Medical Device Manufacturer Not Liable for Inducing Customers’ Patent Infringement

The District of Minnesota recently found a medical device manufacturer did not indirectly infringe a competitor’s patents even though customers allegedly used the defendant’s accused product in an infringing manner, but did so in a way that differed from the product’s instructions for use.
In QXMedical, LLC v. Vascular Solutions, LLC, 408 F. Supp. 3d 996, 1012-1014 (D. Minn. 2019), the federal district court ruled that Roseville, Minnesota device manufacturer QXMedical was not liable for indirect infringement even though the company’s guide extension device was capable of use—and in fact was allegedly used by cardiologists—in a way that directly infringed, where the device’s instructions for use affirmatively told customers not to use the device in an infringing manner.
The case provides an example of how induced-infringement claims can be avoided where a medical device has both infringing and non-infringing uses, without changing the device itself, by changing the instructions to prescribe only legitimate, non-infringing uses.

Induced-Infringement Claims Failed Where Instructions for Use Instructed Users Not to Infringe.

Vascular Solutions accused QXMedical of infringing patent claims requiring insertion of a guide extension into a guide catheter not more than “one French” size—0.0131 inches—smaller than the diameter of the extension. To avoid infringement, QXMedical changed the instructions for use sold with its accused guide extension device, without changing the device itself, to prescribe use only with a guide catheter at least 0.014 inches larger, and outside the scope of the patents’ claims.
There was no medical reason for the change to the instructions. The accused guide extension was cleared for use with the FDA, and could be used, with commonly available, smaller-sized guide catheters in a manner that would otherwise infringe Vascular Solutions’ patents. However, many larger-sized guide catheters are available on the market for use with QXMedical’s guide extension in ways that legitimately avoided infringement of the one-French claims.
The court dismissed Vascular Solutions’ claim for direct infringement because QXMedical itself did not make or sell a one-French size smaller guide catheter required to complete the “system” or practice the “method” covered by the claims. Vascular Solutions alleged that QXMedical nonetheless indirectly infringed the one-French size claims by inducing doctors to perform cardiology procedures using QXMedical’s guide extension with available smaller-sized guide catheters in a way that directly infringed.