Biotechnology utilizes biomolecular and cellular processes to develop products and technologies and puts living organisms to use in the medical industry. Usually, two types of patents are awarded for biotechnical inventions, product patents and process patents. Such patents are awarded based on inventions in biotechnology and not discovery as no one can own organisms in nature. This complicates the process of awarding patents. Additionally, other ethical concerns arise as such inventions use living organisms.
This paper talks in depth about biotechnology patents and analyses the intersection between intellectual property rights of individuals and the ethical concerns that arise from genetic engineering. Further, the rights and liabilities of such patent holders are evaluated along with pros and cons of such patents to conclude the ethicality of biotechnology patents.
Biotechnology Patents and Owners: Rights, Liabilities and More
With the aim of balancing the rights of all liabilities, biotechnology patent holders and owners have to follow certain procedures and fulfil requirements to acquire a patent over their product or technology. It is advised to strictly follow the procedures that are laid down by Acts, guidelines or rules that are laid down by the country for a domestic patent. Such domestic procedures might be based on and inclusive of laws in international treaties as well. The procedure slightly differs for patents over international borders i.e., patent over an invention in other countries. For an international patent, an applicant must apply to the Patent Cooperation Treaty (PCT) as they assist individuals who want patent protection internationally and also help patent offices with patent granting decisions.
Few landmark cases have provided the scope of biotechnology patents on a global scale. Diamond v Chakrabarty permitted the patentability of a microorganism. The US Supreme Court observed that qualifications for a patent cannot consider the status of the invention (living/ non-living).
The US Supreme Court in Association for Molecular Pathology v Myriad Genetics, Inc. held that finding a specific DNA gene sequence by isolating it does not make it eligible for acquiring a patent as it does not fulfil the requirement of an invention or something being made. This was also observed in an Australian case, D’Arcy v. Myriad Genetics Inc.
In Dimminaco AG v Controller of Patents, the Calcutta High Court held that if a process passed the ‘Vendibility Test’ (commercial viability of sale) then regardless of the living organisms involved in the process of manufacture is patentable.
Issues with Biotechnology Patents
First, though there has been significant development in laws regarding patents, the scope and extent of protection under patents is still unclear. Biotechnology patents share similar features with other patents and similar laws and conventions are applied to them too such as WTO’s TRIPS Agreement (Agreement on the Trade-Related Aspects of Intellectual Property Rights). However, a more primary concern is if these products can be qualified for patents and protection under IP law considering they are derived from nature and in most cases, amount to mere discoveries. The argument whether they are ‘discoveries’ or ‘inventions’ has still not reached an end.
Second, an invention is patentable only if it qualifies these three requirements: novelty, inventive step and industrial application. These requirements also apply to biotechnology patents. However, due to the complex nature of the subject-matter, it becomes difficult to assess whether a patent should be awarded to an invention or not. Further issues regarding licensing and exploitation of patents also arise once patent protection is granted. Exceptions to patent protection such as the Experimental Use Exception frequently create difficulties.
Third, most inventions from biological material can be similar to other already-existing technologies or products as they are capable of reproducing similar results. The absence of stricter laws regarding scope of protection, special rules for animal and plant breeders, etc. can create issues. Balance between environmental laws and patent protection need to be clearly established and laid down which is currently missing from the legal framework.
Biotechnology Patents and Ethical Concerns
Biotechnology uses the study of different microorganisms and understanding how they can be incorporated in the lives of individuals to make it better in regards with a healthier lifestyle. Although this branch of science has achieved success in many countries, it still remains a subject of extreme controversy due to the implications it has. It also poses some serious ethical concerns.
Firstly, it often requires understanding microorganisms on a molecular level and studying their genetic information. This leads to manipulating their DNA with the use of various scientific techniques in a manner that is beneficial for human beings. Various groups of people, especially different religious sects, tend to not support this field of science.
Secondly, awareness for the need of environmental laws and environmentally conscious individuals is rising globally. Use of microorganisms and plants raises serious concerns as it contradicts laws for preservation of biodiversity. Further, due to absence of concrete rules in place, commercialization of such inventions that utilize such flora and fauna has been in debate among various international organizations such as the World Trade Organization (WTO), the Convention on Biological Diversity (CBD), etc.
Thirdly, to gain approval regarding the potency of the product or technology, countless inventions are tried on human and animal subjects. Various countries have taken active steps to avoid granting patents to such inventions however, it still gives rise to an ethical conundrum as multiple organizations still conduct such trials.
Biotechnology Patents: Pros and Cons
The main objective of issuing biotechnology patents is to balance interests of parties by allowing investors to get exclusionary rights over the invention in exchange for full disclosure of material information. This promotes further development while awarding the owners and investors get return for their efforts and funding/investing. Such a system was developed solely for achieving maximum public benefit and has proven to be quite useful and effective over the time.
- Protection of the rights of owners while promoting full disclosure of information regarding the invention provides basis for further research and development. This allows for more innovative ideas that have the power to change several aspects of human lives.
- Projects in biotechnology and genetic engineering are often time-taking and costly. These patents protect the owners and investors and awards them with returns for the hard work they put in. Additionally, it helps incentivize creators to continue research and development.
- Granting patents for innovation increases competition in the market which has multiple benefits. They include reasonable prices for acquiring a license for the utilization of invention, companies and creators coming up with better products and technologies, etc.
- In various scenarios, it also facilitates collaborations among companies resulting in the best technologies or products pushing innovation and making the market very productive.
Despite numerous benefits, there are certain disadvantages to biotechnological patents as well.
- Due to the complex nature of these patents, it takes a long time to process the applications and grant the patent. This usually happens as there are multiple requirements that need to be fulfilled before the patent can be granted and the distinction between a ‘discovery’ and ‘invention’ is still tricky to understand.
- Along with the time taken to process such applications, the fee that is required to get an invention patented is often very high. This causes issues when investors do not expect as high monetary returns as the cost.
- There is also lack of transparency in the selection process. Most patent offices do not disclose the stage of the applications or in cases of rejection, why such product or technology was rejected.
- Even when patents are granted and the inventions are subject to protection under them, there are multiple uncertainties regarding the scope and extent of protection. Cases regarding patent infringement might lead to lengthy legal disputes due to such uncertainties and therefore, delay other innovations.
How to mitigate ethical concerns arising from such Patents?
To promote fair grants of patents and licensing, countries have taken numerous steps towards producing and following stricter guidelines that are aimed at making the process clearer and more efficient. They also aim at clarifying the uncertainties that exist in such procedure and therefore, streamline the process for better and timely grants of patents. They further address the ethical concerns arising from biotechnology and genetic engineering and provide stronger laws in response.
While understanding the growing field of biotechnology and genetical engineering along with their fundamental importance in the society, Europe has issued EU Directive No. 98/44/EC 1998 to promote patenting of biotechnology in EU. To promote the interests of all the parties involved, adequate legal protection was deemed essential. Other highlights include the non-patentability of cells/ genes of human body, whether it be whole or partially, non-patentability of naturally-occurring cells, patentability of natural/ human cells after they have been isolated and produced by a scientific technique, etc. It is essential to disclose practical usages to gain patents as otherwise, it amounts to mere discovery. These steps supplement laws that are already in place with additional details and provide a clearer understanding.
In India, biotechnology patents are governed by the Patents Act, 1970 along with Patent Rules of 2003. Additional guidelines were released in 2016, “Guidelines for Examination of Biotechnology Applications for Patents” and they provided specific guidance for the qualification and examination of patent applications. They cover significant aspects and provide great detail regarding qualifications for patentability, requirements for application, sufficiency of disclosure, etc.
In the United Kingdom, guidelines have been released that explain in great detail the basic principles that need to be followed to acquire a biotechnology patent in addition to other requirements. They strongly enforce morality and are against human and animal trials. Inventions that include human or animal trials are deemed unpatentable under law. Other highlights of the guidelines include allowing non-commercial usage of product or technology by medical or veterinary practitioners, strong commitment towards public welfare, etc.
Some general guidelines released include aspects of ‘sufficiency of disclosure’. This means that an individual applying for a biotechnology patent should disclose the information regarding the invention in a way that it can be used by other individuals in the same field. Although it is difficult considering the nature of biotechnological inventions, it has become a requirement which has helped in narrowing the difference between ‘discoveries’ and ‘inventions’. Legislation also includes morality as a consideration towards patentability. These considerations and requirements have been set up to address the various ethical concerns arising out of this field of science.
Conclusion
Despite the numerous ethical concerns arising from genetical engineering, it has been deemed an essential field in science for the benefit and growth of human beings. These concerns have been understood and addressed by countries on a domestic and international level and therefore, steps are being taken to mitigate such concerns while promoting public welfare. Further discussions on international levels are being held and are expected to yield effective solutions.
As discussed, the goal of biotechnology patents is to balance the rights of parties involved. It further aims to achieve a fair place between free access of information and absolute monopoly. Considering the patent laws, biotechnology patents have come a long way. Countless landmark judgements and laws have made the entire process of application and granting more streamlined and efficient however, more deliberation is required on the matter. Professionals from other streams should be included when laws are being formulated for a better and broader outlook. Other suggestions include listing of ethical concerns as they differ across regions and adjusting local laws accordingly and reduction in time period of granting patents among others.
Submitted by Jhanvi Jain, a Law Student pursuing B.Com LL.B. from Jindal Law School.