Judge tears into ‘safe harbour’ ruling in heart valve system case
Judge’s dissenting opinion challenges the interpretation of the safe harbour provision by the US Court of Appeals for the Federal Circuit | Decision concerns Meril's importation of transcatheter heart valve systems in a dispute with Edwards Lifesciences | Court majority upheld the district court's ruling favouring Meril.
The US Court of Appeals for the Federal Circuit found that imports of heart valve systems were protected from infringement claims by the ‘safe harbour’ statute, with one justice strongly dissenting from the majority.
The decision, handed down March 25, 2024, concerned a pair of transcatheter heart valve systems imported into the US by India-based Meril, an action that Edwards Lifesciences said was infringing.
A safe harbour is a provision of a statute or a regulation that specifies that certain conduct will be deemed not to violate a given rule.
The majority of the Federal Circuit panel found that Meril's importation activities were within the scope of the provision because it was part of its preparation for seeking approval from the US Food and Drug Administration (FDA).
According to the court, the importation was covered by the safe harbour provision—protecting Meril from patent infringement claims.
The dissenting opinion, filed by Circuit Judge Alan Lourie, raised concerns regarding the interpretation of the safe harbour provision in this case and its potential implications for patent enforcement.
Lourie called for a clarification of the law, suggesting that an en banc review by the court could help rectify the misinterpretation of the statute.
He asserted that the US District Court for the Northern District of California's summary judgment in favour of Meril should be reversed under a correct understanding of the law, when considering the possibility of commercial motives behind the importation.
Case background
The Myval System, developed by Meril, received regulatory approval in India and Europe in 2018 and 2019, but required pre-market approval from the FDA for the US.
Meril imported the heart valve systems into the US for display at a medical conference for demonstration purposes but, crucially, they were never offered for sale or displayed to conference attendees.
Later, Meril submitted a pre-market approval application to the FDA, proposing trials in and outside the US.
Following the conference, Edwards Lifesciences filed a lawsuit against Meril for patent infringement related to the imported heart valve systems.
The district court ruled in favour of Meril, citing exemption from patent infringement under the safe harbour provision—a decision Edwards later appealed.
The Federal Circuit looked at whether Meril's importation of the heart valve systems was reasonably related to its efforts in securing FDA approval.
It found that Meril had engaged in discussions with regulatory authorities, sought consulting services for FDA submissions, and attended conferences to identify potential clinical researchers.
Of particular significance was Meril's adherence to strict instructions during the medical conference, prohibiting any sales or offers for sale within the US market.
Appeals court decision
As a result, the appeals court found that Meril's importation of the heart valve systems was reasonably related to FDA approval activities, and fell within the safe harbour provision.
The court affirmed that this statue protects activities— that would normally be considered infringement— if they're linked to getting FDA approval.
It stressed that the law covers various actions connected to gathering and presenting information to the FDA, no matter the stage of research or whether the submission is ultimately successful.
The court decided that the safe harbour law applies “as long as there's a reasonable basis to believe the activity will produce relevant information for FDA submission, even if there are promotional aspects involved”.
Addressing arguments raised by Edwards Lifesciences, the court dismissed claims that Meril’s intent or its lack of use of the imported product should remove safe harbour protection.
It also rejected the challenges about credibility of Meril's statements, ruling the district court considered multiple sources of evidence in granting summary judgment.
The district court's decision to grant summary judgment of non-infringement was affirmed.
Judge Lourie’s dissenting opinion
In his dissenting opinion, Judge Lourie argued that the “majority perpetuates the failure of this court and others”.
He argued that the district court's decision in this case failed to properly apply the law, as it overlooked the significance of the term ‘solely’ in the statute.
Additionally, Lourie believed the majority erred in following previous court decisions, arguing that the purpose behind the infringing activity does matter in determining safe harbour protection.
He emphasised that the safe harbour should only apply to activities exclusively aimed at FDA-related development and submission of information.
Lourie suggested that Meril's importation of the accused devices—even if not used or sold— should have raised doubts about whether it was solely for FDA-related purposes, warranting further examination.
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