Tuesday Patent – A Future 101 Battle

The USPTO publishes the Official Gazette on Tuesdays, which is thus when all new patents issue.  Every Tuesday, I’ll highlight one or a few interesting patents with a focus on CPC A61K, the class where most pharmaceutical and cosmetic patents are found.

As promised, a patent for (yesterday), instead of last week.  This one belongs to Emory University and covers a method of treating a subset of bacterial infections.  Specifically, US Patent No. 9,572,864 uses galectin-4 (Gal-4) to treat blood group B positive E. coli infections.

Claim 1 is wonderfully simple, and notwithstanding issues that may arise if the law moves in certain directions, should be a model for claim drafting:

1. A method of treating blood group B positive (BGB+) Escherichia coli infections comprising

administering an effective amount of recombinant human Gal-4 or Gal-4 C-terminal domain peptide to a subject in need thereof.

The claim clearly tells the whole story.  The inventors discovered a utility for a class of compounds and used that discovery to invent an application of the compound: treating infections.  As a society, we should want scientists to make these kinds of discoveries and turn them into treatments we can buy at the pharmacy.

However, because Gal-4 is an innate, naturally occurring peptide, it is worth going through the Mayo-Alice test to see how a court could invalidate it.  Step 1: is the patent directed to a natural phenomenon?  It is important to remember that the claim must be evaluated as a whole in patent law.  Thus, the claim is directed to a method of treating E. coli infections = not a natural phenomenon.

Assuming for the sake of argument that the claim is directed to Gal-4, we move to step 2: is there an inventive something more beyond the natural phenomenon?  Again, the answer is clearly yes.  The product identified is being put to a use that was heretofore unknown.

Outside of the U.S., such method of treatment claims are not uniformly accepted as patentable subject matter.  There are those in the U.S. who advocate a similar result in the U.S., arguing that the compound (here, Gal-4) is naturally occurring, and thus using it to treat a patient is nothing more than “routine” activity (e.g., injecting).  That is, thankfully, not the current state of the law, and is not required by Ariosa v. Sequenom, but we should be concerned that the policy trend is towards less secure patents.  We must guard against these changes to protect a robust and well-functioning patent system.


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