What is Freedom To Operate?

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While the core steps in a commercialization strategy often translate across industries, companies with heavy R&D or regulatory planning have additional considerations before a successful go-to-market.  A Freedom to Operate (FTO) search can be a useful, if not essential, tool for these companies in commercial planning.

What is Freedom To Operate?

Freedom to operate (FTO) is the ability of a company to produce and distribute products without liabilities to third parties based on IP. In other words, FTO ensures that a company’s products and services do not infringe on the patent rights of another person or company.

Why is FTO important to medical device, healthtech & biotech companies?

Without freedom to operate, a commercialization strategy may be blocked or otherwise restricted by a patent-holding competitor. This can result in significant losses to company resources and reputation damage if commercialization is already underway. 

To read more: Top 5 IP Considerations for Medical Device Companies

What is a FTO search?

A freedom to operate search generally involves searching for issued or pending patents, industry-specific publications, and other relevant published materials which may reveal the potential patent rights of others. An experienced IP professional will ensure the search covers key competitors within the technical field to avoid missing any crucial third-party IP.

What is FTO analysis & opinion?

‍By analyzing the FTO search results, your IP attorney can provide a legal opinion as to whether any rights uncovered pose a potential risk of infringement. If the FTO opinion suggests there is freedom to operate, companies may choose to pursue their development plans and to protect their innovation with patenting. If the FTO opinion suggests there is blocked or restricted freedom to operate, companies may consider patent purchases, licensing, or cross-licensing as alternatives.

Can I use any firm for a Freedom to Operate (FTO)?

Intellectual property firms and attorneys with experience in the specific technical field are best equipped to conduct the FTO search, analysis and opinion because of their familiarity with the IP and industry landscapes.

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