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It appears that Darren's guest post has got the ball rolling with not only a healthy debate in the comments section to his post but also in the form of this guest post in response by Siva Thambisetty. Siva is an alumna of the National Law School of India University (NLSIU) and the University of Oxford. She is currently a lecturer in law at the London School of Economics (LSE), where she teaches and writes on patent law, innovation and legal institutions. She contributes to India@LSE. Follow her on @sivathambisetty
Novartis vs UOI: Against
Elastic claims
& why Specialisation
May Still be for Insects
By
Siva Thambisetty
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 socialized 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.
Hi Siva,
ReplyDeleteGreat to see the high quality engagement this one litigation has managed to generate globally.
Deviating from the topic at hand for a moment, I feel what you say (in Indian context) about "the lack of categorical clarity about patent eligibility and patentability, worrying" is pretty much what's coming across as THE key concern from among the comments received against the recent draft "guidelines for examination of Biotechnology patents for application" released by the Indian patent authority (OCGPDT). (http://www.ipindia.nic.in/whats_new/biotech_Guidelines_25March2013.pdf)
I wonder if you are planning to provide your comments too on the same? - While some comments are there, I haven't seen any that are comprehensive enough from the academic rigor point of view . ref: http://www.ipindia.nic.in/feedBack/Feedback_DraftGuidelines_Biodiversity_19January2013.htm
Cheers.
M
** I invite you to have a look at my article on “Factors Influencing the Global Prospects & Investor Attractiveness of Indian Pharmaceutical Industry” where i spoke about the Indian problem with "clear articulation of a policy" at the following link… http://vishrasayan.blogspot.in/2013/03/factors-influencing-global-prospects.html
Hello,
ReplyDeletethe confusion between enablement and infringement in this post is simply inexcusable. Under the previous post I tried to explain the difference between the assessment of infringement and novelty by the example of two inventors, one who invents the bicycle, and another one who then perfects this invention by then adding a gear change. The invention of the second may well be novel and non-obvious with respect to the first and yet infringe it, because it's also a bicycle.
Now, with respect to your observation about "enablement", it's clear that the first inventor didn't "enable" the geared bicycle, since it took the second inventor to do it. And yet, the first inventor's patent should rightfully cover all bicycles. Because that's what he invented: the bicycle.
With respect to your parting shot re. "patent lawyers", I find it rather uncalled for. The logic here is quite simple, and should be at the grasp of anybody with a modicum of good faith:
The specific (imatinib mesylate) can both anticipate and infringe the generic (imatinib or an imatinib salt). The generic, however, can neither anticipate nor necessarily infringe the specific.
I agree with the previous anonymous.
ReplyDeleteMatters of support (in the sense of Article 84 EPC, and the Indian Patent Act section 10(5)) and sufficiency are totally irrelevant.
Disclosure of a genus cannot take away the novelty of a later disclosure of a species of that genus.
Frankly, I cannot understand why some find this so hard to grasp.