Part 1: Understanding the Market Potential of Scientific Innovation
Over the last five years, the U.S. Supreme Court has decided more patent cases than it has in the previous two decades combined. The impact on those making innovative discoveries in the biotech and pharma fields is that it is far more difficult now than ever before to obtain legal protection for many types of scientific innovation.
Prior to 2012, the Supreme Court had decreed that “anything under the sun that is made by man” was patent eligible. Since then, the Supreme Court has started to focus on what is not patentable, including DNA, proteins and many isolated/purified natural products. This turn of events is particularly difficult for those of us in the biotech/pharma sector whose roots are in the natural world.
Frequently the founders are thinking only of the advance that the innovation provides for one area of science and either grossly overestimate its commercial potential or give no consideration to whether the invention can be sold at all.
For example, while many biotech start-ups begin with a particular compound for treatment of a particular disease, oftentimes this is not the case. Perhaps the start-up is founded around a platform technology or is targeting particular combinations of microorganisms, or their products, for application to environmental problems.
An objective view of the potential applications of the innovation not only helps the company to focus and increase its value potential, it can improve the likelihood of achieving patent protection.
As an example, perhaps the innovation allows one to generate novel, and unnatural proteins having new functions and the founders envision using the invention to create improved microorganisms for cultured dairy products.
Here, one of the first issues that must be addressed in developing a patent portfolio strategy is to identify the pertinent market(s) that will support commercialization of the invention. This may or may not be what the start-up founders considered as the target industry, despite the fact that the invention could be used in multiple fields of biotechnology, such as drug screening/development, pesticide improvement, or oil spill remediation.
Identifying viable markets requires consideration of how the purchaser will evaluate whether the costs of adopting the new technology are worth the investment. Perhaps manufacturers of cultured dairy products feel that the advantage afforded by a new microorganism pales in comparison to the costs of altering their procedures/equipment and re-training their workforce. If so, there is no sense in obtaining patent protection for products or methods with no true commercial value. On the other hand, oil companies may be particularly interested in products and procedures that produce any improvement in remediation.
Consequently, it may be that additional experimentation to identify novel proteins that would support the oil spill remediation market should be conducted before filing a patent application so that the protection is clearly apparent to the targeted industry and to increase the potential value of the patent.
Although it is more difficult to obtain broad protection of biotech/pharma innovations, a focused approach to application preparation and filing can ensure that an innovation can obtain solid protection without unduly compromising the scope of the protection.
Susan Gorman, Ph.D., Esq., is principal of Gorman IP Law, a law firm focused on helping companies leverage intellectual property assets to maintain a competitive advantage, enhance market share, plan for growth and better manage resources and expenses. Through a proprietary process, Gorman IP Law helps businesses build a formal IP strategic plan that defines your business goals, establishes benchmarks and allows you to better project costs. Dr. Gorman can be reached at email@example.com.
The information contained herein has been prepared by Gorman IP Law, APC, for informational purposes only and is not legal advice.