The battle continues. We previously wrote about the Federal Circuit’s decision in the case (GlaxoSmithKline v. Teva) and how that case may offer Amarin another chance to bar generics from the market for Vascepa®. Sure enough, on November 30, Amarin filed suit against Hikma asserting three patents covering use of EPA to treat cardiovascular events. What are the takeaways from this suit?
Read MoreJust when you think the Amarin saga to keep out generic competition is over, something else happens. In the latest development, the Federal Circuit issued a precedential decision in an unrelated case (GlaxoSmithKline v. Teva) that suggests that a generic could potentially be liable for inducing infringement of a patented indication, even though that indication has been carved out of the generic’s label. Will this decision benefit Amarin?
Read MoreAmarin’s appeal of the district court’s decision invalidating the Marine patents is now fully briefed. Amarin’s reply brief is strong, but does it tip the odds in favor of Amarin prevailing on the appeal?
Read MoreHikma and Dr. Reddy’s have filed their appellate brief defending Judge Du’s decision invalidating the Marine patents. What does it say?
Read MoreOn May 12, 2020, Amarin ($AMRN) filed its opening appeal brief in its appeal of the decision by the District of Nevada wherein the Honorable Miranda M. Du invalidated six patents that were asserted against prospective generics, Hikma and Dr. Reddy’s. What does the brief say?
Read MoreIn Amarin’s pending Hatch-Waxman Vascepa case against Dr. Reddy’s and Hikma, we see at least obstacles to settlement at this time before resolution of the appeal: money, entry and invalidity.
Read MoreWe have received several follow-up questions, both online and offline, regarding some of our earlier posts – especially on the topics of Kurabayashi and prospective settlement. This post will attempt to collect further thoughts on Kurabayashi. This post gets deeper into the weeds than most of our earlier posts, but it is in response to thoughtful questions and comments that investors clearly looking for areas of weakness in the district court’s opinion. We will follow up shortly on another post discussing dynamics of a potential settlement.
Read MoreThe post mortem of the district court’s decision invalidating Amarin’s ($AMRN) Marine patents continues. We received questions regarding a finding of fact related to the prior art reference, Kurabayashi. The Honorable Miranda M. Du from the District of Nevada found that Kurabayashi was not considered during prosecution of the patents and that Kurabayashi suggested that pure EPA would reduce Apo-B. Are these findings accurate? If not, are they a basis to reverse Judge Du’s decision on appeal?
Read MoreIn the wake of the Nevada district court’s opinion on March 30, which invalidated Amarin’s patents for the Marine indication, we have received questions regarding whether the court committed a procedural error that may justify a reversal on appeal. I mentioned this issue in a parenthetical in our earlier post, but will address this issue in greater depth in this post.
Read MoreAmarin ($AMRN) has lost its trial against Hikma and Dr. Reddy’s. On March 30, the Honorable Miranda M. Du from the United States District Court for the District of Nevada issued a bench order following a multi-day trial in January. Judge Du held that although Amarin had proven that the generics would induce infringement of the asserted patents by selling their prospective generic versions of Vacepa®, all of the patents were nonetheless invalid as obvious. As a result, Judge Du denied an injunction against Hikma and Dr. Reddy’s for selling generic versions of Vascepa®. What happens now?
Read MoreWe previously blogged about the upcoming litigation trial between Amarin Pharmaceuticals ($AMRN) and Dr. Reddy’s and Hikma, which are two prospective generics for Amarin’s Vascepa®. While that blog post provided a general overview of the issues to be litigated at the upcoming trial, there are numerous other issues and questions around the upcoming trial. This post will focus on how the REDUCE-IT trial may impact Amarin’s fight with the existing generics, if at all.
Read MoreAmarin Pharmaceuticals ($AMRN) will be going to trial soon to protect Vascepa® against generic competition. Amarin has asserted 15 claims from six patents against ANDAs filed by Hikma, Dr. Reddy’s and Teva. What are the issues to be addressed at trial?
Read MoreThe Federal Circuit has issued a precedential decision addressing whether a patent covering a given polymorph was invalid as obvious, Grunenthal GmbH v. Alkem Laboratories Ltd. Though the Court explained that it was not establishing a categorical rule that polymorph patents can never be obvious, the case nonetheless provides important guidelines for when a polymorph patents are likely to be invalid. For those following Revlimid®’s patent cases, the immediate question is—does the Grunenthal case have read-through to Celgene’s polymorph patents?
Read MoreWe previously blogged about Dr. Reddy’s IPRs filed against MDS patents covering Celgene’s Revlimid®. Those IPRs attracted considerable attention because they were, for better or worse, one of the few data-points within the Revlimid® patent skirmishes we are guaranteed to see before the Bristol transaction closes. The Lotus IPR attacking one of Celgene’s multiple myeloma patent is another datapoint. The PTAB’s decision on whether to institute the IPR is due March 18. How much does Lotus IPR really matter?
Read MoreSince announcing the pending acquisition of Celgene ($CELG) by Bristol Myers ($BMY), investors have focused upon the patent-cases involving Revlimid®. There are multiple cases and petitions for inter partes review (IPRs) at various stages of resolution. The key question among investors is whether there will be any key milestones in those cases--especially during 2019 before the Bristol acquisition closes—that will clarify exactly when any of the pending generics will enter. In this post, we identify three potential milestones to watch for from the Revlimid® patent landscape in 2019.
Read MoreCelgene ($CELG) has announced plans to be acquired by Bristol Meyers Squibb ($BMY). A settlement conference is scheduled in the Hatch-Waxman patent case between Celgene and Dr. Reddy’s on January 10, 2019. Now that Bristol Meyers is at the table, will the parties be able to reach a settlement that couldn’t be reached before?
Read MoreOn August 3, Dr. Reddy’s filed three petitions for inter partes review (IPR) against three patents owned by Celgene and listed in the Orange Book for Revlimid®. Does this indicate that Celgene and Dr. Reddy’s are close to a settlement? If not, what are the take-aways?
Read MoreIn a slightly new wrinkle in Celgene’s recent Revlimid® saga, Celgene ($CELG) has commenced another suit against Dr. Reddy’s ($RDY). (This is the third patent lawsuit connected to Dr. Reddy’s proposed generic for Revlimid®.) In the most recent suit, Celgene asserts five new patents (the ‘720, ‘977, ‘784, ‘866 and ‘531). The suit was commenced on April 13, 2018 in the federal court in New Jersey, where the other Revlimid® suits are currently pending. What’s this suit all about?
Read MoreYesterday, we blogged about why the Markman hearing was cancelled in Celgene’s Revlimid® patent case against Dr. Reddy’s. Some analysts suggested that this is a positive indication of a settlement approaching with Dr. Reddy’s and possibly with all generics. We weigh in.
Read MoreOn March 23, Celgene and Dr. Reddy’s informed the Court that they jointly have resolved the single pending claim construction dispute—namely, the construction of the word “crystalline” within the two asserted polymorph patents. What does this mean for the case?
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