This holding has important implications for drafting patent claims.  It reinforces the need to draft combination claims that combine a novel ingredient or feature with other ingredients or features that may be included in a commercial product.  Although it is not necessarily the case in pharmaceutical patents, in mechanical patents, claims can often be drafted to cover a novel component as a stand-alone item and to cover a system or assembly including that novel component.  Both types of claims can be important. The claims directed to the novel component alone will be easier to enforce against someone who supplies only that component but not the other components with which it is ultimately combined.  On the other hand, the system or assembly claims can be readily asserted against someone who supplies the completed system or assembly, and will not trigger the application of the entire market value rule (at least as to all of the components in the system claims).  Thus, different claim strategies have different advantages and disadvantages depending on the particular target infringer in the supply chain. 

Another noteworthy feature of AstraZeneca concerns the evidentiary value of license agreements arising out of litigation.  In some cases, courts have held that licenses arising out of litigation have little bearing on the reasonable royalty analysis because they do not reflect the negotiation that would have occurred prior to infringement, which is the relevant time frame for purposes of the hypothetical negotiation used to assess reasonable royalty damages.  In AstraZeneca the infringer challenged the district court's reliance on licenses that AstraZeneca entered into with Andrx and Teva following litigation.  The Federal Circuit first noted that the litigation posture of such licenses may affect their relevance but that "there is no per se rule barring reference to settlements simply because they arise from litigation."  Slip Opinion at 18. 

However, the Court went further and said that the Andrx and Teva licenses were relevant because they were entered into following findings of infringement and validity.  As a result, the Court held that the "setting in which those events took place was . . . similar to the setting of a hypothetical negotiation in which infringement and patent validity are assumed."  Slip Opinion at 18.  This holding was particularly damaging for Apotex because Andrx had taken a license for between 50 and 70 percent of its profits, and Teva had settled its infringement action for 54 percent of its net sales.  Notably, the AstraZeneca Court cites the treatise Patent Damages Law and Practice, which states that "[l]licenses negotiated to settle a case after a court has established validity and infringement of the patent are very probative of reasonable royalty."  Slip Opinion at 19, citing J. Skenyon et al., Patent Damages Law and Practice ? 1:15 at 25 (2013 ed.)(emphasis added).