Forty-five days after Sandoz, a member of the Novartis group, and Momenta filed for approval of their generic version of Copaxone, Teva Pharmaceutical Industries is suing them for violating its patent protecting the multiple sclerosis drug.
Copaxone is Teva's most profitable product. Whereas most of the Israeli company's drugs are generic - copycat - versions of brand drugs, Copaxone is one of its few unique brand drugs.
In its lawsuit, Teva levels harsh accusations against Novartis, alleging theft of trade secrets. The company also dwells on how it believes Novartis came into possession of the secrets. Advertisement In 1997, Teva explains, it entered into a supply and distribution agreement regarding Copaxone with a Slovenian company called Lek. That company undertook to protect any secrets it learned from Teva for 10 years after the termination of the distribution pact, which expired in January 2005.
In fact, Teva claims, during the term of the agreement, Lek handed over a large amount of top secret information about Copaxone, including detailed information about the process of its points, and the analytical testing done in the process. That information is considered to be top-secret and extremely valuable.
Teva claims that by April 2002 (seven months before Sandoz acquired Lek), it had transferred significant sections of its request to market Copaxone in Europe to Lek. The information consisted of thousands of pages and detailed a specification of the drug, and how Copaxone is made.
In short, Lek obtained the information necessary to make a copycat version of Copaxone and gave that into to Novartis, Teva claims.
Copaxone is a complex molecule requiring a consistent, tightly monitored production and verification process, Teva claims. That is the only way to assure the molecule produces the required biological activity.
Teva claims that Copaxone has special mechanisms of activity and unique pharmacological features that preclude the validity of pharmakinetic tests (which are supposed to prove that a generic drug has the same molecular activity as the original molecule), or to prove the biological accessibility of the active substance in the blood.
The Israeli company argues that Copaxone is very difficult to copy and that the trade secrets it gave to Lek would have significantly facilitated the production of a generic version.
Teva also claims that Lek and Novartis are routinely exchanging information since Novartis bought the Slovenian company but that to the best of its knowledge, Teva had not authorized transmission of its proprietary information.
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