Hatch Opposes Provisions in Schumer-McCain Bill That Would Reform Drug Patent Law

Sen. Orrin Hatch (R-Utah) said yesterday that he does not support a bill (S 812) to update the 1984 drug patent statute that bears his name, "dimming prospects" that Congress will pass legislation to make it easier for generic drugs to come to the market, the Wall Street Journal reports. The 1984 Hatch-Waxman Act established the process under which the FDA approves generic drugs and gave brand-name drug makers various legal protections for their products. In recent years, generic makers, consumer advocates and some lawmakers have said that brand-name companies have inappropriately use the law to extend patent protection on their drugs and keep cheaper, generic drugs off the market (Adams, Wall Street Journal, 5/9). Charles Schumer (D-N.Y.) and Sens. John McCain (R-Ariz.) have introduced a bill to reform the law and end some of the tactics drug makers use to delay generic competition, such as filing secondary patents and lawsuits. Drug companies say the 1984 law works well in its current form. Speaking before the Senate Health, Education, Labor and Pensions Committee, Hatch said he could not support the measure because of certain provisions included in the legislation. Hatch took issue with a provision that would eliminate the 30-month extension in patent protection that brand-name drug companies receive when they file a lawsuit against a generic company. He also disagreed with another provision that would give the first generic drug to hit the market 180 days of competition-free marketing, "regardless of whether it was the first generic approved." Instead, Hatch suggested that Congress examine "establishing new rules for subsequent filings that lead to consecutive 30-month stays on the same product" and that the "180-day exclusivity be ended if the first generic that can legally come to the market does not do so within 180 days" (Fulton, CongressDaily/AM, 5/9).

While Hatch is a member of the minority party in the Senate and is not on the "primary committee" considering the bill, "his views on revamping the generics-approval process are keenly watched by people on both sides of the issue," the Journal reports. Some proponents of the Schumer-McCain bill hope the measure benefits from "election-year politics" -- if lawmakers cannot agree on a Medicare prescription drug benefit this year, they could look at increasing the availability of generic drugs as another way to address rising drug costs. Hatch suggested that lawmakers wait for the results of a Federal Trade Commission study on generics and drug patent laws expected to be released this summer before moving on the bill (Wall Street Journal, 5/9). Hatch said, "It will be vitally important that we legislate in a manner that is driven by the facts rather than from the emotion of an election year" (CongressDaily/AM, 5/9).