UK court shoots down Abbott bid for injunction in TMVR patent spat with Edwards

Edwards Lifesciences (NYSE:EW) recently claimed a win in a UK-based patent spat with Abbott (NYSE:ABT) over IP related to each company’s respective transcatheter mitral valve repair devices after a UK court shot down a bid from Abbott for a preliminary injunction.

In the suit, filed on January 28, Abbott claimed that Edwards is infringing on two of its patents with its Pascal TMVR system and sought an interim injunction to keep Edwards from marketing the device in the UK, claiming that the company’s entry into the market could cause irreparable harm.

Edwards denied the infringement and counterclaimed for invalidity on a basis of lack of novelty and obviousness, according to court documents.

After applying for an interim injunction, Abbott applied for an expedited trial, which was granted in March with a slated date of December 2019. A judgement is expected to be delivered by January of next year, according to the documents.

Currently, TMVR procedures are not covered by the UK’s National Health Service, resulting in a very small number of such procedures in the country, according to court documents. “A very small number of [Abbott’s] MitraClip implantations are carried out each year in the United Kingdom at a total of 18 hospitals,” with “several months” between procedures, court documents read.

Edwards said that in light of the suit, it limited its activities in the region to a total of 10 procedures with its Pascal device, according to court documents. Abbott claims that those 10 procedures could still affect the company and its MitraClip brand in a number of ways, including directly decreasing sales.

Abbott also asserted a number of other claims, including the need for retraining surgeons who used the Pascal device, the disassociation of the TMVR procedure with the ‘Mitraclip’ brand, damage to its relationship with consumers, physicians and others.

Chicago-area based Abbott also “characterized the Pascal device as a copycat product, which was piggybacking on investment and training that had been carried out by Abbott,” Mr Justice Henry Carr wrote in court documents.

“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,” Carr wrote. “First, it appears on the evidence before me to be entirely unjustified. Secondly, even if justified, it is irrelevant to the claim of patent infringement advanced by Abbott. If Abbott wish to allege copying, then they should bring a claim for infringement of unregistered design right, if any such right subsists. The courts of the United Kingdom have repeatedly said that allegations of copying are irrelevant to patent infringement. Whilst it is no doubt tempting, nonetheless, to assert copying, it is a sign of weakness rather than strength when this is done.”

Mr Justice Henry Carr did not agree with the majority of Abbott’s other arguments, adding that “in the light of Edwards’ undertaking to limit its activities until judgement, subject to a liberty to apply, to 10 implantations in two hospitals, I do not consider that Abbott will sufficient irreparable prejudice between now and judgement.”

Carr went on to conclude that “even if Abbott will suffer some irreparable prejudice as a result of Edwards’ limited launch, then such prejudice is clearly outweighed by the irreparable harm that would be suffered by Edwards if the injunction is granted,” and refused injunctive relief for both parties.

Edwards lauded the decision in an email to MassDevice.com, saying that it plans to continue its launch in the UK.

“We are pleased to share that the UK Court denied Abbott’s motion for a preliminary injunction, and also ordered Abbott to cover the majority of Edwards’ legal costs in this matter. This means that we can continue with our previously established disciplined commercial launch plans in the UK. We are proud that Pascal represents significant research and development in response to the needs of the clinical community.  Given the burden and complexity of mitral valve disease, we believe this is the best possible outcome for patients. We have always maintained that a broad range of proven therapies will be necessary to address the unmet needs of these patients and to help raise awareness of significant undertreatment,” a spokesperson for Edwards Lifesciences said.

Last month, Edwards saw share prices fall slightly despite posting Street-beating first quarter earnings results that saw the growth on the bottom line of over 20%.