The United States PTO issued a final office action rejecting Teva Pharmaceutical's application seeking a reissue of U.S. Patent No. 5,800,808 (the 808 Patent), which was found to be invalid by the Court of Appeals for the Federal Circuit in July 2013, Natco Pharma said in a statement.
The final rejection issued today finds the first claim of the reissue application, which is identical to the only claim in the '808 Patent, to be indefinite and both claims of the reissue application to be unpatentable based on obvious-type double patenting.
In its ruling, the PTO refused to extend patent protection on Copaxone(R) past the patents that will expire in May 2014. Natco said it is pleased that the PTO has rejected the reissue application, confirming the indefiniteness for the second time and consistent with the Federal Circuit's decision, and that the PTO continues to find all claims to be unpatentable.
Meanwhile, the company has clarified in response to speculation as to the role of Natco related to potential launch or pricing of generic Copaxone in the United States (US).
The company has confirmed that the final decision as to when or whether and pricing of generic Copaxone is launched in the US rests with its partner Mylan, Natco Pharma said in a statement.
Natco remains committed and working to take steps and deploy the necessary resources to ensure that a quality generic US FDA approved Copaxone is made available to patients suffering from multiple Sclerosis upon market information, it added.
The stock opened at Rs 742 and touched a high of Rs 795 on the BSE. A combined 536,000 shares changed hands on the counter so far on the BSE and NSE.
On April 1, the stock had tanked 14% to Rs 685 from Rs 797 after the US Supreme Court agreed to hear a patent case on Copaxone.
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