A biotechnology patent involves using biology to create new products and solve problems. This includes genetic engineering to produce therapeutic proteins and drugs and working with living and non-living organisms like plants, animals, seeds, and enzymes. Biotechnology research has seen significant growth, especially in DNA recombinant engineering, leading to advancements in cloning, pharmaceuticals, and other areas. Biotech has been instrumental in developing medicine and agriculture, but with rapid growth comes a need to protect inventions to ensure continued progress. Unfortunately, conflicts have arisen between patent laws and biotechnological inventions.
Determining whether an invention in biotechnology is eligible for a patent can be challenging because of novelty and non-obviousness. This is particularly true in biotech, which is rapidly evolving, complex, and relatively young. What may seem new and innovative today may become ordinary and evident in just a few years.
Biotechnology
The concept of patenting biotechnology inventions is controversial due to the nature of the subject matter. To be patentable, an invention must be new and non-obvious. However, biotechnology inventions often deal with living organisms and genetic material already in nature. This poses challenges in identifying the novelty and non-obviousness of such inventions.
Moreover, patenting naturally occurring subject matter is considered unethical and against the public interest. The test of obviousness in patent law adds to the difficulty of obtaining patents for biotechnology inventions. The patentability criteria, such as novelty, utility, and non-obviousness, have presented new challenges in biotechnology. Novelty is difficult to identify in living organisms, and obviousness is challenging in gene sequencing due to similar techniques.
The complexity of genetically engineered inventions makes it hard to decide whether they are patentable. The current patent framework may not provide sufficient protection for biotechnology inventions, and there is a risk of granting patents to undeserving patentees. The complexities involved in creating biotech innovations allow for the issuance of patents for gene fragments, genetic tests, and proteins, even if the precise details of their functionality are not fully understood.
The unique features of biotechnology inventions, such as living organisms and genetic material, pose significant challenges to the patent system. While biotechnology inventions are considered from the same perspective as other inventions as far as patent law is concerned, adaptations may be necessary to consider the nature of the subject matter.
Biotechnology and Patent Laws Linkage
In India, patent laws are applicable to new and valuable inventions. This includes articles or substances a manufacturer produces and the manufacturing process itself. However, in the case of medicine, drugs, and certain types of chemicals, a patent can only be obtained for the manufacturing process and not for the product or article itself. Biotech inventions primarily involve products containing “biological material” or processes for producing such material, which essentially refers to genetic material that can reproduce or be reproduced in a biological system for biotechnology patent. Indian law requires the deposition of the biological material used under Section 10(4) and Rule 13(8) of the Patent Act. Despite ongoing debates about whether biotech inventions should be patentable, they are now considered alongside other innovations. However, given that biotech research often involves living organisms, it is crucial to exercise due care. Biotechnology falls under the “Utility Patent” category, available for developing or innovating a new sound machine, industrial technique, material composition, or technology. The challenge in determining the patentability of biotech inventions arises from the concepts of novelty and non-obviousness in a rapidly growing and complex field. It is imperative to develop clear guidelines to protect the interests of inventors. Additionally, patenting life forms is still an area under exploration in India.
The patent laws in India allow for patents to be granted for new and useful inventions, including the manufacturing process of an article. In the case of biotech inventions, patents are typically granted for products containing “Biological Material” or processes for producing such material. Although there is still some debate about whether biotech inventions should be eligible for patents, they fall under the category of “Utility Patent” for novel and sound machines, techniques, materials, or technologies. However, determining the patentability of biotech inventions can be challenging due to the concepts of novelty and non-obviousness. Nonetheless, established practices allow for patents on natural substances that have been isolated and possess increased activity or purity compared to their natural form. Biotech inventions must still meet the four hurdles of patentability: novelty, non-obviousness, inventive step, and usefulness.
1. Novelty:
Under patent law, an invention must be new to be eligible for a patent, which grants the owner a legally enforceable monopoly over their invention. This is intended to prevent granting patents for previously known inventions. The substance doesn’t need to be absent from nature, but it must not have been made public before filing the patent application. Therefore, the argument that biotechnology cannot be patented because the substance already exists in nature is invalid. In the case of Bishwanath Prasad Radhe Shyam v. Hindustan Metal Industries, the court emphasized that a patent must be granted only for a new and useful invention, which is the inventor’s discovery, not simply a confirmation of what was already known before the patent’s filing date.
2. Non-Obviousness:
Non-obviousness is a term used to describe an innovation that is not just a minor improvement or rearrangement of an existing invention but includes a new addition. The concept of non-obviousness is closely related to inventive steps, as it seeks to avoid granting patents for inventions that are simply ordinary product designs or development, in the case of M/s. Bishwanath Prasad Radhey Shyam Appellant v. M/s. Hindustan Metal Industries, the court emphasized that an improvement or combination of known elements must be more than a simple workshop improvement to be patentable. It must independently meet the criteria for an invention or an “inventive step.” The combination must produce a new result or a better, cheaper article than before and must not be a mere collocation of old known elements. An expert in the field evaluates non-obviousness but also from the perspective of a person with common skills in art.
The Drawbacks of an Undefined Non-Obviousness Standard in Patent Law
Ensuring that the non-obviousness standard is appropriately applied is crucial to the functioning of patent law. If the standard is too high, it can reduce the incentives for inventors to create and reveal their inventions. Conversely, the standard is set too low. In that case, excessive patenting may occur, resulting in inefficient patent thickets, anti-commons, minefields, hold-ups, and other issues, which can also diminish inventors’ incentives to invent. Thus, setting a non-obviousness standard that is either too restrictive or too lax can impede technological progress and have social and economic consequences.
However, since the non-obviousness standard is not well-defined, decision-makers cannot apply the standard consistently. Simply using the term “non-obvious” as a standard is insufficient, as it is nothing more than a bare legal conclusion. The non-obviousness standard was only intended to establish the basis for developing criteria for evaluating obviousness. Since this development has not occurred, the non-obviousness standard has become an empty legal conclusion without standards to guide decision-making, leading to indeterminate consequences. As a result, non-obviousness determinations are unpredictable and inconsistent.
Given this, the recent widespread criticism of the judicial system and Patent Office for wrongly applying a low non-obviousness standard appears partly misguided. Since an indeterminate standard cannot be consistently or accurately applied, criticism of the failure to define the non-obviousness standard may be warranted. Still, criticism for failing to apply it correctly may not be justified.
The prevailing viewpoint in patent law is that the non-obviousness requirement is too lenient, leading to patents on insignificant inventions that ultimately impede technological innovation. However, the problem with the non-obviousness standard is not only that it is too low but also that it is indeterminate. This indeterminacy has three leading causes: the lack of clarity regarding the degree of innovation needed to satisfy the standard, the absence of a defined baseline level of skill to measure innovation, and the challenge of expecting a technologically unsophisticated decision maker to assess an innovation from the viewpoint of an expert in the field. The unpredictability resulting from indeterminacy leads to several unintended consequences, such as excessive patent grants on obvious inventions, too many patent applications for prominent innovations and not enough for non-obvious ones, increased patent litigation, and inefficient incentives for innovation. These outcomes may occur even when the non-obviousness standard is correctly applied, indicating that the patent system’s ills may stem from indeterminacy rather than a too-low non-obviousness standard. As a result, calls for adjusting the non-obviousness threshold may be irrelevant until the standard becomes more specific.
To obtain biotechnology patent, an inventor must create something that is not obvious at the time of invention and is a significant advancement over existing technology. The non-obviousness requirement serves to protect society by preventing undeserving patents and monopolies. Inefficient application of this standard can lead to reduced innovation and the creation of trivial advances that result in patent thickets and other inefficiencies. Patent litigation commonly focuses on the non-obviousness requirement, which is critical to innovation policy and the technology economy in the United States.
The non-obviousness prerequisite in patent law, as stated in Section-103 of the Patent Act[1], specifies that a patent cannot be awarded if the idea being patented would have been apparent to someone with average expertise in the relevant field. To meet this legal standard, certain factors must be evaluated, such as the existing knowledge of an average skilled person, the degree of innovation required to satisfy the non-obviousness requirement, and the extent to which the invention improves upon existing technologies. Combining these three elements can determine whether the inventor’s advance over the baseline exceeds the required quantum in meeting the Section-103 standards. the non-obviousness requirement is a crucial aspect of obtaining a patent that ensures deserving inventions receive protection while preventing the granting of undeserving monopolies. It requires assessing what was previously known in the field, the level of innovation necessary to meet the non-obviousness requirement, and the advancement provided by the invention over prior art.
Patentability of Biotechnology Inventions: The Emerging Issues and Challenges
A biotechnology patent invention poses unique challenges due to the fact that the core subject matter of these inventions already exists in nature. Patent law requires an invention to be novel and non-obvious, identifying novelty in living beings is complex, and obviousness is a tricky characteristic in biotechnology due to similar techniques for isolating gene sequences. Additionally, the utility standard has been viewed as de minimis in most technologies but has been raised for innovations in biotechnology, making it challenging to obtain patents for some inventions. Patents for the human genome are also complicated because human genes occur naturally and are discovered, not invented. The unique features of biotechnology innovations and genetically modified organisms can lead to difficult questions of interpretation and understanding of patent law as the difference between invention and discovery becomes blurred. Furthermore, the complex nature of genetically engineered inventions can make it difficult to accurately and precisely describe them, potentially leading to undeserving patentees being granted patents on gene fragments, genetic tests, and proteins where the real work is not entirely known. These factors make obtaining biotechnology patent inventions a challenging and contentious issue.
Conclusion
The patent system poses a challenge for biotechnology to receive equal protection for biotechnology patent. Almost every patent law principle in biotechnology must be reevaluated, particularly the unclear patentability requirement of non-obviousness. Due to the complexities of determining non-obviousness, it is difficult to judge. The question has always been whether biotech patents fulfil the criteria for innovation, usefulness, inventive step, and non-obviousness in some instances. As seen, the courts have established exceptions to patentable subjects. Biotechnology patent enforcement activities are increasing in India, and in the future, more precise tests for determining the existence of innovative steps in inventions are anticipated. Companies should exercise caution when making strategic decisions about patent filings and be aware of the risks associated with non-obviousness evaluation.
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