Source: www.sci.gov.in
Introduction
The issue in the present case revolves around the fact that whether the technology ‘Methods For Transforming Plants To Express Bacillus Thuringiensis Deltaendotoxins’ used by Monsanto Technology LLC. is patentable under the Patents Act,1970.
Facts
A sub-license agreement dated February 21, 2004 was entered into between Monsanto Technology LLC (hereinafter referred to as ‘Plaintiffs’) and Nuziveedu Seeds Ltd. (hereinafter referred to as ‘Defendants’). Monsanto Technology LLC is a joint venture between Monsanto and India’s Maharashtra Hybrid Seeds Co (Mahyco) and is involved in the business of creating a large number of donor Bt. cotton seeds and to distribute them to seed companies. On the other hand, Nuziveedu Seeds Ltd. is a private sector seed company involved in developing new hybrids and varieties of cotton. Under the sub-license agreement, Defendants were entitled to develop “Genetically Modified Hybrid Cotton Planting Seeds” and commercially use the same by using the Plaintiffs’ technology on payment of license fee/trait value on the patented technology. The license was terminated by the Plaintiffs with regard to the issue on payment of trait value after the change of the price control regime by the State.
A suit was preferred by the plaintiffs before the Single Judge of the Delhi High Court for injunction in order to refrain the Defendants from using their registered trademark thereby infringing their registered patent as the license agreement had been terminated.
Single Judge Order
The learned Single Judge after considering the submissions of the either parties observed that the issue in hand regarding the suit patent required an expert opinion and the patent claim could be examined only after completion of the entire trial. In view of the existing patent registered under Section 48 of the Patents Act the parties were ordered to remain bound by the sub-license agreement and the trait value to be paid as per law.
Division Bench Order
Aggrieved by the order of the learned Single Judge, the respective parties preferred an appeal before the Division Bench of the High Court and the Bench dismissed the appeal of the Plaintiffs’ and held that the suit patent of the Plaintiffs falls under the exclusion provided under Section 3(j) of the Patents Act,1970 and hence the suit patent is not patentable. The court also granted the Plaintiffs liberty to claim registration under the Protection of Plant Varieties and Farmers’ Rights Act, 2001(hereinafter referred to as PPVFR Act) stating that the two acts were not complimentary to each other but rather exclusive. It was ordered that the Plaintiffs should be bound by the obligations under the license agreement including the payment of trait value by the Defendants as per law.
Appeal before the Hon’ble Supreme Court
The plaintiffs preferred a Civil Appeal seeking permanent injunction against the Defendants from using their trademark and violating their registered patent No. 214436. Further, to refrain the Defendants from using or selling their hybrid seeds bearing the patented technology.
Contentions raised on behalf of the Plaintiffs
- It was argued that initially the suit was filed for injunction against the infringement of the existing patent and not on account of lack of patentability.
- The Division Bench has committed an error by delving into the issue related to process claims 1-24 which was never in issue.
- The suit patent comprised of a DNA construct or nucleotide sequence in claims 25-27 comprising of three different components. The DNA construct when inserted in a plant produced a ‘fusion protein’ which comprised of Cry2ab S-endotoxin 7 bonded with the transit peptide. The “Nucleic Acid Sequence” (NAS) is not a living organism but a chemical created in the laboratory.
- It was contended that the chemical/gene construct was not a plant variety, hence, not eligible to seek protection under PPVFR Act and the same would be denied registration as per Section 2(za) read with Section 14 and 15 of the PPVFR Act.
- It was submitted that the DNA construct was the creation of human invention and therefore, not covered under PPVFR Act.
- It was alleged that the conjoint reading of Sections 2(j) and 3(j) of the Patents Act will depict that it excludes both patentability of transgenic plants as well as those invented through conventional breeding techniques i.e the production of plants or variety through ‘an essential biological process’ is not patentable under Section 3(j) of the patents Act.
Contentions raised on behalf of the respondents
- It was alleged that the claims 25-27are product claims which are essentially biological process claims.
- It was submitted that the genetically modified cotton planting seeds were not patented as it was developed by the Defendants vide conventional breeding method.
- The Plaintiffs ‘gene’ becomes an inheritable part of the plant by an irreversible biological process is not patentable.
- There is no inventive step involved in the Plaintiffs patent claim and the inventive process starts when the NAS is inserted in a plant cell. The exclusion under Section 3(j) of the patents Act applies as soon as it is inserted in the plant cell.
- It was concluded by stating that the NAS only adds a trait to a plant which leads to development of a transgenic variety donor seeds and the seeds are not patentable under Section 3(j) of the patents Act and entitled to the benefit under PPVFR Act.
Observations and Findings of the Hon’ble Supreme Court
- It was clarified by the Apex court that the patent claims 1-24 were with regard to the processes and claims 25-27 were with respect to the chemical process called NAS.
- The DNA construct was inserted in a plant which confers the trait of insect tolerance to the plant and it comprised of three components i.e. A promoter, a gene for the production of Cry2Ab 5-endotoxin and a component for the production of a transit peptide. Cry2Ab-5, a nucleic acid sequence was used to be inserted in a plant cell at a particular location for the production of ‘a fusion protein’ which comprised of Cry2Ab 5-endotoxin 7 bonded with transit peptide. The Plaintiffs’ technology allowed cotton plant to produce CryAb 8-endotoxin which was a patented invention. The production of fusion protein is important to be effected in a plant which can be done through Plaintiffs’ technology and the ‘bacillus thuringiensis strain’ does not produce a fusion protein.
- It was further stated that the Division Bench should have confined its finding only on the issue regarding injunction. The issues in the present case required expert advice and evidence to ascertain whether patented DNA sequence was a plant or a part of a plant, which was to be considered only at the final hearing of the suit.
- It was finally said that “The order of the Division Bench is set aside. The order of the Single Judge dated 28.03.2017 is restored and the suit is remanded to the learned Single Judge for disposal in accordance with law.”
Conclusion
After rummaging through the entire findings as averred by the Hon’ble Supreme Court in the present case, it is perused that the question with regard to the fact that whether the technology ‘Methods For Transforming Plants To Express Bacillus Thuringiensis Deltaendotoxins’ used by Monsanto Technology LLC. is patentable under the Patents Act,1970, was not conclusively decided by the Apex Court. It was observed by the court that the patentability and the exclusion of suit patent could be examined only after considering the entire evidence(s) on record and considering the expert evidence on the issues related to chemical process, biochemical, biotechnical and micro-biological process. Therefore, the present status remains that the technology of the Plaintiff remained as a registered patent under the Indian Patent No.214436 titled as “Methods For Transforming Plants To Express Bacillus Thuringiensis Deltaendotoxins” until any further finding avowed by the learned single Judge on the concerned issue.