Patent still standing

The appraisal of standing in patent nullity suits in France is complex and harsh. The topic has been addressed in a number posts, for instance this one, that one or that other one.

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. 

There are different ways to achieve standing.

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.

The dead line

There is something ominous about the word “deadline” in English.

It makes you suspect some dire background. And rightly so, according to some online resources, which mention a line that you would cross at the risk of losing your life.

The French word “délai” sounds much less sinister, but the consequences of missing a “délai” are pretty much the same as those of missing a “deadline“, as a recent decision of the Paris Cour d’appel reminds us.

In this case, a French patent application was filed on November 6, 2015, claiming the benefit of the filing date of an earlier French application, namely April 1, 2015. This is what is sometimes conveniently referred to as an “internal priority claim“.

One of the requirements of claiming an internal priority is that you must provide a copy of the initial patent application (plus you must identify the modifications made in the later filing). As the applicant failed to do so upon filing the later application, the INPI issued a communication dated August 9, 2016 and notified on August 16 to the representative, inviting the applicant to submit the missing copy within a two-month period.

The applicant still did not file the requested document, so that a decision to refuse the application was issued on November 4, 2016, and notified on November 10, 2016 to the representative.

On January 8, 2018, the applicant filed a request for restoration of its rights. On August 17, 2018, the INPI issued a negative decision, holding that the request for restoration was inadmissible as it was filed past the statutory deadline.

The applicant lodged an appeal in front of the Paris Cour d’appel, which resulted in a judgment dated November 5, 2019.

The key provision in this case is article L. 612-16 Code de la propriété intellectuelle:

The applicant who failed to comply with a deadline set by the [INPI] may file a request for restoration of its rights, if it has a legitimate excuse and if the non-compliance directly resulted in a refusal of the patent application or of a request, in the lapse of the patent application or patent, or in the loss of any other right. 

The appeal must be filed […] within a two-month deadline from the removal of the cause of non-compliance. The missing act must be performed within this deadline. The request is admissible only within a one-year deadline from the expiry of the missed deadline.

[…]

The main question is that of the starting point of the one-year deadline. The INPI currently considers (and this is reflected in its Guidelines for examination, section E.3.3.1.b, Oct. 2019 edition) that the “missed deadline” starting point is the “initially missed deadline”.

As a side note, this did not appear in the previous versions of the Guidelines – I suspect that they may have been modified based on the present case.

Here, the applicant was notified on August 16, 2016 of the invitation to file the copy of the earlier filing. The deadline for filing this copy expired on October 17, 2016. The INPI thus deemed that the one-year restoration deadline expired on October 17, 2017.

The talking calendar – the must-have gadget for handling your deadlines this year.

The applicant’s defense relied on the fact that there was another possible legal remedy, namely a request for further processing. See article R. 612-52 Code de la propriété intellectuelle:

If a patent application is refused or may be refused due to non-compliance with a time limit set by the [INPI], the refusal is not issued or is revoked if the applicant files a request for further processing. The request must be filed in writing within a two-month deadline from the communication of the refusal decision. The missing act must be performed within this deadline. The request is admissible only if the required fee is paid. 

Thus, the applicant argued that the missed deadline was the two-month further processing deadline, and not the initial two-month deadline starting from the INPI communication. The request for restoration was thus filed with respect to the further processing deadline.

This reasoning will probably sound familiar to many European readers, as this is exactly the approach used at the EPO.

Applying this reasoning to the facts at hand, the deadline for requesting further processing expired on January 10, 2017 (date of notification of the refusal decision + 2 months), and therefore the one-year restoration deadline expired on January 10, 2018 – so that the request for restoration was timely filed.

But the appeal judges did not follow this argumentation. They stuck to the INPI’s interpretation of L. 612-16 and considered that the missed deadline used as a starting point must be the initial missed deadline, and not the further processing missed deadline. The INPI’s decision was accordingly confirmed.

Don’t ask me for the reasons why they chose one interpretation over the other. They just did, and there is no actual justification in the judgment.

This is all the more unfortunate as the summary of the facts reveals that two interesting case law decisions were discussed by the petitioner: a cassation ruling dated April 15, 1986, and a later judgment of the Paris Cour d’appel dated January 14, 1987.

The petitioner argued that the INPI misinterpreted the 1986 cassation ruling – from which it can be inferred that this ruling was the basis for the INPI’s position.

The facts underlying the 1986 ruling are that a patent application was refused for failure to pay the grant fee; a request for restoration was filed but it was held inadmissible as it was filed more than one year after the expiry of the time limit for paying the grant fee. The petitioner tried to take advantage of an additional two-month period corresponding to the filing of a request for further processing – to no avail.

The cassation judges stated the following: 

The non-compliance of the deadline for the request for further processing is not excluded from the provisions of [what is now art. L.612-16]. But the provisions of [what is now art. R. 612-52] do not result in extending the one-year deadline set in the second paragraph of [what is now art. L.612-16]. The Cour d’appel held that, irrespective of the grounds for the request for restoration, it is only admissible within a one-year deadline from the final date on which the initially omitted act had to be performed, and therefore rightly justified its decision. 

This is quite clear, right? The one-year deadline must be computed from the expiry of the initial deadline. Well, not so fast.

Looking at the specifics of the case that led to the 1986 cassation ruling, it turns out that, in that case, the request for restoration had been filed with respect to the initial time limit (i.e. the time limit for paying the grant fee). It had not been filed with respect to the (missing) request for further processing. 

Let’s now turn to the second case discussed by the petitioner. It is an appeal judgment which was issued after the 1986 cassation ruling. In this case, it was also the grant fee which was not paid in time. But the difference is that the applicant filed a request for restoration with respect to the (missing) request for further processing.

And the appeal judges computed the one-year deadline from the expiry of the period for requesting further processing, not from the expiry of the initial deadline for paying the grant fee: 

[…] The petition is admissible as to time limits. Indeed, according to [what is now art. L.612-16] the time limit for filing a request for restoration is one year from the expiry of the deadline not complied with. The request for further processing was due by April 17, 1982, so that the time limit for filing the request for restoration expired on April 17, 1983. The request for restoration was filed on April 15, 1983.

In summary, reading between the lines, we have:

  • On the one hand, a 1986 cassation ruling which could at first sight be seen as supporting the INPI’s position, except that the facts were different and that the relevant statement in the ruling is ambiguous. There is a reference to “the initially omitted act” but it is unclear what we should make of it. The cassation judges did simply not have to decide on a request for restoration with respect to a request for further processing.
  • On the other hand, a 1987 appeal decision based on facts similar to the present facts, and that is manifestly contradictory with the decision commented on today.

It is thus a real pity that the Cour d’appel did not seriously address these issues. 

I would also add that, one a purely pragmatic standpoint, it seems to me that there may be some contradiction in the INPI’s approach (and in the court’s present approach) to this matter. Indeed, the INPI acknowledges that a request for restoration may be filed with respect to a missed deadline for a request for further processing. This is stated in the table that you can find on the last page of the Guidelines for examination.

But what is the point in requesting restoration of right with respect to the further processing deadline, if the one-year time limit is to be computed from the initial missed deadline? I cannot think of any situation in which requesting restoration with respect to the further processing deadline would then be of any use.

I would not like to conclude this post without wishing all readers a very happy new year.

I hope that I have not missed the deadline for doing so – but hey, I have always heard that it is all right to send your best wishes until January 31. This may not be true elsewhere, but as you can see there is some cultural specificity about French deadlines.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, November 5, 2019, … v. Directeur Général de l’INPI, RG No. 18/20057.