Using Landscape, Patentability, and Freedom to Operate Studies to Guide Your Company's IP Strategy
We previously addressed the differences between landscape studies, patentability studies, and freedom to operate analyses so you should have a good understanding of what type of information will be gained from each. While there are some overlaps between the three types of studies, each study is meant to provide different information that can be used at different times to guide a company.
There are no one-size-fits-all rules for these studies as they can be utilized at various points to provide valuable information. In this post, we will examine how each type of analysis fits within a company’s overall business strategy in helping guide research, development, and ultimately, commercialization.
Landscape studies form the foundation of a company’s business strategy. These studies are essentially a market analysis to help companies understand the existing technology and trends in a given technological area. Landscape studies will also identify the companies and inventors working in this technical area.
Understanding the “state of the art” ultimately helps companies develop a plan for their technology. This plan can involve deciding to patent a particular invention, modify an existing one, or identify white space for further technological development. In addition, landscape studies can help identify possible collaborations that may require in- or out-licensing IP.
Overall, a landscape study provides valuable information about the current market and its trends and allows companies to evaluate opportunities for developing new products, abandoning existing products, and exploring possible collaborations within the same space.
Once an interesting idea is discovered, the next question is whether it can be patented. These ideas may be generated from landscape studies but often times they are simply generated in the course of research. Regardless of how they come up, patentability studies are designed to uncover prior art that could present hurdles to obtaining a patent. For instance, a patentability study, when done correctly, should identify both patent and non-patent literature which may interfere with an invention satisfying the standards of patentability, novelty (Section 102) and non-obviousness (Section 103).
Understanding the prior that exists can help a company formulate a strategy for pursuing patent protection. This strategy may involve having to strengthening the support for the idea if there is complex prior art, modifying the idea if there is similar prior art, or simply presenting the idea as-is if no burdensome prior art is found. Often times a patentability study will reveal prior art that is in the same space. In these cases, knowledge of that prior art can help in drafting the patent application to include enough support to later overcome USPTO rejections related to that prior art.
With the help of patentability studies, companies can better plan ways for satisfying the requirements of obtaining patent protection.
Freedom to Operate Analysis
Once the appropriate landscape studies and patentability studies have been conducted, and an idea is determined to be worthy of commercialization, the next question is whether there are any blocking patents that would prevent it from entering the market. This is done by a freedom to operate, or FTO, analysis. This type of analysis determines whether a product infringes another issued patent or may be encompassed by a pending patent application. It is done by identifying patents and patent applications that, if later issued as patents, may be infringed when commercializing your product.
If a product or service is found not to infringe any third-party patents, then the product or service can generally be considered safe for commercialization. If, on the other hand, the product or service is found to infringe a third-party patent, then the company will have to explore possible ways of getting around that third-party IP. This can include designing around the third-party IP, licensing that IP, or challenging the validity of that third-party patent.
Unlike landscape studies or patentability studies, FTOs should only be conducted when a product is already complete and ready for market. This allows its features to be analyzed against the claims of the third-party patent. Nevertheless, waiting too long to conduct an FTO may also be problematic as it could uncover block IP after significant time and expense has already been invested. Therefore, FTO’s should be conducted soon after a final version of the product is developed so that there is still time if changes need to be made or licensing discussions need to be explored.
Conducting and understanding FTOs is an important step in helping a company identify possible hurdles to commercializing its product and to proactively develop a strategy for entering the market.
Utilizing these three types of studies during the regular course of a business provides valuable information about the types of products and ideas already developed. Based on this information, companies can evaluate opportunities for developing, patenting, and commercializing new products.
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BioPharma Law Blog posts updates and analyses on IP topics, FDA regulatory issues, emerging legal developments, and other news in the constantly evolving world of biotech, pharma, and medical devices.