Henry Carr J refuses Abbott's mitral valve preliminary injunction

The AmeriKat's incredibly big heart

Although the AmeriKat did not get her paws on the judgment until Friday afternoon, the ex tempore decision of Mr Justice Carr in Evalve & Abbott v Edwards Lifesciences [2019] EWHC 1158 refusing Abbott's preliminary injunction will have been ringing in the parties' ears since 3 May.  Yes, the English courts do refuse preliminary injunctions from time-to-time.  So what happened?

The facts

Edwards claims that Edwards's PASCAL product  - a medical device for treating life-threatening mitral regurgitation  - infringes two of its patents.  Pascal's product and Edwards' product - the MitraClip - are implanted during a procedure known as transcatheter mitral valve repair (TMVr).  The TMVR market in the UK is very small as it is not currently funded by the National Health Service (NHS).  It is anticipated that NHS England will soon fund a type of TMVr operation, which could implemented by MitraClip or PASCAL, but the date of this decision is unknown.  

Edwards wants to start a controlled launch of a small number of its PASCAL device between October 2019 - February 2020, and then a larger roll-out until June 2020.  This controlled launch is to enable Edwards to properly compete with MitraClip as and when NHS England decides to reimburse or fund the relevant type of operations.  Abbott argued that if this roll-out is permitted, it will suffer irreparable or unquantifiable damage between now and judgment in the expedited trial (judgment would be expected end of January 2020), whereas if Edwards' plans are put on hold for a short period of time no such damage will occur.  

The decision

Henry Carr J refused to grant Abbott a preliminary injunction on the basis that any irreparable prejudice that Abbott might suffer as a result of Edwards' limited launch was "clearly outweighed" by the irreparable harm that would be suffered by Edwards if the preliminary injunction was granted.  

Why?  

Abbott did not establish that it would suffer irreparable harm if an injunction was refused.  In particular:

• Edwards intended controlled launch was limited - only 10 patients in two hospitals in the UK.

• There was no evidence of other competitors, thus no evidence of a downward price spiral.  

• There was no price-undercutting by Edwards; Edwards' PASCAL device is likely to cost more than Abbott's MitraClip.  

• Edwards accepted that, for the purposes of a damages inquiry, a sale of a PASCAL device should be treated as sale of MitraClip.  

• There was no convincing evidence that showed there was any "bundling" of other products to be sold with PASCAL, such that this "cross-selling" element would make quantification difficult.  

• It was also not shown that, given Edwards' limited activities between now and trial, refusing a preliminary injunction would disrupt Abbott's relationships with clinicians or its reputation if Abbott would later have to enforce a final injunction of a life-saving device (should it win at trial).  

• It was also "fanciful" to suggest that irreparable harm would be caused by the costs of having to retrain clinicians on MitraClip who had, during the interim, become familiar with PASCAL.  Indeed, there was no evidence that clinicians were needing to be retrained on MitraClip as it stands.  

The MitraClip

But what about Edwards' irreparable harm?  

Well, first the judge accepted the submissions or Iain Purvis QC (for Edwards) on the law.  Before the question of the defendants' irreparable or unquantifiable  harm is addressed, the claimant must first establish that it would suffer such harm.  If, at this stage, damages are an adequate remedy for the claimant, "there are no grounds for interference with the defendant's freedom of action by the grant of an injunction" (as per Lord Hoffmann in National Commercial Bank Jamaica v Olint Corporation [2009] UKPC 16 at [16] - a Privy Council case) .  Thus the test for a preliminary injunction is a series of gateways. If those gateways are not crossed, then the assessment should stop there.  Thus on the basis of the findings of fact and the law, the judge didn't need to go on to examine Edwards' irreparable harm.   

But what if the Judge was wrong on Abbott's irreparable harm? 

In that event, the Judge found that there would be irreparable or unquantifiable damage to Edwards if the injunction was granted on the basis that:

• The NHS is expected to, at sometime in the near future, beginning reimbursing TMVr procedures.  

• There will then be a change in the TmVR market, such that the UK market will go from a small market with limited competition to a much bigger market with more competition.  

• To benefit from this change in the market, Edwards would need to be able to launch PASCAL by the end of 2019.  

• If they were unable to do so, MitraClip would enjoy an even larger monopoly on the device for all eligible UK sites, making it difficult for PASCAL to enter the market later (keep in mind that the evidence was that PASCAL would be more expensive than the MitraClip).   

• Thus, using the sales of PASCAL made after the start of the reimbursement market to estimate how many sales it would have made had it been able to compete from the very start will be difficult.  

• This calculation is more difficult than calculating Abbott's loss, given that Edwards accepted that each sale of PASCAL should be treated as a lost sale of the MitraClip.

Thus, the harm to Edwards - and in particular the difficulty of quantifying the harm to Edwards - outweighed the harm to Abbot. Preliminary injunction refused.  

But what if the harm to both parties was equally balanced?

In that case, Mr Justice Carr held that other factors would enter into the assessment.  Where irreparable harm to both parties are evenly balanced, additional factors are required to be considered, including the status quo.  This is where the question of whether a defendant "cleared the way" (i.e. commenced revocation proceedings before launch) comes into play.  As summarized by Henry Carr J, "a failure to clear the way is a material factor in cases where irreparable harm to both parties is evenly balanced".  If the defendant "knew the risk and decided it was best not to remove it" then that is a factor in favor of maintaining the status quo and granting an injunction (see Aldous LJ in SmithKline Beecham v Apotex [2003] FSR 31 at [40]; see also Arnold J in Warner-Lambert v Actavis [2015] EWHC 72 at [133]).  But, because the judge considered that this was not an evenly balanced case, this factor does not enter the mix. 

So how much did this cost?  

Stage in the transcatheter edge-to-edge repair

A down payment on a small flat in London.  The judge had criticism for the parties in the "very extensive" comparative clinical evidence between the PASCAL device and the MitraClip device.  The evidence was put in on the assumption that, had the balance been even, an additional factor would be one of public interest (these are life saving devices).  The judge said:  

"I accept that as a matter of law the evidence is admissible. None the less, what this application has illustrated, by the numerous witness statements that have been put in by distinguished clinicians, is the very grave difficulty that a court would face in resolving this type of allegation on an interim basis. Once the clinical benefits were disputed, the evidence spiralled out of control. Indeed, Mr. Purvis suggested that the test that should be applied was the same test as for Abbott's cause of action, namely whether Edwards has an arguable case that PASCAL was clinically superior.

In my view, parties should think very carefully before setting this ball rolling on an interim application, and I have been told that in this case, the combined costs of this evidence alone, concerning clinical superiority, are in six figures."

With a discount applied to costs associated with this evidence, Edwards was awarded £200,000.

Bob also did not take kindly to piggy-backing

What did we learn?

1.  The preliminary injunction test is a series of gateways.  If damages are adequate remedy for the claimant (i.e the claimant can not show that they would suffer irreparable or unquantifiable harm) then you stop there.  This makes sense if the claimant cannot show that they would suffer any irreparable or unquantifiable harm.  But if the claimant has shown that there is arguably some irreparable or unquantifiable harm, then you have to go to the next stage and assess the defendants' irreparable harm.  If, and seemingly, only if,  the parties' harms are evenly balanced do you go on to consider additional factors, such as whether the defendant cleared the way.  Without this legal framework in play, it would be a bit more difficult to reconcile the findings that Edwards' irreparable harm would being greater than Abbott's.  This is because Edwards' irreparable harm was said to be as a result of them potentially not being able to participate in an expanding market at the point that the NHS decides to reimburse the relevant TMVr procedures.  However, it is arguable that Edwards could have mitigated this by seeking to clear the way earlier.  Thus, they themselves had a role to play in their own potential irreparable/unquantifiable harm by not taking proactive steps to participate in the market earlier.  But - as held by the Judge - additional factors, such as "clearing the way", do not enter this stage of the assessment; they are only relevant when everything else is evenly balanced (see Lord Diplock in American Cyanamid v Ethicon [1975] 2 WLR 316 - the matriarch of preliminary injunction case law).

2.  Harm of reputation, even in cases of life saving devices, will be difficult to show where the launch is limited (and on that point, limited launches seem a clever way to get a foothold in the market and limit the injunction risk in this case).  

3.  Parties need to control evidence of public interest at a preliminary injunction stage.

4.  Give 1:1 sale concessions earlier or any concession that makes a patentee's damages calculation easier.  A key factor in the decision was the fact that Edwards' gave a concession that each sale of a PASCAL device would be treated as a lost sale to Abbott.  This made the potential damages calculation much easier and thus much more attractive for the judge when considering which damage was easier to quantify.

5.  Beware of your arguments for expedited trials coming back to nip at your ankles at the PI stage.  At its hearing for expedition of the trial, Abbott recognized that Edwards had planned to only undertake a limited number of procedures by 2019 and thus, a trial before the end of 2019 would enable a decision before Edwards ramped up its launch and possibly before "it had done anything at all".  Abbott continued:  "It is possible that it would remove the need for the preliminary injunction."  This evidence did not bar Abbott from seeking relief, but it showed that they also considered the damage before trial to be limited.  

6.  Mr Justice Carr was not a fan of the use of Abbott's many animal analogies.  In the AmeriKat's favorite paragraph of the decision, the judge said:

"In its evidence and skeleton argument, Abbott characterised the PASCAL device as a copycat product, which was piggybacking on investment and training that had been carried out by Abbott. As I observed at the hearing, this type of advocacy relied on too many animal analogies. The allegation that PASCAL was a copycat product should never have been made." 

This was not like a typical case that we are used to seeing in the innovator v generic space with downward price spirals, market depression. first mover advantage and price undercutting arguments.  Here, the defendant's product was said to likely to be more expensive than the claimant's and there was no evidence of additional competition on the scene.  As such, the fact that the Court did not grant a preliminary injunction in this case is not a sign of a shift in the law or a cooling on a patentee's ability to obtain interim relief; it is juts a reflection of the peculiar facts and evidence (or lack thereof) in this case.