Biotech Values

[genisi]

What if their [Teva] research and tweaking of the process to manufacture the molecule made use of techniques that overlap MNTA's patent, but the end manufacturing process (including quality control) uses techniques that do not infringe? That would be my guess for one of their defenses.

That's my understanding of the § 271(e)(1) of the 35 U.S.C. namely the Bolar exception provision and I expect Momenta to use it as well for one of their defenses about Teva's molecular-weight markers related patents. There were several cases where the court ruled that the Bolar exception provision applied as long as the act of using a patented invention was reasonably related to gaining data for the FDA's regulatory approval.