Multiple news outlets recently reported about a pre-grant patent opposition filed by two TB survivors, with support from MSF, against a patent application filed by Janssen for a salt form of its experimental TB drug bedaquiline. In a press note put out by MSF, it was claimed that this opposition “…is the first ever challenge against a TB drug patent in India”. This is a factually incorrect statement.
The patent application under challenge, as per Sandeep Rathod’s analysis of the opposition on IP Watch is 1220/MUMNP/2009. The online record of the patent application on the website of the patent office indicates that this particular patent application was opposed, as far back as 2013, by the Network of Maharashtra of People Living with HIV (NMP+) through patent agents Gopakumar Nair Associates. The patent opposition filed by Network of Maharashtra of People Living with HIV has been pending for 6 years now and it appears that for all practical purposes the first opposition stopped the patent application in its tracks. The MSF press note makes no reference to this opposition.
The Section 3(d) stumbling block?
One of the main impediments to this patent application proceeding is the Supreme Court’s interpretation of Section 3(d) of the Patents Act. This provision of Indian patent law is meant to target secondary patents like the one filed by Janssen in this case. By ‘secondary patents’, I mean the patents that are filed by pharmaceutical companies for the salt forms of the main active ingredient. As per Rathod’s analysis on IP-Watch, the main patent application for the active ingredient was filed in 2003 and would have expired in 2023. The patent application for the fumarate salt form of the main active ingredient was filed in 2006 and would have delayed the entry of generics till 2026. Section 3(d) however makes it tougher for pharmaceutical companies to patent salt forms such as the one in question in the ‘1220 application. It does so by creating the legal fiction that the salt form is the same compound from which it is derived and by doing so shifts the onus of proof on the patent applicant who has to show the patent office that the new salt form is more efficacious than the previous forms. The Supreme Court has interpreted ‘efficacy’ as meaning therapeutic efficacy meaning the new form has to show significantly superior capabilities in treating a disease. Most salt forms will not be able to demonstrate such efficacy. The main advantages of the fumarate salt of bedaquiline, according to Janssen is that it is more stable with greater bioavailability. Whether increased bioavailability will lead to better efficacy is an issue that will turn on evidence, although going by the reply filed by Janssen to the earlier opposition it appears that Janssen has almost conceded the case.
Were the right set of claims opposed?
One of the strange aspects of this pre-grant opposition is the decision of the opponents to challenge a set of amended claims that have not yet been accepted by the Controller. As with most patent applications, the patentee appears to have voluntary amend its original claims filed as part of the PCT application. But the Controller of Patent objected to these amended on the grounds that it was not in compliance with Section 59 of the Patents Act which allows for patents to be amended only by way to correction, explanation or disclaimer. According to the Controller’s examination report, Janssen had tried to expand on its original claims and this was impermissible. Janssen in its reply to the examination report once again tried amending its claims to conform with the objections in the examination report. After that set of communications, Janssen once again sought to amend its claims in 2013 after the first pre-grant opposition was filed by the Network of Maharashtra of People Living with HIV (NMP+). None of these amendments have been accepted by the Controller in which case the opponents should have challenged the original set of claims as filed in 2009. These original claims were limited to the fumarate salt form while the amended version in 2013 includes a wetting agent in Claim 1. The second opposition refers to the amended claims in 2013 and not the original claims filed in 2009.
Normally challenging the wrong claims could be the end of an opposition but I don’t think it will make a big difference in this particular case because this patent application is anyway going to trip on Section 3(d).
Indian health journalists & activists continue to ignore the ethical implications of the bedaquiline rollout in India
In the meanwhile, most health journalists and activists continue to ignore the ethical implications of the bedaquiline rollout in India. Most of them have simply turned a blind eye to the flawed consent forms and they continue to repose blind faith in the WHO recommendations for increasing the uptake on bedaquiline. What most of them ignore is that the WHO unlike the Indian government is not responsible for making arrangements for the rollout or the consequences that will follow from a flawed rollout. Nobody in India is going to go and sue WHO but they will hold the Indian government liable for possible deaths. It is then understandable as to why the government is being cautious about the rollout.
Only one health journalist Maitri Porecha of the Hindu Business Line has pointed out how the lack of digital ECGs and other crucial equipment is hampering the rollout of bedaquiline. This is the type of reporting that is required to build pressure on the government to ensure a planned, ethical rollout of bedaquiline. The danger of simply asking the government to ramp up bedaquiline without understanding the reasons for the delay is that the government will react in a kneejerk manner in order to counter its critics. In the process the government will not take care of the safety measures that should accompany the rollout of a drug like bedaquiline which has known toxicity issues.
There are other serious ethical issues with the journalism and activism surrounding the bedaquiline rollout but I won’t bore you by repeating them once again in this post. Let me end by saying that over the last 11 years that I have been reading and writing about pharmaceutical patents as a student, lawyer and academic, I’ve seen the same old faces making the same old arguments. There has been little innovation or new thinking from the activist camp. I suspect the reason for this stagnation in thinking is that the ‘activists-in-chief’ tend to become larger than the cause. It would be in everybody’s interests, especially the NGOs working in this space to force the old guard to step aside so that new ideas and thinking may come to the fore.