Patent – a shield for modern biotechnology

Biotechnology-the word suggests that this is biological advancement based on technology. The topic of interest is related to both the cellular and molecular aspects of biological objects. Biotechnological advancements have strong implications in the pharmaceutical and food industries as well as in genetic modifications in animals, microorganisms, and plants. The genetic makeup technique of biotechnology helps animals and plants combat several rare diseases. The dairy, food, and agricultural sectors also depend on biotechnological research. The study needs a high level of patience and huge investments in time and money. Thus, a legal safeguard should be provided to inventors for their inventions to keep their interest in science alive.

What are the biotechnological inventions?

Biotechnological inventions include scientific and industrial disciplines that are mostly concerned with manipulating living and biologically active materials at the genomic level. This technological advancement heals the world at the molecular level and most often involves DNA modification techniques. Some important contributions of this technology based biological advancement include-

• Agriculture-. Biotechnology helps in sustainable agriculture by solving issues related to food production in an ecological manner using genetic engineering. For example, in disease-free crop production, generation of biotic and abiotic stress tolerant plants, generation of biofertilizer for agricultural sustainability in place of commercially available fertilizer such as urea, production of food free of allergens, etc.
• Dairy and food industry: This industry has benefitted from new innovations and advancements in modern biotechnology. These include the generation of bio-preservatives to extend the shelf life of packaged dairy products, production and ripening of milk products such as cheese, generation of transgenic animals capable of producing more milk, identification of genetically different animals, flavored food production, and production of nutrient-enriched food products.
• Healthcare: Research in biotechnology firms revolutionizes the healthcare system. This leads to a reduction in the rate of infectious diseases using vaccines and the development of techniques for detecting, treating, and curing diseases such as cancer, diabetes, respiratory complications, cardiovascular problems, and viral diseases like Covid etc.
• Environment- Research in Environmental biotechnology contribute to making a healthier atmosphere for the living animals. Examples are-development of techniques for reduction of greenhouse gas emissions, the use of bacteria to degrade plastics, removal of heavy metals from soil using bacteria, degradation of water pollutant using different bacteria, the use of algae to absorb the excess nutrient from water to make the environment healthier for flora and fauna etc.

In modern biology research, inventors come from various disciplines such as pharmaceutical, environmental, agricultural, and dairy, and all of them are involved in improving the quality of life. However, researchers need a huge amount of investment to pursue experimentation. This leads them to think about protecting their inventions from unauthorized use. Patents are important and powerful tools that provide safeguards to biotechnicians and help them.

What is patent?

A patent is a legal document that provides exclusive rights to inventors over others in making, using, and selling their inventions for usually 20 years from the date of filling the patent application. Inventors can seek protection from their creations to the government to prevent the infringement of their ideas. This also provides monetary benefits to inventors if someone uses it in the future. All patentable inventions should follow three main criteria: novelty, inventive steps, and industrial applications. New products and processes fulfilling these criteria can be patented according to the Indian Patent Act. The invention should have technical advances as compared to existing knowledge and should have socio-economic significance and implications for industry. This should include an incentive step. It should not be anticipated by publication in any document or used within the country or elsewhere before the filing date of the patent.

Patents provide protection to innovations as well as commercialization of inventions. This multistage process comprised the filling of an application, processing, screening and classification, publication, examination, hearing if required, pre-grant opposition (if any), grant, or rejection.

Details of the inventions, the best method of performing them, and the claims for which inventors seek protection should be mentioned specifically and clearly in patent applications.

Who can file a patent application?

According to Indian Patent Act sec 2(1)y, the true and first inventors can file a patent. Apart from the first inventor, an assignee of the inventor and the legal representative of the deceased inventor can also apply for patents in accordance with Indian Patent Act sec 2(1)ab and sec2(1)k.

Who can provide for patent rights?

Government organizations such as Indian patent offices (India), United States patents and trademark offices (USA), European patent offices (European Union), and Australian patent offices (Australia) have the authority and facilities to provide patent rights.

Importance of patent in biotechnology-

Patents are crucial monopoly rights provided to inventors to protect their intellectual property rights and earn revenue from their inventions. As most of the research works require a large cost for expensive chemicals and instruments, researchers can utilize the monetary benefits from the previously granted patent for their future work. Legal protection of exclusive rights and revenue is necessary for inventors to encourage them to pursue their research work for the socio-economic development of the nation.

Biotech firms related to pharmaceuticals are mostly concerned with the innovation of medical instruments and the effectiveness of drugs in animal cell lines. Restriction enzymes, vectors, genetically modified bacteria, and yeast lines are important in the dairy, food, and agricultural industries. All these modern biological research works are time consuming, costly, and require several replicates and trials on animal and plant model systems before the product launch in the commercial market. Thus, patents are incredibly important in protecting innovators’ intellectual property rights.

Patents in biotechnology are required to maintain competitiveness in the market. Intellectual property rights also encourage investors to fund biotech firms with the hope that getting a patent will give them monetary benefit for at least 20 years from the date of filling. On the other hand, their investment also benefits the research, as they can utilize the money in their chemicals, instruments, etc.

Different types of patents in biotechnology-

Patents in biotechnology can be classified into different categories depending on the product or process for which they are claimed. Thus, the two broad classification categories of patents are(i) Product patents (ii) process patent.

Product patent- This law is important for providing safeguards to products. For modern and synthetic biological drugs, chemical compounds, genetically modified proteins, and gene sequences are protected under product patent law. This patent is important in the pharmaceutical industry and in the food and dairy sectors.

Process patent-This type of law provides protection to the innovative process or method executed during product development. In the biotechnology perspective-process of developing drugs, chemical compounds and recombinant proteins can be patented under it.

Another way to classify patents is to classify them according to their category. This includes-

1. Utility patent- This section covers a new and useful process, machines, composition of matters, or a new, useful improvement thereof. Essentially, it protects the functional aspects of inventions. Examples include medical equipment and tools, genetically modified organisms, and novel methods of producing biological products.
2. Plant patent- This type of patent protects the rights of the inventor who is involved in the generation of asexually reproduced distinct and new varieties of plants according to the plant patent act 1930 in the United States. It excludes sexually and tuber propagated plants. Indian Patent Act restricts the patent acts of new plant breed.

iii. Design patent- This patent protects the unique visual appearance of the manufactured item. This means that a very similar patented design and shape are not eligible for patent grants. In biotechnology, the design of medical equipment can be protected through this act. According to the Indian Patent Act, the 2D structure of a product can be patented, but the 3D structure is under the Design act,2000.

There is a difference between the utility and design acts. The former provides protection to usefulness and functions, whereas the latter protects the way it looks like.

1. Gene patent–Human gene patent results from the cloning and description of sequences of a gene for which a patent will be filled. The function of this gene should be clearly described. In 2013, the Supreme Court of the U.S. gave the verdict that human gene cloning and role identification description do not involve any invention; rather, it is a mere discovery that exists from earlier. Thus, patents for human genes cannot be granted. Indian Patent Act also does not allow patenting of genes.

Extent of restriction of patent act in biotechnology–

Advancements in applied biology cover a large section, and not all these inventions are patentable. First , they must satisfy the mandatory criteria of being novel, innovative, and applicable at the industrial level. Inventions of biological living material, which are mere discoveries of the existing organism, cannot be patented according to the Indian Patent Act section 3(c). Here, genetically modified strains of microorganisms can be patented, but the strain must be deposited to the international depository authority before patent application. The generation of agricultural horticulture methods, along with the production of new plant breeds, cannot be patented according to Sections 3(h) and 3(j) of the Indian Patent Act. New plant breeds were included under the Plant Protection Act of 2001.In the case of pharmaceuticals, isoforms of the earlier patented drug will not get patent unless they have higher efficacy than the earlier protected drug. Diagnostic methods, treatment procedures, and surgical methods cannot be patented according to the Indian patent act Section 3(i). Therefore, it is quite interesting that although most of the investments in biotechnology are concerned about pharmaceuticals and the diagnostic field, the chances of obtaining a patent are quite low. However, sometimes the grant of a patent totally depends on the specification and drafting. Inventions that can harm society against natural laws cannot be patented according to Sections 3(a) and 3(b) of the Indian Patent Act. Researchers should be very careful about prior publication or prior art search, and they should be aware of the patent act before starting their experiments. Patents are always drafted in such a way that it covers a broader perspective for the innovation, which is helpful for the patentee, but sometimes it restricts the other researcher to work and obtain patents on it. Sometimes, licensing charges also remain quite high, which is also a barrier for future researchers. Here, if the invention is inaccessible to the public and three years have passed since the patent’s grant, they can seek a patent office according to Section 84 of the Indian Patent Act. For ordinary patent applications, the timeline from patent applications to patent grants is also high. Survey reports suggest that in recent years, the amount of patent filling and granting has increased significantly, but most of the research works are from the engineering field. The ratio of patents in biotechnological research and engineering is still quite low. The government should take more initiatives to encourage biotechnology researchers by making them more aware of patent law and providing funds for research on the overall socio-economic development of the nation.

Overall, the role of patenting in biotechnology research is quite high, but addressing the loopholes might improve the system. Awareness camps at the school level are necessary to inform students about the importance of patents.

Conclusion-

Granting of patent has legal intricacies, thus seeking of a patent attorney should be a wise choice for the researchers.  Collaboration of biotechnologists with patent attorneys can make the patenting process smoother and comfortable, which help to the researcher to solely concentrate on science . They can assist the innovators through the lengthy and complicated process from patent drafting, filling to grant. Patent attorneys keep themselves updated about the intellectual property laws and conduct searches to ensure the proper execution of the researcher’s innovation to the patent office. They can also attend the hearing at the patent office on behalf of the patentee. Overall, to provide safeguard to the innovation not only research but also legal assistance plays an important role. Hiring of the best patent attorney in India and other countries can make a world of difference to the researcher by securing protection for their invention, providing them the confidence to pursue their dream research work.