Intellectual Property Protection for Diagnostics

The field of diagnostics, particularly in relation to genetic and antibody-based testing, has been in a state of upheaval, caused by recent intellectual property-related court decisions and regulatory changes. The advent of personalized medicine, which strongly relies upon accurate and specific diagnostic testing using genetic and other information about an individual patient to optimize preventive and therapeutic care, has also impacted the field of diagnostics.

These issues have resulted in the need for intellectual property strategies that consider the state of flux in the field of diagnostics. For example, in the United States, it is no longer clear which types of genetic tests may still be subject to patent protection as a result of various pending court decisions and completed judgments. This impacts highly proprietary laboratory developed tests (LDTs) that are developed in the laboratory for internal use, which may be subjected to increased regulatory scrutiny and disclosure requirements. This state of uncertainty also affects personalized medicine in which diagnostic and therapeutic methods are effectively combined. In addition, firms wishing to enter a particular market niche for diagnostic tests need to consider the patents of others, since various court decisions impact entire categories of diagnostic tests. All these factors need to be considered to determine the best infringement avoidance and/or invalidation strategy.

GAI has both the expertise and experience to guide diagnostic firms through this complicated regulatory domain. Whether deciding on a suitable IP strategy for protecting inventions or for avoiding infringement and/or invalidating the patents of others, GAI can optimize IP planning, strategy and execution.

GAI is particularly focused on start-up companies in the field of diagnostics and handles diverse and complicated patent portfolios, optimizing IP strategy specific to the technology and business model.


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