Will the Arrow hit the Humira target? Find out tomorrow!

Will FKB finally catch their mouse?
For years the AmeriKat has been a keen prowler of the Daily Cause list, not only because she needs to know what courtroom she is in, but because you get a preview of what decisions are about to be delivered.  Readers are in for a treat as tomorrow Mr Justice Carr's decision in the first trial between Fujifilm Kyowa Kirin Biologics Co., Ltd and Others v AbbVie Biotechnology Limited ("FKB 1") is being handed down at 10:30AM London time.

As soon as we digest the decision, GuestKat Eihblin Vardy, will be back to let readers know whether, despite having survived various interim attempts by AbbVie to kill it, the Arrow declaration has finally hit the target for Fujifilm ("FKB") and Samsung Bioepis/Biogen who want to market their adalimumab biosimilar.  AbbVie's antibody adalimumab marketed as Humira is the highest selling prescription drug in the world by global sells - net sales in 2014 were $12.5 billion (and in the UK it achieved £1.2 million/day).

So, what has happened to get to this point?  The AmeriKat provides a brief summary in advance of tomorrow's decision:
  • October 2015:  FKB issue claim to revoke AbbVie Biotechnology Limited ("AbbVie Bermuda")'s patents - '656 Patent and '322 Patent (the former was later revoked following AbbVie's abandonment of the patent, but a divisional remained which later was granted as the '044 Patent and subject to the January 2017 trial).  FKB also seek a declaration that "products containing a biosimilar monoclonal antibody to the antibody adalimumab for the treatment of rheumatoid arthritis, psoriatic arthritis and/or psoriasis by the administration of 40mg every other week by subcutaneous injection…" would have been obvious at the priority dates of the '656 and '322 Patents (the Arrow declaration).  If the declaratory relief is granted, AbbVie would find it impossible to claim that FKB's products infringe its patents without putting the validity of its patents in jeopardy (i.e., an obvious FKB product cannot be protected by an inventive AbbVie patent at the same priority date). This is referred to as the FKB 1 case.  
  • February/March 2016:  In the FKB 1 case, AbbVie Bermuda apply to strike out FKB's Arrow declaration that products which FKB proposed to market in the UK were old or obvious. Mr Justice Carr refused to do so ([2016] EWHC 425)   The decision was appealed with permission granted by Lord Justice Kitchin in June 2016 on the ground that it was arguable that the declaration sought was inconsistent with section 74 of the Patents Act 1977.  Samsung Bioepis/Biogen issue its claim at the end of March.  See AmeriKat post summarizing Carr J's decision here.
  • May 2016:  FKB commenced proceedings against AbbVie Bermuda and AbbVie Limited ("AbbVie UK") seeking an Arrow declaration focused on the subject matter of a family of secondary patent applications in the Humira portfolio, particularly the pending European Patent Application No 1 737 491 primarily concerned with the dosing regimens of adalimumab.  This is referred to as the FKB 2 case.  
  • September 2016:   In the FKB 2 case, AbbVie Bermuda and AbbVie UK apply to strike out FKB's action for a similar declaration.  FKB also apply for an injunction against AbbVie UK and AbbVie Bermuda to restrain them from threatening or commencing proceedings for patent infringement for acts subject to the declaration.  Mr Justice Arnold refused AbbVie's application ([2016] EWHC 2204).  The decision was appealed.  See AmeriKat post here.
  • November/December 2016:  AbbVie tries to avoid the UK trial scheduled for January 2017 by taking a number of steps, including de-designating the UK from one of the two patents subject to the trial and offering an undertaking not to obtain patent protection in the UK that would be infringed by the biosimilars' dosage regimens for the indications specified in the sought declarations.  Abbvie applies for summary judgment and strike out for abuse of process.  This was subject to a decision of Mr Justice Carr at the end of December 2016 ([2016] EWHC 3383) who, with the size of the market in mind, rejected both applications holding that the declarations would still serve a useful purpose (the declaratory relief touchstone), in particular in protecting supply chains and providing clarity in the UK .  See post by GuestKat Eibhlin here.
  • January 2017:   The Court of Appeal dismisses the appeals from Mr Justice Carr's and Mr Justice Arnold's interim decisions holding that, as a point of principle, the Court can properly grant declarations that a product lacked novelty or an inventive step at a particular date ([2017] EWCA Civ 1).  Like at first instance, the Court reinforced the discretionary nature of the remedy which should be available in appropriate cases, in particular where a party's pursuit of legal certainty is prevented by a patentee's prosecution decisions:  
"A claimant cannot seek an Arrow declaration simply because it would like to know whether a patent application in the course of prosecution will result in a valid patent. The course envisaged by the statute is that he should wait and see what, if any, patent is granted. The statutory remedy does not constitute a bar in principle to the granting of declaratory relief in appropriate cases, however. Where, for example, it appears that the statutory remedy is being frustrated by shielding subject matter from scrutiny in the national court, it should be open to the court to intervene."
 See the post by GuestKat Eibhlin here.  
The trial of the FKB 1 action is heard before Mr Justice Carr.   

  • March 2017:  Check back tomorrow to find out...!
Will the Arrow hit the Humira target? Find out tomorrow! Will the Arrow hit the Humira target? Find out tomorrow! Reviewed by Annsley Merelle Ward on Thursday, March 02, 2017 Rating: 5

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