The long-running patent dispute between Amgen ($AMGN) and Regeneron($REGN) and Sanofi over their competing PCSK9-inhibitors (Repatha® and Praluent®) has reached another milestone. The case also represents another milestone in the changing landscape for patents covering biologic drugs. The Amgen decision is at least the second district court decision this year that has invalidated biologic antibody patents under the doctrine of enablement. The earlier decision related to MorphoSys patents asserted against Janssen related to Darzalex®. The takeaway is clear: as biologic drugs take up a larger share of the pharmaceutical medications in the U.S., courts are making it harder for drug companies to use overly-broad patents to corner the market on a particular inhibitor.
Read MoreAnd just like that, it’s over. Boehringer Ingelheim has thrown in the towel in its patent fight with AbbVie over Boehringer’s proposed biosimliar for Humira®. Boehringer was a lone hold-out among a long line of proposed biosimilars for AbbVie’s blockbuster. Boehringer’s distinction was that it had raised a unique defense, namely, arguing that AbbVie had built an unfair “patent thicket” around Humira® that was unenforceable. We previously blogged about Boehringer’s “unclean hands” defense here and here and here. Now that Boehringer has settled, what are the larger lessons for future biosimilar patent fights?
Read MoreAmgen ($AMGN) is about to square off once again against Regeneron ($REGN) and Sanofi over whether Praluent® should be pulled from the market. Having prevailed at another jury trial earlier this year showing that Amgen’s PCSK9 protein patents are both valid and infringed, Amgen has renewed its bid for a court order enjoining Praluent® from the market. The injunction hearing is scheduled for June 2019. Over two years ago, Amgen prevailed after an earlier injunction hearing where the court ordered Praluent® to be barred from the market. Will Amgen be able to prevail again?
Read MoreOn January 18, the District Court in Delaware issued an opinion resolving multiple summary judgment motions filed by both parties. The key takeaway from that decision is that the case is now teed-up for trial beginning on February 19. But the Court didi highlight some key issues likely to be the focus of the trial.
Read MoreAmgen’s ($AMGN) patent fight against Regeneron ($REGN) and Sanofi has been quiet for much of this year. But it is likely to heat up again shortly. What is coming up?
Read MoreThe much-anticipated trial in the biosimilar litigation over Enbrel® has been pushed from April, to June and now to September. Although Amgen ($AMGN) has asserted five patents against Sandoz’s ($NVS) proposed biosimilar, Erelzi®, the focus of the case are the two Roche patents directed to the entanercept protein itself. And yet, a skirmish has erupted related to one of the three other patents, which collectively cover indications for using entanercept to treat psoriasis indications.
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