H.R. 7693: Leo’s Law

This bill, known as "Leo’s Law," aims to support the development of orphan drugs—medications designed to treat rare diseases—by extending certain exclusivity periods for these drugs due to the effects of the COVID-19 pandemic. Here's a summary of its key components:

Exclusivity Period Extensions

The bill proposes that, for covered orphan drugs, various exclusivity periods will be extended by an additional 180 days, as long as the current exclusivity period has not yet expired. The extended periods include:

• The 12-year exclusivity period for biologics, as specified in the Public Health Service Act.
• The 5-year exclusivity period for new drugs under the Federal Food, Drug, and Cosmetic Act.
• The 3-year periods related to certain patent certifications under the Federal Food, Drug, and Cosmetic Act.
• The 7-year exclusivity period for orphan drugs as defined in the Federal Food, Drug, and Cosmetic Act.
• Additionally, any corresponding patent-related approval delay periods will also see a 180-day extension.

Definition of Covered Orphan Drugs

A "covered orphan drug" is defined as any orphan drug for which:

• An application is submitted during the COVID-19 emergency period (from December 1, 2019, to a date that is not later than 120 days before the end of the declared emergency).
• The application has been approved based on an investigational new drug application.
• It is intended for a rare disease or condition, and there is no approved indication for the drug that is not related to a rare disease.

Timeframe of COVID-19 Emergency Period

The COVID-19 emergency period is defined as starting on December 1, 2019, and ending on a date that is not later than 120 days before the termination of the public health emergency as stated in applicable laws.

Effective Date

The provisions of this bill would take effect immediately upon its enactment, regardless of whether further guidance or regulations are issued by the Secretary of Health and Human Services regarding its implementation.

Relevant Companies

• AMGN (Amgen Inc.) - As a biopharmaceutical company that develops therapies for rare diseases, Amgen may benefit from the extended exclusivity periods for orphan drugs.
• GILD (Gilead Sciences, Inc.) - Gilead focuses on treatments for rare conditions and may see increased opportunities for their orphan drug pipelines under this bill.
• BIIB (Biogen Inc.) - Known for developing therapies for neurological disorders, Biogen could take advantage of extended exclusivity for their orphan drug candidates.