Copaxone (R) (Glatiramer acetate):Innovator Teva sued generic players Momenta and Sandoz

Teva Pharma has initiated efforts to block generic challenge on Copaxone(R) (Glatiramer acetate) after information of Para IV filings by generic players like Momenta and Sandoz.Teva received Momenta/Sandoz's Paragraph IV certification notice referring to following orange book listed patents

US5981589 (Expiry: May 24, 2014)- Covers Copolymer-1 having a molecular weight of about 5 to 9 kilodaltons, made by a process comprising the steps of: reacting protected copolymer-1 with hydrobromic acid to form trifluoroacetyl copolymer-1, treating said trifluoroacetyl copolymer-1 with aqueous piperidine solution to form copolymer-1, and purifying said copolymer-1, to result in copolymer-1 having a molecular weight of about 5 to 9 kilodaltons.

US6054430 (Expiry: May 24, 2014)- covers an improved composition of copolymer-1 comprising copolymer-1 substantially free of species having a molecular weight of over 40 kilodaltons.

US6342476 (Expiry: May 24, 2014)- covers an improved composition of copolymer-1 comprising copolymer-1 substantially free of species having a molecular weight of over 40 kilodaltons.

US6362161 (Expiry: May 24, 2014)- covers an improved composition of copolymer-1 comprising copolymer-1 substantially free of species having a molecular weight of over 40 kilodaltons.

US6620847 (Expiry: May 24, 2014)- Covers Copolymer-1 having a molecular weight of about 4 to about 9 kilodaltons, made by a process comprising: treating trifluoroacetyl copolymer-1 with aqueous piperidine to form a solution of copolymer-1; and purifying copolymer-1, thereby producing copolymer-1 having a molecular weight of about 4 to about 9 kilodaltons.

US6939539 (Expiry: May 24, 2014)- Covers A copolymer-1 composition comprising a mixture of polypeptides composed of glutamic acid, lysine, alanine and tyrosine, wherein the mixture has an average molecular weight of about 4 to about 9 kilodaltons, wherein the mixture of polypeptides is non-uniform with respect to molecular weight and sequence, and wherein the composition is suitable for treating multiple sclerosis.

US7199098 (Expiry: May 24, 2014)- Covers a copolymer-1 composition comprising a mixture of copolymers of alanine, glutamic acid, lysine and tyrosine, the copolymer species in the mixture being non-uniform with respect to molecular weight and sequence, wherein over 75% of the copolymers in the mixture, on a molar fraction basis, have a molecular weight in the range of 2 kDa to 20 kDa and less than 5% of the copolymers have a molecular weight above 40 kDa, and wherein the composition is suitable for treating multiple sclerosis.
The lawsuit, filed in U.S. District Court in Manhattan, claims that any generic version of Copaxone infringes patents that Teva contends are valid and enforceable.
Teva believes designing around this formulation would be extremely difficult and presents a significant challenge. Also, once injected, it is rapidly hydrolyzed locally and no level of the intact drug can be measured in the blood, rendering a bioequivalence study comparing two formulations extremely difficult.Glatiramer Acetate is the generic name for Copaxone or Copolymer. It is an immunomodulator, licensed in much of the world for reduced frequency of relapses in relapsing-remitting multiple sclerosis. Copaxone is administered by subcutaneous injection at a dose of 20 mg per day. It is a non-interferon and non steroidal medication.Glatiramer acetate was originally discovered by Professor Sela, Professor Arnon and Dr. Teitelbaum at the Weizmann Institute of Science in Israel. Teva got license on this molecule and subsequently commercialised this product.
Teva is till date best IP designing around Pharmaceutical company and now it will be interesting to watch Teva's Defense as innovator.

(Note: Updated earlier news on Glatiramer acetate)