Washington Post Editorial Opposes Automatic Extensions of Drug Patents

The lawsuits that pharmaceutical companies routinely file to extend their patents on prescription drugs facing generic competition is a "species" of lawsuit that "ought to be endangered," the Washington Post writes in an editorial. Under the Hatch-Waxman Act of 1984, companies can receive an automatic 30-month patent extension from the FDA each time they claim that generic competition would infringe on their patent. Because generic competition usually reduces the cost of drugs by more than 50%, their delay to the marketplace "transfers eye-popping sums from consumers to the patent-holder," the Post says. The editorial points to drug maker AstraZeneca's attempt to deny generic competition for its heartburn medication Prilosec; a one-year delay of a generic version of the drug could cost state Medicaid programs $300 million and could add over $15 million to the cost of General Motors' employee health plan. The editorial suggests that the ability of drug makers to extend their patents automatically is a problem that Congress "needs to fix." It calls a bill (S 812) proposed by Sens. Charles Schumer (D-N.Y.) and John McCain (R-Ariz.) to reform drug patent laws "useful," and states that a "sensible reform" of the law would allow the 30-month extension only if patent holders convince a judge that their case has merit; would deter "frivolous filings" by requiring patent holders to post bonds; would allow only one stay per drug; and would restrict the "range of patents that inventors can use to fend off competition." The editorial concludes: "Extending patents beyond their intended life amounts to robbery, and the consequence is that even more Americans will join the ranks of the uninsured and even more seniors won't be able to afford the drugs they need" (Washington Post, 3/29).