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May 17th, 2013

Novartis vs Union of India: Against elastic claims and why specialisation may still be for insects

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Estimated reading time: 5 minutes

Editor

May 17th, 2013

Novartis vs Union of India: Against elastic claims and why specialisation may still be for insects

0 comments

Estimated reading time: 5 minutes

Siva Thambisetty discusses the implications for standards of disclosure of the Indian Supreme Court’s recent decision on a drug patent for Novartis. This post first appeared on Spicy IP.

I was really stimulated by Darren Smyth’s post on the Indian Supreme Court’s decision on Novartis, since I also wrestled with this part of the court’s logic but resolved it very differently. I have also read the same author’s expressive post on IPKAT. The primary claim in both blog posts is that the Novartis decision conflates infringement, with disclosure that anticipates novelty. It’s a complex and important decision and here is how I see it at the moment:

The comparison the court is in effect making is not between infringement and anticipatory disclosure, but between sufficiency of disclosure and anticipatory disclosures both of which have to be enabling. If there is a failing in logic it is that they do not make more of ‘sufficiency’ when analyzing the significance of claim construction in the infringement action for anticipatory disclosure.

I quote from the decision: “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.”

The phrase ‘made public’ tells us that the court is implicitly relying on Novartis’ claims in UK courts to assume that they had sufficiently disclosed Imatinib Mesylate, which therefore amounts to an enabling disclosure that anticipates a future patent application. In terms of evolving jurisprudence, the UK has taken care to whittle down the breadth of claims using sufficiency as a principle; and courts here would hardly countenance effectively using two standards of disclosure – one for sufficiency and one for novelty.  It is precisely to avoid such situations that infringement and validity are addressed together in UK courts. 

The present invention is fairly straightforward – it is not a complicated genus of compounds that may be claimed on broad functional terms, that could give rise to confusion about what exactly is claimed and covered. In other words there may be cases where a patent specification is not required to enable an invention that arose after the date of filing of the application, but these are rare cases, and coverage may yet be constrained by the limited application of purposive construction in the UK.

Novartis did not do themselves any favors by using US precedent in Hogan – a case that explicitly approved ‘broad claims’ and implicitly, Kitch’s prospect theory  (where early and broad disclosures are thought to stimulate innovation (see the Adams paper). Citation of Hogan was a poor choice given that its impact was virtually eliminated in subsequent cases. “Notably Since Chiron, the Federal Circuit has not referred to Hogan in any of its cases that involved claims to a genus where only a single species was enabled.” [Chiron Corp. v. Genentech, Inc F.3d 1247, 1257 (Fed. Cir. 2004)]

The point about not extending this logic to the beta crystalline form, I suggest is because the court is not at that stage in a position to judge whether the beta crystalline form incorporates an ‘additional advantage or technical effect’ and is therefore not sufficiently disclosed, by an application that discloses Imatinib Mesylate. (The court may have taken the position that the beta crystalline form is implicitly disclosed I agree, based on common general knowledge of polymorphs). To equate disclosure of Imatinib Mesylate with anticipation of the beta crystalline form would be to assume that there is no significant difference between the two forms – the very matter the court had set out to decide in the first place.

Finally, I agree that a patent application can under some circumstances be infringed by something not disclosed in the claims. I do not agree however, that you can effectively use two standards of disclosure – one for sufficiency, and a different one for novelty. And I suggest it is this that is at the heart of the ‘fallacy’ that Darren is trying to point out.

I would urge those following Darren’s posts to read in particular paragraphs 140-157 of the decision. The court is at great pains to show that they are not willing to countenance ‘elastic’ claims which has a narrow meaning in the case of validity but a wide meaning in infringement (quoting from Terrell no less). Also see Charles Adams ‘Allocating Patent Rights Between Earlier and Later Inventions’ which explains why use of Hogan under the circumstances was so obviously poor legal strategy on the part of Novartis.

I have a related comment to make on the IPKAT’s despair at senior non-specialist courts, in this case the Indian Supreme Court. Patent lawyers live in a bizarre world where we are used to inverted categories of thought that makes little sense to external observers. Other lawyers, even other IP lawyers, often struggle to understand the pretzel shaped law that we have come to take for granted here. So we find ourselves in a position where patent law institutions huddle together seeking content-free legitimacy in mere uniformity. Mimicking related jurisdictions has in itself become a test of legitimacy.

This is where generalist appellate courts can make a difference as they are not as severely subject to the categories of thought we have been socialised to accept. Take the European Court of Justices decision in Monsanto vs Cefetra for instance – relying on Art 9 of the biotechnology directive to reject infringement and restrict the scope of the gene patent to only those cases where the gene is actually expressed – is extraordinary when compared to the sort of strict liability we are used to in the case of chemical products, but perfectly legitimate from a purposive interpretation point of view. Likewise, the Indian Supreme Court’s approach with respect to parity between what is claimed and what has been disclosed is well supported by material cited.

This is not to say that there aren’t troubling aspects of the decision. I find the lack of categorical clarity about patent eligibility and patentability, worrying. (S 3 of the Indian Patents Act in its entirety makes me long for the relative simpliclity of S 1(2) of the UK patents act in comparison!). The difference between eligibility and patentability is the difference between justifying property rights in the first place and explaining why a particular subject matter should be denied patent protection (on grounds of not being inventive or being inadequately disclosed,for instance). The former is a vehicle for substantive reasoning, the latter for the instrumental rationality of the person skilled in the art. The framing problem with S 3(d) is that it draws the person skilled in the art into the question ‘what is an invention?’. This collapse bears the hallmarks of the disastrous ‘technical contribution’ test in the context of computer-implemented inventions in Europe the perils of which are at least partly explained in Aerotel.

For related posts on this topic, see “Compulsory Licenses for pharmaceuticals: An inconvenient truth?” and “Learning from India? A new approach to secondary pharmaceutical patents“.

Sivaramjani Thambisetty is an intellectual property lawyer who teaches and researches on patent law, emerging technologies, innovation and legal institutions.  

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