Teva Can Launch Neupogen Biosimilar One Month Before Patent Expiration
This article was originally published in The Pink Sheet Daily
Executive Summary
Under a settlement with Amgen, Teva can begin selling its G-CSF product in November 2013; the launch may be sooner if a third party launches or wins an infringement suit.
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Teva Pharmaceuticals USA Inc. will be able to market its biosimilar version of Amgen Inc.'s Neupogen (filgrastim) a month before patents on the drug expire under a settlement the two firms announced July 15. The settlement specifies that Teva will not launch its filgrastim product Neutroval until Nov. 10, 2013 and will not launch Neugranin, a longer acting form of the granulocyte colony-stimulating factor, until that date as well, unless it obtains a final court decision that Neugranin does not infringe Amgen's patents. Teva may launch the products earlier if a third party launches a similar G-CSF product and Amgen fails to sue that party, or the patents are found invalid or unenforceable in a final court decision in an action brought by a third party. Teva had filed suit against Amgen on Nov. 30, 2009 seeking a declaratory judgment that the claims in two Amgen patents are invalid and that Teva's Neutroval does not infringe the patents. Teva filed the complaint the day it submitted a BLA for its version of Amgen's chemotherapy-induced neturopenia product. The two patents at issue, No. 5,580,755 and No. 5,582,823, expire on Dec. 3, 2013 and Dec. 10, 2013, respectively. FDA issued a "complete response" letter for Neturoval in September 2010. At the time Teva said FDA had requested "several items" but was not requiring additional pre-marketing clinical trials (Also see "Biosimilar Road Bump: Teva Filgrastim's Complete Response Shows Even Full BLAs Can Stumble" - Pink Sheet, 1 Oct, 2010.). Teva may have decided that given the delay in getting FDA approval it was not worth the cost of continuing litigation with Amgen. The Emerging Field Of Biosimilar Patent Challenges Teva has been selling its filgrastim product in Europe under the trademark TevaGrastim since November 2008. Analyst Mark Schoenebaum, of International Strategy and Investment Group, noted that the product has obtained only single digit market penetration in Europe. In its complaint Teva said it had invested more than $2 million to develop, secure regulatory approval for, and market its filgrastim product. It noted that under a Phase III clinical program more than 500 patients had been prescribed the drug for various cancer indications. The settlement is another data point in the slowly emerging field of biosimilar patent challenges, and suggests that they may be influenced by many of the same factors that govern the fights over small-molecule products - including confidence in the patent and importance of the product to the parties in the suit. For example, in the other prominent biosimilar settlement so far, the challenger (in that case Roche) secured considerably earlier entry than Teva did (Also see "Roche Can Launch Mircera 10 Months Before Amgen's EPO Patent Expires" - Pink Sheet, 23 Dec, 2009.). Amgen said in a release that the terms of the Neupogen settlement with Teva do not include any financial payments between the two parties. The parties also stipulated to a final judgment and permanent injunction against infringement by Teva, which were entered in the U.S. District Court for the Eastern District of Pennsylvania July 15. - Brenda Sandburg ([email protected]) |