Research directed to understanding the impact of genetic and environmental variables on disease emergence and progression has led to the identification of patient populations that share molecular features or signatures, laying the foundation for precision medicine. These molecular features and signatures are being exploited and have led to the identification of new targeted treatments, the tailoring of existing treatment options by identifying which patient populations are more likely to respond to particular drug classes or treatment modalities and prognostic indicators that identify patient populations that are more or less likely to progress warranting more or less aggressive intervention. A number of targeted treatments have been approved and even more are being assessed in clinical trials. As a result, the promise of precision medicine of more effective and less toxic or invasive treatments, better individualized prognosis and the potential for disease prevention for a number of cancers and a variety of other diseases seems closer than ever.
Precision diagnostics, which can be understood as the “tools” necessary to identify the populations that can be treated with targeted therapy or who are more likely to respond or share a prognosis, is a necessary prerequisite for precision medicine and relies on identifying biological markers or signatures including genomic, other “omic” and phenotypic biological markers or signatures (collectively which can be referred to as “biomarkers”), that identify the populations of patients that can benefit from precision medicine. Considerable discovery research and in particular development research dollars are necessary to identify and validate biomarkers requiring adequate market incentives to encourage market participation.
There are a number of obstacles that may limit the pace of commercialization of precision biomarker based diagnostic advances.
Reimbursement and regulatory challenges have been identified as bottleneck issues for the introduction of new diagnostic innovations. In Canada, different provincial regimes and practices for approving and reimbursing diagnostic tests adds a further layer of complexity.
In addition, recent changes in the practice of examining diagnostic innovations before the Canadian and United States patent offices and recent legal changes to US patent law, have added some uncertainty as to the patent protection available requiring deeper consideration of the strategies that may be available for protecting precision diagnostics.
It is generally accepted, that intellectual property rights (IPR) are a key influence on private innovative activity in the biotech field and it is widely accepted that one of the pillars for building value in a biotech company is a sound patent strategy and robust patent position for key assets of a company.
Diagnostic tests that include a new reagent such as a new antibody or diagnostic tests that involve a new method or combination of methods are still generally considered patentable subject matter. However, diagnostic tests that use standard technologies to detect or measure a level of a newly correlated biomarker face hurdles in both the Canadian and US patent offices.
A key high growth area for precision diagnostics is companion diagnostics. For companion diagnostics, the correlation discovery can generate the most valuable intellectual property (IP) (after claims to the therapeutic composition or use thereof) as it can impact exclusivity for both the drug and the associated diagnostic. Assays and assay reagents can be less valuable as they can usually be designed around with the general exception of platform technologies.
Business models providing diagnostic services can also involve specific patent challenges. For example, it can be more challenging to patent routine methods applied to a newly discovered biomarker correlation or the patents can be more challenging to enforce (i.e., enforcing patents against customers) and this can have an impact on valuation and the barriers for competitors entering the market.
Depending on the type of invention, the jurisdictions of interest and, the business model and the associated value propositions, patentability and infringement considerations in the markets of interest need to be considered. Future freedom to operate risks can be managed to some extent by publishing or filing a patent application. Filing a patent application has the further benefit of allowing for reassessment of the commercial value of the invention. Alternate options such as trade secret protection should also be considered.
Trade secret protection does not prevent others from independently making the invention but particularly where the business model is focused on diagnostic services and where regulatory approval and reporting may be less stringent such as for laboratory developed tests, trade secret protection can prevent others from using or improving upon the invention. If the trade secret is kept secret and not independently made, the owner can benefit from the trade secret indefinitely. Of course, if the trade secret is not guarded, the owner is typically left without any protection. A combination of the two may be warranted for providing the most robust protection for precision diagnostic inventions.
About the Author
Carmela De Luca is a partner with Bereskin & Parr LLP, a lawyer and and a registered patent agent in Canada and the United States. She practices in all areas of intellectual property, focusing on patent matters, including advising clients on strategic global aspects of obtaining and managing patent portfolios, as well as in the preparation and procurement of patents and industrial designs.