A number of companies have announced candidates for a COVID-19 vaccine, including Moderna Therapeutics ($MRNA), AstraZeneca ($AZN), Johnson & Johnson ($JNJ) and Novovax ($NVAX). We looked into the existing landscape of patents that cover many of the existing candidates.
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 MoreSee 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.”
Read MoreMorphosys’ ($MOR) patent trial against Janssen ($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?
Read MoreEarlier 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?
Read MoreThe 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?
Read MoreIn 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?
Read MoreWe previously blogged about Pfizer’s ($PFE) antitrust lawsuit against Johnson & Johnson ($JNJ) related to Janssen’s Remicade®. In short, Pfizer launched Inflectra® in 2016, which is a biosimilar to Janssen’s Remicade®. Yet, Inflectra® has struggled to eat into Janssen’s monopoly for Remicade®. Pfizer claims that Inflectra®’s poor sales are due to anticompetitive rebate schemes by Janssen. Specifically, Janssen forced hospitals and insurers to enter exclusive arrangements and bundled-rebated programs that discouraged them from stocking or covering Inflectra®. Pfizer sued Janssen in the Eastern District of Pennsylvania. Janssen moved to dismiss, but on August 10, the Court denied Janssen’s motion to dismiss. What are the takeaways?
Read MoreFDA’s Commissioner Scott Gottlieb said today that a “rigged” system between drug firms and insurers is stifling entry for less-expensive biosimilars. Gottlieb stated that certain payment arrangements “raise another, perhaps even more insidious barrier to biosimilars taking root in the U.S., and gaining appropriate market share.” Is J&J’s exclusionary contract scheme to discourage competition with Pfizer’s biosimilar for Remicade® a poster child for what Gottlieb is lamenting? Pfizer recently sued Janssen over that very question, and the federal court is scheduled to decide a motion answering that question very shortly.
Read MoreThe biosimilar statute, Biologics Price Competition and Innovation Act (BPCIA, was passed in 2010. Since then, drug companies have been filing biosimilar applications with FDA. And even though, FDA has approved only nine biosimilar drugs today, an interesting trend may be emerging: biosimilars may be more willing to launch at-risk than small-molecule generics.
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