Wednesday, September 05, 2007

Forest prevails at CAFC against Ivax/Teva over Lexapro

Teva lost on appeal in the Lexapro case against Forest. Reuters reported on Sept. 5, 2007 that the CAFC upheld the validity of a key patent on Forest Laboratories' blockbuster depression drug Lexapro and confirmed a lower court's decision to block sales of generic forms of the drug made by Ivax (Teva Pharmaceutical Industries Ltd) and Cipla Ltd. The CAFC did alter D. Del.'s injunction so that it only applies to escitalopram oxalate, the active ingredient in Lexapro.

The CAFC decision gets into issues with enantiomers. A scientific publication by Smith had asserted that one enantiomer would be more potent, but it did not teach "how" to get the pure enantiomer. Thus, the CAFC got into the issue of whether the prior art reference was enabling, citing to Minnesota Mining, 303 F.3d 1294. An interesting point is that the prior art paper predicted INCORRECTLY as to which enantiomer was more potent.

There is a line: a reference that is not enabling is not anticipating, citing to Elan 346 F.3d 1051. This reference could be used by the USPTO in disposing of certain rejections in the WARF / Thomson re-examination.

There is also a line about how IVAX only discusses evidence favorable to IVAX without discussing evidence favorable to Forest.

There is an analysis of a broadening reissue.

[Recall: Teva Pharmaceuticals (TEVA) said in July 2005 that it would buy U.S. rival Ivax (IVX) for $7.4 billion to create the world's biggest maker of generic prescription drugs.]


Anonymous Anonymous said...

My name is Lucas Sneed and i would like to show you my personal experience with Lexapro.

I am 39 years old. Have been on Lexapro for 3 years now. Went through a phase in life where I lost my job and was under-employed for a couple of years. Had descended to an all time low in self-loathing. Doc intially placed me on Welbutrine, which made me un-motived and essentially a disinterested by-stander in the story that is my life. Switched me over to 10mg dose of Lexapro, which has never increased. I now have a job I love (OK, like) and do not worry about the future. I continue to take Lexapro, as I said I am not as easy going if I miss several doses. My wife can tell when I am off of it, as little things will drive me nuts: barking dogs, annoying habits of others, other drivers, belligerent children...the usual list of suspects. My mother's side of the family is full of passionate, emotional rage machines, so it is a genetic thing or I am a product of the environment in which I spent my formative years. When I am on it I am calm cool and in control. Have notfound it to be physically addictive nor experienced any side effects.

I have experienced some of these side effects-
Uneven temperment, lack of patience if I skip several doses.

I hope this information will be useful to others,
Lucas Sneed

Lexapro Prescription Medication

10:30 AM  

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