Known as the Hatch-Waxman Act, the Drug Price Competition and Patent Term Restoration Act of 1984 governs the regulatory approval and commercial marketing of pharmaceuticals, including generic drugs. Hatch-Waxman litigation arises when branded pharmaceutical companies file suit asserting drug patents against companies attempting to market generic versions of branded drugs. This occurs after generic pharmaceutical companies file Paragraph IV notice letters through which generic applicants assert either the noninfringement or invalidity of patents held by brand manufacturers.
The pharmaceutical industry's heavy dependence on patents and patent protection, and the potential market exclusivity Paragraph IV notice first-filers can secure, highlights the important and outsize impact Hatch-Waxman litigation has on the marketplace. Current trends in Hatch-Waxman litigation include case filing trends, changes at the government and court levels, and recent court decisions.
In this Law360 article, Loeb & Loeb Patent Litigation associate Benjamin Dach discusses several notable cases that reveal key takeaways and unresolved issues of which drug companies should be wary.