The Copaxone Story in the U.S. and India: A Further Update

As an update to our March 5th and April 4th postings, The Copaxone Story in the U.S. and India and The Copaxone Story in the U.S. and India: An Update, the U.S. Supreme Court (Supreme Court) yesterday asked Sandoz Inc. (Sandoz) and Mylan Inc. (Mylan) to respond to Teva Pharmaceutical Industries Ltd.’s (Teva) application to recall and stay the Federal Circuit’s mandate pending the Supreme Court’s decision.

Background

On December 27, 2007, Sandoz filed the first abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to manufacture and sell its proposed generic version of Copaxone®, before the expiration of the Orange Book patents. On June 29, 2009, Mylan filed its own ANDA. In view of the ANDA submissions, Teva (and Yeda Research and Development Co., Ltd.) separately sued Sandoz (in August 2008) and Mylan and Natco (in October 2009) in the U.S. District Court, Southern District of New York (District Court) for infringement of the Orange Book patents as well as U.S. Patent Numbers 5,800,808 (‘808 patent) and 6,048,898 (‘898 patent). The District Court issued an injunction barring Sandoz and Mylan from marketing their generic versions of Copaxone® until September 1, 2015 (the expiration date of the ‘808 patent).

The lawsuits were consolidated and on June 29, 2012, the Judge found all nine patents valid, enforceable and infringed. Specifically, the Judge found Mylan had infringed seven of the patents and Sandoz infringed four patents. On July 26, 2013, the Federal Circuit ruled that four of the patents were valid but found five invalid for indefiniteness. Specifically, the Federal Circuit ruled that the claims of the five patents were indefinite because a person skilled in the art could not discern the boundaries of the claims. The patents declared invalid were U.S. Patent Numbers 5,800,808, 5,981,589, 6,048,898, 6,620,847 and 6,939,539. The patents held valid were U.S. Patent Numbers 6,054,430, 6,342,476, 6,362,161 and 7,199,098. The invalidation of the ‘808 patent was significant because of all the Orange Book listed patents, it had the longest expiration date {namely, September 1, 2015 (all of the remaining patents expire on the same date – May 24, 2014)}. The Federal Circuit remanded the case to the District Court to determine whether to modify its injunction.

On November 13, 2013, the Supreme Court denied Teva’s request to stay the Federal Circuit’s decision during appeal. As a result of this denial, the District Court was compelled to follow the Federal Circuit’s mandate and modified its injunction. As a result, Sandoz and Mylan were permitted to launch their respective generic versions of Copaxone® starting May 24, 2014 (rather than on September 1, 2015).

On March 31, 2014, the Supreme Court granted Teva’s writ of certiorari to review the Federal Circuit’s decision. Specifically, Teva petitioned to clarify the correct standard of review used by Federal appellate courts when reviewing factual findings made by a district court. Most Federal appellate courts review a district court’s factual findings to see if they are “clearly erroneous.” However, the Federal Circuit has had a practice of reviewing a district court’s factual findings in support of claim construction using de novo review.

Application to Recall and Stay Federal Circuit’s Mandate

On April 4th, Teva filed an application {a copy of which is available here (Teva_App)} with Chief Justice John G. Roberts (Chief Justice) asking the Supreme Court to recall the Federal Circuit’s mandate which modified the District Court’s injunction. In its application, Teva stated that it will “likely face irreparable harm if the mandate is not recalled.” Specifically, Teva argues:

Absent a recall of the mandate, respondents will be free to launch products that infringe the ’808 patent fifteen months before that patent expires. In analyzing whether that premature launch will cause Teva irreparable harm, the Court assumes that Teva’s legal position is correct, Barnes, 501 U.S. at 1302—an assumption that carries greater weight now that the Court has chosen to grant the petition. Applying that standard, the Federal Circuit’s insistence on lifting the District Court’s injunction while this Court’s review proceeds will leave Teva unprotected and likely cause Teva serious, irreparable harm.

Yesterday, the Chief Justice gave Sandoz and Mylan until April 14th to respond to Teva’s application.

Continue to watch the BRIC Wall Blog for further updates on developments regarding Copaxone® in both the U.S. and India.

This post was written by Lisa Mueller.

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