Protecting Patent Rights In The Life Sciences In India.
Legal News & Analysis - Asia Pacific - India - Intellectual Property - Regulatory & Compliance
1 July 2021
The life sciences industry in India has improved significantly in the past three to four decades. It generates about $10 billion of trade surplus every year and employs around 2.5 million people. During the recent covid-19 pandemic, a further increase in the number of patent filings in India has been observed. Many applicants have been working towards finding solutions for combating the pandemic, including developing vaccines and drugs. The researchers have also been seeking to develop products to boost immunity, help with disinfection and reduce contact with common surfaces so as to avoid accidental contact with coronavirus. While the big participants have been working towards finding vaccines and developing drugs in the fight against covid-19, many smaller actors have come forward with inventions that can boost immunity or provide coronavirus treatment. Many of these inventions have been based on herbal formulations and new use of existing drugs against coronavirus. As the pandemic has significantly affected the global economy as a result of lockdowns and the increase in health expenditure, researchers are careful to get their inventions protected before they launch their products in the market. However, due to the typical provisions regarding patent-eligible subject matter in India, applicants should consider the options available for better protection.
Typical provisions for patent-eligible subject matter
In addition to the universal criteria of patentability (ie, novelty, inventive step and industrial applicability), Indian patent laws have categorised certain subject matter as ‘not an invention’. Research activity is often based on discovering a certain living or non-living substance and its application in a novel way. However, the discovery of any living thing or non-living substance that occurs in nature will not be considered an invention. Hence, inventions on isolated substances, such as isolated proteins, are not considered inventions under this provision. Similarly, a new use or second medical use of any known drug is also not considered to be an invention in India. During covid-19, some known drugs, such as Remdesivir, were found to be effective against coronavirus. However, since the drug is already known, its new use for coronavirus cannot have patent protection in India. But, if a new form of a known drug is invented, patent protection can be sought for that new form, subject to certain conditions. A new polymorph or a new salt of a known drug can be patented in India if the new form of the drug can be established to show enhanced performance over the known form of the drug. The enhanced activity of the new form must be shown in terms of the therapeutic efficacy. In India, even finding a new property or function of a known substance is not considered to be an invention. For a known substance, if a new property or function has been discovered or identified, challenges in obtaining a patent for such inventions will remain.
Another subject matter that is not considered to be an invention in India is the admixture of known substances, unless they have more than additive effect. Combining two known drugs into a single composition (or dosage form) and expecting each one to provide their effects is not patentable. The combination should provide something more than an additive effect. It may be a synergistic effect enhancing the efficacy of either of the drugs or a significant reduction in any side effect that was induced with individual drugs. Providing data in support of a synergistic effect is usually a requirement to support the contention. A method of treatment in human being or animals is also not considered to be an invention in India. In broad terms, the methods for medicinal, surgical, curative, prophylactic, diagnostic, therapeutic uses on human beings or animals are not allowed. Any invasive method for any type of treatment in human beings or animals is also not allowed. However, a patent may be obtained on the instruments or agents used in the treatments, subject to passing the novelty and inventive-step test. Indian patent law does not provide patents for plants and animals and their parts. For plants, a separate sui generis system has been developed: the Protection of Plant Varieties and Farmers’ Rights Act 2001. Microorganisms are excluded from this provision. Recombinant microorganisms are patentable, but recombinant plants are not. However, methods and technologies for preparing recombinant plants are patent-eligible subject matter.
Another important provision, especially with respect to herbal composition or formulations, is related to traditional knowledge. An invention that is based on traditional knowledge is usually not granted patent protection. There is a repository of information regarding the traditional knowledge of India, describing the use of various plants in various diseases and conditions (available via the Traditional Knowledge Digital Library (TKDL)). The TKDL covers the information provided in Ayurveda and other indigenous systems of medicine such as Unani, Siddha and Yoga. Hence, if a researcher is working on herbal formulations, it is important to check whether that information is already available on the TKDL. For obtaining a patent, it is important to differentiate between the proposed composition or herbal formulation and the information and knowledge that is available on the TKDL.
Certain unique provisions of Indian patent laws can pose challenges during the prosecution of patent applications in the life sciences domain. The provisions may be addressed favourably while considering the drafting of patent applications. India is becoming a desirable destination for many applicants, especially in the pharmaceuticals, biopharmaceuticals and biotechnology sectors, and it is highly advisable to consider these provisions before any patent application is filed in India. As the claims of the patent should be directed to either a product or a process, and not to the use of any product or process, patentability is assessed based on the product or process claimed per se. In India, the claims must be directed to the product or process only, and they should pass the test of patentability in addition to qualifying the unique provisions. Inventions that are based on the isolation of substances from some natural source, are not patentable as discovery and it becomes important to distinguish such isolated substances from the substances occurring in natural form when seeking a patent on these substances. This may be done by differentiating the form in which the substance occurs in nature and the form in which it is isolated or further processed or modified. It is further required that after being distinguished on the basis of form, the isolated substance has certain specific characteristics or functions that could not have been present in the substance in its natural form. With respect to inventions residing in new forms of known drug substances, a comparison between the therapeutic efficacy of the known form and the new form can be provided to establish the patentability of the new form. However, there have been instances where the Indian Patent Office has granted a patent to a new form even in the absence of comparative data vis-à-vis the known form. In one instance of this kind, the applicant argued that the known form is not available in administrable form and it cannot be administered only to generate data for patentability. This argument would be acceptable, since the fact that the earlier known form is unavailable in administrable form itself establishes that, practically, there is no therapeutic effect of the known form. Based on this reasoning, the patent was granted for the new form. When the invention resides in new use of a known substance, such as second medical use, it becomes important to identify a specific product that may have a specific composition or a specific formulation that was not previously known for the known uses. Since new use is not patentable, it is important to identify the invention in the product per se and accordingly direct the claims of the patent to a novel combination/composition. But if such a novel product cannot be identified, it would be difficult to obtain a patent solely on the new use aspect. Similarly, when the invention resides in method of treatment or in diagnostic method, which are not patent-eligible subject matter, the applicant must develop or identify a novel composition or combination of the known drug and seek protection over the same. When the invention relates to technologies for producing recombinant plants, disease-resistant or climate-resistant plants, or for improving the yield of plants, it becomes important to cover the aspects of inventions that are related to the technologies for producing such plants, and not only to the recombinant plants. The technologies that can be considered patent-eligible include novel nucleic acid constructs, a novel method of integrating the constructs within the plant’s genome, as well as novel instruments employed in the method. Since the new recombinant plant is patent ineligible subject matter, developing protection around it becomes important by seeking protection on the ancillary technologies in developing the plant. When it comes to developing herbal formulations or compositions, the patent applications filed in India are usually rejected from the perspective of traditional knowledge. The knowledge available on the TKDL is varied and extensive, and it discloses use of a single plant either alone or in combination with other plants, in multiple conditions and uses. It becomes key for an applicant to consider whether the herbal ingredients that they intend to use and protect for a certain use are already known for the same use. Usually, when the herbal ingredients intended for a disease condition are already known individually or in combination for the same use, it becomes difficult to obtain a patent, both from the perspective of traditional knowledge and from the lack of inventive step. Applicants should sufficiently distinguish their composition from traditional knowledge. This can be established by showing that the significant number of ingredients are not known for the same use in traditional knowledge and that the intended composition has synergistic effect in the intended use. When India is an important destination for filing patent applications in these fields of inventions, it is recommended to consider the patentability requirements under Indian patent laws and write the patent specifications accordingly to sufficiently disclose the patent-eligible subject matter aspects.
Since patent applications are mostly filed when sufficient data to establish the actual efficacy of the product or the invention is unavailable, so that an early protection date can be sought, it may not be always feasible to disclose sufficient working information in patent applications. Under Indian patent laws, the controllers usually demand working examples in support of the efficacy or efficiency of the invention. In the absence of sufficient working examples, the applicants can submit additional data during the prosecution stage. Depending on the prosecution strategy and filing a request for examination, an application in India may be examined anywhere between 18 and 36 months from the time of filing. Until recently it used to take much longer for an application to get examined. Wherever the applicants expect a delay in the generation of sufficient data, post filing the patent application, the applicants can consider delaying prosecution in India by filing the request for examination close to the 48-month due date, from the earliest priority. This would provide sufficient time for the applicant to generate the necessary information or data. When the invention is sufficiently captured in the patent application, the working examples for establishing the efficacy or efficiency of the invention can be submitted during the prosecution of the application as well. While such data may be submitted in response to an examination report or a hearing notice, controllers often demand that the information be submitted by way of an expert affidavit or declaration. Usually, the expert can be one of the inventors, an expert working with the applicant or even a neutral expert.
Knowing the unique provisions of Indian patent law relating to the patentability of different fields of inventions helps in describing the aspects of an invention that are more acceptable and have a better chance of securing a patent in India.
Investment in the life sciences sector, especially in biotechnology and biopharmaceuticals, is increasing. The Indian innovation ecosystem is itself providing a conducive environment for more and more participants by creating biotech parks, incentivising research and promoting the culture of start-ups. The trend is also showing a multidisciplinary approach in finding novel solutions to the complex problems arising globally, where researchers from varied fields of technology are collaborating to find and create novel solutions and innovation. For example, robotics and AI appear to have become significant and inseparable partners for finding solutions in other technology fields, including the life sciences domain. With this multidisciplinary approach, the inventions are difficult to categorise and are not restricted to a single technology domain. Pursuing patent protection of these inventions poses new challenges that must be addressed according to patent law provisions.
Indian Patent Laws has unique provisions for eligible inventions, which applicants need to consider while seeking protection for their inventions in India. The article looks at these unique provisions and the possible solutions for better protection.
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Manisha Singh, Partner, LexOrbis