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.

See our post in IPWatchdog. “The case is important to the growing body of patents covering biologic drugs because it delineates more precisely when functionally-claimed antibody patents can survive enablement and written description challenges.”

Morphosys’ ($MOR) patent trial against Janssen ($JNJ) and Genmab was headed for trial in February.  In advance of that trial, however, the parties traded numerous summary judgment motions.  On January 26, Genmab announced that the District Court granted its motion to invalidate the asserted patents.  What happens next?

Earlier this week, we blogged about the series of pending summary judgment motions in MorphoSys’ ($MOR) lawsuit accusing Janssen’s ($JNJ) Darzalex® of infringing its patents.  The Court heard oral argument on December 3.  The transcript of that hearing is not currently publicly available.  The Court, however, did issue oral rulings at the end of the hearing that hit the docket on December 4.  What do the rulings mean?

The Darzalex® patent case commenced by MorphoSys against Janssen is headed towards trial.  Before that, however, the parties recently filed a series of summary judgment motions, and on December 3, 2018, the Court heard oral argument.  Will the Court moot the trial by granting Janssen’s motions to invalidate the patents?

In 2016, MorphoSys ($MOR) sued Janssen ($JNJ) and Genmab for patent infringement.  MorphoSys claims that Janssen’s anti-CD38 antibody, Darzalex®, infringes three of its patents.  The case is scheduled to go to trial in February 2019.  The stakes are big because the patents purport to cover the actual protein used in Darzalex®, which could mean material royalty rates on sales of Janssen’s drug.  What are the strengths and weaknesses of each party’s case?