Tuesday, September 11, 2012

Roche v. Cipla- Inventive Step- II

In this post, I continue with the discussion on the Delhi High Court’s views on inventive step in Roche v. Cipla. In Paras 44- 64, the High Court has effectively said the following:

1. There is nothing in the Patents Act which requires the High Court to employ a stricter approach when it comes to pharmaceutical patents. The test which Indian Courts are governed by in assessing obviousness has been laid down by the Supreme Court in Biswanath Prasad Radhey Shyam vs Hindustan Metal Industries (AIR 1982 SC 1444). The High Court observed that since in the Biswanath decision the Supreme Court had pronounced a final verdict in a trial, the decision assumes greater importance.

2. According to the High Court, the test laid down by the Supreme Court in Biswanath on obviousness in effect is as follows:

“Was it, for practical purposes, obvious to a skilled worker, in the field concerned, in the state of knowledge existing at the date of the patent to be found in the literature then available to him, that he would or should make the invention the subject of the claim concerned ?"

However, to me it appears that the Supreme Court had observed the above with respect to novelty citing the 1969 Bombay High Court’s decision in Farbewerke Hoechst & Bruning Corporation v. Unichem Laboratories & Ors which I have discussed earlier on this blog. Simply put, I think the High Court may have misread the context in which the test was laid down by the SC.

3. The High Court then took the view that in light of the SC’s test on inventive step, the test of an unimaginative person and other such tests ought not to be applied since these are neither supported by the definition nor have they been prescribed by the Supreme Court. According to the High Court, foreign decisions cannot be used to further qualify the test laid down by the Supreme Court. In Para 49, the High Court has observed thus:

“49.The said observations relied upon by the parties are judicially created tests depending upon the nature of the case and the subjective satisfaction of the Judge in the given case. As there is no such requirement which exists at least in Indian Patent Act defining the further qualities of a person skilled in art, therefore, one has to leave the said point there and then which is that what is required to be seen is the obviousness from the standpoint of a person who is skilled in art.”

4. In Para 50, to the best of my reading, it appears that the High Court has confused and conflated the issue of anticipation and obviousness, which is as follows:

Normal and grammatical meaning of the said person who is skilled in art would presuppose that the said person would have the knowledge and the skill in the said field of art and will not be unknown to a particular field of art and it is from that angle one has to see that if the said document which is prior patent if placed in the hands of the said person skilled in art whether he will be able to work upon the same in the workshop and achieve the desired result leading to patent which is under challenge. If the answer comes in affirmative, then certainly the said invention under challenge is anticipated by the prior art or in other words, obvious to the person skilled in art as a mere workshop result and otherwise it is not. The said view propounded by Hon‘ble Supreme Court in Biswanath Prasad (supra) holds the field till date and has been followed from time to time by this Court till recently without any variance.”

Again, this Para gives one the impression that the High Court has conflated a “workshop modification”, which is typically used in connection with an obviousness analysis, with the test of anticipation as to whether a document has sufficient information to help a person skilled in the art arrive at the patented result. Probably, the distinction between anticipation and obviousness was unclear to the High Court. Fundamentally, it seems the Court was not clear on the distinction between novelty and lack of inventive step...

On applicability of foreign decisions to understand the meaning of “inventive step”, the High Court’s categorical observations are as follows:

“57. One must also not forget that the tests are carved out by also considering the language of the Statute, coupled with other factors including avowed object of the Act and constitutional goals to be achieved and not in abstract. Accordingly, the test of obviousness as discussed above in the Indian context holds good so far as Indian Statute is concerned and may change in the future depending upon the change of definition of ―inventive step in case the legislature deems fit to amend the definition of inventive step or in the alternative provide some safeguards to medicinal patents so as to deal with them differently. Till the time it is not done so, it cannot be said that the test of American Courts and European Courts may be applied when it comes to adjudicate the obviousness of Indian Patents.

58. This clarification became necessary as lots of decisions are cited at the bar where American Courts have first laid down some tests and thereafter year after year changed the approach which goes either in favour of the plaintiffs in one case and in favour of defendant in another. I think it is not prudent to just follow such decisions in favour of either side and would be correct approach to consider only those decisions which go in consonance with our Indian patent law regime and judgments passed by the Supreme Court of India. It does not mean that the English and American decisions are not helpful. The aid is being taken from such decisions where it is necessary, which goes consistent with Indian law.

With these observations and a few more in Para 62, the High Court proceeded to address the issue of obviousness on the basis of the test laid down by the SC in Biswanath. In Para 64, the Court has asked itself the question, whether it is sufficient to show a compound which appears similar to the patented drug Erlotinib Hydrochloride and combine it with the requirement of further experimentation to establish obviousness of the patented drug?

Having asked this question on obviousness, it is really surprising that the Court again cites a commentary on novelty. Here are the relevant observations from Para 65:

“65. The chain of events which are necessary for the purposes of finding obviousness in relation to selection of chemical compounds from the larger formula or molecule are discussed in the book titled as "The Modern Law of Patents" by Roughton, Johnson, Cook & Fysh, 2011 Edition, (Lexis Nexis), wherein the learned author quotes an authority from European Patent office. The learned author observed thus:
―2.125 In T279/89 Moulded polyurethane elastomers/ Texaco, the Board of Appeal gave some practical requirements which must be satisfied for a selection invention to be novel, in particular:
(a) The selection invention or range should be narrow.
(b) The selection invention or range should be sufficiently far removed from the known range illustrated by means of the examples.
(c) The selected area should not provide an arbitrary specimen from the prior art, is not mere embodiment of the prior description but another invention (purposive selection) (In T279/89 Moulded polyurethane elastomers/ Texaco (unpublished*) 9th July 1991 at (r 4.1); this test was based on the earlier decision T198/84 Thiochloroformiates/ Hoechst, (1985) OJ EPO 209)”

From the underscored portions above, clearly the High Court did not make the necessary distinction between novelty and obviousness because in Para 66, the Court appears to have applied the above test for novelty and non-obviousness. This is also evident from Para 71:

“71. Let me apply the principle of laws enunciated above relating to obviousness and test the present case on the basis of balance of the probabilities in order to see whether the defendant has discharged the burden as to show the obviousness or lack of inventive step in the suit patent”

From Para 71 to 109, the Court has discussed the prior art cited against Erlotinib and finally in Para 110, the Court held as follows:

“110. I may notice lastly that the finding arrived at as to non-establishment of obviousness is due to the lack of evidence and deposition in the present case wherein the defendant is not able to show by way of positive evidence three requirements as to material facts leading up to obviousness in the chemical compounds. If the chemical compounds are held to be obvious on the basis of mere perusal and appearance of the structures and assuming that the slight change here and there is inconsequential without a positive evidence medically and clinically as to how the said reaction is immaterial, then several novel compounds can be declared obvious by such exercise and the same shall affect the research process adversely. The innovation or invention in the sense of chemical compound is not merely to innovate a new set of the compound per se but also making improvements in the existing state of the art by taking the aid of the already existing compound and working upon the same by way of experimentation by way of the reactants. This is the reason why, the Court cannot simply be satisfied by mere reliance of similar structure in the previous art and thereafter assuming that slight substitutions are inconsequential. Therefore, the establishment of the material facts is essential, which is missing in the present case. Resultantly, no ground of obviousness or lack of inventive step under Section 64 (1) (f) of the Patents Act is made out due to the inability of the defendant to discharge the onus casted upon it.

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