Excluding “Essentially Biological Processes”: Implications for Monsanto vs Nuziveedu

We are pleased to bring to you an insightful guest post by Dr. Deepa Kachroo Tiku on a contested provision of patent law involving the exclusion of plants/animals and essentially biological processes. As readers are aware, this exclusion (section 3(j)) is at the forefront of a big ticket patent battle between Monsanto and Nuziveedu. As we understand, the hearings have concluded and the court is expected to issue a decision sometime soon.

Deepa is a partner at K&S Partners and based out of the Gurgaon (Nation Capital Region) office. She is a registered Patent Agent with the Indian Patent Office and an attorney at law. She specializes in the area of Life Sciences, with an emphasis on patent drafting, prosecution and contentious practice, particularly biotechnology and pharmaceuticals as well as biomedical, nanotechnology, chemistry and polymer related inventions. Her practice also involves advising both domestic as well as International clients on Plant Variety Protection in India as well as Biodiversity Act of India. Deepa also advises on enforcement of patents, freedom to operate, due diligence, technology transfer and licensing. She is a regular speaker at various IP Fora and works on IP policy related issues as well.

Deepa does not represent either party to the dispute and her views are personal. She had written a guest post for us on the judgment pronounced by the Division Bench of the Delhi High Court on the same dispute earlier last year. Prashant’s post on the same judgment can be viewed here.

Excluding “Essentially Biological Processes”: Implications for Monsanto vs Nuziveedu

Dr. Deepa K. Tiku

Section 3(j) of the Indian Patents Act excludes plants, animals and “essentially biological processes” (for the production of plants and animals) from patent protection. The Delhi High Court relied significantly on European precedents to hold that Monsanto’s claimed invention covering the Bt gene construct and a process for preparing the transgenic Bt Cotton plant amounted to an “essentially biologically process”. However, a recent European development casts doubt on the earlier European precedent relied upon by the High court. As such, it is important to reflect on this and what implications it might have for the Supreme court appeal, where the matter is now pending. And a decision expected anytime soon. To appreciate this issue, some background is in order.

As I’d noted in a previous post in relation to the Delhi High court ruling:

“With due respect to the Learned Bench, I must say, I am disappointed with at least the fact that the final order was passed with a fleeting analysis of the science involved and interpretation of claims granted on the invention which made it possible for Indian farmers to grow cotton without getting attacked by the notorious Cotton Bollworm….

The order goes to the extent of stating that all processes involving plant biotechnology are eventually “essentially biological processes”. This in my view, is a dangerously erroneous understanding.

The Patents Act does not provide a definition for the terms “parts of plants or animals” or what constitutes an “essentially biological process”. Thus, since 2005, patent practitioners and patent examiners/controllers have relied upon commonly available dictionary definitions of these phrases or on the European Patent Convention (“EPC”) and the Directive 98/44/EC of the European Parliament (“Biotech Directive”) which also excludes these types of subject matters. Art. 2(2) of the Biotech Directive as well as 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”. Further Art. 4(1)(b) of the Biotech Directive precludes from patentability, essentially biological processes for the production of plants or animals. Art. 4(3) however clarifies that Art 4(1)(b) will be without prejudice to the patentability of inventions which concerns a microbiological or other technical process or a product obtained by means of such a process. Article 53(b) of the EPC echoes the same.

While the order applies the “Tomato” and the “Broccoli” decisions of the EPO Enlarged Board of Appeals to evaluate the meaning of “essentially biological processes”, it is important to know that these decisions pertained to patents on new varieties of tomato and broccoli produced using natural methods of crossing and breeding. Neither of these varieties were transgenic and therefore, no recombinant construct was introgressed to prepare these varieties with improved traits. Hence the reliance on these orders to assess whether Monsanto’s patent which covered Bt cotton recombinant nucleic acid and constructs, invented by Monsanto through wet lab biotechnology, appears misplaced to me.

It is also important to note that in Europe, transgenic plants and animals and biotechnological methods of producing them remain patentable. The consequence of the above decisions and subsequent amendment in the European Patent Rules is that plants and animals obtained by methods which include classical breeding steps (i.e., those which only result in a mixing of genes of the parental lines) are not patentable before the EPO.”

Several European decisions have clarified the scope of “essentially biological process”. However, there have been interesting twists and turns. In 2015, in the Tomato and Broccoli cases (G 2/12 and G 2/13), the EPO’s Enlarged Board of Appeals (EBA) held that, a plant or animal obtained by “classical” breeding means could in principle be patented if it involved a technical step, howsoever trivial, modifying the genome. This is an important point to appreciate, since unlike India which excludes all plants and animals from patentability, Europe only excludes plant and animal “varieties” produced by purely classic methods of crossing and selection from patent protection. Such varieties are anyway protected under a separate regime.

So far so good. Unfortunately, in a bid to reverse the findings of the EBA above, the EU Commission issued a notice in November 2016 stating that the legislative intent of the Biotech Directive was to exclude plants and plant parts (products) obtained by essentially biological processes from patentability. The EPO’s Administrative Council then amended Rules 27 and 28 of the EPC in 2017 to incorporate the Commission’s direction that the products of essentially biological processes (namely plants and animals) be excluded from patentability.

Relying on the Rules 27 and 28 EPC amendments of 2017, the Delhi High Court had observed “Thus, the exclusion of transgenic plants and seeds propagated after hybridization from patentability under section 3(j) of the Patents Act, 1970, is congruent with the amendment of Article 53(b) of the EPC, wherein, patents cannot be granted in respect of plants or animals exclusively obtained by means of essentially biological process. 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”.

The above finding is replete with several flaws as I noted in my previous post and as even noted by another blogger from SpicyIP here. But even more importantly, the very reliance of the court on the European precedent (the amendments to the EPC by the Admin Council) is now misplaced, given that the EPO Technical Board of Appeals (TBA) just ruled that the amendments are without any force whatsoever. More specifically, the TBA held that the amendment to Rule 28(2) is in conflict with Article 53(b) as interpreted in the Tomato/Broccoli EBA decisions. According to Article 164(2) EPC, the Articles prevail and hence the amendment to Rule 28 is null and void. The full text of this decision is still awaited.

Since the Delhi High Court relied heavily on the EBA’s decision and the Rule 28(2) amendments of 2017, will the above reversal of the interpretation of “essentially biological processes” have any impact on the Supreme Court’s findings? Firstly, as I noted in my earlier post, the Delhi High Court conflated the issue of an “essentially biological process” involved in making new varieties of Tomato and Broccoli with that of a biochemical entity which effectively changed the whole genome of a Cotton plant. This by itself should be sufficient for the Supreme Court to overturn on this count. Further, the High Court’s suggestion to Monsanto to protect its variety under PPVFRA should also be easily questionable by the Supreme Court, since Monsanto does not own any such variety in the first place. And lastly, this latest development in Europe which reversed an earlier interpretation (that products of a patent exclusion (essentially biological processes) cannot also be patented) should suggest serious caution in importing the earlier European precedent.

As an unbiased observer of this big ticket patent battle, I can only hope that the apex court’s interpretation of the law does not spell the death knell for biotechnological innovations in India. If technology such as Bt cotton that effectively revolutionized farming, making millions of farmers better off, is not considered innovative enough to be patentable, it is hard to tell what else can be. One hopes that the apex court hands down a decision that balances out all these concerns appropriately.

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1 thought on “Excluding “Essentially Biological Processes”: Implications for Monsanto vs Nuziveedu”

  1. With all due respect to the learned and respected colleague, I disagree with the EDV view above. Albeit I understand that Nuziveedu v Monsanto reviews the European jurisprudence in detail, it also does a similar analysis with the Canadian decision on the matter that is close tot he crux of the problem. It seems that an overlooked aspect was that the foreign patent had a US priority date which claimed more than 57 claims including the ones not accepted by the local Indian Patent Office.

    That is a problem that is left aside but as crucial. It might be that the Patent Examiner or the PCT authority in their clearinghouse affairs to provide due diligence to PCT members by issuing a Preliminary Examination Report did not observe that an amendment was necessary ( due to the exclusion of patentability for the biological subject matter ). Perhaps when the authority examined the awarded foreign patent, one may not have seen that not all claims were accepted in the Indian jurisdiction. Exclusion of patentability is permissible. That is in accordance with the article 27 (3) (b) that permits India to exclude subject-matter, and in fact, India as a member of WTO did, and the High Court of New Delhi in Nuziveedu v Monsanto acknowledged that on paragraphs 71 and 84, stressing that is a matter of “public policy”.

    Concerning EDVs, generally, these need more than a natural breeding process to be eligible. Ingenuity and distinctiveness must be guided by a human hand, and not only by a natural breeding process. Otherwise, native plants that receive uninvited natural breeding process via wind would be then eligible for patent protection producing decisions such as Pioneer Hi-Bred Ltd v Canada (1989) that was just as controversial as Diamond v Chaktabarty U.S. (1980), which opened up the jurisprudence door for what we have today – some good decisions, some controversial decisions on the matter.

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