RNAi Litigation

Archive for September, 2010

Multiple court documents will be posted tomorrow, Friday, October 1.

Today, Benitec Limited in Melbourne Australia announced the USPTO Board of Patent Appeals and Interferences decision reversing all previous claim rejections for US 6,573,099, a basic patent covering DNA-directed RNAi interference in humans (the “Graham patent”). Benitec appears to own gene therapy for RNA interference with a June 19, 1998, priority date.

Here is the information on this decision posted at Benitec’s website www.benitec.com :

USPTO Board of Appeals Decision

Benitec’s Media Release

Benitec will now be able to extend their therapeutic programs in HIV/AIDS, Hepatitis B, and Lung Cancer.

See Dirk Haussecker’s discussion about this Benitec/CSIRO victory.

[from Case 1:09-cv-11116-PBS Document 461 Filed 09/29/10]

UMass’ Motion for a Temporary Restraining Order and Preliminary Injunction to Preserve the Status Quo Among the Co-Owners of the Tuschl I Applications pendente lite

Defendant UMass hereby moves this Court for an order to preserve the status quo pendente lite in light of actions taken this week by Whitehead Institute and Max Planck each purporting to give notice of termination of the 2001 Joint Invention and Joint Marketing Agreement (the “2001 Agreement”). UMass seeks a temporary restraining order and preliminary injunction to prevent threatened termination of the 2001 Agreement as soon as 6:00 p.m. on Thursday, October 21, 2010.

The circumstances in this case have changed rapidly and dramatically in the wake of this
Court’s summary judgment ruling in Max Planck v. Wolf Greenfield & Sacks, PC. On September 20, 2010, Max Planck threatened Wolf Greenfield with claims for unspecified damages if Wolf Greenfield did not immediately withdraw from all prosecution of Tuschl I applications worldwide. The next day, Wolf Greenfield notified Whitehead that it was withdrawing as counsel for the prosecution of Tuschl I. Whitehead then wrote the co-owners on September 22, 2010, requesting written confirmation that they would cooperate with Whitehead’s retention of new prosecution counsel who would represent Whitehead alone and be empowered to carry out Whitehead’s instructions, consistent with Whitehead’s final decision-making authority under the 2001 Agreement.

Whitehead indicated that, if it did not receive such confirmation from each co-owner on September 27, 2010, it would thereupon terminate the Agreement.

In response, MIT and UMass provided the requested confirmation. Max Planck, however, refused, and instead purported to send its own termination notice, to become effective unless within 60 days Whitehead cures unspecified breaches involving the “improper prosecution of the Tuschl I applications.”

On Monday evening, Whitehead responded to Max Planck, stating that unless Max Planck agreed to cooperate in Whitehead’s engaging new prosecution counsel, Whitehead would terminate the Agreement at 6:00 p.m. EDT on Thursday, September 30, 2010, absent a court order delaying termination. Max Planck again refused Whitehead’s request. UMass thereafter met and conferred with the parties concerning this motion. Whitehead has agreed to postpone the termination, but only until 6:00 p.m. on Thursday, October 21. Read the rest of this entry »

[from Case 1:09-cv-11116-PBS Document 456 Filed 09/24/10; ‘Memo to Support Max Planck’s Motion to Compel Production of Communications Involving Wolf Greenfield Under the Joint Client Rule’]

I. Introduction

Plaintiffs Max-Planck and Alnylam respectfully move this Court for an order compelling the production of all communications involving Wolf, Greenfield & Sacks, PC (“Wolf Greenfield”) relating to the prosecution of the Tuschl I patent applications during the period when Max Planck was a joint client of Wolf Greenfield. Wolf Greenfield, as well as Whitehead and UMass together with MIT are currently withholding over a thousand such communications on a claim of privilege. This claim of privilege cannot stand in light of the Court’s recent ruling in the related Wolf Greenfield case that Wolf Greenfield and Max Planck had an attorney-client relationship and that Max Planck and Whitehead were Wolf Greenfield’s “joint clients” with respect to the Tuschl I applications.

It is well settled that when an attorney represents joint clients, one client’s communications with the attorney about the subject of that representation are not privileged as between the other clients. (“The attorney-client privilege does not apply to . . . a communication relevant to a matter of common interest between or among two or more clients if the communication was made by any one of them to an attorney retained or consulted in common, when offered in an action between or among any of the clients”).

The “joint client” rule applies with full force here. In light of the Court’s September 14, 2010 Memorandum and Order finding that Max Planck and Whitehead were Wolf Greenfield’s joint clients, Defendants have no basis for continuing to withhold their communications with Wolf Greenfield. Further, Max Planck has brought this Motion promptly following the Court’s ruling. Accordingly, Max Planck is entitled to, and respectfully requests an order compelling the production of, the communications involving Wolf Greenfield relating to the Tuschl I applications, including all documents reflected in the entries from Defendants’ privilege logs identified in Exhibit 1 to the accompanying declaration of Alan J. Heinrich. Such an order is necessary to ensure that this case is tried on a complete record. Read the rest of this entry »

See Dirk Haussecker’s article here.

“It is official now: Novartis will not exercise its $100M option to broadly license Alnylam’s RNAi trigger IP. …”

As Dirk suggested, it would be interesting to learn the impact of this case on Novartis’ decision. If there is a relationship that can be established, would Alnylam be able to seek damages for the loss of this option?

[from Case 1:09-cv-11116-PBS Document 446-35 Filed 09/16/10]

This is from the Patent Examiner’s report on Tuschl II Application Number: 10/433,050 filed on July 26, 2004.

Double Patenting

“The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper time-wise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s).

A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.

Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). Claims 48,49,51,53-57,60-64,67-73, and 75-125 (Tuschl II application) are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 76-78, 81, 86-88, 91, 106, 108, 110, 112, 115-120, and 124-177 of co-pending Application No. 09/821,832 (Tuschl I application). Although the conflicting claims are not identical, they are not patentably distinct from each other because each of the applications are directed to isolated double-stranded RNA molecules that mediated RNAi interference and have overlapping structural characteristics.

Each of the applications rely on the same priority document (EPO 00126325.0) for the earliest support for each of the sets of claims. With regards to double patenting rejections, the specification can be used as a dictionary. In the instant (Tuschl II) case, each of the applications are directed to molecules with overlapping structural characteristics, wherein each of the applications rely on the same priority document for support for the inventions. The specification of EPA 00126325.0 (Tuschl II application) is considered to provide support to define both the invention of the instant claims and the invention of the claims of application ‘832 (Tuschl I). Read the rest of this entry »

In the hearing yesterday the following steps were scheduled.

Ch. Magistrate Judge Judith G. Dein: ORDER entered re 409 Alnylam’s Motion to Compel Return of Unredacted Invoices. Alnylam shall file a supplement to its motion by 10/1/10; defendants’ response shall be filed by 10/15/10; a hearing shall take place on 11/1/10 at 10:00AM in Courtroom #15 on the 5th floor.

[from Case 1:09-cv-11168-PBS Document 108 Filed 09/14/10 in Max-Planck (Plaintiff) v. Wolf Greenfield & Sacks, PC (Defendant) Civil Action no. 09-11168-PBS]

Max-Planck brought this action against the law firm Wolf Greenfield & Sacks, PC (“Wolf Greenfield”), alleging that Wolf Greenfield committed legal malpractice and breach of its fiduciary duty in the course of its alleged representation of Max-Planck. The parties have filed cross motions for summary judgment. The plaintiff seeks partial summary judgment on the issues of whether or not there was an attorney client relationship between the parties and whether Wolf Greenfield owed Max-Planck a fiduciary duty.

The defendant (Wolf Greenfield) seeks summary judgment on all issues. After a hearing and a review of the record, Max-Planck’s Motion for Partial Summary Judgment is ALLOWED based on the Court’s finding that there was an attorney-client relationship between the parties and the finding that Wolf Greenfield owed a fiduciary duty to Max- Planck.

Wolf Greenfield’s Motion for Summary Judgment is ALLOWED based on the Court’s finding that Plaintiff’s claims are time barred (see in 3rd post down), with the exception of the claim for declaratory judgment, as to which the motion is DENIED.

I. BACKGROUND

The record contains the following relevant facts, which, unless noted, are undisputed …(most of this section summarizing the Max-Planck case against Whitehead and UMass has been reiterated repeatedly in previous posts)… In 2001, the four co-assignees entered into a Joint Invention and Joint Marketing Agreement (the “2001 Agreement”) that assigned Whitehead primary responsibility for filing, prosecuting and maintaining the patent applications relating to the Tuschl I inventions. (Mone Decl., Ex. 10 (2001 Agreement)… In 2003, Whitehead, MIT, and Max-Planck, but not UMass,entered into a second agreement called the Joint Invention and Joint Marketing Agreement for RNAi Therapeutic Purposes (the “2003 Agreement”) that licensed the Tuschl I technology for therapeutic purposes. The 2003 Agreement also provides that the filing, prosecution and maintenance of the Tuschl I patent applications “shall be managed by and the primary responsibility of Whitehead” and that the other parties to the 2003 Agreement shall have “reasonable opportunity to comment and advise.” Between 2001 and 2003, the inventors and co-owners executed powers of attorney appointing the law firm Hamilton, Brook, Smith & Reynolds (“HBSR”) and Patricia Granahan, who was then the in-house counsel for Whitehead, to prosecute the applications and transact all related business before the USPTO.…

While this disagreement was still ongoing, Whitehead engaged Wolf Greenfield to prosecute the Tuschl I patent applications. The engagement letter, sent by attorney Helen Lockhart of Wolf Greenfield to the director of the intellectual property office at Whitehead, is not copied to any third parties and states “…we are very pleased you have selected Wolf Greenfield as your intellectual property counsel in connection with the Tuschl I patent applications.” Read the rest of this entry »

[from Case 1:09-cv-11168-PBS Document 108 Filed 09/14/10 in Max-Planck (Plaintiff) v. Wolf Greenfield & Sacks, PC (Defendant) Civil Action no. 09-11168-PBS]

Wolf Greenfield’s … argument in support of its motion for summary judgment is that Max-Planck’s claim for a declaratory judgment is moot as a result of the Goldstein petition granted by the USPTO. In its complaint, Max-Planck seeks a judgment declaring “that Wolf Greenfield is required to cease its prosecution of the Tuschl I patent applications and withdraw its representation as to Max-Planck and the other co-owners.”

In July 2009, Max-Planck petitioned the USPTO to revoke its power of attorney in favor of Wolf Greenfield and to allow the appointment of Rothwell Figg, another law firm, on its behalf and to act for less than all of the applicants. This is referred to as the Goldstein petition. The USPTO granted the Goldstein petition on September 3, 2009 on the basis of the “divergent interests” of Max-Planck and the other co-owners. Accordingly, now Wolf Greenfield may not prosecute the Tuschl I patent applications in any manner without Max-Planck’s express consent because the USPTO will not act upon filings from less than all of the co-owners. Accordingly, Wolf Greenfield argues that the claim for declaratory judgment in this case is moot.

Max-Planck points out, however, that Wolf Greenfield and Whitehead are attempting to vacate the approval of the Goldstein petition and are arguing that the USPTO acted improperly by granting the petition. Read the rest of this entry »

[from Case 1:09-cv-11168-PBS Document 108 Filed 09/14/10 in Max-Planck (Plaintiff) v. Wolf Greenfield & Sacks, PC (Defendant) Civil Action no. 09-11168-PBS]

In July 2009, Max-Planck petitioned the USPTO to revoke its power of attorney in favor of Wolf Greenfield and to allow the appointment of Rothwell Figg, another law firm, on its behalf and to act for less than all of the applicants. This is referred to as the “Goldstein petition”. The USPTO granted the Goldstein petition on September 3, 2009 on the basis of the “divergent interests” of Max-Planck and the other co-owners (Whitehead, UMass, MIT). Accordingly, now Wolf Greenfield may not prosecute the Tuschl I patent applications in any manner without Max-Planck’s express consent because the USPTO will not act upon filings from less than all of the co-owners.

[from Case 1:09-cv-11168-PBS Document 108 Filed 09/14/10 in Max-Planck (Plaintiff) v. Wolf Greenfield & Sacks, PC (Defendant) Civil Action no. 09-11168-PBS]

Ruling on Proximate Causation of Damages by Wolf Greenfield & Sacks PC

Wolf Greenfield argues that Max-Planck cannot prove that Wolf Greenfield’s actions were the proximate cause of any harm to the plaintiff. A plaintiff in a legal malpractice action proves causation by proving it would have achieved a different, better result had the malpractice not been committed.

This Court has previously written that “Max-Planck will have to show that Wolf Greenfield’s conflict of interest in the prosecution of the Tuschl I applications proximately caused the PTO to reject in whole, or in part, patent claims sought by Max-Planck. In other words, it must show that if Wolf Greenfield were conflict-free, the Tuschl II patent claims would be stronger.”

Wolf Greenfield argues that because the mammalian and 3′ data and the cross-claim of priority were already in the Tuschl I application when the firm was retained to prosecute the applications before the USPTO, any actions taken by the firm could not have been the cause of Max-Planck’s injury. Under the co-assignees’ agreement, Whitehead was delegated the responsibility to prosecute the patent applications. Since Whitehead made the decision to keep the contested information in the Tuschl I applications, the argument goes, Wolf Greenfield’s actions had no effect on the content of the applications. Max-Planck responds that Wolf Greenfield did in fact cause its injury.

In 2004, Max-Planck asked Wolf Greenfield to remove the alleged Tuschl II material from the Tuschl I applications, and to withdraw from the Tuschl I applications the claim of priority to the Tuschl II application.

Wolf Greenfield drafted a memorandum stating that it was “not aware of a compelling reason to maintain the priority claim in the Tuschl I applications with the currently pending claims that are fully supported by the Tuschl I provisional applications.” Wolf Greenfield did not, however, remove the data and the priority claims. Defendant states that this decision was based upon direction from its client, Whitehead. Nonetheless, Max- Planck argues that discovery in this case has revealed that Wolf Greenfield was in fact complying with requests from another coassignee, UMass. The Court notes that the deposition testimony cited to support that argument is not included in the excerpted depositions currently in the record. In any event, even if UMass requested Whitehead to make this decision, there is undisputed evidence that Whitehead, not its counsel, was the ultimate decision-maker.

It is clear from the record that Wolf Greenfield could not have removed the contested data from the Tuschl I patent applications over Whitehead’s objection. Read the rest of this entry »