Designing around patents with an immunotherapy case: a take-home message of a full court decision by the US Federal Circuit.

In TiVo Inc. V. EchoStar Corp case (2010), all judges of the US Court of Appeals for the Federal Circuit (CAFC) reemphasized that legitimate design around a competitor's patents is always encouraged as a route of innovation. The modified elements of the design-around must be evaluated against the asserted claim(s) to ensure that each limitation is met before concluding that the modification is not substantially different from the previously adjudged infringed product. Regarding the significance of the differences between the features adjudged as infringement and the modified characteristics of the newly designed products, CAFC stated that the determination may refer to the rule of obviousness. In this article, we present an immunotherapy case that shows how to overcome an obviousness rejection by showing an unexpected result. The new design using an anti-VEGF antibody-encoding sequence in vaccinia virus should significantly increase its therapeutic effect. Furthermore, the newly-designed virus would provide tumor-localized delivery of the antibody and enhance anti-tumor activity.