Hikma and Dr. Reddy’s have filed their appellate brief defending Judge Du’s decision invalidating the Marine patents. What does it say?
Read MoreWhen does a pile of sand become a heap? When is a portfolio of patents too many patents? Can using too many patents to compel generics to take a later entry date turn into monopolistic conduct? These questions lurk the heart of the antitrust litigation brought by buyers of the blockbuster drug, Humira®, against its manufacturer, AbbVie ($ABBV). The case is currently pending within the Northern District of Illinois (In Re: Humira (Adalimumab) Antitrust Litigation, No. 19-cv-1873 (N.D. Ill.)). We previously blogged about related allegations before the case was filed when Boehringer Ingelheim raised them within its biosimilar litigation against AbbVie. On June 8, 2020, the Illinois federal court dismissed the antitrust action pursuant to AbbVie’s motion to dismiss. What are the takeaways from the case?
Read MoreOn June 4, the Federal Circuit issued a precedential decision holding that § 285 under the Patent Statute is inapplicable for awarding attorneys’ fees to the prevailing party in a proceeding for inter partes review. The case is Amneal Pharmaceuticals, LLC v. Almirall, LLC, Case No. 2020-1106 (Fed. Cir. Jun. 4, 2020). While the Court’s decision dispenses rather cleanly with the possibility of collecting fees for prevailing in an IPR, the Court nonetheless left open the door to collecting fees if the IPR is intimately tied to a pending parallel district court case. How much does that matter?
Read MoreIn a precedential decision that issued on May 19, ESIP Series 2, LLC v. Puzhen Life USA, LLC, the Federal Circuit confirmed that the Supreme Court’s recent Click-to-Call decision precludes judicial review of decisions by the PTAB concerning real-parties-in-interest. recent Click-to-Call decision precludes judicial review of decisions by the PTAB concerning real-parties-in-interest.
Read MoreOn May 12, 2020, Amarin ($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 MoreThe PTAB’s decision in Apple, Inc. v. Fintiv, Inc., Case No. IPR2020-00019 (Paper No. 11) has been designated precedential as of May 5, 2020. The decision outlines the factors that the PTAB will consider when determining whether petitions should be denied under § 314(a) based upon a parallel district court litigation in which the same invalidity arguments have been raised. The case implicates the balance between patent owners and patent challengers, and who carries the heavier load.
Read MoreThe next great mobile video IP dispute has just kicked off, with starring roles assigned to some of Wall Street and Hollywood’s leading lights. Enjoy the show.
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 MoreThe United States Supreme Court has issued its ruling in Thryv, Inc. v. Click-To-Call Technologies, LP. The case is either surprising or unsurprising given your palette for the changing nature of patent rights. But one thing is certain—the stripping of appellate review for institution decisions deprives litigants of valuable jurisprudence that would otherwise make the IPR process more predictable and more efficient.
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 MoreUltimately, these parallel cases are critical for both Altria and BAT investors to monitor going forward. If the products at issue really have such commercial promise domestically, successful patent assertion by BAT could have a material impact on Altria’s profits going forward. The tobacco patent war of 2020 is under way…
Read MoreWhile investors can draw their own conclusions as to whether Kite’s strategy paid off (for itself, or for Gilead) even with the negative patent litigation results to date, it is clear that the appeal of this case is one to watch for both Gilead and BMS investors. With so much money at stake, as well as the risk that BMS will benefit going forward from YESCARTA® sales, this case illustrates the importance of IP due diligence in biopharma acquisitions, as well as the outsized value patents continue to command for true scientific advances.
Read MoreThe post mortem of the district court’s decision invalidating Amarin’s ($AMRN) Marine patents continues. We received questions regarding a finding of fact related to the prior art reference, Kurabayashi. The Honorable Miranda M. Du from the District of Nevada found that Kurabayashi was not considered during prosecution of the patents and that Kurabayashi suggested that pure EPA would reduce Apo-B. Are these findings accurate? If not, are they a basis to reverse Judge Du’s decision on appeal?
Read MoreIntel’s lawsuit takes aim at a new aspect of PAEs. That aspect is patent aggregation. Intel and Apple, two big-tech companies, are seeking a court ruling that would essentially hold that the very act of aggregating patents can give rise to antitrust violations. The implications of that could redound far beyond the alleged scourge of “patent trolls.” Indeed, the real targets of Intel’s lawsuit are not PAEs, but rather startups.
Read MoreIn the wake of the Nevada district court’s opinion on March 30, which invalidated Amarin’s patents for the Marine indication, we have received questions regarding whether the court committed a procedural error that may justify a reversal on appeal. I mentioned this issue in a parenthetical in our earlier post, but will address this issue in greater depth in this post.
Read MoreAmarin ($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 recently blogged about the pending appeal of an IPR that upheld the patentability of the ‘405 patent covering Gilenya®. If Novartis ($NVS) prevails in that appeal, then that could potentially secure another seven years of exclusivity for Gilenya® without generic competition. Novartis, however, has a back-up plan. The Patent Office recently granted Novartis an additional patent (U.S. Patent No. 10,543,179) covering Gilenya®, which will also not expire until December 2027. Novartis has already commenced Hatch-Waxman suits against numerous generics to enforce the ‘179 patent. How strong is this patent?
Read MoreNovartis’ ($NVS) blockbuster drug, Gilenya®, is facing an onslaught of prospective generic competition. In response, Novartis has wielded one of its patents – the ‘405 patent. The patent survived an IPR challenge, and that decision has been appealed to the Federal Circuit. The appeal is fully briefed and heard oral argument earlier this year in January. If Novartis prevails in the appeal, that means it could potentially exclude generics until the ‘405 patent expires in 2027. What is the likelihood Novartis will prevail?
Read MoreWe previously blogged about ViiV Healthcare’s ($GSK) patent lawsuit against Gilead ($GILD) when the case commenced in February 2018. In the case, ViiV alleges that Gilead’s Biktarvy® infringes ViiV’s ‘385 patent. The case is heading for trial in late 2020. Before that, however, Gilead has moved to dismiss the case outright before trial. Will Gilead succeed? Whether or not Gilead’s motion is granted, the issues outlined below will likely form the crux of the dispositive issues in dispute.
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.
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