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.
Very Informative
ReplyDeleteVery interesting. Kudos to Mylan for having initiated the innovative action against 3272/kolnp/2008 divisional and probably the other two as well, and then letting Genentech commit hara kiri on the one granted patent.
ReplyDeleteAntara
Your posts are increasingly becoming colored. Are you even in favor of the patenting system as a whole or not. I have no issues with the latter as long as you don't write on behalf of spicyip which i believe supports patent protection, irrespective of which nationality the patentee belongs to. As far as the procedural issue of restoration is concerned, we must not assume and 'hope' that the patent will not get restored. If the patentee can prove that the failure to pay annuity had genuine reasons, the patent should be restored. Not because, the government would like biosimilars to gain free entry in the absence of a patent! I hope you dont get worked up as usual:)
ReplyDeleteAnonymous @ 10.56AM. This post by Reddy is hardly 'colored'. Though going by that spelling you are evidently from the Northern Hemisphere or are using MS Spellcheck.
ReplyDeleteReddy does not say anywhere that he 'hopes' that the patent will not be restored. What he does point out are the glaring prosecution irregularities and carelessness - not appearing for hearings on divisional applications and failing to pay renewal fee on a timely basis.
It should be assumed that India is in full compliance with the Paris Convention, and that the Paris Convention may thus be used to interpret the IP laws of India. Article 5bis of the Paris Convention allows charging a surcharge, but does not say that using the period of grace may be made subject to the filing of a request for extension within the main period.
ReplyDeleteIt is important to note that Section 53 says that a patent ceases to have effect ... on the expiration of the period prescribed for the payment of any renewal fee, if that fee is not paid within the prescribed period or within such extended period as may be prescribed. So, the patent does not automatically lapse at the end of the main period if the fee has not been paid within the main period; the patent only lapses at the end of the main period if the fee is neither paid within the main period nor within the extended period.
It thus appears that the information in the email from the Patent Office is correct.
For Anon @5.20 - we do not actually need to go to the Paris Convention - the simple logic is that the Rule does not mandate applying for extension prior to expiry of the renewal period, unlike Rule 138 which specifically mandates that the extension must be applied for prior to the expiry of the statutory deadline.
ReplyDeleteThe second part of the argument based on Sec. 53 is absolutely correct.
All this of course does not take away from the fact that someone simply forgot to pay the renewal fee - truly an "Ooops" moment.
Isn't Genentech lucky that revival of the patent right in this six month window period is not subject to the Controller's discretion!!!
The only other reason why it was not paid is that Genentech has decided to not renew - which given the profits it makes on this product is highly unlikely (there is a greater likelihood of the Sun rising in the West!!!)
Cheers
It is still possible for the Applicant to pay the 15th Annuity on or before 03.11.2013 with extension. There will be no necessity for the Applicant to file for restoration before this period. It is only after this period the annuity remains unpaid, the Applicant will have to restore its patent by way of providing circumstances that led to non-payment of the annuity.
ReplyDeleteI appreciate your approach but i have checked in Manual of Indian Patent Office regarding the retoration of Lapsed patent which Manual has written as "the
ReplyDeletePatent may be restored by filing an application for restoration, in Form 15, within eighteen months from the date on which the patent ceased to have effect" (page no. 121-122 of Patent Office Manual) and the date of ceased in present case is 03-May-2013.
Could you please explain how you calculate restoration period of 6 month only.
Your early reply will be highly appreciate.
anilverma2@gmail.com
For Anon@7:20 - it's not always an oops moment. We have had cases, where patentee lost interest and did not pay renewel fee only to realize some commercial interest and therefore, file for restoration by paying the prescribed fees! What is wrong with that? Lets not have a cynical approach to things, always!
ReplyDeleteCheers.