Journal of Intellectual Property Rights Vol 5 November 2000 pp 327-332

Technology Trends in Biosensors as Reflected by Patent Analysis

M M S Karki

National Institute of Science Communication Dr K S Krishnan Marg, New Delhi 110012

Analysis of patents in the area of biosensors has been made to identify the technologi­cal opportunities in the field of biosensors, and indicate their potential commercial uses. The industrial firms of USA, Japan, and Germany owned the sizable number of US patents on biosensors. Patenting activity was found more intense in the healthcare sector. There were more patents in the area of manufacturing of biosensors than in use-based inventions.

A biosensor is generally an immobilized en­zyme or cell that is combined with a transducer to monitor a specific change in the microenvironment. The probe tip is im­mersed in the liquid phase and is in contact with the process either directly or through a membrane. 1 The term biosensor is used for a whole class of sensors that utilize a bio­chemical reaction to determine a specific compound. Continual measurements of raw materials and products are important for the control of biochemical processes.

Biosensor technologies is a field which is only beginning to make its mark on many fields ranging from medical diagnostics to environmental monitoring2. In fact, biomedi­cal area is the one where the major efforts have been concentrated3 because biosensor

industry holds great promise in addressing the needs in every aspect of health care rang­ing from home health care to most sophisti­cated critical care hospitals.4 There are a number of commercial successes, the most successful to-date being the home blood glu­cose monitor for use by people suffering from diabetes.5 The other potential applica­tion areas of biosensors ranges from mining and industrial to military and security, in­cluding agriculture.3

With the growing importance of biosensors and th e massive investments and efforts be­ing made in R&D all over the world, the question of securing adequate protection of new innovations in the field has assumed considerable importance. A study of the in­novative activity in the field of biosensors

328 J INTELLEC PIWP RIGHTS, NOVEMBER 2000

during 1983-95 has already been covered in one of the earlier issues of this journal. 6 This study has shown that biosensor is an area of growing importance in scientific research, and the niche areas, on the basis of patenting activity, are enzyme membrane biosensors followed by electrochemical biosensors. The present study aims at to further analyse the patenting activity during the period 1996-2000 (till 4 August 2000) so as to indicate the current thrust of technological opportunities in the field. Such an analysis may be of im­portance for R&D organizations in this area.

Data and Methodology

The United States of America is one of the leading countries in technological innova­tions whose market dynamics tend to attract cutting-edge innovations from across the world. The US patent database, therefore, is an important source of information on the patenting activity in any field of research .

In the present study, the bibliographic search was made in the US patent database7

in the titles of the patents using the keyword 'biosensor'. This resulted in a set of 74 pat­ents granted by the US Patent and Trade­mark Office. The keywords in the titles of the patents of 1996-2000 were used to iden­tify the emerging technological opportuni­ties. The abstract and the first page of each of the patents were examined to obtain in­sights into the inventive activity and the own­ership of the patents.

Patenting Activity

There has been a steady growth in the pat­enting activity during 1996-2000. A list of US patents on biosensors granted during 1996-2000 is given in Annexure 1. There were 15 patents each in 1996 and 1997. In 1998 this figure rose to 18. During 1999-2000 the total number of biosensor patents was 26.

As mentioned earlier, biosensor research and development has been largely concen­trated in the biomedical area because that area represents the largest market opportu­nity and that market is most receptive to short-lived or disposable devices~. Maxi­mum patents during this period pertained to healthcare sector. This included biosensors for detection of glucose in urine, glucose in blood, and non-invasive glucose biosensor, urea biosensorfor hemodialysis monitoring, breath alcohol biosensor, toxicity detecting biosensor system, and cholesterol biosen­sor.

Analysis of the inventive activity was also made on the basis of key technical terms appearing in the titles of these patent docu­ments as there were number of terms such as fibre optic biosensor, optical biosensor, electrochemical biosensor, protein biosen­sor, urea biosensor, glucose biosensor, etc. Ofthese, there were more than three patents in areas like electrochemical biosensors, op­tical biosensors, and fibre optic biosensors.

The nature of activity was further examined on the basis of the analytes8 such as: (i) pesticides, (ii) organic compounds, (iii) met­als (specific), and (iv) biological parameters. There were 10 patents pertaining to organic compounds, e.g. protein biosensor and method for protein measurement with the same, or breath alcohol biosensor; six pat­ents relating to biological parameters, e.g .. assay method for biological target com­plexes on the surface of a biosensor; and there were two metal (specific) patents, e.g. biosensor for detecting iron.

Ownership 0/ Patents

There are 22 patents by inventors from USA. Japan (17) and Germany (7) were other main patenting countries followed by the Republic of Korea (4), UK (3) and Australia

KARKI : TECHNOLOGY TRENDS IN BIOSENSORS .. ... .. .. . 329

(2) .Number of patents are shown within pa­renthesis. Besides, Italy, Switzerland, and Sweden had one patent each.

The role of companies is predominant in accelerating the pace of technological devel­opmentin this area. Major contributing com­panies were from United States and Japan followed by Germany, Republic of Korea and Britain. Major contributing companies were Matsushita Electric Industrial Co, L G Elec­tronics, Inc, NEC Corporation, Bayer Corpo­ration, and Goldstar Co Ltd. Fujitsu Ltd. E.!. Du Pont, Abbott Laboratories, Bayer Ak­Iiengesellschaft, Biosensor System Design , Inc, Biomedix, Inc, Roche Diagnostics Cor­poration, Lockheed Martin Energy Re­search Corporation, Motorola, Inc, and NOK Corporation are some of the other companies which have also taken one or two patents during this period.

There are research groups active at the uni­versities/research institutes like University of California, and University of Washington . They have been granted nine patents during the period 1996-2000. Government depart­ments of USA and UK own one patent each. Further, there were three patents jointly taken by institutions in the academic sector. There were four individual patents.

Technological Opportunities

There are two major areas of emerging tech­nological importance in the field of biosen­sor research, viz. (i) manufacturing of biosensors, and (ij) use-based inventions. The patenting activity was more intense in the former category.

(i) Manufacturing of biosensors

In this field, the patents have been taken mainly for biosensor devices or apparatus and these patent documents provide the de-

tails of such technological developments. In addition to these inventions, this group in­cludes the patents relating to inventive fea­tures on technological dim ens ion s pertaining to methods of manufacture/fabri­cation of biosensors/ devices/ apparatus or their composition or properties.

During 1996-2000 there were 56 patents in this category. A few examples of such pat­ents are: oxygen electrode, biosensor and processes for manufacturing same, biosen­sor including chemically modified enzyme, electrochemical biosensor stability, biosen­sor and method for producing the same, biosensor and interface membrane, electro­chemical biosensor, nanoparticles biosen­sor, electrostatic enzyme biosensor, optical diffraction biosensor, biosensor mem­branes, interference free biosensor, and dia­mond film biosensor.

(ii) Use-based inventions

The inventions in the field of biosensors have found applications in medical diagnos­tics and environmental monitoring. This study of the patenting activity of biosensors also reflects a continued thrust towards use­based technological opportunities. During 1996- 2000, 18 patents have been taken for use-based inventions which include: breath alcohol biosensor, biosensor for detecting iron, toxicity detecting biosensor system, method for detection of buried explosives u s ing biosensor, urea biosen sor for hemodialysis monitoring, substrate regen­erating biosensor, biosensor and chemical sensor probes for calcium and other metal ions, cholesterol biosensor, and multi­biosensor for GPT and got activity.

Results and Conclusion

Recently, many biosensors have been· devel­oped which provided methods of rapid and

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continuous measurements of various com­pounds. During the period under review the number of patents in biosensors has in­creased. It indicates that this is an area of growing importance in scientific research. Patenting activity was found more intense in healthcare sector. Similarly, there were more patents in the area of manufacturing of biosensors than in the use-based inventions. The role of companies was found predomi­nant in accelerating the pace of the techno­logical development in the area of biosensors. Of these, the industrial firms of USA, Japan, and Germany owned the sizable number of patents. This information can be made use of by the organizations engaged in biosensor research.

Acknowledgement

The author is thankful to Mr VK Gupta, Scientist, National Institute of Science, Technology and Developmental Studies, New Delhi, for his useful suggestions and comments leading much needed improve-

ments in the analysis and presentation of the results.

References

1 Biosensors,htt.p:i /www.eng.rpi.edu / dept! chem-eng/Biotech-environ / B IOSEN2/biosensor.html

2 Biosensor.http://www.biosensor.com /bio/ index. htm

3 Introductiontobiosensors, http://www.biosensor.com/ bio/in tro. htm

4 Biosensor.http:// www.biosensor.com / bio/ tony.htm

5 Biosensors.http://www.cranfield.ac. uk/ biotech/ biosensor. htm

6 Garg K C, Patenting activity in biosen­sors, Journal of Intellectual Property Rights,4, 1999,67-79

7 http:// 128.109.179.23/ cgi-bin/searc h4?INDEX+O

8 Current biosensor applic a tions, http://pubs. acs. org/hotartcl/ est/ 96/ nov/current. html

KARKI: TECHNOLOGY TRENDS IN BIOSENSORS ... ..... . .

Annexure 1- US Patents on biosensors during 1996-2000

5,589,133 Oxygen electrode, biosensor and processes for manufacturing same 5,582,697 Biosensor, and a method and a device for quantifying a substrate in a sample

liquid using the same 5,575,895 Biosensor and method for producing the same 5,571,395 Breath alcohol analyzer using a biosensor 5,543,326 Biosensor including chemically modified enzymes 5,542,676 Biosensor feedback device for spOlting implements 5,525,511 Electrochemical biosensor stability 5,516,697 Biosensor for detecting iron 5,512,159 Biosensor 5,496,701 Optical biosensor method for determining an analyte 5,496,522 Biosensor and chemical sensor probes for calcium and other metal ions 5,496,453 Biosensor and method of quantitative analysis using the same 5,496,452 Substrate regenerating biosensor 5,494,639 Biosensor for measuring changes in viscosity and/or density of a fluid 5,492,840 SUliace plasmon resonance sensor unit and its use in biosensor systems 5,702,915 Toxicity detecting biosensor system 5,695,947 Amperometric cholesterol biosensor 5,690,894 High density array fabrication and readout method for a fiber optic biosensor 5,672,256 Multi-electrode biosensor and system and method for manufacturing same 5,665,215 Method and apparatus for making predetermined events with a biosensor 5,658,732 Assay method for biological target complexes on the suIiace of a biosensor 5,658,443 Biosensor and method for producing the same 5,656,142 Biosensor for measuring gas and the manufacturing method thereof 5,653,864 Protein biosensor and method for protein measurement with the same 5,651,869 Biosensor 5,650,062 Biosensor, and a method and a device for quantifying a substrate in a sample

liquid using the same 5,631,170 Method for improving measurement precision in evanescent wave optical

biosensor assays 5,631,141 High resolution biosensor for in-situ microthermometry 5,629,213 Analytical biosensor 5,624,537 Biosensor and inteIiace membrane Patent Database 5,846,392 Miniaturized circulatory measuring chamber with integrated chemo- and / or

biosensor elements 5,842,983 Biosensor 5,837,196 High density array fabrication and readout method for a fiber optic biosensor 5,814,525 Piezoelectric biosensor with a ladder polymer substrate coating 5,798,031 Electrochemical biosensor 5,798,030 Biosensor membranes 5,795,774 Biosensor 5,783,056 Electrochemical enzyme biosensor

331

Contd.

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5,777,372 Diamond film biosensor 5,770,439 Thick-film conductivity enzyme electrodes in a vertical stack as biosensor 5,762,770 Electrochemical biosensor test strip 5,759,796 Method for the determination of lactic acid in organic materials of alimentary

interest and biosensor for putting this method into effect 5,759,364 Electrochemical biosensor 5,755,953 Interference free biosensor 5,738,825 Optical biosensor matrix 5,736,342 Biosensor for detecting the presence of chosen analytes

5,711,915 Optical solid-phase biosensor based on polyionic layers labelled with

fluorescent dyes 5,705,045 Multi-biosensor for GPT and got activity 6,107,080 Biosensor device and method 6,103,033 Process for producing an electrochemical biosensor

6,096,497 Electrostatic enzyme biosensor 6,077,408 Biosensor and method of manufacturing the same 6,060,256 Optical diffraction biosensor 6,059,946 Biosensor 6,033,866 Highly sensitive amperometric bi-mediator-based glucose biosensor 6,027,944 Capillary-fill biosensor device comprising a calibration zone 6,024,924 Biosensor system for detecting organic trace compounds produced by

smoldering fires 6,004,441 Biosensor 5,997,817 Electrochemical biosensor test strip 5,985,116 Biosensor 5,981,297 Biosensor using magnetically-detected label 5,972,638 Method for detection of buried explosives using a biosensor 5,961,451 Noninvasive apparatus having a retaining member to retain a removable biosensor 5,958,199 Biosensor 5,955,379 Biosensor device and method 5,952,236 Enzyme-based fluorescence biosensor for chemical analysis

5,938,595 Fiber optic D dimer biosensor 5,922,537 Nanopartic\es biosensor 5,922,188 Biosensor and method for quantitating biochemical substrate using the same

5,906,921 Biosensor and method for quantitative measurement of a substrate using the

same 5,892,144 Biosensor 5,882,494 Polyurethane/polyurea compositions containing silicone for biosensor

membranes 5,879,878 Method of producing a first layer electrode membrane for a biosensor 5,876,952 Non-invasive glucose biosensor: determination of glucose in urine 5,866,353 Electro chemical biosensor containing diazacyanine mediator for co-enzyme

regeneration 5,858,186 Urea biosensor for hemodialysis monitoring