LSIPR Newsletter 04:14


enormously expensive to develop. If certain countries protect a pharma product and others don’t, then the consumers of the first country end up paying disproportionately more to fund that innovation. In effect, certain countries are funding the healthcare of others. Few begrudge sub-Saharan Africa this relief, but an emerging superpower such as India is seen as another issue altogether. What is the reality?


Pharmaceutical inventions typically


include: (i) compounds, including salts and polymorphs; (ii) uses of the compound to treat disease; (iii) formulations; and (iv) processes for manufacture.


Te Indian guidance has little that is contentious to say about the patentability of formulations and processes, and such claims are rarely important in defining exclusivity for a product. Turning to compounds and uses, however, it is clear that the IPO has strong objections to inventions that transgress the infamous Section 3 of Indian patent law.


Compounds


Te guidance on patentability of basic compounds appears sensible and standard. It departs on what are regarded as new forms of a known substance.


Section 3(d) of the Patents Act describes non-patentable inventions as including:


“Mere discovery of a new form of a known substance which does not result in enhancement of known efficacy or mere discovery of any new property or new use for a known substance.”


Most major patent offices would regard a new compound form, such as a salt of a known free base, as novel. Te question of patentability then turns upon whether the new form, such as a salt, is inventive over the free base, ie, does it have any surprising advantageous properties?


Te Indian guidelines state: “for the purposes of this clause, salts, esters, ethers, polymorphs, metabolites ... shall be considered the same substance unless they differ significantly in properties with regard to efficacy”.


At first glance these guidelines appear confused, deciding that novelty will be assessed when conflated with inventive step. However, most importantly, does it work in practice and get to the ‘right’ answer? Most patent offices would view a salt that has significantly different properties when compared to the free base with regard to efficacy as inventive.


INDIAN PATENT LAW 23


“In effect, certain countries are funding the healthcare of others. Few begrudge sub-Saharan Africa this relief, but an emerging superpower such as India is seen as another issue altogether.”


Te IPO goes on to offer strong guidance that efficacy is a narrow test of therapeutic efficacy.


A compound may show efficacy in an in vitro assay. Tat efficacy may then be confirmed in clinical trials. But there is a huge leap from efficacy as a mode of action and a successful drug. A successful medicine needs to be formulated into a stable composition where the active drug does not stick in tableting machines. Te formulation needs to have on-the-shelf stability and not decompose before it reaches patients. It needs to be tolerated, avoiding side-effects. A narrow focus on ‘efficacy’ is not helpful.


Much of the argument the IPO brings relies on the idea that such properties are implicit in a compound and that these advantages are brought blinking into the sunshine in an effortless manner. Tey’re not. However this takes no account of predictability or incentive: how likely is it that if I research a new form it will have properties that solve the problem?


In summary, one should consider the value of the invention. If a further form of the basic compound has an intrinsic value or advantage then there is an advantage to consumers using it. Te innovator has given the world something and should be rewarded. However, if the new form is not fundamentally advantageous to patients then why would they not use the form patented in the earlier patent? Te refusal of such applications is politics interfering in the logical application of law.


Use patents


Te same thinking infects the other contentious element around Section 3: the inability to patent


a new use of a compound in the treatment of disease. Such claims are a cornerstone of pharma innovation and patenting.


For example, the compound sildenafil was marketed by Pfizer as Viagra™ for the treatment of erectile dysfunction. Later, the same compound was found to be useful in pulmonary arterial hypertension. Pfizer chose to develop the medicine as Revatio™. It is not an obvious leap from erectile dysfunction to pulmonary arterial hypertension so most countries would acknowledge that patent protection is in order. Tis could be either in the form of a second medical use claim or a method of treatment claim, as a reward for the insight, perseverance and expense of a patent.


Not so in India. Te IPO’s guidance is notably terse:


“[Use claims] are not to be considered as inventions, since the claimed subject matter pertains to neither product nor process.”


Te IPO has clearly maintained that Swiss- style claims: “the use of X in the preparation of a medicament to treat disease Y” are clearly not process claims.


Te guidance goes on to say: “Further, an objection with regard to Section 3(i) would be invoked.”


Section 3(i) lays out that methods of treatment are unpatentable. In terms of Section 3(i) the IPO is merely following explicit statute.


Te position taken by the IPO strikes at the heart of what the patent system is set up for: the incentivisation of research to treat human suffering. If every country followed India’s line there would be no research and clinical development would stop. However, this does not seem to pose a problem for patent officials, and instead they seem confident that they can appropriate the technology because other countries will pay for it.


Tis is an unsustainable position in the longer term, but there are no clear answers as to how matters will play out as India’s global economic position strengthens. n


Jason Rutt is head of patents at Rouse. He can be contacted at: jrutt@rouse.com


Rouse is a global IP law firm, headquartered in London and with offices across Russia, the Middle East and Asia. Rouse’s affiliate firm in India is RNA IP Attorneys, with offices in Gurgaon and Chennai.


www.lifesciencesipreview.com


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