Biotech Values

[Biopharm investor]

bladerunner1717

Why do generic drug makers make their generics that are not exactly equivalent to the branded drug? Is it really that difficult to make an exact copy once they're got the active ingredients the same?

If a generic company does not want to break the patent (i.e., not file a PIV certification), this is exactly what they do. They characterize the shit out of the brand, replicate it, and then wait until the expiration of the patent to launch.

But if you want to open the market before the expiration of the patent (i.e., a PIV patent challenge), there are essentially two ways of doing so:

1. Argue the patent is invalid (invalidity)

2. Develop a noninfringing formulation of the drug (non-infringement)

If you're going to argue invalidity (#1 above), then replicating the brand is fine. But this approach necessarily entails some fairly high risk because you are admitting from the start that you are infringing the patent...you're just arguing it isn't valid in the first place. If you adopt this approach and launch at-risk and the patent is subsequently held to be valid and enforceable, you're screwed.

If, on the other hand, you can develop a noninfringing formation, you don't have the same risk, and may not even get sued.