Recent developments at the Federal Circuit and the USPTO may inform evolving patent strategy on medical technology. In one case, the Federal Circuit invalidated a patent relating to catheter insertion technology. In addition, the Patent Trial and Appeal Board (PTAB) considered subject matter eligibility of medical technology inventions in two decisions issued less than a year apart. In the first decision, the PTAB upheld the validity of claims involving medical device location. In the second decision, the PTAB affirmed a final rejection of claims involving heart failure stratification.

On Sale Bar and the Federal Circuit

In a decision that may have escaped due attention, the Federal Circuit provided another reason for medical technology companies not to delay patent application filings. One basis for early action has been legal consequences arising from preparations for marketing and sale of a medical device invention, including regulatory compliance. In this regard, medical technology companies should be familiar with patent validity issues that can arise for a medical device invention through, for example, an early 510(k) summary filed with the FDA or even a referenced predicate device. Recently, the Federal Circuit has provided a reminder that sales and marketing activities in other contexts also can bar patent rights on medical technology.

In Junker v. Medical Components, Inc., 2021-1649 (Fed. Cir. 2022), the Federal Circuit decided the issue of whether commercial activities relating to a medical device prior to the critical date invoked the on sale bar of pre-AIA 35 U.S.C. §102(b). In Junker, the inventor of the patent at issue created a new design for an peelable introducer sheath based on his experience with catheter insertion procedures. In particular, the inventor focused on the design for the handle of a peelable introducer sheath, which facilitated handling of the peelable introducer sheath during catheter-insertion procedures.