By Briana Barron
I thought I would kick off my contributions to the AAPS Blog by answering a question that, as a patent attorney, I get asked all the time: “Why such a long patent application?”
This question often comes in the context of the often exhausting review that many inventors contribute to the drafted application before it is filed, a task that many complete on top of their ordinary job responsibilities. The answer to the question is multifaceted, but one major factor contributing to the length of patent application is the written description requirement, which, in short, requires that the claims are supported by a written description that shows that the inventor actually invented what is claimed.
The written description requirement is deceptively simple. Within the last five years, courts have wrestled with whether the written description should be a requirement at all. The result of these cases, however, is a resounding “yes.” The written description is still a requirement for all patents, and a patent is invalid if an adequately written description is not provided.
The written description is particularly important to the pharmaceutical sciences. Although the requirement is not specific to chemical and biotechnology fields, many important cases have dealt with chemicals, biotechnology, or pharmaceutical formulations.
In the chemical context, the Federal Circuit used the following example to distinguish the written description from a related requirement, the enablement requirement, which requires the patent application teach how to make and use the invention. The court stated:
…a propyl or butyl compound may be made by a process analogous to a disclosed methyl compound, but, in the absence of a statement that the inventor invented propyl and butyl compounds, such compounds have not been described and are not entitled to a patent.
This type of specificity has been explored in the context of formulations (Alcon Research Limited v. Barr Laboratories, 2014) and also in the context of biotech inventions (Novozymes v. Dupont Nutrition Biosciences APS, 2013). A direct product of this level of specificity is a longer patent application, which lists, sometimes in painful detail, each and every amino acid that can be used to substitute a given position of an enzyme, for example, or each and every substituent possible for a chemical compound. For formulations, a number of preferred embodiments are often laid out with much greater specificity than the protection that will ultimately be sought.
Time-strapped inventors often tell me further description is not necessary because any variations that may later prove to be their winning formulation or exact chemical structure would be obvious based on what the description already details. But this is not the correct inquiry. While it might prevent someone from getting a patent in view of your disclosure, it will not help you establish the written description support in the face of a validity challenge.
So next time you prepare for a patent application, know that you do indeed need that detailed written description, and for good reason.