The minimum exclusivity under Hatch-Waxman is independent of the patent landscape.
The exclusivity provision does not create additional years of market exclusivity; it's a guarantee of a "minimum" number of years of market exclusivity. If a patent is legit and enforceable, the innovator can have much more market exclusivity than the minimum guaranteed under Hatch Waxman.
For new chemical entities, Hatch Waxman gives the innovator a minimum of 5 years of market exclusivity. A generic company cannot even file an ANDA that challenges the patents on an NCE until the NCE date - 1 year (or 4 years after the NCE is approved by FDA). If the innovator sues the generic company within 45 days of filing its challenge, the FDA cannot approve the generic application until the earlier of a court decision in favor of the generic challenge or 30 months (the 30 months is to give the parties time to litigate). GPhA and the Obama administration are embracing this same criteria for biologics as for new chemical entities.
Another important but often overlooked aspect lost in all this is the concept of "evergreening".
BIO (and the bill that made out of committe last year) would have allowed innovators to "evergreen" their exclusivity for every life cycle management technique they bring to the drug. In other words, BIO wanted a minimum 14-year exclusivity (the draft legislation provided 12 years), and any change to the drug made by the innovator at any point prior to the expiration of that initial exclusivity period would start the clock over with another new 12 or 14-year exclusivity period. In this manner, innovators would have been able to "evergreen" their exclusivity, almost in perpetuity.
In comparison, line extensions of marketed small molecules are, by definition, not "new chemical entities". So an innovator doesn't get any minimum guaranteed exclusivity by coming out with these life cycle management drugs (e.g., extended release versions of IR drugs). That is, because they are not NCE's per se, there is no waiting period for a generic company to file a patent challenge on these drugs (i.e., there is no NCE-1 date). In fact, generic companies are working on these drugs even before the innovator has won FDA approval of the drug, and it is not uncommon for a patent challenge to be filed literally a month or two after FDA approves the brand. So an innovator gets one, and only one, 5-year period of guaranteed exclusivity for each NCE it develops. Patents, to the extent they stand up to challenge, can add to that.
p.s., Sorry for the redundant post, as I see Dew already answered this, and did so much more succinctly!
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