As has already been reported by several newspapers, Genentech, now a part of Roche, faces the loss of more than one of its several patent applications covering Herceptin, the extremely effective and expensive breast cancer drug. According to the ‘Statement of Working’, (Thanks to Madhulika we have a copy of the form here) data filed by Genentech this year, for the ‘parent’ Herceptin patent (205534), the company earned a whopping Rs. 127,65,31,000 (127.65 crores) from the sale of 23,280 units of Herceptin – since each course of Herceptin involves between 12 to 18 units, it is likely that only around 1,500 women have received Herceptin treatment last year – that’s an extremely low figure for a population of a billion people. And mind you, this is the state of affairs after Genentech/Roche slashes the prices for Herceptin from over Rs. 1,50,000 to Rs. 75,000 per vial last year.
But getting back to the news at hand, in the initial reportsseveral newspapers had mistakenly reported that the Herceptin patents had been revoked by the Indian patent office. This was later corrected, when in an unusual step, the Kolkata Patent Office responded by issuing a press release explaining that Genentech’s patent applications had lapsed because they had missed statutory deadlines.
The entire chain of events in this case appears to have germinated from this letterdated April 24, 2013 by the Campaign for Affordable Trastuzumab (which is the generic name from Herceptin). The letter was addressed to the Controller General of Patents, complaining about the practice of the Kolkata Patent Office, in allowing Genentech to file multiple divisional patent applications, to create a patent thicket around Herceptin and delaying the entry of bio-similars in the market.
The practice of divisional patent applications has been a topic of much controversy in the Indian patent practice with the IPAB recently coming down heavily on the practice, over here. As originally envisaged, divisionals could be filed, when the parent patent application covers multiple inventions and all the divisionals resulting from the patent application can claim the same priority date as the main patent application. Since all the divisionals claim the same priority date, all these applications once granted, will expire on the same day as the parent patent application. The obligation to allow for the filing of divisional patent applications flows from the Paris Convention, to which India is a signatory.
The problem with the divisional patent application practice lies in the fact that patentees often use these divisional patent applications as a safety net, whereby if the claims in the main patent are rejected by the patent office, the divisional application with similarly worded claims is kept as a standby for a second shot at patenting. If the patentee succeeds in converting all the divisionals to patents, it would able to protect its product with a thicket of patents making it more expensive and difficult for competitors to enter the market.
In this specific case, Genentech had filed three different divisional patent applications from the main patent application (IN/PCT/2000/391/KOL), which had converted into a patent 205534 in 2007. Each of the divisionals are explained below:
(i) 1638/KOLNP/2005: This was the first divisional, created in 2005, while the Patent Office was still in the process of examining the parent application. According to the press release put out by the Patent Office, “the Controller found that the Request for Examination had been filed on 17.03.2006, i.e., beyond the prescribed period (which was due on 16.02.2006) according to Rule 24(B)(iv) of the Patents Rules.” According to the patent office’s interpretation of the rules, a request for examination, for a divisional patent application has to be filed within 6 months of the filing date, failing which it is presumed to be abandoned.
In the circumstances, the Patent Office would certainly be justified in its decision except for the fact that as per its website, the Patent Office had already issued a First Examination Report for this divisional way back in August of 2008. You can access the FER over here. As per the last check on the Patent Office website, the application is shown to be pending examination.
The fact that the FER was issued after the statutory deadline, obviously raises questions about the conduct of the Kolkata Patent Office? Why was the FER issued if the Request for Examination was filed for after the due date? More importantly, has the Patent Office learnt from its mistakes and created an automated mechanism to prevent such requests to be registered in the system after the due date?
(ii) 3272/KOLNP/2008 & 3273/KOLNP/2008: Although both these divisionals claim the same priority date as the parent application filed in 2000, you will note that the divisionals were in fact filed in 2008, after the parent application was granted in 2007.
The Campaign for Affordable Herceptin objected to both divisionals on two grounds:
(i) The first objection was with the fact that the Request for Examinations of both patent applications were filed a day after the 6 month deadline;
(ii) The second objection was based on IPAB decisions which supposedly prohibited the filing of divisional patent applications after the parent patent application had been granted.
When informed of the hearing, Genentech’s counsel filed a response with the Patent Office informing the Controller that as per the Patent Office’s own records, the Form 18 requesting an examination for both patent applications was received by the Kolkata Patent Office on February 9, 2013 i.e. two days before the deadline of February 11, 2013. It appears that the relevant Form 18 and the accompanying fees were delivered to the patent office via post, which logged the request in its system and generated the receipt only on February 12, 2013, a day after the deadline. The Controller’s order (accessible over here) records this contention of the Patentee but then rules that the Patentee should have had the error corrected before the hearing.
On the second objection, we don’t know of Genentech’s reply because it never even showed up for the hearing. For its part the Controller appears to agree with the objections raised in the letter from Campaign for Affordable Herceptin. The Controller also includes an additional ground: that is the divisionals were not properly divided on the basis of a plurality of inventions. While this may certainly be true, the order of the Controller contains no analysis of the claims to actually back this conclusion.
As reported by Fierce Pharma, although the divisionals have lapsed, it may still be some time before we see bioisimilars entering the market not only because the parent application continues to be on the record but also because of the complexity involved in manufacturing Herceptin.
Co-authored with Gopika Murthy