GlaxoSmithKline (GSK) filed a patent infringement suit against Apotex concerning its filing of abbreviated new drug application with FDA with its intent to commercialize a generic version of Avodart. The patent involved in suit was US5565467, entitled ‘Androstenone derivative’, issued on Oct 15, 1996 and expires[i]by Oct 15, 2013. Smithkline Beecham Corporation is the current assignee[ii]of the patent (source: MaxVal’s Assignment Database).
GSK alleged that Apotex’s abbreviated new drug application (ANDA) no. 204292, to manufacture generic Avodart capsules, filed with the FDA had infringed the ‘467 patent covering the drug. GSK currently holds[iii]New Drug Application (NDA) no. 21-3199 (source: MaxVal’s Patent Marker), approved by FDA on Nov 2001 for dutasteride capsules, which it sells under the trade name Avodart ®. The capsules are used for the treatment of symptomatic benign prostatic hyperplasia (BPH)--essentially, enlargement of the prostate gland. GSK wanted judgment that Apotex has infringed the patent and an injunction barring Apotex’s products until expiration of the patent, along with costs and expenses.
Initially, the case was stayed as the parties requested a stay due to pending entry of judgment in another case 11-46-RGA, by Apotex Inc. against GlaxoSmithKline LLC. Later, the stay was removed as Judgment has been entered in 11-46-RGA. In Sep, GSK filed a stipulation and proposed order, considering which Court granted the same and ordered the case to be administratively closed.