Tuesday, 27 May 2014

10 Points on Patent Applications Directed to SNPs (single nucleotide polymorphisms)

1. Some inventions concern the finding of SNPs being associated with a particular condition. A SNP represents a position in the DNA of an organism where there can be variation.  Within the population different people will have different variants. These variants can cause functional differences, and in some cases they can cause susceptibility to disease conditions.

2. SNPs can be the basis of diagnostic method or personalised medicine inventions.  The typing of the SNP can thus be used to diagnose susceptibility to a condition or to determine the responsiveness of a patient to a particular therapy. An example of patent claims of an SNP-based invention can found here.

3. The main claims will often be diagnostic claims directed to detecting the presence of the SNP in an individual in order to determine susceptibility to the condition.  However other independent claims may also be appropriate depending on the prior art situation and the specific manner in which the SNP acts.  See points 4 to 7 for the sorts of questions that should be asked when thinking about possible claims.

4. Are the SNP’s themselves novel? If so, should novel polynucleotides comprising them be claimed?  Should probes and primers capable of detecting the SNP’s be claimed?

5.  Do the SNP’s cause a change in the sequence of the protein that is expressed? If so, should the novel protein be claimed? Should an antibody specific to the new protein be claimed?

6.  Does the SNP link that gene or protein to the condition for the first time? If so should diagnosis by measuring the activity or level of the protein be claimed?  This could be done in the form of single claim that covers diagnosis either by detection of the SNP or by detection of the protein level or activity.

7.  Does the discovery suggest new therapies that could be claimed for treating the condition?  Does it suggest a new screening method for identifying drugs to treat the condition?

8.  If the invention has personalised therapy embodiments then these can generally be claimed in two ways:

- a claim directed to use of the diagnostic method to select a patient for a particular therapy, and then administering the therapy

- a claim covering giving therapy to a person with the  relevant SNPs.

Clearly the second claim is broader, but it raises more patentability issues, possibly even novelty if the therapy is already being given to a broad range of patients.

9. The types of claims which are possible will also depend on the data that is available.  Whether or not the data supports each claim should be carefully reviewed.  Some claims may require the generation of further data before they are fully supported and it may be more appropriate to pursue them via a later filing.

10.  Given the new Guidelines that have issued from the USPTO about implementing the Myriad and Mayo decisions thought should be given to claims which refer to specific reagents and typing methods (see our post here about the Guidelines).

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