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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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Don't Sleep on Settlement...

Judge Hellerstein, however, recently disagreed. His short order upends a lot of conventional thinking about the confidentiality of patent settlement agreements, with its finding that the public interest in transparent court proceedings and in the "legitimate scope" of patent monopolies outweighs the interests of the parties in keeping the agreement confidential. Except for the actual payment amount, the "strong common law and constitutional presumptions of public access" compel disclosure of the other settlement terms in Judge Hellerstein's view. Especially where the the "court and parties should be publicly accountable for private settlement arrangements" involving patent rights that affect the public-at-large. 


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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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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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No Groupons Available for Big Blue Patent Trial

Nothing says summer in Wilmington, Delaware like a full-on patent trial. Especially when the trial involves two brand name companies -- in this case IBM and Groupon -- fighting more over principle than anything else. Sure, IBM has a big demand for over $150mm in damages sitting out there. What's really on trial, however, is IBM's insistence on extracting a toll from e-commerce providers, backed by its getting-creaky-with-age but extensive patent portfolio. And a company on the other side, Groupon, that doesn't feel like IBM's demands are justified.

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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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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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Korlym®: Can Corcept defeat Teva’s motion to dismiss?

Earlier this year, Teva ($TEVA) filed an ANDA to distribute a generic version of Korlym®, and soon thereafter, Corcept Therapeutics ($CORT) commenced a Hatch-Waxman patent suit in federal court in New Jersey.  On June 15, 2018, Teva moved to dismiss the case.  What is this motion all about? And will Teva’s motion prevail?

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Apple Enlists Alice in Qualcomm Battle...

As investors (should) know, the current worldwide patent war between Qualcomm and Apple is perhaps the most important set of ongoing patent litigation there is. As Bloomberg notes in a overview article of the dispute, the stakes are high. Apple faces the possibility of injunctive relief against, most importantly in its key manufacturing site and second-most important sales market, China. For its part, Qualcomm needs to recover billions in lost revenue from Apple (up to $4.5bn, according to some estimates) while maintaining the industry perception that Qualcomm's vast patent portfolio is indispensable and of inordinate value.

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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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Can Kite Pharma reverse its IPR loss challenging Juno’s CAR-T patent?

On June 5, 2018, the Federal Circuit will hear oral argument on Kite Pharma’s ($GILD) appeal of its IPR loss related to Sloan-Kettering’s and Juno Therapeutic’s ($CELG) CAR-T patent.  What issues will it be important to listen for in the panel’s questions?

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