Trends in ‘Oppositions’ against Pharmaceutical Patents

The amendments to the Patent Act, 2005 created a dual opposition mechanism before the Patent Office i.e. the pre-grant opposition mechanism and the post-grant opposition mechanisim. Thanks to the digitization of the Opposition decisions it is possible to analyze some basic trends in the strategies of the generic pharmaceutical industry in filing such oppositions. The analysis below pertains to only those oppositions which have been decided by the Patent Office and the accuracy is completely contingent on the patent office website.

As will be shown below the Patent Office has decided a total of 14 oppositions that have been filed by Cipla. This is the highest number amongst generic companies. Cipla is followed by Ranbaxy which has had a total of 12 of its oppositions decided by the Patent Office. Then comes Torrents which has a total of 10 oppositions decided by the Patent Office. Torrents is the last company to have filed oppositions in double digits. NATCO has had only 6 of its oppositions decided by the Patent Office. While Cadila has had 3 of its oppositions decided by the Patent Office other companies like Glenmark, Matrix, Ajanta, Hetero, Wockhardt have had only one opposition, each, decided by the Patent Office. Please note that some of the oppositions are overlapping. For example Hetereo, Cipla & Ranbaxy were all part of the pre-grant opposition against the Glivec patent. Similarly Cipla, Ranbaxy, Matrix were opponents against the grant of the Valcyte patent.

It is interesting to note that leading generic pharmaceutical companies like Dr. Reddy’s, Lupin, Sun, all of whom are regular para IV litigators in the USA, have not had a single opposition decided by the Patent Office. In fact I’m not even sure whether they have even filed any oppositions before the Indian Patent Office. Piramal is another company which has refrained from any opposition. That does not come as any surprise because Piramal has been quite candid about its ‘respect’ for patents.

Of the companies which have been opposed, it appears that Novartis, Roche, Gilead and Pfizer have bore the brunt of oppositions. The top disease segments in the opposition appear to be oncology & AIDs. Surprisingly Indian companies like Wockhardt, Cipla and Cadila have also faced oppositions by other Indian companies against patents filed by them. Innovator companies like Bristol Myers Squibbs, Genentech have escaped unscathed so far.

A. Cipla – Oppositions against:
(i)Novartis (2)
(ii)Roche (2)
(iii)Gilead (4)
(iv)OSI (2)
(v)Tibotec Pharmaceuticals (2)
(vi)Rikhter Gideon Vegyeszeit Gyar (2)
Total = 14 Oppositions

B. Natco – Oppositions against:
(i)Astrazeneca U.K. Ltd.
(ii)Pfizer Products Inc.
(iii)Yeda Research & Development Co.
(iv)Millennium Pharmaceuticals Incs.
(v)Abraxis BioScience LLC
(vi)Novartis
Total = 6 Oppositions

C. Torrents – Oppositions against:
(i)Novartis (3)
(ii)Warner Lambert
(iii)Astrazeneca AB
(iv)Astra Aktie (3)
(v)Pfizer Products Inc.
(vi)Wockhardt (1)
Total = 10

D. Ranbaxy – Oppositions against:
(i)Novartis (4)
(ii)Roche (3)
(iii)Pfizer Health (3)
(iv)Eli Lilly Co
(v)Gilead Sciences Inc.
Total = 12

E. Ajanta – Oppositions against:
(i)Eli Lilly

F. Hetero – Opposition against:
(i) Novartis

G. Cadila – Oppositions against:
(i)Schering Corporation (2)
(ii)Cipla

H. Glenmark – Opposition against:
(i) Abbot Biotechnology Ltd.

I. Ind-Swift Labs. – Opposition against:
(i) Cadila

J. Matrix Labs – Opposition against:
(i) Roche

K. Wockhardt – Opposition against:
(i) Roche