In an extremely surprising development, which was first reported by Vikas Dandekar of PharmAsia, in an article available over here, Roche (which owns Genentech) has announced that it will no longer “pursue” its Herceptin patents in India.
In his statement to PharmAsia, Roche’s spokesperson was quoted as saying that Roche will “not pursue its Indian Patent 205534 and the related divisional applications”. All of these patents and applications which are owned by Genentech have been in trouble for the last few months.
First, there was the news of the Patent Office refusing to allows three divisional applications filed by Genentech from the parent 205534, on the grounds that the Genentech had missed several deadlines. The divisionals themselves were under attack from Indian generics like Glenmark, which had filed post-grant oppositions and also Mylan, which was the first company to point out that Genentech had been missing statutory deadlines.
Then there was news, first reported on SpicyIP, that Genentech had not paid its annuity for the main 205534 patent. The Patent Office at the time had confirmed to us that the patent had indeed lapsed, although the message from the Patent Office indicated that it would be open to considering a request for extension up till November, 2013. Although we were skeptical about the Patent Office’s interpretation of the 6 month rule for extension, there was no denying that Genentech did have a right to file an application for restoration provided that it had a valid enough reason for letting the patent lapse.
Roche has however surprised the industry by deciding to not fight these battles. I think it was a smart move on their part, especially since these Herceptin patents had the potential to slide into a PR disaster of ‘Glivecian’ proportions. That the Government was interested in issuing a CL for the drug didn’t really help their cause. Given the political climate, Roche correctly guessed that it would not receive any mercy for missing deadlines. In the circumstances, it was probably a good idea to let the patents go especially since there are no bio-similars on the horizon. Readers may remember the revocation of the Pegasys patent last year owned by Roche. Despite the patent being revoked by the IPAB, there is no biosimilar in the Indian market for Pegasys, which earns Roche a significant Rs. 50 crores.
Herceptin sales in India have brought Roche Rs. 130 crores (or $23 Million dollars) last year despite dropping the price of its product substantially. This may appear to be pretty low by Western standards but given the ultra-competitive Indian market, $23 million dollars for a single drug is a pretty good deal.
According to Vikas Dandekar, Biocon is in advanced stages of trials with its biosimilar of Herceptin and maybe poised to be the first entrant in India provided it gets regulatory approval. Herceptin would not be the first bio-similar to be given the regulatory approvalin India but it is likely to be the focus of intense scrutiny. Similarly, the Indian regulatory process for biosimilars will also be in the spotlight of foreign companies who have so far had the monopoly in the biologics space. Any mistake by Indian regulators will cost the entire Indian industry. Hopefully the regulator will avoid any such disaster through a transparent decision making process.
Roche’s strategy is very preemptive and can be understood looking at the following factors:
– They are facing multiple challenges to this patent family:
i. the health ministry want a compulsory licence issued;
ii. CAT and other access groups are vociferously demanding outright revocation pointing out the ridiculous pricing strategy;
iii. they face potential challenge from Mylan, which going by the tone and content of their letter on 3272/KNP/2008 is supported not only by a strong inhouse team but also probably one of the finest and most underrated legal minds in patent law as their outside counsel;
– the patent strength is probably weak and has been realised by Roche considering the specific requirements in our law.
Given all this, it is not surprising that they would rather not lose their patent publicly in a post-grant opposition or revocation or through CL and have these facts appear in the public domain.
Regards,
Antara
Antara – I must tell Sandeep Rathod, that he seems to have an ardent fan in you! 🙂 Three comments on two different websites praising Mylan’s in-house legal team. I’m almost jealous of Sandeep.
But jokes aside, given the manner in which Genentech’s patents were being prosecuted I think they were more threatened by their own lawyers rather than the lawyers from the opposite side.
Best,
Prashant
Dear Prashant:
Just to clear the air – I do NOT know Ms. Antara nor am I nor Mylan Counsel is connected to her.
I kept silent all these days on every single post you wrote on Trastuzumab since a) this project comes to me from my Employer + work; b) my name did not appear in any of the SpicyIP posts and c) no one from media or SpicyIP asked me (till date) to comment from the start of the news/ documents coming on-line on IPAIRs in Feb 2013.
However, am putting this comment now (in my personal capacity) since you mentioned me by name here and there could be (mis)interpretations amongst readers that Ms. Antara is ‘praising’ me since she is a friend/ employee/ well-wisher or what-not. So, repeat- for sake of clarification – I or my counsel do not know Ms. Antara or have any connection with her.
Continuing – again in personal capacity – I whole-heartedly agree to later part of Ms. Antara’s comment regarding Mylan’s external counsel – since I have worked with and against multiple top “IP” counsel in India – I can state with confidence that G. Nataraj is amongst the best in the country – much superior in analysis and work product compared to what I have seen – as a user and sufferer 🙂
Finally, I do have a small disagreement with you on the last part of your comment regarding Roche’s own lawyers. This law firm is “India’s leading IP law firm” per SpicyIP itself and importantly, Roche/ this law firm did litigate (not abandon/ let die) the Herceptin matter for some years now with the other earlier challenger – the Roche/ Law firm decision is made only post June 2013. So, something changed in the last few weeks that made a sea-change.
Sandeep K. Rathod
I think Roche is switching to lobbying for a strict biosimilar policy, rather than relying on patent protection.
Dear Suleman,
Ur point toward strict Bio-similar policy is unclear.
If Roche is indeed switching to lobbying for a strict Bio-similar policy, rather than relying on patent protection then we should see Roche abandoning all patents related to biological products, which I thing would be an absurd thing to do.
Here there is some thing catch as pointed out by Mr. Sandeep above and not just as simple as u think.
Regards
Anon