There are a variety of reasons why a new idea or a new finding (i.e. new data) might not be patentable. That could be technical (e.g. points 1 to 3 below), legal (e.g. point 4), policy (e.g. points 5, 6 and 8) or due to the definition of a legal fiction (e.g. point 7).
- Finding Out How a Known Invention Works
Often data that explains how something known in the art works will not lead to a patentable invention. For example if one discovers the mechanism of action of a known treatment it will only be patentable if suggests a new way of carrying out the treatment, for example in a new class of patients or by delivering in a particular way. One cannot draft a novel claim based on the new finding which covers carrying out the invention according to the prior art.
- Finding of a New Technical Effect in a Known Method
In Europe it is possible to claim a use based on a new technical effect even if the new effect was inherently occurring in the prior art. This was confirmed in decision G2/88 of the Enlarged Board of the EPO which suggested that ‘intention’ can be a limiting feature. However subsequent case law seems to suggest the claim must be drafted in a way where the prior art method is not covered, i.e. that the intention to make use of only the new technical effect is not enough to give novelty. It must be borne in mind that ‘Use’ claims are not available in certain territories, such as the US and India.
- Method of Treatment Claims in the US
In the US all inherent treatments that occur when a drug is given to a patient are seen as disclosed when a particular treatment is disclosed in the prior art. That is why the feature of giving the drug to a patient ‘in need thereof’ can be needed to give novelty for a treatment of a new condition with a known drug.
- Nature, Natural Laws, Natural Principles
In many territories substances which are found in nature can be patented as long as they are claimed in a way where their occurrence in nature would not be covered. Usually the feature of being ‘isolated’ is sufficient to do this. However the US is presently much stricter on this. According to the USPTO guidelines (see here) which issued after the Mayo and Myriad Supreme Court decisions any substance found in nature is not patentable. In addition claims relating to natural laws and principles are also not patentable. Thus diagnosis based on measuring the level of specific substance in a patient is potentially not patentable. The full impact of the guidelines is unclear but on the face of it they represent a major change in what is patentable in the lifesciences.
- Medical Uses
In certain territories the new medical uses of known substances are not patentable or subsequent medical uses might not be patentable. Thus there may be problems trying to patent certain medical inventions. However often the situation is unclear and the policy may change in the future. The Andean region, the GCC countries and India are places where the situation is unclear for medical use invention.
In addition Section 3(d) of the Indian patents act requires new forms of drugs to have enhanced efficacy before they are patentable, which is seen as a measure that prevents evergreening.
- In Vivo Diagnosis
In vivo diagnosis inventions are not patentable in Europe, China and India. However it may be possible to obtain protection for substances or devices used in such inventions. In addition it may be possible to obtain protection for devices that conduct analysis of in vivo parameters but do not lead to an immediate diagnosis.
- Medical Use Claims in Europe
In Europe medical use claims set up a legal fiction which allows medical inventions to be patented. However such claims only apply to substances, and therefore certain types of medical invention remain unpatentable, such as new uses of known medical devices. In addition it can be uncertain as to whether some multi-step medical inventions are patentable using this claim format, for example where the invention concerns a first step of selecting a patient and a second step of treatment.
- Software and Business Methods
In general many territories have some prohibitions on software and business methods. In the US the situation for computer-implemented methods remains unclear after the Alice decision (see here). However it is clear that patentability requirements are now stricter for such inventions. New ‘apps’ often raise complex patentability issues, but on the whole many will be seen as unpatentable software or business methods in many territories.