OK oral

As a patent professional well used to the EPO’s way of reasoning, the aspect of French patent litigation which often strikes me as the most fascinating one is claim interpretation.

This is because there is such a significant difference between the EPO and French courts when it comes to deciding what is and what is not covered by a patent.

Today’s case, Bayer v. Ceva, provides a noteworthy example.

I have actually already talked about this case in a previous post. It is indeed one of these disputes which gives rise to a large number of procedural developments.

Here is the context, in quite a few bullet points:

  • Bayer Intellectual Property GmbH owns European patent EP 2164496 (EP’496), granted in April 2017, on “Formulations containing triazinones and iron”.
  • Bayer Animal Health GmbH, a licensee, developed a veterinary product named Baycox Iron®. The product is an injectable formulation of a combination of toltrazuril and a dextran iron (III) complex. The veterinary indication is the treatment of coccidiosis in piglets.
  • In parallel, Ceva Santé Animale developed a similar veterinary product, called Forceris®.
  • Ceva contacted Bayer in November 2017 to let them know about their intention to market Forceris®. Ceva argued that their product was out of the scope of the EP’496 patent.
  • Ceva filed an opposition against the patent. The opposition was rejected by the EPO in a decision dated July 16, 2019. An appeal is pending.
  • Bayer disagreed and filed a petition for preliminary injunction against Ceva in France, in December 2017.
  • Ceva Santé Animale filed an opposition against EP’496 in January 2018.
  • In parallel, Ceva filed an action for a declaration of non-infringement in France, in January 2018. As far as I understand, this action is still pending.
  • In April 2018, the judge in charge of urgency proceedings rejected Bayer’s request for preliminary injunction, because Ceva’s letter of November 2017 was not enough to represent an imminent threat, and because there were serious doubts as to the scope of the patent.
  • In February 2019, Ceva obtained its marketing authorization for Forceris®.
  • Ceva started marketing Forceris® in France in April 2019.
  • In May 2019, Bayer obtained its marketing authorization for Baycox Iron®. The product started being marketed in France a few weeks thereafter.
  • Still in May 2019, the oral proceedings of the opposition against EP’496 took place, and the opposition was rejected (the written decision was issued on July 16, 2019; an appeal is pending).
  • On the same day, a cease and desist letter was sent by Bayer to Ceva.
  • An infringement seizure was carried out at Ceva’s French premises a few days later.
  • Ceva countered by requesting that the seized evidence be placed under seal. In a judgment dated June 7, 2019 (commented upon in my previous post), the judge rejected most of Ceva’s requests.
  • On June 20, 2019, Bayer filed a second petition for preliminary injunction against Ceva.
  • Petitions for preliminary injunctions have also been filed at least in Italy, Denmark, Spain and the Netherlands. It seems that Bayer prevailed at least in Spain, an ex parte injunction having been issued on July 17, 2019.

Not a straightforward case indeed.

A first interesting question is why Bayer filed a second petition for preliminary injunction (PI) in June 2019, after having lost its first petition for PI in April 2018.

This is probably an easy one: the main reason for the April 2018 decision was that it was not established at that time that there was an imminent infringement threat. Obviously, the situation had changed once Ceva had obtained its marketing authorization and started marketing its product.

However, there was a second reason for the April 2018 ruling, which was the existence of doubts as to the validity and scope of the patent. Bayer probably took a gamble on the fact that the rejection of the opposition which took place in May 2019 would be a game changer and would lift all doubts that French judges could have regarding the validity of the patent.

But the gamble was lost.

The court in charge of urgency proceedings (unusually a full panel, and not a single judge) quickly agreed that there was indeed an imminent threat this time.

But when they turned to the issue of the likelihood of infringement, things got trickier.

Claim 1 of EP’496 is directed to a formulation containing triazinones of formulas (I) or (II) (let me spare you the details), as well as polynuclear iron (III)-polysaccharide complexes.

Ceva’s argument was that the scope of the patent was limited to formulations for an oral administration. Remember that Forceris® (just like Bayer’s Baycox Iron®) is an injectable formulation, not an oral formulation.

Ready for oral administration?

In front of the EPO, especially when looking at novelty and inventive step, I think that there would never be the slightest doubt that claim 1 of EP’496 covers all formulations, whether oral, injectable or other.

This was actually confirmed by the opposition division in its written decision.

In fact, claim 13 is directed to the use of the formulation for making a drug. And dependent claim 15 adds that the drug is for oral administration. This can be viewed as further confirmation that claim 13 and hence claim 1 are not limited to an oral administration.

But national courts, and especially French courts, can be much more creative when it comes to claim interpretation.

Making reference to article 69 EPC and its protocol, the court performed a detailed analysis of the description of the patent. They noted that all examples relate to oral formulations, and that the general part of the description is also very much concerned with the provision of oral formulations. The technical effects of the claimed combination were also demonstrated in the context of oral formulations. The technical problem was thus formulated in relation with an oral administration, and the court was persuaded by Ceva’s argument that the same technical problem did not arise in connection with injectable formulations.

To put it otherwise, the inventive step of the claimed invention seems to be closely related to the oral mode of administration.

Here are some relevant excerpts of the decision:

The technical problem described by the patent is thus the absence of formulations available in the prior art for treating piglets simultaneously against coccidiosis and anemia, which the skilled person would be dissuaded from doing because the appropriate administration timing of each treatment to ensure efficacy is not the same. If an administration by injection is contemplated, this problem does not arise in the same terms since, as mentioned in the description, this iron compound is then efficiently absorbed and can be administered on day 3 at the same time as toltrazuril. 

[…]

Therefore, the purpose of the formulations of the patent is to efficiently treat piglets against coccidiosis and iron deficiency with a single operation and with an oral administration. It is indeed either the absence of a common treatment window, or the difference in mode of administration, which did not suggest to couple the two active substances at stake in a single formulation.

[…]

Beyond this particular context of oral administration [Bayer] does not demonstrate – and does not in fact claim – that its combination formulation would be more efficient than the separate intake of the two products.

[…]

It is only this surprising effect obtained in the context of an oral administration, and not of an injection (the alternative use of which on the third day is known and is clearly not encouraged), which is shown and that the patent intended to protect.

Most interestingly, the court also made reference to statements made by Bayer during prosecution of foreign patent applications.

This is a form of unofficial file wrapper estoppel which I would say is quite uncommon in French decisions. But I think the court only made reference to foreign prosecution in this particular case because it nicely confirmed their understanding of what the invention is about:

[…] This scope of protection was claimed by Bayer in the context of examination proceedings of the same patent in front of the Canadian patent office. On June 9, 2015, Bayer mentioned in its response to the examiner’s report that “the present formulation is related to addressing two problems simultaneously. One of which is to arrive at an orally administrable formulation, the other being that this formulation thereby allows for the treatment of anemia in animals that are affected by coccidiosis even via the oral route (being biased in the prior art per se to be the less reliable route even in otherwise healthy animals – see D5 above)”.

It is also emphasized that “the presently claimed invention does provide a non-obvious formulation over the art cited. Moreover, as it is clear from pages 10 and 11 of the application, providing an oral formulation that can be used to address both anemia and coccidiosis is clearly advantageous over problems associated with the monotherapy, such as the use of non-oral formulations and divided administration times” […]. The Canadian version of the granted patent is directed to “an oral formulation” […]. 

In front of the Indian patent office, it was also stated that the invention provided “means to simultaneously treat iron deficiency and coccidiosis by an (oral) mode of administration”.

As a result, the court rejected Bayer’s second petition for PI.

For other striking instances of narrow claim interpretations by French courts, see for instance this post, or this one, or this one.

I do find some merit in this way of looking at things. Assuming that the court was indeed right in finding that the actual contribution of the invention to the art was limited to an oral administration (which I have not formed an opinion on), it then seems only fair that the scope of protection should be limited to this contribution. One major issue is legal uncertainty, though: the more the scope of protection may differ from the literal wording of the claims, the more difficult it is for all stakeholders to know where they stand.

Another possible way to handle this situation would be to accept that claim 1 of the above patent is broad and covers all kinds of modes of administration, but that it may then lack inventive step over the entire scope of the claim, if indeed only the oral administration is truly inventive.

Yet, again, I do not believe that this would be a typical EPO-approved approach. When a combination of compounds provides a certain technical effect in a very specific context, in my experience the EPO generally allows a claim to the combination per se, without any restriction to the specific context in which the technical effect actually arises. But could this tradition in fact be too generous?

** Update (Sept. 30, 2019) **

Amandine Métier, counsel for Ceva, has kindly informed me that, in the parallel European lawsuits, a request for PI filed by Bayer in the Netherlands was also rejected on September 17, 2019, due to a serious doubt as to the existence of an inventive step. The Dutch judge analyzed the opposition division’s decision of rejection of the opposition and came to the conclusion that there is a reasonable chance that it will be overturned by the technical Board of appeal.

Amandine has also confirmed that an ex parte PI was issued in Spain. The inter partes hearing will take place next November.

Finally, an ex parte PI was also issued in Germany, which was then confirmed inter partes. The grounds for the decision are not yet known, and an appeal is pending.

Many thanks for this information! As always, pan-European litigation is a roller-coaster for litigants.


CASE REFERENCE: Tribunal de grande instance de Paris, September 11, 2019, Bayer Intellectual Property GmbH & Bayer Animal Health GmbH v. SA Ceva Santé Animale, RG No. 19/56082.

3 thoughts on “OK oral”

  1. In my experience at examination level, a lack of inventiveness objection is often raised by arguing that the claims are an obvious solution to another technical problem that the one quoted in the patent.
    I understand from your experience that it is probably more difficult to use by an opponent.
    This would apply here, and it is -to my point of view- a better legal solution to cancel a broad claim forcing then a limitation, than maintaining it and limiting its scope bases on Article 69, but maybe this defence was not raised by the defendant in the TGI.

  2. Just found your blog.. very interesting.

    I would tend to consider that if the formulation only has advantages in oral administration, then exactly that is the technical effect: Increased suitability for oral administration. This would (and should, IMHO) allow the formulation to be protectable as-is.

    Like you I don’t like it if judges deviate from the literal wording of the claims.

    I am not an expert on claim construction, but I always understood A69 and the protocol as allowing a (somewhat) wider scope of protection than the literal meaning of a claim, not as giving a judge the liberty to limit a claim.

    It is up to the patentee to define the claims, and he will suffer the consequences (nullity) if the claims are worded too broadly and fall foul of one of the legal requirements. If no objections can be found against a broad claims, well…. then clearly the claim represents the actual contribution to the art, and should not be limited (relatively randomly) by a judge.

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