Patents play a crucial role in protecting biotechnological innovations. – Simran Kaur Khalsa 

Patents play a crucial role in protecting biotechnological innovations. Simran Kaur Khalsa breaks down the Patent Act, 1970 as it applies to the patentability of biotechnology.  

Biotechnology, which has its basis in cellular and molecular biology, stands at the forefront of innovation, offering innovative solutions to various concerns of the world, from medical treatments to sustainable agriculture. Patents play a crucial role in this field by providing legal protection for these innovative inventions.  

The Indian Patent Law, governed by the Patents Act, 1970, is pivotal in fostering innovation. It ensures that inventors in the biotechnology industry can secure exclusive rights to their patented inventions. By providing patent protection, the Indian Patent Law encourages research and development, enabling advancements in biopharmaceuticals, genetic engineering, drug delivery systems and more. 

In the biotechnology sector, a wide range of inventions can be patented, provided they meet the necessary criteria of novelty, inventive step, industrial applicability and cross the barriers laid under Section 3 of the Patents Act, 1970. These inventions include:  

• Polynucleotides or gene sequences, constructs or cassettes or gene libraries, 

• Polypeptides or protein sequences  

• Vectors (e.g., plasmids or phage vectors), 

• Host cells, recombinant micro-organisms, and transgenic cells,  

• Plants and animals tissue culture  

• Pharmaceutical or vaccine compositions comprising micro-organisms, proteins, polynucleotides, 

• Antibodies or antigen-binding fragments thereof, 

• Diagnostic kits and tests such as a test for the detection of a mutation in a gene/protein which might be associated with a particular condition such as protein expression or a disease. 

Patentability issues in biotechnology 

Patenting biotechnological inventions poses unique requirements due to the complex nature of biological molecules and processes. Additionally, biotechnological inventions often intersect with ethical, environmental, and public health considerations, which further increases the hurdles in the patenting process. In India, Section 3 of the act outlines several categories of non-patentable subject matter, presenting specific fence for biotechnological inventions. 

Section 3 of the Patents Act: Detailed examination  

The below provisions are crucial for innovators in the biotechnology field to understand, as they define what cannot be patented in India and provide guidance on how to potentially overcome these restrictions. 

Section 3(b): Inventions contrary to public order or morality 

Non-patentable invention examples: 

• Cloning processes for humans or animals 

• Genetic modifications of human or animal germ lines 

• Preparation of seeds or genetic material with adverse environmental impacts 

• Use of human embryos or stem cells for commercial exploitation 

Possible solutions: 

• Emphasize the benefits, technical advancements, and importance of the innovation 

• Argue that the invention does not harm public order, morality, or the environment 

Section 3(c): Discoveries and natural substances 

Non-patentable invention examples: 

• Discoveries of scientific principles or abstract theories 

• Naturally occurring micro-organisms, nucleic acids, proteins, and enzymes 

Possible solutions: 

• Demonstrate significant human intervention and genetic engineering 

• Show structural variation from naturally occurring substances 

Section 3(d): New forms or uses of known substances 

Non-patentable invention examples: 

• New forms of known substances without enhanced efficacy 

• New properties or uses of known substances 

Possible solutions: 

• Highlight structural differences from known substances 

• Demonstrate enhanced efficacy, such as improved therapeutic effects 

Section 3(e): Mere admixtures 

Non-patentable invention examples: 

• Simple mixtures of known substances without synergistic effects 

Possible solutions: 

• Provide data showing synergistic effects of the combined components 

Section 3(h): Methods of agriculture or horticulture 

Non-patentable invention examples: 

• Methods for producing plants or improving soil fertility 

Possible solutions: 

• Avoid generic agricultural processes 

• Emphasize technical ingenuity and human intervention 

Section 3(i): Methods of treatment 

Non-patentable invention examples: 

• Medicinal, surgical, curative, prophylactic, diagnostic, or therapeutic methods 

Possible solutions: 

• Seek patent protection for medical devices, drug compositions, or diagnostic instruments 

Section 3(j): Plants and animals 

Non-patentable invention examples: 

• Whole plants, animals, seeds, and essentially biological processes for their production 

Possible solutions: 

• Patent genetically modified micro-organisms and methods for producing them 

• Protect plant varieties under the Protection of Plant Varieties and Farmers’ Rights Act 2002 

Section 3(k): Mathematical and Business Methods, Computer Programs 

Non-patentable invention examples: 

• Mathematical methods, business methods, algorithms, and computer programs 

Possible solutions: 

• Avoid claims related to software per se, computer programs or data processing methods  

Section 3(p): Traditional knowledge 

Non-patentable invention examples: 

• Traditional remedies or herbal compositions 

Possible solutions: 

• Seek protection scientifically advanced or significantly improved forms of traditional known component or ingredient 

• Check what is indigenous to communities possessing the traditional knowledge  

Understanding these provisions helps biotechnology innovators navigate the intricate requirements of Indian patent law and develop strategies to secure patent protection for their inventions in India. 

Indian courts perspective on biotechnological inventions 

Section 3(c) 

(T)CMA(PT) No. 134/2023 – Genmab A/S v. Assistant Controller of Patents & Designs 

Facts of the case: 

The appellant challenged the rejection of Indian Patent Application No. 4718/CHENP/2007, titled “Antibodies against CD38 for Treatment of Multiple Myeloma,” for lack of inventive step, non-compliance with Section 10(4)(c), and ineligibility under Section 3(c) of the act. 

The respondent found that the DNA and protein in Claims 1-24 and 25 originated from Homo sapiens, classifying the antibody as a naturally occurring molecule. Consequently, it was deemed not patentable under Section 3(c) of the act, which excludes natural substances from patent protection. 

Analysis of the judgment 

The court held that the contention of the respondent that the claims are in respect of the discovery of an antibody/non-living substance occurring in nature cannot be allowed merely because the organism specified in the sequence listing is Homo sapiens. The court overruled the objections based on Section 3(c) and lack of inventive step and directed the grant of patent application subject to deletion of certain claims. 

(T)CMA(PT) No. 118/2023 – Immunas Pharma, Inc v. Assistant Controller of Patents & Designs 

Facts of the case 

The appellant challenged the rejection of Indian Patent Application No. 5542/CHENP/2010, filed for an antibody capable of binding specifically to A-beta oligomers and use thereof related to Alzheimer’s disease. The application was refused on the grounds that the antibody was a naturally occurring substance under Section 3(c) of the Patents Act, 1970 and was merely discovered by the appellant. The appellant argued that the antibody 6E4, though targeting naturally occurring A-beta oligomers, was created through synthetic processes, distinguishing it from a mere discovery of a natural substance. They contended that this synthetic nature should qualify the antibody for patentability. 

The court overturned the rejection, ruling that the antibody was engineered, not merely discovered in nature. The court found that the interpretation of Section 3(c) should not exclude engineered substances/molecules from patent protection, provided they are novel and involve an inventive step. 

Analysis of the judgment 

The judgment clarified that Section 3(c) of the Patents Act excludes naturally occurring substances but does not bar patents for engineered or synthetic substances/molecules which are products of human intervention. This decision reinforces the patentability of innovations for engineered or synthetic substances/molecules, provided they involve inventive ingenuity and are not mere discoveries or isolation of substances which exist naturally. 

Section 3(d) & 3(e) 

(T)CMA(PT) No.33 of 2023 – Novozymes v. Assistant Controller of Patents & Designs 

Facts of the case 

The case concerns an appeal against the rejection of a patent application (No. 5326/CHENP/2008) for “Phytase Variants with Improved Thermostability.” The appellant claimed variants of the phytase enzyme were designed to withstand higher temperatures, which is crucial for applications like animal feed. 

The court addressed two main issues: 

• Section 3(d) of the act: The rejection was based on whether the variants sufficiently enhanced the efficacy of the known substance (phytase). The court ruled that improvements in thermostability, aiding practical applications like feed production, qualify as enhancing efficacy of the phytase variants under the act. 

• Section 3(e) of the act: Claims for compositions including these variants were rejected under Section 3(e) for being mere mixtures without demonstrated synergy. The Court upheld this rejection, emphasizing the requirement for compositions to show properties beyond their individual components. 

Analysis of the judgment 

The judgment clarifies that Section 3(d) applies broadly to new forms or uses of known substances, not limited solely to pharmaceuticals. It highlights that enhancements in properties such as thermostability can constitute as enhanced efficacy of the phytase variant under the act, influencing the scope of patentability for biochemical related innovations to show reasonable enhancement of efficacy. Such reasonable enhancement may be defined as enhancement that is material from an improvement of efficacy perspective. With respect to Section 3(e), the court held for a composition claim to be allowable, it should show evidence that the composition is more 

than the sum of its parts. 

Section 3(i) 

(T)CMA(PT) No.33/2023 – The Chinese University of Hong Kong, SEQUENOM, INC v. The Assistant Controller of Patents & Designs 

Facts of the case 

The case involved patent application 4812/CHENP/2012 for a method in foetal genomic analysis using maternal biological samples. The application initially included 44 claims but faced objections in view of Section 3(i) under the Patents Act, 1970. The appellants contended that the determination of the foetal fraction does not diagnose a disease and that, therefore, the claimed invention is not a diagnostic method and is patent eligible under Section 3(i) of the Patents Act, 1970. 

Analysis of the judgment 

The court ruled that the claimed invention did not qualify as a diagnostic method under Section 3(i) since it did not directly diagnose a disease but indicated the need for further testing. If the person(s) skilled in the art would not be in a position to diagnose the disease, disorder or condition, as the case may be, on the basis of the process because the process is not designed to diagnose diseases, disorders or conditions, such process, whether labelled as screening or anything else, would not qualify as diagnostic for purposes of Section 3(i). The court allowed the appeal and directed the patent to be granted. 

The judgment clarified the scope of “diagnostic methods” under Section 3(i), emphasizing that it should neither be limited to in vivo methods or definitive diagnosis, nor should it be expanded by implying the words “relating to” diagnosis. 

Section 3(j) 

CMA(PT) No.30 of 2023 – Sakata Seed Corporation v. The Controller of Patents & Designs 

Facts of the case 

The case concerns an appeal against the rejection of a patent application (No. 1221/CHENP/2015) for “Eustoma having Cytoplasmic Male Sterility and method for producing said Eustoma”. The claimed method for producing said Eustoma plant were rejected by the respondent on the ground that it is essentially a biological process and hence, not patentable under Section 3(j) of the act.  

Analysis of the judgment 

The appellant pointed out that the method of the present invention is a process of “cytoplasmic substitution” or “cytoplasmic replacement” to produce cytoplasmic male-sterile plant. The present invention is not aimed at crossbreeding but aims at “successively backcrossing” and involved significant human intervention, which distinguished it from being a mere biological process. The court in their judgment acknowledged that the present invention involves human intervention at important stages which are claimed to throw up unexpected male sterile characteristics. The court also observed that the respondent failed to give reasoning, despite acknowledging the human intervention in the present invention, as to how the human intervention claimed by the appellant would not be sufficient to take it away from still being essentially a biological process. The court allowed the appeal and remanded the matter back to patent office for fresh hearing. 

Other requirements and provisions to consider 

Apart from crossing the hurdles under Section 3 of the act, care should also be taken to comply with the provisions of Section 10(4) of the Patents Act, 1970. Section 10(4) of the act mandates that patent specifications must fully describe the invention, including its operation and method. This includes providing sufficient working embodiments and disclosing the best method known to the applicant for performing the invention. For inventions involving biological material, the specification must also disclose the source and geographical origin of the material if it is not publicly available. Such material must be deposited with an international depository under the Budapest Treaty, with full disclosure of its characteristics. 

Moreover, if the biological material is obtained from India, then applicants must obtain prior approval from the National Biodiversity Authority (NBA), established under the Biological Diversity Act, 2002 now amended as Biological Diversity (Amendment) Act, 2023. The NBA regulates access to India’s biological resources and oversees benefit-sharing arrangements in line with international agreements like the Nagoya Protocol, ensuring that local communities and stakeholders receive fair compensation for such indigenous biological resources. 

Frequently asked questions 

What cannot be patented in biotechnology? In biotechnology, certain inventions are not eligible for patent protection under the Patents Act,1970. The following are some exemplary exclusions of biotechnological innovations according to Section 3 of the act: 

• Cloning processes for humans or animals 

• Genetic modifications of human or animal germ lines 

• Preparation of seeds or genetic material with adverse environmental impacts 

• Use of human embryos or stem cells for commercial exploitation 

• Discoveries of scientific principles or abstract theories 

• Naturally occurring micro-organisms, nucleic acids, proteins, and enzymes 

• New forms of known substances without enhanced efficacy 

• New properties or uses of known substances 

• Simple mixtures of known substances without synergistic effects 

• Methods for producing plants or improving soil fertility 

• Medicinal, surgical, curative, prophylactic, diagnostic, or therapeutic methods 

• Whole plants, animals, seeds, and biological processes for their production 

• Mathematical methods, business methods, algorithms, and computer programs 

• Traditional remedies or herbal compositions 

These limitations are designed to balance innovation with ethical, environmental, and societal considerations. 

What is the process of patenting? The process of patenting involves several steps: 

• Conducting a patent search 

• Drafting the application 

• Filing the application 

• Publication 

• Examination by the patent office 

• Response to examination report 

• Issuance of Hearing Notice by the patent office (if further objections are sustained in examination report) 

• Written Submission to Hearing Notice 

• Grant of patent 

What are some key strategies for enforcing biotechnology patent rights in India? Enforcing biotechnology patent rights in India involves: 

• Vigilant monitoring: Regularly monitor the market for potential infringements. 

• Legal actions: File patent infringement suits in the intellectual property division of the respective high courts. 

• Interim injunctions: Seek interim injunctions to prevent the infringer from continuing their activities during the trial. 

• Evidence collection: Gather comprehensive evidentiary materials, including patent certificates, details of infringing products, and sales information. 

• Engage experts: Utilize expert reports to strengthen the case for infringement. 

• Negotiations and settlements: Consider out-of-court settlements or licensing agreements to resolve disputes efficiently. 

How are patent protections for biotechnological innovations regulated in India? Patent protection for biotechnological innovations in India is governed by the Patents Act, 1970. The act outlines: 

• Eligibility criteria: Inventions must be novel, involve an inventive step, and be capable of industrial application. 

• Non-patentable subject matter: Specific exclusions under Section 3, such as natural substances, ethical concerns, and biological processes. 

• Examination process: A rigorous examination process to ensure inventions meet all legal requirements. 

• Enforcement mechanisms: Legal provisions for addressing patent infringements and protecting intellectual property rights through litigation and injunctions. 

It is also important to know that innovations utilizing biological resources that are obtained from India must comply with the National Biodiversity Authority’s regulations. 

By adhering to these regulations, inventors can secure robust patent protections for their biotechnological innovations in India. 

Understanding and navigating the Indian legal framework is vital to ensure robust patent protection. By effectively leveraging India's patent laws, inventors can safeguard their biotechnological innovations, fostering continued growth and advancement in the industry.