Microspherix has been embroiled in a long-running patent suit against Merck and its spinoff Organon. The suit alleges that Organon’s drug, Nexplanon, is infringing multiple Microspherix patents. Nexplanon is a contraceptive implant that accounts for 10 percent of Organon’s sales. After several years, the suit is finally teeing up for trial in October 2023. Yet, Microspherix has recently tried to short-circuit the trial by asking the court to knock out one of Merck’s primary defenses in the case before trial. Will Microspherix’s ploy work?
Read MoreOne of the common refrains from the pro-patent drug chorus is that patents are necessary to protect and incentivize expensive research and development by pharmaceutical companies. While that may be true in some cases, there are examples where it is clearly not. One current example includes deuterated analogs for ruxolitinib. One company researched which deuterated analogs among thousands of possibilities might be useful, whereas a different company cornered the market on all deuterated analogs based upon two sentences in patent disclosure years ago. Guess who wins.
Read MoreOn April 28, Google published a policy statement on the need for specific patent reforms. The statement was published by Google’s General Counsel, Halimah DeLaine Prado, and titled, Reforming the patent system to support American innovation. The statement is a notable read given that it issued from one of the largest Big Tech companies. The statement identifies four concrete areas where patent reform is purportedly required. Behind its prescriptions lingers its agenda—namely, that patents should have no value at all.
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I previously blogged about the patent tussle between iRobot and SharkNinja when the dispute originally erupted in late 2019. At the time, the prevalent concern was that iRobot would secure a quick injunction against SharkNinja’s sales in advance of the critical holiday shopping season. More than two years on, what started as a single pre-emptive suit commenced by Shark Ninja has ballooned into a multi-front war over whether SharkNinja is infringing iRobot’s patents. This has involved multiple litigations filed in district court, scores of invalidity proceedings filed at the Patent Office, and an investigation commenced before the International Trade Commission. What is the status of this ongoing patent war?
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 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 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 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 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 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 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 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 MoreIn a recent district court decision from the District of Delaware, the court granted a preliminary injunction, and ordered the defendant to pull the accused products, even though, a few months earlier, a Final Written Decision by the PTAB in an inter partes review proceeding held all asserted claims of the patent-in-suit unpatentable. What was the court’s reasoning? And what are the implications?
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 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 MoreLast week, we wrote about milestones to watch for in Celgene’s ($CELG) Revlimid® patent landscape in 2019 that could potentially impact the Bristol Myers ($BMY) transaction. One data-point that investors were anticipating were institution decisions in three petitions for inter partes review (IPRs) filed by Dr. Reddy’s. This week, the PTAB denied institution of all three IPRs. How will those decisions read-through to the overall Revlimid® patent landscape?
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.
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