RNAi Litigation

Archive for March, 2012

Professor Brenda Bass claims to have invented siRNA according to complaints and memoranda filed in this lawsuit by the University of Utah.

[from Case 1:11-cv-10484-PBS Document 61 Filed 03/21/12]

Dr. Bass has been researching RNA biochemistry since graduate school in 1980-1985, where she worked with Dr. Thomas Cech, who received the Nobel Prize in 1989 for discovering RNA molecules that catalyze reactions. Her Ph.D. studies focused on such molecules that cleave (cut) and ligate (join) RNA. In her postdoctoral work from 1985-1989, she discovered enzymes that act on dsRNA, which began her study of dsRNA and laid the foundation for the inventions at issue here. In 1989, Dr. Bass was appointed Assistant Professor at the University of Utah, where she researched and analyzed dsRNA binding proteins, searching gene databases to identify genes that would produce proteins with dsRNA binding motifs.

Dr. Bass was appointed Associate Professor in 1995, a full Professor in 1999, and a Distinguished Professor in 2007. She has been awarded numerous honors, including: a Pew Scholars Award; a David and Lucile Packard Fellowship; a named Investigator at the Howard Hughes Medical Institute; and election to the American Academy of Arts & Sciences. She is an editorial board member of the journal RNA, and was an editorial board member of the journal Science from 2004-2007. She was a founding member of the RNA Society in 1993, has been committee chair and a board member, and was elected its president in 2007.

In searching gene databases, Dr. Bass identified a gene “K12H4.8” in a species of worm “C. elegans” that is now known to produce an enzyme of a type known as “RNase III,” colloquially known as “Dicer.” Unlike the Tuschl II named inventors, Dr. Bass knew that Dicer cleaves dsRNA into 21-23 nucleotide pieces. As early as 1993, Dr. Bass understood that Dicer cleaves longer strands of dsRNA into short dsRNA and makes staggered cuts that leave 3’ overhangs of about two nucleotides in length. She was the first to discover that the K12H4.8 gene plays a role in dsRNA metabolism, well before the RNAi phenomenon was demonstrated. Read the rest of this entry »

Transcript kindly provided by Lee Marzilli, Court Reporter

During the discussions in this hearing the settlement of the previous lawsuit is discussed in the context of this case.

APPEARANCES: (By Telephone)

STEVE W. BERMAN, ESQ. and MARK S. CARLSON, ESQ., Hagens Berman Sobol Shapiro, LLP, 1918 8th Avenue, Suite 3300, Seattle, Washington, 98101, for the Plaintiff (Univ. Utah).

DAVID I. GINDLER, ESQ., Irell & Manella, LLP, 1800 Avenue of the Stars, Suite 900, Los Angeles, California,90067, for the Defendants (Max-Planck, Whitehead, MIT, Umass, and Alnylam).

SCOTT McCONCHIE, ESQ., Griesinger, Tighe & Maffei, LLP,176 Federal Street, Boston, Massachusetts, 02110, for the Defendants.

PROCEEDINGS

THE CLERK: Court calls Civil Action 11-10484, University of Utah v. Max-Planck. Could counsel please identify themselves.

MR. BERMAN: Good afternoon, your Honor. This is Steve Berman and Mark Carlson of Hagens Berman for the University of Utah.

MR. GINDLER: Good afternoon, your Honor. This is David Gindler of Irell & Manella for all of the defendants.

MR. McCONCHIE: Good afternoon, your Honor. Scott McConchie from Griesinger, Tighe & Maffei in Boston, also on behalf of the defendants.

THE COURT (Judge Saris): All right, thank you. I wanted to hold this status conference, and let me first apologize. I’m on emergency duty, and an emergency matter came up, so I do apologize for this 20-minute delay. But give me a sense of where we are. We haven’t had a scheduling conference. Has everyone been served? What’s happening?

MR. BERMAN: This is Steve Berman, your Honor. Everyone has been served. Currently before the Court is a motion to dismiss the Second Amended Complaint. Our responsive brief is due on March 21, and there has been no schedule set in the case.

THE COURT: Right, and so what happens often is, when a motion to dismiss is filed, we wait till the argument on that, but that could be forever at this point. So what I wanted to do was figure out what we should be doing. Do you all agree that we shouldn’t be doing discovery in the interim, or do you think it should be ongoing?

MR. BERMAN: We haven’t discussed it, your Honor, but I think that from the plaintiff’s perspective, since so much of the discovery was already done in effect in the case that you are familiar with, you know, we could wait until you rule on the motion. I don’t think there’s going to be a very lengthy discovery period needed in this case.

MR. GINDLER: Your Honor, this is David Gindler for the defendants. So we would agree that it would not be appropriate to take discovery at this time. We have a different reason, which is, one of our motions to dismiss – we have two - addresses whether the Court has jurisdiction over this case, and for that reason, we’re not sure it’s appropriate to move forward with discovery -

THE COURT: Why wouldn’t I have jurisdiction, no diversity or -

MR. GINDLER: Your Honor, this case - over - well, let me just explain.

THE COURT: It’s asking to rename the patent as far as one of the kinds of relief was. Isn’t that a federal cause of action?

MR. GINDLER: Well, it is, but let me explain. The plaintiff in the case is the University of Utah. When the case was first filed, one of the defendants was the University of Massachusetts. The University of Utah is an instrumentality of the State of Utah. The University of Massachusetts is an instrumentality of the Commonwealth of Massachusetts. There is only one court in the United States that has jurisdiction of a lawsuit between two states, and that is the United States Supreme Court. It is the original and exclusive jurisdiction of the Supreme Court that can handle a case from one state against the other.

When the complaint was first filed, we filed a motion to dismiss on that ground, that the Court did not have jurisdiction. In response to that, what the plaintiff did is dismissed the University of Massachusetts from the case, and in its place named a number of University of Massachusetts officials and sued them in their official capacities on the theory that that would eliminate the jurisdictional issue. In the motion that we filed, we explain that it does not. There is an exception to sovereign immunity, which is called the Ex Parte Young Doctrine, that allows you to sue individuals acting in their official capacity but only to enjoin essentially future illegal activity. This is an action based upon something that was allegedly done wrong in the past to correct inventorship of a patent, so no claim can be stated against those individuals acting in their official capacity. Not having the University of Massachusetts in the case is a problem because they are an indispensable party. They are one of the owners of the two patents at issue.

THE COURT: Well, can I ask you just as a practical matter - this was such a mess the first time around, it was so complex and took so much effort - you think the Supreme Court is going to try it?

MR. GINDLER: Your Honor, I don’t think there’s really an issue as to whether the case can be brought. In other words -

THE COURT: Well, what happens? Just tell me practically speaking what happens. Let’s assume I agree with you. What happens?

MR. GINDLER: What practically happens, your Honor, is that the Supreme Court actually doesn’t sit down and hear cases in their original jurisdiction. They appoint a special master. That’s essentially what happens. So there have been a number of cases state against state, and people don’t go to Washington -

THE COURT: Well, why wouldn’t I stay the case against the UMass officials - let’s assume you’re right — try the rest of it, and then whatever is left essentially send to the Supreme Court?

MR. GINDLER: Because you can’t try the case without the University of Massachusetts in the case.

THE COURT: Well, I’m not dismissing them.

MR. GINDLER: We have not included the University of Massachusetts in the case because that creates the jurisdictional problem. And UMass is an indispensable party because they’re one of the co-owners of the patent. You can’t have a litigation without a co-owner of the patent.

THE COURT: Well, I agree with that, and so but - excuse me, can I just say, I’m not saying to dismiss them.

MR. GINDLER: I’m sorry.

THE COURT: I’m not saying dismiss them. I’m saying litigate as much as you can with respect to the rest of it, and then leave the -

MR. GINDLER: Your Honor, I think that what the case law says is that if the University of Massachusetts is joined as a defendant, that it’s not appropriate to try part of the case in the District Court and then part of the case in the U.S. Supreme Court. The whole thing goes to the original jurisdiction of the U.S. Supreme Court.

THE COURT: Well, that’s interesting. I can guarantee you I’ve never had one of these before.

MR. GINDLER: — previously filed.

THE COURT: Excuse me?

MR. GINDLER: Sorry?

THE COURT: I can guarantee you I’ve never had one of these before. So your view is that — it would just be lovely to watch the nine Justices walking their way through what I did for the last few years, but you think there’s no out here?

MR. GINDLER: Well, your Honor, the one thing I can tell you is that if the case goes to the original jurisdiction of the Supreme Court, what the Supreme Court does is, they appoint a special master to hear the case. The Supreme Court is not actually going to have a trial where the nine Justices are going to listen about RNA interference.

THE COURT: Just it would be a glorious sight. Let me ask you this, Mr. Berman: What do you think here on the merits?

MR. BERMAN: Well, your Honor, we think that you do have jurisdiction. There is a case that we think is on point that we will cite to you when we respond. It’s called Connecticut v. Cahill. It’s a Second Circuit case which endorsed the exact approach that we took here; namely, that we name the individuals who are responsible for making sure that our client, Dr. Bass, was listed as one of the inventors. And in a two-to-one opinion, they ruled that the case like this did not have to go to the Supreme Court, and there are other cases that we will cite that have followed this and have expanded on it saying that basically the Supreme Court doesn’t have original jurisdiction unless the dispute between states involves core sovereign interests. And this is a commercial dispute. It’s not over water rights, it’s not over so-called core sovereign interests; and in those situations the courts have accepted jurisdiction at the District Court level.

THE COURT: So would it make sense - well, let me ask you this: Let’s assume it’s a close question and it’s a difficult matter of law. Would I then certify it straight to the Supreme Court before we went through two years of litigation?

MR. BERMAN: Well, I assume that if you denied their motion, that the defendants would ask you to certify it somewhere. I’m not sure if it’s the Federal Circuit. I think it would be the Federal Circuit in the first instance.

THE COURT: It’s very interesting. Read the rest of this entry »