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Biotechnology patents and the problem of non-obviousness

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Introduction

When biology is used to make new products and solve problems, it is known as Biotechnology. The noteworthy use of biotechnology is producing therapeutic protein and some other drugs by the use of genetic engineering. It covers both living organisms like plants, animals as well as micro-organisms and also with non-living organisms like the seeds and enzymes.

In recent times there has been some intense growth in the field of biotechnology research, mainly in DNA recombinant engineering. Society has been the spectator of the successful cloning of animals, pharmaceutical research, and various other remarkable developments in this field. Biotech has been a helping hand in developing the medicine and agriculture industry. With this rapid growth in this industry, it has become essential to provide a safeguard to all the upcoming inventions or innovations. Ensuring an adequate level of protection to the upcoming inventions ensures continued innovations in the field.

As a result of the notice, it has come to notice that there is a conflict between the patent laws and biotechnological inventions.

Biotechnology and Patent Laws

Patent laws in India are granted for inventions that are new and useful. A patent can not only be obtained for articles or substances produced by a manufacturer but also in the process of manufacture of an article. Here comes the interesting part, when it comes to medicine or drugs or a certain class of chemicals, a patent can only be obtained from the manufacturing process and not the product/article itself. Biotech inventions are mostly concerned with products containing “Biological Material” or processes by which “Biological Material” can be produced, which is in its essence genetic material which has the capability of reproducing itself or being reproduced when put in a biological system. Under Section 10(4) and rule 13 (8) of the Patent Act, it requires for deposition of the “Biological material” used.  Notwithstanding the conflict, whether biotech inventions should be allowed to be given patents or not, now the inventions share the same space with other innovations. All due care has to be maintained as the research often involves living organisms. Patenting life forms are a subject that is still being explored in India. Biotechnology falls under the subject of “Utility Patent”, which is available for the development or innovation of a novel and useful machine, industrial technique, material composition, or technology. In a field like biotech, which relatively a young subject and has seen rapid growth, the difficulty in determining its patentability comes from the notions like novelty and non-obviousness. There is a pressing need of developing clear guidelines to protect the interest of inventors.

(1) Novelty

Novelty under patent law means that an invention to be patentable must be new as compared to earlier patents. The owner of the patent obtains a monopoly over their invention, which is legally enforceable. The purpose of novelty is to deny a patent to any invention which has been already thought of before filing of application of the patent application. Having novelty does not mean that the substance should be present in nature, but it means that it should not have been made available to the public yet. Therefore, the argument against biotechnology on the ground that the substance had been already present in nature stands no ground. The court in Bishwanath Prasad Radhe Shyam v. Hindustan Metal Industries held that “The fundamental principle of Patent Law is that a patent is granted only for an invention which must be new and useful. That is to say, it must have novelty and utility. It is essential for the validity of a patent that it must be the inventor’s own discovery as opposed to mere verification of what was, already known before the date of the patent. ”(Emphasis added)

 (2) Non-Obviousness

Non-obviousness, as the name suggests, means that innovation which not merely an improvement or rearrangement of an earlier invention, but there should be some new addition to the invention. Non-obviousness is related to the inventive steps, as it requires steering clear from granting patents for inventions that are merely the usual product design or development. The court in the case of M/s. Bishwanath Prasad Radhey Shyam Appellant v. M/s. Hindustan Metal Industries, on the subject of inventive step, stated that “It is important to bear in mind that in order to be patentable an improvement on something known before or a combination of different matters already known, should be something more than a mere workshop improvement; and must independently satisfy the test of the invention or an ‘inventive step’. To be patentable the improvement or the combination must produce a new result, or a new article, or a better or cheaper article than before. The combination of old known integers may be so combined that by their working interrelation they produce a new process or improved result. Mere collocation of more than one integer or things, not involving the exercise of any inventive faculty, does not qualify for the grant of a patent”(Emphasis added). The non-obviousness is judged as per the perspective of an expert in that field but from the eyes of a person having common skills in art. To look into the aspect involved in the concept of non-obviousness, let’s look into “Graham factors”, which were laid down by the US Supreme court in the landmark case of “Graham et al. v. John Deere Co. of 2 Kansas City et al”:

  1. To consider the scope and extent of prior art
  2. What is the difference between the prior art and claims at the issue?
  3. to determine the level of ordinary skill in the prior art

The concept of non-obviousness is a question of both fact and law. The factual portion of the investigation focuses on prior art, distinctions between the invention and the prior art, the level of expertise in the art, and other factors. The legal portion of the investigation entails determining whether the distinctions between the invention and the prior art would have been clear to a person with ordinary skill in the art.

Conclusion

In the patent system, biotechnology has struggled to achieve equal protection. In biotechnology, almost every patent law principle must be reassessed and construed from scratch. The fundamental and also the most unclear patentability condition is non-obviousness. Due to the complexities involved in making the judgment, determining non-obviousness is a huge challenge. The only question was whether biotech patents met the criteria for innovation, utility, inventive step, and non-obviousness in certain instances. As we’ve already seen, the courts have had to deal with some judicially established exceptions to the patentable subjects. Patent enforcement operations have been on the rise in India. In the future, significantly more refined tests for evaluating the presence of innovative steps in inventions are expected. Companies must be cautious when making strategic judgments about patent filings in light of the recent change in the law relating to non-obviousness. They should be cognizant of the risks associated with non-obviousness evaluation.

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Contributed:- Nidhi Jha, Intern at LLL

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