With the Federal Circuit decision earlier this year in Eli Lilly v. Teva Parenteral, the reach of divided infringement into the life sciences left the realm of the hypothetical. Akamai v. Limelight and other prior cases about divided infringement involved software and the Internet, but the Lilly case involved a medical method of treatment. The case is also the first Federal Circuit decision to affirm a finding of divided infringement using the new standard for “direct or control” established by the en banc Federal Circuit in August 2015. Under that standard, an infringer can be found guilty of infringement, even if one did not perform all steps of a patented method. In addition to exerting control through traditional means, an infringer can now be held liable when one “conditions participation in an activity or receipt of a benefit upon performance of a step or steps of a patented method and establishes the manner or timing of that performance.” The relationship between doctor and patient is discussed in this context in the Lilly opinion.
Our panel, which includes an in-house patent counsel at a drug company and two patent prosecutors, will analyze Lilly, and extract principles that can be used to guide patent claim drafting in such fields as personalized medicine and companion diagnostics, measuring the efficacy of treatment through biomarkers, and methods involving pretreatment. The panelists will also consider the interplay of factors unique to the drug industry, such as the role of the FDA label.
