1 00:00:00,040 --> 00:00:02,800 Speaker 1: In a novel move, Allergan sold the patents to its 2 00:00:02,840 --> 00:00:07,200 Speaker 1: blockbuster Ristasis drug to the St Regius Mohawk Tribe, paying 3 00:00:07,200 --> 00:00:10,800 Speaker 1: the tribe three to thirteen point five million dollars up 4 00:00:10,800 --> 00:00:14,120 Speaker 1: front and fifteen million dollars a year in royalties for 5 00:00:14,200 --> 00:00:16,759 Speaker 1: the exclusive use of the patents that it once owned. 6 00:00:17,120 --> 00:00:19,800 Speaker 1: In a federal court case, the judge who is considering 7 00:00:19,800 --> 00:00:23,200 Speaker 1: whether to allow generic versions of the eye drug question 8 00:00:23,280 --> 00:00:25,920 Speaker 1: whether that sale is a sham that he should disregard. 9 00:00:26,360 --> 00:00:28,680 Speaker 1: The tribe has asked that the case be dismissed from 10 00:00:28,680 --> 00:00:32,440 Speaker 1: another venue, the Patent Review Board, citing its sovereign immunity 11 00:00:32,880 --> 00:00:36,600 Speaker 1: joining us as old griss Backer, the senior healthcare litigation 12 00:00:36,640 --> 00:00:41,240 Speaker 1: analyst for Bloomberg Intelligence. Oh, this is a complicated case 13 00:00:41,280 --> 00:00:44,880 Speaker 1: and seems to be getting more complicated every day. Explain 14 00:00:45,000 --> 00:00:49,120 Speaker 1: why Allergan made the deal? Yeah, thank you, June. So, 15 00:00:49,200 --> 00:00:52,279 Speaker 1: there are two key components to this, and one is 16 00:00:52,360 --> 00:00:55,720 Speaker 1: the interparties reviews that are actually going to come to 17 00:00:55,760 --> 00:00:57,840 Speaker 1: an end at the end of the year, and the 18 00:00:57,920 --> 00:01:01,160 Speaker 1: other is the district court case that's in the Eastern 19 00:01:01,200 --> 00:01:05,759 Speaker 1: Diustry of Texas. The reason, the main reason why Alegan 20 00:01:05,840 --> 00:01:08,880 Speaker 1: would have assigned these patents to tribes so that they 21 00:01:08,880 --> 00:01:13,480 Speaker 1: could dismiss the into party's review proceedings, where patents can 22 00:01:13,520 --> 00:01:17,280 Speaker 1: just be invalidated in a much faster pace and an 23 00:01:17,319 --> 00:01:22,319 Speaker 1: easier um way than in the courts. So how does 24 00:01:22,360 --> 00:01:25,400 Speaker 1: that work? I mean, it's it's the United States UM 25 00:01:25,560 --> 00:01:28,039 Speaker 1: Patent Office that it looks at them, right, And so 26 00:01:28,120 --> 00:01:30,840 Speaker 1: why would why would they be able to get out 27 00:01:30,840 --> 00:01:35,600 Speaker 1: of a that proceeding I guess claiming sovereign immunity, but 28 00:01:35,640 --> 00:01:39,119 Speaker 1: not the lawsuit. Well, they could get out of the lawsuit, 29 00:01:39,200 --> 00:01:42,120 Speaker 1: except that they're not the ones being sued. So you know, 30 00:01:42,200 --> 00:01:46,120 Speaker 1: in the lawsuit, Alagan is suing the generic drugmakers miland 31 00:01:46,200 --> 00:01:48,320 Speaker 1: have A, And so they don't want to get out 32 00:01:48,320 --> 00:01:51,440 Speaker 1: of that lawsuit because with that lawsuit, they're trying to 33 00:01:51,560 --> 00:01:56,880 Speaker 1: block the generic entry of any erostasist generics. So you know, 34 00:01:56,920 --> 00:01:59,840 Speaker 1: they can pick and choose where they actually claim so 35 00:02:00,000 --> 00:02:04,600 Speaker 1: own immunity. Has this been done before? Is this a 36 00:02:04,680 --> 00:02:07,920 Speaker 1: new thing or a different version of it? So we've 37 00:02:07,920 --> 00:02:11,320 Speaker 1: seen this recently in the interer partase review context. It's 38 00:02:11,360 --> 00:02:15,560 Speaker 1: not that old because these proceedings aren't um that old themselves. 39 00:02:16,240 --> 00:02:20,000 Speaker 1: So we've had a few cases now with state universities, 40 00:02:20,040 --> 00:02:24,160 Speaker 1: so states can also claim sovereign immunity. We've had three 41 00:02:24,200 --> 00:02:29,280 Speaker 1: cases um at the Patent office where twice the Patent 42 00:02:29,280 --> 00:02:34,239 Speaker 1: Office has dismissed the i prs be because of sovereign 43 00:02:34,240 --> 00:02:38,040 Speaker 1: immunity of the state universities once it hasn't. And the 44 00:02:38,240 --> 00:02:40,880 Speaker 1: you know, what they're looking at is really um whether 45 00:02:41,280 --> 00:02:46,000 Speaker 1: the licensee of these patents um whether they're more like 46 00:02:46,040 --> 00:02:48,880 Speaker 1: an owner or more like a passive licensee. So the 47 00:02:49,360 --> 00:02:52,959 Speaker 1: nature of the agreement matters. Well, explain how that would work, 48 00:02:52,960 --> 00:02:56,200 Speaker 1: how would they go about analyzing that kind of uh, 49 00:02:56,360 --> 00:02:59,840 Speaker 1: that kind of question, because that's going to be It 50 00:03:00,040 --> 00:03:02,600 Speaker 1: does seem kind of odd that you'd have a tribe 51 00:03:02,960 --> 00:03:08,200 Speaker 1: sort of taking ownership for only for litigation reasons. Essentially, Yeah, 52 00:03:08,200 --> 00:03:11,600 Speaker 1: that's right. So you know with the state university that 53 00:03:11,880 --> 00:03:15,560 Speaker 1: these universities are really just developing these drugs early on 54 00:03:16,000 --> 00:03:18,680 Speaker 1: and or you know, these technologies, and so they they're 55 00:03:18,680 --> 00:03:20,480 Speaker 1: the rightful owners. And then they go on in the 56 00:03:20,639 --> 00:03:24,240 Speaker 1: license two companies where in the case of Allergan, you 57 00:03:24,280 --> 00:03:27,920 Speaker 1: know this is really just assigning for the purpose of 58 00:03:27,960 --> 00:03:30,600 Speaker 1: being able to claim that's defense and have these i 59 00:03:30,680 --> 00:03:36,680 Speaker 1: prs dismissed, and so Circuit Judge William Bryson conducted a 60 00:03:36,720 --> 00:03:40,640 Speaker 1: non jury trial in a suit that were alegant file 61 00:03:40,760 --> 00:03:45,440 Speaker 1: to prevent Tavla and Milon from selling generic versions of Stasis, 62 00:03:45,520 --> 00:03:48,280 Speaker 1: and he says he needs to know whether the tribe 63 00:03:48,400 --> 00:03:51,560 Speaker 1: is joined as a co plaintiff. If they're not in 64 00:03:51,640 --> 00:03:55,600 Speaker 1: that lawsuit, what is the defense that's being used there 65 00:03:55,680 --> 00:04:00,040 Speaker 1: as to why it shouldn't be a generic Well, so, 66 00:04:00,040 --> 00:04:03,280 Speaker 1: so the judge needs to know whether the owners part 67 00:04:03,280 --> 00:04:05,160 Speaker 1: of a lawsuit, because that's one of the requirements to 68 00:04:05,200 --> 00:04:09,520 Speaker 1: being able to defend your your patent, which is really property. 69 00:04:09,680 --> 00:04:13,000 Speaker 1: And so the judge is really saying, if if your owners, 70 00:04:13,040 --> 00:04:15,000 Speaker 1: you need to be part of this lawsuit, otherwise you know, 71 00:04:15,080 --> 00:04:17,720 Speaker 1: this is not a legitimate lawsuit. But if you're if 72 00:04:17,760 --> 00:04:20,640 Speaker 1: this is just a sham or just you know, an 73 00:04:20,640 --> 00:04:24,159 Speaker 1: illusory kind of agreement, then that's fun. I can just rule. 74 00:04:24,680 --> 00:04:27,960 Speaker 1: So you know, we'll see whatever the judge decides there 75 00:04:27,960 --> 00:04:31,039 Speaker 1: will be interesting because if if he decides it's just 76 00:04:31,080 --> 00:04:33,760 Speaker 1: a sham agreement, you know, we'll have to see what 77 00:04:34,040 --> 00:04:37,000 Speaker 1: that means for the Patent office and how they decide 78 00:04:37,480 --> 00:04:39,760 Speaker 1: what to do with the these I pr s. So, 79 00:04:39,760 --> 00:04:41,800 Speaker 1: but what have they been for the whole week trial? 80 00:04:41,920 --> 00:04:44,320 Speaker 1: What's what has been the issue? Oh? So the issue 81 00:04:44,360 --> 00:04:46,360 Speaker 1: is all in these In these types of cases, it's 82 00:04:46,360 --> 00:04:50,360 Speaker 1: always the brand drug company suing the generic right and 83 00:04:50,440 --> 00:04:53,880 Speaker 1: so the um the way that these suits come about 84 00:04:53,960 --> 00:04:57,040 Speaker 1: is that the generics, very early on in the FDA process, 85 00:04:57,320 --> 00:05:00,160 Speaker 1: actually look at these patents that the brand ha us 86 00:05:00,200 --> 00:05:02,920 Speaker 1: and say is, you know, we don't infringe these patents 87 00:05:03,040 --> 00:05:06,240 Speaker 1: or these patents are invalid. And so the entire trial 88 00:05:06,480 --> 00:05:09,560 Speaker 1: is is really to decide that is, if a generically 89 00:05:09,600 --> 00:05:12,680 Speaker 1: came on the market, would it infringe patents or if 90 00:05:12,680 --> 00:05:15,440 Speaker 1: it does infringe patents with these pans actually just be invalid. 91 00:05:16,080 --> 00:05:18,920 Speaker 1: And it sounds like the judge is none too pleased 92 00:05:19,000 --> 00:05:23,000 Speaker 1: because there's been no appearance of the of the tribe 93 00:05:23,120 --> 00:05:25,719 Speaker 1: and that the trial is over. Yeah, I mean, this 94 00:05:25,880 --> 00:05:29,280 Speaker 1: is a really interesting timing because everything is already set 95 00:05:29,320 --> 00:05:31,120 Speaker 1: and down. Now he's going to wrap this up. But 96 00:05:31,200 --> 00:05:33,360 Speaker 1: what's interesting about Judge Bryson is that he's actually a 97 00:05:33,360 --> 00:05:36,400 Speaker 1: circuit judge. So he is a judge that sits on 98 00:05:36,440 --> 00:05:38,599 Speaker 1: the U. S. Court of Appeals to the Federal Circuit. 99 00:05:39,120 --> 00:05:41,320 Speaker 1: That's the court that really decides all patent matters, and 100 00:05:41,360 --> 00:05:44,760 Speaker 1: so he knows quite a lot about all of this already, 101 00:05:44,839 --> 00:05:47,479 Speaker 1: which is an interesting aspect of it. Well, it's a 102 00:05:47,480 --> 00:05:50,720 Speaker 1: really interesting case. I find it fascinating. Thanks so much 103 00:05:50,760 --> 00:05:53,599 Speaker 1: for being here. On Bloomberg Law, that's Ogre Spacker. She 104 00:05:53,839 --> 00:05:58,120 Speaker 1: is the senior health care litigation analyst for Bloomberg Intelligence.