	Introduction

Both patents and regulatory exclusivities have been the subject of congressional interest in recent years. The patent system has traditionally served as the primary innovation incentive for new medicines. Patents, which are administered by the U.S. Patent and Trademark Office (USPTO), allow for a uniform 20-year term of protection for a variety of inventions. Regulatory exclusivities apply to drugs and biologic medicines regulated by the Food and Drug Administration (FDA). Federal legislation establishes a complex range of regulatory exclusivities applicable to, among other subjects, new chemical entities, orphan drugs, and generic drugs. In general, these intellectual property rights require the FDA to protect an approved drug from competing applications for a set period of time. Contemporary legislative trends may elevate the regulatory exclusivity from a supplemental protection scheme to the primary driver of innovation within the pharmaceutical industry. The Biologics Price Competition and Innovation Act of 2009 created a 12-year regulatory exclusivity, and under the Generating Antibiotics Incentives Now (GAIN) Act a "qualified infectious disease product" that consists of a new chemical entity enjoys an exclusivity period of 10 years. That unenacted legislation would have effectively allowed brand-name pharmaceutical firms, in certain circumstances, to exchange their patents for a 15-year period of regulatory exclusivity. These proposals have been placed before the 114 th Congress in the form of a discussion draft of the 21 st Century Cures Act. Congress has established fifteen regulatory exclusivities. Comparing Patents and Regulatory Exclusivities

The growing prominence of this intellectual property right invites comparison between regulatory exclusivities and patents. They must be asserted by their proprietors through litigation in the federal courts. In contrast, the FDA enforces regulatory exclusivities automatically, without the intervention of the proprietary rights holder, and sometimes without even his knowledge. More recent legislation has extended the terms of regulatory exclusivities. Recent Legislative Proposals

Statutory distinctions between the pharmaceutical industry and other industrial sectors with respect to intellectual property may be increasing, however. The MODDERN Cures Act

Legislation introduced in the last several sessions of Congress, but not enacted, would have continued to emphasize regulatory exclusivities as a driver of pharmaceutical innovation. For example, the regulatory exclusivities could be divided into categories based upon the extent of protection, including (1) denial of approval of any competing product for the same indication, as provided under the Orphan Drug Act, (2) denial of access to the sponsor's data package, as is the case for the new chemical entity exclusivity, and (3) protection limited to a specific use, formulation, or route of administration of an approved drug, the scope of rights provided by the new clinical study exclusivity. Congress may wish to ensure that regulatory exclusivities incorporate exceptions that provide for the continued sale of safe and effective medicines that are currently available to the public.
Patents and regulatory exclusivities have each been the subject of congressional interest in recent years. Patents, which are administered by the U.S. Patent and Trademark Office (USPTO), allow for a uniform 20-year term of protection for a variety of inventions. In contrast, regulatory exclusivities apply to drugs and biologic medicines regulated by the Food and Drug Administration (FDA). Federal legislation establishes a complex range of regulatory exclusivities applicable to, among other subjects, new chemical entities, orphan drugs, and generic drugs. In general, these intellectual property rights require the FDA to protect an approved drug from competing applications for a set period of time.
Patents and regulatory exclusivities each create intellectual property rights for their proprietors, but operate through distinct mechanisms. Patents must be enforced through litigation in federal court and may be invalidated during judicial proceedings. In contrast, the FDA ordinarily maintains regulatory exclusivities through agency procedures, without the intervention of the rights holder. Unlike patents, regulatory exclusivities may restrict the sale of public domain medicines. And although patents traditionally provided a longer term of protection, more recently enacted regulatory exclusivities tend to have more comparable durations.
The patent system has traditionally served as the primary innovation incentive for new medicines. But recent legislative trends may elevate the regulatory exclusivity from a supplemental protection scheme to the primary driver of innovation within the pharmaceutical industry. For example, the Generating Antibiotics Incentives Now (GAIN) Act and the Biologics Price Competition and Innovation Act created regulatory exclusivities of 10 to 12 years, respectively, for certain products.
Legislation introduced most recently before the 113th Congress, the MODDERN Cures Act, H.R. 3116, would have continued to expand the role of regulatory exclusivities. That unenacted legislation would have effectively allowed brand-name pharmaceutical firms, in certain circumstances, to exchange their patents for a 15-year period of regulatory exclusivity. While proponents of the legislation believe it would provide a more certain and effective innovation incentive for the pharmaceutical industry, others assert that it significantly expands intellectual property rights and represents a windfall for the brand-name drug industry. These proposals have been placed before the 114th Congress in the form of a discussion draft of the 21st Century Cures Act.
Congress has several options as it considers the relationship between patents and regulatory exclusivities. If the current situation is deemed satisfactory, then no action need be taken. Other options include rationalizing the various terms of protection and scope of rights that regulatory exclusivities provide. Congress may also consider providing distinct names for the regulatory exclusivities and ensuring that these rights do not remove safe and effective medicines from the public domain.