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Waxman bill rises from the ashes

By Johanna Gibson, David Pearce, Jeremy Phillips and Ilanah Simon.

The IPKat's friend Annsley Merelle Ward (Gallant Macmillan LLP) has been busily tracking the latest developments in the US with regard to biologics. She writes:

"President Obama's budget proposal last month called for greater facilitation for the production and marketing of generic versions of biologics -- the fastest growing sector of the pharmaceutical industry. Answering President Obama?s call last week, Representative Henry Waxman (D-California) ?re-introduced? a bill which would provide for regulation that would enable generic drug makers to produce copies of biologic medicines by proposing that such brand-name biologics be granted a guaranteed period of market exclusivity distinct from any other patent protection available to them.

Right: Rep. Waxman, as viewed by his supporters

The production and marketing of generic biologics is currently hindered in the US because the Food and Drug Administration (FDA) lacks authority to approve generic versions of expensive drugs. This has the effect, as argued by proponents of the Waxman Bill, of enabling pharmaceutical companies to ?charge monopoly prices even after all patents have expired?. Representative Waxman previously attempted to pass similar legislation without success but now, with a specific mention of the need for such a measure in the President?s budget, chances of success under this Administration may be greater.

The Waxman Bill would allow five years of exclusive marketing for new brand-name drugs, with three additional years for modifications to that drug. Predictably, the pharmaceutical industry is demanding a longer 14-year term. However, with pharmaceutical companies starting to acknowledge the attractiveness of entering the generic biologics sector themselves (see Merck?s CEO Dick Clark?s announcement in December of last year), such demands over the Bill?s proposal may be short lived.

We wait in eager anticipation to see how well the latest Bill incarnation survives in comparison to its previous predecessors and whether there will be a warm reception to the Bill from the EU after the Commissioner for Competition?s earlier denunciation of the pharmaceutical industry?s obstruction of the production and competition of generic drugs". 

The IPKat thanks Annsley for keeping him up to date, and he looks forward to learning what happens next. Merpel's chuckling at the imagery. Last week we were all following a straw man; this week it's a wax man ...

Full post as published by IPKat on March 16, 2009 (boomark / email).