Recently the Indian Patent Office revoked the patent granted to Novartis for a heart failure drug named Vymada also known as Entresto, which was a combination of drug sacubitril and valsartan. The main grounds of revocation of patent was lack of novelty and inventive step and also it was invariably coming under section 3(d) of Indian Patents Act, these grounds are considered primary requirement when there is a question of granting patent in India. While the pharma companies see this as an action to prevent evergreening of patents.
In order to understand its significance, we need to analyse several components such as the TRIPS Agreement and its requirements, non-patentable subject matter under section 3(d) and its application in Novartis case, revocation of patent, implication on public health.
Understanding TRIPS Agreement and Its Flexibilities
India is bound by the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement which explicitly requires member states to grant patents for any inventions if it involves inventive steps and is capable of industrial application. But it is important to note that TRIPS does not lay down the definition of “Inventive step,” “novelty,” or for that matter “industrial application,” this gives the flexibility to the member states to interpret and implement these concepts as per their own laws keeping in mind the public health and socio-economic conditions. Moreover, the TRIPS agreement gives flexibility for compulsory licensing by laying down exceptions for public health. This came from an idea to protect public health and to promote the idea of accessible medicines for all.
The enhanced efficacy as laid down in section 3(d) is consistent with the requirement of inventive steps; if a change in invention is of trivial nature then the criteria of inventive step will not be fulfilled
Interpretation of section 3(d) of Patents Act, 1970
The section 3(d) of the Indian Patent Act which was substituted by the Patent amendment act of 2005, prevents grant of patent for ‘new forms of known substance’ until and unless there is enhanced efficacy in that invention; this provision invariably prevents modification or variants of known patented drugs being patented without enhanced therapeutic efficacy or any kind of genuine improvement. Section 3(d) lays down some specific requirement such as:
- Mere novelty is not enough for invention there must be improvement not just a new form of known substance
- There must be genuine inventions and it’s important to prevent monopolistic extension as it will always keep the drug price high which will invariably affect the general public.
- Protection of public health.
Revocation of Novartis Patent on Vymada was correct ?
The landmark case of Novartis AG v. Union of India (2013) where Novartis claimed a patent on a beta crystalline form of Glivec (imatinib mesylate), a known substance. The hon’ble Supreme Court in this case rejected the grant of patent mainly because Novartis failed to prove enhanced therapeutic efficacy over the known substance which was imatinib. This decision of the hon’ble court clarified that section 3(d) of Patents Act is constitutional and is inline with TRIPS agreement, meaning thereby “efficacy” in the context of pharmaceutical patents reflects therapeutic efficacy. The main reason and precedents cited by the Supreme Court in the judgment are as follows:-
- Lack of Novelty and Inventive step – The Indian Patent Office found that the patent claimed on Vymada’s “Supramolecular complex” fails to show novelty or an inventive step over the existing drug formulations. It is important to note that for the purpose of granting patent an invention needs to be non-obvious and new, it should not be merely a rearrangement of any sense or only a slight modification without any sort of technical advancement in comparison to prior art.
- Not in accordance with section 3(d) – Novartis fails to provide any kind of experimental comparatives, empirical data in order to prove that the new form has sufficient therapeutic efficacy over known forms of Glivec. The Indian Patent Office found that there was no such advantage when it comes to treatment outcome; section 3(d) requires much more than just a “new form of a known substance”.
Therefore, if we analyse the judgment from a legal perspective, revoking the patent is correct.
Evergreening and Revocation of Patent
When it comes to pharmaceutical industry evergreening of patent refers to the practice where a company seeks to extend the patent life of a drug by applying for new patents on slightly modified version of a drug which is existing, now these modifications can include some kind of new components, formulations or combinations which may or may not give some different or unique therapeutic benefits. If we are to analyze this concept of evergreening we will gather that it exploits the patent system, meaning thereby it doesn’t allow cheaper versions of drugs to enter into the market and keeps prices high; now this can be highly detrimental for public health, particularly in countries like India where the affordability of essential medicines is a critical issue.
The section 3(d) is considered as a safeguard against evergreening of patents because it ensures that patents cannot be granted for “new forms of known substances” if a particular invention is just showcasing nothing more than enhanced therapeutic efficacy; this is because exclusivity in such cases becomes a question. In Novartis’ case, the IPO found that modification failed to show exclusivity and meaningful innovation,it was an attempt towards evergreening which is why revocation of patent was seen.
Implication on Public Health
The revocation of patent of the Vymada has various implications on public health in India such as:
- Lowered prices of medicine – On revocation of patent what happens is, the generic manufacturers can enter the market which is why the competition decreases thereby making the drug more affordable and this could create a substantial impact on public health.
- Prevents monopoly – As patents grant exclusive rights to the patent holder so if the invention is not a genuine one then in that case extending a monopoly is not beneficial as it blocks access of other companies.
- Promoting real innovation – It is crucial to invest in real innovations and support the pharma industry. This would invariably ensure affordable and accessible medicines to the public at large.
- Setting precedent – This revocation can invariably deter frivolous patent filing and will encourage better research and development (R&D).
Critical Review
While this judgment is praised for public health, if we see this on a larger scale there are some legitimate critical points. It is also important to note that in order to satisfy section 3(d) we need data and generating such data is not easy, it is costly, companies might face uncertainty and risk which would financially impact them.
To conclude this we could say the revocation of Novartis’s patent reaffirms the legal and ethical principles of patent law; it also reflects that section 3(d) is valid and enforceable, it also aligns with the TRIPS agreement and invariably promotes public health and transparent ecosystem for innovation.