In the face of a raging pandemic, the only constant that appears to exist is change. Businesses, hospitals, academic institutions, and financial markets have had to continually adapt in order to optimize efficiency. The federal government has also taken steps to keep up with this demand at both the Food and Drug Administration (FDA) and the United States Patent and Trademark Office (USPTO) to help address the pandemic. These changes are intended to provide life science innovators access to faster paths for patent protection and clinical trials, ultimately facilitating manufacturing and commercialization efforts for accelerated product development directed to COVID-19.
The FDA has implemented the Coronavirus Treatment Acceleration Program (CTAP) to facilitate and expedite its review of possible therapies targeting COVID-19.1 By working with researchers to design and oversee studies, as well as streamlining a review and advice process utilizing FDA experts, CTAP aspires to allow the FDA to move new treatments to patients as soon as possible.2 The option for expedited review channels at the FDA using CTAP may reduce the time it will take for life science innovators to provide potential returns on investments to address COVID-19, where multiple phases of drug trials testing for safety and efficacy can take many years.
The USPTO has announced its own version of an expedited review process, in the form of a pilot program, as it relates to small and micro entities submitting COVID-19-related patent applications.3 Under the pilot program at the USPTO, the expedited review process not only aspires to reach a final disposition on an application within six months, but it also promises to do so without the need for any fees normally associated with other forms of prioritized examination.4 As it pertains directly to patent approval, the faster feedback from the USPTO will allow life science companies to more efficiently strategize, prioritize, and organize patent prosecution considerations that in turn should help facilitate manufacturing and commercialization planning earlier on in the life cycle of product development.
When life science companies are in a position to more quickly understand the strengths of their patent portfolio, they are able to make more informed investment decisions for product development. While downstream patent litigation issues may arise for any given patent, the fact that certain patent claims have been examined by the USPTO can provide some guidance to investors and innovators on how best to proceed to product development. Just as importantly, faster realization on the vigor of claims in any issued patent will also provide the life science entity more runway as it pertains to finding potential partnerships or licensing deals that can be used to expedite the steps needed to manufacture and commercialize a given product. Finally, the ability for a company to more quickly receive feedback on its IP portfolio may place it in a position to better assess its own valuation and potentially pursue options to raise capital in order to be able to fund its ongoing trials and pipeline development.
While issued patents may encounter potential issues downstream during patent enforcement, an issued patent does signal a certain level of legitimacy for the patent owner as it pertains to its business in the particular field.5 Moreover, considerations regarding the interplay between the USPTO and the FDA can facilitate product protection of novel therapeutic and diagnostic inventions. Patent term and market exclusivity considerations for novel therapeutic options, or statutory constructs and mechanism related to potential challenges by competitors, highlight how the interplay of the decisions from the FDA and USPTO can impact a life science company’s ability to protect its products from future competition. Therefore, the simultaneous implementation of CTAP and the USPTO’s pilot program can help offer life science companies a framework to protect their products, thereby further driving innovation.
The combination of CTAP and the USPTO’s Pilot Program for patent prosecution related to COVID-19 has provided life science innovators an opportunity to sprint towards therapeutic and diagnostic solutions to help combat a raging pandemic. Streamlined mechanisms for patent prosecution and clinical trials may allow life science enterprises quicker access to patent protection and clinical trial results, which in turn may facilitate endeavors seeking out potential partnerships or licensing opportunities. Moreover, an expedited timeframe for product development, particularly in the earlier stages of the product’s life cycle where more uncertainty exists, can offer faster and more effective realization of IP assets that can drive future investments in ongoing clinical trials and pipeline development. While the direct benefits of expedited review programs at the FDA and USPTO are clear, the potential indirect benefits to life science enterprises offer hope for better informed investments in product development.
1 See Coronavirus Treatment Acceleration Program (CTAP), https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap (Last accessed June 25, 2020).
2 See The Path Forward: Coronavirus Treatment Acceleration Program, https://fda.gov/news-events/fda voices/path-forward-coronavirus-treatment-acceleration-program (Last accessed July16, 2020).
3 See USPTO Announces COVID-19 Prioritized Examination Pilot Program For Small and Micro Entities, https://www.uspto.gov/about-us/news-updates/uspto-announces-covid-19-prioritized-examination-pilot-program-small-and (Last accessed July 7, 2020).
5 David Pridham et al., The Top 10 Reasons Why Your Startup Needs Patents, Forbes, https://www.forbes.com/sites/forbesleadershipforum/2015/08/18/the-top-10-reasons-why-your-startup-needs-patents/#6aec574b22c7 (Last accessed July 9, 2020)
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