Tuesday, April 9, 2013

IPAB Stays Revocation of Sunitinib Patent until May 13, 2013

Vide an order delivered on April 5, 2013 (available here), the IPAB has stayed the revocation of the Sunitinib patent IN209251 which was revoked by the Controller of Patents on February 11, 2013. The revocation order has been stayed until May 13, 2013 subject to an undertaking from Sugen Inc that the patent would not be used against Cipla in “other proceedings”. I thank a friend and well-wisher for alerting me to this development!

The matter has been fixed for hearing on Sugen’s main appeal against the revocation on May 13, 2013.

The primary ground for stay of the revocation order raised by Sugen was that the Controller had considered the ground under Section 25(2)(b) when such a ground had not been pleaded by the Opponent Cipla. On this issue, the IPAB observed thus:

"14.        Union of India v. Col.J.N.Sinha [(1970) 2 SCC 458]  was cited to support the appellant’s case that the rules of natural justice can operate only in areas not covered by any law and they do not supplant law but supplement it.  Bachhaj Nahar v. Nilima Mandal [(2008) 17 SCC 491] was cited in support of their case that no amount of evidence can be looked into upon a plea which was never put forward in the pleadings and that the Court cannot make up a case not pleaded.  But in the same case, the Hon’ble Supreme Court has stated that the case not specifically pleaded can be considered where the pleadings in substance, though not in specific terms, contain the necessary averments and the parties were conscious of the plea put forward.   Therefore, the fact that in the statement of case certain grounds were taken and certain grounds were not taken will not clinch the issue,  if in the body of opposition, the opponent had in clear and categorical terms raised the objection against the grant of patent.  Therefore, this issue relating to Section 25(2)(b) will not prevail with us at this stage of grant of stay."

To me, this appears to be an unduly broad position. A challenge to the grant of a patent does not mean that by implication all grounds of challenge have been raised by the Opponent. If a specific ground has not been raised, and there are no pleadings to support the ground, mere challenge to the grant of the patent cannot be used to raise the unused ground at a later stage.

Sugen also challenged the fact that Cipla’s reply evidence was filed beyond time and therefore ought not to have been taken on record. To this the IPAB said that this ground was being raised at a belated stage when this could have been raised before the Controller.

The other ground raised by Sugen was that its expert’s affidavit had not been submitted to the Opposition Board for its consideration. Consequently, a critical document had not been evaluated and therefore the procedure stood vitiated. To this, Cipla countered saying this objection was being raised for the first time.

Sugen responded saying it could not have raised this ground until it had access to the contents of the report of the Opposition Board. Since the Report of the Board was supplied to it only after direction from the Supreme Court, it was justified in raising this ground at this stage. Following were the observations of the IPAB on this issue:

It is the appellant’s contention that the ground relating to non-furnishing of the second Dr.Cui affidavit to the Opposition Board was known to them only after the report was filed and therefore, they could not have raised this ground earlier.  Assuming without accepting this plea, we definitely feel that the other two grounds could have been raised in the earlier writ petition, but they had not chosen to do so. Therefore, they cannot be grounds which can be raised now for the purpose of grant of stay.

Having said this, the IPAB went on to grant a stay on the revocation on the following grounds:

19.  The grounds that were raised on merits by the appellant are grounds that are to be examined in detail while we hear the appeal.  According to the appellant, they have a strong case for patentability of the invention and the prior arts are actually  teaching away from the invention.  The jurisdiction of this Board is restricted and limited by the statute.  We have no powers to restrain the second respondent from marketing the drug or to direct them to keep accounts if they so market the drug.  However, we cannot brush aside the apprehension of the appellant that if stay is not granted,  third parties will rush in with their generic drugs and that it will be impossible to set the clock back thereafter.  We are also informed by the letter from the Controller’s Office that the patent will not be removed and the details of the patent remain on the Register with the endorsement as to the orders passed by the Controller or IPAB or the High Court. 

20.  Considering the injury that may be caused to the appellant, if the order of revocation is not stayed,  we grant stay till 13th May, 2013, subject to the undertaking given by the appellant that they will not use the revoked patent against the second respondent herein in other proceedings.  The petition is ordered accordingly. List the main appeal along with the connected appeal on 13th May, 2013.”

We will keep our readers posted on the developments in the case. 

1 comment:

  1. Will Cipla be singing "Kya hua tera vada"???