Follow-On Biologics: Intellectual Property Issues (CRS Report for Congress)
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| Release Date |
Aug. 28, 2015 |
| Report Number |
R44173 |
| Report Type |
Report |
| Authors |
John R. Thomas. Visiting Scholar |
| Source Agency |
Congressional Research Service |
Summary:
The term "biologics" refers to a category of medical preparations derived from a living organism. These medicines have added notable therapeutic options for many diseases and impacted fields such as oncology and rheumatology. The biologics industry invests extensively in R&D and contributes to a rapidly expanding market for these treatments. Biologics are often costly, however, in part due to the sophistication of the technologies and the manufacturing techniques needed to make them.
Compared to the number of generic drugs available in traditional pharmaceutical markets, few "follow-on" biologics compete with the original, brand-name product. The lack of competition in the biologics markets was perceived to be a consequence of the complexity of biologics in comparison with small-molecule, chemical-based pharmaceuticals. As a result, previously existing accelerated marketing provisions for traditional generic drugs provided under the Federal Food, Drug, and Cosmetic Act have not been as effective in accelerating biologics competition.
Congress turned to these concerns when it enacted the Biologics Price Competition and Innovation Act (BPCIA) of 2009. The BPCIA was incorporated into Title VII of the Patient Protection and Affordable Care Act. The BPCIA included three significant components. First, the BPCIA established a licensure pathway for competing versions of previously marketed biologics. In particular, the legislation established a regulatory regime for two sorts of follow-on biologics, termed "biosimilar" and "interchangeable" biologics. Second, the BPCIA created FDA-administered periods of regulatory exclusivity for certain brand-name biologics and follow-on products. No application seeking licensure of a follow-on biologic may be filed for four years from the date the referenced product was licensed. In addition, the FDA may not approve an application for a follow-on biologic for 12 years from the reference product's licensure date. The BPCIA also provides for a term of regulatory exclusivity for the applicant that is the first to establish that its product is interchangeable with the brand-name product. Finally, the BPCIA created patent dispute resolution procedures for use by brand-name and follow-on biologic manufacturers. These procedures are commonly termed the "Patent Dance," perhaps due to their complex nature.
Several intellectual property issues with respect to the BPCIA have emerged since the statute was enacted. Some have asserted that the "Patent Dance" established by the BPCIA is not obligatory and may be waived by either the brand-name or follow-on firm. Others have argued that the BPCIA does not apply to biologics approved before the passage of the law. Finally, the term of regulatory exclusivity that should be afforded to biologics within the Trans-Pacific Partnership, a proposed international trade agreement, has been subject to debate.
