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 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 MoreNovartis’ ($NVS) blockbuster drug, Gilenya®, is facing an onslaught of prospective generic competition. In response, Novartis has wielded one of its patents – the ‘405 patent. The patent survived an IPR challenge, and that decision has been appealed to the Federal Circuit. The appeal is fully briefed and heard oral argument earlier this year in January. If Novartis prevails in the appeal, that means it could potentially exclude generics until the ‘405 patent expires in 2027. What is the likelihood Novartis will prevail?
Read MoreAbbVie ($ABBV) has commenced its latest litigation in its campaign to keep biosimilars for Humira® at bay. On August 10, AbbVie brought suit against Sandoz ($NVS) asserting that two of AbbVie’s patents will be infringed by Sandoz’s proposed biosimilar. Sandoz is the fifth biosimilar to throw its hat in the ring. Does this increase the odds of the US market seeing a biosimilar for Humira® before 2023?
Read MoreThe Federal Circuit recently issued a strong decision instructing the PTAB to rethink the way that it decides who is an RPI (real-party-in-interest). While the decision involved RPX, it presents a more existential threat to Unified Patents, which has risen as one of the most prolific non-party filers of IPRs. Can Unified survive the CAFC’s RPX decision?
Read MoreThe Federal Circuit has sided against the Tribe and Allergan. On July 20, the Federal Circuit affirmed the decision by the Patent Trial and Appeal Board that denied the motion by the St. Regis Mohawk Tribe to terminate a series of inter partes review proceedings commenced by Mylan ($MYL) against patents listed in the Orange Book for Allergan’s ($AGN) drug Restasis®. What are the takeaways from this decision?
Read MoreSenator Orrin Hatch (R-UT) recently proposed an amendment to the Hatch-Waxman Act that would significantly upset the availability of petitions for inter partes review (IPR) for generic pharmaceutical companies. Senator Hatch appears to believe that brand pharmaceutical companies deserve patents more than others.
Read MoreOn June 4, 2018, the Federal Circuit heard oral argument in Allergan’s effort to assert tribal immunity at the PTAB to shut down six IPRs against its Restasis® patents. The St. Regis Mohawk Tribe has appealed the PTAB’s prior decision that it cannot assert its immunity as a basis to terminate the IPRs. While there was no clear indication for how the three-judge panel at the Federal Circuit would rule, there were some interesting exchanges revealing how the Court views these types of transactions, and how viable they may be in the future.
Read MoreOur earlier post on VirnetX’s recent $502M jury verdict commended the company and its counsel on an incredible win, but nevertheless pointed out that it might be for naught. The patents asserted in the trial for the $502M damages currently stand invalid pursuant to petitions for inter pares re-examination and inter partes review. But what about Oil States? The case is currently pending before the Supreme Court, and it addresses the constitutionality of petitions for inter partes review (IPR). The case has already heard oral argument, and a decision is expected imminently. Some commentators have suggested that if the Supreme Court holds IPRs unconstitutional, then that will vacate the invalidity decisions of VirnetX’s patents from the PTAB, and nothing will finally stand in the way of VirnetX’s damages. What are the considerations that may keep alive VirnetX's prospect of collecting damages?
Read MoreThe PTAB has issued its much-anticipated decision on whether Allergan managed to pull off it’s scheme to avoid IPRs of its Restasis® patents by “selling” the patents to the St. Regis Mohawk Tribe. On February 23, 2018, the PTAB denied the Tribe’s motion to terminate the IPRs on the ground based on its tribal sovereign immunity. What were the PTAB’s reasons for denying the Tribe’s motion to terminate the IPRs? And what are the ramifications for similar deals in the future?
Read MoreSandoz recently prevailed in court against Amgen by showing it does not infringe a patent covering two of Amgen’s drugs, Neulasta® and Neupogen®. No biosimilar has yet to receive FDA approval for Neulasata® within the U.S. Sandoz recently announced successful Phase 1 data indicating it may be getting closer. Further, other biosimilars for Neulasta® are in the works. Given that Neulasta® accounts for a third of Amgen’s sales, will Amgen’s recent loss in its case against Sandoz read-through to other biosimilars?
Read MoreIn an earlier post, we discussed the pending IPRs filed by Coherus Biosciences against Amgen’s two patents covering its Enbrel® protein (entanercept). Whereas our earlier post summarized Coherus’s argument for why the fusion protein claimed in Amgen’s ‘182 and ‘522 patents should be found obvious by the PTAB, this post will summarize Amgen’s preliminary response.
Read MoreDupixent® is a recently-released drug forecasted to reach $4B in annual sales. The drug is a co-venture between Regeneron and Sanofi, which also teamed up to launch Praluent®, one of the two available drugs within the new class of PCSK9-inhibitors. In the case of Praluent®, Amgen brought Regeneron to court arguing that Praluent® infringed Amgen’s patents and thus the drug should be taken off the market. Once again, Amgen, Regeneron and Sanofi are back in court. Amgen has squared off against Regeneron and Sanofi and argued that Dupixent® infringes one of Amgen’s patents.
Read MoreAmgen’s Enbrel® blockbuster faces encroaching biosimilar competition from Sandoz and Coherus Biosciences. Coherus Biosciences has filed petitions for inter partes review against Amgen’s two protein patents covering Enbrel®, the ‘182 patent and the ‘522 patent. The institution decisions are due before the trial: March 15, 2018 for the ‘182 IPR, and March 13, 2018 for the ‘522 IPR. If the IPRs are instituted, that could shift the dynamics, and push the parties to agree on an entry date. What are Coherus's invalidity arguments?
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