Recently, the U.S. Court of Appeals for the Federal Circuit overturned a ruling by the District Court of Massachusetts in a dispute over heart pump patents, determining that the district judge misunderstood the contested claim terms, which led to both parties reaching a 'non-infringement consensus' based on the incorrect interpretation.

The protagonists of the case are Abiomed of Johnson & Johnson and Maquet of Getinge.

The lawsuit can be traced back to December 2015, when Maquet, a subsidiary of the company J&J, sent a letter to Abiomed (now part of the MedTech department of Roche) in Massachusetts, accusing the Impella series of infringing on three patents and seeking a licensing agreement.

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

In 2017, Maquet sued Abiomed, alleging that its Impella heart pump infringed two other blood pump patents (Nos. 10,238,783 and 9,789,238), referred to as the 783 and 238 patents.

District Judge F. Dennis Saylor IV adopted the prosecution disclaimer proposed by Abiomed, concluding that the statements made by Maquet during the application for other related patents constituted a clear relinquishment of the scope of the disputed patent rights. Based on this interpretation, both parties had reached a consensus of "no infringement."

However, the Federal Circuit Court noted that the district court erroneously used Maquet's statements made when applying for other patents to interpret the scope of rights at issue in the patent at hand (No. 783). The court emphasized that a patent renunciation occurs only when the patent owner 'clearly and unambiguously renounces' (unequivocally disavowed) specific claims during the application process.

The case will be retried in the district court after the original case is reheard by the court of appeals. Maquet must prove that Abiomed's product infringes its patent.

It is worth noting that shortly after the local court made the original ruling, Johnson & Johnson announced its acquisition of Abiomed for $16.6 billion, which may cast a shadow of uncertainty over its subsequent operations due to this patent dispute.

In November 2022, Johnson & Johnson announced its acquisition of Abiomed, a manufacturer of artificial hearts, for approximately $16.6 billion, marking its high-profile entry into the artificial heart market.

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

As early as 1987, the target company Abiomed had already gone public on NASDAQ. It has experienced a remarkable turnaround from the brink of bankruptcy to significant growth, successfully stepping into the forefront of the global heart disease sector.

The Impella cardiac pump resembles a gray pen with stripes, featuring a slender wire at its tip. It is implanted into the patient's heart via a catheter introduced through the groin and connected to an automated Impella controller beside the patient's bed, providing continuous blood flow support to enable more efficient pumping by the heart, thereby improving cardiac function.

Source: Abiomed的官网

Down below, Abiomed possesses the world's only FDA-certified transcatheter cardiac assist device, with its Impella product line having few competitors in the global field of transcatheter heart pumps.

In 2023, Abiomed received three Class I recalls.

Source: FDA website

In 2024, following 49 fatalities, Abiomed initiated its largest recall in history, recalling six models of Impella heart pumps on a global scale. A total of 66,390 units were recalled in the United States, while over 26,000 units were recalled outside the U.S., with the combined total reaching 90,000 units.

Recall involves multiple countries including the United States, Japan, Canada, Germany, France, India, Mexico, and Taiwan in addition to China.

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