Biotechnology Is a Totally Inappropriate Field for Patents Essay

Introduction

Whether patents can be applied to biotechnology is a question that remains lingering in the minds of numerous people, yet it is difficult to establish a conclusive answer to the question. Recent times have witnessed massive developments in the field of life sciences. As of today, thousands of products have been developed and others are still in the testing phase. There is still a wide range of legal and safety issues that surround the development and distribution of products that are developed through biotechnology.

Research denotes that patent laws existed way before the field of biotechnology was known and embraced. However, the development of the field of biotechnology has watered down the patent law, which now focuses a lot on the field of biotechnology. It is argued that the inventions in the pharmaceutical industry had raised issues of the introduction and enforcement of patent laws. However, this was not taken into consideration fully.

The question that should be asked is why patent law is increasingly pursued in the modern times when biotechnology is highly practiced and embraced in different industries. The issue that concerns patents in biotechnology is the inventions in the industry and inventions in the academic field. Patenting is quite complex, especially when it is applied to the field of biotechnology.¹ Complexities of patents in biotechnology emanate from the fact that the field is very dynamic and changes in technology keep taking place at an increasing rate. The complexities of applying patent laws in the field of biotechnology are, therefore, far from being ironed out.

The more the field of biotechnology expands the more complex and harder it becomes to enact and enforce patent laws in the field.² In this paper, it is argued that although there are ongoing efforts to develop and enforce patent laws in the field of biotechnology, it is quite complex to fully enforce patent laws in the industry due to the prevailing and emerging dynamics in the field of biotechnology.

This paper explores patents in the field of biotechnology. Of greater focus in the paper is bringing out the complex issues that appertain to patenting of biotechnology products and technologies and what they mean in as far as the enforcement of patent laws in the field of biotechnology is concerned. The paper begins by giving an overview of the developments that appertain to application of patents in the field of biotechnology. This is followed by a discussion of a wide range of complexities that relevant in applying patent laws in the field of technology. Examples of cases of patenting in biotechnology and their implications are brought out in the discussion.

An overview of patenting in biotechnology

It is critical to begin the discussion by understanding the meaning of patents and how it applies to biotechnology. Patents form part of the developments in the field of intellectual property rights. Patents refer to sets of exclusive rights that are given to an inventor of a given technology or product. Such rights are offered by the state as a way of recognizing the efforts of given individuals or sets of individuals and are aimed at preventing other people from encroaching on the invention and using it as if were their own. Patents define the legal ownership of a given technology and states the amount of time for which the technology is owned by the inventors or applicants.

The period is often stated at 20 years from the time of development. Exclusive rights that are given to technology developers entail the prevention of other people from developing, using and marketing any products that are developed from the patented technology. For a technology to qualify for patenting, it must fulfil a substantial number of attributes, which are measured through subjecting the technology to test. The technology must be novel and be applicable in industry. The inventive steps involved in the development of the technology must, therefore, be evaluated before the technology is considered worthy to be patented.

The main goal of developing a patent system in biotechnology is to protect a given type of an intellectual property; invention. Developers of inventions who include individuals and companies are protected so that they can make money out of the inventions that they develop. However, the process of developing the inventions is a critical issue. It is out of the process and the acceptability of such inventions that questions about the worth of applying patent laws in the field of biotechnology.³

According to Crespi⁴, patent rights have been applied in a substantial number of fields for a long time. However, the complexity of the subject of patenting was witnessed when the field of biotechnology propped up and there was need for the application of patents in the field. It is critical to note that the field of biotechnology began gaining prominence in the mid years of the 20^th century when there was a need for the development of technology to aid in improving human life.

The rapid growth of the field attracted a lot of players, leading to the emergence of issues of intellectual property rights in the industry. During the early times of development in biotechnology, there was massive support from governments and agencies, thus the field was subjected to only minimal controls for a long time. However, the continued development in biotechnology has resulted in the need for commercialization, which has attracted controls. The other thing is that biotechnology is a broad field and the technologies that are developed in the field have an effect on people’s lives when they are applied in the industry.⁵

According to Sreenivasulu and Raju⁶, the patent law in biotechnology covers a substantial number of inventions, which include plants, animals, micro-organisms, and human genetic materials. Patenting in biotechnology is critical since entails the protection of technologies that entail human and animal life. The enactment of patent laws in biotechnology can be traced from the early years of the 20^th century. However, comprehensive laws were developed in Europe and the United States in the post-mid years of the 20^th century when the scale of technology and its subsequent influence on industry rose.⁷

Ramani, Malkoc, Murlis and van Wesemael⁸ observed that there are different sub-fields, which have been developed as far as the field of biotechnology is concerned. This depicts the need for controls in biotechnology and especially the protection of the development of technologies in the field of biotechnology. Biotechnology is being developed from two perspectives: the field of science that is based on institutions in the industry and the field of academics, which is based on academics and academic institutions.

This raises a stalemate about how to adjust the patent laws so that they cannot impede the advancement of technology in the field of biotechnology. The development of technology takes place on a developmental course. This implies that the development of a given technology often comes as a result of looking into other technologies and coming up with ideas on how to improve the prevailing technologies. This is one of the main complexities in the application of patent legislation in biotechnology.⁹

Crespi¹⁰ observed that the patent law is critical to people who venture into research, as well as those people who venture in technological innovation. The broadening of the field of biotechnology has resulted in conflicts over rights of technology, resulting in court cases over the infringement on technology. Patent laws in biotechnology have been subjected to scrutiny by the public. This raises questions about whether there is full application of moral and ethical considerations in the development and enforcement of patent laws.

The question of morality resonates from the cases that have been presented, which denotes the ignorance of a number of factors by the patent attorneys while developing and enforcing the legislation on patents in the field of biotechnology. The moral consideration of patents in the field of biotechnology is that biotechnology is supposed to advance the development of technology, while at the same time promoting the safety of human and animal life. Human beings and animals are the epicentre of the development of biotechnology.¹¹

A substantial number of arguments featuring in disputes between players in biotechnology bring out issues revolving around morality and rights of protection of technologies.¹² One of the recent developments in the field of biotechnology is the trend of concerns on legalization of technologies that involve the mixing of animal and human species and the implication of such development on the value of humanity. The separation of patents and research is something that has not seen the development of boundaries, which is why there is a considerable amount of friction in biotechnology. There is a divided opinion about the possibility and implication of granting exclusive patent rights to researchers.¹³

Developments and complexities of patents in biotechnology

One critical question that ought to be explored concerning biotechnology is whether patents can be applied in the field. As observed in this paper, the field of biotechnology has witnessed tremendous growth over the past few years. The growth in biotechnology is considered as a positive development, yet it is surrounded by complexities. Among the complexities is the issue of morality in genetic engineering and the standoffs in as far as the advancement of technology is concerned. Biotechnology also has a lot of impact on the users of technology, which raises a lot of concerns about giving exclusive rights to the biotechnologists.¹⁴

One of the critical factors that affect biotechnology companies that want to patent their products or inventions concerns the types of inventions that qualify to be patented. The response to this concern is quite complex and cannot be answered without expounding on issues of jurisdictions of rights that have been brought about by the emergence and growth of inventions in the biotechnology industry. In most regions in the world today, biotechnology has caused a review of legislations concerning the kinds of inventions that qualify to be patented and those that do need to be approved for patenting. It is quite daunting to convert technologies into real ventures.

This adds to the complexity of the procedures that are undergone by companies to patent the inventions. This is one of the hindrance factors in the development of the biotechnology industry in a substantial number of countries across the world.¹⁵

A lot of issues keep emerging in the field of biotechnology, according to Biotechnology Patent Wars Continue.¹⁶ The friction about the enforcement of patent laws in the industry keeps rising in scale, thereby raising more concerns about the future of patents in biotechnology. The complexity in patenting biotechnology inventions becomes quite elusive as more and more firms enter the industry and seek to secure biotechnology rights.

The possibility of infringement on the rights of other companies, therefore, becomes more likely with the rise in the number of firms that are seeking to gain a position and a name in the industry. Several patent cases concerning patents in biotechnology have been settled since the last quarter of the 20th century when the world began witnessing an upsurge in the number of investments in biotechnology.¹⁷

The search for competitiveness by companies in the industry is causing alliances in the biotechnology industry where firms collaborate to advance research to promote inventions. This is another factor that denotes a diverse angle to the issue of patents in biotechnology. The issue of formation of alliances in the biotechnology industry is a factor that causes a shrink in the seemingly widening environment in biotechnology in which patenting has taken root. The implication of this issue is that biotechnology firms are shifting their trend in invention and are now focusing more on the modalities of making huge profits out of the patents that they managed to secure.¹⁸

Patentability in biotechnology

As observed earlier in the paper, the issue of patents in the field of biotechnology has been subjected to a wide range of debates, as well as disputes. There have been a number of legal suits that have been pursued in the United States pointing to the possibility of opening up the exercise of patents in biotechnology.¹⁹

The Diamond v. Chakrabarty case that was heard in the United States Supreme Court is one of the most famous cases that have promoted patents in biotechnology. In the case, the Supreme Court held that everything that has been made by man can be patented. The ruling by the Supreme Court paved way for the patentability of inventions in the field of biotechnology. The case was based on the novel idea by Chakrabarty in which “he discovered the possibility of using four different plasmids to degrade four different components of oil and the maintenance of the compound in a single Pseudomonas bacterium that has no capacity to degrade the oil”.²⁰

The bone of contention in the case was that not all the claims by Chakrabarty were disallowed. This was based on the argument that he developed a new bacterium that had different features compared to the existing bacteria. Basing on this case, a substantial number of patents have been given on biotechnology inventions and numerous other living organisms, including the patent on a mouse that was genetically modified. Several other cases have also been pursued by the Supreme Court of the United States, whose outcomes have resulted in further opening of patents in biotechnology. It can be said that the future of the biotechnology industry is founded on allowing patents in the industry as it has come out in the legal cases on patents.²¹

Several sentiments have been made about the impacts of the outcomes of most of the litigations in the cases of patents in biotechnology. One of the cases that were closely monitored by practitioners in biotechnology is the Festo Corporation v Shoketsu Kinzoku Kogyo Kabushiki Company case. The case concerned the application of the equitable doctrine (DOE), which protects the holders of patents from researchers who make limited changes and escape from liability of infringement on the invention.

The result of the limitation as argued by Festo is that approximately 1.2 million patents in the United States would narrowed, thereby making it difficult for the developers of the technologies to make claims of ownership of the technologies. The impact of limiting the DOE is, therefore, likely to hound the biotechnology industry. This can be likened to the argument presented earlier in the paper, which pointed to the fact that biotechnology innovations are quite expensive to develop.²²

There is need to protect the patentees in the field of biotechnology from people or firms who are fond of making unsubstantial changes to innovations. This may also imply duplication of technology, thereby hindering the value of technology besides eliminating the incentives on the side of the developers of inventions in biotechnology.

In the law that governs patents, biotechnology is viewed as an art that is quite unpredictable. This implies that it is quite difficult to determine how any minor change in any biological invention will affect the functions of that invention. This forces the developers to provide more details as one of the minimum requirements for gaining a patent for any invention. However, the interference with the DOE promotes the infringement on patents through the utilization of the details that are offered by the developers of invention.²³

‘Patent trolls’ is another issue that affects patents in biotechnology. There are a number of companies in the biotechnology industry that make profits by virtue of the enforcement of patents that are owned by them rather than engaging in the development of new products. This raises the question of whether patenting is favourable in as far as the increase in the scale of innovation in the field of biotechnology is concerned. Such an issue comes out in the case of “Classen Immunotherapies of Baltimore, Maryland v. four biotechnology companies and one medical group in which the companies were accused of infringing on the patent”. It entailed the attempt to link infant vaccination with the immune disorders that emerged later.

The patent entails referring to and using research that would help in making a vaccine that can tackle immune challenges in children. In the case, it was argued by Classen that the other biotechnology companies were using the ideas that had been developed by Classen in that it was Classen who first established the relationship between vaccine schedules to the immune disorders using animal studies. A district court had ruled that the idea did not meet the threshold required for patenting. However, the US Court of Appeal differed with the ruling.²⁴

According to a substantial number of researchers, this and numerous other cases of a similar dimension depicts the issue of opportunism by way of using litigation as a protection tool. The number of opportunistic litigators in patents is on the rise in the contemporary economy. There is a trend whereby litigators in the current economy are turning out to be opportunistic. Biotechnology companies are, therefore, ending up in the hands of such opportunists. This can be blamed on the worsening of economic conditions, which results in such behaviour by companies in the biotechnology industry.²⁵

Morality and patents in biotechnology

Patents in biotechnology involve the application of technology for the advancement of animal, human and microorganisms. This is done in a substantial number of countries that embrace technology. Morality entails the separation of right actions from wrong actions in as far as research and invention in biotechnology is concerned²⁶. Despite the fact that patent laws in biotechnology are restricted to countries, there have been a number of controversies that surround moral issue in the patenting biotechnology inventions. Interest groups in a substantial number of countries in the world, among them the United States, have carried out research and reported on the moral issues and how they affect patenting in biotechnology.²⁷

There is variation in the way in which the view of morality is expressed concerning the patent of plants, animals and human beings. Morality seems to pay attention to the value of human beings and draw away the impacts of inventions on the value of animals and plants. Whether patents in biotechnology should go on is an issue that is dependent on how much morality comes out as a critical concern.²⁸

According to Hoedemaekers²⁹, moral issues can only be effectively brought out through assessment of the development of genetic products. They usually come out at given states in the processes of developing genetic products. Risk analysis of such processes and the assurance of safety of the genetic developments on the users are two critical issues that should govern the process of detecting the desirable inventions in biotechnology. In Europe, concerns about the possibility of effective patenting of biotechnology attributes are tackled in the European Patent Code. The code has a provision on morality, which defines and expounds on the nature of moral issues in gene patenting.

The clause on morality raises a lot of concerns to an extent that it becomes quite hard to provide ample time to the researchers in the field of genetic engineering. Is it right for the patent system to allow for the introduction and the pursuance of morality in genetic patenting? This question comes out of the concerns that are increasingly raised about the European patenting laws that have opened up and allowed for the pursuance of moral issues in the biotechnology field. However, there were a lot of difficulties in the formulation of the patent law in biotechnology.³⁰

Hoedemaekers³¹ observed that patents in the field of genetic engineering are a concern for most people since they seem to ignore concerns about nature. Three main concerns come out in as far as patenting in genetic engineering is concerned. There is the issue of preventing the patenting of genetic modifications, which are contrary to the dignity of human beings and those that are non-therapeutic.

The code of ethics that promote genetic research on animals without subjecting them to suffering is also an issue of moral concern of people who assess developments in the field of biotechnology. Whether the suffering that is inflicted on animals in genetic advancements is justified is a question that relies on the outcomes of the genetic engineering process. Whether the enhancement of patenting in genetic developments, which involve restructuring of the human body is justifiable, is a question that remains rhetorical especially when it is linked to nature.³²

In the application of patents in the field of biotechnology, two main issues come out. These are: the specification of the technology and invention developer and the claims that are made about the patent. The inventor is given a room to explore the process that was utilized in inventing the product. However, in a number of circumstances the claimed patent can go far beyond the rights that are enlisted. Patents and the resultant applications, therefore, contain a substantial number of claims of various scopes. The scope of variations in biotechnology inventions is spearheaded by the claims of the qualities that are patentable.³³

Reasons that back the patenting of biotechnology research and inventions

Research indicates that biotechnology is one of the most vocal fields of development in the contemporary global environment. Biotechnology is competing with the information technology industry and is bound to take charge of the developments in the globe in the near future. The contemporary growth of the biotechnology sector is attributed to the protection of the inventions that have been developed by companies and individual researchers in the field.

According to the Organization for Economic Cooperation and Development (OECD), there has been a significant rise in the number of patents that have been given in the field of biotechnology. Between 1990 and 2000, the number of patent grants by United States Patent and Trademark Office rose by 15 percent. A similar trend was also witnessed in the European Patent Office, where there was a 10.5 percent rise in the number of patents that were granted. Intellectual property in the field of biotechnology comes with an extraordinary high-priced value, and this explains the growth witnessed.³⁴

The question that needs to be explored at this juncture is the reason why patents seem to be relevant in biotechnology. It is quite daunting to answer the question without digging into the biotechnology industry. As of today, the biotechnology industry forms one of the industries that attract intensive research in the entire globe. Most of the capital in the biotechnology industry, about 40-50 percent, is spent in research and development.

With this magnitude of investment in the biotechnology industry, protection of the research outcomes becomes a fundamental issue.³⁵ The development of products and processes in the biotechnology industry is cost intensive. However, it is quite easy and less costly to imitate the processes and technologies that are developed in the industry. There are also a lot of risks that are posed to researchers in biotechnology.

When biotechnology companies invest in research that aims at bringing about inventions, they are often not sure whether they can attain results that can be marketed. The protection of research and development work in biotechnology is, therefore, an issue that is paramount. In biotechnology, there is a profound linkage between basic and applied research, unlike other fields where the link between basic and applied research is not very strong. Most companies in the biotechnology industry are reported to be engaged in acts of patenting basic research from academic institutions. This implies the need to protect biotechnology research and inventions that are developed in academic institutions.³⁶

Research that has been conducted in Canada denotes that the complexities in patenting inventions in biotechnology can be simplified. Patenting of inventions in animal technology can raise the level of biotechnology investment in the agriculture industry, thereby enhancing innovation in the industry. While it is argued that patenting biotechnology enhances undesirable competition between researchers in the biotechnology industry, research has proven otherwise. Research denotes that the scale of such competition is not destructive as pointed out by a wide section of the opponents of patenting in biotechnology.³⁷

Patenting opens up the industry to more research and development through the identification of firms and researcher that are committed to advancing biotechnology research and invention. This is critical to solving the problem of research funding, which has been mentioned as one of the impediments that inhibit the development of biotechnological research.³⁸ The funding can be done in three ways. These include: funding of research and development that depict a high probability of being commercialized and the provision of revenues from royalties to the institutions of research to manage to license the products that they have patented to other players in the industry who have the potential of commercializing the inventions.

The other way of eliminating complexities in patenting of biotechnology products is the provision of revenues from biotechnology products that have been commercialized. In other worlds, the suggestions that are made by researchers imply the need to build a transparent environment in the field of technology by fostering the establishment of transparent regimes to administer and manage patents in biotechnology.³⁹

Conclusion

This paper has explored the critical developments about the issue of patents in the field of biotechnology. From the discussion in the paper, several critical issues have been brought out concerning the complexities that surround the enforcement of patents in biotechnology. The first issue in as far as patents in biotechnology are concerned is commercialization of biotechnology. Commercialization of biotechnology results in the concentration of firms on making gains from the patented technologies, instead of enhancing the development of new inventions. Morality and ethics have also come out as critical issues in patenting biotechnology.

It emerged from the discussion that a number of concerns are being raised about the features of certain inventions and the attribution of the inventions to the respect and validity of human and animal life. It can, therefore, be concluded that the biotechnology industry will keep encountering issues as more players enter the industry. There are a substantial number of pointers in the discussion on the fact that innovation in biotechnology is suppressed by patents. However, there are other developments that back the validity of patenting in biotechnology.

Bibliography

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Brody Baruch, ‘Intellectual property and biotechnology: The European debate’, 17(2), KIEJ 69.

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Footnotes

1. Check Hayden Erika, ‘Patent trolls’ target biotechnology firms’, [2011] 477(7366), N 521.
2. Stephen Crespi, Patenting in biotechnology: the saga continues’, [1998] 15 BGER 229.
3. Radder Hans, ‘Exploiting abstract possibilities: a critique of the concept and practice of product patenting’, [2004] 17(3), JAE 275.
4. Stephen Crespi, Patenting in biotechnology: the saga continues’, [1998] 15 BGER 229.
5. Nese Sreenivasulu and Chandranna Raju, Biotechnology and patent law: Patenting living beings (Manupatra, 2008) 69.
6. Ibid.
7. Ibid 70.
8. Shyama Ramani V, Malkoc Sirma, Murlis Simon and van Wesemael Karel, ‘Biotechnology patents in the food sectors’, [2001]19(4), NB 383.
9. Stephen Crespi, Patenting in biotechnology: the saga continues’, [1998] 15 BGER 229.
10. Stephen Crespi, ‘Biotechnology patents and morality’, [1997] 15(4), TB 123.
11. Peter Yu K, Intellectual propert and information wealth: Issues and practices in the digital age (Praeger, 2007), p. 32
12. Stephen Crespi, ‘Biotechnology patents and morality’, [1997] 15(4), TB 123.
13. Peter Yu K, Intellectual propert and information wealth: Issues and practices in the digital age (Praeger, 2007), p. 33.
14. ‘Biotechnology patent wars continue’ [1999] 32(2), FIN 18.
15. Burrone Esteban, Patents at the Core: the Biotech Business, (2006). Web.
16. ‘Biotechnology patent wars continue’ [1999] 32(2), FIN 18.
17. Ibid.
18. Patents plague biotechnology, Investment Adviser, (2008). Web.
19. Kalyan Kankanala, Complications in patenting biotech inventions: A peek at US law, 2005. Web.
20. Ibid
21. Kalyan Kankanala, Complications in patenting biotech inventions: A peek at US law, 2005. Web.
22. Edward Ergenzinger R Jr and Murray Spruill, ‘Biotechnology patent holders beware!’ [2002] 15(6), BP 58.
23. Edward Ergenzinger R Jr and Murray Spruill, ‘Biotechnology patent holders beware!’ [2002] 15(6), BP 58.
24. Hayden Erika Check, ‘Patent trolls’ target biotechnology firms’, [2011] 477(7366), N 521.
25. Ibid.
26. Radder Hans, ‘Exploiting abstract possibilities: a critique of the concept and practice of product patenting’, [2004] 17(3), JAE 275.
27. Peter Yu K, Intellectual propert and information wealth: Issues and practices in the digital age (Praeger, 2007), p. 33.
28. Rogeer Hoedemaekers, ‘Commercialization, patents and moral assessment of biotechnology products’, [2001] 26(3), JMP 273.
29. Ibid.
30. Baruch Brody, ‘Intellectual property and biotechnology: The European debate’, 17(2), KIEJ 69.
31. Rogeer Hoedemaekers, ‘Commercialization, patents and moral assessment of biotechnology products’, [2001] 26(3), JMP 273.
32. Baruch Brody, ‘Intellectual property and biotechnology: The European debate’, 17(2), KIEJ 69.
33. Radder Hans, ‘Exploiting abstract possibilities: a critique of the concept and practice of product patenting’, [2004] 17(3), JAE 275.
34. Burrone Esteban, Patents at the Core: the Biotech Business, (2006). Web.
35. Radder Hans, ‘Exploiting abstract possibilities: a critique of the concept and practice of product patenting’, [2004] 17(3), JAE 275.
36. Burrone Esteban, Patents at the Core: the Biotech Business, (2006). Web.
37. Vicent Amanor-boadu, Morris Freeman and Larry Martin, The potential impacts of patenting biotechnology on the animal and agri-food sector, (1995). Web.
38. Ibid
39. Nese Sreenivasulu and Chandranna Raju, Biotechnology and patent law: Patenting living beings (Manupatra, 2008), p. 98.