Patent Valuation, Monetization and Investments

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Markman Advisors Patent Blog

by Zachary Silbersher

Posts tagged Revlimid
Are polymorph patents necessarily obvious? A recent CAFC decision may read-through to Revlimid’s polymorph patents.

The Federal Circuit has issued a precedential decision addressing whether a patent covering a given polymorph was invalid as obvious, Grunenthal GmbH v. Alkem Laboratories Ltd.  Though the Court explained that it was not establishing a categorical rule that polymorph patents can never be obvious, the case nonetheless provides important guidelines for when a polymorph patents are likely to be invalid.  For those following Revlimid®’s patent cases, the immediate question is—does the Grunenthal case have read-through to Celgene’s polymorph patents? 

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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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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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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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How important is Celgene’s latest Revlimid® suit against Dr. Reddy’s over REMS patents?

In a slightly new wrinkle in Celgene’s recent Revlimid® saga, Celgene ($CELG) has commenced another suit against Dr. Reddy’s ($RDY).  (This is the third patent lawsuit connected to Dr. Reddy’s proposed generic for Revlimid®.)  In the most recent suit, Celgene asserts five new patents (the ‘720, ‘977, ‘784, ‘866 and ‘531).  The suit was commenced on April 13, 2018 in the federal court in New Jersey, where the other Revlimid® suits are currently pending.  What’s this suit all about?

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Why was the Markman hearing cancelled in Celgene’s Revlimid® patent case against Dr. Reddy’s?

On March 23, Celgene and Dr. Reddy’s informed the Court that they jointly have resolved the single pending claim construction dispute—namely, the construction of the word “crystalline” within the two asserted polymorph patents.  What does this mean for the case?

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Celgene’s New Revlimid® Lawsuits Shows Shifting Tactics From Earlier Natco Case

Celgene faces a new gang of generics moving in on its blockbuster Revlimid®.  Over the past year, a number of generics have filed ANDAs against Revlimid®, including Dr. Reddy’s, Zydus, Cipla, and Lotus Pharmaceutical.  Those ANDAs have triggered corresponding Hatch-Waxman lawsuits from Celgene.  Among the asserted patents, most of them expire by 2022, with the exception of two polymorph patents that could extend Revlimid® monopoly until 2027.  The lawsuits are in their early stages, but an upcoming Markman hearing in the case against Dr. Reddy’s is shaping up to be critical to whether Celgene can protect is Revlimid® monopoly past 2022.  See our recent publication in IPWatchdog outlining the case in more detail.

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