RNAi Litigation

Archive for November, 2010

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[from the transcript of the November 5th hearing]

THE COURT: … Now, before we get to the motion for PI (Preliminary Injunction), I want a trial date. It’s getting late, and I want a trial date. So –

MR. WARE (Lead Attorney for UMass): I propose late January, if it’s available.

MR. CHU (Lead Attorney for Max-Planck: So after your Honor announced your intent to discuss trial date, I was looking at my calendar with care. Up through the first many months of next year, my calendar is very busy, but I know that what I have in June, July, and August I can make work so that there are not irreconcilable conflicts. I looked for earlier periods of time. I have trial dates and other hard commitments. March 21 through April 1 — I’m assuming a two-week trial — I believe I can make work.

THE COURT: 9:00 to 1:00?

MR. CHU: If we talk fast, your Honor?

THE COURT: My life is a little bit up in the air too.

MR. CHU: Right, yes. We would try to make it work, your Honor, and it may be — it’s dependent upon exactly what issues are tried and not tried and a variety of other things. And I want to emphasize, I think none of us have had a chance to speak with our colleagues and witnesses, and as you know, particularly with Max-Planck — Read the rest of this entry »

[from the transcript of the November 5th hearing]

THE COURT: … And last but not least, are you pressing your motion for preliminary injunction?

MR. WARE (UMass Lead Attorney): Yes. So are we on the record?

THE COURT: Yes.

MR. WARE: And I could be pretty brief on that, your Honor, I think, but what we are faced with here is that Whitehead, and certainly out of understandable frustration, but Whitehead has sent a notice of termination of the agreements (UMass is not a party to the second 2003 agreement. JL), and they have informed us — they agreed to postpone any termination until after this hearing, and we’re grateful for that, but they wrote to both Max-Planck and UMass and said that absent the Court’s intervention, they would terminate at 6:00 p.m. tonight. And so we would ask the Court to preliminarily enjoin up through trial termination of the agreements because I think the Court recognizes the devastating impact that that would have. If there are no agreements and there’s no party that has responsibility for prosecuting, then these applications really are dead in the water, and the Commonwealth of Massachusetts will be the one that suffers.

THE COURT: Well, why can’t you renegotiate a contract once the rights are sort of worked out, either by settlement or with a jury or me or whoever?

MR. WARE: I think we’ve spent a year hearing that any resolution between the parties must include removal of the data from the patent and removal of the priority claim.

THE COURT: Sure, but that’s the key claim. I mean, I
21 can’t fix that problem. That’s whether the parties, what they agreed, whether that was part of the agreement or not. And there was that side agreement in whatever year it was, and that’s the issue.

MR. WARE: Well, this is what we have to try, and so my only proposition is that until those issues are tried – and now we have a trial date — let’s keep these agreements in place, because if the Court were to rule that Max-Planck is not permitted to demand that the information and the priority claim be removed, then it’s possible to cure what we have asserted as the breach. And the agreements did contemplate the opportunity for cure. Originally that cure period would have been during a period where the Court could have acted beforehand. And Whitehead earlier on in this case in January when they sent a notice of termination said at that time that they would not terminate until five days after the Court ruled on the merits on these issues, and so we’re just trying to keep these agreements in place.

Now, Whitehead says, “Well, we have a contractual right to terminate for breach because the breaches are uncured.” But we, I submit, the Commonwealth, has the right to seek equitable relief in the form of specific performance from the Court that would direct Max-Planck to conform to the agreement as we understand it. Read the rest of this entry »

[from the transcript of the November 5th hearing]

Judge Saris: The Goldstein petition.

MR. HEINRICH (Plaintiffs’ Lead Attorney): Right. So the Goldstein petition, they’ve counterclaimed against us for filing the Goldstein petition to remove conflicted counsel, Wolf Greenfield, from continuing to — to revoke the power of attorney.

THE COURT: Suppose I ruled for you on that one, but, coming into the third issue which is the motion for preliminary injunction, is it on the table that you’re not agreeing to anyone? (as a replacement for Wolf Greenfield & Sacks. JL)

MR. HEINRICH: No one has been proposed. They’re asking for carte blanche for us to simply give them a blank check, so to speak, a blank power of attorney.

THE COURT: Well, who would you agree to?

MR. HEINRICH: We haven’t had that discussion yet, your Honor.

THE COURT: Well, who? I mean, would you agree to anyone? Let’s say you took the fanciest-schmanciest patent lawyer that you could get, you know, utmost integrity, top ten patent — they’re probably all sitting in this room, but, you know, if you could find someone who wasn’t in this room, would you agree to the person?

MR. HEINRICH: Well, under certain conditions, but certainly not under the condition that they –

THE COURT: All right, so you’re not going to agree to anyone because you’re worried about the conflict of interest, right?

MR. HEINRICH: They asked us to declare that we would not be a client of the new counsel, and that’s certainly not something we can do because we have an ownership interest in Tuschl I –

THE COURT: I understand that. I understand that. But it is sort of ripe if you’re not going to agree to anyone unless they agree that Tuschl II is — to take out the material from Tuschl I. I mean, that’s essentially saying you’re going to veto it.

MR. HEINRICH: Well –

THE COURT: Right? I mean, there is an inherent conflict here right at this point.

MR. HEINRICH: I think that –

THE COURT: You’re not going to agree to anyone unless he agrees to your position, or she, right?

MR. HEINRICH: Right.

THE COURT: So, I mean, there is a conflict.

MR. HEINRICH: There’s certainly a conflict, and I think that –
THE COURT: You’re not going to agree to anyone, and –

MR. HEINRICH: No, no.

THE COURT: — I need this trial to clear this up because once the rights are resolved, then I can issue their injunction.

MR. HEINRICH: We certainly can’t agree to anyone if the condition is, we have to disclaim any attorney-client relationship with counsel that’s prosecuting patent applications that we’re co-owner of on our behalf. Read the rest of this entry »

[from the transcript of the November 5th hearing]

(Judge Saris): All right, your motion, your turn.

MR. HEINRICH (Plaintiffs’ Lead Attorney): Right. So since we have been talking about the priority claim, let’s go back to that. And the priority claim is a very key issue in this case. It goes to the core issues about the prosecution of Tuschl I. So this is the priority claim in Tuschl I to the ‘325 application. And, as your Honor knows, the Tuschl II patent examiner has been relying on that priority claim to the ‘325 to reject Tuschl II claims on obviousness-type double-patenting grounds. The patent examiner has determined or has stated that the Tuschl I claims are first defined — that’s the examiner’s term – first defined by the Tuschl II ‘325 application; and as a result of that priority claim in the Tuschl I to the Tuschl II ‘325, the examiner is saying, well, the Tuschl I claims and the Tuschl II claims are really the same invention because they’re both claiming priority to the same priority document.

THE COURT: Sure. That’s been the basis ever since I first saw Mr. Chu the week of July 4th a year — that’s the key issue.

MR. HEINRICH: Exactly, exactly. So here’s the problem. Well, there are a few problems with the priority claim. As a matter of law, we’ve raised one particular issue here. The priority claim was originally raised in the Tuschl I prosecution through four declarations from each of the four Tuschl I inventors, Zamore, Sharp, Bartel, and Tuschl. Dr. Tuschl subsequently withdrew his claim to priority to the ‘325. So the current stance in prosecution is that the priority claim is only supported by the declaration, the declarations of Sharp, Zamore, and Bartel. But there’s no dispute that none of those three individuals were entitled to claim priority to the ‘325.

THE COURT: But isn’t this properly raised before the Patent Office, as I’m sure you’ve done? I’m not going to overrule the Patent Office here. That’s wrong. You have a whole process you go up through, and it ends at the Federal Circuit.

MR. HEINRICH: The problem is that Whitehead has refused to withdraw these declarations –

THE COURT: Sure, because the Patent Office ruled its way.

MR. HEINRICH: No. Respectfully, that’s –

THE COURT: Well, what happened?

MR. HEINRICH: There has been no ruling on the validity of those declarations.

THE COURT: So raise it there.

MR. HEINRICH: There’s no process to raise it there. So the question is whether Whitehead has conducted its prosecution responsibilities with good faith by refusing to withdraw declarations that it’s unable to defend here because there’s –

THE COURT: When you say there’s no way to raise it, I’m assuming you’ve moved for reconsideration of the Patent Office’s ruling on the grounds that he withdrew the priority date and that the claim to priority is invalid. Didn’t you? Read the rest of this entry »

The arguments made in the two remaining motions will be posted today. JL

[from the transcript of the November 5th hearing]

MR. WARE (UMass Lead Attorney): Great. Thank you, your Honor. The UMass motion — and to be clear, the UMass motion would in fact eliminate all of the remaining claims against the University of Massachusetts. The University of Massachusetts does have counterclaims, however, so it would not remove UMass from the case.

The reason we filed this motion is because it became apparent that all of the claims that remained turned on contract interpretation and therefore were for the Court, and so it seemed appropriate as a matter of summary judgment to put the issue before the Court; and, secondly, because these claims are so separate from the core issues of patent prosecution,the issues that really need to be resolved, and in order to deal with, as your Honor has pointed out, both sets of patent applications are stalled, and the parties have filed continuation applications. But the Sirna claims are very separate. They were not part of the original complaint in this case. They were added in the amended complaint that was filed in January at a time when the plaintiffs were, from our perspective anyway, the plaintiffs were seeking to find a damages claim they could pursue to justify a jury demand. The other thing about these claims, and another reason why they’re so separate from the other issues in the case, is that they’re really all about activities and statements that Sirna made in the period 2003 to 2004, which Alnylam contested — that is to say, there was correspondence between Alnylam and Sirna — but it’s essentially about what Sirna was doing in the marketplace in that early period. There isn’t, I don’t think, any allegation of any activity that relates to these claims today.

THE COURT (Judge Saris): Was Sirna’s deposition taken?

MR. WARE: Two former employees of Sirna were deposed, yes.

THE COURT: So is it clear what they said? I was just trying to figure out what they actually said.

MR. WARE: About the contract, you mean?

THE COURT: Yes.

MR. WARE: They both said — this was the former president of Sirna and the former general counsel, I believe, or chief patent counsel, I guess it was. They both said that they understood this agreement to be an agreement about Tuschl I applications. No representations were made by University of Massachusetts about Tuschl II or anything else, and that was their understanding.

THE COURT: And they said they only said things about Tuschl I, the first patent?

MR. WARE: That’s what they understood this license was. So to the extent we get to extrinsic evidence at all, if we needed to get to extrinsic evidence –

THE COURT: No, but I’m just talking about — I understand your pure contract issue. I understand that, but there were also claims about misrepresentations with respect to what Sirna received. And what’s the evidence of that, that there were misrepresentations at all?

MR. WARE: And just to clarify what I think that claim is, essentially I believe the claim to be a claim that the license agreement itself misrepresented that University of Massachusetts had a right to license the ‘325 application to Sirna. I don’t think there’s any other claim for misrepresentation. There are some claims that –

THE COURT: Excuse me, not by UMass.

MR. WARE: Oh, by Sirna.

THE COURT: By Sirna.

MR. WARE: By Sirna.

THE COURT: What was Sirna saying? I just want to understand what the beef is.

MR. WARE: We probably have to hear that from the plaintiff, but I think that in substance it was that the plaintiffs believed that Sirna was overstating the extent of rights that it obtained by taking a license to the Tuschl I patent applications because Sirna pointed out that the applications contained within them, for example, references to 3-prime overhangs.

THE COURT: But was Sirna saying that? In other words, is there evidence from Alnylam that Sirna was actually misrepresenting the rights that it got under the contract?

MR. WARE: There is evidence of some slide presentations that were, I believe, authenticated in their depositions. I think the parties would probably disagree as to whether they misrepresented anything. I think Sirna was essentially saying to potential licensees that they didn’t need a license from Alnylam to Tuschl II. Read the rest of this entry »

Lead Attorney for Max-Planck, Alan Heinrich, stated in yesterday’s hearing “The priority claim is the key issue.” He disagreed that the 2001 agreement between the four assignees gives the Tuschl I assignees the right to claim priority to the Tuschl II ‘325 priority application which went abandoned two months after filing on December 1, 2000. Heinrich actually stated that UMass and Whitehead are ‘using the ‘325 application as a Tuschl I application’. Even though the application was abandoned this document serves as a benchmark for the Tuschl II invention in which the nature of the invention was fully disclosed.

Max-Planck patent attorney Wolfgang Weiss explained the practice of filing to claim a priority date and then letting the application go abandoned here. Max-Planck instructed Weiss to file the application for the sole purpose of securing an appropriate priority date for the Tuschl II invention. The December 1st priority date was appropriate because Elbashir, Lendeckel, and Tuschl had already submitted their paper to Genes & Development a week earlier describing the nature of the Tuschl II invention and this paper would be published on January 15th, 2001. Therefore a December priority date was appropriate since the invention had already been reduced to practice.

In court yesterday UMass defense attorney, Donald Ware, suggested that the claims of this Tuschl II priority document do not mention 3′ overhangs or other specific details about the effective structure of siRNA; instead the claims describe diverse alternative RNA structures just like the Tuschl I priority application filed on March 30th, 2000. But in contrast to the Tuschl I priority application, the Tuschl II priority document describes in detail the Tuschl II invention (short double-stranded RNA molecules of a precise size with two-nucleotide 3-prime overhangs) in the embodiment of the application document. According to attorney Heinrich, it’s the embodiment that fully discloses the invention. Let’s face it, the embodiment of the ‘325 application is exactly what is described in the results section of the January 15, 2001, paper. There can be no question that the Tuschl I priority application fails to disclose the precise features of the Tuschl II invention because these features were not predicted and reduced to practice by Tuschl I inventors Zamore, Bartel, and Sharp; nor were inventive features disclosed in the Tuschl I Cell paper published the day after the filing of the Tuschl I priority application on March 31st, 2000.

It is the Plaintiffs’ position that the Tuschl I priority application is non-enabling (to Tuschl II). If this is the case and the Tuschl I assignees drop or lose their ability claim to the Tuschl II priority date, the Tuschl I invention would only be able to claim the filing date of their first utility application which is March 30, 2001, and therefore would be invalidated by the prior art of Elbashir et al. published on January 15th 2000.

The plaintiffs’ motion for Summary Judgment asks for a Declaration from Judge Saris that the Defendants UMass and Whitehead have no right to claim the priority date of ‘325 (Tuschl II). In support of this motion by the Plaintiffs, attorney Alan Heinrich stated “you can’t license a priority date!” - since the ‘325 application was abandoned it could not be licensed. Judge Saris said that she had never heard of licensing a priority date. She said that the intent of the 2001 agreement would have to be determined to resolve what was being licensed.

Heinrich also reminded the court that the license UMass gave to Sirna Therapeutics lists the ‘325 Tuschl II application as intellectual property covered by the licensed to Sirna. Attorney Donald Ware dismissed the fact that the ‘325 was on the list of IP being licensed as an innocent “mistake by a paralegal.”

Another part of this discussion related to the fact that Thomas Tuschl withdrew his declaration claiming priority of the Tuschl I patent family to the ‘325 application. It’s easy for me to believe that the four inventors of Tuschl I were merely following instructions of attorneys when they signed these declarations. Apparently it’s a matter of law that declaration to an earlier priority application requires that all inventors of Tuschl I file the same declaration.

If the Tuschl I patent estate is abandoned, all of this may be moot. But it is these Helter Skelter arguments and others that made it clear to me that removal of claims of priority to ‘325 by Tuschl I is fundamental to preserving Tuschl II and ending this case.

Today’s hearing was for arguments on three motions: (1) A motion by UMass for Declaratory Judgment on issues surrounding UMass’ licensing of Tuschl I (and elements of Tuschl II) to Sirna Therapeutics; (2) the Plaintiffs’ motion for Declaratory Judgment against the Defendants for their failure to drop the priority claim to Tuschl II provisional application ‘325 (priority date December 1, 2000); and (3) UMass’ motion for a preliminary injunction against Whitehead and Max-Planck to prevent termination of the 2001 contractual agreement between the four Tuschl I assignees - Max-Planck, Whitehead, MIT, and UMass.

You may recall that in September Judge Saris ruled against Wolfe, Greenfield and Sacks (WGS) in a separate case, Max-Planck v. WGS, causing WGS to withdraw as the Tuschl I prosecuting law firm for Whitehead. Whitehead then asked the three other assignees to agree to Whitehead’s conditions for hiring a new law firm to continue prosecution of the Tuschl I patents, and gave a deadline of October 26th for all parties to agree to its conditions. Both MIT and UMass quickly agreed but Max-Planck refused because there was no remedy to the issues that Max-Planck is litigating in this case.

Then came Donald Ware’s (UMass lead attorney) seemingly desperate plea for a restraining order and preliminary injunction against Whitehead to preserve the 2001 agreement that gave Whitehead the responsibility for prosecution of the Tuschl I patent family. Because of the urgency of preservation of this agreement, UMass requested that oral arguments for this motion be added to the other two motions at today’s hearing. Then Whitehead agreed to extend their deadline for termination of the 2001 agreement to 6 PM tonight after the hearing.

The arguments relating to the first two motions on the agenda were fast paced and complex. I have ordered the transcript and will describe these arguments more accurately (also my pen ran out of ink) a week from next Monday after the transcript arrives.

The twenty minutes devoted to this third argument were riveting. Donald Ware (UMass presented essentially the same argument that he made in his brief found here posted on October 28th. The bottom line of his argument is that if the 2001 agreement is not preserved, then the Tuschl I patent family will be abandoned because no institution will have the right to continue it’s prosecution.

There are several issues surrounding the validity of the Tuschl I patent family that should not be ignored. Motion 2 is primarily about Whitehead’s refusal to drop the priority claim to the abandoned Tuschl II ‘325 provisional application with an enduring priority date of December 1, 2000 (based on the description of this invention in the embodiment). If Judge Saris or the USPTO determines that this is an illegal claim, then Tuschl I applications would have a priority date of March 30, 2001, the filing date of their first utility application. This is apparently because their provisional filed on March 30, 2000, is not enabling to Tuschl II. If this is the case (and I’m not a patent attorney), Tuschl I (with Tuschl II inventive material) would be invalidated by the January 15th 2001 paper by Elbashir, Lendeckel, and Tuschl in Genes & Development (see it in the left sidebar). This is of course why Whitehead with UMass’ ‘encouragement’ refused to remove this priority claim to the Tuschl II ‘325 application. I’m just guessing but might there have been some ‘encouragement’ coming from Sirna or possibly Merck? Read the rest of this entry »

[from Case 1:09-cv-11116-PBS Document 524 Filed 11/02/10]

Yawn … This is Judge Dein’s decision resulting from the hearing on Monday November 1st.

‘In sum, the invoices were not prepared in anticipation of litigation, the entries do not reflect the attorneys’ mental impressions, and any work product privilege was waived by the voluntary production of the invoices. For all the reasons detailed herein, “Alnylam’s Motion to Compel Return of Unredacted Attorney Invoices Improperly Retained by Defendants” is DENIED.’