Confusion surrounding ‘essentially biological processes’ in India
Until 2002 in India, there was a blanket ban on granting patents for inventions related to natural or artificial living entities, biological materials, substances derived from these materials, and any processes involved in the production of living substances/entities (including nucleic acids). Fortunately, the Patents Amendment Act 2002 paved the way for patent grants for inventions in the biotech field and introduced Section 3(j), which prohibits the patenting of “plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production and propagation of plants and animals”. However, the expression ‘essentially biological processes’ is not defined in the Patents Act 1940 or the Examination Guidelines and is therefore left open to judicial interpretation.
The expression “essentially biological processes” has roots in Article 27.3(b) of the Agreement on Trade-Related Aspects of Intellectual Property Rights, which clarifies certain inventions that member states can exclude from patentability (ie, plants, animals and “essentially” biological processes). Further, the agreement allows member states to devise their own standards of patentability and definition of ‘essentially biological processes’.
Scope and definition of ‘essentially biological processes’
The expression “essentially biological processes” forms an integral part of Section 3(j) as it carves out an exception from the otherwise patentable processes for propagation and production of plants and animals. Unlike in the United States and the European Union, where attempts have been made to define this expression either in statute or via judicial decisions, in India, interpretation of this expression through judicial proceedings has been limited. Although the Patent Examination Guidelines for Biotechnological Inventions were published in 2013, they were bereft of any concrete explanation of this expression. The Intellectual Property Appellate Board’s (IPAB) decision in the 2013 case of Monsanto Technology v Controller General of Patents sheds some light on the issue. In this case, Monsanto’s invention for a method of producing a transgenic plant with increased heat, salt and drug tolerance was not granted a patent on the grounds that it lacked any inventive step and consisted of a new use of a known substance. Further, the claims in the invention were held to be essentially biological processes of regeneration and selection and hence ineligible as per Section 3(j). The IPAB sided with the controller on the first two grounds and rejected Monsanto’s application. However, with regard to Section 3(j), the IPAB held that the method claimed involved human intervention – in the manner disclosed in the claims – in the plant cell, which produced technical changes in the cell and therefore took the claims outside the purview of an essentially biological process.
Monsanto’s Bt cotton and Section 3(j) in Monsanto Technology v Nuziveedu Seeds
Monsanto’s patent validity dispute over a nucleic acid sequence containing the Bt gene could become a landmark judgment in the Indian patent landscape with regard to offering an interpretation of Section 3(j). In this case, Monsanto had licensed its Patent IN214436 for Bt cotton seeds to several seed manufacturers in India, including Nuziveedu Seeds and its subsidiaries. Monsanto terminated the agreement following various disputes between the parties over the payment of licence fees and trait value in view of the Cotton Seed Price Control Order. Monsanto filed suit before the Delhi High Court claiming that Nuziveedu had infringed its patent. Nuziveedu then filed a counter claim for revocation of Monsanto’s patent, claiming that it violated Section 3(j).
The Delhi High Court did not rule on the validity of the patent at the interim stage. Instead, the court held that Monsanto’s termination of the contract was illegal as it could not demand a licence fee higher than that fixed by the government and accordingly reinstated the agreement. Monsanto appealed before the Division Bench of the High Court with regard to restoring the licence. Nuziveedu then challenged the validity of the patent. The Division Bench summarily revoked Monsanto’s patent on the grounds that the company’s invention was part of a seed and therefore fell within the purview of Section 3(j). This decision was overruled by the Supreme Court on appeal. The bench revoked Monsanto’s patent on the following grounds:
- What was claimed was neither a process nor a product, but rather an event.
- The invention was essentially a biological process.
- The invention was a plant variety.
These multiple interpretations by the court were problematic as each gave rise to different implications.
The Supreme Court stated that the Division Bench had not confined itself to the examination of the grant of injunction and had gone overboard by deciding on the validity of the patent without a full trial or taking into consideration any expert evidence and inspection of documents. Without expressly going into the validity of Monsanto’s patent, the Supreme Court set aside the order of the Division Bench and restored the judge’s order for reinstating the agreement. The matter has now been remanded back to the trial court for disposal.
It will be interesting to see how the trial court considers the issue of whether Monsanto’s patented DNA sequence is eligible for protection under Section 3(j). The final judgment in this case will be critical to define the scope of Section 3(j) and could set a precedent for disputes relating to the scope of essentially biological processes.
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