Patent

3(d)-ed by IPAB, Monsanto denied patent on method of producing climate-resistant plants


Image from here
On July 5, 2013, the IPAB upheld the decision of the Controller against grant of patent to Monsanto Inc. for a method of producing plants which can withstand harsh environmental conditions. Monsanto filed the application in India (2407/DELNP/2006) on May 1, 2006 (priority date of Sept. 29, 2003) for a ‘recombinant DNA molecule for enhancing stress tolerance in plants, recombinant plants and methods thereof’. As is evident from the title, the application initially claimed (a) recombinant DNA (rDNA) molecule encoding a specific cold shock protein (CSP) (b) steps for inserting the rDNA into plant cells and (c) transgenic plants expressing CSP. Later, Monsanto restricted the scope of the application to ‘a method of producing a transgenic plant with increased heat tolerance, salt tolerance, or drug tolerance’. The claims on proteins of the ‘cold shock domain’ responsible for the cold tolerant properties and the resultant stress resistant plants were excluded.
Nonetheless, the Controller refused registration for lack of inventive step and that the subject matter is ineligible in terms of Sections 3(d) and 3(j). The IPAB concurred with the Controller’s findings on all counts except Section 3(j).
Summary of the IPAB Order
Although, Monsanto’s claims were limited to the method of producing stress-resistant plants, the IPAB held that the true construct of the application seeks to cover the ‘use’ of cold shock protein for expression of heat, salt and drug tolerant traits. Since the cold tolerant properties of CSPs is known from the prior art, the Board concluded that the patent lacked the inventive step and was ineligible in terms of Section 3(d). Below is the gist of IPAB’s findings:
(i) Lack of inventive step: The Controller held that the structure and function of cold shock protein responsible for climate resistant is a ‘known’ and hence rejected the claim as obvious. Monsanto argued that that the application of single bacterial gene (i.e. CSP) in developing climate resistant variety was unclear and results were ‘unpredictable’ at the time of the filing (i.e. prior art). Furthermore, the prior art suggested that environmental tolerance ‘is a quantitative trait under the control of many genes’ and hence the invention claimed ‘teaches away’ from the existing science.
The IPAB, however, refused Monsanto’s arguments relying on prior art which demonstrated reasonable degree of predictability in employing CSPs in developing stress-resistant varieties. The Board reaffirmed the Controller findings that:

the claimed invention is related to production of transgenic plant by transformation with admittedly known cold shock protein. Claims do not define any invention under section 2(1)(ja) of the Patents Act, 1970 as structure and function of cold shock protein was already known in cited prior art and it is obvious to person skilled in plant to make transgenic plant.

(ii) Section 3(d): Monsanto argued that the invention does not claim any ‘new’ use of known substance (i.e. CSP) instead, it submitted that the invention relates to a ‘method’ of producing a ‘new product’ (i.e. stress resistant plants). Further, it adduced post filing data which demonstrate ‘superiority’ of transgenic plants produced using the claimed method vis-à-vis wild plants.
The Board again rejected the arguments reiterating that the cold tolerant properties of CSPs are already known. The Board rightly concluded that the application in essence claims ‘new use’ of specific proteins from ‘cold shock domain’ for producing desired traits and therefore ineligible under Section 3(d).
(iii) Section 3(j): Monsanto argued that the production of transgenic variety involves ‘substantial human intervention’ in inserting the rDNA molecule into the plant cell and transforming the cell into climate resistant plant. The Controller, however, rejected the claim on the ground that the invention relates to essential biological process of regeneration and selection and hence ineligible as per Section 3(j). The IPAB agreed with Monsanto’s submission that the plant cell is transformed as a result human intervention in the manner claimed in the application. To this extent, the Controller’s findings were set aside.
Exaggerated political overtones
Expectedly, the decision attracted reactions from environmental activists who viewed the decision as an end to Monsanto’s monopoly on climate resistant varieties. Some were quick to draw parallels with the Novartis decision of the Supreme Court applauding the IPAB for ‘standing up to corporate greed and domination of the world food supply’. Dr. Vandana Shiva of Navadanya stated that ‘what the Novartis case is to Right to Health, the Monsanto case is to the Right to Food and Farmers Rights to Seed and Livelihoods’. These views in my opinion are a tad bit far-fetched and misleading.
The IPAB decision on Section 3(d) relies on same reasons that found lack of inventive step. This again raises the issue of whether Section 3(d) is a patentability or patent-eligibility standard, a question which the Supreme Court dodged to provide a categorical answer in the Novartis decision. Be that as it maybe, the IPAB did not look into the patentability of genetically modified organisms (GMOs) that demonstrate improved climatic resistance. Hence, drawing huge conclusions on India’s patent regime based on the decision with little clarity on Section 3(d) is far-fetched. Therefore, Monsanto could still obtain a patent on such plant varieties.
Furthermore, the Protection of Plant Varieties and Farmers’ Rights Act, 2001 (PPV&FR Act) could offer an alternative to patent protection in this regard. The legislation provides for a sui generis model of protection for ‘extant’ varieties among others. Unlike new and farmer varieties, protection of extant verities need not fulfill the criteria of ‘novelty’ [Sec. 15(1)]. Under the Act, the right holder obtains exclusivity to sell, market, distribute, import and export the registered variety for a limited period.

[Jul. 31, 2013: An error in the earlier draft has been corrected based on Mrinalini Kochupillai’s comment. Relevant portion appears as struck-out]

Tags:

2 comments.

  1. AvatarMrinalini Kochupillai

    Hi Sai

    Well written piece – just one point: As far as I know, your statement that “…, Monsanto could still obtain a patent on such plant varieties” is incorrect in the Indian context. India chose to not opt for patent protection for plant varieties, but adopted a sui generis regime as permitted under Article 27.3(b) of TRIPs. It would be strange if the patent office were to now grant patents in addition to the PVP protection that the PVA is granting to Monsanto and other seed cos producing genetically modified plant varieties (transgenic varieties).

    Here we see the major dilemma that faces corporations seeking complete protection of their varieties in India – a PVP protection would not prevent competitors from using the underlying GM technology and a patent type protection is not mandatory under TRIPs for plant varieties. I haven’t read the case, but from the facts you relate in your post, it looks like Monsanto was trying to circumvent this problem by making a methods claim instead of a claim on a transformed plant variety. In the EU, there are cases discussing whether a certain method amounted to an “essentially biological” one, which, again, TRIPs does not require patenting of. In this case, it might have been difficult to prove that Monsanto’s method is an essentially biological one. So 3(d) certainly helped. Overall, from this perspective, it may indeed be a “victory” for activists like Vandana Shiva because Monsanto’s attempt to circumvent the “no patents on Plant varieties” law via a method claim has failed. However, it is not clear whether the patent office and IPAB will grant a patent to a method which is not covered by 3(d).

    What Monsanto can perhaps seek patent protection for in India is a new non-obvious GM technology per se, without claiming a transformed plant variety incorporating that technology. This, coupled with a PVP protection over the transformed plant variety might give it broader protection. But then again, there is a farmers’ right and a breeders’ right under the Indian PVP law. This is what would be the more interesting legal issue – which of the two laws would have precedence in case a farmer were to multiply (by replanting season after season) plant varieties incorporating a patented gene – the law of patents granting exclusive rights to Monsanto over the gene, or the farmers’ right to save and resown seeds of all types as codified under the PVP law?

    I look forward to hearing your comments on these thoughts.

    Best wishes

    Mrinalini

    Reply
  2. AvatarSai Vinod

    Hi Mrinalini,

    Thank you so much for sharing your thoughts. With the disclaimer that my knowledge on the subject is very little on the subject, my view below:

    1. I was confused between new varieties and breeding material for producing plant varieties. I’ve made the correction.

    2. As you pointed out the possibility of patents on non-obvious GM technology – I was only trying to drive home the point that
    would Vandana Shiva’s argument might not hold good if Sec. 3(d) is held to be a patentability standard.

    3. Sec. 92 of the PVP Act has a non-obstante clause. To the extent of inconsistency between rights of patent holder and farmer’s rights, the latter would prevail (to my understanding).

    Look forward to hear from you.

    Thanks,
    Sai.

    Reply

Leave a Reply

Your email address will not be published.