IANAL, but it seems to me that the rebuttal of TRCA hinges on lines 22-24 on page 4. That INSM didn't show that it had made substantial investments before August 8, 1994.
This should, IMO, be correctable by INSM in her reply to this rebuttal by TRCA, which is due next week. It would be, IMO, enough that INSM shows that Celtrix started development of Somatokine before August 8, 1994.
If INSM can show start-of-development before that date I'd say that the case of INSM is quite good concerning their URAA defence.
Also concerning the next point: Safety of iPlex vs. Increlex:
why no declarations of independent physicians on the side of TRCA? It now all hinges on the Kumamoto declaration which basically says that good-is-good-enough, that's rather thin.
And again TRCA/DNA try to point again and again at the alleged narrowness of the injunction asked.
This has all to do with balance-of-hardships.
E.