More on Ariad v. Lilly, pertinent claims of US 6,410,516

PatentBaristas identifies the claims of the '516 patent related to infringemet in the Lilly case:

Regarding Evista, the jury found that the drug infringed claims 80 and 95:

80. [A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-kappaB-mediated intracellular signaling, the method comprising altering NF-kappaB activity in the cells such that NF-kappaB-mediated effects of external influences are modified ... wherein NF-kappaB activity in the cell is reduced] wherein reducing NF-kappaB activity comprises reducing binding of NF-kappaB to NF-kappaB recognition sites on genes which are transcriptionally regulated by NF-kappaB.

The single step of the method claim is -->altering NF-kappaB activity<-- and then altering is further limited to reducing and then reducing must include -->reducing binding of NF-kappaB to NF-kappaB recognition sites on genes which are transcriptionally regulated by NF-kappaB<--.

If any use one year prior to the filing of the Harvard application altered NF-kappaB activity through -->reducing binding of NF-kappaB to NF-kappaB recognition sites on genes which are transcriptionally regulated by NF-kappaB<-- THEN there is inherent anticipation. See the 2003 Schering case or the 2005 Apotex case.

95. [A method for reducing, in eukaryotic cells, the level of expression of genes which are activated by extracellular influences which induce NF-kappaB-mediated intracellular signaling, the method comprising reducing NF-kappaB activity in the cells such that expression of said genes is reduced] carried out on human cells.

Patent Baristas noted:

This also begs the question of if a researcher discovers a drug without ever knowing the drug acts on a patented pathway [IPBiz: technically it is NOT the pathway which is patented; it is a method for modifying effects] or before the pathway is understood, does that constitute infringement? If the drug was acting on the pathway before the pathway was discovered, does the existence of the drug invalidate the patent on the pathway by rendering it not "new"? [IPBiz: the use of the drug, if the use inherently meets the claim elements, does invalidate under 35 USC 102(b)] This could also give rise to an ever-increasing number of conflicting patents. Because NF-kB can activate so many genes, more than 150, it is implicated in many diseases. [IPBiz: more likely, in this case, it suggests the Harvard/MIT patent is invalid.]

A separate bench trial with the U.S. District Court of Massachusetts will be held on Lilly's contention that the patent is unenforceable and will also consider the patent's improper coverage of natural processes. In June 2005, the U.S. Patent and Trademark Office commenced a reexamination of the patent (Reexam. C.N. 90/007,828). The reexamination is currently in progress although the USPTO has not issued any substantive action.