The 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 ($AMRN) and Dr. Reddy’s and Hikma, which are two prospective generics for Amarin’s Vascepa®. While that blog post provided a general overview of the issues to be litigated at the upcoming trial, there are numerous other issues and questions around the upcoming trial. This post will focus on how the REDUCE-IT trial may impact Amarin’s fight with the existing generics, if at all.
Read MoreSo why did the USA decide to put its (our?) patents at risk against Gilead? Moreover, why would the DOJ be willing to risk its existing license relationships for these HIV prevention treatments by attacking a sophisticated patent litigant like Gilead?
Read MoreWe previously blogged about Teva’s ($TEVA) petition for post-grant review (PGR) of Corcept Therapeutics’ ($CORT) ‘214 patent. Since then, on November 20, 2019, the PTAB granted institution of Teva’s petition. The proceeding will now be litigated for another year before a final decision. On a recent earnings call, Corcept stated that it believes the standard for institution is “pretty low,” and not necessarily dispositive that Teva will prevail. Now that we have the institution decision, what can we glean from it, and how likely is that Corcept’s patent survives?
Read MoreAmarin Pharmaceuticals ($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 MoreIntel recently sued Fortress for antitrust violations based upon its alleged monopolistic aggregation of patents. Intel’s allegations mirror those by Capital One against Intellectual Ventures, which were recently rejected by the Federal Circuit. Over the past several years, any patent assertion has had to contend with certain expected defenses: Alice, IPRs, threats of Octane Fitness. Are antitrust counterclaims the next trend?
Read MoreThe Federal Circuit’s current interpretation of a “sale” and “offers to sell” under 35 U.S.C. § 271(a) has permitted vendors that supply components for end products destined for the United States to directly market to and compete for a share of the U.S. market, but simultaneously avoid liability for patent infringement by offshoring all manufacture and delivery of their products. We recently published an article in Law360 discussing how downstream customers from these vendors are likely to bear the brunt of defending more patent suits given that traditional recourse to the customer suit exception or severance under Rule 21 may not be availing. Follow this link to the article.
Read MoreWe previously blogged about an ongoing patent fight between Moderna Therapeutics ($MRNA) and Arbutus Biopharma ($ABUS). That fight could implicate whether Moderna’s pipeline depends upon technology that is patented by Arbutus. Moderna has sought to invalidate three patents owned by Arbutus, and has so far met with mixed success. Who is winning this fight?
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?
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