Boston Scientific’s transcatheter heart valve patent upheld on appeal

Medical device patents are less often in the news than those protecting pharmaceuticals. But the growing transcatheter heart valve (THV) market, predicted to reach $3.8bn in 2020, is worth fighting over. Nasdaq listed medical equipment manufacturer Edwards Lifesciences Corporation received an expanded FDA approval for its SAPIEN 3 product in mid-2017 and is set to benefit as treatment moves away from high-risk open heart surgery to catheter-based approaches.

Boston Scientific's patents

Boston Scientific Corporation owns a suite of patents in the THV area, and is in litigation against Edwards in the US.

In the UK, Edwards launched a validity challenge against a pair of patents owned by Boston Scientific (EP (UK) 2 749 254 ("254") and EP (UK) 2 926 766 ("766"). Boston Scientific alleged patent infringement by Edwards' SAPIEN 3 device in return. The patents are divisionals of the same application, with a priority date of 23 December 2003. They both claim ways of sealing the gap between the device and the surrounding natural aortic valve to prevent damaging blood leakage.

The trial judge decided in March 2017 that only one of Boston Scientific’s pair of patents (766) was valid, but that the Edwards product did infringe the valid claims. 

Both parties appealed.

Success on appeal

The judge's decision has now been confirmed on appeal. The key piece of prior art, a US patent relating to an endograft for treatment of abdominal aortic aneurysm, disclosed information close enough to 254 to render it obvious. But it did not invalidate the 766 patent as that required the presence of one or more sacs to provide a seal around the device - not present in the prior art disclosure.

Boston Scientific, welcomed the ruling, with Desiree Ralls-Morrison, senior vice president, general counsel and corporate secretary saying:

“We see the U.K. court’s decision as an important validation of our patents and supports our goal to bring differentiated solutions to patients suffering from severe and symptomatic aortic valve stenosis.”

How to calculate financial compensation

In parallel, a procedure to establish financial compensation for Boston Scientific for the infringement has been underway. Successful patent owners can elect to receive either damages calculated to compensate them for the loss they have suffered or an account of the profits made by the infringer. Boston Scientific has faced technical difficulties with its own products, and reportedly initiated a voluntary global recall of its Lotus device in February 2017. This could make an account of profits generated by the competing product a more attractive option.

But it seems that Boston Scientific has concerns about requesting an account of profits. Internal arrangements within the Edwards group might see profits from UK sales recognised elsewhere and not forming part of the profits they would have to pay over as arising from the infringement.

After the 2017 trial, the judge gave Boston Scientific the opportunity to obtain further information from Edwards in order for it to make the election, but he has now declined to look at whether intra-group transfer of profits are a proper deduction from profits. Boston Scientific will have to make its choice on the information available.

James Fry and Isabel Teare

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