Select Committee on Science and Technology Minutes of Evidence

Memorandum by the Patent Office

EXECUTIVE SUMMARY

  The Patent Office is responsible for the administration of intellectual property rights. In addition, as part of the DTI Science and Innovation Group we are committed to playing an important role in supporting innovation in the UK. We are pleased therefore to support the House of Lord's Select Committee on Science and Technology enquiry into allergic disease in the UK. Patenting is a key marker of innovative activity. In the following report we have endeavoured to provide information in the context of six of the questions outlined in the Call for Evidence: [1]

—  What is allergy?

—  What is the difference between allergy and intolerance?

—  What is and what is not known about the origins and progression of allergic disease?

—  Treatment and management?

—  What is the evidence-base for pharmacological and non-pharmacological management strategies?

—  Is the level of UK research into allergy and allergic disease adequate?

—  What are the most promising areas of research into preventing or treating allergy?

  A detailed analysis of patent information in a database containing patent records from all major industrialised countries was conducted. The report shows:

—  Chronological filing trends by country.

—  Trends in particular technologies, for example organic compounds, biotechnology and foodstuffs—globally, chronologically and by country.

—  The top 10 companies world-wide and top 10 UK organisations ranked by their patent activity.

—  An analysis of the top 50 inventors filing at the UK Patent Office, their associated organisation and the relationships between those organisations.

  A significant body of world-wide patent filings on allergy derives from UK based pharmaceutical companies. The majority of this UK patent activity is on classical heterocyclic chemical pharmaceuticals. Whilst a number of UK organisations show innovative activity in the biotechnological aspects of the treatment of allergy, this area is less extensive than classical organic chemistry.

1.  INTRODUCTION

  Reference to "patents" relates to both patent applications and granted patents unless otherwise indicated.

  For this study the European Patent Office (EPO) database EPODOC was used which encompasses published patent documents derived from the majority of leading industrialised countries and patent organisations, for example the World Intellectual Property Organisation, EPO and the African Regional Industry Property Organisation (ARIPO). This report includes data in the period from 1996 up to and including 2005. However, it is pointed out that the apparent down-turn in 2005 may be due to the incompleteness of the database. Since patents are usually published eighteen months after filing, the data reflects the time when the information became available rather than when the research was carried out.

  The Patent Office is currently trialling patent information analysis software, supplied by Thomson ScientificTM. The two pieces of software used to generate the data presented in this report are Thomson Data Analyser (TDA) and AurekaTM.

2.  WHAT IS ALLERGY?

Question 1

  Our study was based on a broad definition of allergy as "an inappropriate or exaggerated immunological response of the body to a substance". The International Patent Classification system (IPC) now provides six "marks" specifically catering for allergy: allergens and pollen allergens, anti-allergic agents, antiasthmatics, antipsoriatics and ophthalmic antiallergics.

2.1  What is the difference between allergy and intolerance?

  We considered intolerance to relate to "a defect in the processing of substances within the body, particularly gastro-intestinally" which is distinguished from allergy because it does not necessarily require the significant involvement of the immune system. Food intolerances are often caused by enzymatic deficiencies. Patents relating to food intolerance enzymes and medicines that promote digestion also have specific marks in both international and domestic classification systems.

  Immunological intolerance is the physiological status quo relating to foreign material and characterised by a normal immune response. In this respect allergy is distinguished from immunological intolerance by the magnitude and often acute level of response. Both domestic and international classification systems provide marks for the identification of immunosuppressants and immunostimulants.

3.  WHAT IS AND WHAT IS NOT KNOWN ABOUT THE ORIGINS AND PROGRESSIONS OF ALLERGIC DISEASE?

Question 2

  There is a wealth of patent information on allergy. Nearly thirty thousand patents were identified. Over one third of these have been published in the last five years (Figure 1). In common with journal articles, individual patents are likely to outline and discuss contemporary theories surrounding a disease. The relative increase in patent filings in allergy this century reflects an overall trend in the patent activity in the area of biotechnology, pharmaceuticals and organic chemistry in general. This expansion of patent activity may to some extent reflect the increase in knowledge about underlying disease mechanisms as well as corporate intellectual property strategies.

Figure 1

Figure 1: Chronological trends in patent records relating to allergy

Figure 2

Figure 2: Chronological trends in patent records in biotechnology, pharmaceuticals and organic chemistry

4.  TREATMENT AND MANAGEMENT

Question 6

  There is a lag time between patent filings and time taken to get to market for therapeutic products. Nonetheless, a range of therapeutic strategies can be identified in a variety of patent classification areas: organic compounds, particularly nitrogen-containing heterocyclic compounds, recombinant genetic technology and antibody engineering (Figure 3).

  Clearly the most prominent area of patent activity is in nitrogen-containing heterocyclic organic molecules. Within the biotechnology area, particularly notable is that the European Patent Office classification scheme provides a specific term for antibodies against IgE indicating a significant level of patent activity in the area of limiting the allergic response by engineering antibodies (anti-idiotypic antibodies) against IgE. The other biotechnological area showing significant activity is in T-cell receptor-based inventions and the engineering of proteins making up that receptor or associated with it.

  Strategies for diagnosis appear in genetic-based testing and immunoassays and these can also provide information about disease mechanisms. About 6 per cent of patents on allergy are concerned with genetic diagnostics and a similar number with immunoassays.

Figure 3: Distribution of patent documents by technology term

5.  EVIDENCE-BASE FOR PHARMACOLOGICAL AND NON-PHARMACOLOGICAL MANAGEMENT STRATEGIES

  Clearly the abundance of patent information relates to pharmaceuticals and the majority of these are organic compounds. About 4 per cent of allergy-associated patents are found in the area of food modification. Direct genetic engineering based therapies comprise a small number, less than 30, of the overall therapeutic patents; notably half of these have published in the last five years.

6.  IS THE LEVEL OF UK RESEARCH INTO ALLERGY AND ALLERGIC DISEASE ADEQUATE?

  UK-based companies GlaxoSmithKlineTM and PfizerTM rank first and third, respectively, in terms of the number of patents on allergy worldwide in the last 10 years (See Figure 4).

Figure 4: World-wide patent activities in allergy by organisation

6.1  Global patent activity in allergy

  Looking at the country distribution of the gross number of patent records in the last five years it is apparent that the UK ranks third behind America and Japan[2] (see Figure 5).

  A comparison of the number of patent filings over the last five years measured against Gross Domestic Product in 2005 shows that the UK falls lower than Japan and the USA but is ahead of Germany (Table 1). Other European countries were not considered here because it is likely that organisations in these countries do not predominantly file directly in the country of origin but instead make first filings at the European Patent Office.

Table 1

PATENT FILINGS/GDP 2005

Country	Patent Filings/GDP 2005 (104 million USD) [3]
Japan	5.05
USA	4.32
United Kingdom	3.5
China	3.25
Germany	2.48

Figure 5: Patent activity on allergy by country. US: America, JP: Japan, CN: China, DE: Germany, EP: European filings via the European Patent Office,RU: Russia, FR: France; DK: Denmark and SE: Sweden

6.2  Technology activity across the globe

  A more detailed analysis of national activity by technology area is given in Figure 6. This plot indicates that the relative level of patent activity in the main technology areas for the UK is similar to US and Japan.

Figure 6: Percentage of Technologies by 100% Figure 6: Technology activity by country. WO indicates global filings via the World Intellectual Property Organisation, US: America, JP: Japan, CN: China, DE: Germany, EP: European filings via the European Patent Office, RU: Russia, FR: France and DK: Denmark.
Percentage of Technologies by Country

6.3  UK patent activity on allergy

  An assessment of activity within the UK was conducted. The top 50 companies and top 50 inventors appearing on GB patent specifications were analysed (Annexes 1 to 3) (most of the inventors are based in the UK but where a company has an overseas location, ie USA, some of the inventors are based in that country).

  Two universities, University of Southampton and the University of Oxford (ISIS Innovations) which include spin-off organisations from them rank among the top 10 UK-based organisations filing in the field of allergy. Seventeen UK Universities/Medical Schools have filed at least one patent application on allergy. Of the top fifty organisations twenty have collaborated on patent filings.

TOP 10 ORGANISATIONS FILING UK PATENT APPLICATIONS IN ALLERGY

No patents	Patent Assignee
113	Smithkline Beecham CorpTM
61	AstraZeneca AbTM
33	Celltech Therapeutics LtdTM
29	Reckitt BenckiserTM
19	Peptide Therapeutics LtdTM
17	University of SouthamptonTM
12	Allergy Therapeutics LtdTM
12	Evolutec LtdTM
10	Circassia LtdTM
10	Isis InnovationTM

7.  WHAT ARE THE MOST PROMISING AREAS OF RESEARCH INTO PREVENTING OR TREATING ALLERGY?

Question 10)

  A chronological analysis of technology terms (Figure 7) indicates that, whilst patent activity in pharmaceuticals and heterocyclic organic compounds continued to rise this century, activity in biotechnology appears to have slightly decreased. However, this could in part be due to changes in filing strategies by biotechnology organisations. Nevertheless biotechnology patent activity is higher than it was 10 years ago. Patenting in the area of non-cyclic organic therapeutic compounds appears to be relatively flat.

Figure 7: Chronological trends of patents on allergy by technology cluster

Number of Records by Technology and Year

7.1  Top 50 Inventors filing in UK; their relationship with companies and field of activity

  To gain an insight into current patent activity two strategies were used:

(i)    analysis of 10 most cited patent applications; and

(ii)   analysis of the top fifty inventors filing patents in UK and to group these with their corresponding companies (Annexes 1 to 4).

  The 10 most cited patents all concern nitrogen-containing heterocyclic compounds. Analysis of the most recent patent filings from each company (see Annex 1) revealed a more diverse spread of activity within three main areas: (a) heterocyclic organic compounds; (b) biotechnology and (c) environmental allergen deactivation.

7.1.1  Nitrogen containing heterocyclic compounds

  The most abundant patent filings by GSKTM, MerckTM, PfizerTM, NovartisTM, AstraZenecaTM and CellTechTM all concerned nitrogen-containing heterocyclic compounds:

—  Knowles et al and Jones et al (GSK) phosphodiesterase inhibitors;

—  Maccoss et al (Merck)—tachykinin receptor antagonists;

—  Lethwaite et al (Pfizer)—bronchodilatory ß2agonists;

—  Warrellow et al (CellTech)—anti-inflammatory phosphodiesterase inhibitors;

—  Danahay et al (Novartis)—syngeristic anti-asthmatic compounds; and

—  Stocks et al and Baxter (AstraZeneca)—modulation of chemokines (interleukins and chemoattractants) with pyrazinyl phenylsulphonamides.

7.1.2  Biotechnology-based inventions

—  Ames et al (GSK)—recombinant peptides as therapeutic agents; Wheeler et al (also Allergy Therapeutics Ltd)—the surface modification of allergens;

—  GSK and Peptide Therapeutics collaborated on engineering protein vaccines (mimitopes) to neutralise IgE antibodies;

—  Moffat et al (ISIS)—recombinant proteins associated with IgE -mediated atopic disorders; and

—  Lamb et al (Lorantis)—modification of T cell interactions via cell signalling proteins (Notch) ligands.

7.1.3  Allergen deactivation

  The Reckitt BenckiserTM/University of Southampton collaboration produced patent applications on the deactivation of dust mite allergens with dispersable deactivants such as terpene hydrocarbon oils.

8. CONCLUSIONS

  There is an abundance of world-wide patent information relating to allergy. The main findings of this report are:

1.  Patent trends in allergy mirror those of the biotechnology and pharmaceutical sectors.

2.  GDP indicators suggest the level of patent activity in the UK is less than in the USA or Japan but at least as strong as Germany.

3.  There is a substantial body of patent information emanating from the UK on classical organo-chemical pharmaceuticals relating to allergy. There are several UK institutions generating patent filings in biotechnology but the level of innovation is not as extensive as for classical organo-chemical pharmaceuticals.

4.  UK private sector companies make a significant contribution to the patent landscape on allergy. Two UK university entities rank in the top 10 UK organisations in the field of allergy.

5.  Patent databases provide the opportunity to perform a detailed analysis of the information and patent trends relating to particular molecules in the molecular pathways involved in the allergic response and also about particular companies and individuals involved in this area.

Note: Please refer to the PDF version for an improved rendition of the following two maps.

Annex 1:

Inventor collaboration, each group having at least 1 UK based investor

  At least one inventor in each cluster is based in the UK. Where a company has an overseas location, ie USA, some of the inventors shown may reside in that country. The number of patents is indicated by the size of the dot. The bold lines indicate over 75 per cent collaboration. Dotted lines indicate less than 25 per cent collaboration.

Annex 2:

UK-based companies or companies collaborating with UK based companies

  The number of patents is indicated by the size of the dot. Bold lines indicate over 75 per cent collaboration. Dotted lines indicate less than 25 per cent collaboration.

Annex 3

NUMBER OF PATENT RECORDS FOR TOP UK-BASED COMPANIES OR COMPANIES COLLABORATING WITH UK-BASED COMPANIES

No patents	Patent Assignee
113	GlaxoSmithkline TM
61	Astrazeneca AbTM
33	Celltech Therapeutics LtdTM
29	Reckitt BenckiserTM
19	Peptide Therapeutics LtdTM
17	University of SouthamptonTM
12	Allergy Therapeutics LtdTM
12	Evolutec LtdTM
10	Circassia LtdTM
10	Isis InnovationTM
8	Phytotech LtdTM
7	Britannia Pharmaceuticals LtdTM
7	Corixa CorpTM
7	Helperby Therapeutics LtdTM
7	Imperial College
7	Lorantis LtdTM
7	PfizerTM
6	Acambis Research LtdTM
6	Cambridge Antibody TechologyTM
6	University of Manchester
6	Vernalis LtdTM
5	Imperial College Innovations LtdTM
4	Darwin Discovery LtdTM
4	Hewlett Healthcare LimitedTM
4	Human Genome Sciences IncTM
4	St George S Enterprises LtdTM
4	Wyeth CorpTM
3	Acaris Healthcare Solutions PlTM
3	Arakis LtdTM
3	Cambridge Bioclinical LimitedTM
3	Danbiosyst UkTM
3	Mars IncTM
3	Pilgrim Bed LimitedTM
3	SpesTM
3	University of Cranfield
3	University of LondonTM
3	Vectura LtdTM
2	Affymax Tech NvTM
2	Beatson Inst For Cancer ResearchTM
2	Beth Israel Hospital
2	Biofocus Discovery LtdTM
2	BOC Group PlcTM
2	Boots Co PlcTM
2	Chiroscience LtdTM
2	Dzhejms Blehk Faundejshn LtdTM
2	E San LtdTM
2	Innovata Biomed LtdTM
2	Molecular Skincare LtdTM
2	National Research DevelopmentTM
2	Oratol LimitedTM

Annex 4

NUMBER OF PATENT RECORDS FOR TOP UK-BASED INVENTORS OR INVENTORS COLLABORATING WITH UK-BASED INVENTORS

No patents	Patent Assignee
29	Mckechnie Malcolm Tom
28	Lane Charlotte
27	Lewthwaite Russell Andrew
24	Brown Alan D
24	Hughes John
23	Biggadike Keith
22	Bunnage Mark
21	Friede Martin
21	Glossop Paul
20	Warrellow Graham John
19	Mason Sean
18	Ward Peter
16	Alexander Rikki P
16	Clarke Jeremy G
16	Danahay Henry L
16	Hassan Ian F
16	Vinals Y De Bassols Carlota
15	Mantell Simon
15	Turnell William G
15	Van Mechelen Marcelle Paulette
14	Lewin Ian V
14	Maccoss Malcolm
14	Mills Sander G
14	Springthorpe Brian
14	Wheeler Alan Worland
13	Baxter Andrew
13	Bryans Justin
13	Chambers Jon
13	Stanworth Denis R
13	Stocks Michael
12	Cookson William
12	Jones Paul
12	Ladduwahetty Tamara
12	Paesen Guido Christiaan
12	Taylor Iain
11	Coates Anthony R M
11	Cornelius Gay
11	Dallman Margaret Jane
11	Edlin Chris
11	Horwell David C
11	Moffatt Miriam
11	Thompson Ian Andrew
11	Wheeler Alan
10	Ames Jr Robert S
10	Dorn Conrad
10	Foley James J
10	Hale Jeffery
10	Knowles Richard Graham
10	Lamb Jonathan Robert
10	Monaghan Sandra Marina

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1   http://www.parliament.uk/parliamentary-committees/lords_s_t_select/allergies.cfm Back

2   The data was extracted from priority patent filings-that is the country where the first patent filing was made as an indicator of filing in that country. In extracting this data European Patent designations were not counted Back

3  World Bank- World Development Indicators Database, 1 July 2006.Back