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Biotechnology & IPR: A Relatable Discussion



INTRODUCTION TO THE THEME

With the progress of science and technology, human civilization is touching new horizons of development. The advancement in the field of biotechnology is influencing the progress tremendously. Biotechnology[1] is that scientific knowledge that utilizes living organisms for the commercial purpose. It is considered as one of the oldest sciences.[2] The World Intellectual Property Organization (WIPO) defines biotechnology as any technology using living entities, in particular animals, plants, or microorganisms, or causing change in them."[3] However the way the modern technology has developed, it can be differentiated from the age old fermentation technology.[4]Whether we talk about its applications in the Industrial area or the health care sector, whether its crop production or agriculture, biotechnology[5] is involved everywhere. The science is also applied for the environmental uses (biodegradation processes etc).

Very similar to other fields of technology, legal protection is also needed in the biotechnology sector as the processes that are involved in it are none other than human creations and human creativity when applied and practiced is in great need of being protected from the rising threats of biopiracy and exploitation of traditional knowledge[6]. Patent laws in most of the countries are tuned for non-biological material.[7] However biotechnological inventions[8] do need legal protection.[9]

Critically, biotechnology is divided into three of its branches. While the ‘red biotechnology’ deals with drug discovery, ‘green biotechnology’ deals with the agriculture. Industrial biotechnology is dealt under ‘white biotechnology’. Principally, wide research part dealt under each branch can be protected by IPR. The protection is not only in the interest of the investors but also in the interest of the public.

The next major question arises that how IPR deals with the subject matter of biotechnology? In India, there exist no separate laws on biotechnology however the IPR laws of the country comprise of a large web of rules and regulations on patent protection, trademarks, registered designs, trade secrets, plant breeders’ rights, domain names etc. These separate legislations make a possible connection to the science of biotechnology and hence work for its protection.

THE BENEFITS OF BIOTECHNOLOGY CANNOT BE SIDELINED

Ranging from biomedical technologies[10]to the agricultural sector[11], from marine biotechnology[12] to the environmental biotechnology[13], the wide benefits cannot be sidelined in the modern world as it coddles the need of the society. Hence in order to secure this form of science to its fullest, IPR protection is indispensable. However what raises the controversy is the dearth of entrenched practice. Again the Indian tradition does not allow fixing monetary value to anything that is intangible and engages no market value.[14] Hence defining clear IPR policies is not only a need but also a necessity.

PATENTS

(Patents Act, 1970)

Basically work for the protection of medical devices, methods for preparation or use of enzymes, microorganisms, viruses, antibodies, vaccines, plants, seeds etc.

TRADEMARKS

(Trademarks act, 1999)

Work for the protection of words or names, computer icons, graphical designs, multimedia elements or use of the above.

REGISTERED DESIGNS

(Designs Act, 2000)

Medical devices, biochemical, biophysical or bio-electrochemical apparatus are covered under this.

TRADE SECRETS

(Uniform Trades Secrets Act, 1970)

Involve the protection of Laboratory notebooks, customer information, documented internal processes etc.

PLANT BREEDERS' OR PLANT VARIETY RIGHTS

(Protection of Plant Varieties and Farmers' Rights Act, 2001)

Involve the protection of Plant varieties, propagating and harvesting material from plant varieties.

DOMAIN NAMES

Involve the protection of web addresses.

LEGAL REGULATION OF BIOTECHNOLOGY

The Indian Patents Act, 1970 is based on the philosophy that patents must be granted to secure and encourage inventions on a commercial scale. However the law also keeps a check that the patentee is not enjoying monopoly over the patented thing. The Indian patents act has been amended several times to make it competent according to the terms of TRIPS[16] agreement. India being a signatory to WTO’s TRIPS agreement was put under the contractual obligation to amend its Patents Act in compliance with the provisions of TRIPS. Accordingly the Indian Patent Act, 1970 was amended in 1999, 2002 and 2005 to meet the requirements of TRIPS. The discussion with respect to EUROPE has been limited to the European Patent Convention (EPC). As per the European Patent Convention, any invention is patentable unless it falls within the list of excluded inventions.[17] According to Article 52 of EPC, any invention irrespective of the technology to which it belongs can be considered as patentable subject matter so long as it is new, inventive and has an industrial applicability and does not fall within the list of excluded inventions provided in Article 53 of the EPC.[18] To be patentable subject matter in USA, an invention should be a process, machine, manufacture or composition of matter or any improvement thereof.[19] The biotechnological inventions have been lowered to certain extent in the U.S.A. Courts from time to time have held that purified ‘gene sequences’ even if they match what has been created by the nature fit the definition of novelty.[20]

MAJOR PROVISIONS IN RELATION TO BIOTECHNOLOGY AND SOME OF THE PERSISTENT ISSUES:

  • Article 27 (1) of the agreement provides that “patents shall be available in all fields of technology, without discrimination, provided that they are new, involve an inventive step and are capable of industrial application.

  • Again Article 27(2) enables a Member to exclude from patentability inventions whose commercial exploitation may be contrary to public order or morality.[21]

  • Further, Article 27(3) allows Members to exclude from patentability certain subject matter, such as plants and animals.

CRITERIA FOR PATENTING

The general patentability requirements include novelty, industrial applicability (utility), non-obviousness and disclosure of the invention. However there has been an intense debate on this subject matter. (1) The criteria of industrial application is challenging to prove in the case of inventions in biotechnology. Again (2) benchmarks of novelty and non-obviousness are very difficult to be established in the case of living organisms. Now in various countries, it is equally considerable that if the invention does not exists in any of the prior art, then it is suited for the protection procedure. The “prior art” includes anything which, under the statute, can destroy novelty (a result known as ‘anticipation’) or render the invention “obvious”.[22] To determine novelty, it is necessary to first identify the prior art and then individually compare each prior art reference with the claims. Again the disclosure criteria is met as has been enshrined in the Budapest Treaty merely by depositing microorganisms in any of the internationally recognized depository.

INADEQUATE PROTECTION TO BIOTECH PATENTS

A large no. of industries are extracting the benefits of sound human resource, vast bio-diversity and large domestic market in the Indian platform. These enormous characteristics also result into the low cost research as compared to other countries and that makes it the primary reason what fascinates the international companies to start their venture at the Indian markets. However this particular actuality raises questions to one peculiar question that “Is Indian Patents law framework really compatible according to the needs of the nation in relation to Biotech Patents?” This concern is high lightened because though India remains the member to various international treaties and agreements still momentous enhancement in the areas of operation and enforcement of patent laws is the need of the hour.[23]

INVENTION VS DISCOVERY

While it comes to the issue of securing Biotech patents, the seperatiblity of a ‘Discovery[24]’ from an ‘Invention’ stands as a major form of debate. Whether finding new ‘life forms’ be counted as a discovery or an invention can be gathered a hint by making the differentiation between the two. A substance freely occurring in nature, if merely found or discovered, is not patentable.[25] However, if the substance found in nature has first been isolated from its surroundings and a process for obtaining it, is developed, that process is considered invention and hence patentable. But the field of biotechnological patents are not only restricted to the ‘discovery’ part. The inventions regarding production of replicas, parts of organs, tissues or cells, other biotechnological innovations etc do count as ‘biotechnological inventions’ and such are smoothly granted protection under the head of law. Hence it is a critically dealt dispute as to what constitutes an invention in contrast to a discovery.

WHAT IS PATENTABLE AND WHAT IS NOT

The US Supreme Court in Diamond v. Chakrabarty, a landmark biotech case, held that everything under the sun made by man is patentable.[26] However, as per the arguments raised by several Civil Society Organizations (CSO) and Non-Governmental Organizations (NGO), what has been created by the God should be left for the application by the entire mankind and hence cannot be appropriated by any particular individual, organisation or group.[27] Iver P. Cooper explains this in terms of the “product of nature” doctrine. This doctrine states that a thing occurring in nature which is substantially unaltered is not a manufacture and is therefore not patentable.[28] The term ‘manufacture’ refers to something made by the hand of man, and not by nature alone.[29] These contenders do not see much advancement and innovation being done in the field of biotechnology and hence secure the idea that life form innovations must not be patented. They are also the proponent of the belief that all human beings are equal before each other and carry equal rights. No one should be granted higher rights than the other.

THE REQUIREMENT OF DISPOSITION

No patent protection shall be availed unless the invention has been made available in the public. Hence before any protection can be claimed, the work has to be made public so as to check any infringement. Such disposition requirement has been drafted in the Budapest Treaty[30] of 1977 which requires a single deposit made at any of the depositories will suffice. However such public availability surely does includes the competitors and hence the chances of emergence of similar work cannot be estopped. This can be suitably described as a ‘pocket factory handed over to the imitator on a silver plate’.[31]

BIOPIRACY: A THREAT TO BIOTECHNOLOGICAL ADVANCEMENT

The term `biopiracy' normally refers to the unauthorized extraction of biological resources and associated traditional knowledge from developing countries without compensation of the fake inventions that have been generated in application to that knowledge. Intimidation of the work of the poor farmers and indigenous people of the developing countries by the private entities or corporations belonging to the developed countries is leading to exploitation at large scale.[32] Such practice leads to the transfer of the patent right that basically decides the exclusive right to produce and sell the patent product. Hence in effort that the endeavor of these communities does not go in vein, the IPR system of granting patents must be made stricter.[33] These corporations at the first instance start making huge revenues by the utilization of the patents, they further come out as a major source of threat by selling the products at a much higher price.[34] The major defeat of the protection laws can be understood in way that the local communities stand unrewarded. The present IPR system is proving supportive only to the private multi-national corporations who are aware of such protection schemes and legal aids hence at the first place they register the patent in their name.[35] While there is a great need to redefine the guidelines and policies for the implementation of the IPR, wide scale awareness also needs to be ensured. Such efforts can help prevent bio-piracy.

THE CONCLUSION

India is a country where legal norms have developed with respect to ethics and morality. It is into the Indian tradition and culture to worship plants and animals. Moreover all that is created by the God is said to be the property of all hence such things are not appreciated for the purpose of patent protection. The Indian patents act does adhere to the moral ethics. It clearly defines the law in terms that “any invention, the exploitation of which is against public order and morality and that may cause serious prejudice to the health of human beings, animals or to the environments cannot be patented.” There certainly resides a great connection between the science of biotechnology and India as the country is preferred over others for its abundance of resources, cheap labour and lesser regulation of laws.[36] In recent years, the Biotech Industry has achieved its pace and is the fastest growing. There has also been a hike in the investments in the present sector. Considering the tremendous growth of the industry, the need for proper and effective laws seems obvious. India is considered a rich country of Traditional Knowledge[37] and this factor makes it the priority of the developing countries. However, all such entries must be well aware of the legal norms that are persistent in the country in regards to biotechnology. While the number of biotech patent applications day by day is increasing, such have to be interpreted under the new definition which must comprise of a mental rethought over the International policies and mechanisms that are running parallel in other countries. The refreshment of laws seems quite mandatory in observation of the present day incompetent legal norms. Today, though the field is under issues, the biotechnological inventions have contributed towards the progress of the society in a large efficient manner and such serving the society shall continue in the near future. This science has the potential to furnish the needs of the society.

REFERENCES

[1] The word bio is taken from Greek word ‘bios’ which means life. Technology means application of scientific knowledge for practical purposes to get desired results.

[2] For example the production of wine or beer, cheese or curd, all these products involves the utilization of micro organisms.

[3] Graeme T. Laurie, Biotechnology and Intellectual Property: A Marriage of Inconvenience?, in CONTEMPORARY

ISSUES IN LAW, MEDICINE AND ETHICS 237, 238 (Sheila A. M. McLean ed., 1996) (citing Committee of Experts

on Biotechnology Inventions and Industrial Property, Second Session (Geneva, Feb. 3-7, 1986), reported in

INDUSTRIAL PROPERTY, June 1986, at 251, 256.

[4] Some of the procedures involved in modern technology include the DNA techniques, the cloning methods and the well known nano technology. The modern biotechnology is aged to be 50 years old only.

[5] The Organisation for Economic Co-operation and Development (OECD) has defined biotechnology as: 'The application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, goods and services as available at http://www.stat.fi/tk/yr/ttbio_en.html?tulost visited on 16th September, 2005 accessed on 6th Jan, 2015

[6] The term Traditional Knowledge refers to the content or substance of knowledge resulting from Intellectual activity in a traditional context, and includes the know-how, skills, innovations, practices and learning that form part of traditional knowledge systems and knowledge embodying traditional lifestyles of indigenous and local communities, or contained in codified knowledge systems passed between generations. It is not limited to any specific technical field and may include agricultural, environmental and medicinal knowledge, and knowledge associated with genetic resources- Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore, WIPO, available at http://www.wipo.int/edocs/mdocs/sct/en/wipo_grtkf_ic_17/wipo_grtkf_ic_17_inf_9.pdf accessed on 6th Jan, 2015

[7] H.S. Chawla, Patenting of Biological Material and Biotechnology, Journal of Intellectual Property Rights, Vol 10, January 2005, pp 44-51 available at nopr.niscair.res.in/bitstream/123456789/.../1/JIPR%2010(1)%2044-51.pdf accessed on 6th Jan, 2015

[8] Patent laws under intellectual property rights make for the protection of biotechnological inventions.

[9] http://www.palgrave-journals.com/jcb/journal/v14/n1/abs/3050079a.html, accessed on 5th Jan, 2015

[10] Recombinant drugs, recombinant diagnostic kits and vaccines

[11] Producing GM crops- more pest resistant and high nutritional qualities

[12] Fish farming

[13] Treatment of air pollution

[14] http://www.ciesin.org/docs/008-265/ch31-bio.html, accessed on 5th Jan, 2015

[15] Referred from “Biotechnology Intellectual Property management manual”, Spruson & Ferguson, 2008

[16] The Agreement on Trade Related Aspects of Intellectual Property Rights introduced intellectual property law into the international trading system for the first time and stands as the most comprehensive international agreement on intellectual property till date.

[17] Article 52, European Patent Convention

[18] Article 52, European Patent Convention 1973 as amended in 2000

[19] 35 USC Section 101 (2005)

[20] It has been held that isolation and purification of a naturally existing gene sequence lends novelty to the sequence; as taken from Dr. Kalyan C. Kankanala, Patenting Biotechnology Inventions available at www.slideshare.net/Brainleague/introduction-to-patent-law accessed on 6th Jan, 2015

[21] The same ideology has been maintained in European Patent Convention, Article 53 (a). The article reads denies patentability to “inventions, the publication or exploitation of which would be contrary to “ordre public” or morality.

[22] Introduction to Novelty, Nonobviousness, and Double Patenting- Chapter 4, Biotechnology and the Law, Volume 1.

[23] http://russianlics.sstu.ru/globelics.nsf/0/18CC45447D998BFFC32572CF003EBCC8/$File/Globehelics%20-%20P.Arora%20(India).doc, accessed on 6th Jan, 2015

[24] Discovery means merely making available what already exists in nature.

[25] http://ijme.in/index.php/ijme/article/view/1168/2643

[26] Diamond v. Chakrabarty, 100 S.Ct. 2204 (1980); It also stated that living organisms were not excluded from the scope of patentable subject matter in USA

[27] http://www.iprhelpdesk.eu/sites/default/files/newsdocuments/IP_in_Biotechnology.pdf, accessed on 5th Jan, 2015

[28] Iver P. Cooper, Biotechnology and the Law- Volume 1, 2014

[29] Oxford English Dictionary: “Manufacture 1.a The action or process of making by hand, the process of making articles by mechanical power, the most perfect manufacture is that which dispenses entirely with manual labour.”

[30] Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure on April 28, 1977 and into force on August 9, 1980.

[31] http://www.voiceofresearch.org/Doc/Jun-2014/Jun-2014_9.pdf , accessed on 5th Jan, 2015

[32] Such is a common experience that is faced by the Indigenous people who always face difficulty in protecting their knowledge against the piracies occurring.

[33] http://www.fbae.org/2009/FBAE/website/our-position-ipr.html, accessed on 6th Jan, 2015

[34] Monopolizing the profit drawn out of the application of traditional knowledge in the sector of pharmaceutical firms is a common trend.

[35] It should be noted that IPR’s are primarily based on the concepts and standards that have been developed by few western countries. These concepts and standards, it has been realized, not necessarily fulfill the IP requirements or standards of majority of the developing countries. Hence as a result the codified or non codified Traditional Knowledge has also become an open treasure for misappropriation.

[36] http://www.mondaq.com/india/x/26049/Healthcare/Biotechnology+Laws+in+India accessed on 6th Jan, 2015

[37] The linkage between biodiversity, traditional knowledge and IPR is the product of the exploitation done by big pharmaceutical companies and the loss of various indigenous plant varieties from the forest. Reading CBD Article 8(1)(j) illustrates that the International instruments are having some focus towards commercializing the TK or sharing the economic benefits hence derived from it. The growing commercial importance of Biodiversity increases the necessity of framing Indigenous people centric mechanism to protect from exploitation.

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