One of the most common questions we answer at BioPharma Law Group is when we need to do freedom to operate, landscape, and/or patentability analyses. There is a lot of confusion surrounding these three different types of analyses, namely what information they each provide and when is this information most helpful. In the next several posts, I will attempt to discuss the purpose of each type of analysis, what information it provides, and when this information is useful. I will start with the freedom to operate, or FTO.
The purpose of an FTO analysis is to determine whether a product infringes another issued patent or may be encompassed by a pending patent application. This analysis is done by identifying patents and patent applications that, if later issued as patents, may be infringed when commercializing your product.
Determining infringement will require examining the elements of each third-party patent claim and determining whether your product or service contains each and every element of that third-party patent claim. If this is the case, your invention infringes that patent. For instance, if your new product contains elements A, B, and C, but a third-party patent contains elements A and B, then your invention will likely infringe the third-party patent because each element of the third party patent (e.g., elements A and B) are found within your invention.
It is important to understand that a product may both be patentable and still infringe a third-party patent. This is because the standard for patentability is different from the standard for infringement. When determining patentability, the question is whether your product or service satisfies the requirements of patentability, including patentable subject matter, utility, novelty, non-obviousness, and written description/enablement. Generally speaking, this determination turns on whether your invention is novel and non-obvious over a third-party patent alone or in combination with other prior art. In the above example, your invention with elements A, B, and C may infringe a third-party patent because it contains elements A and B, but it could still be patentable because element C is not found in the third-party patent. We will discuss patentability in more detail in a separate post.
For products with multiple components, such as chimeric antigen receptor or CAR T cell therapies, an FTO should be conducted on each component. In other words, a separate FTO should be conducted for the antigen binder, the signaling domain, the binder, the linker, each co-stimmulatory domain, and so forth.
An FTO should further be conducted in each country where you intend on launching, manufacturing, or shipping your product. This is because patents are geographic in nature and the types of claims that are allowed can vary from country to country. Moreover, some types of patent claims are not allowed in certain countries. For instance, method of treatment claims are not allowed in many countries outside of the U.S. These differences can result in different FTO analyses.
When compared to patentability and landscape analyzes, an FTO is generally conducted later on in the process, when a company already has a product that it wants to commercialize. This is because the features of the proposed product need to be known in order to analyze each feature against the claims of a third-party patent. If your invention is not yet complete, it could be difficult to determine whether its features (which are not yet finalized) infringe a third-party patent.
If a product or service is found not to infringe the third-party patents, then the product or service can generally be considered safe for commercialization, assuming all other regulatory or other requirements are met. Of course, it should be understood that there is always a chance that a product manufacturer/seller could be sued for infringement down the road especially with the constantly changing patent landscape. However, having an FTO analysis can help minimize or proactively identity these threats.
If, on the other hand, product or service is found to infringe a third-party patent, then not all hope is lost. In such situations, certain options including designing around, licensing, or challenging the third-party patent could be considered. We will examine these in an upcoming post.
In the long run, an FTO opinion is important in helping a company or inventor identify possible hurdles to commercializing its product or services and to proactively develop a strategy for entering the market.
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.