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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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Can Teva’s patents block Lilly’s anti-CGRP Emgality from the market?

The anti-CGRP market is heating.  Amgen’s ($AMGN) Aimovig® received FDA approval in May 2018, and Teva’s ($TEVA) Ajovy® received approval in September.  Hot on their heels, Eli Lilly’s ($LLY) Emgality® just received FDA approval at the end of September.  The drugs will all be sold for essentially the same price of $6900 / year.  Given the tight competition, can Teva use its patents to kick anyone off the market?

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Can Merck resurrect its $200M Sovaldi patent judgment against Gilead at the Supreme Court?

Merck ($MRK) lost a $200M patent judgment against Gilead ($GILD) after the Court found that Merck engaged in business and litigation misconduct.  Merck is now appealing to the Supreme Court, asking to resurrect that judgment.  Will it prevail?

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Will MorphoSys win the Darzalex patent case against Janssen and Genmab?

In 2016, MorphoSys ($MOR) sued Janssen ($JNJ) and Genmab for patent infringement.  MorphoSys claims that Janssen’s anti-CD38 antibody, Darzalex®, infringes three of its patents.  The case is scheduled to go to trial in February 2019.  The stakes are big because the patents purport to cover the actual protein used in Darzalex®, which could mean material royalty rates on sales of Janssen’s drug.  What are the strengths and weaknesses of each party’s case?

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UC loses the CRISPR-Cas9 patent appeal—now what?

The CRISP-Cas9 saga has effectively come to an end.  For now.  On September 10, the Federal Circuit affirmed the decision of the PTAB dismissing the interference between UC and Broad.  What are the implications for UC’s patents? What are the chances UC can successfully appeal to the Supreme Court?

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Korlym: Will Teva prevail on its motion to dismiss the amended complaint?

We previously wrote about Corcept’s ($CORT) amended complaint in its Hatch-Waxman patent litigation against Teva ($TEVA) regarding Korlym®.  On July 27, Teva filed another motion to dismiss.  Corcept opposed the motion on August 21, and Teva filed its reply on August 28.  The motion is now fully briefed.  Who will prevail?

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Did AbbVie create a wrongful “patent thicket” around Humira®?

​​​​​​​Boehringer Ingelheim has claimed that AbbVie wrongfully created a “patent thicket” around Humira®, and it is delaying biosimilar competition.  While that defense is unique, and may be hard to prove on its face, the FDA appears to agree with Boehringer.  Did AbbVie create a wrongful “patent thicket” around Humira®?

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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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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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