The discovery and use of biomarkers presents opportunities and risks in the patent area. There are opportunities to patent biomarkers and methods of using biomarkers to further commercial ventures. There is also the risk of infringing third-party patents when making or using certain biomarkers. When discovering a biomarker or a new use of a biomarker, it is important to consider capturing biomarker patent opportunities. At the same time, it is important to be conscious that the use of a biomarker can pose risks of infringement and seek ways to minimize those risks.

The top three questions to keep in mind when working with biomarkers are:

1. Is it desirable to patent the biomarker invention?

2. Is the invention patentable?

a. Is the biomarker unknown?

b. Is the biomarker known but the use is not?

c. Does the invention meet the criteria for patentability?

3. Are there risks to making and using a biomarker?

a. Is the use "reasonably related to the development" of information that might be submitted to support FDA approval and therefore exempt from infringement?

b. Is there a patent that could block the making and using of the biomarker?

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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