The US Court of appeal for Federal Circuit (CAFC) has upheld Disctric Court for Delaware’s summary judgment opinion, wherein, district court held that innovator Amgen and Wyeth’s blockbuster molecule Etanercept [Enbrel, a tumor necrosis factor alpha (TNF-alpha) inhibitor used to treat arthritis pain] do not infringe Ariad pharma’s following patent:
US6410516 (Assignee: Massachusetts Institute of Technology, President & Fellows of Harvard College & Whitehead Instittue for Biomedical Research, Date of Grant: June 25, 2002) Entitled “Nuclear factors associated with transcriptional regulation” which has total 203 claims.
The said patent covers a method for inhibiting expression, in a eukaryotic cell, of a gene whose transcription is regulated by NF-kB, the method comprising reducing NF-kB activity in the cell such that expression of said gene is inhibited.
NF-κB plays a major role in regulating the immune response in wide range of infections and disease like cancer, inflammatory and autoimmune diseases, septic shock, viral infection, and improper immune development.
As TNF-alpha binds with cell and the NF-kB activity is increased in eukaryotic cell which is mainly responsible for harmful effect and pain. The reduction of NF-kB activity is important as increased activity of NF-kB can led to expression of harmful genes.
Earlier, Amgen and Wyeth filed declaratory judgement of invalidity and non-infringement of ‘516 patent in Disctric Court for Delaware, subsequently, patentee of ‘516 counterclaimed infringement of claims number 6, 18, 70-72, 183 and 184. The district court granted Amgen's DJ of non-infringement, subsequently, patentee Ariad appealed against said decision.
The court construed the meaning of claim langauage in the light of specification, prosecution history and expert testimony. The disputed term “reducing NF-kB activity in cell” were first construed and than Enbrel mechanism was compared in the light of construed claims. Court observed that ‘516 patent covers compound which can act inside (intracellular) the inflammed cell. Further, court held that Enbrel acts outside (extracellular) the inflammed cell (like some prior art molecules like some antibiotics), accordingly, will not be covered under the scope of 516 patent.
Opinion of court Here
Eralier in 2006, Ariad successfully asserted ‘516 patent against innovator Eli Lilly’s blockbuster medicines like Drotrecogin alfa (Xigris) and Raloxifene HCl (Evista). Further, U.S. District Court of Massachusetts awarded the patentee approximately $65 million in royalties and a 2.3 percent royalty on future U.S. sales of Evista and Xigris until the patent’s expiration in 2019.
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