Monday, April 19, 2010

Follow the Court Proceedings of the Tuschl Tussle

The ‘RNAi Litigation Blog’ is a service by John Leavitt and his colleagues Doug Naab and Scott Lloyd from the technology Research and Advisory firm Nerac that provides a great deal of background information on the Tuschl case and real-time summaries and insights of the court proceedings. As you will remember, this case touches on the ownership of the fundamental Tuschl I and II RNAi trigger patents and of which the outcome could decide what kind of economics Alnylam will be able to extract from its IP and what type of workaround strategies Alnylam’s competition will have to adopt (primers on the Tuschl Tussle and the potential fallout can be found here and here).

The most recent entry on the RNAi Litigation blog was on a hearing held on April 12 about Whitehead’s and UMass’ (the defendants) motion to dismiss the plaintiffs’ (Max Planck and Alnylam) First Amended Complaint. A lot of the hearing seem to have concerned Zamore’s assignment of his rights to the Tuschl I invention to UMass which the plaintiffs strongly feel Whitehead was contractually obligated not to have allowed. After all, it is UMass’ involvement in all of this which makes this case so important because UMass then decided to go it alone and essentially licensed all of the Tuschls most importantly to Sirna Therapeutics (now Merck). This could very well substantially deprive Alnylam of the economic benefits of its, what it believed to be exclusive rights to Tuschl II. To me, it actually seems quite fantastic how UMass believes that the one month that Zamore worked at UMass until the first filing of Tuschl I would now entitle them to the entire Tuschl inventions. Should the plaintiffs prevail in the assignment question alone, then much of the risk to Alnylam’s future business dealings would be taken off the table, unless of course events would escalate in such a way that both the Tuschl patents explode because the USPTO declared the patents invalid because of mishandling of inventorship. The defendants first line of defense is to claim statute of limitations on the assignment question to which the plaintiffs responded that they only became aware of the fact that Whitehead allegedly deceived them in their recent discovery and that they were first damaged in 2007 as Tuschl II ran into problems at the USPTO because of the way Whitehead prosecuted it.

There was an awkward moment in the hearing when the judge asked why Sirna/Merck was not part of the case as it appears that overlooking for a moment the few million in royalties that UMass may enjoy, it is Merck that stands to lose their $1B investment should they end up with a therapeutically useless Tuschl I. It appears, however, that UMass will have to bear the brunt instead because it apparently told Sirna/Merck that they were able to provide access to the inventions described in both the Tuschl patents. Maybe not surprisingly, Merck (‘outside pressures’) also appears to be the reason why attempts to settle this case have failed miserably.

The next important milestone in the case seems to be which counts will eventually be admitted. Unfortunately, it seems as if the judge is not keen at all to delve into the technical details of the case and would rather let the USPTO agonize over it. I am afraid, however, that in order to understand and solve any of the counts at hand, she would eventually have to refresh her high-school biology...

Well, instead of my second-hand account, why not bookmark and visit the 'RNAi Litigation Blog' here directly.

9 comments:

tufulipo said...

I must say this Judge gives me pause. This is a case that demands the most, and she seems to be regularly protesting the requisite workload attached. It becomes a factor as much as the evidence and the science when the judge just wants the case to go away.

Anonymous said...

In your opinion, likely what will be the outcome? And what should be the impact upon Alnylam and say, Tekmira stocks?
Guy.

Anonymous said...

I am confused about the patent office's seemingly ambiguous stance on the Tuschel II. What is the problem?

Dirk Haussecker said...

Guy,

You can read my speculations on the outcome and consequences in the following blog entry:

http://rnaitherapeutics.blogspot.com/2010/01/rnai-trigger-marketplace-in-post-tuschl.html

The case seems to be stacked heavily in Alnylam’s favor as it seems that UMass and Whitehead undertook a lot of effort, some of that secretly, to incorporate key inventive material from T-II into T-I and thereby deprive MP and Alnylam of the economic benefits of the important T-II estate.

Anonymous,

The problem with the USPTO is one of double-patenting since overlapping material are included in the T-I and T-II application and the USPTO does not appear to be willing to move forward with either application until that is resolved. This case will most likely decide how and therefore in whose favor this will be resolved.

Tufulipo,

I am also concerned that the judge’s apparent unwillingness to put much work into this could create uncertainties and leave important issues unresolved. On the other hand, I don’t know her enough and that’s just the way how she likes to carry herself in the courtroom.

tufulipo said...

Any chance USPTO is waiting for the outcome of this trial to help them sort out the Tuschl issues?

Dirk Haussecker said...

That's my understanding.

Anonymous said...

In a news release today, Silence Therapeutics refers to access it has to UMASS' Zamore patents having to do with designing siRNA's. Are they referring to the Tuschls?

Dirk Haussecker said...

No, definitely not. These cover siRNA design rules, not the siRNA themselves.

Anonymous said...

Thanks Dirk. Guy.

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