Cert Denied in Barr's Prosecution Laches Patent Challenge

By Robyn Hagan Cain on November 03, 2011 | Last updated on March 21, 2019

Federal Circuit Court of Appeals Judge Alan Lourie recently mentioned that he hates reading headlines about the Supreme Court reversing the Federal Circuit. This week, Judge Lourie has one less headline to dread: On Monday, the Supreme Court denied cert in Barr Laboratories v. Cancer Research Technology.

The case involved a patent challenge to Merck’s brain cancer drug, Temodar. Barr, a division of generic giant Teva Pharmaceuticals, contested Merck’s patent on the drug, alleging that the patent was unenforceable.

Cancer Research Technology received a patent for temozolomide, a critical component of Temodar, in 1993 following an 11-year application and amendment process. Cancer Research later awarded Schering, (now part of Merck), an exclusive license for the patent.

Barr filed an Abbreviated New Drug Application with a Paragraph IV certification under the Hatch-Waxman Act, challenging the validity of the patent and seeking FDA approval for generic version of Temodar.

After a bench trial, the district court held the patent unenforceable for prosecution laches. Merck appealed after a legal strategy session that we hope included the line, "Laches? We don't need no stinkin' laches."

The Federal Circuit Court of Appeals reversed, holding that prosecution laches requires a finding of prejudice - evidence that the accused infringer "invested in, worked on, or used the claimed technology during the period of delay" - as well as unreasonable delay in prosecution, reports Harvard's Jolt Digest.

The Supreme Court's denial means that Merck can continue to distribute Temodar, approved in 1999, exclusively through August 2013. Merck came to an agreement with Teva last year, which allows Teva to sell a generic version of Temodar six months before the patent expires even if Merck won the patent challenge, according to Bloomberg.

Temodar generated $1.1 billion in sales in 2010, reports Fox Business.

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