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iRobot vs. SharkNinja: What should investors expect from the patent battle?

A veritable patent storm has developed between two purveyors of robotic vacuum cleaners, iRobot ($IRBT) and SharkNinja.  In September 2019, SharkNinja launched the Shark IQ Robot, which iRobot claims is a knock-off of its highly-innovative Roomba® “i” and “s” Series products.  By October 15, 2019, the parties had each filed their own lawsuits, and iRobot has asked a Court to immediately enjoin the Shark® IQ Robot from the market in advance of the critical holiday shopping season.  What can we make of these cases?

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Will Teva’s PGR against Corcept’s ‘214 patent covering Korlym be instituted?

The saga over Corcept Therapeutics’s ($CORT) patent battles against prospective generics for Korlym® is approaching another stage.  We previously discussed Teva’s ($TEVA) petition for post-grant review (PGR) of the ‘214 patent.  Corcept has filed its preliminary response to Teva’s PGR, and the PTAB is scheduled to decide whether or not to institute the PGR by about November 23, 2019.  The ‘214 patent is potentially the strong patent Corcept is currently wielding against generics, since it arguably does read upon Korlym®’s label.  Now that the papers are in, what are the odds Teva’s PGR is instituted? 

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Will Bio-Rad’s patent fight stop 10x Genomics’ trajectory?

10x Genomics ($TXG) launched its IPO on September 12, trading up as much as 49% on its debut.  While the market is rewarding the company’s prospects, its lingering patent fight with Bio-Rad Laboratories ($BIO) continues.  Bio-Rad and 10x have been locked in a patent battle over technology allegedly covering most of 10x’s products.  The case, which has been pending since 2015, is now heading to appeal.  10x suffered a fairly significant loss at the jury trial, after which the court ordered an injunction against essentially all of 10x’s products.  Earlier this year, 10x launched a redesigned product to circumvent, Next GEM, to circumvent the injunction.  Yet, on the eve of 10x’s IPO, Bio-Rad hit 10x with another patent suit, now directly targeting 10x’s Next GEM product.  Can Bio-Rad’s patents stop 10x’s trajectory? 

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Should NPE patent-aggregators be worried about violating antitrust law?

The Federal Circuit recently ruled on a case brought by Intellectual Ventures against Capital One ($COF).  The case is Intellectual Ventures I LLC v. Capital One Financial Corp., 2018-1367 (Fed. Cir. Sep. 10, 2019).  While the underlying case arose out of IV’s assertion of its patents against Capital One, the appeal focuses on Capital One’s counterclaim that IV was an unlawful monopolist by aggregating a series of patents and asserting them through litigation.  Capital One lost the appeal.  But the question remains – how much teeth do antitrust counterclaims have against aggregating and enforcing patents through litigation?

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Will Amgen’s PCSK9 loss read-through to patents covering other biologics drugs?

The long-running patent dispute between Amgen ($AMGN) and Regeneron($REGN) and Sanofi over their competing PCSK9-inhibitors (Repatha® and Praluent®) has reached another milestone.  The case also represents another milestone in the changing landscape for patents covering biologic drugs.  The Amgen decision is at least the second district court decision this year that has invalidated biologic antibody patents under the doctrine of enablement.  The earlier decision related to MorphoSys patents asserted against Janssen related to Darzalex®.  The takeaway is clear:  as biologic drugs take up a larger share of the pharmaceutical medications in the U.S., courts are making it harder for drug companies to use overly-broad patents to corner the market on a particular inhibitor.

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Korlym® faces another potential generic from Sun Pharma

Another generic has filed an ANDA with the FDA for a license to distribute a generic version of Korlym®.  Teva is no longer the only company seeking to sell generic Korlym®, which therefore increases the likelihood that Corcept Therapeutics ($CORT) will face a generic competitor for its main drug at some point in the future.

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Can Sentaor Rubio really block Huawei from pursuing patent infringement against Verizon?

It’s rare that patents make the mainstream news, and even more rare that one company’s allegation of patent infringement touches—even remotely—on issues of national security.  Yet, that appears to be happening with U.S. Senator Marco Rubio’s proposed legislation to block Huawei from seeking relief for infringement of its granted U.S. patents.  There isn’t really much precedent for legislating that a certain set of patents are unenforceable.  Can this really happen?

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Comcast can't take six shots against a Rovi patent in PTAB...

Yes, the PTAB declined to institute 5 out of 6 of Comcast’s IPRs. At the same time, the PTAB did not say there was anything per se wrong with Comcast’s multiple attacks on a single patent, even as it paid lip service to the “potential for abuse of the review process” by filing multiple petitions. For Comcast, therefore, there is not much downside to the PTAB’s decision, especially since the ‘363 patent has already been deemed likely invalid. For Rovi - and other patent owners for that matter - there is little solace in the PTAB determining that 6 IPRs against a single patent is overkill in this particular case. For them, even one IPR can be deadly to their property rights…

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Markman Advisors
What are the lessons from Boehringer’s settlement with AbbVie over its Humira biosimilar?

And just like that, it’s over.  Boehringer Ingelheim has thrown in the towel in its patent fight with AbbVie over Boehringer’s proposed biosimliar for Humira®.  Boehringer was a lone hold-out among a long line of proposed biosimilars for AbbVie’s blockbuster.  Boehringer’s distinction was that it had raised a unique defense, namely, arguing that AbbVie had built an unfair “patent thicket” around Humira® that was unenforceable.  We previously blogged about Boehringer’s “unclean hands” defense here and here and here.  Now that Boehringer has settled, what are the larger lessons for future biosimilar patent fights?

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Another reason drug prices are too high: drug companies can patent an FDA mandate.

High drug prices remain in the news.  A recent precedential decision from the Federal Circuit shows that certain drug prices will stay high if drug companies can simply take a mandate from the FDA, which was not their idea, and file a patent on it, thereby cornering the market on all IP around that mandate.  The case is Endo Pharmaceuticals Inc. v. Actavis, LLC, Case No. 2018-1054 (Fed. Cir. May 3, 2019).

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The Valueless Method Patent in Hologic v. Minerva...

Senior Judge Joseph F. Bataillon of the District of Delaware issued a comprehensive ruling on the various post-trial motions filed by the parties. As his decision notes, during the pendency of the post-trial motions the Federal Circuit decided to affirm an earlier IPR decision cancelling claims (including the asserted claims) from the ‘183 Patent. Which therefore tasked the Court with deciding whether the invalidation of one of the two patents underlying the jury verdict would impact on the damages award.

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Markman Advisors
Will Amgen win another injunction against Regeneron’s Praluent?

Amgen ($AMGN) is about to square off once again against Regeneron ($REGN) and Sanofi over whether Praluent® should be pulled from the market.  Having prevailed at another jury trial earlier this year showing that Amgen’s PCSK9 protein patents are both valid and infringed, Amgen has renewed its bid for a court order enjoining Praluent® from the market.  The injunction hearing is scheduled for June 2019.  Over two years ago, Amgen prevailed after an earlier injunction hearing where the court ordered Praluent® to be barred from the market.  Will Amgen be able to prevail again? 

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What happens when a district court and the PTAB disagree over the validity of a patent?

In a recent district court decision from the District of Delaware, the court granted a preliminary injunction, and ordered the defendant to pull the accused products, even though, a few months earlier, a Final Written Decision by the PTAB in an inter partes review proceeding held all asserted claims of the patent-in-suit unpatentable.  What was the court’s reasoning?  And what are the implications?

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Will patents save the unicorns? No, they won’t.

This is the year of the unicorns.  Or maybe just the year of unicorns going public.  Firms including Lyft, Uber, AirBnB, WeWork and Pinterest either have, will or are contemplating going public.  Last week, The Economist published an interesting briefing on unicorns.  The primary thesis is that they are overvalued.  At heart, their users are not faithful, and barriers to entry won’t stop competitors from encroaching on their base.  Yet, for all the reasons unicorns try to downplay this concern, there’s no mention of patents and IP as a line of defense.  Why not?

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Federal Circuit clarifies patent-eligibility for diagnostic method patents: Endo v. Teva and Natural Alternatives v. Creative Compounds.

The Federal Circuit has recently issued two precedential decisions that clarify when method-of-use and diagnostic patents are directed to eligible subject matter rather than natural laws.  Some clear guidelines are solidifying that should make enforcement of these principally pharmaceutical-type patents easier to handicap.

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Are polymorph patents necessarily obvious? A recent CAFC decision may read-through to Revlimid’s polymorph patents.

The Federal Circuit has issued a precedential decision addressing whether a patent covering a given polymorph was invalid as obvious, Grunenthal GmbH v. Alkem Laboratories Ltd.  Though the Court explained that it was not establishing a categorical rule that polymorph patents can never be obvious, the case nonetheless provides important guidelines for when a polymorph patents are likely to be invalid.  For those following Revlimid®’s patent cases, the immediate question is—does the Grunenthal case have read-through to Celgene’s polymorph patents? 

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The lesson from Theranos is that investors do not know how to read a patent.

Theranos’ patents may have assured investors that the company was a good bet, but that does not mean those patents were a failure of the patent system.  Rather, the patents illustrate a deficiency of IP literacy.  Investors—and recent commentators still—have taken the patents to mean something they are not.  Indeed, the patents—and the file histories behind them—have been public for years. Those patents and file histories revealed many red flags that were apparently ignored. 

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Is Novartis’ S1P modulator titration patent a “roadblock” to Celgene’s ozanimod?

While Bristol Myers ($BMY) proposed acquisition of Celgene’s ($CELG) remains in question by activists questioning Revlimid®’s pending patent cliff, a new patent angle emerges.  A Credit Suisse analyst recently identified a patent owned by Novartis ($NVS) that could purportedly act as a “roadblock” to Celgene’s MS drug ozanimod.  Is this true?

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