Tuesday, September 11, 2012

Roche v. Cipla- Inventive Step- I

In the last post on the Roche-Cipla judgment, I had given a brief primer on the facts and timelines. I intend to continue the discussion in a few posts discussing the various issues dealt with in what must be the most-awaited patent decision in India in recent times, besides the compulsory licensing order in the Bayer-NATCO case.

Before I proceed to discuss the judgment, what is important to note is that for a suit which was instituted in January 2008, the final verdict has been pronounced in September 2012, which for me is an achievement in itself. Considering the speed with which other matters are generally decided, it is encouraging to note that a patent trial was concluded in 4 years.

Although some might say this is still slow considering the expedition with which IP matters are dealt with outside the country, I prefer to take an optimistic view of the decision at least in this respect. If 4 years were to be taken as a benchmark for conclusion of patent matters, it is certainly not a bad time frame considering how our Courts function. Now, to the merits of the case.

From Para 28 on, the issue of patent validity has been dealt with. 9 grounds of challenge were raised by Cipla against the patent IN196744. From internal Page 24-48 of the judgment, the rival contentions of both parties with respect to obviousness have been captured. Para 30 on, the ground of obviousness has been discussed.  The Learned Single Judge gives his views on the various grounds of revocation from Para 36 on.

The first issue the Court has dealt with is lack of inventive step. The standard that is to be applied to understand as to who would qualify as a person skilled in the art in order to evaluate the inventiveness of the invention appears to have engaged the Court quite a bit. The Court observed that before applying US or UK tests, it is necessary to discuss the patent law governing in India in form of Patents Act 1970 in order to find out the true test on the basis of which the obviousness or inventive step in the patent is required to be tested”.

The discussion of the Court on the definition of “inventive step” is not entirely accurate in my opinion. In Paras 41, 42 and 43, the Court has observed the following on the basis of Section 2(1)(ja) and Section 64:

“41. On the bare reading of the aforementioned Sections, it is clear that the definition of inventive step nowhere accords any differential treatment to any particular type of invention. Rather, it lays down the general test which is indicative towards technological advancement and the non obviousness of an invention to a person skilled in art. Besides the same, the said definition of inventive step u/s 2(ja) which has been newly inserted in the Patents Act (Amendment) 2005 once read with grounds of revocation u/s 64 nowhere indicate any special treatment or different tests to be applied for any particular type of invention more specifically medicinal, chemical, industrial, etc.

42. On conjoint reading of the Section 64 read with Section 2(ja), it is clearly discernible that there are certain essential ingredients of Section 2(ja) in order to call any invention to qualify the threshold of inventive step. The said ingredients are:-
a) That the said invention involves a technical advancement as compared to existing knowledge or economic significance or both; and
b) That makes the invention non obvious to the persons skilled in art
43. These are conjunctive requirements u/s 2(ja) which means that not merely there should be a technical advancement in the invention but at the same time, it should not be obvious to the person skilled in art. Therefore, both the requirements are to be satisfied conjunctively. It is noteworthy here again that beyond the said two ingredients, there is no further ingredient which should be read into in order to enlarge or limit the scope of the Section.

The underscored portion above is a matter of concern because to me it appears the Court has limited the definition of “inventive step” to the presence of a “technical advancement which is not obvious to a person skilled in the art”. This is a misreading of the section and it has the effect of abridging its scope. I had discussed the same issue in an earlier post titled “Inventive Step Under the Patents Act, 1970: Where is the Confusion?” In that post, the following is what I said:

The abridged and incorrect interpretation of the definition is that inventive step is equated to “a non-obvious technical advance”. This, however, has no basis in the wording of the definition or the legislative policy that is reflected in the definition.

If inventive step were to only mean a “non-obvious technical advance”, it renders nugatory the use of “or having economic significance or both”. The simpler way of understanding the definition is to expand it as follows:
1. Inventive step means a feature of an invention that involves technical advance as compared to the existing knowledge and that (reference is to feature, not "technical advance") makes the invention not obvious to a person skilled in the art
2. Inventive step means a feature of an invention having economic significance and that (reference is to feature, not "technical advance") makes the invention not obvious to a person skilled in the art
3. Inventive step means a feature of an invention having technical advance and economic significance and that (reference is to feature, not "technical advance") makes the invention not obvious to a person skilled in the art.

In other words, inventive step refers to that feature of the invention which satisfies the following twin criteria:
1. The feature involve a technical advance or must have economic significance or both; and
2. The feature must be non-obvious to a person skilled in the art.
Therefore, inventive step does not refer solely to a “non-obvious technical advance”, but in fact refers to a “non-obvious feature” which involves either a technical advance or has economic significance or both.

The corollary is that the definition distinguishes “technical advance” from the requirement of non-obviousness. “Technical advance” is a misnomer owing to the presence of the word “advance”.  Under the definition, a technical advance by itself is not non-obvious, since if that were to be the case a “non-obvious technical advance” would be redundant.

One of the principles of statutory interpretation is that no word or term or phrase used in a statutory provision must be rendered redundant/repetitive. Applying this principle to the definition of inventive step, it bears out that a technical advance simply refers to a feature which is technical in nature, whose qualitative contribution is to be further assessed by the requirement of “that makes the invention not obvious to a person skilled in the art.

The other important corollary is that the presence of technical advance is not the sole criterion to judge if an invention has an inventive step. Economic significance of a feature which is non-obvious too by itself could help the product or the process satisfy the “inventive step” requirement. Importantly, the criterion of economic significance is equally applicable to products and processes.”

Therefore, on the interpretation of the definition of inventive step, I disagree with the Hon’ble Court because in my humble opinion is the Court has unduly curtailed the scope of the definition to only technical advancement. In the next post, I will continue with the Court’s discussion on inventive step.

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