Waxman Hatches A Biologics Bill

Alongside his cosponsors, Senators Schumer and Clinton, House Representative Henry Waxman, best known to the patent fraternity as one half of the Hatch-Waxman Act, has a new proposal. Modestly named the "Access to Life-Saving Medicine Act" (H.R. 6287), this bill proposes to extend favorable legal treatment to some generic "biologics" (also referred to as "biopharmaceuticals" or "biotech drugs"), while weakening the legal rights of holders of biologics patents.

Derived from living cells, biologics are drugs - usually proteins - that tend to possess more complicated chemical structures than traditional small-molecule drugs. H.R. 6287 would introduce into patent and drug law two new categories of biologics: "comparable" (Section 2(4)) and "interchangeable" (Section 2(6)). A comparable biologic lacks "clinically meaningful differences [to] the [patented] reference product in terms of the safety, purity, and potency of the product based upon [specified sources of data]", whereas an interchangeable biologic, among other features, "contains an active ingredient or ingredients with principal molecular structural features comparable to the [patented] reference product..."

At 39 pages in length, the bill would add a new layer of complexity to federal patent and drug legislation. It has not been welcomed by the Biotechnology Industry Organization, which views it as an attack on patent rights covering the most promising source of new drugs. However, portrayed by its three Democratic sponsors as an effort to rein in the prohibitive cost of biologic drugs, H.R. 6287 might alternatively be entitled the "Access to Working and Middle Class Votes Act".