I have blogged about the Amgen v. Sanofi case several times, and the case has been summarized in my prior posts andelsewhere. The case pitted two competing PCSK9-inhibitors against one another, and after several years, resulted in cancelling broad patents covering the new class of antibodies. Whenever there is any case that cancels patents within the pharmaceutical or biotech space, the common knee-jerk retort from some commentators is that the decision will suppress innovation, chill R&D and discourage any investment in life-saving medicine. In this case, the opposite is true.
Read MoreThe 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 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 MoreRegeneron ($REGN) and Sanofi released positive topline results from their ODYSSEY clinical trial Praluent®. In addition was the announcement that prices for Praluent® may be cut. Investors who may have grown skeptical with the new PCSK9-inhibitor class may now be interested again, which may include the pending patent lawsuit between Amgen ($AMGN) and Regeneron. What is happening in the case?
Read MoreDupixent® is a recently-released drug forecasted to reach $4B in annual sales. The drug is a co-venture between Regeneron and Sanofi, which also teamed up to launch Praluent®, one of the two available drugs within the new class of PCSK9-inhibitors. In the case of Praluent®, Amgen brought Regeneron to court arguing that Praluent® infringed Amgen’s patents and thus the drug should be taken off the market. Once again, Amgen, Regeneron and Sanofi are back in court. Amgen has squared off against Regeneron and Sanofi and argued that Dupixent® infringes one of Amgen’s patents.
Read MoreEarlier this year, in October, the Federal Circuit vacated Amgen’s hard-earned injunction against Praluent®, the only other PCSK9 drug competing with its own, Repatha®. The case has been remanded to the District Court of Delaware for a new trial on the validity of Amgen’s patents. Before that could happen, however, earlier this week Amgen petitioned the Federal Circuit for en banc review of its October 5, 2017 decision that cut against Amgen. What are Amgen's chances?
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