Indian patent law: up for a fight
India has been the hub for all that excites ire and admiration in those with an interest in pharmaceuticals. Generic manufacturers and access-for-medicine foundations applaud, and innovators seethe at the way India has become a tough place for innovative companies to do business. There is frequent debate about the extent to which Indian law is being correctly applied and whether Indian statute is compliant with the World Trade Organization’s Trade-Related Aspects of IP Rights (TRIPS) Agreement.
Amid the controversy, many forget that the issues associated with Indian patent law have a strong retrospective element. After India signed up to TRIPS at the beginning of 1995, it was granted ten years to introduce all the necessary changes. The key one for the pharmaceutical industry was the introduction of pharma product patents in 2005. Given that the lead time for development of a new pharmaceutical is more than ten years, a product marketed in 2014 was probably the subject of a pre-2005 patent application. Glivec (imatinib) is a good example of such a product.
Given how much conflict is based on past law, what can we expect in the future? The Indian Patent Office (IPO) has issued draft guidance to examiners on how to treat future applications. India is unrepentant, unapologetic and bristling for future clashes.
The preamble to the guidance gives a useful insight into the IPO’s mindset. It acknowledges the value that good patents bring in terms of ‘promoting innovation and technological development’ (para 1.17). However, it is proud of the way that India is viewed as the ‘pharmacy of the world’ (para 1.16) and quotes a World Health Organization request to the Indian government in 2004:
“As India is the leader in the global supply of affordable antiretroviral drugs and other essential medicines, we hope that the Indian government will take the necessary steps to continue to account for the needs of the poorest nations that urgently need access to antiretrovirals, without adopting unnecessary restrictions that are not required under the TRIPS Agreement and that would impede access to medicines.”
This is the ‘level playing field’ point frequently made by innovative pharmaceutical companies. Medicines are researched, developed and sold in a global marketplace. Pharmaceuticals are 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.
The 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
The 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. The 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?
The 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.
The IPO goes on to offer strong guidance that efficacy is a narrow test of therapeutic efficacy.
“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.”
A compound may show efficacy in an in vitro assay. That 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. The 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. They’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. The 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? The refusal of such applications is politics interfering in the logical application of law.
Use patents
The 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. This 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. The 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.”
The IPO has clearly maintained that Swissstyle claims: “the use of X in the preparation of a medicament to treat disease Y” are clearly not process claims.
The 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.
The 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.
This 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.
Jason Rutt is head of patents at Rouse. He can be contacted at: jrutt@rouse.com
