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Two recent Federal Circuit decisions could undermine early Alice motions.

Anyone who has followed Federal Circuit cases addressing Alice decisions has felt the whip-saw brain squeeze of trying to reconcile them all.  While some clear guidelines have emerged that have made assessing whether a given patent is susceptible to Alice, there remains a thick, gray cloud over how, exactly, the two-step framework applies in practice.  Two recent decisions from the Federal Circuit, Berkheimer v. HP and Aatrix Software v. Green Shades Software, may have established some more concrete guidance on handling early Alice motions in patent cases.

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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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Kite and Juno Continue to Square Off in the Federal Circuit

Despite lingering concerns about the future profitability of Car-T based cancer treatments, there is no doubt that 2017 was a year of great change in the space. From the first FDA-approved product offering to the acquisition of two leading companies, Kite and Juno, by biotech behemoths Gilead and Celgene respectively, 2017 was truly Car-T's year in the sun. While investors in both Kite and Juno were rewarded for their belief in Car-T's commercial potential, it would be a mistake to ignore the ongoing patent dispute between these fierce competitors. 

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Markman Advisors
What is Gilead's exposure from GSK's patent lawsuit against Biktarvy®, Gilead's new integrase inhibitor HIV therapy?

Gilead’s new HIV drug, Biktarvy®, has received FDA approval.  Almost immediately, Gilead was hit with a patent-infringement lawsuit by ViiV Healthcare, which is owned by GSK, along with Pfizer and Shionogi.  What is Gilead’s exposure?

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Will Amgen's latest Neulasta® patent loss against Sandoz read-through to other biosimilars?

Sandoz recently prevailed in court against Amgen by showing it does not infringe a patent covering two of Amgen’s drugs, Neulasta® and Neupogen®.  No biosimilar has yet to receive FDA approval for Neulasata® within the U.S.  Sandoz recently announced successful Phase 1 data indicating it may be getting closer.  Further, other biosimilars for Neulasta® are in the works.  Given that Neulasta® accounts for a third of Amgen’s sales, will Amgen’s recent loss in its case against Sandoz read-through to other biosimilars?

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When do biosimilars launch at risk?

The biosimilar statute, Biologics Price Competition and Innovation Act (BPCIA, was passed in 2010.  Since then, drug companies have been filing biosimilar applications with FDA.  And even though, FDA has approved only nine biosimilar drugs today, an interesting trend may be emerging: biosimilars may be more willing to launch at-risk than small-molecule generics.

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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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Sandoz’s aBLA for HUMIRA® has been accepted by FDA -- what happens next?

Sandoz, the generic arm of Novartis, has announced that its abbreviated Biologic License Application (aBLA) for a Humira® biosimilar has been accepted by FDA.  Now that Sandoz’s aBLA has been accepted for review by FDA, what happens next on the patent front? 

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What is the Dupixent® patent fight among Amgen, Regeneron and Sanofi all about?

Dupixent® is a recently-released drug forecasted to reach $4B in annual sales.  The drug is a co-venture between Regeneron and Sanofi, which also teamed up to launch Praluent®, one of the two available drugs within the new class of PCSK9-inhibitors.  In the case of Praluent®, Amgen brought Regeneron to court arguing that Praluent® infringed Amgen’s patents and thus the drug should be taken off the market.  Once again, Amgen, Regeneron and Sanofi are back in court.  Amgen has squared off against Regeneron and Sanofi and argued that Dupixent® infringes one of Amgen’s patents.

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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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Patent Venue in the Age of Fulfilled by Amazon...

The questions left standing by the Supreme Court's TC Heartland patent venue decision are slowly being answered by District Courts around the country. One question in particular poses an interesting challenge for litigants arguing for or against whether venue is proper: What role if any, do Amazon's Fulfillment Centers play with respect to establishing venue? 

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Markman Advisors
Does Sandoz have a double-patenting defense to Amgen’s Enbrel® patents?

In February 2016, Amgen brought suit against Sandoz in connection with its proposed biosimilar for Amgen’s Enbrel® blockbuster.  The case is on a relatively fast track, currently scheduled to go to trial later this year in April.  Some investors have inquired about whether Sandoz has a strong obviousness-type double-patenting invalidity defense for the ‘182 patent.

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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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What is the take-away from the Federal Circuit’s latest BPCIA decision?

Since the first BPCIA cases hit the courts a few years ago, the Federal Circuit and the Supreme Court have slowly been entangling the knots and confusions around the complicated regulatory scheme.  Innovator companies and biosimilars have wrangled over the “patent dance” and the 180-days notice of commercial marketing, including what’s required, what’s not, and who can leverage a regulatory tactical advantage.  A case between Amgen and Sandoz has helped resolve many of these issues, and this week, the Federal Circuit took another step towards gutting the statute.  What are the take-aways?

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Can you patent blockchain?

Bitcoin is through the roof, and cryptocurrency technologies are drawing significant investment. Yet, regardless of whether bitcoin is a bubble, the long-term story remains that blockchain is slated to be the next potential big disruptive technology. Like any disruptive technology, those thinking ahead, including startups and established institutions, know that acquiring a portfolio of patents on blockchain features or uses could pay enormous dividends years from now. But the Supreme Court’s harrowing precedent in 2014, Alice v. CLS Bank, which has already doomed so many software patents, may create a formidable obstacle to acquiring blockchain patents.

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Jazz and Lupin Play Hide and Seek...

Generic challenges to Jazz's Xyrem continue apace. In the latest development, the Court issued an order compelling Jazz to produce to Lupin copies of the license agreements Jazz had previously reached with other Xyrem generic challengers (namely, Roxane, Wockhardt, and Ranbaxy), with some noteworthy restrictions.

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Markman Advisors
Amgen asks the full Federal Circuit to reconsider its PCSK9 loss

Earlier this year, in October, the Federal Circuit vacated Amgen’s hard-earned injunction against Praluent®, the only other PCSK9 drug competing with its own, Repatha®.  The case has been remanded to the District Court of Delaware for a new trial on the validity of Amgen’s patents.  Before that could happen, however, earlier this week Amgen petitioned the Federal Circuit for en banc review of its October 5, 2017 decision that cut against Amgen.  What are Amgen's chances?

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