Thursday, June 12, 2014

Alnylam Pulls Chair from Underneath Arrowhead Research

Machiavelli would have blushed. Feeling the heat from both RNAi and antisense competition for targets in the liver, Alnylam has made it clear in its recent McSwiggen patent-related press releases that it is determined to wipe out at least the RNAi competition through patent and contract strategy (see here and here).  

Whereas before it used to call out Tekmira/Marina/Arcturus by claiming that unlocked nucleic acid would fall under their patent estate, today it added Arrowhead Research to the club of companies that entered an RNAi trigger licensing contract with Alnylam, but then find that those contracts were not worth the paper written on: Merck, Tekmira, Arrowhead Research, and others.

In brief, the McSwiggen patents that Alnylam bought from Merck claims RNAi triggers that satisfy the following conditions:

1)      RNAi trigger with strands that have a length that fall within the classical range for siRNAs;
2)      At least 10 or more bases (often pyrimidines) of either or both strands have to be one of the following modifications: deoxy, 2’F, or 2’0-methyl.

Depending on the patents there are slight variations as to the strand lengths covered, additional requirements for phosphorothioate linkages etc.

Given the above limitations, it is strange that coincident with the acquisition of the McSwiggen patent estate, Alnylam repeatedly adds in the related press releases that it owns RNAi triggers, including those modified with acyclic nucleotide analogues (--> usiRNAs).  By contrast, it would appear that replacing any of those modifications with the very unlocked nucleic acid analogue would be a simple way of circumventing McSwiggen without any destabilizing effect on the RNAi trigger. 

Isn’t that odd?  A company in a position of strength would not do that.  But we all knew that Alnylam still wishes Tekmira to disappear from the face of the earth, so that’s not really new.

The real shocker may be to investors of Arrowhead Research (from Alnylam’s press release):
we intend to maximize the value of this newly issued IP solely through the advancement of ALN-HBV - our GalNAc-conjugated siRNA targeting the HBV genome for the treatment of HBV infection

In other words, Alnylam says that the HBV target-specific license it gave to Arrowhead just 2 years ago does not include rights to the newly acquired McSwiggen patent estate.  And indeed, ARC520 by Arrowhead infringes the newly issued patent subject of today’s press release (US 8,618,277).  I will just use si-74 (one of the 2 siRNAs in ARC520) to illustrate why.

chol-siHBV-74 sense: chol-uAuCfuGfuAfgGfcAfuAfaAfuUfgGfuAf(invdT) 23 bases,
chol-siHBV-74 antisense: dTAfcCfaAfuUfuAfuGfcCfuAfcAfgdTsdT 21 bases.

I’ve highlighted the pyrimidine bases in red.  ‘f’ after a symbol stands for 2’-fluoro, small case is 2’-o-methyl, dT is deoxy-T.

1.       ‘277 claims an HBV-targeted RNAi trigger which meets the following requirements:
a)      Each strand 18-24 bases (applies to si-74);
b)      the sense strand comprises 10or more 2'-deoxy, 2'-0-methyl, 2'-deoxy-2'-fluoro, or universal base modified nucleotides (applies to si-74 where 21 nucleotides are accordingly modified in si-74 sense);
c)       the antisense strand comprises 10or more 2'-deoxy, 2'-0-methyl, 2'-deoxy-2'-fluoro, or universal base modified nucleotides (applies to si-74 where 21 nucleotides are accordingly modified in si-74 antisen);
d)      10 or more pyrimidines (i.e. U or C) of either strand modified by 2'-deoxy, 2'-0-methyl, 2'-deoxy-2'-fluoro nucleotides (applies to si-74 as each strand has at least 10 of those modifications).

Genius, by acquiring the Merck patents in January, Alnylam not only gave the withering Kreutzer-Limmer patents a new life given that Merck was in some cases the only party fighting it.  No, Alnylam thereby also pulled the chair from underneath Arrowhead given the reliance of that company on ARC520 for its valuation.  Of course, a crumbling valuation of Arrowhead could really help Alnylam as it tries to catch up and develop its own version of DPCs based on what Merck has been able to copy from Arrowhead.  Given that ‘277 will only expire in 2022/3, just waiting it out may not be an option for Arrowhead.


Sorry, Arrowhead, just because Alnylam really, really ‘dislike’ Tekmira and is calling you ‘a friend’ does not mean that you can trust them any more than Tekmira or that you are any more savvy in your drafting contracts.

42 comments:

Anonymous said...

You're jumping the gun Dirk, unless John Maraganore left you a voicemail today telling you that they intend to sue? No? I thought not.

Anonymous said...

And readers, just because Dirk may have unknowingly misinterpreted Alnylams comment "‘we intend to maximize the value of this newly issued IP solely through the advancement of ALN-HBV - our GalNAc-conjugated siRNA targeting the HBV genome for the treatment of HBV infection’", which obviously means "WE intend", does not necessarily follow that he shorted Arrowhead today trying to make a fast buck (before it rebounds when Alnylam might just as easily acquire Arrowhead as sue them). Fact is, this site gets more like TheStreet dot com every day - take everything with a grain of salt.

Anonymous said...

This issue is really just old news...

1. Issued US 8618277 patent out since December 2013 - so, not sure why surprising all of the sudden. Old news.

2. Notice of Allowance August 2013. Older news.

3. Patent *application* US 20130018082 published January 2013 with near identical claims. Oldest news.

Back to sleep...

Anonymous said...

People, time to stop bringing traffic to this manipulative trader's blog.

The gems we've heard specifically above and beyond more subtle insinuations since the trader sold while telling folks to hold for at least two years for $200:

- 3mg/kg, why no 3mg/kg?, it must be toxic!

- DPC is not as potent as the toxic TKMR brew.

And now, le piece de resistance, HBV is ARWR's valuation prop and ALNY is yanking the license.

"a crumbling valuation of Arrowhead..."

And there you have it.

The portrait that accompanies this blog piece is non other than Dirk H.

- investron

bikerieder said...

I may be wrong but what ist that all about that (not new) patent?
It is a US patent not a world patent.
How many people are infected with HBV in the US?
After a presentation from ARWR last march on their HBV analyst day, 1.46 to 2.2 million people...
About 0.5 % of HBV infected people in the world...
I may be wrong, but ARWR DPC are not using the same chemistry....
ARWR is at least 2.5 years earlier...
Let's go back to love ARWR again!
The US are not the world, specially not with that chief in command...

Dirk Haussecker said...

Yes, bikerieder, Arrowhead should move to Switzerland, or better Ireland.

Anonymous said...

Thanks for the update. However, The phrase "solely through" simply means that HBV is the only indication in which ANLY will utilize the tech covered by said 277 patent. Therefore, one cannot simply make the inferences you seem to make!

From a legal standpoint I find this somewhat unclear. Without even considering the enforceability of the 277 patent in patent litigation, which is an art form of its own. I find this highly suspect: ANLY would essentially have sold a trigger that infringes on a then Sirna patent application, then ANLY would have acquired the rights to the patent pending and claim that the trigger sold to ARWR would infringe said patent. Unless ARWR has had essentially the worst legal and technical advisers during the ARWR ANLY deal I find this highly unlikely. First: the contract language itself should include some warrants and representations that the sold trigger does not infringe on any issued or filed patent application. Second: the persons responsible for the legal/technical DD of the trigger itself should have been aware of this application if it were this big of a risk as you state in your blogg.

That said, I appreciate your updates and writings, thank you! As for people constantly getting offended on behalf of either TKMR or ARWR, please; the HBV pie is double the size of the HCV pie and a company years after drugs already on the market and comming to the market within a year was just acquired for 4B!! Therefore there is a significant value in all the HBV companies TKMR, ARWR and ANLY and RepliCor. Applying the same logic: if the Tx's work even the one that is the last to the party would be worth ~8B that is over a 10x increase for ARWR and ~20x increase for TKMR, this on HBV alone!!! If the RNA Tx's work and get to the market these companies will be worth tens of billions of dollars! So take it easy!

Ps. the troll artist known as Investron: quit trolling every single board with your ARWR TKMR antagonism! Your manic approach makes me think that the whole RNA tech is just a hoax mainly attracting loonies! For your own sake, buy all the relevant companies, you'll sleep better. If your prediction is right that ARWR alone will succeed and all the other stocks would be worthless then your gain in ARWR more than offsets these losses. Then again, if RNA Tx ever gets to the market and you own all the relevant companies you'll make tons of money.

bikerieder said...

ARWR was very prudent, when they decided to run the phase 1 and 2A outside of the US.
They learnt from that ALNY - tkm dispute.
They saw that all coming!
Great Mgmt.

Anonymous said...

investron • 56 seconds ago

Why ARWR Can Not Be Adversely Affected

Press release:
Alnylam has granted Arrowhead a license under its intellectual property that enables the discovery, development, and commercialization of an RNAi therapeutic targeting the hepatitis B virus (HBV). Alnylam is eligible to receive from Arrowhead milestone payments and royalties on sales of product resulting from the license. In addition, Alnylam has received a license from Arrowhead to utilize their Dynamic Polyconjugate (DPC) delivery technology for an RNAi therapeutic product. Alnylam expects to deploy this technology for an undisclosed target in its "Alnylam 5x15" pipeline which is focused on genetically defined targets and diseases. Arrowhead is eligible to receive from Alnylam milestone payments and royalties on sales of product resulting from the license. No additional financial details were disclosed.

"We view Arrowhead's DPC technology as a promising emerging delivery approach, with the potential to complement our existing delivery platform which currently includes lipid nanoparticles and our siRNA conjugate platform," said Laurence Reid, Ph.D., Senior Vice President and Chief Business Officer of Alnylam. "In addition, by granting Arrowhead a license for their HBV program, we are enabling their efforts with access to Alnylam intellectual property which we believe is critical for the development and commercialization of RNAi therapeutics. We look forward to continuing to work with Arrowhead, who is already a partner and licensee of Alnylam."
_

"Alnylam has granted Arrowhead a license under its intellectual property that enables the discovery, development, and commercialization of an RNAi therapeutic targeting the hepatitis B virus (HBV)."

If party AL granted party AR the license to a collective containing parts 1, 2, 3, ..., where say, for 2, it did not have explicit rights to before, now that it does in no way can that jeopardize AR the licensee.

Au contraire, the licensee is now further protected against possible claims by previous owner of 2.

- investron

Anonymous said...

"Ps. the troll artist known as Investron: quit trolling every single board with your ARWR TKMR antagonism! Your manic approach makes me think that the whole RNA tech is just a hoax mainly attracting loonies! For your own sake, buy all the relevant companies, you'll sleep better. If your prediction is right that ARWR alone will succeed and all the other stocks would be worthless then your gain in ARWR more than offsets these losses. Then again, if RNA Tx ever gets to the market and you own all the relevant companies you'll make tons of money."

This must be mulletman99 from the TKMR Yahoo! and Investorsvillage board.

If you look at it fairly you would discover that the real troll and Machiavelli is none other than Dirk Haussecker.

Ever since Dirk H. cashed in on ARWR in December of last year all while telling followers to hold for 2 years for $200, and rolled his loot into the TKMR laggard, he had been increasingly insinuating against ARWR and boosting TKMR.

That culminated in the options expiry post calling into question the potency competitiveness of DPC.

But before that was the one ranting on why Arrowhead did not pursue 3 mg/kg in Ph 1, insinuating that there were issues with safety.

And now that Tekmira's supposed more potent delivery is showing problem old Dirk is bringing it up again.

Before you Tekmira people think Dirk is your true champion let's not forget when he recently dumped TKMR et al. in the downturn and then blogged that the industry was now faced with three years of famine.

Dirk is Dirk's pocket champion. If he sold he wanted to make sure he could buy it back lower.

The recent positive ARWR DPC 2.0 blog came only after his obvious taking a position in ARWR for all the coming catalysts.

And now that he dumped it yesterday he came out with a blog post calling for the collapse of ARWR due to ALNY patent infringement.

This guy needs a strong reprimand by a judge in court and his blog shut down for obvious stock price manipulation.

If Dirk's recent constant tweet about Ebola and calling for TKMR brew undergoing Ph 1 to be used right now in Africa didn't convince you nothing will.

After it was pointed out that Ebola market is almost non-existent and no analysts in their right minds would give it any huge valuation (contrary to Dirk's clueless call for the doubling of the stock price) it sure put an end to that.

Don't be so easily manipulated people. We're investing in biotech and many followers here may be school wise but depressingly street dumb.

- investron

Anonymous said...

Many of the posters just don't understand what Dirk is saying. Alnylam had licensed their trigger IP to Arrowhead and not the chemistry IP that goes into formulation. Arrowhead was already infringing on Sirna's patent even before it was acquired by Alnylam. Sirna's chemistry IP has nothing to do with trigger IP of Alnylam. They are two entirely separate IP.

Anonymous said...

"Many of the posters just don't understand what Dirk is saying. Alnylam had licensed their trigger IP to Arrowhead and not the chemistry IP that goes into formulation. Arrowhead was already infringing on Sirna's patent even before it was acquired by Alnylam. Sirna's chemistry IP has nothing to do with trigger IP of Alnylam. They are two entirely separate IP."

Look at the agreement:

"Alnylam has granted Arrowhead a license under its intellectual property that enables the discovery, development, and commercialization of an RNAi therapeutic targeting the hepatitis B virus (HBV)."

Alnylam granted a license that enables the discovery, development, and commercialization of an RNAi Therapuetics, ARC-520, targeting the hepatitis B virus (HBV).

ARC-520 is the collective that contains parts 1, 2, 3, ...

Anylam had right to 1, the trigger, and granted it to Arrowhead to develop the collective 1, 2, 3, ...

Now that Alnylam also claims the right to 2, chemistry, strengthens the agreement to allow Arrowhead to develop the collective 1, 2, 3, ..., as apposed to 2 belonging to a third party.

For this enablement Alnylam received in return explicit benefits.

Alnylam is constrained to maintain the benefits it offered in exchange for the benefits it received in return.

- investron

Anonymous said...

This ain't no mullet man, son! And here comes another Investron rant! Agreed that the quality of Dirk's reporting has deteriorated significantly since he apparently decided to become a full blown trader! Notwithstanding, the explications of the science are interesting and most welcome.

But seriously, Investron, why not own all three companies, or at least TKMR and ARWR?!

Cannot quite understand your pessimism regarding the Ebola project! Granted, it will hopefully not become a megablockbuster, but they have been able to develop this Tx FOR FREE, even earning a small incentive! If approved, they will see stockpiling revenues raging anywhere from 50M - ~400M a year, starting next year, without marketing expenses!! For a company with MC of ~320M what is there not to like?! If the PLK1 program shows efficacy, its hard to even quantify the worth thereof! Then comes the HBV; I dont care if TKMR is one or two years after ARWR to the market! If their TX's work it'll be mega-billions for both. I find it somewhat reasonable to expect that if the RNAi HBV-antigen approach is sound that both companies will succeed (As well as ANLY)! Ergo own both or none at all if you expect the RNAi hypothesis to fail!

Anonymous said...

ANy impact crossover to MRNA ? Would this make MRNA IP more valuable. Since ISIS is partnered w/ BIIB for Myotonic dystrophy and has recently entered the clinic, any BIIB competitor would be wise to look MRNAs way??
THanks as always

Anonymous said...

Some readers would be familiar with the phrase 'this was the recession we had to have'..

It seems sirna players now face a long bumpy road of patent battles they have to have (thanks Alnylam...).

The expressed RNAi patents seem far less disputable. Are they now becoming a better investmentt for the viral, ocular and CNS disease targets given the vast leaps happening in gene therapy delivery(esp AAV's)?

mulletman99 said...

Thanks Dirk. Another quality and timely post.

Question regarding Tekmira's HBV candidate. You seem to imply that since Tekmira is using UNA technology for the HBV candidate they will not be infringing.

This patent appears to be very broad in its language and coverage to me. It appears to cover ANY modification (not just the specific ones listed, 2-o-methyl, etc.) based on the following (key phrase, IMO, in caps)

-- sense and antisense strand each comprising 10 or more 2'-deoxy, 2-O-Me, 2'-F OR UNIVERSAL BASE MODIFIED NUCLEOTIDES and 10 or more pyrimidines of the sense and/or antisense strand are 2'-deoxy, 2-O-Me, 2'-F.

My question to you is.....how do we know that the UNA modification doesnt fall into the universal base modification category? I know that ALNY (since acquiring Sirna) has stated that UNA fall sunder their patent umbrella, Do you feel that it is a separate issue that ALNY included in this PR by adding the phrase "OR UNIVERSAL BASE MODIFIED NUCLEOTIDES"?

Anonymous said...

"But seriously, Investron, why not own all three companies, or at least TKMR and ARWR?!"

ARWR is as clear cut as it gets.

Off the chart rewards, very low risks.

As certain as it gets with regard to the science.

Even then look at the butt pounding these two days.

- investron

Dirk Haussecker said...

Mulletman...UNAs contain a specific base and therefore are not universal bases (which can base-pair to any other base which U, C, G, and A don't do).

Anonymous said...

Jun 13, 2014

Arrowhead Issues a Statement on Intellectual Property Protection for ARC-520

PASADENA, Calif.--(BUSINESS WIRE)-- Arrowhead Research Corporation (NASDAQ:ARWR), a biopharmaceutical company developing targeted RNAi therapeutics, today reaffirmed its belief that it has broad access to intellectual property required to develop ARC-520, its clinical candidate against chronic hepatitis B infection. The Company has licenses to relevant patents and patent applications enabling the development and commercialization of ARC-520 in key pharmaceutical markets globally. Arrowhead does not believe there are additional unlicensed patents directed to RNAi therapeutics targeting the hepatitis B virus that affect its freedom to operate.

The company signed a license agreement with Alnylam Pharmaceuticals in January 2012, giving it access to intellectual property that enables the discovery, development, and commercialization of an RNAi therapeutic targeting the hepatitis B virus. Moreover, Arrowhead holds multiple levels of patent protection on ARC-520 including U.S. Patent Nos. 8,313,772 and 8,501,930 covering the Dynamic Polyconjugate (DPC) delivery system, and U.S. Patent Application number 13/535,454 covering ARC-520's siRNA component, which was recently allowed by the U.S. Patent and Trademark Office.

Arrowhead and its legal advisors continually review the patent landscape to ensure freedom to operate and the Company believes that development and commercialization of ARC-520 would not infringe patents governing RNAi therapeutics targeting the hepatitis B virus, including U.S. Patent No. 8,618,277 in the McSwiggen patent estate.

"We are moving ARC-520 as quickly as possible to market and do not believe anything limits our ability to do so," said Christopher Anzalone, Ph.D., Arrowhead's President and Chief Executive Officer. "The roughly 400 million people world-wide with chronic hepatitis B infection currently

_____



Time to shut down this irresponsible blogger.

Find yourself in court, bubba.

- investron

Dirk Haussecker said...

With this press release, Arrowhead only confirmed that they lack access to McSwiggen.

Anonymous said...

Did SAC sell on your advice?

Anonymous said...

From press release:

"Arrowhead and its legal advisors continually review the patent landscape to ensure freedom to operate and the Company believes that development and commercialization of ARC-520 would not infringe patents governing RNAi therapeutics targeting the hepatitis B virus, including U.S. Patent No. 8,618,277 in the McSwiggen patent estate."

"...legal advisors continually review.."

From "continually review", can we infer that ARWR was aware of the McSwiggen patent before yesterday? If so, would give me more comfort.

Anonymous said...

Dirk isn't a lawyer and he isn't in lab- pure entertainment.

Anonymous said...

Dirk,
It might be time to turn the keys over for this blog to Latebloomer. She seems to have surpassed you in her unbiased knowledge of this field.

Perhaps you have been too caught up in making and losing money, and you have gotten too far from what once made this blog an informative place to browse.

It seems the science is now secondary, and biased speculation is now at the forefront.

Best of luck to you, though. I have learned a lot here in the past, and I thank you for that. We all want to get rich investing, but your posts of late seem a little too self serving and transparent to keep reading.

-Shannon Mumford

Sheldon Robbins said...

I enjoyed the commentary. I am a long term investor in TKMR, ALNY, and ARWR. All three companies should do just fine in the next three years. With continued success in the clinic, one or more will be bought out.

Anonymous said...

Dirk, regarding UNAs why don't you re-read your blog from Nov 12 2010 where you seemed to come to a different conclusion...it's clear that your stock portfolio influences your scientific "judgment"

Anonymous said...

Dirk, you should have known from the start that your blog post was in error because you did not consider two key questions: Why would Alnylam license the technology to Arrowhead previously, and then not re-license it now? Why would Arrowhead hold an analyst day next week if its IP was in doubt?

Arrowhead has now put out a PR stating that it is free to operate in these areas, and that its legal team is more on top of these issues than you are.

When do you post a big old "Never Mind" retraction of your foolish blog post?

Dirk Haussecker said...

Regarding UNA/usiRNAs...I still believe it's a 'cheap' workaround strategy from the view of a scientist. On the other hand, even if it's cheap, such a workaround could be quite valuable commercially. I am also not convinced that usiRNAs will necessarily stand up in the courts, but there are more than a few that consider it quite likely to be the case.

Anonymous said...

When will Dirk H. "put out a big old never mind retraction"?

Kidding?

Have you seen one for the prior ones?

He's got them circle-jerking non-stop on the Investorsvillage boards, his old haunt.

It's the revenge of the nerd.

The sensationalist yells fire for attention and he's getting the traffic.

- investron

Anonymous said...

Let's look at this McSwiggen Patent Estate issue another way.

What are the chances of the following:

1. Roche acquires Mirus but its patents don't give Roche wide latitude to operate in the RNAi space.

2. Roche invests hundreds of millions of dollars in Mirus but fails to gain access to fundamental RNAi patents. Roche IP lawyers or decision makers, for whatever reason, drop the ball. Either they know they don't have broad freedom to operate (fto) and fail to rectify it or they believe they have broad fto but actually don't.

3. ARWR acquires the Roche assets, including its patent estate, but now ARWR IP lawyers drop the ball. Upon acquisition, ARWR issues a press release to the effect that they have broad freedom to operate but this is false and inaccurate.

4. ARWR decides they are going to advance their HBV compound that has been developed by the scientists acquired in the Roche acquisition. Somehow they believe that whatever IP they have, it does not include viral targets such as HBV. Therefore, they seek out ALNY in order to gain access to the needed viral IP. ALNY says, no problem, just give us access to your DPC technology for one application and you are free to operate in HBV.

5. Meantime, MRK does due diligence with regard to ARWR's DPC. This entails gaining access to ARWR's technology with ARWR's blessing and cooperation. MRK possesses the McSwiggen patent estate but either does or doesn't say to ARWR, "btw, your HBV candidate infringes on our patents. You know, those McSwiggen patents." If Merck does alert ARWR, ARWR says, "Oh," and then does nothing. (DH blogged at length about Merck's effort regarding ARWR's DPC technology. See his blog post dated April 1, 2013.

6. MRK decides it is going to get out of RNAi altogether but doesn't go to ARWR and say, we are going to sell this to someone, you better pay up or else. Or it does but ARWR says in essence, "McSwiggen, we don't need no damn McSwiggen," without having their IP people look closely at those patents in order to determine whether they need them.

---Can anyone really assert with a straight face that this is a substantial IP problem for ARWR? Personally, I think the more plausible scenario is that ARWR's DPC technology, something that, according to DH, Merck tried to mimick or learn from, has caught the eye of ALNY. They are looking for a cheap way to gain access to this technology and this McSwiggen gambit is the first play. Maybe next ALNY will simply put a candidate using DPCs in the clinic, and, if challenged, assert the IP was acquired from Merck. In essence, they will try to do to ARWR what they tried to do to TKMR. Hopefully, should this come to pass, ARWR's Anzalone will take a page from TKMR and vigorously pursue all legal remedies.

Bottom line, if anyone believes that ARWR and/or Roche failed to do its DD as miserably as DH seems to believe, I have my own Brooklyn Bridge Patent Estate to sell you.

Anonymous said...

Anybody that has ever owned a share of RMBS, IDCC or VHC knows that their is a very long distance between a granted patent and a royalty or an injunction. If ARC-520 is as big of a success as many believe, and ALNY appears to be afraid of, a major could very easily buy or partner with ARWR and sell ARC-520 while fighting it out in he courts with ALNY until the McSwiggen patent suite expires in 2022, when they would either settle for a fair royalty, or most likely settle for pennies on the dollar rather than appeal and litigate for another 5 years. Unfortunately that is the current state of the U.S. Patent litigation system. If ARWR is worried at all about infringement, they would likely initiate a patent re-exam where plaintiffs are currently having a much higher success rate than they should be.

Does anybody know if any of the McSwiggen patents have ver been proven via litigation?

Latebloomer said...

I know that Arrowhead doesn't have a legally binding HBV patent in the US until such a time as a patent for US 35/535454 is officially issued. But it is getting close. As Arrowhead noted in its release, the USPTO has given them a notice of allowance.

From what I can tell,

Sirna's/Alny's 277 patent would NOT be considered prior art to Arrowhead's patent.

filing date for 277: May 25, 2012, with no priority date earlier than that, as far as I can tell.

filing date for ARWR's 13/535454 is June 28, 2012 (which is after the filing date for ALNY's 277);

However, ARWR's 13/535454, has a "priority date" of June 30, 2011 (due to a foreign application made just less than a year earlier), which does predate any date for ALNY's 277 patent application that I can see.

~~~~~

I don't know quite what the implications of the above are EXCEPT to say that ALNY's 277 patent would NOT be considered "prior art" to Arrowhead's 13/535454.

And perhaps that will be important going forward *IF* ARWR's 13/535454 is ultimately granted patent status?

Linda

Latebloomer said...

John Tucker (from twitter) has since informed me that since ALNY's 277 is a CIP from at 2002 patent, the 2002 patent would be considered prior art.

But the 277 patent itself, and its continuations, would not be considered prior art to Arrowhead's application, or would it?

Latebloomer said...

From this - http://tinyurl.com/p5pem2l - it looks like anything *NEW* from ALNY's 277 has to go by 277's filing date, which comes after ARWR's priority date of June 30, 2011 (which would perhaps become quite meaningful *IF* Arrowhead's HBV application is ultimately issed a patent).

Linda

Latebloomer said...

(cont.) If the above is meaningful, then I guess the key question would be: how does Arrowhead's HBV patent application compare to the key McSwiggle patents/patent applications *prior to* the 277 patent?

(I'm afraid I'm confused about what exactly to turn to as the key prior McSwiggle patent application/patent to turn to before the 277 patent; otherwise, I'd post those claims to compare to both ALNY's 277 - to determine what's new - and ARWR's HBV patent application, 13/535454.)

Linda

Latebloomer said...

Whoops!

"McSwiggen," not "McSwiggle."

Linda

Latebloomer said...

It seems that "The Paris Convention" would apply to Arrowhead - regarding its key "priority date" of June 30, 2011, which is just shy of a year earlier than its US filing date of June 28, 2012.

See http://www.intellogist.com/wiki/The_Paris_Convention

"Most importantly, the Paris Convention included the vital concept of “priority". This means that under the Paris Convention, patent applicants are granted the date of their first filing as the active application date for patent applications in all additional Paris Union countries, for up to 12 months after filing the original application. In other words, this means that if an inventor wants to obtain patent protection in multiple Paris Convention countries, he/she needs only to file an application in one of those countries, and the filing date of the first application will be honored and taken as the effective filing date of any other Paris Union country applications that are filed within the next 12 months. This allows inventors to get their international patent filings done over a yearlong period, as opposed to rushing to complete many international patent filings as quickly as possible after the initial invention is completed."

Linda

Latebloomer said...

And yet another twist!

The Hilmer Doctrine

~~~~~

The Hilmer Doctrine - foreign applications as "a shield, but not a sword."

Ah, then Dr. Z informed me of what in the US is called "the Hilmer Doctrine," in which, in the US, foreign application dates can be "a shield, but not a sword." (The Hilmer Doctrine is not the same now, with the newer patent law, but at the time of the ARWR and ALNY HBV patent applications, both in the first half of 2012, the Hilmer Doctrine was still in effect.)

See, for example:

http://www.obvipat.com/2010/07/cafc-weekly-july-9-2010/

"In the Hilmer doctrine, when a US patent application claimed priority of a foreign application, the filing date of the foreign patent application was useful only in defending against references asserted against the application. That is, in arguing against a reference asserted against the application or the patent obtained from the application, the reference had to have an effective date prior to the filing date of the foreign patent application. But when the US patent resulting from the foreign patent application was used as a reference against another application, the effective reference date was the date of the filing of the US application, not the filing date of the foreign patent application. This is usually referred to as the filing date of the foreign patent application being a 'shield, not a sword.'"

Whew! How DO patent lawyers hold it together?

Well, in the end, maybe as Dr. Z suggested, ALNY and ARWR will find their way to a game of chess, rather than war...

Here's Dr. Zoidberg's Post:

tl.gd/n_1s255uo

Linda

Anonymous said...

Doesn't this also mean that Tekmira will be blocked by ALNY in the development of HBV ?

Anonymous said...

ARWR starting back into the $teen now.

Soon the teens will be history as it gets back to the $twenties and beyond.

The science is indisputable and that's where it matters.

All else is just noise.

The only thing left crumbling is Dirk H.'s reputation as a trader without a clue.

Or worse, intentionally misleading stock manipulator.

- investron

Anonymous said...

Dirk Haussecker @RNAiAnalyst
$ARWR I could speculate why Co does not disclose start of new cohorts,but then again some prefer to live in ignorance.

Dirk Haussecker @RNAiAnalyst
$ARWR The best joke by those fanatics is that a small knockdown is best outcome of phase IIa, because of safety.


Maybe you should give it a rest.

Perhaps permanently.

You and your "speculations" are becoming the butt of a joke.

- investron

Anonymous said...

Dirk, you tweeted, "$ARWR The best joke by those fanatics is that a small knockdown is best outcome of phase IIa, because of safety."

Are you referring to the comments made during the May Deutsche Bank presentation by ARWR's Bruce Givens?

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