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

As an update to our March 5th posting, The Copaxone Story in the U.S. and India, the U.S. Supreme Court (Supreme Court) this week granted Teva Pharmaceutical Industries Ltd.’s (Teva) writ of certiorari to review the Federal Circuit’s decision invalidating several of Teva’s patents covering its multiple sclerosis drug, Copaxone®.

Background

On December 27, 2007, Sandoz Inc. (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 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 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 patents, it had the longest expiration date (September 1, 2015).

On November 13, 2013, the U.S. Supreme Court denied Teva’s request to stay the Federal Circuit’s decision during appeal. As a result of the Supreme Court’s denial, Sandoz and Mylan can launch their respective generic versions of Copaxone® in May 2014 (rather than in September 2015).

Significance of the Case before the Supreme Court

Teva petitioned for writ of certiorari to clarify the correct standard of review used by Federal appellate courts when reviewing factual findings made by a district court. The only issue on appeal is encompassed by the question presented:

QUESTION PRESENTED:

Rule 52(a) of the Federal Rules of Civil Procedure provides that in matters tried to district court, the court’s “[f]indings of fact . . . must not be set aside unless clearly erroneous.”

 The question presented is as follows:

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.

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.

The Supreme Court is no longer adding cases to the docket for this term. Therefore, this case will be decided in the October 2014 term. A finding by the Supreme Court for Teva will restore its patent protection for Copaxone® until September 2015. It will be interesting to see whether Sandoz and Mylan proceed with launching their generic versions of Copaxone® “at risk” in May 2014 or will wait a few more months for the decision of the Supreme Court.

This post was written by Lisa Mueller.

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