These are based on a talk given by Anthony Tridico at Finnegan on 8 May 2014.
- At the start of the talk Dr Tridico spoke of how in the new Guidelines the USPTO has gone further than expected in interpreting the Myriad and Mayo decisions and that an element of inventive step now seems to be part of determining eligibility. The Guidelines apply to all claim types and to all molecules (not just DNA and proteins) and so will have far reaching consequences.
- The Guidelines introduce a 3 step test an important part of which is to ask whether there is something ‘significantly different’ from the judicial exceptions (abstract idea, laws of nature, natural principles, natural phenomena and natural products).
- For natural products the important cases are Myriad, Chakrabarty and Funk Brothers.
- In order to determine what ‘significantly different’ means 12 factors are provided which need to be weighed up together. Words such as ‘synthetic’, ‘isolated’, ‘recombinant’, ‘cDNA’, ‘composition’, ‘primer’, ‘purified’ and ‘vector’ do not influence this determination. One of the factors is whether the claim recites elements which are well understood, conventional and routine. The Guidelines give examples of how they apply to natural products, combinations of natural products, processes and diagnostic claims.
- As an example the Guidelines show that a naturally occurring fruit juice would not be eligible matter. A new combination of the juice with a naturally occurring preservative would not be eligible matter, but the pasteurised juice would be. Clearly ‘pasteurisation’ is the man-made difference which is sufficient for patentability.
- A bacterium with a naturally occurring plasmid is not eligible matter and neither is a naturally occurring chemical. However a modified version of the chemical would be patentable as this would be a structural difference, particularly if it gave a functional difference. Giving a naturally occurring drug in a defined dosage regimen should also be patentable, but it might be difficult to get a claim to simply treating a condition with a naturally occurring drug.
- For combinations of natural products a mere ‘mixture’ or ‘aggregation’ is not enough. So gunpowder would not be patentable, but an alloy, having a different crystalline arrangement, would be. A bacterium with 2 stable energy generating plasmids that each provide separate hydrocarbon degradative pathways would be patentable because possession of the 2 plasmids represents a structural and functional difference. A pair of primers would not represent eligible matter.
- A method of identifying a mutation in a gene would not be eligible matter on its own, but performing this using a specified PCR reaction would be. Diagnosis using new specific antibody should be eligible matter.
- For a natural principle, exposing a patient to sunlight to change mood would not be eligible matter, but specifying placing the patient at a particular distance from a light source would be.
- It is clear that when drafting a patent application one should be mindful of mentioning non-routine modifications. One should careful saying what is routine, conventional, well understood or well known, and in claims one should avoid words like ‘analyse’, ‘compare’ and ‘determine’. Layers of claims should be provided, particularly until more guidance is available on what claims represent eligible matter. One should be prepared to take cases to appeal on eligibility issues, but in the meantime there will be a lot of uncertainty on biotech and diagnostics cases.
You may also be interested in the related articles 10 Points on US Patent Law Developments Focusing on Biotech and Top 10 Observations on Antibodies.