Senior advocate Prathiba M. Singh, a leading intellectual property (IP) litigator, on why India is emerging as a jurisdiction with a distinctive patent regime
New Delhi: Indian patent litigation has been contentious with domestic generic companies locking horns with big Western pharmaceutical patentees. The Indian patent regime has also been criticized, particularly by the US.
Against this backdrop, Mint spoke with senior advocate Prathiba M. Singh, a leading intellectual property (IP) litigator and until 2013, managing partner at IP specialists Singh and Singh Law Firm LLP. She has appeared for both innovators and generic companies and been part of landmark Indian patent decisions, notably the 2013 judgement rejecting Swiss pharmaceutical company Novartis’s patent on its cancer drug Glivec, where she represented Indian drug makers Cipla and Ranbaxy.
Edited excerpts from the interview:
Would it be correct to say that India is emerging as a jurisdiction with a distinctive patent regime?
Absolutely. Earlier Indian patent prosecution was a cut-and-paste job of foreign applications. Now, India is viewed as an important jurisdiction where patent prosecution strategies have to be customized. This shows we are not blindly following what is happening in other parts of the world but we are evolving a patent jurisprudence which is unique, balancing innovation protection and public life/health. Applicants have started taking measures to prosecute their matters more seriously in India.
Increasingly big pharma companies patents holders are able to get injunction against generic drug makers and stop them from manufacturing. Injunction is being granted ex parte i.e. without hearing the generic drug manufacturers, in Indian courts, which can hamper availability of cheap generic drugs. Is this a new trend?
I wouldn’t say that there is a trend; I would say there is no hesitation in granting injunctions. Where judges feel that the patent appears to be strong even at the first brush and it has never been challenged by anyone else then there’s no hesitation in granting injunctions. While I think there is nothing wrong with granting ex parte injunctions, I do think there is a requirement of consciousness with respect to those drugs which are especially going off patent in the next three or four years. I feel an ex-parte injunction should not be misused to stop the delay of entry of generics. That’s where there is a concern.
And how can these injunctions impact the global market?
In the US for example, the law permits any generic company who wishes to launch a patented product to file an Abbreviated New Drug Application (ANDA)—it serves as a notice to the patentee that I intend to launch a generic product. For a period of 30 months, the patentee has the option of suing and getting an injunction against that generic. If they don’t get an injunction then the generic can launch. Even for filing that regulatory approval application, the generic company needs to do a lot of work with that molecule. Those generics in the US may be sourcing their products from an Indian company. Then an ex parte injunction against the Indian company leads to a chain reaction—you can’t supply to that foreign company and that generic can’t apply for an ANDA so it’s delaying the entry of generics. That’s not permissible. So injunctions have to be worded and carefully crafted or drafted.
There is an uproar against India’s prohibition of evergreening i.e. patentees seek extension of patents on grounds of minor improvement in the drugs and thereby discourage generics. What is your opinion?
Their argument is that we are not TRIPS (trade-related aspects of intellectual property rights agreement) compliant; we are adding another layer to patentability of chemicals and drugs and therefore we are discriminating. TRIPS says you cannot discriminate between products. My reaction is that a review of all patents goes to show that there are multiple patents being sought for the same compound or molecule. In the case of Imatinib, for example, there were more than 15 patents filed on different forms. So while protecting innovation on the original molecule, we will give patents to new forms but you have to show the advantage of that new form. There was a reason why TRIPS said 20 years—you cannot abuse 20 years to become 40 or 60.
What is your biggest take away from Novartis? What do you feel about compulsory licensing which permits generics to manufacture patented drugs subject to certain conditions?
Biggest take away is that India is serious about patents and India has to be looked at as a serious jurisdiction for prosecution of patents. And I would think that India is the game-changer in patent law.
On compulsory licensing, I feel that India has been unfairly targeted. Compulsory licensing provisions are very stringent. There are 3 or 4 essentials: firstly, you cannot get a compulsory licence for 3 years from the grant of the patent. Secondly, you have to acknowledge the validity of the patent; then you have to negotiate bona fidely with the patentee. And if you don’t do all this, you can’t get a licence. It is not easy to get a compulsory licence in India and I think that makes this provision in favour of the patentee rather than the licensee.
How do you view the recent takeover attempts of Indian generic manufacturers by big pharma companies?
It is a very big cause of concern if Indian companies get taken over by “innovators". Collaboration, transfer of technology is the way India should go, not takeovers. Article 7 of TRIPs says specifically that while giving product patent the intention is that technology disseminates into these countries. The big concern is that none of the patented drugs are manufactured in India. When the generics can make it on their own, they can make it even for the innovators.
There is a huge backlash against the Indian patent regime, especially in the US. Your thoughts?
India and US need to talk. I believe that in the US Congressional hearing, the people who have deposed there, a large number of facts were not brought to the notice of the US government. The USTR (US Trade Representative) report says that India is bad on trademarks, copyrights and patents. My own experience is, barring pharma patents where there are issues which people feel are unjustified, India is doing extremely well on trademarks and even copyright. The maximum relief in Indian courts has been given to foreign companies. Indian judges are absolutely non-discriminatory. Representing both foreign and Indian industry, I think that there is no bias. It is high time the Indian government bucks up, collects all the information about how IP is being enforced in India, presents it and talks to the US.
Whereas the Indian prohibition on evergreening is heavily criticized, we see it being accepted by other jurisdictions, especially Argentina, the Philippines, etc. What is the reason?
Most countries feel that S. 3(d) (evergreening prohibition provision) strikes the right balance. As a patent attorney appearing both for generics and innovators, I agree. My experience has been that most jurisdictions would want to adopt this law and it’s only the tremendous amount of, perhaps “lobbying power" which doesn’t allow it. It is a fact that most countries would love to adopt this law in the interest of their own citizens. We are dealing with a completely human issue here.
What are your thoughts on our policy on patents?
The Indian government has had a very balanced approach- pro-innovation plus the interests of the larger patient community. Our experience in almost 10 years is that the Indian system has streamlined patent law in a fantastic manner. Though the law has been there for 10 years, it is only in the last 6-7 years that we have seen bulk patent litigation. Almost every procedure where there was an issue, the courts have streamlined it. In the next 10-20 years patent law will grow in a major way in India and it is not far off from becoming equivalent to other jurisdictions like US. You will start seeing the big patent litigations here, the big damages. Patent litigation has increased maybe ten or twenty times in the last 2-3 years. In terms of policy, there are bound to be creases, which can always be ironed out but I don’t see any major challenges as are being portrayed.
Do you think the judiciary is sufficiently equipped to adjudicate on these extremely technical issues?
Today we are in the process of evolution. Some courts have developed a good pool of IP judges and with more litigation, we will see larger pool of judges being created. Initially judges wouldn’t have been able to understand trademark. But now trademark has penetrated right till the district courts. So if you fast forward to maybe 2020, you would see patent litigation having trickled down to the lowest judiciary. Also, it is always better to have general judges because specialized judges may come with biases. In most countries of the world judges are not specialized.
What are the outstanding trends that we see in pharma patent litigation as of now?
As a broad trend, strong patents are protected and weak patents are being challenged. Strong patents are really being protected; it does not matter whether it is an Indian or foreign company. They are being protected across the board. Wherever patents relate to second or a third form (of a known substance), they tend to get challenged. However even there we see a lot of awareness amongst applicants and patentees. They’ve started taking steps to strengthen their prosecution so as to not be affected by legal objections.
In India IP is just not about foreign companies, IP is about domestic industry. At least 40% of litigation involves domestic industry.
What do you feel about compulsory licensing which permits generics to manufacture patented drugs subject to certain conditions. India has been criticized for that too.
On compulsory licensing, I feel that India has been unfairly targeted. Compulsory licensing provisions are very stringent. There are 3 or 4 main things in compulsory licensing: firstly, you cannot get a compulsory licence for 3 years from the grant of the patent. Secondly, you have to acknowledge the validity of the patent; then you have to negotiate bona fidely with the patentee. And if you don’t do all this, you can’t get a licence. I think the conditions are extremely strict. It is not easy to get a compulsory licence in India. It is extremely tough and I think that makes this provision very much in favour of the patentee rather than the licensee.
And do you think we are equipped to handle this growth in patent litigation or do you see some challenges?
The challenge is to have domain knowledge experts. We don’t have enough expertise in the legal community in patent law. We are treating patents like an outsourced industry. That’s not how it should be. We need more specialized people in every field of patent law—biotechnology, nano-medicine, software, electronic, pharma. We don’t want ‘cut-and-paste’ patent filing people. We need a large pool of patent agents; patent lawyers who can draft well. There needs to be middle level of training. IP lawyers are doing a better job because of IP-centric courses, as in IIT (Indian Institute of Technology) Kharagpur. I think that there needs to be more specialization within the law schools. In fact, it should be introduced in MBA courses by IIMs (Indian Institutes of Management), even in normal economics, commerce courses in normal colleges. IP consciousness has to trickle down into the education sector in a big way and that will make a huge difference.
How is incremental innovation dealt with?
Incremental innovation is patentable in India—even as per Novartis (judgement)—provided you show in what manner it will give an advantage. There is a mistaken impression what the advantage could be. The advantage could be anything—stability, solubility could be an advantage if you prove it. If a particular form is not at all soluble in the human body and another form of that product is 80% soluble then it efficacy. There is no hard and fast rule that India has laid down on efficacy. You have to show it with empirical data and I’m sure all these companies can show it with empirical data.
Shreeja Sen and Pretika Khanna contributed to this story.
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