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U.S. Supreme Court agrees to hear patent case that could impact timing of availability of more affordable generic copaxone

The United States Supreme Court has granted certiorari in a patent case that could extend the market exclusivity of a top-selling multiple sclerosis drug, forcing generics to wait to enter the market.

Copaxone®, developed by Yeda Research and Development Company Ltd. and licensed to Teva, is a unique multiple sclerosis immunomodulator, and is Teva Pharmaceutical Industries Ltd.'s top-selling drug. However, with patent protection for the drug due to expire next month, several of Teva's competitors (including Sandoz, Momenta Pharmaceuticals, Mylan Pharmaceuticals, and Natco Pharma Ltd.), are vying to bring generic versions of Copaxone to the market. In an effort to postpone generic competition for Copaxone, which earns approximately $4 billion a year, Teva recently asked the U.S. Supreme Court to consider an adverse decision by the U.S. Court of Appeals for the Federal Circuit (CAFC), which cut short patent term for Copaxone by about fifteen months.

In 2007 and 2009, several of Tevas competitors (including Sandoz, Momenta, Mylan, and Natco) filed abbreviated new drug applications (ANDAs) with the U.S. Food and Drug Administration (FDA) seeking to market generic Copaxone prior to the expiration of Teva and Yeda's patents covering the drug. Teva sued the competitors for patent infringement in the U.S. District Court, Southern District of New York. The cases were joined, and in June 2012, the District Court found all nine patents-in-suit to be valid and infringed. The Defendants (Teva's competitors) appealed to the CAFC. In July 2013, the CAFC held that, of the nine patents-in-suit, four were valid and infringed, but five were invalid for indefiniteness. As a result of the CAFC's decision, patent protection for Copaxone expires in May 2014, instead of in September 2015 (the expiry date of one of the patents held to be invalid). Teva filed a petition for a writ of certiorari, asking the U.S. Supreme Court to decide whether a district court’s factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case), or only for clear error, as Rule 52(a) requires.

On March 31, 2014, the U.S. Supreme Court agreed to hear the case, which will be argued during the court's term beginning in October 2014, with a decision likely to issue by June 2015. The stakes are high for Teva, as a favorable decision would extend the Copaxone patent life for an additional fifteen months. Nonetheless, generics may not have to wait for the Supreme Court's decision to make their market entry. In November 2013, the Supreme Court denied Teva's request to stay the CAFC's decision while it prepared its petition for review. On Monday April 7, 2014, Teva filed a new request to stay the decision during appeal, which could prevent Teva's competitors from introducing generic versions of Copaxone for a year or more. Momenta, Sandoz, and Mylan now have until April 14, 2014 to weigh in on Teva's request.

Over the past decade, the cost of multiple sclerosis treatment has skyrocketed. reports that the cost of Copaxone is over $60,000 per year, which is more than the U.S. median household income. Market entry of generic versions, once approved by the FDA, could potentially provide considerable cost relief to market payers.