Another step in the ongoing battle between Galderma and Mylan over the right to manufacture generic Oracea.
A judge has declared that Mylan infringes 1 of the patents that protects Oracea from generic copies.
Some History
In July 2010, Mylan was banned from selling generic Oracea, despite having regulatory approval, pending the outcome of the litigation between Galderma and Mylan.
The Result
Finding no clear winner, Judge Stark has declared that only 1 of the 4 claimed patents are infringed by Mylan Pharmaceuticals.
Both sides are to submit further arguments, though, because the only patent that was found to be violated was in fact only granted AFTER that July 2010 order.
Mylan was 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. Sadly for those wanting access to cheaper Oracea, this is not the case.
U.S. Patent No. 7,749,532, the so-called Chang Patent ("Once Daily Formulation of Tetracyclines," issued July 6, 2010), is licensed to Galderma.
Some Encouragement
In an encouraging move to others that might want to sell generic Oracea (Impax and Lupin for eg.), Judge Stark ruled that two of the other patents were invalid because they aren’t different enough to earlier inventions. Further the third claimed patent, relating to dosage forms was rules as uninfringed.
Mylan Violated Patent for Acne-Drug Oracea, Judge Rules
By Steven Church – Aug 27, 2011 6:55 AM GMT+0800
Mylan Pharmaceuticals Inc., a generic drugmaker, violated one of four patents related to the acne drug Oracea, a judge ruled.
U.S. District Judge Leonard P. Stark in Wilmington, Delaware said today he’ll wait to decide whether to bar Mylan from selling a generic version of Oracea, as requested by Galderma Laboratories LP. A temporary ban will remain in place, Stark ruled.
“Galderma is entitled to some relief,” Stark wrote in his opinion. Still, he said, he will delay imposing any permanent restrictions on Mylan until after hearing from both sides “given that neither party prevailed in the entirety of its position.”
Mylan has regulatory approval to sell the medicine, which is used to treat acne rosacea and is known by its active ingredient doxycycline monohydrate. In July 2010, Stark ordered Mylan not enter the market for the drug until he ruled on Galderma’s patent-infringement claims.
Galderma is seeking an extension of that order until the patent expires in 2027
What Does it All Mean?
Well it means we still have to wait to see what sort of `relief’ will be granted to Galderma once further arguments are considered.
The worst possible outcome for rosacea sufferers believing that Oracea is too expensive, will be an extension of the ban until the patent expires in 2027.
Stay tuned, this battle isn’t over yet.
