Johnson & Johnson's Flagship Impella Heart Pump Faces Renewed Patent Lawsuit as Abiomed IPO Prospectus Emerges

Source: Medical Device Business Review

Recently, the U.S. Court of Appeals for the Federal Circuit overturned a ruling by the District Court of Massachusetts in a patent dispute over a heart blood pump, concluding that the district judge had misunderstood the disputed claim terms, which led both parties to previously reach a "non-infringement agreement" based on the erroneous interpretation.

The protagonist of the case is preciselyJohnson & Johnson's AbiomedAndGetinge's Maquet Company。

This lawsuit dates back to December 2015, when Maquet, a subsidiary of Getinge, sent a letter to Abiomed, a heart pump manufacturer located in Danvers, Massachusetts (now part of Johnson & Johnson's MedTech division), accusing it of...Impella SeriesTranscatheter Heart PumpInfringed on three patents and sought to reach a licensing agreement, threatening otherwise to take patent infringement actions.

In 2016, Abiomed filed a declaratory judgment action against Maquet for non-infringement of patent rights. As the case progressed, counterclaims from both parties increased the number of disputed patents to six.

Maquet sued Abiomed in 2017, alleging that its production ofImpella Heart Pump Infringes on Two Additional Blood Pump Patents (Patent Nos. 10,238,783 and 9,789,238)(hereinafter referred to as 783 and 238).

Local Judge F. Dennis Saylor IV adopted Abiomed's "prosecution disclaimer".That is, it was considered that the statements made by Maquet when applying for other related patents constituted a clear abandonment of the scope of rights of the disputed patent. Based on this interpretation, both parties had previously reached a consensus of "no infringement."

However, the Federal Circuit Court pointed out this time,The local judge mistakenly used Maquet's statements made during the application for other patents to interpret the scope of rights of the disputed patent (783) in this case.The court emphasized that patent abandonment only occurs when the patent holder "unequivocally disavowed" specific claims during the application process.

This case will be remanded to the district court for a retrial, where Maquet will need to re-prove that Abiomed's products infringe on its patent.

Notably, shortly after the local court made the original ruling, Johnson & Johnson announced the acquisition of Abiomed for $16.6 billion. This patent dispute may cast a layer of uncertainty over its subsequent operations.

In November 2022, Johnson & Johnson announcedInvesting approximately $16.6 billionJohnson & Johnson Makes a High-Profile Entry into the Artificial Heart Arena by Acquiring Abiomed, a Manufacturer of Artificial Hearts.

Artificial hearts can be classified into surgical implantation and interventional types according to the implantation method. Abbott dominates the left ventricular assist device field, while Johnson & Johnson's Abiomed "rules" the percutaneous ventricular assist device (pVAD) field.

As early as 1987, the target companyAbiomed was already listed on NASDAQ.From the brink of bankruptcy to significant growth, successfully standing in the first tier of the global cardiac field.。

The Impella heart pump, which resembles a striped gray pen with a pigtail at the tip, is implanted into the patient's heart through a catheter that passes through the groin. It is connected to an automated Impella controller beside the patient’s bed, providing continuous blood flow support and enabling the heart to pump more efficiently, thereby improving cardiac function.

Source: Abiomed Official Website

At present,Abiomed owns the world's only FDA-certified interventional artificial heart, and its Impella series products also have few rivals in the global interventional cardiac pump field.

However, after being brought under Johnson & Johnson, negative incidents related to this product have continued to unfold. For instance,In the year following the acquisition (2023), Abiomed issued three recalls at the most severe level.

Source: FDA official website

In 2024,Abiomed Launches Largest Recall in Its History Following 49 DeathsRecall of Six Models of Impella Heart Pumps Worldwide. A total of 66,390 products have been recalled in the United States, while more than 26,000 products have been recalled outside the United States, bringing the total number to as high as 90,000.

With the resurgence of the patent dispute with Getinge, this cardiovascular giant is set to face new challenges.