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Walking away from Bruno? October 7, 2008

Posted by Brian Schar in Federal Circuit, General, Patent prosecution.

In Bruno Independent Living Aids, Inc. v. Acorn Mobility Services, Ltd., 394 F.3d 1348 (Fed. Cir. 2005), the Federal Circuit found that a 510(k) submission for a medical device was material prior art to a patent application filed for that medical device.  The rationale, in part, was that the 510(k) included a section entitled “Substantial Equivalence,” in which the filer stated that the medical device in question was “similar in design and function” to a competitor’s product.  However, this rationale ignored the fact that the FDA looks at “equivalence” at a much different way than does the Patent Office.

Happily, at least one panel of the Federal Circuit may finally understand that difference.  Last week, the Federal Circuit stated that “FDA equivalence is irrelevant to patent law because it involves fundamentally different inquiries.”  (Johns Hopkins University v. Datascope Corp., 2007-1530 (Fed. Cir. 2008, footnote 3)). This is certainly true, in that “substantial equivalence” in FDA parlance refers to a 50,000 foot view of the two products, and relates as much to efficacy as to structure, in my understanding.  For example, the FDA would consider the great majority of bare metal stents as “substantially equivalent” to one another.  But from a patent standpoint, there are literally thousands of stent patents dealing with improvements on and variations in bare metal stents, because “equivalence” from a prior art standpoint during examination is governed by 35 USC 102 and 103 and not by the sections of the US Code that govern the FDA. 

Footnote 3 is dicta, and fails to mention Bruno.  But that footnote is perhaps a harbinger of a decision to come in which Bruno may be overruled at least in part, or at least isolated and distinguished on its facts.  That would be good news indeed for medical device patent prosecution.


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