Unexpected Results : CAFC Alert

Unexpected result for combination therapy using two known drugs

| July 24, 2013

Novo Nordisk A/S v. Caraco Phamaceutical Laboratories, Ltd.

June 18, 2013

Panel:  Newman, Dyk and Prost.  Opinion by Prost.  Dissent by Newman.


A patent claims a combination therapy using two drugs.  The patent was issued by overcoming prior art as an examiner recognized an unexpected result proved by an inventor’s declaration.  In the district court, defendant presented new evidence challenging the validity of the patent.   The evidence showed that one of the claimed drugs was well known to be used in the therapy, and another drug having similar mechanism as the other was also well known to be used in such combination therapy.  Relying on the evidence, the district court hold that the patent was obvious because the evidence created a strong prima facie case of obviousness, and it was so strong that the patentee’s evidence showing certain superior effects did not overcome the prima facie obviousness. The majority agreed with the district court holding.  Judge Newman dissented.



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Unexpected results, not disclosed in the specification, of a compound may overcome a prima facie case of obviousness

| April 2, 2012

Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc.

August 23, 2011

Panel:  Lourie, Plager and Dyk.  Opinion by Lourie.  Concurrence-in-part and dissent-in part by Dyk.


Today, we bring you the first in a series of three articles regarding an important case from last year.   This article discusses the following question:

Question:  Can evidence of unexpected results of a compound be used to overcome a prima facie case of obviousness, where the unexpected result is not disclosed in the specification as originally filed?

Answer: Yes.

Evidence of unexpected results to a property of a compound, where the unexpected result is not disclosed in the specification as originally filed, can be used to overcome a prima facie case of obviousness.

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