Seagen’s patent lawsuit against Daiichi Sankyo is nearing resolution at the district court. In April of this year, Seagen convinced a Texas jury that Daiichi Sankyo’s breast cancer drug, Enhertu®, is infrining Seagen’s U.S. Patent No. 10,808,039. Daiichi Sankyo also failed to convince the jury that the ‘039 patent was invalid. As a result, the federal court in the Eastern District of Texas is scheduled to conduct a bench trial on what appears to be Daiichi Sankyo’s last defense before the Court enters judgment. On June 28, the court will conduct a bench trial (no jury) on the issue of prosecution laches. The trial is scheduled to commence at 1:00 pm and will last only three hours. Can Daiichi Sankyo avoid paying Seagen royalties?
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 MoreI previously blogged about the Exelixis patent dispute. The Cabometyx patent trial occurred last week (May 16). A recent note on Seeking Alpha indicates that comments from the court during the trial suggests that Exelixis may lose on the ‘776 patent, but win on the ‘473 patent. (I was one of two patent experts on the Truist call referenced in the note.) If that happens, will Exelixis still be able to secure freedom from generics through 2030 based upon the ‘439, ‘440 and ‘015 patents asserted in its second lawsuit?
Read MoreAs I previously blogged here and here, Moderna has been tagged with two patent-infringement lawsuits directed to its LNP technology for delivering its mRNA vaccine for Covid. Moderna has now lodged its first defense two each suit—and in each case, it’s the same. Moderna claims that both plaintiffs, including Arbutus/Genevant and Alnylam, have each sued the wrong party. Moderna contracted with the U.S. Government to provide the vaccine, and pursuant to that contract, Moderna claims that the Government agreed to bear the brunt of any residual patent liability. Will the Government have to pick up the tab for Moderna’s patent infringement?
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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 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.
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 MoreThe debate around whether patents are unnecessarily propping up drug prices has been simmering for years. A recent policy memo from the Hudson Institute has thoughtfully raised concerns about the data underlying this debate, and the memo made its way up to the U.S. Senate Judiciary Subcommittee on Intellectual Property. While the memo may have successfully poked holes in some of the data, it draws questionable conclusions regarding what those holes might mean. Unpacking this debate is therefore necessary to guide the correct policy on the intersection of patents and drug prices. Read the full article at IPWatchdog.
Read MoreModerna faces a new patent lawsuit related to its Covid vaccine. On March 17, Alnylam Pharmaceuticals commenced two separate patent lawsuits—one against Moderna and another against Pfizer. Both suits claim that the Covid manufacturers’ vaccines are infringing a patent owned by Alnylam. So what are Alnylam’s lawsuits all about?
Read MoreOn March 7, Moderna updated its patent-pledge with respect to enforcement of its IP rights for its Covid vaccine. In short, Moderna pledged that it will never enforce its patents against Covid vaccines manufactured within certain middle and low-income countries, but may enforce them against vaccines in other countries, such as the US. What are the take-aways from the pledge?
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 MoreElizabeth Holmes, the founder of Theranos, has been convicted of securities fraud. There are many lessons and take-aways from Holmes’ story and the verdict. For one thing, fake-it-till-you-make-it may now yield concrete consequences for failure. Yet, one overlooked lesson is that the Theranos downfall illustrates a failure of patent-literacy—particularly among investors. (This is, after all, a patent blog.)
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?
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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 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 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 MoreTrillium Therapeutics is a clinical stage immune-oncology company that focuses on cancer treatments, and in particular, treatments that inhibit CD47. Trillium is among a group of drug candidates exploring CD47 targeting agents that are attracting investment from Big Pharma. Pfizer recently announced a $25M investment in Trillium. In conjunction with developing its own two CD47-inhibitor candidates, Trillium is also building out its patent portfolio. On February 2, 2021, two additional U.S. patents issued to Trillium, including U.S. Patent Nos. 10,906,954 and 10,907,209. Will Trillium’s patents offer protection against brand competitors or eventual biosimilars?
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?
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