Updates on Herceptin saga in India

Here are some important updates on the Herceptin in India. As I previously reported in my blog about facts about divisional patent applications viz. 3272/KOLNP/2008 and 3273/KOLNP/2008 rejection and negative hype by media.

Now interestingly the basic patent IN205534 on which above divisional are based is lapsed because of non-payment of annuity fees as of 03.05.2013. However Section 53 of the Patents Act reads with Rule 80 allows the Patentee to pay the same within the extended period not more than six months, if the request for such extension of time is made in Form-4. But this request should be made before the expiry of last date of renewal ie 03.05.2013. Patentee still can restore the patent under Rule 60, but patentee has to be able to give the Patent Office a good enough reason to allow the restoration application. Already this patent is under post grant opposition filed by Glenmark. So it seems quite difficult path ahead for Genentech if they wish to restore the patent because Glenmark most likely to oppose the restoration.

And Roche (Genentech) said that it has no plans to seek a restoration of the patent. The decision to let the patent lapse was part of a new strategy it wants to follow in the local market for the high-value biological drug. “Regular reviews of our patent portfolio are a routine business practice. In this connection, Roche has come to the conclusion not to pursue Indian patent for trastuzumab”.

Herceptin contributes close to Rs 127 crore to Roche's annual turnover, according to industry estimates. Roche's decision of giving up its patent is a smart move, say IP experts as there is no Indian company manufacturing this drug due to the complex science involved. So, even after giving up the patent, Roche will be the only company that will be manufacturing this drug, and the company knows it. While the patent for Trastuzumab may no longer be in force, it is important to note that there are currently no approved biosimilars of Trastuzumab in India.

But latest news about Biocon launching the biosimilar of Herceptin could change the game. As announced by Ms. Shaw, Biosimilar version is in phase III studies and they intend to launch in India by end of March 2014. She has not disclosed the price but it would be much cheaper than the current price of Herceptin in India. Herceptin’s price, at around Rs 1 lakh a vial in 2011, was lowered to Rs 92,000 last year and then further Rs 72,000. Treatment cost with Herceptin may be reduced to about half with the launch of the drug’s cheaper version

Apart from Biocon, two other Indian firms, namely Dr. Reddy's Laboratories and Intas Pharmaceuticals are planning to launch their own version of Herceptin biosimilars.

Hue and cry about revocation of Herceptin patents in India Vs. Real facts and analysis of the case

Recent statement by Roche’s spokesperson regarding revocation of Herceptin Patent in India and its (mis)interpretation by world media led to the series of confusions. World media saw this news again through its pre-conceived notion about India’s weak intellectual regime and blindly followed it. Indian Government later opposed this statement and gave clarification about the whole issue.

I would rather put the facts of the present case for your better understanding and would try to clear doubts regarding situation.

First, patent office has not partly revoked any patent on Herceptin as with the present case. The said issue is with the patent applications filed by Genentech (Roche) viz. 3272/KOLNP/2008 and 3273/KOLNP/2008 (both filed on Aug.11, 2008). These are not yet granted, so what media has interpreted was absolutely wrong about revocation. Patent office instead has refused both applications u/s 16 (divisional application) of Indian patent Act.  To qualify as a divisional application, the application in question must be distinct invention and filed before the parent application is granted, abandoned or deemed to withdrawn.

1.      Both these patent application are divisional of 1638/KOLNP/2005, which is again divided out of IN/PCT/2000/00391/KOL (Granted as IN205534 on Apr.05, 2007). According to Indian Patent Act one cannot file the divisional application from divisional application. Therefore these applications cannot be regarded as proper divisional u/s 16(1) of the Act.

2.      Applicant concealed this fact and stated 1638 application as parent application for the both applications (viz. 3272 and 3273) and filed same with patent office. But these applications are considered to be divisional of IN/PCT/2000/00391/KOL. 391’ application was granted on Apr 05, 2007 and both these applications were filed on Aug.11, 2008, much after the grant date. Therefore they cannot be considered as timely filed as per the Act.

3.      For the sake if we consider that both these applications divided out of 1638/KOLNP/2005, but request for examination (RFE) was not timely filed for 1638 application and therefore deemed to withdrawn as of Feb.16, 2006. Therefore any divisional application filed after this date cannot be considered as divisional application according to Act.

4.      Again both these applications (3272 and 3273) cannot stand as their RFE also filed after due date ie Feb. 11, 2009. Therefore as per section 11B(1), these applications cannot be examined further.

The above objections/grounds were also communicated to the applicant before refusing the applications but hearing was not attended by applicant. Therefore both applications viz. 3272/KOLNP/2008 and 3273/KOLNP/2008 are not considered to be divisional applications within the meaning of section 16 of the Act and also they have not been properly filed complying the requirements of Acts.