Docket No. 2014-1377
LOURIE, DYK, REYNA
August 22, 2014
Brief Summary: DC conclusion of no infringement of amended ANDA after finding of infringement by original ANDA proper under Glaxo (FC 1997) (patent-holder must prove ANDA application “would likely sell an infringing composition”).
Summary: Ferring appealed DC dismissal of its claims that Apotex infringed its three patents by filing an ANDA related to tranexamic acid for treating heavy meunstral bleeding (menorrhagia; the product being Lysteda). The DC determined that Apotex’s amendment to its ANDA rendered it non-infringing. The claims require particular in-vitro dissolution rates (< about 40% at about 15 min, < about 70% at about 45 min, and not < about 50% by about 90 min) as measured “by a USP 27 Apparatus Type II Paddle Method”. Apotex’s ANDA only included the dissolution specification “at least 80 percent by weight of the active ingredient…would dissolve in 60 minutes.” In a Markman hearing, “about” was construed to mean “approximately” but both parties argued it should include a numerical range (e.g., within 10% of the 70% value). The DC concluded that Apotex’s ANDA could infringe under Sunovian (FC 2013) since it “was silent with respect to the weight percent”. Apotex then amended its ANDA “to include a restriction that not less than 75 percent by weight…was released at 45 minutes.” The DC concluded this restriction was outside the scope of the patents-in-suit and did not therefore infringe. The FC panel first explained that the decision regarding the original ANDA based on Sunovian was incorrect and that the proper analysis was under Glaxo (FC 1997) (patent-holder must prove ANDA application “would likely sell an infringing composition”). And the FC panel disagreed with Ferring regarding its proposal that 70% should include a range of +/- 10% (63-77%), finding that USP27 provides a 10% variance regarding the volume that may be used in testing but not the dissolution rate. It also found the DC “did not err in giving the term ‘about’ its ordinary meaning and in refusing to give it a more specific construction” (Merck, FC 2005) and that “the party with the burden of proof on infringement” by the amended ANDA (which “speaks directly to the question of infringement and would not permit Apotex to market an infringing product”) is Ferring. It also found no issue with the amendment of the ANDA after the finding of infringement citing Bayer AG (FC 2000) because “the statute does not refer to the date of the infringement determination” but “to the date the ANDA was filed” (as amended and at the discretion of the DC “guided by principles of fairness and prejudice to the patent-holder”). It was also concluded that Ferring was not prejudiced by the late amendment to the ANDA because it “did not request to reopen the record to submit additional evidence”.