Generic Oracea Legal Trial now in July 2011

Written by on April 12, 2011 in Oracea (40mg doxycycline) with 0 Comments


I have been watching for a while to see for any developments in the legal proceedings between Mylan and Galderma. These proceedings will determine whether Mylan is allowed to sell Generic Oracea. This is of interest to many rosacea sufferers who consider that Oracea is too expensive.

Previously it seems that Generic Oracea may be available as soon as First Quarter 2011. Now we learn that legal proceedings are only scheduled to begin in earnest on July 5, 2011.

Mylan Pharmaceuticals is pushing to be allowed to sell Generic Oracea, and have been joined in this request by two other companies; Impax Laboratories and Lupin Pharmaceuticals. Clearly there is potential to make a lot of money in this market.

Mylan is hoping to obtain a declaration that its generic formulation of Oracea does not violate any of the “valid claims” of the newly issue Patent 7,749,532. This patent granted and thus added to Galderma’s war chest after Oracea was released to the market.

Mylan Pharmaceuticals vs. Galderma Laboratories and Supernus Pharmaecuticals

The two cases have been consolidated for purposes of trial, which is scheduled to being July 5, 2011.

All of the patents – the Ashley patents, the Amin patents and the Chang patent are directed toward using antibiotics for purposes other than treating bacterial infection.

The patents-in-suit, therefore, teach doxycycline dosages that are below a certain level, in order to prevent antibiotic resistances that accompanies the use of antibiotics at higher dosages for longer time frames.

If you think new drug development is slow, then also consider the law, that moves kind of slow too !

So Why This Update Now?

This particularly enthralling court document, dated March 24, 2011, was devoted to whether the `532 Chang’ patent should be construed to mean the singular or plural form for the language plasma concentration or plasma concentrations.  The judgement of the court declared that the plural form would be the way forward.

No wonder this stuff takes a year and an age (and a lot of dollars).

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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