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September 13, 2017

Comments

Thanks Kevin. Two points you didn't mention with regard to the specific transaction here: first, IPRs have already been instituted against the Allergan patents in question; and second, a 5-day trial on the patents in ANDA litigation concluded in EDTX on September 1.

Those points nicely illustrate the fact that in the context of OB-listed patents, potential infringers who file a paragraph IV certifications will still have their day in court and an opportunity to challenge patents before launching a product; with respect to such patents, the invocation of sovereign immunity, should it be recognized as applying here, will merely move the situation back to what it was pre-AIA.

I suppose that formally, transferring the ownership of *non*-OB patents, including the sorts of patents asserted by trolls, to a tribe also moves the clock back to pre-AIA days. But it seems to me that other developments, apart from IPRs, have made trolling a less lucrative business since 2011. Maybe I'm wrong, and we'll start to see a flood of non-OB patents being transferred to tribes, which would undermine the rationale behind IPRs. But like you, I wouldn't count on Congress to act so quickly to remove tribal sovereign immunity even if that does happen.

This is an obvious legal abuse and must be remedied, as it is a "loophole" path to rapid destruction of the patent system and particularly the drug industry. In this legal climate there is apparently nothing to prevent states, ever hungry for more revenue, from entering the drug business, filing ANDAs seeking to market, for example, the ten top selling patented drugs, with a paragraph 4 certification that the orange book claims will not be infringed because applicant is a sovereigns and is immune from suit.

The Allergan decision was made in the context of a Hatch Waxman "situation", I believe, in which Allergan had already sued an ANDA filer. So the big question coming up is whether or not a patent holder can avail themselves of the federal courts to sue a competitor and later (or even prior to suit) shift the ownership of the patent to a tribe to block an IPR petition.

Kevin correctly points out that any Tribal Federal immunity [versus Federal control of tribal commerce] is judicial, not Constitutional, and thus can be removed to any extent that it wants to by Congress. But did the AIA already do that by allowing IPR petitions to be filed by any “person” other than the patent owner itself against any patent owner? Also, parties to an IPR must disclose the real party in interest and its privies.

What does "judicial, not Constitutional" even mean?

Did some judge (common law or otherwise) drat up this notion of Indian nation sovereign immunity?

Can you provide the citation to that?

Thanks Dan for adding that - I presume we don't have a verdict in the ANDA litigation yet?

E.R.: just to be clear sovereign immunity hasn't applied for States under circumstances where the state owns a patent and enforces it. And here as Dan points out there has been ANDA litigation in this case. All that happened here is what has happened in other cases - applying sovereign immunity to preclude the patents being invalidated in an IPR. The Hatch-Waxman regime worked for 30 years before IPRs were created, to the extent that today 90% of drugs sold are generic. The system is working, and recall that there is a possibility (however remote) that the Supreme Court will invalidate IPRs in Oil States.

Thanks for the comment.

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