Claritin Litigation Rehearing Denial Could Affect New Drug Patents
This article was originally published in The Tan Sheet
A Washington, D.C. federal appeals court ruling not to rehear Schering-Plough's adverse desloratadine patent infringement decision en banc could hold serious implications for future new drugs and biologics, two dissenting judges argue
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FDA approves Abbreviated New Drug Application for 10 mg loratadine orally disintegrating tablets, Andrx Corporation announces Nov. 4. The tablets are bioequivalent to Schering-Plough's Claritin RediTabs. Perrigo already markets Andrx's generic versions of Claritin D24 and Claritin RediTabs. Andrx is one of at least three companies facing suits filed by Schering-Plough arguing that the firms violated certain patent claims for Clarinex (desloratadine). A Washington, D.C. federal appeals court recently upheld a D.C. appeals court decision ruling that manufacturers of generic Claritin were not infringing on those claims (1"The Tan Sheet" Nov. 3, 2003, p. 4)...
The Aug. 1 decision by a Washington D.C. federal appeals court finding certain loratadine patent claims invalid "does not preclude patent protection for metabolites of known drugs," the judges write
Schering-Plough will not be able to rely on patent claims covering desloratadine to keep generic versions of its Claritin antihistamine off the OTC market before 2004 if a federal judge's ruling is upheld on appeal