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Posts tagged Repatha
Will Amgen’s PCSK9 loss read-through to patents covering other biologics drugs?

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.

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Will Amgen win another injunction against Regeneron’s Praluent?

Amgen ($AMGN) is about to square off once again against Regeneron ($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? 

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For Amgen’s PCSK9 patent case, is there any read-through from Court’s summary judgment order to the trial?

On 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.

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What is the status of Amgen’s PCSK9 patent lawsuit against Regeneron?

Regeneron ($REGN) and Sanofi released positive topline results from their ODYSSEY clinical trial Praluent®.  In addition was the announcement that prices for Praluent® may be cut.  Investors who may have grown skeptical with the new PCSK9-inhibitor class may now be interested again, which may include the pending patent lawsuit between Amgen ($AMGN) and Regeneron.  What is happening in the case?

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Amgen asks the full Federal Circuit to reconsider its PCSK9 loss

Earlier 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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