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Does Moderna Therapeutics’ pipeline depend upon its patent dispute with Arbutus Biopharma over mRNA delivery?

Moderna is currently embroiled in an intellectual-property dispute that may be material to its long-term profits, regardless of which of the products in its pipeline eventually succeed.  At least one company, Arbutus Biopharma, has already claimed that Moderna’s tech uses its mRNA delivery technology.  Two pending patent disputes may decide whether Arbutus’ patents are a roadblock to Moderna’s revenue.

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Is Boehringer Ingelheim planning to launch its Humira biosimilar at-risk?

Boehringer Ingelheim has been one of the lone holdouts in AbbVie’s ($ABBV) campaign to delay biosimilar competition against Humira® until 2023.  To date, AbbVie has settled with almost all proposed biosimilars for entry dates in 2023.  Is Boehringer going to launch at-risk?

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What do the Court’s December 4 rulings mean for MorphoSys' Darzalex patent case?

Earlier this week, we blogged about the series of pending summary judgment motions in MorphoSys’ ($MOR) lawsuit accusing Janssen’s ($JNJ) Darzalex® of infringing its patents.  The Court heard oral argument on December 3.  The transcript of that hearing is not currently publicly available.  The Court, however, did issue oral rulings at the end of the hearing that hit the docket on December 4.  What do the rulings mean?

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Will MorphoSys’ Darzalex patent case against Janssen make it to trial, or be stopped at summary judgment?

The Darzalex® patent case commenced by MorphoSys against Janssen is headed towards trial.  Before that, however, the parties recently filed a series of summary judgment motions, and on December 3, 2018, the Court heard oral argument.  Will the Court moot the trial by granting Janssen’s motions to invalidate the patents?

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What are the takeaways from Unified Patents v. Realtime, the PTAB’s first post-AIT RPI decision?

The PTAB has issued its first post-AIT decision, Unified Patents, Inc. v. Realtime Adaptive Streaming, LLC.  In Realtime, the Patent Owner sought to defeat institution by arguing that Unified has run afoul of the AIT decision by failing to identify all RPIs, namely, its members.  The PTAB disagreed and instituted Unified’s IPR.  (The institution decision was entered in October, but the redacted decision issued on November 27, 2018).  How do we square the AIT decision with the Realtime decision?  Will third-party filers, such as Unified and RPX, no longer face RPI issues?

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The CAFC Curbs Personal Jurisdiction For Declaratory Judgment Actions.

A recent precedential case by the Federal Circuit, Maxchief Investments, Ltd. v. Wok & Pan, Ind., Inc., shows that the risk of a DJ action resulting from a pre-suit notice letter may be less troubling for a different reason than the one that preceded TC Heartland—namely, personal jurisdiction.

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A very important CAFC decision for induced infringement: Enplas Display v. Seoul Semiconductor

Today, the Federal Circuit issued an important precedential decision for induced infringement.  The case, Enplas Display Device Corp. v. Seoul Semiconductor Co., Ltd., Case No. 2016-2599 (Fed. Cir. Nov. 19, 2018), indicates that defendants that manufacture and sell components abroad cannot so easily evade induced infringement by claiming ignorance that their products end up within the U.S. market. 

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Why Can't Cisco Stop An Arista Founder From Attacking His Own Patents?

While this decision hurts Cisco’s enforcement efforts, it also suggests that companies that own patents that have been assigned to them by former employees must be careful going forward. Because the inventors of those patents could file IPR petitions to invalidate their own patents. Sophisticated companies should research whether they can contract with departing employees for non-aggression clauses that would preclude filing IPRs against patents owned by the company. As the Federal Circuit has reminded us, with IPRs almost no patent owner is safe…

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Markman Advisors
When did Mylan agree to launch its Herceptin biosimilar?

Mylan’s biosimilar for Herceptin® has FDA approval since December 2017.  Several months earlier, in March 2017, Mylan reached a global settlement with Roche and Genentech regarding their patents covering the drug.  The terms of the settlement have not been made public, which raises the question – when did Mylan agree to launch? 

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Why would acting Attorney General Matt Whitaker’s affiliated invention business, World Patent Marketing, need ex-Israeli Special Ops for security?

The day after the midterms, Trump fired AG Sessions and tapped Mr. Sessions’ chief-of-staff, Matthew G. Whitaker, to serve in the role as acting Attorney General.  Shortly thereafter, the press started to report that Mr. Whitaker was previously an advisory board member for a company known as, World Patent Marketing, before it closed shop following a consent decree with the FTC.  It is worth taking a moment to highlight the need for increased IP literacy.

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If Hatch-Waxman cases are governed by TC Heartland, will that lead to “generic friendly” districts?

Mylan ($MYL) recently prevailed on a motion to dismiss for improper venue in a pending Hatch-Waxman case for the drug Eliquis®.  Mylan successfully argued that Delaware was an improper venue under the recently test for venue in patent cases enunciated by the Supreme Court in TC Heartland.  What are the implications of TC Heartland governing venue in all Hatch-Waxman cases?  Will it lead to “generic friendly” judicial districts?

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Is every individual inventor a patent troll?

Unified Patents recently released statistics on patent lawsuit filings.  The statistics show patent filings to be trending downwards fairly significantly from a peak in 2015.  Yet, the statistics also show that the individual inventor, asserting his or her own patent, is behind many patent suits.  Does that matter? 

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Will damages for infringing a U.S. patent soon reach foreign sales?

In June of this year, the Supreme Court issued a decision in WesternGeco LLC v. Ion Geophysical Corp.  On its face, the case had minimal potential impact because it was limited to a more rarified form of infringement.  Now, however, the District Court in the long-running dispute between Power Integrations and Fairchild Semiconductor has suggested WesternGeco could justify taxing foreign sales for other forms of infringement of a United States patent.  And the Court has also kicked this question up to the Federal Circuit to decide.  Will damages for infringing a U.S. patent soon reach foreign sales? 

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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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