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Posts tagged PTAB
Does the Lotus IPR matter to Celgene’s Revlimid or the Bristol transaction?

We previously blogged about Dr. Reddy’s IPRs filed against MDS patents covering Celgene’s Revlimid®.  Those IPRs attracted considerable attention because they were, for better or worse, one of the few data-points within the Revlimid® patent skirmishes we are guaranteed to see before the Bristol transaction closes.  The Lotus IPR attacking one of Celgene’s multiple myeloma patent is another datapoint.  The PTAB’s decision on whether to institute the IPR is due March 18.  How much does Lotus IPR really matter?

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What to make of Dr. Reddy’s IPR losses for Celgene’s Revlimid patent cases?

Last week, we wrote about milestones to watch for in Celgene’s ($CELG) Revlimid® patent landscape in 2019 that could potentially impact the Bristol Myers ($BMY) transaction.  One data-point that investors were anticipating were institution decisions in three petitions for inter partes review (IPRs) filed by Dr. Reddy’s.  This week, the PTAB denied institution of all three IPRs.  How will those decisions read-through to the overall Revlimid® patent landscape?

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Does Moderna Therapeutics’ pipeline depend upon its patent dispute with Arbutus Biopharma over mRNA delivery?

Moderna is currently embroiled in an intellectual-property dispute that may be material to its long-term profits, regardless of which of the products in its pipeline eventually succeed.  At least one company, Arbutus Biopharma, has already claimed that Moderna’s tech uses its mRNA delivery technology.  Two pending patent disputes may decide whether Arbutus’ patents are a roadblock to Moderna’s revenue.

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What are the takeaways from Unified Patents v. Realtime, the PTAB’s first post-AIT RPI decision?

The PTAB has issued its first post-AIT decision, Unified Patents, Inc. v. Realtime Adaptive Streaming, LLC.  In Realtime, the Patent Owner sought to defeat institution by arguing that Unified has run afoul of the AIT decision by failing to identify all RPIs, namely, its members.  The PTAB disagreed and instituted Unified’s IPR.  (The institution decision was entered in October, but the redacted decision issued on November 27, 2018).  How do we square the AIT decision with the Realtime decision?  Will third-party filers, such as Unified and RPX, no longer face RPI issues?

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Coherus denied institution on Enbrel® IPRs – how does that affect Sandoz?

The PTAB has denied institution of two IPRs filed by Coherus Biosciences against patents covering Enbrel®’s proteins, the ‘182 and ‘522 patents.  The IPRs were not filed by Sandoz, but they will most likely affect Sandoz.  Sandoz already has FDA approval to market Erelzi®, which is its biosimilar for Enbrel®.  And Sandoz is going to trial against Amgen in April.  How do Coherus IPR decisions affect Sandoz's decision to launch at risk?  Or to settle with Amgen?

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The PTAB's Allergan / St. Regis Mohawk Decision: Explained

The PTAB has issued its much-anticipated decision on whether Allergan managed to pull off it’s scheme to avoid IPRs of its Restasis® patents by “selling” the patents to the St. Regis Mohawk Tribe.  On February 23, 2018, the PTAB denied the Tribe’s motion to terminate the IPRs on the ground based on its tribal sovereign immunity.  What were the PTAB’s reasons for denying the Tribe’s motion to terminate the IPRs?  And what are the ramifications for similar deals in the future?

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Sandoz lost two IPRs challenging Humira® patents - what does this mean for other biosimilars?

Sandoz was denied institution on two IPRs against Humira® patents owned by AbbVie.  As we previously discussed, in late 2017, Sandoz filed eight different IPRs against Humira® patents.  Two of those IPRs just failed to reach institution.  What are the take-aways, for Sandoz and any other Humira® biosimilars?

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Can Coherus invalidate Amgen's Enbrel® patents? Part 2

In an earlier post, we discussed the pending IPRs filed by Coherus Biosciences against Amgen’s two patents covering its Enbrel® protein (entanercept).  Whereas our earlier post summarized Coherus’s argument for why the fusion protein claimed in Amgen’s ‘182 and ‘522 patents should be found obvious by the PTAB, this post will summarize Amgen’s preliminary response. 

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Can Coherus invalidate Amgen’s Enbrel® patents?

Amgen’s Enbrel® blockbuster faces encroaching biosimilar competition from Sandoz and Coherus Biosciences.  Coherus Biosciences has filed petitions for inter partes review against Amgen’s two protein patents covering Enbrel®, the ‘182 patent and the ‘522 patent.  The institution decisions are due before the trial:  March 15, 2018 for the ‘182 IPR, and March 13, 2018 for the ‘522 IPR.  If the IPRs are instituted, that could shift the dynamics, and push the parties to agree on an entry date.  What are Coherus's invalidity arguments?

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Latest developments on whether the “litigation waiver” really dooms the Tribe’s assertion of sovereign immunity against the Restasis® IPRs

Allergan’s PTAB Restasis® fight continues, and a recent email tiff before the PTAB between the St. Regis Mohawk Tribe and Mylan has added a further wrinkle to this case.  As we previously blogged, a recent decision by the PTAB (between the University of Minnesota and Ericsson) held that a State’s sovereign immunity against an IPR is waived under the Eleventh Amendment where the State affirmatively asserts the challenged patent in litigation.  That decision appeared to potentially doom Allergan’s strategy of passing off its Restasis® patents to the Tribe to defend against the IPRs.  A recent email exchange between the Tribe and Mylan (the Petitioner in the pending Restasis® IPRs) at the PTAB suggests the University of Minnesota decision may not, in fact, be the nail in the coffin that Mylan had likely hoped.  But it also shows that the Tribe may not be on as sound footing as it is claiming.

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The PTAB’s latest sovereign immunity decision leaves open as many questions as it answers.

In the latest twist in the saga pitting sovereign immunity against inter partes review, the PTAB issued a decision on December 19, 2017 that potentially jams a spoke into the wheels of future partnerships between brand pharma and Tribes.  What does this decision bode for Allergan’s Restasis® deal with the St. Regis Mohawk Tribe?  What are the consequences of this decision?

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