This article briefly explorers recent pharma patent rejections from Indian Patent office. It tries to calibrate information focusing on rejections from the Indian patent office to arrive at a matrix which can serve as a reference tool for pharmaceutical patent prosecution. It outlines the available information to understand the coordinates based on which pharma patents are rejected from the Indian patent office.
Following table lists recently reported cases:
Please download complete list (Link) with other field of information such as :
Application Number, Date filed, Date of decision, and Basis of Rejection
It seems that majority of the rejections can be related to the sections 2(1)j,3b, 3d and 3e of the Indian patent law. Also, that any application that jeopardizes the position of a generic drug in India would face opposition.
However, the case of Tasigna(Nilotinib) from Novartis (237430 3003/CHENP/2004) was granted despite of all the features of rejected application. This seems to be an exception and it would be interesting to see its prosecution history. A article on (Link) relates to this story.
Does this data show that the Indian patent office is trying to balance ‘Indian Health and Welfare’ and patentability standards?
Is it only the commercially successful drugs that are opposed, rejected or revoked?
Do these stringent patentability standards raise the quality of patents/innovation?
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This information is provided by Dr. Sarasija Padmanabhan (Profile) who is registered patent agent at Indian Patent office. She is the lead writer of this report. Please note that the information by no means is complete and needs to be updated regularly. Writers are not responsible for any error in the presented data . This article does not represents writers' employer position on the subject .
Following table lists recently reported cases:
Please download complete list (Link) with other field of information such as :
Application Number, Date filed, Date of decision, and Basis of Rejection
It seems that majority of the rejections can be related to the sections 2(1)j,3b, 3d and 3e of the Indian patent law. Also, that any application that jeopardizes the position of a generic drug in India would face opposition.
However, the case of Tasigna(Nilotinib) from Novartis (237430 3003/CHENP/2004) was granted despite of all the features of rejected application. This seems to be an exception and it would be interesting to see its prosecution history. A article on (Link) relates to this story.
Does this data show that the Indian patent office is trying to balance ‘Indian Health and Welfare’ and patentability standards?
Is it only the commercially successful drugs that are opposed, rejected or revoked?
Do these stringent patentability standards raise the quality of patents/innovation?
-------------------------------------------------
This information is provided by Dr. Sarasija Padmanabhan (Profile) who is registered patent agent at Indian Patent office. She is the lead writer of this report. Please note that the information by no means is complete and needs to be updated regularly. Writers are not responsible for any error in the presented data . This article does not represents writers' employer position on the subject .
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Good piece of information Sarasija. I feel IPO is getting more mature with patentibility standards. Novartis (Glivec) case is a wonderful example. Since patents definitely are more valuable in pharma industry, validity of same matters a lot leading to more oppositions and revocatons.
ReplyDeleteVery nice work, Sarasija.
ReplyDeleteThis is a very interesting project. It clearly shows you’ve done a lot of work on these cases. It should be very helpful for Indian patent prosecutors.
To add additional value to the chart (from my perspective anyway), one might want to add a footnote or comment on the "Basis of the Rejection". I’m guessing that when you review these cases, occasionally you might have some insight or thought about the basis of the rejection. This might not be true for every case, but occasionally a comment like, “The Patent Office determined that the claims to [compound X] were too similar to known [compound Y] because the only difference was the addition of substituents onto the phenyl group of [compound X], therefore the application lacked inventive step. That might be a lot of work, but occasionally it might be an interesting summary.
It might also be helpful to some readers to have a one sentence or short phrase that sums up the type of claims that Applicant is seeking. For example, “claims directed to a new use of a known compound”,“claims directed to a new dosage form of known compound”. My guess is that it would be rare to find claims to “novel compounds” rejected by the office, but there might also be some of those. This might be a lot of work but some readers might find it very helpful. These are just my personal thoughs though. Nice work!
Excellent observation Dr.Sarasija. The study shows the trend in rejection/oppositions by IPO.The chart can be used by Pharma industries for their business strategies. I wish such studies are made in other fields such as patents of automobile industries, where there are lot of overlapping of technologies
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