Quarterly Journal Volume 51, Issue 4 December 2023

COPYRIGHT, LITERALLY

The Copyright Act is a statute, but courts seldom treat it as one. Instead of relying on the precise language of the statute, courts often treat the Act as some general prohibition on plagiarism or copying writ large. This article argues for a different approach. It argues that courts should treat the Copyright Act like a statute and define a copyright owner's exclusive rights according to the precise language by which Congress defined those rights. The results are startling. Treating the Copyright Act as a statute, courts should define the exclusive rights far more narrowly than they currently and generally are.

ORPHAN DRUG EXCLUSIVITY AND CATALYST: A POSSIBLE CATALYST FOR GAPS IN TREATMEMT WITHIN SUBPOPULATIONS OF RARE DISEASES AND CONDITIONS

Persons with rare diseases or conditions already are often left without treatment, due to inadequate research, or funding for research. Congress thus enacted the Orphan Drug Act ("ODA") to incentivize pharmaceutical companies to perform further research and development to treat these diseases. What is often neglected, sadly, is how there are subsets—subpopulations—within these diseases for whom drugs are not FDA-approved. Under the new Catalyst Pharmaceuticals, Inc. v. Becerra ruling, the Eleventh Circuit interpreted the ODA to grant orphan drug exclusivity ("ODE")—which traditionally was understood by FDA to be seven years’ exclusivity of the market for a particular approved “intended use”—for the entire condition for a particular drug. If FDA follows this interpretation, subsets of the population may be left without treatment while they wait for the exclusivity period to pass so that FDA can grant approval for their use of the drug. To avoid this result, there must be a legislative fix that amends the ODA such that the exclusivity provision relating to the “same drug for the same disease or condition” is applied for only the “approved use or indication.” To further enhance access to critical therapies for rare diseases, a clinical testing requirement should be imposed to include subpopulations of rare diseases or conditions. Alternatively, FDA should, as it has in its January notice, find ways to side-step the Catalyst ruling so that subpopulations have access to necessary treatment.