When is patent infringement not patent infringement? Merck v Integra and the 'safe harbour' | Boyd | Journal of Commercial Biotechnology. The PDF file you selected should load here if your Web browser has a PDF reader plug-in installed (for example, a recent version of Adobe Acrobat Reader). If you would like more information about how to print, save, and work with PDFs, Highwire Press provides a helpful Frequently Asked Questions about PDFs. Alternatively, you can download the PDF file directly to your computer, from where it can be opened using a PDF reader. To download the PDF, click the Download link above. Fullscreen Fullscreen Off Refbacks There are currently no refbacks. Copyright © thinkBiotech LLC. What does "Freedom to Operate" mean? "Freedom to operate", abbreviated "FTO", is usually used to mean determining whether a particular action, such as testing or commercialising a product, can be done without infringing valid intellectual property rights of others.
Since IP rights are specific to different jurisdictions, a "freedom to operate" analysis should relate to particular countries or regions where you want to operate. If you want to commercialise a new variety of lentil seed in your own country, for example, you might have complete freedom to operate if there are no patents, plant variety rights, trademarks or other IP rights covering the seed, the process used to make it or the way you wish to market it or in your country.
However, you might not have the same freedom to operate if you want to export the seed to another country, where patents or other IP rights may have been issued covering the plant genotype, methods, etc. That doesn't give you rights with respect to any other IP, though. Freedom to Operate. A discussion with a colleague the other day brought up a point about drug patents. When you're thinking about the chemical matter you have for your project, one of the things you have to worry about is the patent situation.
Are your molecules patentable? For that to be the case, you need novelty and utility. Utility is pretty much a given in this business - you wouldn't be interested in the compounds if they didn't do something - so novelty (prior art) is what we spend time wondering about. There's usually a way through on that, though. Then there's "freedom to operate". But here's where we got to talking: in the drug business, where we're patenting particular chemical matter (and the use of it for particular medical needs), it seems like freedom to operate isn't as big a deal as it is in some other areas.
So when you're talking chemical matter, does anyone know of drugs (or programs) that have been derailed in development just because of freedom-to-operate concerns? Freedom to Operate and Risk Management. Home > Topics > Freedom to Operate and Risk Management Summary and Overview Key Implications and Best Practices Topic Chapters Show All Abstracts Abstract 14.1 Freedom to Operate, Public Sector Research, and Product-Development Partnerships: Strategies and Risk-Management Options by Anatole Krattiger Abstract: Freedom to operate (FTO) is—first and foremost—a strategic management tool. Research exemptions exist in many jurisdictions, so most university research does not generally need to be concerned with FTO unless product development takes place. Legal/IP management strategies: license-in, cross-license, oppose third-party patents, seek nonassert covenant, seek compulsory license R&D strategies: modify product, or invent around Business strategies: merge and/or acquire, wait and see, abandon project Each option presents its own risks and opportunities.
Abstract 14.2 Freedom to Operate: The Preparations by Stanley P. Related Chapters.