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Bruce Lehr

Thanks for your comments Pharma Conduct Guy (Eric). Sometimes, thinks like extended release add real value and maybe even combo formulations at times (probably more germane to vaccines though) but many times innovation is used a shield for exclusivity without much patient benefit. Along those lines, I've enjoyed observing the back and forth that is going on in India now between foreign MNCs and local Indian companies with regard to their patent rules - which are effectively pushing a company to show data of improved efficacy vs previous therapy to gain a patent extension (see several posts on this blog) I think that would make for better progress and make R&D stretch more in their thinking.

Pharma Conduct Guy

Although many companies will claim that regulation stifles innovation, I guess that depends on how you define innovation.

If you take it to mean coming up with clever ways to game the patent system in order to increase exclusivity time and charge 10x over other available therapies, then I guess the companies could have a point.

Some examples of ways that companies extend their patents include 1) taking two separate drugs and combining them as a combination therapy (e.g. Pfizer's Caduet), 2) reformulating an active ingredient as an extended release version (many drugs), 3) studying pediatric indications for "adult drugs" (think anticholesterol or sexual disfunction), or 4) preparing an isomerically pure variant of a racemic blockbuster that is losing patent protection (e.g. AstraZeneca's Prilosec vs Nexium).

By requiring companies to show a 'significant' improvement either in safety or efficacy, drug companies will have more incentive to reallocate marketing budgets for RD. Perhaps innovation will increase.

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