Last week, I read this highly critical post by Darren Smyth, on the fantastic IPKat blog, where he takes apart some of the analysis in the Supreme Court's judgement denying Novartis a patent for Glivec. Darren's analysis had very accurately identified a significant flaw in the judgement and let's just say that he doesn't mince his words when he takes to the pen or the keyboard. Since we have had almost no critical commentary on the judgement so far, I invited him to write us a guest post on the issue.
I do hope, some of our other readers send in such guest posts, there are a lot of problematic portions in the Novartis judgement of the Supreme Court and I understand that not many in India want to be seen criticizing the judgement but honest academic criticism never really hurt anybody.
First a little bio about Darren: Darren Smyth is a UK and European patent attorney, specialising in chemical subject matter, particularly in the fields of food products and pharmaceuticals. He is a partner in the intellectual property law firm EIP and head of the chemistry practice EIP Elements. He contributes to the IPKat weblog, and also maintains a personal blog the IP Alchemist (www.ipalchemist.com). He holds an MA in Chemistry and DPhil from Oxford University, and conducted research at the Tokyo Institute of Technology before entering the patent profession.
More on concerns about Glivec
by Darren Smyth
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| Darren Smyth |
Last week, I posted on the IPKat a piece that identified significant deficiencies in the decision of the Indian Supreme Court in the Glivec case. At the kind request of the Spicy IP team, I would now like to amplify that post. In particular, the IPKat post was directed towards a readership that would (I believed) immediately appreciate wherein lies the error in reasoning, once it was pointed out. But perhaps the fallacy in the logic requires greater exposition.
I cannot emphasise enough that I am NOT talking about the part of the decision that refers to Section 3(d). Nor am I particularly criticising the outcome of the decision – the refusal of the patent application – I don’t agree with it, but neither do I consider it particularly heinous. The novelty analysis is however a dreadful piece of jurisprudence, and should not be allowed to escape criticism merely because it lies in an early part of the analysis.
What the Supreme Court did was to confuse the examination of whether a patent is infringed with the examination of what that patent, as a document, discloses.
To determine whether a patent is infringed, the comparison that is conducted is whether the alleged infringement reproduces all of the features of the claims (specifically, of the broadest independent claim). If those features are reproduced in the alleged infringement, then it infringes. But it is important to appreciate that this applies irrespective of what additional features the infringement may have.
So if the claim is to “imatinib or salt thereof”, then this is infringed by imatinib, or any salt (including the mesylate), in any physical form such as amorphous or crystalline, in combination with any other pharmaceutical, or any excipient, in any dosage form or packaging or whatever.
On the other hand, to determine whether the same patent document as a prior art document anticipates a later patent application, the comparison is of the claimsof the later application with the disclosure of the prior document. If the prior document discloses all of the features of the claims of the later application, then the later application lacks novelty.
It requires a little careful thought, but it is not difficult to see from the foregoing that a patent can be infringed by something that it does not disclose. For example, the earlier patent that claims “imatinib or salt thereof” would be infringed by a combination pill containing imatinib with another pharmaceutical, even if it had no disclosure of any such combination. But if it had no such disclosure, it would not anticipate a later patent application with claims directed towards the combination of imatinib and another specific pharmaceutical. (I am not necessarily saying that such a combination would be patentable – it might not involve an inventive step, or it may not be allowable under Section 3(e) of the Indian Patents Act, but it would be new).
This distinction comes from the logic of what is being compared with what: the features of the infringement with the claims of the prior patent in the first case, and the claims of the later patent application with the disclosure of the prior patent in the second case. It does not rely on any particular national law regarding novelty or patentability and is therefore, I suggest, universal.
But what the Indian Supreme Court did was to say [see paras 125 - 126 of the judgment; Novartis counter-arguments at 134-138, and their dismissal at 139 - 157] that because Novartis had alleged, in relation to the UK designation of the corresponding European patent, that their prior patent was infringed by imatinib mesylate (by the marketing in the UK by NATCO Pharma of a drug called VEENAT 100 containing imatinib mesylate as the active ingredient), therefore that patent disclosed imatinib mesylate. The Supreme Court thereby committed a basic category error of the variety frequently encountered in first year trainee patent attorneys. (The criticisms in the judgment of Novartis in relation to referring to the patent in the application for US regulatory approval for imatinib mesylate, and obtaining a US patent term extension for the patent [see paras 115-122 of the judgment], commit the same category error so for simplicity I shall refer only to the infringement one).
I shall reproduce again one paragraph [156] of the judgment:
“However, …. , we would like to say that in this country the law of patent, after the introduction of product patent for all kinds of substances in the patent regime, is in its infancy. We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skilful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.”
I suspect that some readers may take issue with my analysis and say “Just because the law of other countries distinguishes between the scope of a patent for the purposes of infringement and its disclosure for the purposes of prior art, it does not follow that Indian law must do so.” This is the view reflected in the quoted paragraph above. But it is not a question of any particular legal theory, it is a matter of logic. It is actually not logically possible to conflate infringement and disclosure, because the comparison being made in each case is not the same. Put another way, the advancement of knowledge is always made within earlier generic knowledge, so if this view were taken of novelty, then nothing would ever be new.
And actually the Indian Supreme Court implicitly recognised the error of their logic, because they only applied it halfway. They found the mesylate to lack novelty because it infringed the earlier patent, but they balked at the logical next step, of finding that the beta crystalline form, which would certainly also infringe the patent, also lacking in novelty. The Supreme Court took the beta crystalline form to be new [158]. If the conflation of infringement and disclosure tests is valid, then in fact not only the mesylate but also any specific crystalline form should lack novelty. The fact that this did not happen shows that the Supreme Court actually in some manner realised the flaw in the logic.
Why does it matter? Well, first of all it is essential that courts, particularly senior courts, apply the basic law correctly, because otherwise their utterances lack credibility. Secondly, it is particularly important that novelty be correctly determined, because it is to the new subject matter that any subsequent patentability test (inventive step, Section 3(d) etc.) is applied. So if the novelty foundation is defective, then the whole edifice of the judgment is liable to crumble. The Supreme Court, based on this flawed novelty argument, insisted [171] that the comparison for Section 3(d) was between the amorphous (non-crystalline) and beta crystalline forms of imatinib mesylate, rather than, as Novartis probably correctly argued, the beta crystalline form of imatinib mesylate and the free base form imatinib. If the novelty assessment had been conducted properly, perhaps the result would have been quite different.
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