Generic Pharmaceuticals and IP: Generic v/s Generic……..

Monday, March 05, 2007

Generic v/s Generic……..

Generic v/s Generic……..

Further to my earlier post where I had raised the issue of generic companies fighting against other generics … here are some more thoughts:

a) The trend can be explained primarily by the argument of cut-throat competition in the generic arena…

b) The generic giants are possibly thinking that even if they can increase their initial 180 day gold run a little further by a few days, then the miniscule cost of filing complaints against the smaller players is worth the effort.

c) I personally believe that the Sertraline story [detailed below] is not the end … it is the beginning of a disturbing trend.

Sertraline details:

a) TEVA was the holder of the 180 day exclusivity for this drug, which was to expire in the first week of FEB 2007;

b) It already had a strong and huge portfolio of patents on processes and polymorphs;

c) It started sending strong letters to all the generic players in the first week of DEC 2006;

d) I believe that the possible though would have been to create an atmosphere of discomfort in the day 181 launch. TEVA can legitimately argue that it is only protecting its granted patents.

e) But the interesting part is that the generic companies all went ahead and launched their versions of the generic on day 181.

TEVA has used courts at multiple places - Delaware/ Maryland/ New Jersey, E.D. of Pennsylvania & New York. Note that only three complaints were filed in Feb. All other complaints are from Jan 12 date. The Zydus & Genpharm complaints were voluntarily withdrawn on Feb 22. [TORRENT complaint- voluntarily dismissed by Teva without prejudice on February 15 itself].

UPDATE: MAR 17: I have been [informally] told by colleagues in the industry that quite a few of the complaints listed below have NOT been served by TEVA to the defendants.

List of patents covered in this entire fracas:

6,600,073; 6,500,987; 6,495,721; 6,897,340

Below are the Sertraline complaints filed by TEVA:

Teva Pharmacuetical Industries Ltd. et. al. v. Aurobindo Pharma Ltd. et. al.

filed February 5, 2007 in the District Court of New Jersey for the ‘721 patent

Teva Pharmaceutical Industries Ltd. et al v. Mutual Pharmaceutical Co. et. al.

filed February 6, 2007 in the Eastern District of Pennsylvania for the ‘073; ‘987; ‘721 & ‘340 patents

Teva Pharmaceutical Industries Ltd. et. al. v. Torrent Pharmaceuticals Ltd. et. al.

filed January 12, 2007 in the District Court of Delaware

Teva Pharmaceutical Industries Ltd. et. al. v Hetero Drugs Ltd.

filed January 12, 2007 in the District Court of Maryland

Teva Pharmacuetical Industries Ltd. et. al. v. Cipla Ltd. et. al.