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 MoreIn February 2023, United States Senator Elizabeth Warren penned a letter to Kathi Vidal, Director of the USPTO, asking what the Patent Office can do to blunt Merck’s use of patents to stall entry of lower-cost alternatives for Keytruda. Unfortunately for consumers, the answer may be, not that much.
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Exelixis is on the eve of trial against MSN over its prospective generic for Cabometyx. Yet, there are now two separate patent litigations between the companies related to Cabometyx. Exelixis succeeded in slowing down MSN’s entry by keeping the cases separate, but an MSN victor in the upcoming trial may increase the odds of an at-risk launch.
Read MoreI previously blogged (here and here) about the pending Hatch-Waxman lawsuit between Exelixis ($EXEL) and MSN Pharmaceuticals in connection with MSN’s prospective generic for Cabometyx®. The case has been barreling towards trial in May of this year, which would theoretically provide insight into how soon Cabometyx® may face generic competition. This trial date is important because the 30-month stay is scheduled to expire in November 2022. However, a current dispute over scheduling has called into doubt if the trial in May will proceed, and even if it does, if it will provide certainty on MSN’s entry.
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 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 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 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 MoreAmarin Pharmaceuticals ($AMRN) will be going to trial soon to protect Vascepa® against generic competition. Amarin has asserted 15 claims from six patents against ANDAs filed by Hikma, Dr. Reddy’s and Teva. What are the issues to be addressed at trial?
Read MoreThe American University Law Review recently published a very timely and compelling article on the intersection between the Hatch-Waxman Act and the BPCIA, on the one hand, and post-grant proceedings at the PATB, on the other. The article, which is titled, Ships in the Night: Resolving Administrative Conflict Between FDA- and Patent-Related Legislation, American Univ. Law Review [Vol. 68:1111], (hereinafter, “Garcia & Stroud”), is authored by Carlos A. Garcia, Patent Counsel, Eli Lilly & Company, and Jonathan Stroud, Chief IP Counsel, Unified Patents Inc. The article is a comprehensive and thorough overview of how petitions for inter partes review and other post-grant proceedings may be impacting efficient resolution of patent issues for generic drugs.
Read MoreExelixis ($EXEL) recently received a Paragraph IV certification against its drug, Cabometyx, which is indicated for kidney cancer and as a second-line treatment for liver cancer. The certification was sent by MSN Pharmaceuticals. A lawsuit is likely to be filed by Exelixis against MSN within 45 days of the Paragraph IV certification. How well-positioned is Exelixis to fight this generic challenge?
Read MoreHigh drug prices remain in the news. A recent precedential decision from the Federal Circuit shows that certain drug prices will stay high if drug companies can simply take a mandate from the FDA, which was not their idea, and file a patent on it, thereby cornering the market on all IP around that mandate. The case is Endo Pharmaceuticals Inc. v. Actavis, LLC, Case No. 2018-1054 (Fed. Cir. May 3, 2019).
Read MoreCorcept Therapeutics ($CORT) recently filed a new lawsuit against Teva ($TEVA) related to Teva’s proposed generic for Korlym®. The new suit asserts three new patents that were recently listed in the Orange Book. Are the three new patents a game-changer?
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 MoreOn January 10, counsel for Corcept ($CORT) filed a letter with the Court in the pending patent litigation against Teva ($TEVA) over its proposed generic for Korlym®. (See Dkt. 49). Within that letter, Corcept requested an extension of one week to respond to Teva’s Answer to the Amended Complaint. Corcept’s letter further stated that the “parties are currently discussing a potential agreement that would eliminate the need for Corcept to respond to Teva’s Answer . . . .” Is that potential “agreement” a resolution to the litigation?
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?
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