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 MoreTrillium Therapeutics is a clinical stage immune-oncology company that focuses on cancer treatments, and in particular, treatments that inhibit CD47. Trillium is among a group of drug candidates exploring CD47 targeting agents that are attracting investment from Big Pharma. Pfizer recently announced a $25M investment in Trillium. In conjunction with developing its own two CD47-inhibitor candidates, Trillium is also building out its patent portfolio. On February 2, 2021, two additional U.S. patents issued to Trillium, including U.S. Patent Nos. 10,906,954 and 10,907,209. Will Trillium’s patents offer protection against brand competitors or eventual biosimilars?
Read MoreThe long-running patent dispute between Amgen ($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 MoreIn an earlier post, we discussed the pending IPRs filed by Coherus Biosciences against Amgen’s two patents covering its Enbrel® protein (entanercept). Whereas our earlier post summarized Coherus’s argument for why the fusion protein claimed in Amgen’s ‘182 and ‘522 patents should be found obvious by the PTAB, this post will summarize Amgen’s preliminary response.
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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