A Critical Component of Due Diligence
Commercial success for pharmaceutical and biotechnology products requires companies to take full advantage of the market protection opportunities provided by the interaction of patent protection and regulations of the Food and Drug Administration (FDA). In order to obtain the maximum benefit from available market protection opportunities, companies must move beyond a basic assessment of the various market protection provisions to an understanding of the strategies that are available to enhance market protection for their products. Such strategies might include: improving market protection by adjusting the timing of follow-on product development, modifying dosage forms or product presentations, and leveraging market protection incentives that are available for research and development in specialized patient populations. The pursuit of such strategies might increase the attractiveness of the products to potential partners or increase the value of the products to potential investors.
Market Exclusivity Provisions for Pharmaceutical and Biotechnology Products
Patents and FDA regulations interact to provide a period of market protection for a product before generic or competitor products enter the market. Common aspects of market protection include: data exclusivity, patent term restoration, patent litigation procedural protections (frequently described as Hatch-Waxman protections for patents listed in the Orange Book), pediatric exclusivity, and Orphan Drug exclusivity. A company can enhance these basic market protection provisions by keeping a focus on patent prosecution and opportunities for Orange Book listings and patent term restoration.
- Patent Prosecution. Strategic considerations in patent prosecution include a focus on whether the types of claims being pursued would be “listable” in the Orange Book, frequent review and update of pending patent claims to correspond to changes in product development, a consideration of the types of product characteristics which, if patented, would create regulatory hurdles for would-be competitors, and creating protection against pathways for non-identical – yet, competitive – variations on your product.
- Orange Book Listings. Strategic considerations for patent listings in the Orange Book should include procedures for resolving close questions regarding which patents/claim types can be listed in light of the approved product or method of use.
- Patent Term Restoration. Strategic issues for patent term restoration include which of the eligible patents will be restored – particularly, in circumstances where the restoration of one of several eligible patents might benefit one party to the detriment of another.
Strategies to Enhance Market Protection
Frequently, an assessment of market protection for a product can reveal issues related to the scope of patent protection, the limited time for data protection or other exclusivities, or a delay in the timing of the market introduction of follow-on products. In these circumstances, a strategic review might reveal further opportunities to enhance market protection in order to diminish or overcome those issues. For example, the marketing life for the active pharmaceutical ingredient might be extended by:
- strategic timing of new product introduction to take maximum advantage of the available regulatory exclusivities;
- the development of new dosage forms or product presentations – whether or not associated with new intellectual property protection; or
- leveraging market protection incentives available for pursing research and development on the use of the products in specialized populations.
A company can also combine these and other strategies to enhance the protection for a particular product. In considering any of the possible strategies, a company must weigh the potential market protection benefits against the time and resources necessary to pursue these strategies.
A strategic review of market protection opportunities should be added to the basic assessment of the market exclusivity benefits that arise from the interaction of patents and FDA regulations. For assistance in evaluating market protection opportunities, please contact us at 202.589.1780.