (0)1223 345520
BionanotechnologyDr. Paul Chapman
UK & European Patent Attorney
19 Royal Exchange Square,
Glasgow, G1 3AE, UK
T: +44 (0)141 221 5767
Cancer TherapeuticsDr. Claire Irvine
UK & European Patent Attorney
4220 Nash Court, Oxford Business Park South,
Oxford, OX4 2RU, UK
T: +44 (0)1865 397900
About Marks & ClerkMarks & Clerk is recognised internationally as one of the leading firms of patent and trade mark attorneys. Our highly
qualified attorneys advise clients in all sectors on acquiring, securing and registering IP rights and managing IP portfolios.
We have notable experience and expertise in both traditional and cutting edge technologies including biotechnology,
chemical, pharmaceutical, nanotechnology, medical devices, IT/software, electronics, mechanical and engineering.
With a network of 12 UK offices, offices in Europe, North America and the Far East and long-established relationships with
other leading IP firms worldwide, we are able to meet clients’ IP requirements on a local and global basis.
www.marks-clerk.com
MARKS & CLERK CONTACTS
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