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Posts tagged IPR
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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Is Corcept’s new Korlym lawsuit a game-changer against Teva?

Corcept Therapeutics ($CORT) recently filed a new lawsuit against Teva ($TEVA) related to Teva’s proposed generic for Korlym®.  The new suit asserts three new patents that were recently listed in the Orange Book.  Are the three new patents a game-changer?

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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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Three milestones to watch for in 2019 that could impact generic entry for Celgene’s Revlimid.

Since announcing the pending acquisition of Celgene ($CELG) by Bristol Myers ($BMY), investors have focused upon the patent-cases involving Revlimid®.  There are multiple cases and petitions for inter partes review (IPRs) at various stages of resolution.  The key question among investors is whether there will be any key milestones in those cases--especially during 2019 before the Bristol acquisition closes—that will clarify exactly when any of the pending generics will enter.  In this post, we identify three potential milestones to watch for from the Revlimid® patent landscape in 2019. 

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Will Celgene and Dr. Reddy’s settle the Revlimid dispute now that Bristol Myers is at the table?

Celgene ($CELG) has announced plans to be acquired by Bristol Meyers Squibb ($BMY).  A settlement conference is scheduled in the Hatch-Waxman patent case between Celgene and Dr. Reddy’s on January 10, 2019.  Now that Bristol Meyers is at the table, will the parties be able to reach a settlement that couldn’t be reached before?

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The Federal Circuit sends a message about attorneys’ fees in Spineology v. Wright Medical

A recent precedential decision from the Federal Circuit sheds important light on how the Court views attorneys fees in patent cases.

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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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Is Boehringer Ingelheim planning to launch its Humira biosimilar at-risk?

Boehringer Ingelheim has been one of the lone holdouts in AbbVie’s ($ABBV) campaign to delay biosimilar competition against Humira® until 2023.  To date, AbbVie has settled with almost all proposed biosimilars for entry dates in 2023.  Is Boehringer going to launch at-risk?

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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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When did Mylan agree to launch its Herceptin biosimilar?

Mylan’s biosimilar for Herceptin® has FDA approval since December 2017.  Several months earlier, in March 2017, Mylan reached a global settlement with Roche and Genentech regarding their patents covering the drug.  The terms of the settlement have not been made public, which raises the question – when did Mylan agree to launch? 

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Roche prevails on two IPR challenges to Herceptin patents—does it matter?

We previously wrote about Roche’s encroaching biosimilars for Ritxuan®, Herceptin®, and Avastin®.  This week, Roche prevailed on two IPRs covering patents for Herceptin®, but lost a third IPR covering another patent for the same drug. What does this mean? 

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Why did Dr. Reddy’s file three IPRs against Celgene’s Revlimid patents?

On August 3, Dr. Reddy’s filed three petitions for inter partes review (IPR) against three patents owned by Celgene and listed in the Orange Book for Revlimid®.  Does this indicate that Celgene and Dr. Reddy’s are close to a settlement?  If not, what are the take-aways?

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Can Unified Patents survive the Federal Circuit’s RPI decision?

The Federal Circuit recently issued a strong decision instructing the PTAB to rethink the way that it decides who is an RPI (real-party-in-interest).  While the decision involved RPX, it presents a more existential threat to Unified Patents, which has risen as one of the most prolific non-party filers of IPRs.  Can Unified survive the CAFC’s RPX decision?

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How long can Roche keep back biosimilars for Avastin®, Herceptin® or Rituxan®?

The biosimilars are biting.  And they are biting at three big biologics distributed by Roche through its biotech subsidiary, Genentech.  Roche currently faces pending biosimilar competition against Avastin® (bevacizumab), Roche’s biggest selling cancer drug, Herceptin® (trastuzmab), Roche’s breast-cancer drug, and Rituxan® (rituximab), Roche’s immunotherapy drug.  All three drugs are involved in patent litigations. How long will these cases last? And how long can Roche keep the biosimilars out?

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Senator Hatch Thinks Some Industries Deserve Patents More Than Others

Senator Orrin Hatch (R-UT) recently proposed an amendment to the Hatch-Waxman Act that would significantly upset the availability of petitions for inter partes review (IPR) for generic pharmaceutical companies.  Senator Hatch appears to believe that brand pharmaceutical companies deserve patents more than others.  

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Takeaways from the Tribe’s Oral Argument at the Federal Circuit: St. Regis Mohawk Tribe v. Mylan

On June 4, 2018, the Federal Circuit heard oral argument in Allergan’s effort to assert tribal immunity at the PTAB to shut down six IPRs against its Restasis® patents.  The St. Regis Mohawk Tribe has appealed the PTAB’s prior decision that it cannot assert its immunity as a basis to terminate the IPRs.  While there was no clear indication for how the three-judge panel at the Federal Circuit would rule, there were some interesting exchanges revealing how the Court views these types of transactions, and how viable they may be in the future.

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Startups want a strong patent system—they just don’t know it yet.

This week’s edition of The Economist addresses an interesting spin on the prospects of budding Silicon Valley startups living under the shadow of Big Tech.  The fantasy of getting bought is being supplanted by the reality of getting taken out.  The Economist argues that startups now live within a kill zone maintained by Big Tech—either sell out on our terms, or we’ll co-opt your technology and launch our own product.  While antitrust may be one solution to give more leverage to innovators, what about patents?

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How will Oil States impact VirnetX? Will VirnetX's damages be increased to $1.5B?

Our earlier post on VirnetX’s recent $502M jury verdict commended the company and its counsel on an incredible win, but nevertheless pointed out that it might be for naught.  The patents asserted in the trial for the $502M damages currently stand invalid pursuant to petitions for inter pares re-examination and inter partes review.  But what about Oil States?  The case is currently pending before the Supreme Court, and it addresses the constitutionality of petitions for inter partes review (IPR).  The case has already heard oral argument, and a decision is expected imminently.  Some commentators have suggested that if the Supreme Court holds IPRs unconstitutional, then that will vacate the invalidity decisions of VirnetX’s patents from the PTAB, and nothing will finally stand in the way of VirnetX’s damages.  What are the considerations that may keep alive VirnetX's prospect of collecting damages?

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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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