Pharma’s Cutting Edge

CNN is reporting Lilly’s plans to return to court in early August to ask it to overturn an absurd jury decision in Ariad v. Lilly, in which a jury awarded Ariad $65M in damages and a royalty on sales of Evista and Xigris based on Lilly’s supposed infringement of Ariad’s patent on NF-kB-based therapies. As you’ll read, Lilly contends that Ariad’s patent (licensed from Harvard College, MIT and Whitehead Institute) is far too broad to be valid, likening it to a patent on gravity.

Typically, I’d say that Lilly was employing hyperbole to sway opinion their way, but not in this case. Ariad’s patent really is absurdly broad. It contains over 200 claims, many of which are constructed like Claims #7 and #9 (which were the specific basis for the Evista infringement claims):

Claim #7: “A method for modifying effects of external influences on a eukaryotic cell, which external influences induce NF-.kappa.B-mediated intracellular signaling, the method comprising altering NF-.kappa.B activity in the cells such that NF-.kappa.B-mediated effects of external influences are modified.”

Claim #9: “A method for reducing, in eukaryotic cells, the level of expression of genes which are activated by extracellular influences which induce NF-.kappa.B-mediated intracellular signaling, the method comprising reducing NF-.kappa.B activity in the cells such that expression of said genes is reduced.”

Not very specific, are they? They are even less so when you consider how ubiquitous is NF-kappa-B signaling throughout the body’s cells. For the uninitiated, NF-kB is a transcription factor that mediates general stress and inflammation responses. The NF-k-B/Ik-B protein complex interacts with at least 200 known proteins to modify the expression of thousands of genes. Apparently, and not surprisingly, these transcription factors also play a role in the regulation of some genes influenced by the two Lilly drugs above. Did the inventors know this when they filed their patent in 1995 (after Phase 3 studies for Evista and Phase 2 studies for Xigris had begun)? If they did, they didn’t bother mentioning it in the patent. No where among the roughly 52,000 words in the patent do the following words appear: raloxifene, SERM, Protein C, drotrecogin, osteoporosis, sepsis, estrogen, antiestrogen, coagulation.

For the good of therapeutic innovations generally, Ariad’s patent must not be allowed to benefit Ariad financially. Let’s hope that Lilly gets the jury verdict overturned, and that the judge sends a clear message to would-be filers of patents such as this: Gravity by any other name is still gravity and it may not be patented.

(Disclosure: I was once employed by Lilly and assisted in the development of Evista.)