Exclusion of biotechnological inventions from patentability – problems and solutions.
In 2014, biotechnology was one of the three technological fields in which patent applications filed at the European Patent Office (EPO) grew the fastest. An increase of 12.1% led to over 5,900 biotech patent filings. As these applications are substantially examined by the office for patentability, often problems with patentability are encountered. Some of these problems, as well as possible solutions, are discussed herein.
At the EPO, patents are not granted for plant or animal varieties, or “essentially biological processes for the production of plants or animals.” The relevant provision of the law can lead to severe objections from the EPO’s patent examiners. For example, in the past, the question arose whether the exclusion of essentially biological processes also precludes patents directed to plants or plant material such as fruit. This question is particularly relevant for a scenario in which the only available method for generating such plants or plant material is actually an essentially biological process.
Another problem in this context is how the plants or plant materials can be described in a patent application, specifically in cases where they are predominantly characterized by their way of production. This is because an indirect description of a product by virtue of its synthesis or production method is often not allowed in patents.
Additionally, biotechnology is a cutting-edge technology. Cutting-edge means that new production methods and analytical tools for monitoring them are continuously developed. When such methods and analytical tools shall be used in patent applications for defining the invention, the inventor might consider the applied techniques “usual”. Patent examiners however, might not be aware of the very latest developments in that technical field. Then, the definitions used for describing the invention could easily be considered “unusual” and “unusual” definitions are not allowed in patent law.
Solutions for obtaining patents for biotechnological inventions
Good news for the biotechnological industry comes from the EPO’s highest legal authority (the Enlarged Board of Appeal). The Board has recently ruled that the exclusion of essentially biological processes does not preclude the grant of a patent claim directed to a plant obtained in such a process. This is contrary to some national patent laws in Europe. Accordingly, applicants who intend to obtain a patent for such plants in Europe should be aware that the best way of doing so is by filing their patent applications at the European Patent Office.
Further, according to the Board, the patentability exclusion does not extend to so called product-by-process patent claims. Such product-by-process claims are a way of indirectly defining a biotechnological invention, e.g. plants or plant materials defined by reference to their synthesis or production methods. Product-by-process claims must be carefully worded; however, they are a way out of the dilemma that an indirect product description in a patent is potentially not allowable, but would be factually necessary. The patent applicant should consider how to best phrase their patent claims in order to solve the problem in this manner.
With regard to how to define the invention in the patent claims, it is recommendable to try to describe and define the invention by parameters, production methods, and analytical methods that can reasonably be considered “usual”. Where this is not possible, referring to manuals or textbooks can be of help. This also holds true for references to frequently used ASTM/ISO standards, pharmacopoeias, and the like. The best way forward is a detailed description of the parameters, production methods, and analytical methods in the patent application itself and preferably in the patent claims.
When filing patent applications for biotechnological inventions, the inventor should make sure that the application is drafted and filed with a view to problems and solutions the application may face upon examination. When doing so, patents for biotechnological inventions may well be granted. So yes, biotechnology is patentable when done carefully.