Tuesday, March 24, 2015

Isis Pharmaceuticals and Roche/Santaris About to Settle Patent Dispute

According to court documents dated March 20, 2015, it looks like Isis and Roche, the new owner of the original defendant Santaris, are about to settle the RNaseH antisense patent infringement suit brought by Isis.  A settlement would have important implications for the future of Antisense Therapeutics. 

To wit, in 2011 Isis sued Santaris for infringing its RNaseH gapmer patents by Santaris signing on Big Pharma partners regarding RNaseH Therapeutics development.  Isis viewed this as a form of monetizing their IP and consequently sued.  If decided in Isis’ favor, the case would have been a notable departure from the long-held practice of shielding preclinical business and drug development under the safe harbor of the Research Exemption

As such, the case could have had a chilling effect on particularly small innovative biotech companies seeking to improve upon existing technologies, but by this using aspects of those technologies.  Big Pharma, after all, do not rely on partnerships to finance technology development and can thus go on using and improving the IP of other companies in their own labs impugned.
Although one could have thus taken the view that losing the case would have been in Roche’s interest in a perverted sort of way, it could also have more immediately jeopardized the value of their acquisition of Santaris (USD 250M) in addition to payable damages.  For example, Roche might have been ordered to cease any RNaseH work in the US which may be impractical for a global research organization like Roche.

Since I cannot imagine that Isis would tolerate Roche to challenge their control over RNaseH antisense gene knockdown and compete for pretty much the same targets, I expect the settlement to take the form of a significant broadening of the companies’ existing relationship around Huntington’s Disease in the form of additional target picks in exchange for a sizeable upfront fee. 

Unlike Isis’ more recent Big Pharma deals with J&J, GSK, BiogenIdec, and AstraZeneca, however, I expect this to involve less early development work by Isis as some of this would be the obvious job of the former Santaris crew.


Anonymous said...

What trading activity would you like to boast about today Dirk?

Anonymous said...

A change of leader within the sector is the call made today.

We are aware of Dirk's pro-ISIS and anti-ALNY stance.

ISIS and ALNY are THE leaders in this space.

If his call is right and RGLS, SRPT, BLUE or anyone else becomes the new industry leader with a new scientific standard then what to make of ISIS and ALNY views shared by him?

Potential to be bigger than Apple I believe was the call. Now its leadership to be changed.

Dirk Haussecker said...

Sell-offs often result in new leadership once the market is recovering. Usually this applies to the various sectors in the market, say pharmaceuticals versus energy or financials. However, even within a sector like biotech there has been recent leadership in the big cap biotechs, gene therapy, and immuno-oncology. Last year before the sell-off, RNA Therapeutics was the hottest sector in biotech, but failed to take charge in the new run-up (except the ALNY+ISIS which at least got back to around their highs a year ago).

My sense is that recent momentum biotech stocks will not re-assert leadership, but that it is RNA Therapeutics' turn once more, and within RNA Therapeutics, it seems that RGLS, SRPT, and ARWR have the most catch-up to do.

Having said that, ISIS remains my single-largest position (but I do not trade that position).

PfizerSloth said...

Following on from your who do you trust tweet, I guess in your case you are saying Stan is OK.

We shall see.

As everyday passes it becomes more and more obvious to me that we are not waiting for a FDA decision or a consensus ad idem between CEO's or similar. Instead, it appears the TPP is where it's at. Beyond that though is the requirement to get it through Congress. That depends on the Fast Track Authority bill. Until we see that passed, the sector is just going to slop about according to tide and wind while tethered to its anchor.

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