EARLIER this week, Patterson Belknap Webb & Tyler LLP (more specifically, the firm's Andrew D. Cohen and Irena Royzman) published in a couple of lawyers' sites [1, 2] an article about a now-expired EPO patent, noting that it's about an Epogen (“EPO”) patent at EPO. To quote:
In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents protecting Epogen€®. Notably, the damages relate to product that Pfizer is not yet approved to sell in the United States. The jury found that Pfizer’s subsidiary Hospira, in manufacturing its proposed biosimilar ahead of FDA approval, was not protected by the statutory safe harbor covering pre-marketing regulatory uses (35 U.S.C. €§ 271(e)(1)).
The Court examined the EPO file history in detail. In the text of the original patent application, the claims extended to the entire class of antifolates. It was subsequently limited by the patentee to 'pemetrexed', and finally to 'pemetrexed disodium'. These changes to the claims were consistent with changes to the EP '508 description. The Court noted that these changes were a 'clear delineation of patent protection', for only pemetrexed disodium. Other compounds, such as pemetrexed diacid were therefore excluded from the scope of the EP '508 claims. Further, while Fresenius' product has the same therapeutic effect as Alimta, the association of pemetrexed disodium associated with tromethamine could not also be considered an obvious substitution of the expression pemetrexed disodium in combination with vitamin B12. Any form of direct infringement, including on the basis of equivalents was excluded. Further, there was no indirect infringement - the SmPC of the generic product indicated that reconstitution and dilution would happen in a glucose solution, rather than a saline solution as specified in the claims of EP '508.