NOVARTIS’(“Glivec”) Supreme Court Judgement

Does it change the patent contour in India?

“ In view of the finding that the patent product ,the beta crystalline form of Imatinib Mesylate, fails both the tests of invention and patentabilty as provided under clauses (j), (ja) of section 2 (1)and section 3 (d) respectively, the appeal filed by Novartis AG fail and are dismissed with cost,…”

This is the concluding part of the judgement delivered by Hon.Justice Aftab Alam and Hon. Justice Ranjana Prakash Desai, of the Supreme Court of India. This was an important and significant judgement eagerly awaited by the people of India and the Pharmaceutical Companies .The judgement was delivered in the month of April, 2013 .(i.e on April 1 to be precise ;ironically on an ‘ April Fools’ day -widely recognized and celebrated as a day when people play practical jokes and hoaxes, on each other ).

Reactions on the judgement were intense, varied but on expected lines. NGOs and organizations working for cancer patients felt it was a land mark judgement -wise and balanced. They were of the opinion that every year at least ten thousand new cancer patients (mainly patients with chronic myeloid leukemia) would hope to survive because they would now afford the treatment. Thanks to this judgement.

But multinational pharma companies were very critical of this judgement .According to them, the judgement was a great set back and hindrance to medical progress and innovation. Some of them even threatened to withdraw their R&D set ups and stop further R&D investments in India.

I am of the humble opinion that nothing has changed much as far as the Indian Patent law and its interpretation is concerned.. The judgement is a simple and straight forward interpretation of the law of the land by the highest court .The Supreme Court had just clarified certain issues. I would go one step ahead and comment that the Hon. Judges have gone into the micro-details of the background and history of Indian Patent Act and have shown great insight in interpreting the complex and so called ‘controversial’ sections of the patent law in the right context. This was clear from the judgement and I quote “A statute is best understood if we know the reasons for it. The reason for a statute is the safest guide to its interpretation”. The fear & confusion created and expressed are probably borne more out of mere ignorance of the critical aspects of the judgement, self interest or sheer prejudice..

Let us see what the judgement says and why I feel that nothing has changed as far as the Indian the patent law or its interpretation of the critical sections like 3 (d) are concerned

1.In India (like in other countries ) patents are granted to only ‘new’ products and not for ‘known’ products. A ‘new’ form of a known product should satisfy the condition of 3 (d) to become patentable. :

The Indian Patent office, the Appellate Board, and the Madras High courts were of the same opinion. The Supreme Court was also of the same view. Nothing really new. Status Quo has been maintained.

Let us see what the Supreme Court has said:

“On facts we are unable to accept the Imatinib Mesylate or even Imatinib was not a known substance with known efficacy .It is seen above that Imatinib Mesylate was a known substance from the Zimmerman patent. In the NDA submitted by the appellant before the US FDA, it was clearly stated that the drug had undergone extensive preclinical, technical and clinical research…………referred to above.”

“The subject product that is beta crystalline form of Imatinib Mesylate is clearly a new form of a known substance i.e Imatinib Mesylate, of which the efficacy was well known. It therefore fully attracts Section 3(d) and must be shown to satisfy the substantive provision and the explanation appended to it.” (Page .84)

2 Validity of 3 (d):

The 3 (d) was included in the Patent Act after a lot of discussions and deliberations. Madras high court has held that it is constitutionally valid and the Supreme Court just confirmed the same. Nothing has changed

INVENTIONS NOT PATENTABLE: (SECTION 3;Patent Act )

3 (d) “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property ----------------------------------------------------------------------------------------------------------“-

What SUPREME COURT has said:

“……It is seen above that, in course of the Parliamentary debates, the amendment in section 3(d) was the only provision cited by the Government to allay the fears of the opposition members concerning the abuses to which a product patent in medicine may be vulnerable. We have therefore, no doubt that the amendment /addition made in section 3 (d) is meant especially to deal with chemical substances, and more particularly pharmaceutical products. The amended portion of section 3 (d)clearly sets up a second tier of qualifying standards for chemical substances /pharmaceutical products in order to leave the door open for true and genuine inventions but, at the same time ,*to check any attempt at repetitive patenting or extension of the patent term on spurious grounds’’ (page56-57)

3. MEANING OF THE WORD “EFFICACY” in 3 (d); Clarified and in agreement with the earlier Appellate Boards and Madras High courts view. : Nothing has changed

Supreme Court:

“Efficacy means the ability to produce a desired or intended result –(New Oxford Dictionary;)… In case of medicine that claims to cure a disease, the test of efficacy can only be “therapeutic Efficacy’

“…….With regard to the genesis of section 3 (d)and more particularly the circumstances in which section 3 (d) was amended to make it more constrictive than before, we have no doubt that the “ therapeutic efficacy” of a medicine must be judged strictly and narrowly. Our inference that the test of enhanced efficacy in case of chemical substances, especially medicines should receive a narrow and strict interpretation is based on not only external factors but there is sufficient internal evidence that leads to the same view. It may be noted that the text added to section 3 (d) by the 2005 amendment lays down the condition of “enhancement of the known efficacy”. Further the explanation requires the derivative to “differ significantly in properties with regard to efficacy”. What is evident therefore is, that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy which in case of medicine, as seen above, is its therapeutic efficacy.” (page90,91)

4.Better flow properties ,better thermodynamic stability ,or low hygroscopy are beneficial properties but are not considered “enhanced therapeutic efficacy”: This was the view of the Patent Office ,Appellate Body, and Madras High Court .The Supreme Court has just endorsed the same.

Supreme Court:

“One does not have to be an expert in chemistry to know that salts normally have much better solubility than compounds in free base form. If that be so, the additional properties that may be attributed to beta crystalline form of Imatinib Mesylate would be limited to the following :

1. More beneficial flow properties
2. Better thermodynamic stability. And
3. Lower hygroscopicity.

The aforesaid properties ( “physical attributes” according to Manley),would give the subject product improved processability and better and stronger storability but, as we shall see presently ,on the basis of those properties alone ,the beta crystalline form of Imatinib Mesylate certainly cannot be said to posses enhanced efficacy over Imatinib mesylate, the known substance immediately preceding it, within the meaning of section 3 (d) of the Act.” .(page 88-89)

5. Enhanced bioavailability can be considered as “Enhanced therapeutic efficacy” only if experimental evidence suggest that enhanced bioavailability in a particular case leads to enhanced therapeutic efficacy. The confusion regarding the significance of bioavailability has been further clarified by the Supreme Court.

Supreme Court:

“Thus even if Mr.Groover’s submission is not taken into consideration on the question of bioavailability, the position that emerges is that just increased bioavailability alone may not necessarily lead to an enhanced therapeutic efficacy. Whether or not an increase in bioavailability leads to enhancement of therapeutic efficacy in any given case must be specifically claimed and established by research data. In this case, there is absolutely nothing on this score apart from the adroit submissions of the counsel. No material has been offered to indicate that that beta crystalline form of imatinib Mesylate will produce an enhanced superior efficacy (therapeutic) on molecular basis than what could be achieved with imatinib free base in vivo animal model”. (Page94-95)

6. 3 (d) does not bar patent protection for all incremental inventions: Neither the Appellate Board nor the Madras high Court had said that incremental innovations are barred on account of 3 (d);Supreme Court has confirmed the same ‘

Supreme Court: “We have held that the subject product, beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3 (d)of the Act but that is not to say that section 3 (d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances. It will be a grave mistake to read this judgement to mean that Section 3 (d) was amended with the intent to undo the fundamental change brought in the patent regime by deletion of section 5 from the Patent Act. That is not said in this judgement.”(page 95)

When reflecting on this judgement we should also remember that:

1. Patent is a territorial right,
2. TRIPS has provided enough flexibility to member countries to make their IPR laws
3. Countries are within their rights to exclude certain inventions from patentabilty.
4. Recent International agreements have emphasized on the need of the countries to make laws keeping in view of public health.
   

While concluding, I feel it is appropriate to quote Ching –Chow who said:

“IF THERE WERE MORE GOOD PEOPLE THERE WOULD BE FEWER LAWS”

Probably there would not have been need for sections like; 3 (d)s……

*Highlighting of the portions of the judgement is done by us –to emphasize a point

“The purpose of this article is to give an overview of the subject and should not be construed as a professional advice”

Reference

Supreme Court Judgement on the Novartis (“Glivec”) case.

Source: http://judis.nic.in/supremecourt/imgs1.aspx?filename=40212 – downloaded may 13

Dr Ravindra Shetty (June 2013)