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? 

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?

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?

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.

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? 

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. 

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?

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?

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?

Corcept Therapeutics ($CORT) recently filed a new lawsuit against Teva ($TEVA) related to Teva’s proposed generic for Korlym®.  The new suit asserts three new patents that were recently listed in the Orange Book.  Are the three new patents a game-changer?

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?

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?

The Court in AbbVie’s patent fight over Humira with Boehringer Ingelheim said that it “seems clear enough” that AbbVie had a patenting program designed to mitigate biosimilar entry for Humira®.  Though AbbVie clearly danced around ways to avoid producing much of its behind-the-scenes strategizing for building a patent estate sizeable enough to practically coerce settlements, the Court has ordered AbbVie to pull up its skirt.

Since announcing the pending acquisition of Celgene ($CELG) by Bristol Myers ($BMY), investors have focused upon the patent-cases involving Revlimid®.  There are multiple cases and petitions for inter partes review (IPRs) at various stages of resolution.  The key question among investors is whether there will be any key milestones in those cases--especially during 2019 before the Bristol acquisition closes—that will clarify exactly when any of the pending generics will enter.  In this post, we identify three potential milestones to watch for from the Revlimid® patent landscape in 2019. 

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.”

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?

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.

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?

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?

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.