The Federal Circuit’s decision in Vanda Pharm. Inc. v West-Ward Pharm. Intl. Ltd. (2016-2707, 2016-2708 April 13, 2018) provided some good news on the subject matter eligibility front for innovators and other stakeholders in the personalized medicine space, as discussed in a previous post. So there is some hope for getting issued claims that will withstand a validity challenge under the Mayo/Alice framework. But what about enforcement? How does one prove infringement of claims that require various discreet steps that can, and typically are, performed by separate actors?
The Vanda Pharma decision had some encouraging news for innovators on the enforcement issue as well. A more detailed analysis can be found HERE but in brief, where at least a single act of direct infringement can be proven, a service provider such as an entity carrying out the method steps for performing the claimed diagnostic assay can be found liable for indirect infringement under an inducement theory where the product label is found to encourage or recommend a direct infringer, such as a doctor, to perform all of the claimed method steps. Importantly, not all of the claimed method steps need to be explicitly recited on the label. In Vanda Pharma, there was no label instruction satisfying the claim element of “obtaining a biological sample”. But the Court agreed with the finding below that the label implicitly recommends obtaining a biological sample, since a sample is required in order to perform the genotyping test.
This case illustrates the importance of ensuring that patent counsel are kept informed during the regulatory approval process of the product, preferably from the pre-investigational new drug (pre-IND) stage onward. Frequent communication between intellectual property and regulatory personnel will maximize the chances of obtaining strong patent protection.