Members of Congress want answers about a multinational drug company's deal to save its patents by handing them off to a Native American tribe.
Last month, Allergan gave the St. Regis Mohawk Tribe six patents that protect Restasis, the company's blockbuster eye drug. The goal is a sophisticated legal strategy to avoid having the US Patent Office proceed with a process called inter partes review, which is a kind of quasi-litigation in which opponents of a patent can try to have them revoked. Lawyers for Allergan are hoping that the principle of sovereign immunity, in which Native American tribes are treated as sovereign nations in certain ways, will protect their patents from government review.
The strategy may well succeed. IPR proceedings against patents held by public universities have been canceled on at least two occasions, when the Patent Trial and Appeals Board held that the universities benefit from sovereign immunity because they are state actors. The St. Regis Mohawk tribe will be paid an annual royalty of $15 million as long as the patents are valid.
The move is a legal maneuver to avoid challenges to their patent.
takyon: Allergan.
Previously: Allergan Pulls a Fast One
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Dr. Lowe has scary patent news. Allergan's patent on Restasis is being questioned in court.
Last December, the US Patent Office granted an inter partes review of the relevant patents, a decision that did not go down well with Allergan or its investors. That form of patent review has been around since 2011 and the America Invents Act, and its purpose is specifically for prior art objections to a granted patent.
Looks bad for Allergan, but then they got sneaky. They transferred the patent rights to St. Regis Mohawk Indian Nation. Why? The Indian Nation is a sovereign nation, and our patent laws don't apply to them.
Scary stuff.
A U.S. Senator is seeking to close the patent loophole used by the pharmaceutical company Allergan:
Allergan's move to stop its patents from being reviewed by handing them off to a Native American tribe is winning support from few people outside the drug company. Now one lawmaker is seeking to ban it.
Sen. Claire McCaskill (D-Mo.) has introduced a bill (PDF) that would head off Allergan's strategy without waiting to see whether the judges at the Patent Trial and Appeals Board will even approve it. "This is one of the most brazen and absurd loopholes I've ever seen, and it should be illegal," McCaskill said last week in a statement to a pharmaceutical lobby group.
The Native American patent shelter, promoted by Allergan's outside law firm, seeks to avoid the process of "inter partes review," or IPR, for the patents protecting the blockbuster drug Restasis. The IPR process is a kind of quasi-litigation that takes place at the Patent Trial and Appeals Board for the sole purpose of determining whether a patent is valid or not. Now that the Restasis patents are owned by the St. Regis Mohawk tribe and licensed back to Allergan, the drug company's lawyers have asked for an impending IPR to be dismissed. The tribe argues that it's protected from IPRs by "sovereign immunity."
Previously: Allergan Pulls a Fast One
Congress Will Investigate Drug Company That Gave Its Patents to Mohawk Tribe
Court: Native American tribe can't be a "sovereign" shield during patent review
In a unanimous decision, an appellate court has resoundingly rejected the legal claim that sovereign immunity, as argued by a Native American tribe, can act as a shield for a patent review process. On July 20, the United States Court of Appeals for the Federal Circuit found in a 3-0 decision that the inter partes review (IPR) process is closer to an "agency enforcement action"—like a complaint brought by the Federal Trade Commission or the Federal Communications Commission—than a regular lawsuit. IPR is a process that allows anyone to challenge a patent's validity at the United States Patent and Trademark Office—it was used famously in 2017 to reject the "podcasting patent."
"This win is a victory in our ongoing efforts to stop patent abuses by brand companies and to help drive access to more affordable medicine," Mylan CEO Heather Bresch said in a statement on July 20. "Today's ruling reaffirms that Allergan's attempt to leverage the Saint Regis Mohawk Tribe for patent protection represents another inappropriate tactic to delay the availability of generic medicines for patients who need them."
This case, Saint Regis Mohawk Tribe, Allergan Inc. v. Mylan Pharmaceuticals et al, really began in September 2015. That was when Allergan, a pharma company, sued rival Mylan, claiming that Mylan's generics infringed on Allergan's dry eye treatment known as Restasis. Saint Regis Mohawk Tribe was initially filed in the Eastern District of Texas, known as a judicial region that is particularly friendly to entities that are often dubbed patent trolls.
Previously: Allergan Pulls a Fast One
Congress Will Investigate Drug Company That Gave Its Patents to Mohawk Tribe
Bill Introduced to Close Allergan's Native American "Sovereign Immunity" Patent Loophole
(Score: 5, Insightful) by bob_super on Thursday October 05 2017, @04:59PM
> Congress Will Investigate Drug Company
"Hey, nice trick you just used. People didn't like it, and I haven't seen my cut yet. It'd be a shame if any law was to happen to it"
(Score: 5, Insightful) by Hartree on Thursday October 05 2017, @05:00PM (1 child)
Given what I've seen happen when tribes try to hold up their sovereign status, this sounds like a good route to more restrictions on said sovereign status.
I remember when the Chief of the Pojoaque Pueblo threatened to erect a toll booth on a highway running through the Pueblo between Santa Fe and Los Alamos.
The double talk over what was and wasn't sovereign that flew was simply amazing to watch.
Even more so when the Chief of the Mescalero Apaches talked about opening a radioactive waste dump.
It seems that sovereignty is fine until it conflicts with self interest of the government or lobbying groups.
(Score: 2) by Runaway1956 on Thursday October 05 2017, @06:18PM
No matter how you look at it, in the final analysis, Allergan is just using the Mohawk. Few, if any, Mohawk will pocket any money. Their lives won't improve. They will get no respect from the white man. The Mohawk will remain outcasts on their own land, just as all Native Americans who have maintained tribal affiliations. If Allergan wins their bet, they pocket many millions, if not billions. If Allergan's strategy fails, they lose little to nothing.
Cynical bastards. They all need to die a fiery death.
IMO, the strategy will fail. They applied for a patent. The patent has not been awarded. They can't give away a patent that has never been awarded. They can't sell a patent that has never been awarded. Either the patent is invalid, or it is valid. Only the agency to which they originally applied can make that determination. Analogy with courts would be, you file suit against someone, the court seems to be siding with the defendant, so you move to have the trial moved elsewhere. I really don't think that's going to work.
(Score: 4, Insightful) by Anonymous Coward on Thursday October 05 2017, @05:04PM (13 children)
Yet another big business looking to skirt the law using complex loopholes. We the people, keep getting fucked five ways from friday by these sons of bitches yet somehow it's always the fault of Trump, Obama, liberals, conservatives, illegals, terrorists, or $BoogeyManOfTheDay. It's all about money and how much you can fuck everyone over for it. These SOB's are bribing both sides and lobbying like hell: https://www.followthemoney.org/entity-details?eid=9904 [followthemoney.org]
I sincerely hope that congress actually does something to curtail these lazy corporate cheaters.
(Score: 4, Insightful) by DannyB on Thursday October 05 2017, @05:21PM (10 children)
I find your lack of faith disturbing.
Congress will definitely do something about it. It might not result in any new laws. But you can bet that some how, some way, money will flow into the pockets of congress critters. If Allergan is making billions of dollars a year on this drug, congress is going to want its cut. Under the table is preferred so it is not taxable.
The lower I set my standards the more accomplishments I have.
(Score: 2) by meustrus on Thursday October 05 2017, @05:56PM (9 children)
Too bad there isn't a mod for -1 Cynical.
...mainly because politicians care about influence more than money. That kind of corruption is illegal and provable, but influence peddling is much harder to track.
If there isn't at least one reference or primary source, it's not +1 Informative. Maybe the underused +1 Interesting?
(Score: 4, Insightful) by bob_super on Thursday October 05 2017, @06:02PM (3 children)
> That kind of corruption is illegal and provable
Campaign contributions are unlimited.
Leftover campaign funds can be pocketed.
Drug companies are just exercising their First amendment rights, mmmkay?
(Score: 2) by meustrus on Thursday October 05 2017, @07:12PM (2 children)
But they already contribute to the campaign. Congress shaking them down is more likely to make them contribute less, not more.
If there isn't at least one reference or primary source, it's not +1 Informative. Maybe the underused +1 Interesting?
(Score: 4, Insightful) by bob_super on Thursday October 05 2017, @07:32PM (1 child)
Whoa! "Congress will investigate", is nowhere near "congress passed a law declaring the bastards will be punished for screwing everyone".
Companies which feel threatened by a Congress investigation, are Free to ... exercise their First Amendment right ... to encourage individual key Congress members to use their very precious time on more important policies in dire need of support. Contributing less does not help Congressmen pivot to these other issues.
(Score: 2) by meustrus on Friday October 06 2017, @03:09PM
It's a little too late for that now. An investigation isn't going to result in anything more than the media storm that's already happening (and potentially find other violations like the FDA found with the "how cute, love on the ingredients list" company). Clearly there are other, better-funded priorities to ignore.
If there isn't at least one reference or primary source, it's not +1 Informative. Maybe the underused +1 Interesting?
(Score: 4, Touché) by Anonymous Coward on Thursday October 05 2017, @06:15PM (4 children)
Shouldn't that be +1 Cynical?
(Score: 2) by bob_super on Thursday October 05 2017, @08:37PM (1 child)
I'm hoping they use at least 32-bit integers in the code, if we start being allowed to rate posts as "Cynical"...
Maybe-future-feature question (to TMB, as usual): What about listing all the mods a comment gets, rather than whatever fancy algorithm currently decides the sum of Funny+Insightful+Touche+troll to be? I've got a very wide browser window, so I wouldn't mind a long title showing all the types of mods some comments get.
(Score: 0) by Anonymous Coward on Thursday October 05 2017, @09:34PM
It would be nice, maybe a show/hide button. Clicking the comment ID to load a new page just to see moderation history is kinda lame.
@bob, I'm pretty sure the fancy algorithm is a complex combination of plus and minus. +5 interesting, that's a mighty big minus isn't it?
(Score: 3, Touché) by mhajicek on Thursday October 05 2017, @08:44PM (1 child)
+i Cynical.
The spacelike surfaces of time foliations can have a cusp at the surface of discontinuity. - P. Hajicek
(Score: 2) by LoRdTAW on Friday October 06 2017, @11:56AM
i=Cynical++;
(Score: 0) by Anonymous Coward on Thursday October 05 2017, @09:30PM (1 child)
Of course they won't, even if some other big players feel like this is bullshit they will support them because next it could be THEM on the chopping block. Sorta like the thin blue line.
I propose a new phrase, "The Thin Red Line" which symbolizes how corporations collude against the people. Red of course symbolizing corporate profits.
(Score: 2) by WalksOnDirt on Friday October 06 2017, @03:08PM
Red is commonly used only for corporate losses.
(Score: 5, Insightful) by bradley13 on Thursday October 05 2017, @05:11PM (7 children)
Since the tribe is an independent nation, they will make it impossible to contest the patent. But that doesn't matter, because there's no reason at all for the US to recognize patents registered in a foreign nation. Especially when that nation does not have any sort of actual patent office with a reasonable review process. Certainly, the tribe is not listed as a signatory [wikipedia.org] to international patent treaties.
tl;dr: I'd love to see the US say, so sorry, but your patent is no longer recognized.
Everyone is somebody else's weirdo.
(Score: 4, Informative) by NewNic on Thursday October 05 2017, @05:38PM (4 children)
The patents are not *registered* in a foreign nation, merely owned by a foreign nation.
The stupidity here is that the IPR process is unable to review patents that are owned by a state actor. Why is this? I can only imagine that this piece of idiocy was put into the law by some crafty lobbyist with the future use of this particular trick in mind.
lib·er·tar·i·an·ism ˌlibərˈterēənizəm/ noun: Magical thinking that useful idiots mistake for serious political theory
(Score: 3, Insightful) by RamiK on Thursday October 05 2017, @06:59PM
I'm guessing the thinking was that state actors wouldn't own patents in the first place seeing how patents weren't a tax system, a regulatory measure or even made with international treatises in mind. Richard Stallman made a similar mistake when the original GPL was put together without a patent disclaimer since they didn't believe in software patents.
The worst of it is that IP for American corporations is like crack cocaine. They can't get enough of it but it's slowly killing them as they become reliant on local regulatory protections and stop competing at the world stage. From automobile to Apple, eventually, they become parasites on the economy and the people as they block foreign competition while gouging prices until they collapse in one manner or the next.
compiling...
(Score: 0) by Anonymous Coward on Thursday October 05 2017, @07:02PM
This is exactly the problem. Ownership of a patent should be irrelevant to the process of reviewing or enforcing the patent. The US patent system is seriously broken.
(Score: 3, Insightful) by Arik on Friday October 06 2017, @03:32AM (1 child)
It's a nasty problem, clearly it's getting big enough profile congress will feel compelled to 'do something' and of course when that happens they normally do something stupid :(
Ultimately, the root problem has little to do with sovereign immunity, or with some tribe trying to make a little money by exploiting the legal system that's been imposed on them. It has to do with patents being issued for just about anything, with little to no meaningful review, by an office that's been encouraged to see its job as simply processing applications and issuing patents, under statutes written by and for the patent lawyers, under the assumption that patents themselves are valuable things, 'drivers of innovation' and the economy etc. and so the more of them we make the better.
If laughter is the best medicine, who are the best doctors?
(Score: 2) by NewNic on Friday October 06 2017, @05:38PM
Sovereign immunity works both ways. The US government can also invalidate a patent that is owned by another sovereign state.
But this really isn't a case of sovereign immunity. This is a case of the powers that the patent office has.
If a sovereign state owns a patent, it should be required to defend it.
lib·er·tar·i·an·ism ˌlibərˈterēənizəm/ noun: Magical thinking that useful idiots mistake for serious political theory
(Score: 0) by Anonymous Coward on Thursday October 05 2017, @06:33PM (1 child)
The "sovereign immunity" doesn't stop there. If you work at a casino or any other business on an Indian reservation you are not protected by any workers rights, including work comp or wage violations. Those fuckers will screw over everyone but themselves. They won't even honor doctors orders for light duty work for injured workers.
(Score: 0) by Anonymous Coward on Thursday October 05 2017, @11:18PM
Yeah, but screwing over little people is a far different thing than screwing over multinationals. If they had kept it at the worker-and-gambler level, they'd have been able to continue as long as they wanted. Now they've probably found a way to get their sovereign immunity reduced or outright revoked, because they're pissing off people with some real power over lawmaking.
(Score: 5, Insightful) by crafoo on Thursday October 05 2017, @05:22PM (2 children)
They patent office should declare the patents null and void. If the patents are protected from opponents of the patent through the means of this transfer, then the protections the patent grants should also be voided.
I have a simple test I like to invoke when considering the legal and tax tricks of large corporations: if an individual came into a court room and presented this strategy, would it work? Would the judge stand for such obvious and transparent manipulation? Then why should a corporation be allowed to do it?
(Score: 4, Informative) by TheLink on Thursday October 05 2017, @06:24PM (1 child)
Go figure ;).
(Score: 0) by Anonymous Coward on Thursday October 05 2017, @09:38PM
Its the circle of profits (corporate life)
Nants ingonyama bagithi Baba
Sithi uhm ingonyama
Nants ingonyama bagithi baba
Sithi uhhmm ingonyama
Ingonyama
Siyo Nqoba izinzuzo zakho
(Score: 2) by takyon on Thursday October 05 2017, @05:26PM
Previous story and wikipedia link added.
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 2, Interesting) by Anonymous Coward on Thursday October 05 2017, @05:54PM (2 children)
In order to use the courts, you have to submit to the courts.
If the tribe wants to use the courts to defend their patents, they should have to submit to the courts for a patent review.
They need to pick a plan.
(Score: 4, Interesting) by Phoenix666 on Thursday October 05 2017, @06:53PM (1 child)
They can have it both ways. As TheLink observed upthread, corporations nearly always do.
Washington DC delenda est.
(Score: 1, Insightful) by Anonymous Coward on Friday October 06 2017, @10:17AM
Corporations are the best known example of quantum superposition observable at macro scale.