Partial win for Mylan as Fed Circuit cancels Boehringer patents
The US Court of Appeals for the Federal Circuit has rescued one Boehringer Ingelheim patent, covering a type 2 diabetes treatment, from invalidation but affirmed a New Jersey district court’s cancellation of two others.
In a decision issued yesterday, March 16, the Federal Circuit affirmed the US District Court for the District of New Jersey’s invalidation of two Boehringer patents for obviousness (numbers 9,173,859 and 8,673,927) but overruled the cancellation of a third (number 8,853,156).
The dispute arose when Boehringer sued Mylan Pharmaceuticals for infringing the three patents, which cover the treatment of type 2 diabetes with DPP-4 inhibitors such as linagliptin.
DPP-4 inhibitors block an enzyme that impedes the production of insulin and has been prescribed to type 2 diabetes patients who do not respond well to drugs such as metformin.
Mylan responded to the lawsuit by arguing that the three patents should be invalidated. The drug company said that the ‘156 patent was directed towards ineligible subject matter and the ‘859 and ‘927 patents were obvious.
The New Jersey court granted summary judgment in favour of Mylan on the ‘156 patent and ultimately granted the drugmaker’s request to cancel the other two patents after a bench trial.
The Federal Circuit today reaffirmed the district court’s decision to invalidate the ‘859 and ‘927 patents, on the grounds that a person of ordinary skill in the art would “have a reasonable expectation of arriving at the claimed 2.5mg and 5mg dosages” of the DPP-4 inhibitors through “routine experimentation”.
But the appeals court overruled the decision to invalidate the ‘156 patent for being directed to ineligible subject matter.
Mylan had successfully persuaded the district court that the patent covered the “abstract idea” of administering a DPP-IV inhibitor to type 2 diabetes patients for whom other treatments may not be appropriate.
But in today’s decision, the Federal Circuit said that the patent claims were “directed to a particular method of treatment” and were therefore patent-eligible.
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