The ruling commented upon today revisits the issue, in a quite unusual way.
Today’s case relates to the LEVOTHYROX® controversy.
LEVOTHYROX® is a drug containing a manufactured form of the thyroid hormone thyroxine (T4). It is used to treat thyroid hormone deficiency. The drug is marketed in France by Merck Biopharma.
According to a press release, the French health authorities (ANSM) requested a modification of the formulation so as to better stabilize the active upon storage. In March 2017, Merck Biopharma thus switched to a new formulation containing different excipients. A few months later, a number of patients complained about side effects seemingly caused by the new formulation. A couple hundred thousand people signed a petition demanding that the old formulation be put back on the market.
The existence and the origin of the side effects were hotly debated and I am not aware that any consensus has been reached yet as to what may have gone wrong.
Anyway, it turns out that there is also an IP aspect to this matter. Indeed, European patent EP 2885005 B1, owned by Merck Patent GmbH, protects the new LEVOTHYROX® formulation. Claim 1 is directed to a solid pharmaceutical preparation comprising levothyroxine sodium, gelatin, citric acid and a filler.
In December 2018, 139 individuals claiming to be patients affected by side effects related to the new LEVOTHYROX® formulation filed a lawsuit in front of the Paris TGI, requesting the revocation of the EP’005 patent. They were later joined by 34 additional individuals as well as a patient association, Alerte Thyroïde.
As a defense, Merck Patent GmbH claimed that the plaintiffs lacked standing. A hearing on this defense took place on December 4, 2019, and the judgment has just been handed down. The court has sided with Merck and dismissed the nullity suit for lack of standing.
To some extent, the outcome is unsurprising. As I said in the beginning, the appraisal of standing in patent nullity suits is harsh – excessively so, in my view. If even competitors of a patent owner are sometimes considered as lacking standing, a reasonable gut feeling would be that there is no way individual patients or even a patient association can have standing.
But in fact, looking at the reasons for the decision, the court seems to have actually walked a fine line when deciding the issue.
The starting point in the reasoning is article 31 Code de procédure civile, per which “any person having a legitimate interest in having a claim accepted or rejected may initiate legal proceedings, except if the law restricts the possibility to sue to specific persons […]“.
First, the court recalled the usual criteria that are applied when the litigants are competitors:
When the nullity action relates to two competing parties, the advantage expected from the action under article 31 Code de procédure civile is traditionally understood […] as being an improvement in the legal situation of the plaintiff. It is generally requested from said plaintiff that they should demonstrate the existence of a sufficient interest to free a future exploitation of the patented technology or a similar one.
But then the court accepted that non-competitors, including members of the general public, could also have standing under article 31:
However, […] the competition / economic case is not the only situation in which a nullity suit could be initiated, and cannot define standing, which by nature is shape-shifting. Therefore, the standing of the plaintiffs, who are not competitors of the proprietor of the patent at stake but consumers and patients directly impacted, notably in terms of material and financial availability of the drug subject to a monopoly, must be appraised in concreto, based on the object and the purpose of the nullity suit […], without neglecting the fact that such an action, which aims at terminating any undue monopoly, is also useful for the general interest, since a revocation would benefit to all.
In other terms, the court did not completely close the door to the initiation of patent nullity proceedings by non-traditional plaintiffs. The notion of “general interest” in the last sentence is in fact pretty far-reaching.
The court went on in the following terms:
In fact, whether the grant of a patent is a compensation for investments and efforts made by the creator of the invention or for the disclosure of the invention, it confers a beneficial monopoly to its owner, and additionally an undeniable control over prices. In a context of free competition and free innovation, this is legitimate and admissible only if the validity conditions are met. It is of general interest, in particular in the pharmaceutical field and in case public prosecution, which is first and foremost in charge of defending general interest, fails to act, that an end should be put to the monopoly when the patent is invalid or merely aims at preserving a monopoly conferred by a previous patent about to expire, thus allowing competing generic pharmaceutical companies to offer accessible generic drugs at a lower cost to patients in need of the initially patented drugs.
I have never heard of a public prosecutor filing a patent nullity suit to open up a market. But the court, based on the above statements, seems to accept the possibility that members of the public could take up this role.
In this respect, the plaintiffs precisely argued that the patent generally protects any levothyroxine formulation containing citric acid, gelatin and any filler, so that the existence of the patent prevents competitors from marketing alternative formulations with other fillers. This is relevant because the filler used in the new LEVOTHYROX® formulation, namely mannitol, was suspected to be responsible for the side effects.
The court responded to the argument as follows:
It is true that, by suppressing the monopoly on [the new formulation] in France, the revocation of the French part of the EP’005 patent […] would not only make it possible to market generics of this drug with perhaps a reduced price, but would also make it possible for other laboratories to make a formulation identical to the old formulation of LEVOTHYROX, which is, according to the plaintiffs, currently impossible because it may infringe the patent at stake which unduly covers the old formulation.
However, as rightly noted by the defendant, the potential success of the nullity suit would not result in the automatic production and marketing of the old formulation […], which currently no longer benefits from a marketing authorization.
The causal link between the nullity suit and the expected effect, namely that Merck or a third party should resume the manufacturing and marketing of [the old formulation] thus appears to be purely hypothetical and may not improve the legal and/or economical situation of the plaintiffs, so that they do not have standing in this case.
In summary, the ultimate goal of the plaintiffs was to have a different levothyroxine drug available on the market. The court acknowledged that the revocation of the patent would be helpful for this goal. But it would not automatically result in the achievement of the goal, as a MA for a different drug would still be necessary – and is currently lacking.
To my mind, the reasoning is not really satisfactory. Has the court considered that a pharma company may not want to take the pain of requesting a new MA if a patent stands in the way? Therefore, can’t the revocation of the patent be considered as a necessary prerequisite for achieving the claimants’ stated goal?
At the risk of oversimplifying the discussion, shouldn’t any person or company willing to spend the (sometimes considerable) time and effort needed to revoke a patent be presumed to have a legitimate interest in the revocation? Shouldn’t the standing bar be lowered so as to only set aside abusive and frivolous lawsuits?
CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 3ème section, January 24, 2020, Alerte Thyroïde et al. v. Merck Patent GmbH, RG No. 18/14575.