Biotech Values

[DewDiligence]

Re Generics:

As rph and biowatch noted, Synthroid/Levoxyl is an atypical case.

If it were up to me to make policy on generic drugs, I would consider these revisions:

1. Eliminate or curtail extensions to marketing exclusivity when the first patent on a drug expires but other patents remain in force.

2. Reduce (or eliminate) existing statutory patent extensions for 50% of the time a drug is in clinical trials. (I would retain the 1:1 patent extensions for the time a drug is undergoing FDA review.)

3. Do away with the mandatory 30-month delay in a generic launch when a patent is litigated.

4. Abolish exclusivity from patents on isomers or metabolites of a drug that extend beyond the term of exclusivity afforded by the patent on the parent compound.

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These ideas are somewhat “raw” and fine-tuning may be necessary to make them practical. However, the general idea is that I would favor an increased role for generic drugs in the overall provision of healthcare. Regards, Dew