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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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Does the Lotus IPR matter to Celgene’s Revlimid or the Bristol transaction?

We previously blogged about Dr. Reddy’s IPRs filed against MDS patents covering Celgene’s Revlimid®.  Those IPRs attracted considerable attention because they were, for better or worse, one of the few data-points within the Revlimid® patent skirmishes we are guaranteed to see before the Bristol transaction closes.  The Lotus IPR attacking one of Celgene’s multiple myeloma patent is another datapoint.  The PTAB’s decision on whether to institute the IPR is due March 18.  How much does Lotus IPR really matter?

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Does UC’s new CRISPR-Cas9 patent really cover eukaryotes?

In the latest episode in the long-running CRISPR-Cas9 patent battle between the University of California and Broad, UC has obtained a new patent related CRISPR-Cas9.  UC has touted this patent, as well as another expected to issue shortly, as “useful to locate and edit genes in any setting, including within plant, animal, and human cells.”  So, did UC just win patents covering CRISPR-Cas9 in eukaryotes?  How does this square with the patent interference that UC recently lost at the Federal Circuit on this very issue?

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Does Uniqure or Spark Therapeutics own the key patents covering FIX-Padua for hemophilia B?

Uniqure ($QURE) and Spark Therapeutics ($ONCE) are squaring off over who will soon provide the best haemophilia B gene therapy.  Meanwhile, the companies have acknowledged that intellectual property issues may be critical to which drug will come out on top.  Will the patent issues cloud either drug’s commercial performance?

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What to make of Dr. Reddy’s IPR losses for Celgene’s Revlimid patent cases?

Last week, we wrote about milestones to watch for in Celgene’s ($CELG) Revlimid® patent landscape in 2019 that could potentially impact the Bristol Myers ($BMY) transaction.  One data-point that investors were anticipating were institution decisions in three petitions for inter partes review (IPRs) filed by Dr. Reddy’s.  This week, the PTAB denied institution of all three IPRs.  How will those decisions read-through to the overall Revlimid® patent landscape?

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District of Delaware Makes it Harder to Corner the Market on Antibody Patents in MorphoSys v. Janssen

See our post in IPWatchdog. “The case is important to the growing body of patents covering biologic drugs because it delineates more precisely when functionally-claimed antibody patents can survive enablement and written description challenges.”

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MorphoSys loses its Darzalex patent case against J&J—what happens next?

Morphosys’ ($MOR) patent trial against Janssen ($JNJ) and Genmab was headed for trial in February.  In advance of that trial, however, the parties traded numerous summary judgment motions.  On January 26, Genmab announced that the District Court granted its motion to invalidate the asserted patents.  What happens next?

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For Amgen’s PCSK9 patent case, is there any read-through from Court’s summary judgment order to the trial?

On January 18, the District Court in Delaware issued an opinion resolving multiple summary judgment motions filed by both parties.  The key takeaway from that decision is that the case is now teed-up for trial beginning on February 19. But the Court didi highlight some key issues likely to be the focus of the trial.

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Did Corcept and Teva tell the Court they are about to settle the Korlym patent dispute?

On January 10, counsel for Corcept ($CORT) filed a letter with the Court in the pending patent litigation against Teva ($TEVA) over its proposed generic for Korlym®.  (See Dkt. 49).  Within that letter, Corcept requested an extension of one week to respond to Teva’s Answer to the Amended Complaint.  Corcept’s letter further stated that the “parties are currently discussing a potential agreement that would eliminate the need for Corcept to respond to Teva’s Answer . . . .”  Is that potential “agreement” a resolution to the litigation?

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Will Celgene and Dr. Reddy’s settle the Revlimid dispute now that Bristol Myers is at the table?

Celgene ($CELG) has announced plans to be acquired by Bristol Meyers Squibb ($BMY).  A settlement conference is scheduled in the Hatch-Waxman patent case between Celgene and Dr. Reddy’s on January 10, 2019.  Now that Bristol Meyers is at the table, will the parties be able to reach a settlement that couldn’t be reached before?

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Does Alice require fact questions or not? The Federal Circuit appears split.

Earlier this year, the Federal Circuit issued two precedential decisions that were predicted to stem the tide of early dismissals based upon Alice motions.  The cases were  Berkheimer v. HP and Aatrix Software v. Green Shades Software, and there were both deemed precedential by the Federal Circuit.  A recent concurrence at the Federal Circuit, however, shows that the Court may be splitting over the rationale underpinning Berkheimer and Aatrix, and that split may be heading for the Supreme Court. 

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The Federal Circuit sends a message about attorneys’ fees in Spineology v. Wright Medical

A recent precedential decision from the Federal Circuit sheds important light on how the Court views attorneys fees in patent cases.

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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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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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