SpicyIP Tidbit: Patent Office confirms status of Genentech’s Herceptin patent

Following my post yesterday, the Patent Office has finally confirmed the status of the main Herceptin patent 205534 with the following email:

“As per the E-Register, 15th Annuity was due on 03.05.2013 and same has not been paid so far, therefore it shows ceased 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.Therefore, Patentee still can pay the 15th Annuity on or before 03.11.2013 with extension.” 

In other words, the website of the Patent Office was indeed accurate and Genentech had indeed failed to pay the renewal fees. The Patent Office however appears to be ready to accept the renewal fees from Genentech until November 3, 2013 under Rule 80. However I doubt whether companies like Glenmark and Mylan are going to give Genentech a walkover in this regard. 

It is possible to argue that the request for extension in time required, to pay, the renewal fees under Section 53(2) read with Rule 80(1A) can be made only before the expiry of the last date for renewal, which in this case was May 3, 2013. Since the rule uses the word “extension” as opposed to condonation or restoration, it implies that the right should be applied for before the proposed deadline rather than after the deadline, in which case the right has to be “restored” or the delay has to be “condoned”. You can’t “extend” a right which has already been extinguished. In other words Genentech should have applied before the May 3, 2013 deadline for an extension and if granted such an extension by the Patent Office, it could have paid the renewal fees even after May 3, 2013. 

An application under Rule 80 is an affair between the Patent Office and the patentee – Glenmark and Mylan, which want the patent struck off the register will have little opportunity to intervene directly, although they could rake up the issue in a High Court at a later stage. 

Assuming that the Rule 80 route fails, the Patentee still has the option to file an application under Section 60 for “restoration of a lapsed patent”. Such restorations are long drawn affairs since the Patent Office has to advertise the restoration application and any interested party can oppose the restoration of the application. More importantly, the patentee has to be able to give the Patent Office a good enough reason to allow the restoration application – a mere ‘Oops! I forgot’ isn’t going to do the trick.

It is not going to help Genentech’s case that the Government of India is looking for ways to over-ride its patent due to public health concerns. By not paying up on time, Genentech has left the door wide open for the Government of India to exert pressure on the Patent Office to not consider any renewal or extension in the payment of renewal fees. Since the patent was otherwise valid till 2019, this mistake on Genentech’s part is going to cost it, an average of Rs. 150 crores every year (this drug earned Roche/Genentech Rs. 127 crores last year) and with a cancer drug this figure will keep climbing) – which means that over the next six years Genentech could lose approximately Rs. 800-900 crores – this is of course presuming that a biosimilar can enter the market without infringing any other patents owned by Genentech – the renewal fee charged by the patent office for the 15th year is approximately Rs. 12,000.