Tag Archives: biological inventions
Monsanto Vs Nuziveedu Patent dispute: Brief Analysis of Judgement
Follow
The recent advancements in the field of plant biotechnology has promoted multifold growth of agro-biotech industry. The recent research in the plant genomics has resulted in producing sustainable varieties of plants and crops. The increase in the number of patents stands as a witness for the paradigm shift in the field of plant biotechnology.
However, enforceability of these patent rights remains a challenge. The increase in the number of patent infringement litigations in the agro-biotech industry in the recent times, is an indication of said challenge. A brief analysis of patent litigation between agro-biotech based companies, Monsanto and Nuziveedu Seeds is presented below.
Background of the case
Monsanto is an American multinational agrochemical and agricultural biotechnology corporation, whereas Nuziveedu Seeds is an Indian agribusiness company, known to be among the largest hybrid seed companies in the country. Monsanto had licensed its patent IN214436 relating to Bt. Cotton technology to different Indian companies including Nuziveedu Seeds, for which a lifetime fee of Rs. 50 lakh was charged along with a recurring ‘trait value’ as compensation. The Indian companies utilized said patented technology to produce cotton seeds that are resistant to boll-worm attacks.
The Indian companies demanded Monsanto to reduce the trait fee as the State Governments were passing new price control orders to fix the trait fees. Monsanto refused to reduce the trait fees. Consequently, the Indian companies stopped paying royalties to Monsanto since October 2015. Subsequently, Monsanto sent a notice to Nuziveedu in November 2015 regarding the termination of their sub-license. Nuziveedu and few other Indian companies approached Competition Commission of India (CCI) against Monsanto and alleged Monsanto of anti-competitive practices including “the abuse of dominant position” and “anti-competition agreements”.
Monsanto terminated its contract and initiated arbitration proceedings for the recovery of the due amount of Rs. 400 crores from the Indian companies. Additionally, a lawsuit was initiated by Monsanto before Delhi High Court against Nuziveedu Seed Ltd., Prabhat Agri Biotech Ltd. and Pravardhan Seeds Pvt. Ltd, seeking an injunction for patent and trademark infringement.
As a response to the infringement allegations, the defendants filed a counter-claim for the revocation of the plaintiff’s patent. The defendant urged to revoke the patent as per the provisions of Section 8, Section 10(4) and argued that the patent is invalid, as it falls within the scope of Section 3(j) and 3(h) of Patents Act.
Decision by Single Judge of the Delhi High Court
The Single Judge of the Delhi High Court reinstated the sub-licence that was terminated by Monsanto. It allowed Nuziveedu Seeds and other Indian companies to continue using the patented technology till the suit is disposed, wherein, the trait fee must be paid in accordance with the government set rates. The Single Judge also rejected the arguments of the defendant about the validity of the patent.
Appeal to Division Bench of Delhi High Court
Both the parties appealed to the Division Bench of Delhi High Court against the order of Single Judge. Monsanto challenged the decision of the Single Judge to re-instate the licence terminated by them. The defendants challenged the rejection of their arguments about the validity of plaintiff’s patent.
Decision by Division Bench of the Delhi High Court
The Division Bench concluded that the subject patent falls under the provisions of Section 3(j) of the Patent Act and held that the claims of the patent are unpatentable. The Division Bench upheld the order of Single Judge regarding the trait fee payable by the Indian companies to Monsanto. The court gave a time period of three months to Monsanto to seek protection for its invention under “The Protection of Plant Variety and Farmers Right Act, 2001”.
Analysis on the Judgement
The order of the Division Bench to invalidate the patent under Section 3(j) is not convincing in our view. The court appears to have arrived at the judgement without adequate claim construction and expert witness. The claim construction is the primary requirement in deciding the validity of a patent, which in the present case, appears to have been inadequate. The misinterpretation of Section 3(j) to invalidate the patent is a major setback to innovation in the field of plant biotechnology.
According to Section 3(j), following inventions are not patentable:
“(j) plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals”
According to Section 3(j), plants and animals per se or any part thereof are not patentable. Moreover, ‘essentially biological processes’ to produce plants and animals are also not patentable. Though the definition of ‘essentially biological processes’ was not defined in the Patents Act, Rule 26(5) of the EPC states that “a process for the production of plants or animals is essentially biological if it consists entirely of natural phenomenon such as crossing or selection”.
In the present case, the court made an observation that:
“The conclusion that the court draws therefore, is that transgenic plants with the integrated Bt. Trait, produced by hybridization (that qualifies as an “essentially biological process” as concluded above) are excluded from patentability within the purview of section 3(j), and Monsanto cannot assert patent rights over the gene that has thus been integrated into the generations of transgenic plants.”
It is to be observed that, Monsanto got a patent for the introgression of specific Bt. bacteria genes into the cotton genome with human intervention. This cannot be considered as an essentially biological processes. So, the court’s observations in considering the claims of the Monsanto’s patent as essentially biological processes appears to be inappropriate.
Monsanto had alleged infringement of Claim 25 of the patent; claim 25 is recited below:
“A nucleic acid sequence comprising a promoter operably linked to a first polynucleotide sequence encoding a plastid transit peptide, which is linked in frame to a second polynucleotide sequence encoding a Cry2Ab Bacillus thuringiensis 8-endotoxin protein, wherein expression of said nucleic acid sequence by a plant cell produces a fusion protein comprising an amino-terminal plastid transit peptide covalently linked to said 5- endotoxin protein, and wherein said fusion protein functions to localize said 5-endotoxin protein to a subcellular organelle or compartment.”
The claim deals with the extraction of a specific nucleic acid sequence from Bacillus thuringiensis (Bt bacterium) and inserted into a plant cell. The modified nucleic acid sequence produces toxins that are resistant to boll-worm attacks.
Better claim construction and expert witness would have helped the court to prevent the misinterpretation of Section 3(j).
Monsanto has appealed before the Supreme Court and challenged the decision of Division Bench. We wish the apex court pronounces a judgement with reasoning, such that companies can continue to innovate and seek protection within the framework of the Patents Act and international obligations, which India has agreed to by way of TRIPS, and the like.
We hope this article was a useful read.
Please feel free check our services page to find out if we can cater to your requirements. You can also contact us to explore the option of working together.
Best regards – Team InvnTree
This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License
Monsanto Challenges High Court Judgement Adversely Affecting Patentability in the Field of Agricultural Biotechnology
The Delhi High Court on April 11, 2018 pronounced its judgement in a litigation between Nuziveedu and Monsanto. The judgement held one of Monsanto’s important patents invalid. The patent was critical to Monsanto for protecting its business interest in their hugely successful Bt cotton seed variety Bollgard II.
The patent was held invalid under Section 3(j) of the Patents Act. Section 3(j) disallows patenting of “plants and animals in whole or any part thereof other than micro organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals.” The Court held that the subject matter covered by the patent is “essentially biological process”, and therefore not patentable.
In the general sense, the patent in question claimed a selected sequence of a specific bacteria placed at a specific location in the plant genome, to produce a specific type of fusion protein. In practice, the resulting fusion protein would adversely affect pest(s) that are common to cotton plants.
The judgement is specifically important because it was common practice of the agro-biotech industry to protect key genetic material by claiming the same in a manner similar to the approach explained above, to work around the provisions of Section 3(j). Especially, the strategy enabled patent applicants in similar situations to argue that the claims are not directed at protecting plants and animals in whole or any part thereof, including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals. Instead, the claims are directed at micro-organisms, which is not a subject matter barred from patenting. However, given the present judgement, the above discussed strategy, and in most cases the only available strategy, will not work anymore in securing patent protection for “inventions” of similar nature in the agro-biotech industry.
Monsanto has appealed to India’s Supreme Court against the ruling by the Delhi High Court. The agro-biotech industry and patent professionals will be closely watching this space given the far-reaching consequences of the outcome.
We hope this article was a useful read.
Please feel free check our services page to find out if we can cater to your requirements. You can also contact us to explore the option of working together.
Best regards – Team InvnTree
This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License
Meeting Enablement Requirement In Patent Applications Dealing With Biological Material – Indian Perspective
Introduction
A patent application has to meet various requirements of patentability for it to be granted. One such requirement of patentability is the enablement requirement. A patent application is said to be enabled if the application provides sufficient details that enables a person of ordinary skill in the related filed to practice the invention.
Patent applications dealing with biological inventions involving living organisms may face specific challenges in meeting the enablement requirement. In several instances, it may not be feasible to fulfil the enablement requirement by simply disclosing the details about the invention in the specification of the patent application.
Such challenges may be caused because the description concerning living organisms especially microorganisms, how so ever elaborate it might be, would lack the reproducibility factor due to the typical characteristic features associated with such species. It is also difficult to analyze the properties of some species completely. As an example, the microorganism isolated from soil cannot be described in detail except some documentation about their properties which may be provided. In addition, it is not easy to ascertain if the isolated strain of the species belongs to the same ecological niche. Even in cases that involve changes in characteristics of species such as genetic mutation, it is difficult to replicate the experiments for obtaining exactly the same change in mutation features. Hence, the inventions involving the subject of biotechnology, biochemistry or microbiology are usually subjected to complete disclosure by depositing the relevant biological material at some authorized depositories.
Budapest Treaty and Indian Patent system
Indian Patent system offers a provision for submission of the biological deposit in order to complete the patent specification. The patent application related to bio-technology which does not fully disclose the invention due to reasons discussed earlier and hence need to fulfil the requirement of deposition, can be usually done within the scope of Budapest treaty. The Budapest Treaty is an international treaty administered by the World Intellectual Property Organization (WIPO) and was signed in Budapest, Hungary on April 28, 1977 with a total of 79 countries being a part of it by the year 2014. This treaty provided a platform for the deposition of biological material at a single international body rather than making the deposition in several countries where the patent applicant needs to file the application. India became a member of the Budapest treaty in 1977. The provisions of the Budapest treaty could be found in the Patent Act 1970, Section 10(4)(d)(ii) as “… if the applicant mentions a biological material in the specification which may not be described in such a way as to satisfy clauses (a) and (b), and if such material is not available to the public, the application shall be completed by depositing the material to an international depository authority under the Budapest Treaty…”
The treaty does not define any limitation for the type of material to be included as the biological material and also does not restrict the biological material to ‘micro-organism’ but it does accept wide variety of materials including fungi, bacteria, plant spores, eukaryotic cell lines, genetically modified material or materials that can be used for expression of a gene, plant tissue cells, nucleic acids, etc. As per Section 3(j) of Patent Act 1970, “Plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals are not inventions.” The above mentioned section excludes the micro-organisms from being non-patentable subject matter. Hence, patentable inventions would undoubtedly encompass genetically modified micro-organisms.
Amendments in Indian Patent system with respect to Biological deposition
In 2002, a decision concerning Dimminaco – A.G. Vs.Controller of Patents & Designs and Others, the High Court held that the invention, related to a process of preparation of a vaccine for protecting poultry against Bursitis infection, is patentable wherein it emphasized that the way of manufacture of the said vaccine cannot be considered as unpatentable even though it involved living organism as end products. The argument set by the Controller was mainly concerning the fact that the claimed process involved a natural process and the end product involves a living organism. However, in this matter, the courts emphasized on the significance of ‘vendibility test’ rather than the criteria of ‘manner of manufacture’. The vendibility test considers the factors that result in the invention giving rise to some ‘vendible’ product which can be commercialized or that can assist in enhancing the properties of the vendible product or would assist in the preservation or preventing deterioration of such products. The term ‘vendible’ was defined by the courts as something that can be passed on from one entity to another via purchase or sale.
Post-effects of the above mentioned case was observed in the year 2002 when amendments in the Patents Acts 1970 were introduced with regards to grant of patent such that biotechnological, biochemical and microbiological processes were included within the scope of chemical processes. In addition, this newly introduced Patents Amendment Act 2002 modified the definition of the term ‘invention’ as any ‘new product or process’ that involves non-obviousness and industrial applicability, whereas the earlier definition mainly focussed on the ‘manner of manufacture’ as per the previous Act. Further, the enablement criteria were satisfied by means of deposition of biological samples at the International Depositories as per the Budapest Treaty. The above referred decision concerning Dimminaco – A.G. Vs.Controller of Patents & Designs and Others can be downloaded for your reference.
Procedural regulations for biological deposition
For India as a member country, the Budapest treaty makes it obligatory for an applicant to deposit the biological material with an international depository authority (IDA) not later than the filing of the application in India. Owing to the fact that the deposit is the source of description for satisfying the enablement criteria, it is significant to make the deposit on or before filing in order to actually complete the specification. In any case, the depository authority will allow availability of the biological material to the public only after the publication of the patent application.
The International Depository Authority (IDA) in India is situated at Chandigarh, viz. Microbial Type Culture Collection and Gene Bank (MTCC) which was recognized as an IDA on October 04, 2002. Another IDA in India is the Microbial Culture Collection (MCC) located in Pune. These depositories keeps a database of its collections and transactions with maintenance of electronic record. The process of deposition requires submission of duly filled forms obtainable from the IDA depending on the type of species being submitted and the subsequent payment of the deposit fee for storage (as per rule 12.1 (a)(I) of the Regulations under Budapest Treaty). The form for deposition is termed as BP/1 whereas the one used for performing the amendment in the technical description is BP/7. In addition, there are some essential criteria regarding the purity of submitted samples and the submission mode or type of sampling involved. The IDA pursues the tasks of performing the viability tests, sub-culturing the material and also preservation of the original samples submitted by the inventor.
Once the deposit has been made, the applicant is provided with an accession number by IDA that relates to that particular deposit. The Indian patent office requires the applicant to provide reference to the deposit within three months of filing of the patent application. However there has been a discrepancy in following these regulations owing to which the Indian patent office, in a notification dated July 02, 2014, issued a forewarning to the applicants with regards to the consequences of not depositing the sample related to their patent applications. The notification was released in view of many patent applicants who deposited their samples much after the filing date or who did not include a reference in the specification within three months of the filing date. The above referred notification can be downloaded for your reference.
The other forms involved in the process include the acknowledgement of receipt of the submitted sample on BP/4 form and a viability statement issued on BP/9 form. There is also a provision for requesting IDA to send the copies of receipt and viability statement to the depositor and also the patent agent. In addition to the deposition task, the complete application also demands a mention of the source of origin of the biological sample. In case the application specifies the source of the biological material to be from India, then it is required that the applicant should submit a permission taken from National Biodiversity Authority at any time before the patent is issued. A complete specification also demands a clear mention of all the details related to the characteristics that would be required for the material to be correctly identified. These details include the name, address of the depository organization and the date and number associated with the material deposited at the institution.
In conclusion, the Indian Patent system offers the inventors with a convenient mode of depositing the biological samples for enabling completion of specification. In addition, the amendments in the Indian statutes widens the scope for better biological inventions.
I hope you found this article helpful. You may also download a copy for your reference.
You may subscribe to our articles to receive notification of such interesting articles in your inbox.
Feel free to check our patent services page to find out, if we can cater to your requirements.
Best regards – Team InvnTree
This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License
