Patent

A Second Opposition Is Filed Against Janssen’s Patent Application For The Fumarate Salt Form of Bedaquiline


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.

Prashant Reddy

Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).

3 comments.

  1. Sandeep Kanak Rathod

    Dear Prashant:

    Many thanks for linking back to my short article on IP-watch. I think it is pertinent to put some patent law / practise related points here- and I will not refer to clinical aspects (as I am not competent in those areas):
    a) The line ‘patent application for the active ingredient was filed in 2003 and would have expired in 2023’ is not totally correct – please note, the active ingredient patent is already granted (no longer an application)
    b) The line ‘would have delayed the entry of generics till 2026’ is not correct. The ‘1220 carries a PCT filing date of 03/12/2007 and hence a granted Indian patent to 1220 would expire in Dec 2027.
    c) As for your observation on the claim set being opposed, I have a different view as a practitioner. In my view, it is indeed correct for Opponents to oppose the latest claim set. I have not seen any Controllers at IPO issuing interim S.57/59 decisions. The Controller – during the forthcoming S.14 (or S.25(1) hearing) will refer to these claims and decide. In case the claims are beyond original scope, Controller may bring in S.57/59 but not otherwise.
    On the other hand, based on my experience, I have actually seen more than 1 Applicant arguing against the proposition you laid- their specific position is that ‘Opponents have not even bothered to read the entire file in detail and are opposing an older set of claims’.
    Both the earlier opponent and present opponent have opposed the right claim set (in my view).
    d) Personally, as a patent attorney- if this application trips only on S.3(d), I would be most disheartened. I think the obviousness arguments are very relevant and a decision on them – independent of 3(d) would make me look at our examination standards with more reverence.
    Over the years,for oppositions where I was professionally involved, it has always been my endeavor to get more caselaw on obviousness as I believe that we need more Controller given cases on obviousness.
    e) Importantly, am a bit surprised that the entire angle of large-scale copy-pasting of technical text did not catch your attention as a lawyer. While such an issue directly has no bearing on efficacy / 3(d), it indirectly, could hurt the non-obviousness angle.

    Wrapping up, as an Indian patent professional (though not involved on either side in this particular case), I would love to see how IPO assesses obviousness assessment in the final decision.

    Sincerely,
    Sandeep K. Rathod

    Reply
  2. Prashant ReddyPrashant Reddy Post author

    Hi Sandeep,

    Thanks for the comment – surprised you made no reference or comment on the earlier oppositoin filed through GNA.

    a) The meaning of that sentence is quite obvious to anybody who reads it.
    b) You are right, I misread the priority date as the PCT date.
    c) Your reading is incorrect. The Controller had already raised an objection to the new claims. In any event the opposition should be drafted against the claims allowed by the Controller. There is no point in drafting an opposition against claims that have not been allowed by the Controller.
    d) IF the application can be chucked on Section 3(d) I don’t see why the patent office should waste its time on an obviousness analysis. Under 3(d) the onus is on the patentee, while obviousness requires a time starved patent office to do a lot of work. I think we can live with a 3(d) rejection.
    e) On copying of large parts of the specification, I don’t really see the big deal. If the science is similar it is similar. Its of little relevance to the 3(d) outcome in this case.

    Going by the timing of your IP Watch piece, it looks like you were most certainly coordinating with MSF 🙂

    Regards,
    Prashant

    Reply
  3. Sandeep Kanak Rathod

    Dear Prashant:

    I have been following this molecule for a some time now – around 2017 or so.

    I did not make a mention of the earlier opposition in my article for a single reason only – that I can’t quote here but we can talk on it. I did not use the word ‘first’ or sole opposition in my article or on my Twitter handle.

    Coming to the points,
    a) While I disagree with your reply on meaning of sentence, since the 2023 year was at least there, lets move forward.
    b) Happens to all of us 🙂
    c) I will still say – opposing the latest claim set on file is what I have seen other practitioners do and it is what I have also done in other cases. We can agree to disagree on whether it is right or wrong.
    d) Here, I stand on a completely different footing than you. I have been clear on why I think am obviousness decision is important- for me, it builds jurisprudence, not only for India but countries looking at India. I have, since my first opposition in 2006 (Valganciclovir), always striven to focus on getting an obviousness based victory than a 3(d) based victory since I think a 3(d) based victory does not give me that ‘high’. As for IPO being resource starved, let’s just say that I think IPO has enough resources to grant quick patents and so for me to expect an obviousness based decision – is my sincere wish, not an additional burden on IPO.
    e) I have myself said – the copy-pasting per se does not run afoul of S.25(1). What caught my eye was the large scale verbatim reproduction – down to the para, punctuation etc. in a case like this & I don’t think it is irrelevant to the ‘obviousness’ outcome of this case. The other issue I had with copying at this scale is in your email 🙂

    As for close coordination, dear friend, you are seeing ‘clues’ where there are none.
    The opposition itself was available almost a day in advance to anyone who sees PODB database (which is where I got it from). I have always used my name in public for issues that I think are worth debating and I do not have any problems with team JnJ. They honestly have a tough case to defend and still wish that an obviousness based decision is released 🙂

    SKR

    Reply

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