The much-anticipated trial in the biosimilar litigation over Enbrel® has been pushed from April, to June and now to September.  Although Amgen ($AMGN) has asserted five patents against Sandoz’s ($NVS) proposed biosimilar, Erelzi®, the focus of the case are the two Roche patents directed to the entanercept protein itself.  And yet, a skirmish has erupted related to one of the three other patents, which collectively cover indications for using entanercept to treat psoriasis indications.

On May 3, 2018, Nike ($NKE) sued Puma for patent infringement.  Nike’s principle gripe is that Puma ripped off its groundbreaking “knitwear” sneaker as well as its tech for Air and cleats.  Nike’s lawsuit touches three large product segments, and Puma faces considerable exposure if Nike prevails.  That exposure is increased based upon Nike’s request for potentially triple damages, lost profits and an injunction.  Is this the start of the sneaker patent wars?

On April 30, the Federal Circuit convened oral argument in the highly-watched patent case between UC and Broad over the interference proceeding covering patents for CRISPR-Cas9.  (An overview of the case and the respective arguments were published in an earlier post.)  The hotly-contested argument suggests the Court is leaning towards Broad, but raises deeper questions about whether this is a success or failure for the patent system.

The epic CRISPR-Cas9 patent dispute has reached the Federal Circuit.  UC previously lost its bid to the Patent Office to eviscerate Broad’s patents through an interference proceeding.  That decision is now on appeal.  The briefing at the Federal Circuit is complete, and oral argument is scheduled for April 30, 2018.  Who will win at the Federal Circuit—UC or Broad? 

On April 17, 2018, a new patent issued to Corcept Therapeutics ($CORT) that covers Korlym®.  The patent is U.S. Patent No. 9,943,526 pursuant to U.S. Patent Application No. 15/133,791.  The ‘526 patent has already been added to the Orange Book.  Korlym® was already protected by two patents listed in the Orange Book, and Corcept recently commenced a Hatch-Waxman litigation against Teva asserting these two patents.  How effective is the new ‘526 patent at keeping Teva at bay?

Our earlier post on VirnetX’s recent $502M jury verdict commended the company and its counsel on an incredible win, but nevertheless pointed out that it might be for naught.  The patents asserted in the trial for the $502M damages currently stand invalid pursuant to petitions for inter pares re-examination and inter partes review.  But what about Oil States?  The case is currently pending before the Supreme Court, and it addresses the constitutionality of petitions for inter partes review (IPR).  The case has already heard oral argument, and a decision is expected imminently.  Some commentators have suggested that if the Supreme Court holds IPRs unconstitutional, then that will vacate the invalidity decisions of VirnetX’s patents from the PTAB, and nothing will finally stand in the way of VirnetX’s damages.  What are the considerations that may keep alive VirnetX's prospect of collecting damages?

In a slightly new wrinkle in Celgene’s recent Revlimid® saga, Celgene ($CELG) has commenced another suit against Dr. Reddy’s ($RDY).  (This is the third patent lawsuit connected to Dr. Reddy’s proposed generic for Revlimid®.)  In the most recent suit, Celgene asserts five new patents (the ‘720, ‘977, ‘784, ‘866 and ‘531).  The suit was commenced on April 13, 2018 in the federal court in New Jersey, where the other Revlimid® suits are currently pending.  What’s this suit all about?

VirnetX ($VHC) has won another trial against Apple ($APPL) in the federal court in Texas.  This time the verdict is approximately $502M.  But the patents stand invalid based upon PTO decisions, and those decisions are pending before the Federal Circuit.  Who's winning this battle?

Yesterday, we blogged about why the Markman hearing was cancelled in Celgene’s Revlimid® patent case against Dr. Reddy’s.  Some analysts suggested that this is a positive indication of a settlement approaching with Dr. Reddy’s and possibly with all generics.  We weigh in.

On March 23, Celgene and Dr. Reddy’s informed the Court that they jointly have resolved the single pending claim construction dispute—namely, the construction of the word “crystalline” within the two asserted polymorph patents.  What does this mean for the case?

Novartis has filed a patent lawsuit against Regeneron seeking damages for sales of Eylea® and Zaltrap®.  On March 19, 2018, Novartis sued Regeneron in the Southern District of New York, White Plains Division, for infringing U.S. Patent No. 5,688,688.  The ‘688 patent claims gene expression constructs for the expression of polypeptides in mammalian cells.  How strong is Novartis’ case, and what is Regeneron’s exposure?

A case currently pending before the Supreme Court, WesternGeco LLC v. ION Geophysical Corp., may make it easier for U.S. businesses to fight IP theft abroad.

Regeneron ($REGN) and Sanofi released positive topline results from their ODYSSEY clinical trial Praluent®.  In addition was the announcement that prices for Praluent® may be cut.  Investors who may have grown skeptical with the new PCSK9-inhibitor class may now be interested again, which may include the pending patent lawsuit between Amgen ($AMGN) and Regeneron.  What is happening in the case?

The PTAB has denied institution of two IPRs filed by Coherus Biosciences against patents covering Enbrel®’s proteins, the ‘182 and ‘522 patents.  The IPRs were not filed by Sandoz, but they will most likely affect Sandoz.  Sandoz already has FDA approval to market Erelzi®, which is its biosimilar for Enbrel®.  And Sandoz is going to trial against Amgen in April.  How do Coherus IPR decisions affect Sandoz's decision to launch at risk?  Or to settle with Amgen?

FDA’s Commissioner Scott Gottlieb said today that a “rigged” system between drug firms and insurers is stifling entry for less-expensive biosimilars.  Gottlieb stated that certain payment arrangements “raise another, perhaps even more insidious barrier to biosimilars taking root in the U.S., and gaining appropriate market share.”  Is J&J’s exclusionary contract scheme to discourage competition with Pfizer’s biosimilar for Remicade® a poster child for what Gottlieb is lamenting?  Pfizer recently sued Janssen over that very question, and the federal court is scheduled to decide a motion answering that question very shortly. 

Corcept Therapeutics recently received a Paragraph IV notice letter from Teva for its drug, Korlym®.  The market’s reaction crushed the stock, sending it from approximately $23 to roughly $17 within a day.  Corcept Therapeutics has essentially one drug, Korlym® (mifepristone).  But whether Teva will enter with a generic version of Korlym® any time soon depends directly on the patents that Corcept has in its arsenal.  What are those patents?  Is the market’s reaction justified?  Or is this a buying opportunity? 

Cloudflare recently prevailed on its motion to invalidate patents as ineligible in a case commenced by Blackbird Tech.  But Cloudflare’s win may be in jeopardy.  Two recent decisions from the Federal Circuit have held that winning on early Alice motions, like the one on which Cloudflare prevailed, will now be more difficult. 

The PTAB has issued its much-anticipated decision on whether Allergan managed to pull off it’s scheme to avoid IPRs of its Restasis® patents by “selling” the patents to the St. Regis Mohawk Tribe.  On February 23, 2018, the PTAB denied the Tribe’s motion to terminate the IPRs on the ground based on its tribal sovereign immunity.  What were the PTAB’s reasons for denying the Tribe’s motion to terminate the IPRs?  And what are the ramifications for similar deals in the future?

Anyone who has followed Federal Circuit cases addressing Alice decisions has felt the whip-saw brain squeeze of trying to reconcile them all.  While some clear guidelines have emerged that have made assessing whether a given patent is susceptible to Alice, there remains a thick, gray cloud over how, exactly, the two-step framework applies in practice.  Two recent decisions from the Federal Circuit, Berkheimer v. HP and Aatrix Software v. Green Shades Software, may have established some more concrete guidance on handling early Alice motions in patent cases.

Sandoz was denied institution on two IPRs against Humira® patents owned by AbbVie.  As we previously discussed, in late 2017, Sandoz filed eight different IPRs against Humira® patents.  Two of those IPRs just failed to reach institution.  What are the take-aways, for Sandoz and any other Humira® biosimilars?