The Patent Trial and Appeals Board: A Target for Prescription Drug Patent Reform?

Patents are essential to the pharmaceutical industry, with brand-name manufacturers charging high prices in the US during periods of market exclusivity largely defined by patents on the products. Manufacturers routinely build large portfolios of patents around successful products covering not only the active ingredient but also other features of the drug such as its method of use, formulation, and manufacturing process. With each patent lasting 20 years, portfolios can delay entry of generic or biosimilar competitors that contribute to price reductions, allowing manufacturers to sustain higher prices for longer. But recently there has been growing recognition that some drug patents in manufacturers’ portfolios should not have been granted. Improper patents and anticompetitive strategies used to obtain and enforce patents have faced heightened attention from the Federal Trade Commission, Patent and Trademark Office, and Congress. One notable patent reform effort that has gained attention is the bipartisan Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act.1 But this bill only threatens to make problematic drug patent portfolios worse by impeding efforts to challenge drug patents as improperly granted, with potential for big impacts on drug availability and prices.