TITLE: Patenting of Microorganisms AUTHOR: Patent Facilitating Centre, New Delhi DATE: circa June 2000 URL: http://www.indianpatents.org/ach/micro.htm NOTE: On sale for Rs500 (approximately US$11). Contact details below. PATENTING OF MICROORGANISMS For the first time in India perhaps in any developing country, a comprehensive report on Patenting of Microorganisms has been prepared by the Patent Facilitating Centre. Ever since the US Supreme Court allowed the patenting of microorganisms in 1980, this subject has been drawing a great deal of attention all over the world. As microorganisms are important constituents of biodiversity, issues like the origin of a microorganism and its patentability and ownership have gained importance. Main Features of the Report The report has certain features which make it unique. It has analysed patent laws of developed and developing countries in relation to microorganisms, patent granted for microbiological processes and microorganisms per se, and also the policy implications, and put forward an action plan. The most interesting part of the report is the responses received from many developing and developed countries in regard to interpretation of the term microorganism. Case studies of patents issued by the USPTO and European Patent Office (EPO) have been presented in the report with specific information about what really have been the subjects of these patents. The report provides an insight into the depositary mechanism followed at one of the International Depository Authorities and the examinations standards followed while determining the patentability of microorganism related inventions. The report is of use to industries, R&D institutes, scientists, technologists, consultants, research scholars dealing with drugs and pharmaceuticals, chemicals, life sciences, food processing and genetic engineering. It is also of benefit to lawyers, patent attorneys and policy makers. The report is now available for Rs.500/- . Major Findings The study mainly focuses on the patentability criteria of microorganisms per se based on laws and practices of 30 countries, both developed and developing. In order to have a feel about the claims awarded by different patent offices, about 10,000 patent titles were scanned . The report traces the history of patenting in this area, discusses the deposition mechanism and examination standards followed by some countries covering different aspects of patenting of microorganism (per se) are also included. 1. It would appear that India is not obliged to introduce laws for patenting microorganisms per se before 31.12.2004. This is derived from the fact that per se patent is equivalent to a product patent. Therefore, the transition period available to us should be fully utilised for understanding the intricacies of patenting in this area and also making allied preparations for launching a product patent regime by 31.12. 2004. However, process patents for microbiological inventions will be required to be given for a period of 20 years from the date of filing after 31.12.1999. Presently this period is either 5 years from the date of grant or 7 years from the date of filing. Some preparations are also essential for awarding process patents e.g., the patent examiners have to be trained in examining such applications which entail modern and complex scientific concepts and methodologies. 2. Patenting of microorganisms and their related processes and products involves some unresolved questions and seems to be in a state of flux. Considering that the patenting of microorganism per se started in 1981, it is natural that the laws and practices in this regard will need some time to stabilise. This situation is further complicated by the rapid scientific and technological developments in biotechnology. The technical complexity involved in the patenting of microorganisms needs to be understood by Indian professionals. They need to sit down and study different patent documents and claims to determine whether such claims / some new claims should be allowed or not keeping the status of Indian R&D and trade in mind. This report may be used as a first step in that direction. 3. The question whether the term microorganism should be defined in a generic manner or not will need to be decided carefully. Considering our near zero experience in this area, it would be better to keep away from finding a generic definition. Instead, it would be advisable to spell out the scope of this term. This will be in line with the practices followed by many countries. It would, however, be prudent to review the situation after 5 to 10 years to re-establish the usefulness of this approach. 4. There is one clear and important distinction between the legal practices of the developing and developed countries. The former, unlike the latter, do not allow patenting of microorganisms already existing in nature; some do not even consider such a `discovery' an invention. However, as WTO members many countries have now allowed patenting of genetically modified organisms. It may be noted , at this point, that the R&D and industrial base in this area in the developing countries would be very small and in some cases non-existent. Therefore, their legal practices are based more on the experience of other countries and these may be considered for developing broad principles. 5. The other important thing to be noted from the laws of many countries is the detailing of requirements for the deposition and the rules for accessing microorganisms from depositories. In this respect laws of Finland may be read which are quite explicit and easy to understand. As strict biosafety norms have to be followed while handling microorganisms, the laws for accessing strains from a depository have to be carefully worked out to ensure that these do not land into wrong and/ or technically incompetent hands. Our patent laws for protecting microorganisms will have to spell out requirements for deposition and rules for accessing strains from a depository. It would be essential to build an internationally recognised depository in the country before introducing patenting of microorganisms per se if not before that. Obviously, to have an internationally recognised depository for facilitating patenting of microorganisms and microbiological inventions, India will have to become a member of the Budapest Treaty. As some time will be required to set up a depository of that class and substantial funds may also be required, it would be desirable to become a member of the Budapest Treaty at an early date and utilise the transition time up to 31.12.2004 for building a world class depository in India and having it accredited by under the said Treaty. A thought may also be given to the building of more than one depository. 6. The moment process patents are started in India for microbiological inventions, the Indian Patent Office will have to find a way out to accept the accession numbers of microorganisms allotted by foreign depositories. This may not be possible until we become a member of the Budapest Treaty. Otherwise, we may have to insist that samples are also deposited in one of our recognised laboratories such as IMTEC in Chandigarh. This may require some understanding with some foreign depositories. 7. It is known that deposition of samples in a foreign depository will be very expensive, Any sample going from India, for example, to the ATCC, USA would be subject to some additional screening and in vivo/ in vitro tests for biosafety which may be time consuming and costly. Each sample may cost about Rs 2 lakhs. The depository may decide not to store the sample even after such testing. Once we have our own depository, we save such costs and time. The most important outcome will be that our researchers would start depositing samples of microorganisms isolated or developed in the local depository. 8. It may be made mandatory that microorganisms isolated in India and their modified forms under any type of R&D programme, including collaborative programmes being carried out in India partially or fully, with outside agencies, should be deposited in the Indian depository. This step needs to be further supplemented by a tracking exercise on a continuous basis to find out if microorganisms from India have been deposited in foreign depositories. 9. It has been shown in the report that samples of microorganisms isolated from India are being deposited in the ATCC. One could easily guess that such depositions are also being made in depositories situated in other countries. The information so collected may be linked with R&D or other activities under which such microorganisms would have been isolated. This would be best done by making references to different government agencies involved in funding, coordinating and clearing such programmes. 10. Patenting of GMOs per se will also entail some additional questions. Would the gene responsible for designing the GMO be patentable? If an already known and isolated gene is used, who then, will be the owner of the GMO? Should a GMO satisfy biosafety conditions before it is granted a patent? It is felt that, once a GMO is patented, there will be a tendency to establish biosafety with short term trials which may not be really adequate. Therefore, in such cases where there is no evidence of meeting of the biosafety requirements in a patent document, a statement may appear in the document stating that the GMO has not undergone detailed biosafety trials. Further, it may be remembered that inventions , which are likely to be injurious to public health do not qualify for patents. As the behaviour of GMOs, when put into real use, may not be completely known before hand, thought needs to be given as to whether patents should be granted at all with out the GMO meeting the safety requirements. The other question is whether all systems for determining biosafety of a GMO should be in place in India before allowing patenting of GMO. These questions will also be applicable while allowing process patent in respect of microbiological inventions involving GMOs. 11. With the introduction of sui generis system for the protection of new plant variety, new seeds including seeds produced through the transgenic route will be protected. In spite of the fact that microorganisms and genes do not have any protection through patents in India, these will get a indirect protection through the protection of new seeds and plant variety in India. In the proposed plant variety Act, a stipulation may be considered so that the genes used in such protected variety may not get any protection. 12. How the criteria of novelty and inventive step will be applied in respect of microbiological inventions, especially for patenting of microorganism per se, is an important issue. There is one fundamental question to be resolved and that is, whether discovery of a microorganism from the nature for the first time can be considered to embody novelty and inventive step. To avoid this basic issue, some countries have put a condition that the microorganism should not have been described in the literature. Some countries have associated the element of human intervention with the discovery for it to be patentable. As a microorganism exists in nature as a part of the nature, its discovery cannot be considered an invention. The moment it is treated as an invention, the logic of treating scientific theories and principles as non- patentable inventions gets defeated. This may lead to a shift in the basic thinking that scientific principles are meant for the larger good of the humanity and therefore these are kept outside the patent regime. 13. If microorganisms isolated from the nature for the first time are considered patentable, then minerals and ores discovered from the interior of earth and deep sea bed would qualify for patenting. The isolation of ores and minerals from deep sea bed and greater depths of earth , than the presently achieved, will call for a much higher class of technology and large financial resources. Obviously, the countries having such resources will have a very distinct advantage and smaller countries may have the risk of losing their own resources if the ores and minerals are allowed to be patented. Thus, the issue needs to be discussed in detail. 14. Following microorganisms and biological materials are considered patentable in many countries: bacteria, virus, filamental fungi, protozoa, unicellular algae, plant and animal virus, plant and animal cells ( cell lines, tissue culture ), fused cells, mushrooms, DNA ( eukaryotic and prokaryotic origin ), transformants and pure culture. Types of patents and claims being awarded in these countries have been detailed in the report. The information may be used by the practitioners of this technology and its patenting including scientists, technologists, legal professionals, science managers and policy makers to decide how many of these microorganisms and biological materials may be considered for patenting in India. 15. A discussion in international fora on shifting from the term ' microorganisms' to 'biological materials' may come up soon. It would be desirable to stick to the term 'microorganism' as TRIPS uses this term and we still do not have enough experience in this area to figure out relative advantages of shifting from one term to the other. 16. Patents granted abroad on microorganisms (per se patents) do not have an influence on the domestic scenario in India, because product patents are not granted in India at present. Many product patents will be granted in India and other countries after the introduction of product patent regime in India and this would lead to a highly competitive situation in India. However, process patents may have significant effects from the commercial angle as these can be patented in India at present. It may be borne in mind that patent documents are a source of tremendous knowledge and these should be used for deciding our R&D goals and corporate objectives. 17. Patent examiners, patent attorneys, scientists and technologists working in the area of biotechnology are not really familiar with the patenting of microorganisms and microbiological inventions. On one hand there is a need to create awareness among scientists, on the other hand there is an urgent need for training patent examiners and attorneys to handle applications in the area. Please discuss and offer ideas and suggestions at Patent Facilitating Centre (PFC) Technology Information, Forecasting & Assessment Council (TIFAC) Technology Bhawan New Mehrauli Road New Delhi -110 016 INDIA Tel: (91-11) 6859581 or 6863877 or 6967458 Fax: (91-11) 6863866 E-mail: tifac(at)nda.vsnl.net.in PFC web site: http://www.indianpatents.org TIFAC web site: http://www.tifac.org.in