I have blogged about the Amgen v. Sanofi case several times, and the case has been summarized in my prior posts andelsewhere. The case pitted two competing PCSK9-inhibitors against one another, and after several years, resulted in cancelling broad patents covering the new class of antibodies. Whenever there is any case that cancels patents within the pharmaceutical or biotech space, the common knee-jerk retort from some commentators is that the decision will suppress innovation, chill R&D and discourage any investment in life-saving medicine. In this case, the opposite is true.
Read MoreThe Supreme Court has denied the recent bid to fix Alice and Section 101 jurisprudence. In two cases that each petitioned for certiorari, Tropp v. Travel Sentry, Inc. and Interactive Wearables, LLC v. Polar Electric Oy, the Federal Circuit affirmed district court decisions holding the asserted patents directed to ineligible subject matter. The Supreme Court’s denial is particularly acute since the Solicitor General recommended that cert be granted. And it is more painful given that this denial follows another recent instance where the Solicitor General also recommended that the Supreme Court take up Alice. Once again, the patent community mourns another lost chance to clear up the mess that has become Alice. But let’s face it—will the Supreme Court ever save us from Alice? . . . The answer is, probably not.
Read MoreCorcept Therapeutics has been battling for years to halt Teva’s generic for Korlym®. Although Corcept started off with only two patents, it has been adding patents to the Orange Book ever since Teva’s ANDA was filed. By periodically litigating those patents in piecemeal fashion, Corcept has delayed generic Korlym®’s availability to consumers at lower-cost prices. Yet, in a recent order, the court finally called out Corcept’s delay tactics and indicated it would award attorneys’ fees. What happened?
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 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.
Read MoreSenator Warran recently asked what the Patent Office can do about patent thickets. Yet, the courts are in the unique position of having to contend with scores of patents asserted within a single suit. When a brand pharmaceutical company shows up with 20, 60 or 100 patents in a single suit, those challenges can be exacerbated by orders of magnitude. So, how have courts face this challenge? Regeneron’s pending patent suit against Mylan over its prospective biosimilar for Eyelea® is an interesting example.
Read MoreOn August 26, Moderna issued a press release announcing it will be filing suit against Pfizer and BioNTech for patent infringement. Both Moderna and Pfizer/BioNTech sell Covid-19 vaccines that is based upon mRNA technology. Moderna is accusing Pfizer/BioNTech’s Covid-19 vaccine, Comrinaty®, of infringing Moderna’s patents covering certain features of Moderna’s mRNA technology. (At the time of publishing this post, Moderna’s complaint had not yet been filed. Once the complaint is filed, I will update the post.)
Read MoreDr. Stephen Thaler has done something that few have done in decades – made Philosophy professors suddenly relevant. He filed patent applications around the world that named an artificial-intelligence (AI) device as the inventor. The AI device is named “DABUS,” or Device for Autonomous Bootstrapping of Unified Sentience. Courts in the EU, US and UK have initially held that only humans can be inventors on patents, but South Africa and Australia have disagreed. The question of whether an AI device should be permitted to be a named inventor on a patent opens up a host of rich questions – including both policy and philosophical ones. What are some of the awkward implications of AI inventorship?
Read MoreSeagen’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.
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