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September 20, 2009


Innovator pharma on one hand claims that biological products are more complex as well as making a generic will need more investment + time. Looks like the FDA and generally everyone too agrees. Typically, this ought to result into fewer generic companies, pursuing less bio products when compared to the small molecule situation even with the same 5 year data exclusivity. Strangely, the same companies in the same breath argue for a data exclusivity period which is 2.5 to 3 times that for small molecule NCEs. Intriguingly, the politicians, unmindful of their duty towards the citizens, seem to have bought this entirely preposterous line of argument of the innovator pharma. We just hope better sense prevails, sooner than later. President Obama seems to be the last hope on this matter.


The post says that Love and Glassman are concerned that the current FOB legislation has "the potential to harm millions of sick people, in the United States and beyond." But did Love and Glassman address the bigger and potentially more scary issue that Kevin noted about how to determine when a FOB is "biosimilar" to avoid a potential "pure red cell aplasia" issue like Europe encountered in 2001? Again, these two folks appear to be focused strictly on the speed and cost of biologic drugs while ignoring the safety concerns these FOBs raise if the standard for "biosimilar" isn't strict enough.


Love and Glassman did not address the issue of bioequivalance, but as you note, focused on the length of the proposed exclusivity period and how his would impact the introduction of biogenerics. Setting aside the difficulties in determining whether a biogeneric is equivalent to a biologic, and the related issue of whether an FOB is as safe as an innovator's biologic, the authors' focus on short-term costs savings disregards the impact of a 5-year exclusivity period on long-term innovation. When a regulatory pathway is being created where none currently exists, and as a result, generic drug companies are allowed to use an innovator's data to expedite approval where they currently cannot, it is not sufficient to merely state that innovation will be fine with a 5-year exclusivity period. Rather, proponents have the burden of establishing through studies and economic analyses that innovation will be fine. At Patent Docs, we try to write up every study we can get our hands on, and so far there have been very few that have attempted to demonstrate that exclusivity periods of 5 years or less will not adversely impact innovation.

Thanks for the comment,


Why not let the free market take care of the safety concerns? As long as the public knows the risks, what's the problem? You know, like those expensive TV commercials that Big Pharma uses to push drugs on people? Just hire some fast talker to recite a bunch of "buyer beware" legalese at the end and it's all good.

You mean like we let the free market take care of home financing?

"the authors' focus on short-term costs savings disregards the impact of a 5-year exclusivity period on long-term innovation."


Couldn't agree with you more. As Kevin has said, there is no FOB pathway now, so the burden should be on those who want it to justify that "data exclusivity" periods of only 5 years won't impact development of biologic drugs. And as you correctly point out, the evidence supporting periods as short as 5 years having no impact is sorely lacking. Instead, all we hear is rhetoric about speed, cost, and the "harm" to so many millions of sick. It would be ironic if those "many millions of sick" suffered because the "data exclusivity" period was so short that no one even developed the biologic drugs because of insufficient ROI.

Dear TJ:

Different timeframes is the answer to the seeming conundrum. The biogenerics have the innovators to copy, and so the issue is how well they can do it and when they should be able to use the innovator's safety and efficacy data. The innovators had to develop the biologic drugs in the first place, which takes a greater amount of time and investment (including not only R&D costs but building manufacturing plants to make the specialized biologic drugs, for example). As a result, there must be sufficient ROI to support these efforts.

No contradiction, just the difference between being the first to develop a new biologic drug and being a follow-on.

Thanks for the comment.

The courts have interpreted the Constitution's "Limited Times" Clause as a check on the potential monopolization of patent rights and other IP. Double-digit exclusivity periods seem to conflict with this inferred intent. I appreciate the suggestion about implementing different time frames for innovators and generics; I hope this option becomes part of the continued discussion on this topic.

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