Monday, January 3, 2011

Guest Post: Patenting ‘Life forms’ under the Patents Act, 1970- Patent Unconstitutionality? - II

This is a continuation from Aditya Arun Kutty's guest post.
Use of the term ‘Variety’
The use of the word ‘variety’ in s. 3(j) is further unreasonable and leads to discrimination between those who are breeders of plant variety and those breeders of animal variety. On one hand, breeders of plant variety are entitled to protection under ‘The Protection of Plant Varieties and Farmers’ Rights Act 2001 (PVRFR), and on the other, breeders of animal variety not only succumb to Section 3(j), they are left in the lurch since there is no separate legislation to protect their interests.

Furthermore, what constitutes ‘variety’ is also unclear as the dictionary meaning fails to identify what can be patented by virtue of its general nature and the Plant Varieties Act defines ‘variety’ only in the context of plant variety.

Also, the phrase ‘animal varieties’ was interpreted narrowly by the European Patent Office to limit the phrase to a variety and as not extending to animals per se. However 3(j) will not permit such an interpretation as it includes ‘animals in whole or any part thereof’.

Lack of a Clear definition
The EPO defines essentially biological process as consisting of entirely natural phenomena such as crossing or selection. Hence, EPO allows patenting of genetically modified plants or animals since genetic modification ensures that what is patented is not purely a natural phenomenon. 

Li Westerlund in his book on Biotech Patents,[i] states aspects of a biological process, which in practice, could lead to problems while deciphering its patentability quotient:
(i)                  Purely biological or essentially biological steps or a mixture of those steps, in a process.
(ii)                Purely biological/essentially biological steps but put together in a manner that levels the process at the higher technical standard.
(iii)               Biological/essentially biological steps plus a technical step in a process.[ii]

These steps clearly colour the fact that in the absence of a specific test to delineate patent-worthy inventions from the rest, the patent office to date remains ill-equipped to decide.

Article 14 strikes at arbitrariness because an action that is arbitrary must necessarily involve negation of equality. In this regard by not defining ‘seed’, ‘species’, ‘essentially biological process’ s. 3(j) leaves a tremendous scope for arbitrariness.

The only other legislative definition of a ‘seed’ would be that under the Plant Varieties Act, i.e. ‘a type of living embryo or propagule capable of regeneration and giving rise to a plant which is true to such type’. (s. 2(x))

In a case where seed is made by human interventions, (falling within this definition)its patentability would depend on the absolute discretion of the patent office.

Integration of words like patents, animals, essentially biologically process, without qualifying them with certain meaning, could well-nigh lead to denial of a patent (which inadvertently goes against the balancing objective of TRIPS under article 7) and this when provisions in foreign regimes such as the UK Patent Act specially accommodate for biotechnological inventions.

The situation in India as far as micro-organism patenting took a turn for the positive post the Dimminaco judgment of the Calcutta High Court (Process for preparation of alive vaccine for Bursitis). Subsequently, under the 2002 amendment to the Patents Act, only a micro-organism per se was unpatentable, qualifying the transgenic as patentable subject matter.

 Judicial Decisions/ Directives to seek Inspiration from

In the U.S. Animal Legal Defense Fund v. Quigg, the court held that an organism, “given a new form, quality, properties or combination not present in the original article existing in nature in accordance with the existing law”, could be patented.

Moreover, in the Harvard Oncomouse case, the first patent on a “non-naturally occurring non-human multicellular living organism”, patent was granted to a genetically engineered mouse.

In Ex Parte Allen, the patent examiner’s rejection of claims for a genetically engineered life-form was overruled. The board held that an oyster genetically engineered to be edible year round, constituted patentable subject matter. It was also opined that any multi-cellular organism may be patented by the inventor provided it:
A. it is created for the first time,
B. it is not a naturally occurring ,
C. is not a human being,
D. it is an item of manufacture or composition of matter, and
E. it meets all of the other conditions of patentability.

The EPC directive on legal protection of biological inventions 98/44/EC directly addresses patenting of life-forms. Under the directive, plants or animals may be patentable, if the technical feasibility of the invention is not technically confined to a single plant or animal variety. (This altered the EPC’s prior wording which explicitly excluded plant and animal varieties from patentability)

Article 6 of the Directive states that the human body, at the various stages of its formation (including the embryo and sequences or partial sequences of genes), is not patentable.

That said, it goes on to envisage that in case of an element of a human body, which has been removed through a technical process, can be patented even if the structure of the element is identical to that of a natural element.

In conclusion, I believe that the legislature needs to take a definitive stance prior to any litigation that may arise. Although common law will always factor equity into its analysis of legal issues, a statutory reference would serve to clarify the intention of the legislature. It would also give Courts the flexibility, precision and independence from subjective bias, to adjudicate an area of law in which the subject-matter is said to be ‘unforeseeable’.

Until and unless the law clarifies these terms, as was held in Sheo Nandan Parwan v State of Bihar- ‘the law will always frown on uncanalised and unfettered discretion conferred on any instrumentality of state.’

[i] Biotech Patents: Equivalency And Exclusions Under European And U. S. Patent Law, Kluwer Law International (August 2002)
[ii] Ibid.

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