Medical / Clinical Discussions, page-492

Hi Daniel,

I'm pretty sure the answer to these questions must be yes, but I don't remember seeing them explicitly asked/answered before, so in the interests of putting my mind (and probably some others) at ease...

Is the strategy of patenting manufacturing techniques and uses of drugs where the original molecule patent has expired one that is recognised and accepted as a legitimate strategy to protect IP by the pharmaceutical industry? Has this successfully been used in the past to protect and/or defend drug IP, including buyout/takeover scenarios?

As the value of Bisantrene is proven up and (hopefully) grows into the billions of dollars, that provides quite a lot of incentive to play around with alternative manufacturing techniques or other ways to potentially try and sidestep patents that aren't on the molecule itself if an entity decided not to 'play fair' and tried to avoid a takeover. I assume given the due diligence you and others have performed as well as involvement recently of Prof. Chen etc. that Race is pretty watertight regarding IP protection, but is there any possibility this sort of thing could happen?

Also, could you please clarify how the Orphan Drug Designation compliments the patent protection? With that granted, does the ODD cover general usage of Bisantrene for medical purposes in the US, or apply only to the specific condition or conditions in the application, or apply only to the formulation of Bisantrene that Race produces, etc.?

Thank you again in advance.