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Will AbbVie’s latest patent suit against Sandoz mean a Humira-biosimilar before 2023?

AbbVie ($ABBV) has commenced its latest litigation in its campaign to keep biosimilars for Humira® at bay.  On August 10, AbbVie brought suit against Sandoz ($NVS) asserting that two of AbbVie’s patents will be infringed by Sandoz’s proposed biosimilar.  Sandoz is the fifth biosimilar to throw its hat in the ring.  Does this increase the odds of the US market seeing a biosimilar for Humira® before 2023?

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What are the takeaways from the Remicade® antitrust decision between Pfizer and J&J?

We previously blogged about Pfizer’s ($PFE) antitrust lawsuit against Johnson & Johnson ($JNJ) related to Janssen’s Remicade®.  In short, Pfizer launched Inflectra® in 2016, which is a biosimilar to Janssen’s Remicade®.  Yet, Inflectra® has struggled to eat into Janssen’s monopoly for Remicade®.  Pfizer claims that Inflectra®’s poor sales are due to anticompetitive rebate schemes by Janssen.  Specifically, Janssen forced hospitals and insurers to enter exclusive arrangements and bundled-rebated programs that discouraged them from stocking or covering Inflectra®.  Pfizer sued Janssen in the Eastern District of Pennsylvania.  Janssen moved to dismiss, but on August 10, the Court denied Janssen’s motion to dismiss.  What are the takeaways?

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Can Corcept’s amended complaint hold back Teva’s generic for Korlym®?

We previously discussed Teva’s ($TEVA) motion to dismiss Corcept Therapeutic’s ($CORT) Hatch-Waxman lawsuit commenced in response to Teva’s ANDA for Korlym®.  In response to that motion to dismiss, on July 6, Corcept filed an amended complaint.  What are the implications of that?  And how does the case currently dovetail with the pending patent applications?

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Yes, Judge Plager’s admonishment that district courts stop applying Alice does matter.

 On July 20, in an otherwise unremarkable opinion, the Honorable S. Jay Plager issued a stinging dissent that should resound throughout the patent community—and may, in fact, resound throughout district courts.  See Interval Licensing LLC v. AOL, Inc., No. 2016-2502 (July 20, 2018).  Interestingly, Judge Plager did not dissent from the majority’s holding itself, but rather concurred in the reasoning of the majority.  Instead, and importantly, he dissented in the Federal Circuit’s “continued application of [Alice’s] incoherent body of doctrine.” Judge Plager’s dissent is nothing short of a recommendation that district courts stop applying the Alice doctrine, at least not until resolution of other defenses in the case. Does that matter?

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Will the Federal Circuit’s tribal immunity decision in St. Regis Mohawk Tribe v. Mylan make it to the Supreme Court?

The Federal Circuit has sided against the Tribe and Allergan.  On July 20, the Federal Circuit affirmed the decision by the Patent Trial and Appeal Board that denied the motion by the St. Regis Mohawk Tribe to terminate a series of inter partes review proceedings commenced by Mylan ($MYL) against patents listed in the Orange Book for Allergan’s ($AGN) drug Restasis®.  What are the takeaways from this decision?

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Will Nevro win its patent suit against Boston Scientific over its high-frequency SCS therapy?

Nevro Corp. ($NVRO) claims to have invented pioneering technology for improving the life of individual suffering from chronic pain.  Nevro’s product, the Senza® system, received FDA-approval in May 2015.  Rather than relying upon opioids, the Senza® system uses innovations for spinal-cord stimulation (SCS) therapy.  In 2016, Nevro sued Boston Scientific ($BSX) for copying its patents protecting its innovative SCS therapy.  The case is scheduled to go to trial in November of this year, but the Court has already issued preliminary rulings that show a mixed bag of wins and losses for both parties.  Where is this case heading?

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Has the entire-market-value rule survived the CAFC’s decision in Power Integrations v. Fairchild?

Every year, it seems, the Federal Circuit issues a precedential decision on damages, which seems to make the whole process more difficult.  The latest of these decisions comes in the long-running patent battle between Power Integrations and Fairchild.  In its latest opinion, the Court addresses the entire-market-value rule.  The Court essentially guts the rule, and leaves open the question whether there is an reasonable scenario where it will ever be applicable.

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How important are UC’s two new CRISPR patents?

UC was recently awarded two patents on CRISPR technology.  UC is currently embroiled in a highly-watched dispute with the Broad Institute over who owns the heralded first patents covering CRISPR-Cas9 in plant and animal cells.  (We previously blogged about the dispute here and here.)  While that dispute remains pending, the question remains how important UC’s two new CRISP patents are?  How much will they impact the overall intellectual-property being claimed over the burgeoning CRISPR-Cas9 technology?

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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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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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