Is it Time to Do Away with Data Exclusivity?

By , July 8, 2020 July 16th, 2020 Data Exclusivities, Patents

If there is a lesson from COVID-19, it is the need to look at the nature of our health care systems with a keen eye towards dismantling the barriers to accessing health care. While there are several barriers to access health care, this blog particularly focuses on the impact of regulatory exclusivities on access to pharmaceuticals

It is estimated that it takes at least six to seven years to go from initial discovery of a molecule to the marketplace, wherein drugs undergo extensive clinical trials.  Exclusivity was introduced to compensate for the high cost of clinical trials and the fact that the end result of those trials is the data that demonstrates the relative safety and efficacy of a drug. During this monopoly period, when generic or biosimilar drug manufactures are unable to launch follow-on products clinical trial data is protected from competition, allowing an additional opportunity, on top of the patent term, during which time companies could recover the cost of the innovation.  But, if the benefits of the end of that exclusivity period are to be realized as quickly as possible, it is critical for follow-on producers to use this data in order to enter the market as soon as the period of patent exclusivity ends. Obstacles to access this data have become a barrier that deserves to be reconsidered closely.

For small-molecule drugs especially, the proprietary data developed by the original medicine producer is important for follow-on producers to file generic applications.  Idhifa is an example of a small molecule drug used for the treatment of acute myeloid leukemia. It is currently priced at $28,000 for a month’s supply of the medication. The drug was approved in 2017 by the FDA for marketing and its patent is set to expire in 2034. Although the data exclusivity period for this drug will expire before the end of the patent term, the patent exclusivity monopoly in and of itself provides adequate incentive such that the data on the efficacy of the drug need not require an additional layer(s) of protection. Considering that small molecule drugs (like all inventions) already benefit from a 20-year period of patent monopoly, the question of whether we need clinical trial data to be protected separately and to achieve what goals remains critical.

In a paper published in the University of Pacific L.J., we assert, specifically with reference to biologics, that technological innovations undermine the justifications for data exclusivity. Although our paper’s focus was on biologics, the same arguments fully apply to small molecules as well. First, technological advancement reduces the cost and the time for drug discovery per se, whether small molecule or biologics. New and emerging technologies (e.g., artificial intelligence, the use of biomarkers in drug discovery and clinical trials, mobile technology, etc.) are being deployed every day to enhance efficiencies and reduce the time taken to bring a drug to the market.  As new technologies are adopted and advances in scientific understanding are leveraged, it results in shorter drug development timelines.

BenchSci, the blog, highlights how about 230 plus start-ups exclusively use AI to discover relationships between diseases, targets, and drugs; to curate imaging, to create databases; to create genomic datasets and more using AI. The use of AI and related technologies as well as big data has shortened the period of clinical trials and has simultaneously strengthened it.

Second, the COVID-19 pandemic has highlighted the need for not only innovating medications, but also the importance of making those innovations widely accessible. All diseases can result in loss of productivity – relatively simpler ones such as diabetes or, more aggressive ones, such as forms of cancer can all affect productivity of not only patients but also caregivers and others who are immediately impacted by it. COVID-19 highlights the important role that a healthy population plays in facilitating world trade. Given that technology has minimized the trial to table time for drugs, it is important to eliminate those barriers that are no longer necessary to incentivize innovation, but instead prevail as mechanisms that delay the use of the clinical trial test data, thus impeding competition, and forestalling lower prices that result in increased access.

Reconsidering the importance of regulatory exclusivities is important at this time.  A reduction in the period may contribute to the lower cost of medication, resulting from increased competition as soon as a patent monopoly expires. While technology has enabled a shorter time for innovators to get to the market by completing clinical trials faster, limiting regulatory exclusivities may allow generics to enter the market more quickly by having access to clinical trial data, and thus, leading to faster access of the medication to the public.

The authors make their case more extensively in the paper titled Reconsidering the Rationale for the Duration of Data Exclusivity.

About the Authors

  • TradeRx Report Coordinator & Advisor
    Professor of Law and Director of India Programs, Texas A&M University School of Law.

  • Vice President of Trade and International Affairs, Association for Accessible Medicines (AAM).

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