Biotechnologys/… · Three biotechnology fields were selected by Marks & Clerk for analysis –...

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 first filings

The key players

Conclusions

Cancer therapeutics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . page 11

The market


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)


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


Fig.4 Patenting activity


“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)


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


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


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)


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


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

E: [email protected]

BionanotechnologyDr. Paul Chapman


19 Royal Exchange Square,

Glasgow, G1 3AE, UK

T: +44 (0)141 221 5767


Cancer TherapeuticsDr. Claire Irvine


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

page 16

Biotechnologys/… · Three biotechnology fields were selected by Marks & Clerk for analysis –...

Documents

Transcript of Biotechnologys/… · Three biotechnology fields were selected by Marks & Clerk for analysis –...