We are extremely pleased to bring to you a guest post by Adarsh Ramanujan. Adarsh is an Advocate with Lakshmikumaran & Sridharan, New Delhi, primarily assisting clients as a litigation attorney. He obtained his B.Sc. LL.B. (Hons.) degree (Gold Medalist) from National Law University, Jodhpur and LL.M. degree from University of California, Berkeley. A major portion of his time is spent, practicing in the areas of IP & Technology Laws as well as in International Trade Law. His expertise also extends to regulatory laws such as environmental laws, biodiversity laws and cyber laws. Adarsh is also a visiting lecturer at the National Law Universities in Jodhpur and New Delhi as well as at the CEIPI Institute (University of Strasbourg). He has authored or coauthored close to 30 publications on diverse topics, including on IP, WTO, constitutional law and international tax.
What’s All the Fuss About in India, Concerning the EPO?
Adarsh Ramanajun
The European Patent Office has recently amended the Implementing Regulations to the European Patent Convention (EPC). Rule 28(2) now reads as follows –
Rule 28
Exceptions to patentability
…
(2) Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.
No doubt, this is a big deal in the EU because this a 180 degree shift in the position of law in the EU. The IPKat blog entries (here and here) on this bring out the history and details and I don’t intend to repeat all of this.
But surprisingly, not one, but several people have asked me about the importance of this development in India. Given some similarity Section 3(j) of the Patents Act, 1970 in India and Article 53(b) of the EPC (emphasis on the fact that the provisions are not identical), one can understand the reason for this. The implication of this development in the EPO, however, is far more limited.
To better understand this, let’s consider the following before / after table from the EPO perspective, juxta-posed with the Indian Section 3:
| EPC Before | EPC After | India | |
| Products isolated from nature (e.g. genes or proteins isolated from nature) | Patentable as per conditions in Article 5(2)-(3) of Directive 98/44/EC | No change | Not-patentable as per Section 3(c) |
| Man-made DNA sequences | Patentable | No change | Sub judice before Hon’ble Delhi High Court in Monsanto Technology LLC & Ors. v. Nuziveedu Seeds Limited & Ors. |
| Biotech method claims | Patentable | No change | Patentable |
| Essentially biological processes (these are methods / process claims) | Not patentable | No change | Not patentable |
| Plant or animal varieties | Not patentable | No change | Not patentable |
| Plants or animals (as opposed to plant varieties) developed using genetic engineering techniques | Patentable | No change | ? |
| Plants or animals (as opposed to plant varieties) developed using essentially biological process (these are typically product claims) | Patentable | Not patentable | Not patentable |
Be that as it may, the above comparison chart makes it apparent that the latest development at the EPO presents a diametric shift only on one subject-matter – plants or animals developed using essentially biological processes. Indian law anyway does not permit patents on it.
Note that I have left a question mark when it comes to the Indian position on patentability of plants or animals developed using genetic engineering techniques. Personally, I do not think the answer is apparent from the reading of the statute – does the term ‘plants’ as used in Section 3(j) refer to genetically engineered plants as well? Of course, there are those who are quite certain that genetically engineering plants will also get covered by the Section 3(j) exclusion, and this includes the Indian Patent Office.
To me, though, the question is open because of the peculiar legislative history behind the Patents Act, 1970 as well as the harmonious construction of the various Articles of TRIPs. Since the issue pertaining to the legislative history is sub judice before the Hon’ble Delhi High Court (directly or indirectly), I won’t touch that area. However, let me elaborate on the TRIPs angle on this specific sub-issue –
- Article 27.1 of the TRIPs requires that “…patents shall be available for any inventions…in all fields of technology…”.
- Article 27.3 of the TRIPs states that “[m]embers may also exclude from patentability… (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes”.
- Article 28.1(b) states that for process patents, the rights granted include the right “to prevent third parties not having the owner’s consent …from the acts of: using, offering for sale, selling, or importing for these purposes at least the product obtained directly by that process”. Section 48(b) states something similar.
- Article 27.3 read with Article 27.1 effectively declares biotech methods, say, a biotech method for genetic transformation of a plant, to be patentable (I assume here that the invention otherwise qualifies the traditional requirements of patentability). Under Article 28.1(b), the exclusive right attached to such a method claim extends to the product obtained by it, in this case, the genetically transformed plant.
Under the above circumstances, to grant a patent on the method for genetic transformation of a plant, but deny a patent on the genetically transformed plant, seems a little absurd, to put it mildly. It is not as if patentees will seek separate patents on this method and product – they are almost always claimed together in the same patent because justifying them as separate inventions are almost impossible.
Disclaimer: The views expressed here are personal and do not represent the views of the firm he is retained by, nor any of their clients. It is also not to be construed as legal advice and does not create any attorney-client relationship.
Sir
The 3(j) exclusion is absolute and not relative in India. It would become meaningless if transgenic plants are excluded from patentability. Transgenic plants are also plants, where a trait is added and propagated through an essentially biological process (Plant breeding of natural pollination). Therefore all transgenic plants and their descendants are excluded from patentability even if they have trait added by human intervention. That is the reason PPVFR act also defines Transgenic plant varieties and provides an option for benefit sharing for trait developer as a collaborator in Plant variety development. When we define a plant variety it is the whole genome including transgenic trait which becomes integral part of the genome and which can be propagated by a natural process. So a part of the genome if the process of its insertion or existence is protected by a patent, then the rights relating to the patent get exhausted once the insertion is complete and successful and donot flow into the descendant plants which are products of essential biological processes.
What happened in EPO, is confirmation with the legislators intent of excluding all plants out of patent. One very important principle for plant biotech patents is the harmony between patent claims and commercial business model within the regulatory limitations. Therefore while plants in total are excluded, if innovation is to be rewarded, the patent holder has to arrive at a right business model which considers 3(j) exemption. Therefore, if transgenic plants are excluded from patentability, the patent holder who has a patent on the process or for development of transgenic plant or specific product related to transgenic plant, shall have rights limited to that extent and such rights will not spill over into all universe infringing on the legitimate rights of other participants or entities like plant breeders or plant breeding based seed companies.
The Freedom to operate of a patent should not therefore infringe on the Freedom of operation of other entities and their legitimate rights including business profitability. Even though the above table shows transgenic plants are patentable as per EPC and several patents have been awarded, there are no transgenic plants grown in entire Europe, except for Spain and Portugal where transgenic Corn is grown with MON 810 event. Further if the Plant variety industry is assessed ( Seeds are carriers of genetic blueprint of Plant varieties), a single plant variety encompasses a combination of multiple traits developed through breeding effort out of which one transgenic trait, could have been achieved through a targeted integration process aided by Biotechnology. For one such “trait” even if it has significant economic value generated out of a patented process or a nucleotide sequence information, the same needs to be positioned and packaged into a viable business model as per law of the land to reward the patent holder and not force fit it into a situation where 3(j) exemption exists. The EPO decision therefore is a landmark decision which excludes all products of essential biological processes including those which have been created through a biotechnological means and there need not be much ado about the right fuss.
transgenic plants and animals should be allowed. a lot of effort goes into design and development of such transgenic plants and animals which are highly beneficial to humanity. so why not afford protection to them? after all, why afford protection to transgenic microbes, but not transgenic plants and animals? 3(j) no where includes transgenic animals, but the language allows for inclusion of ‘all’ plants and animals. in my opinion, if one were to read 3(j) i conjunction with 3(c), it would seem that only naturally occurring plants and animals are to be excluded, which makes sense since naturally occurring isolated microbes are also not patentable. without direct patent protection to transgenic animals and plants, what would be the incentive to develop them?