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Arbutus Biopharma Corporation (ABUS)

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3.3200+0.1500 (+4.73%)
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3.1100 -0.21 (-6.33%)
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  • G
    GuyGuy
    3/22/2021 - Appeal from the United States Patent and Trademark Office,
    Patent Trial and Appeal Board in No. IPR2019-00554
    JOINT MOTION TO DESIGNATE APPEAL NO. 2020-1184, -1186 & NO.
    2020-2329 AS COMPANION CASES AND COORDINATE ORAL ARGUMENT
    For the reasons explained above, Arbutus and Moderna jointly request that
    Appeal No. 2020-1184, -1186 and Appeal No. 2020-2329 be made companion
    cases and coordinated for purposes of oral argument. The parties further
    respectfully request that oral argument in Appeal No. 2020-1184, -1186, which is
    scheduled for April 9, 2021, be taken off the calendar in favor of hearing both
    cases on the same day following completion of briefing in Appeal No. 2020-2329.
  • S
    Sebas
    Modera and Pfizer both are saying RNA would be the future and they both are going to make more and more medicine based on RNA, COVID Vaccine is not the end for ABUS, I am on this for a long haul, patience will prevail and make you a future millionaire.
  • G
    GuyGuy
    Zachary Silbersher
    Update July 23, 2020: Moderna loses IPR for ‘069 patent. All 22 claims of patent upheld. Decision is available at PTAB website here for AIA Review Number IPR2019-00554.
    Update July 28, 2020: We published a post addressing whether Moderna’s COVID-19 vaccine is using Arbutus’ patents here.
    We previously blogged about an ongoing patent fight between Moderna Therapeutics ($MRNA) and Arbutus Biopharma ($ABUS). That fight could implicate whether Moderna’s pipeline depends upon technology that is patented by Arbutus. Moderna has sought to invalidate three patents owned by Arbutus, and has so far met with mixed success. Who is winning this fight?
    As we previously discussed, Moderna’s pipeline relies upon drugs that harnesses a patient’s own protein-making machinery to essentially manufacture its own therapeutic protein. One method is through lipid nanoparticles, or LNPs. Moderna previously licensed mRNA delivery technology using LNPs from a small Canadian company called Acuitas. Acuitas had itself acquired a license to this technology from Arbutus. Arbutus subsequently claimed that Acuitas’ sublicense to Moderna was improper, and won a preliminary injunction in Canada against Acuitas’ sublicense.

    In connection with this settlement, in a February 22, 2018 press release, Arbutus stated: “The settlement stipulates that the four non-exclusive viral vaccine sublicenses previously granted to Moderna are the only sublicenses to survive. These four sublicenses, previously granted by Acuitas to Moderna under the pre-April 15, 2010 Arbutus LNP patent families, are each limited to a specific viral target. Moderna has no other rights to Arbutus’ broad suite of LNP intellectual property.”

    Right around that time, Moderna began challenging the validity of patents owned by Arbutus that appear to cover its LNP technology. On February 21, 2018, Moderna filed a petition for inter partes review (IPR) against Arbutus’ U.S. Patent No. 9,404,127. On March 5, 2018, Moderna filed another IPR against Arbutus’ U.S. Patent No. 9,364,435. And on January 9, 2019, Moderna filed a third IPR against Arbutus’ U.S. Patent No. 8,058,069.

    Two of those IPRs have now reached final decisions, and the third remains pending. In the first IPR against the ‘127 patent, Moderna prevailed. On September 10, 2019, the PTAB issued a Final Written Decision that invalidated all claims of the patent. In the second IPR against the ‘435 patent, Moderna had mixed results. On September 11, 2019, the PTAB issued a Final Written Decision that invalidated some of the claims (1–6, 9, 12, 14, and 15), but upheld the validity of other claims (7, 8, 10, 11, 13, or 16–20).

    We anticipate that appeals will be filed in both of these IPRs. The time to notice appeals to the Federal Circuit will expire before mid-November. To the extent the parties do not reach some form of settlement beforehand, Arbutus is likely to appeal both IPR decisions, and Moderna is likely to appeal the PTAB’s decision to uphold certain claims of the ‘435 patent. To the extent that the Federal Circuit upholds the final decisions of the PTAB, then theoretically Moderna will not have to worry about the ‘127 patent or several invalidated claims from the ‘435 patent.

    For the third IPR against the ‘069 patent, on July 24, 2019, the PTAB granted institution of Moderna’s petition. The ‘069 patent is a parent of the ‘435 patent. Does that mean that the results of the IPR against the ‘435 patent may read-through to the IPR against the ‘069 patent? Quite possibly. Both IPRs rely upon the same prior art, and more importantly, they also rely upon the same three prior-art combinations as grounds for challenging the claims. Put another way, those features of the ‘435 patent that were deemed patentable over those same prior art combinations should, theoretically, survive a validity challenge in the IPR challenging the ‘069 patent.

    Putting that aside, the biggest takeaway right now is that at least some claims of one patent (the ‘435 patent) have been upheld by the Patent Office. In light of that decision, the next immediate question is whether Moderna is using technology covered by those claims. That would include claims 7, 8, 10, 11, 13, or 16–20 of the ‘435 patent.

    This raises another related question, namely, why did Moderna file these IPRs in the first instance? Arbutus has not sued Moderna for patent infringement of any of the three patents challenged by Moderna. Thus, Moderna’s choice to file the IPRs was not purely a defensive reaction to contain a lawsuit. If that was the case, it would be harder to conclude that Moderna was particularly concerned that it was necessarily using Arbutus’ LNP technology.

    Rather, by filing the IPRs pre-emptively, does that mean Moderna may have concerns that its LNP technology may infringe Arbutus’ patents? If so, now that the ‘435 patent’s validity has been upheld, those concerns would presumably be exacerbated.
  • S
    Sebas
    Update: Moderna released an updated statement Friday afternoon saying that the LNPs used in its Covid-19 vaccine, mRNA-1273,  are not part of the disputed intellectual property. “Moderna is not aware of any significant intellectual property impediments for any products we intend to commercialize, including mRNA-1273,” they said. 

    For years, Moderna has been battling a tiny Pennsylvania biotech over patents for a technology required to deliver its mRNA drugs and vaccines. Yesterday, a ruling came down at what might be the most inopportune time for Moderna, potentially delaying their Covid-19 vaccine or cutting into the potential profits that quintupled their stock in less than 5 months.

    The US Patent and Trademark Office ruled that Arbutus Biopharma’s patents on that delivery method, known as lipid nanoparticles or LNPs, were not invalid, as Moderna had claimed.

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    The decision means that Arbutus could potentially stake a claim to the Covid-19 vaccine Moderna is planning to put into Phase III next week. They could do so either by filing an injunction to halt development or commercialization of the vaccine altogether — a potentially risky PR move amid a generational pandemic. Or by staking a claim for royalties — a move that, with a relatively low-margin product like vaccines, could chip at Moderna’s expected profits.

    Moderna’s share price immediately fell 10%, continuing a roughly $20 slide that began last Friday, amid word of pending data on AstraZeneca and Oxford University’s coronavirus vaccine. Arbutus, which began Thursday trading at less than $3, has more than doubled.

    All of that, though, is just potential for now. Arbutus has not indicated how they intend to proceed. Moderna has not said whether they plan to appeal the ruling to a federal court.

    It is not even clear whether or not the patent, known as ‘069, actually applies to Moderna’s Covid-19 vaccine, mRNA-1273. Moderna put out a statement Friday afternoon saying that it was not.
  • G
    Good
    It's a loss if you sell it, but you'll make a profit if you wait. The lawsuit against Modern has yet to come out, but the royalties from Bntx are certain. I think the royalty from Bntx alone is 10 times higher than the price of abus. May earnings will be at least 5 times more sales than last year's Q4. Wait. The earnings results will be an earnings surprise in the next month.
  • J
    John 5x25x56
    Moderna TX, Inc. v. Arbutus Biopharma Corporation
    Case Number 20-2339
    US Court of Appeals, Federal Circuit

    I can not discover and additional info regarding this case. If there is an attorney here, by all means, led the way.
  • x
    xxx
    anyone know why abus website does not have secured certificate? does not look good for its image of a high tech company.
  • J
    JC
    $ABUS $MRNA Oral Argument in Arbutus LNP Patent Dispute Set for April 9
    The appeals court has scheduled oral argument for Moderna's challenge of an Arbutus LNP patent. The PTAB found that Moderna failed to demonstrate some claims invalid. We think Moderna has an uphill battle for a reversal. Importantly, it remains unclear if this dispute actually matters to Moderna. The Federal Circuit appeals court has scheduled oral argument on 4/9 for one of the three Arbutus LNP patents that Moderna has challenged in inter partes review (IPR). In the challenge of this patent (9,364,435), the Patent Trial and Appeal Board (PTAB) found that Moderna failed to demonstrate that some of the challenged claims are unpatentable. Moderna is seeking to get the PTAB decision on those claims reversed or have the case remanded back to the PTAB for a second look.

    Does this dispute matter with respect to Moderna's COVID-19 vaccine? Based on our review of the Moderna's PhIII protocol and various agency documents, we have seen no evidence that Moderna's LNP has the four components (a cationic lipid, a PEG-based lipid, a phospholipid, and cholesterol) in the percentages required by the Arbutus patents. Although some investors have pointed to preprint articles on the early-stage development of Moderna's vaccine as suggesting that it has the patented percentages, we note two points. First, mgt. has said that those preprint articles do not reflect the actual percentages in Moderna's COVID-19 vaccine. Second, a document from the EMA (here) states that the lipid percentages were modified during the PhIII trial: "the lipid concentrations [of Moderna's vaccine] were slightly modified during manufacture for Phase III." We thus continue to believe that no evidence indicates that Moderna's commercially marketed COVID-19 vaccine literally infringes this Arbutus patent. As we explained in another note (here), though, even if Moderna's LNP does not literally infringe Arbutus's patent, Arbutus could sue Moderna for patent infringement under the doctrine of equivalents, if Moderna's percentages are different from but similar to the patented percentages. Indeed, in a brief that Moderna recently filed in a dispute on another Arbutus patent (Fed. Cir. 20-22329), Moderna said that "there is a substantial risk that Arbutus will sue Moderna for infringement.
    When can we expect any litigation to arise between Moderna and Arbutus? We think that if this patent survives the appeal, if Arbutus will ever sue Moderna on this patent, it will do so shortly after the appeal decision. That is, if Arbutus does not sue Moderna within a few months after an appeal decision upholding the validity of at least one patent claim, we think it will become less and less likely that Arbutus will ever sue Moderna on its LNP patents.

    As an alternative to litigation, we note that after any patent decision upholding the validity of at least one patent claim, Arbutus may seek to settle its disputes with Moderna. In that case, Moderna may have to pay a low-to-mid-single-digit royalty.

    When will the Federal Circuit appeals court likely issue a decision? The Federal Circuit typically takes up to four months to issue a decision after oral argument. Given that the oral argument is scheduled for April 9, that would take us to August 9, 2021. Thus, a decision could be issued shortly after April 9 and up until around mid-August. Will the oral argument be available to the public? Yes. Given the pandemic, the Federal Circuit has made all oral arguments available to the public live.
  • S
    Sebas
    does any one know what time the Court argument about LNP Patent is tomorrow
  • I
    Ingrid
    Who delete my message? My question: April 9 - was this a fake message? Who knows something about it?
  • S
    Sebas
    Shwaab Index Fund and Susquehanna International LLP Invested in ABUS in the last 5 days

    https://fintel.io/so/us/abus
    ABUS Institutional Ownership Arbutus Biopharma Corporation
    fintel.io
  • C
    Courtney
    2.75 here we come
  • T
    Terry
    Good news ABUS signs research agreement for Coronaviruses. Also very interesting one of the partners is Proteros who already has direct affiliations with Biontech. This should provide a little jump in the stock price.
  • N
    Nick
    at 9th April court Moderna against Abus. if abus will win it will go up to the moon
  • x
    xxx
    There are no lawsuits on abus royalties. The lawsuits were a challenge on abus patents. Best case abus can keep its patents. Management needs to sell to keep from being bullied by the big boys.
  • O
    One of few words
    Fairly steady, if not spectacular, rise in the share price today. Wonder if there still might be some sort of settlement prior to the hearing.
  • S
    Sebas
    folks be ready for $9 today
  • x
    xxx
    another day, another lawsuit. did anyone sue abus today?
  • C
    Courtney
    Can anyone confirm if this is the first scheduled court date, if so I wouldn’t be surprised if it isn’t postponed.