Friday, December 9, 2011

What Business Does Alnylam’s Counsel Have at the City of Hope?

The Tekmira and Alnylam dispute is a classical David versus Goliath encounter. By my standards, Protiva/Tekmira clearly deserves credit for developing the industry’s most advanced systemic siRNA delivery technology, SNALP. Alnylam, however, is trying to take all of that away from a company that it knows it stands a good chance at silencing with sheer money and influence.

It therefore struck a nerve when I read ‘Opposition 4’ in the ongoing VPS02-related patent interference filed on November 30 by Protiva/Tekmira (Interference No. 105792). It reveals that Alnylam’s counsel, Rothwell Figg*, went to the City of Hope, the employer of a key technical witness by Tekmira (John Rossi), to gently urge them that John Rossi should perhaps consider to withdraw his testimony (from Opposition 4):

For example, Material Fact 6, drafted by Alnylam’s counsel, clearly references “the meeting between representatives of City of Hope and Rothwell Figg.” Indeed, in questioning Dr. Rossi, Alnylam’s counsel appears to have acknowledged rather than disputed the occurrence of one or more meetings between Alnylam’s counsel and Dr. Rossi’s employer.’

And this is apparently what Dr. Rossi was informed of happened in those meeting(s):

‘[Dr. Rossi] Well, I was also informed that there was evidence that was evolved that would be used against my disclosure or my declaration in terms of the credibility of me as a -- basically as a scientist. In other words, I would be contradicting my own words, whether they be – I didn’t know what the source was of where my contradiction was going to be brought up, but it was in something that I had published or in publications or in patent applications or patents. That was all I was told. And I felt that it couldn’t be the case. I felt very strongly.

And in fact, Mr. Huntington asked me if I wasn’t worried about the fact that I could actually invalidate my own patents. I said no, not because I don’t want those to be invalidated, but because I didn’t feel that anything I had said or done would contradict those.’

It reads as if Alnylam’s counsel suggested to the employer of the witness that in following his conscience as a scientist, the employee would hurt the financial interest of his employer (City of Hope is the beneficiary Dr. Rossi’s patents). I’m no lawyer, and have no idea whether such apparent manipulation of the judicial process is legitimate or even legal, but it strikes me as very wrong (and desperate).

This episode though is just the latest in the game of politics Alnylam has been playing with Tekmira. It is high time for it to stop it and instead focus on the science. Otherwise, it risks wasting the opportunities that come with the ongoing clinical validation of Tekmira’s SNALP technology to which it is (still) a licensee.

* As I wrote in a blog entry in October, Rothwell Figg seem to have been replaced as Alnylam's counsel in the Interference, to be replaced by Wilmer, Cutler et al. which are also responsible for the larger SNALP Misappropriation case.

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Anonymous said...

Of all the scientists to try and spray mud on!
Precarious stuff indeed.

Alnylam are seriously in need of someone with
sound reasoning ability within their senior ranks.
Aggression and hungry ambition isn't enough
to successfully steer a company over the long

Maybe they bought up Nucleonics IP out of a personal admiration or friendship of it's leadership..?
of it's leadership style.

Anonymous said...

Your "David vs Goliath" portrayal makes a good story and everyone likes to root for an underdog, but there doesn't seem to be any getting around the issue that MC3 does not appear to be unequivocally a Tekmira invention that was simply stolen by Alnylam. All of the evidence points to a dispute that centers on exactly how much was contributed by each party, and this and the attendant rights & obligations will have to be sorted out by the courts. You do a disservice to yourself (and the industry) by your amateur-hour insistence that this is a morality play with good guys and bad guys.

Anonymous said...

Notwithstanding it's now on the record Alny counsel have mad an unspecified threat to Rossi's credibility as
a scientist of course. That speaks volumes for itself to
me about the way Alny roll. You could only defend that
if you were vested in Alny.

Rossi backing himself and not being pushed around by some sweaty pinstripes also speaks volumes about his calibre.

Anonymous said...

Thugs are thugs. What's new?

Anonymous said...

Dirk, There seems to be a disagreement between you and John Leavitt about the merits of Tekmira's suit against Alnylam. Tekmira entered into a supplemental agreement with Alnylam, UBC and Alcana giving them the right to develop novel compounds based on Tekmira's technology. Leavitt seems to suggest that Tekmira only became concerned about this permission when Alcana developed a novel compound that was at least ten times as potent as the flagship compound they had developed.

It is understandable that they would be chagrined at the success of the Alcana group, but it is a little late to claim that they did not really mean to agree to the terms of the supplemental agreement.

Dirk Haussecker said...

To my memory, The Supplemental Agreement differentiates between novel lipids and non-novel/derived lipids. There is also the important question of whether Tekmira was aware of all the AlCana shenanigans at the time they signed the Supplemental Agreement, e.g. how certain lipids came about.

Finally, AlCana is only part of the wider lawsuit involving the disclosure of trade secrets to third parties, exploit trade secrets to interfere with Tekmira's IP strategy, and the manufacture of SNALP LNPs for 3rd parties.

These issues are not addressed by the Supplemental Agreement and it is obviously wrong to say this case is all about the MC3 lipids as Alnylam would like to make us believe(likely because they sense this is where they have the most leverage while on the other points, especially where 3rd parties are involved, they have much less confidence).

PS: strange that you bring up John Leavitt. Why would a 'disagreement' between John Leavitt and myself matter to you?

Anonymous said...

Plenty of companies know how to manufacture liposomes. Your insistence and emphasis on Tekmira's claimed manufacturing prowess smacks of towing the company line. I'm of the mind that if Tekmira's "trade secrets" were actually really valuable they would have patented them.

Additionally, SNALP was a rather lackluster platform before these newer lipid materials were discovered - the development of which Tekmira's new management apparently didn't think was so important when they fired the AlCana scientists responsible for developing not only MC3 but ALSO its precursors. Perhaps instead of MC3 being a red herring it is talk about Tekmira's alleged manufacturing prowess that tries to obscure the HUGE difference between the 1st and 2nd generation LNPs and de-emphasizes what the critical innovation was that separates them.

Dirk Haussecker said...

"not only MC3 but ALSO its precursors."

You hit upon an interesting point. These people invented some of these precursors (as you admit, these are the logical precursors of MC3 and the likes), including 'second gen KC2, while employed by Tekmira, yet Alnylam's supporters seem to ignore the obvious, namely that this means that the lipids belong to Tekmira, whether the employees hated their new management or not.

Anonymous said...

“…..this means that the lipids belong to Tekmira”

False reasoning……

MC3 was invented and developed by Alcana under the supplemental agreement signed by Tekmira. So it belongs to Alcana unless Tekmira somehow succeeds in voiding the supplemental agreement in the court. Supplemental agreement gives Alcana a very broad and unrestricted right to develop novel lipids. I don’t see how Tekmira can get out of it.

Anonymous said...

Dirk, you ask why a disagreement between you and John L. matters to me. It's because you carry his "
RNAi Litigation" blog on yours. I regularly read both so I am curious about how the two of you could have such a different take on this issue. Would you care to elaborate?

Anonymous said...

The Alnylam / Tekmira just took an exciting new dimension with the $4 million over-subscribed offering that was closed swiftly. TKM's cash runway now extends well past 1013 / Q-3, which sends a solid optics signal that TKM invariably will 'David' not be bullied by Goliath.
I find it frightening that Alnylam's B of D are seemingly immune to their fudiciary rights of their shareholders. Pundits and opinion leaders through-out message boards are starting to realize that if Alnylam loses this litigation, their entire RNA pipeline goes DARK. TKM will cancel their licence and no space shuttle will deliver Alnylam's cargo. No delivery? No drug.
Through-out the life science industry, Alnylam is known to be arrogant and the company culture toxic at best. This will be an interesting 2012...

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