The ineligibility of gene patents is driving rapid innovation in pathogen response – the plan reverses this

Since 2013, a vibrant genetic testing industry has flourished. Reports indicated that there are over 175,000 clinically available genetic tests9 overall, with 14 new tests introduced daily.10 Thanks to the AMP v. Myriad decision, patients and their providers have vast choices in selecting appropriate clinical testing. As the Subcommittee considers PERA, we urge you to also explore the potential unintended negative consequences stemming from this policy change, especially in the nascent and still expanding precision medicine industry. Invitae is concerned that reverting back to the pre-2013 state of patent eligibility would stifle innovation, create barriers to access, and harm the post-pandemic fragile economy. We offer the following data to support the fact that the diagnostic industry and precision medicine more broadly has benefited greatly in the past decade.

Illumina, the US-based powerhouse at the center of the genomics revolution, has experienced considerable growth in recent years, in large part fueled by the expanding market for genetic sequencing for which the current patent eligibility jurisprudence has provided freedom to operate. Just five years after the 2013 Myriad decision, in 2018, Illumina reached $3.3 billion in revenue while sustaining a gross margin of about 70%.

Similarly, companies in life sciences and diagnostics have been increasing in value significantly since 2013, with genetic medicine companies outpacing the rest. Even as the healthcare industry slowed at the outset of the COVID-19 pandemic and now as the country faces economic challenges, the cumulative market cap for the precision medicine industry continues to grow, gaining $19 billion more than it was in 2019. Reflecting the significant surge in testing for COVID-19 in 2020 and 2021, the diagnostic industry reached a cumulative market cap of $165 billion. Unsurprisingly, this was not sustainable as the demand for PCR based testing for COVID-19 dropped in 2022 reflecting a new phase in COVID-19 response efforts.

Although, had the RNA sequence of the SARS-CoV-2 virus been patent eligible, we anticipate that we would not have seen such growth in the industry in 2020-2021. Thankfully, the Myriad decision meant that the sequence was not eligible and hence, innovators were able to rapidly develop and deploy countermeasures such as vaccines, diagnostics, and therapeutics specific for COVID-19. Moreover, they were able to modify diagnostics and vaccines as the virus mutated and new variants circulated. A patent on the sequence itself, its association with disease, patents on novel variants, etc. would have greatly stunted the country’s ability to adequately respond to the pandemic as a result of monopolies on biotechnology, expensive testing and therapeutics, and limited access to patient care, much like what patients experienced with hereditary cancer testing before 2013. As Sandra Park wrote in her analysis, “the current ongoing public health crisis is an excellent example of what’s at risk if these patent law changes move forward.”11