We previously addressed what a freedom to operate analysis is and what information it provides. In this post, we will examine patentability analyses and the five pieces of information that can be gained from conducting one.
Uncovering hurdles to patentability
The first piece of information gained from a patentability study is simply uncovering prior art that may present hurdles to obtaining a patent. This is, after all, the purpose of a patentability analysis.
A patentability study is done by identifying prior art, both patent and non-patent, which may interfere with an invention satisfying the standards of patentability, novelty (Section 102) and non-obviousness (Section 103). To this end, a patentability study will uncover any printed publications—such as journal articles, scientific papers, textbooks, abstracts, conference presentations, and any other papers—that have been published and that may impact patentability. A good patentability study should not be limited only to patents and publications published only in the U.S. but should be global in scope. Both prior art hurdles, Section 102, and Section 103 are based on publications worldwide and in any language.
In the Section 102 case of In re Hall, an invalidating piece of prior art reference, a doctoral dissertation, was found in the basement of a library in Germany. The reference was neither available online nor written in English, but it was indexed according to the author's name and title in the library’s indexing system. As such, the court decided the reference could have been accessible by anyone visiting the library to look through the indexing system as early as 1977.
While such references may be difficult to find, a good patentability study should uncover these and other potentially problematic references. Once uncovered, those references can help a company better formulate a strategy for differentiating a product to satisfy patentability requirements.
Draft better patent applications
Knowing what prior references you may be faced with during patent prosecution can also help you better draft patent applications with adequate support to later overcome any such prior art rejections. If you know what possible rejections the USPTO can come up with based on the prior art, you can begin crafting your responses and making sure support for those responses is in the patent application when it is filed.
Identify possible blocking IP
A patentability study can also help uncover potential blocking third-party IP, the type that would come up in an FTO. Not only will a patentability study show you which patents have already been issued, but it will show which applications and claims are still pending. Knowing which applications are pending is important because pending applications could quickly turn into potentially problematic blocking patents if they are not monitored and carefully examined. Having this information can help you proactively mitigate a potential problem with blocking IP.
Identify opportunities for expanding development pipeline
A patentability study can also help uncover further opportunities for development and patenting. When dealing with a lot of prior, the patentability analysis is important in helping guide a company to patentable areas or to help avoid pursuing a product with too much prior art.
For instance, if a drug were previously patented for cancer indications, you will not likely be able to patent the drug composition (without modification of the composition) nor will you be able to patent the use of the drug for cancer treatment. You may, however, be able to patent the drug for other indications, such as treating cardiovascular disease or neuroinflammation. You may also be able to patent a different dosage form of the drug. Instead of having an immediate-release formulation, you may be able to patent a sustained or extended-release formulation.
In general, a patentability study will reveal options for patenting products as well as existing hurdles.
Explore opportunities for collaboration
Finally, a patentability study can help you identify potential partners for collaborations. Since a patentability study identifies patents and patent applications directed to similar content, the inventors and assignees of those patents and applications can be found on the documents. This will allow a company to reach out to the assignees to discuss possible collaborations and even to try to hire personnel with certain know-how and skill sets.
When complete, a patentability study provides valuable information about what is already in the public domain with respect to your product. Based on this information, a company can evaluate opportunities for patenting a new product, developing a pipeline of products, or exploring possible collaborations with other parties within the same space.
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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.