A US court invalidated four patents covering Teva's three-times weekly version of Copaxone (glatiramer acetate) based on obviousness, following a challenge by a number of companies, including Mylan. The Israeli drugmaker, whose shares fell as much as 10 percent on the news, said it plans to appeal the decision.
The four patents, numbers 8,232,250, 8,399,413, 8,969,302 and 9,155,776, were scheduled to expire in 2030. In December last year, the US Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) reaffirmed a prior decision that three of these patents are unpatentable in its inter partes review (IPR) proceedings initiated by Mylan. The PTAB is expected to issue a ruling on the fourth patent IPR by May 16 following a challenge by Mylan.
Heather Bresch, chief executive of Mylan, noted that the latest ruling by the District Court for the District of Delaware "is yet another positive step in our effort to bring to market a more affordable generic version of Copaxone 40 mg/mL." The company suggested that it is one of the first drugmakers to have filed a substantially complete abbreviated new drug application containing a paragraph IV certification for a three-times weekly version of the multiple sclerosis treatment.
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Teva indicated that the latest patent infringement case involved five of six companies who have filed applications seeking approval of generic versions of the thrice-weekly version of Copaxone. The Israeli drugmaker added that it filed suit against all six companies on December 19, 2016 to assert a fifth patent, number 9,402,874.
Teva received FDA approval for its three-times-a-week formulation of Copaxone in January 2014. The product generated sales in the US of approximately $3.3 billion for the 12 months ending November 30, 2016. Earlier this year, Teva announced that full-year global sales for Copaxone are expected to be in the range of $3.8 billion to $3.9 billion. At the time, the Israeli company noted that although it does not expect generic competition this year for the thrice-weekly formulation of the therapy, the possible launch of two generic alternatives in the US in February could suppress revenue by $1 billion to $1.2 billion.
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