Unlike any other industry, health care industry (including pharmaceuticals, biotechnology, and medical device industry) is more actively involved in devising new and revolutionary technologies and innovations. For such a plethora of innovations emerging every other day, it becomes imperative for these companies to seek regulatory approval on commercialization of these innovations from the United States Food and Drug Administration (FDA) while protecting their intellectual property (IP) rights issued by the United States Patent and Trademark Office (USPTO).
Technically speaking, a company could be issued patent protection well before obtaining FDA approval, but it cannot sell its product until it gets the FDA approval for the said. In other words, health care companies need to go through two regulatory processes before launching their product in the market, which require them to be extra careful to avoid any conflict between the IP and FDA clearance.
IP Protection and FDA Regulation
Since IP protection and FDA regulation are compatible for the most part, it is important to understand that decisions made by USPTO do not impact the one granted by FDA and vice versa. For instance, FDA’s approval of a medical innovation doesn’t guarantee issuance of a patent on the same by the USPTO, and issuance of a patent on a medical innovation by the USPTO doesn’t prohibit the FDA from declaring the same unsafe for public use.
Issues In Obtaining IP Rights and FDA Approval
For most of medical innovations including pharmaceuticals, biologics and medical devices, FDA approval is a must prior to their marketing in the United States. One of the most critical issues that health care companies face in the regulatory approval of their innovations is to make disclosures to both the FDA and USPTO. To avoid any such regulatory complication both in securing the FDA regulatory approval and in securing the IP protection, health care companies need to implement integrated IP and FDA strategies. And the best way to do that is to use the same evidence (i.e. showing substantive differences between the prior art and the innovation being patented) for the innovation going through the review processes when making disclosures about them.
FDA Regulatory Issues In IP Valuation
Another area where FDA regulation impacts IP is IP valuation. So, it becomes necessary for a health care company to assess the impact of the FDA regulation on its innovations. A better and careful assessment of FDA regulatory scheme can mean obtaining ultimate approval for innovations in the expected time.
Conclusion and Recommendations
It’s obvious that in the health care sector, IP and FDA regulation are closely linked. Considering that, lack of a business strategy to address issues inherent in the IP and FDA clearance might result in unwanted delays and loss of the intellectual property value of innovative technologies. To avoid the problems associated with the regulatory and patenting processes of medical innovations, a carefully planned joint IP and FDA strategy is desired. This joint strategy should be developed in a way best to secure both the regulatory approval without any delay and quality of protection of IP, while minimizing the chances of any conflict between the IP and FDA clearance.