One of the privileges of being a blogger is the ability, from time to time, to rant. This moggy doesn’t do this very often, and indeed tends to eschew the polemical most of his time. If you want to know why, you will have to ask his therapist (psycatatrist, corrects Merpel). But occasionally something happens that makes this Kat really rather annoyed, and today is one of those days. “What”, feline ears hear readers cry “can it be that has disturbed the serenity of the usually irenic IPKat? Well, it is the Indian Supreme Court Glivec decision, refusing the patent application directed to imatinib mesylate in beta crystalline form.
Since this decision was excellently reported by fellow feline Stefano Barazza, your humble servant did not look at the original decision until just now. Previously his attention, and that of most commentators, focused on the Section 3(d) issues – that unique part of Indian patent law that declares:
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 or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.
This Kat hates this section in its current form, as it is laden with conclusory terms such as “mere discovery” and “known efficacy”, but he is not opposed to the principle that inventive step in the case of derivatives of compounds known in the art should be rigorously examined.
But the section of the judgment that this Kat had previously overlooked and now has his blood boiling is that relating to novelty.
Imatinib per se was known from an earlier US patent number 5,521,184(“Zimmermann”), which disclosed the compound and made it in free base form in example 21. Zimmermann stated that the compounds claimed therein included their respective salts, and stated:
“Salt-forming groups in a compound of formula I are groups or radicals having basic or acidic properties. Compounds having at least one basic group or at least one basic radical, for example a free amino group, a pyrazinyl radical or a pyridyl radical, may form acid addition salts, for example with inorganic acids, such as hydrochloric acid, sulfuric acid or a phosphoric acid, or with suitable organic carboxylic or sulfonic acids…”
The claims to the compounds ended with the customary wording “or a pharmaceutically acceptable salt thereof.”
Now, the Supreme Court could have said that the effective list of available salts is limited and that therefore the mesylate is implicitly disclosed, even though not explicitly recited. Instead, it went on to observe the following:
Now, the Supreme Court could have said that the effective list of available salts is limited and that therefore the mesylate is implicitly disclosed, even though not explicitly recited. Instead, it went on to observe the following:
“It is, however, interesting to note that Gleevec, the drug was launched much earlier in the market, on the basis of the Zimmermann patent itself".
“In the patent information furnished in connection with the NDA as required under (US Code) 21 C.F.R. § 314.53, the active ingredient of the drug was stated as Imatinib Mesylate. The Drug Substance (active ingredient), Drug Product (composition/formulation) and method of use were declared to be covered by US Patent No. 5,521,184 (i.e. the Zimmermann patent). It was further declared that the United States Patent No. 5,521,184 covered the composition, formulation, and/or method of use of Imatinib Mesylate (STI571).”
“After the grant of drug approval for Gleevec, on July 3, 2001, the appellant made a Patent Term Extension Application for the Zimmermann patent (US Patent No. 5,521,184) under 35 USC § 156(g)(1)(B), for extending the term of the patent for the time taken in the regulatory review for Gleevec. This application leaves no room for doubt that Imatinib Mesylate, marketed under the name Gleevec, was submitted for drug approval as covered by the Zimmermann patent.”
It was further noted that the corresponding European patent had been asserted against NATCO Pharma Ltd in relation to sales of “VEENAT 100 capsules, the active pharmaceutical ingredient of which was Imatinib Mesylate as claimed in the Zimmermann patent.”
After considering some further points, the Supreme Court concluded:
“In the face of the materials referred to above, we are completely unable to see how Imatinib Mesylate can be said to be a new product, having come into being through an “invention” that has a feature that involves technical advance over the existing knowledge and that would make the invention not obvious to a person skilled in the art. Imatinib Mesylate is all there in the Zimmermann patent. It is a known substance from the Zimmermann patent.”It is completely unforgivable to conflate the issues of infringement and anticipation. This Kat is appalled that a senior court has done this. Understanding the difference between the two tests is fundamental to any grasp of patent law.
Not that counsel for Novartis did not do their best.
“Mr. Andhyarujina and Mr. Gopal Subramanium, learned Senior Advocates appearing for the appellant, strenuously argued that the patent information furnished by the appellant before the US FDA, or its Patent Term Extension Application, or the legal notice given at its behest to NATCO Pharma Ltd. should not be construed to mean that Imatinib Mesylate was anticipated in the Zimmermann patent.”They patiently explained (no doubt crying inwardly with frustration):
“The learned counsel further submitted that there was a difference between that which is covered and that which is disclosed. Imatinib Mesylate is covered by the Zimmermann patent but not disclosed therein.”Quite right. But the Supreme Court was having none of it. On reading the following sections, the IPKat wanted to stab himself [claw himself?]:
“The submissions of Mr. Andhyarujina and Mr. Subramanium are based on making a distinction between the coverage or claim in a patent and the disclosure made therein. The submissions on behalf of the appellant can be summed up by saying that the boundary laid out by the claim for coverage is permissible to be much wider than the disclosure / enablement / teaching in a patent.” [no, they are based on applying the test for anticipation which is separate from and independent of the question of whether the claims of the prior patent might be infringed]
“The dichotomy that is sought to be drawn between coverage or claim on the one hand and disclosure or enablement or teaching in a patent on the other hand, seems to strike at the very root of the rationale of the law of patent. Under the scheme of patent, a monopoly is granted to a private individual in exchange of the invention being made public so that, at the end of the patent term, the invention may belong to the people at large who may be benefited by it. To say that the coverage in a patent might go much beyond the disclosure thus seem to negate the fundamental rule underlying the grant of patents.” [no, it recognises that a patent is infringed if the features of the claim are reproduced. The patent needs to teach those features. It does not need to teach each and every unclaimed feature for every possible context in which the claimed invention might be put into practice. Still less does it disclose all of those contexts for the purposes of assessing the novelty of later patent application.]
“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 claimsby 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.” [At this point the IPKat gives up. It is nothing to do with “artful drafting of its claims by skilful lawyers” it is the basic operation of the concepts of disclosure and claimed subject matter.]
It is inevitable that senior courts are more generalist and less specialised in technical areas of the law such as patent law. But how is one supposed to give deference to a decision that contains so many elementary howlers in the fundamental precepts of patent law? This decision does no credit to the court that issued it.
The IPKat is not particularly quibbling with the conclusion of lack of patentability - this is not the issue, it is the reasoning used. It would have been perfectly possible for the Supreme Court to deny the novelty of imatinib mesylate based on Zimmermann and its disclosure of "suitable organic ... sulfonic acids", perhaps coupled with the observation that mesylate is arguably a rather conventional pharmaceutical salt. The issue of the patentability of the beta crystalline form could then have been analysed starting from a sound foundation. If the Supreme Court had done that, and not looked at irrelevant issues relating to the subsequent conduct of the applicant, then the judgment would have been many pages shorter and vastly more credible. Then one may have disagreed with the conclusion, but it would have been hard to argue that it was a conclusion that a Court was entitled to reach.
The IPKat is not particularly quibbling with the conclusion of lack of patentability - this is not the issue, it is the reasoning used. It would have been perfectly possible for the Supreme Court to deny the novelty of imatinib mesylate based on Zimmermann and its disclosure of "suitable organic ... sulfonic acids", perhaps coupled with the observation that mesylate is arguably a rather conventional pharmaceutical salt. The issue of the patentability of the beta crystalline form could then have been analysed starting from a sound foundation. If the Supreme Court had done that, and not looked at irrelevant issues relating to the subsequent conduct of the applicant, then the judgment would have been many pages shorter and vastly more credible. Then one may have disagreed with the conclusion, but it would have been hard to argue that it was a conclusion that a Court was entitled to reach.
Those who cautioned against drafting of the legislation for the European Unitary Patent and Unified Patents Court in a way that would render fundamental precepts of patent law open to review by the (non-specialist) CJEU will see in this decision what can happen when senior courts have insufficient fundamental experience of the field. US commentators seeing the US Supreme Court conflate novelty and patent-ineligible subject matter, as in the Prometheus case last year, may feel that the US is not immune to judicial misunderstanding at high level either. Observers of the oral argument in the Myriad case may have formed the same conclusion. Surely the highest level courts of major jurisdictions can do better.
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