In late September, Corcept Therapeutics finally went to trial against Teva in the parties’ long-running patent dispute over Teva’s prospective generic for Korlym. The Hatch-Waxman litigation between the two companies has been waging since 2018. Numerous patents have come in and out of the case over that time. Yet, by the time of the trial a few weeks ago, Corcept had narrowed its case down to alleging Teva’s infringement of only two patents: U.S. Patent No. 10,195,214 and 10,842,800. The parties’ post-trial brief have been filed. What do they say?
Read MoreAcadia Pharmaceutical has been litigating to keep out generics for its Parkinson’s Disease drug Nuplazid®. Although Acadia initially sued five separate generics for infringement of multiple patents, all the generics settled-out except one, MSN Pharmaceuticals. And in the case against MSN, only a single patent remains at issue (U.S. Patent No. 7,601,740). MSN recently moved for summary judgment on the ground that the ‘740 patent is invalid for obviousness-type double patenting (ODP). A recent precedential Federal Circuit decision, In Re: Cellect, LLC, addressed the ODP doctrine in detail. How will Cellect affect Acadia’s defense against the last generic holdout for Nuplazid®?
Read MoreBad facts make bad law. The case of GlaxoSmithKline’s lawsuit over Teva’s generic Coreg® drug is a case-in-point. I previously blogged about the case here and here. Given that the Supreme Court declined to grant certiorari, we’re now stuck with Federal Circuit precedent holding that a generic can still face liability for induced infringement of a method-of-use patent covering a section viii carved-out indication. What will be the consequences of this?
Read MoreI 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 MoreThe Supreme Court has denied the recent bid to fix Alice and Section 101 jurisprudence. In two cases that each petitioned for certiorari, Tropp v. Travel Sentry, Inc. and Interactive Wearables, LLC v. Polar Electric Oy, the Federal Circuit affirmed district court decisions holding the asserted patents directed to ineligible subject matter. The Supreme Court’s denial is particularly acute since the Solicitor General recommended that cert be granted. And it is more painful given that this denial follows another recent instance where the Solicitor General also recommended that the Supreme Court take up Alice. Once again, the patent community mourns another lost chance to clear up the mess that has become Alice. But let’s face it—will the Supreme Court ever save us from Alice? . . . The answer is, probably not.
Read MoreThere is the distinct possibility that Section 101 is finally returning to the Supreme Court. In American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, No. 20-891, the Supreme Court invited the Solicitor General for the views of the United States on the pending petition for certiorari. In response, Solicitor General recommended granting the petition, at least with respect to one of the questions. The SG’s brief underscores the consensus that Alice has spawned more uncertainty than predictability.
Read MoreWhere is the line between writing a letter that asks for licensing discussions, based on a reasonable assessment of existing infringement, versus one that triggers a DJ action where you are hauled into court in a foreign forum. A recent precedential decision from the Federal Circuit, Apple Inc. v. Zipit Wireless, Inc., addresses this question. While the law generally favors pre-suit settlement discussions that avoid litigation, the practical effects of the Zipit decision may inadvertently do the opposite.
Read MoreArbutus has finally sued Moderna for allegedly infringing its LNP patents. I previously blogged about the Arbutus/Moderna patent dispute here, here and here. Arbutus has already defended the validity of two of its patents, which puts it case on strong footing. But Moderna may nevertheless have a targeted non-infringement defense that could neutralize Arbutus’ claim to any royalties on Moderna’s Covid vaccine.
Read MoreI previously blogged about the surprising case, GlaxoKlineSmith v. Teva (GSK), where the Federal Circuit held that a generic pharmaceutical company can, under the right circumstances, be liable for inducing infringement of a method-of-use pharmaceutical patent despite carving out the patented indication from its label. The decision at first spooked the generic pharmaceutical industry, but was then followed by two additional opinions—one related to a panel rehearing, followed by another one, which issued on February 11, 2022, denying a hearing en banc, which included a fiery dissent. These decisions show clear disagreements among the Judges at the Federal Circuit. What is at the heart of this dispute?
Read MoreThe Federal Circuit issued its precedential decision within the dispute between the California Institute of Technology (“Caltech”) versus both Broadcom and Apple. (Case Nos. 2020-2222, 2021-1527 (Fed. Cir. Feb. 4, 2022)). The Court held that there is no categorical bar against considering domestic sales activities—apart from the locations of actual manufacturer, delivery and contract execution—in the course of determining the location of an accused “sale” under Sec. 271(a).
Read MoreThe 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 MoreOn November 5, 2020, the Federal Circuit issued a precedential decision, Vaeleant Pharmaceuticals v. Mylan Pharmaceuticals, that is likely to have a significant impact on the litigation of Hatch-Waxman cases—including the possible development of “generic-friendly” districts. In short, if this decision stands, the future of patent pharma litigation against multiple generics for the same drug will likely be spread out, difficult to consolidate, subject to multiple forums determining in parallel common issues related to infringement and invalidity. Costs for brands are likely to go up along with settlement leverage for generics. Although, exactly who wins and who loses from this decision remains to be seen.
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 MoreWe previously blogged about Moderna Therapeutics’ ($MRNA) ongoing patent dispute with Arbutus Biopharma ($ABUS). On July 23, 2020, Arbutus prevailed in Moderna’s third IPR challenge to one of its patents, the ‘069 patent. Given that Moderna’s COVID-19 vaccine candidate is currently one of the most promising, the question is, will Moderna’s vaccine infringe Arbutus’ patents?
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 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 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.
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