Time for the third round

The postman may always ring twice, but Lionel Vial, as a seasoned post-writing man, always rings three times. Here is thus his third foray into the Truvada® litigation.

As our faithful readers surely remember, there have already been two rounds in the Truvada® litigation in France (reported here and here). For the less faithful readers, here is a short reminder.

Truvada® (Gilead) is an anti-HIV drug comprised of the combination of tenofovir disoproxyl fumarate (TDF) and emtricitabine (FTC) approved for Pre-exposure Prophylaxy (PreP) of HIV infection, since it has been shown to allow for a reduction of 86% of the risk of being infected by HIV.

Truvada® was covered until 25 July 2017 by European patent EP 0915894. The effects of the patent have been extended by supplementary protection certificates (SPCs) expiring between 21 and 24 February 2020 depending on the countries.

The SPCs are based on European Union marketing authorization EU/1/04/305/001 and on claim 27 of the basic patent, which reads as follows:

A pharmaceutical composition comprising a compound according to any one of claims 1-25 [N.B. tenofovir disoproxil is claimed in claim 25] together with a pharmaceutical carrier and optionally other therapeutic ingredients. (Emphasis added).

The essential question repeatedly asked to the French courts was whether the use of the expression “other therapeutic ingredients” to refer to emtricitabine (FTC) is indeed sufficient to protect the TDF/FTC combination pursuant to Article 3(a) of Regulation (EC) No. 469/2009 of the European Parliament and of the Council (i.e. the SPC regulation).

Round one saw the rejection, on 5 September 2017, of Gilead’s request for a preliminary injunction under urgency proceedings to prohibit the sale of Mylan’s generic, because the SPC was considered “in all likelihood invalid” by the French judge in charge of the case.

Round two saw the Paris Tribunal de Grande Instance confirm this preliminary ruling by invalidating the SPC on 25 May 2018.

Which brings us to round three, which took place before the Paris Cour d’Appel.

Bam! Wham! … and Pow!

In our previous post on the subject, we had expressed the thought that there was not much suspense left, especially in view of the opinion of the Advocate General (AG) of the CJEU delivered on April 25, 2018 in the then pending case C-121/17, relating to the corresponding UK SPC, and according to which it would not have been obvious to a person skilled in the art that the active ingredient emtricitabine was specifically and precisely identifiable in the wording of the claims of that patent.

Referral C-121/17 yielded a decision on 25 July 2018:

Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

            • the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
            • each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.” (emphasis added)

Let’s see what the Cour d’Appel made of it in its decision handed down on 19 June 2020:

The court, which studied the consultations and scientific articles submitted by the parties, retains that if it is not contested that the person skilled in the art knew that for treating HIV a therapy combining several active principles was more effective than a mono-therapy, nothing establishes that in 1996 the person skilled in the art, given the the general state of its knowledge, necessarily and specifically thought of emtricitabine to combine it to TD upon reading claim 27 which is drafted in very general terms.

The [first instance] judgement will be therefore confirmed in that it retained that no functional formula necessarily and specifically related to emtricitabine and that consequently the combination of the two products TD and emtricitabine could not be made the subject of an SPC on the basis of the EP 894 patent […]” (emphasis added)

Thus, not much suspense indeed, as round three also ends in a knock-down. Time to throw in the towel?


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, June 19, 2020, Gilead Sciences Inc. et al. v. SASU Mylan, RG No. 18/15906.

Karmic retribution

Or should that be cosmic irony?

Today’s tale is that of an inventor applicant who is successful in obtaining the grant of a European patent – which is no small feat for a self-represented individual; and who then loses the French part of his European patent due to a minor misstep.

But he does not give up and is fully reinstated by the Paris Cour d’appel… due to what might also be a procedural error by the French patent office (INPI). Tit for tat.

And now, the somewhat more complete account of these events.

Mr. F (as he is referred to in the redacted version of the ruling) filed a PCT application in 2007, claiming the priority of a French patent application. The invention is a gas turbine engine. Based on this PCT application, a European patent was granted in 2011. If you have a look at the European patent register, you will see that the examination proceedings were mostly conducted by phone, the applicant being instructed which taxes he should pay and being advised as to which modifications would be acceptable for the examining division. Kudos to the EPO for explaining what needed to be explained – and for documenting these explanations in the record accessible to the public (more on this topic below).

Then, Mr. F started paying renewal fees at the INPI to keep the French part of his patent in force.

In 2015, the 9th renewal fee became due. That year, there was an increase in the schedule of fees, and the new rate was 180 euros. But Mr. F paid only 170 euros.

At the EPO, this would (presumably!) not have been a major difficulty, as “the EPO may, where this is considered justified, overlook any small amounts lacking without prejudice to the rights of the person making the payment (Art. 8 RFees)” (Guidelines, A-X, 7.1.1).

But the INPI was not lenient. “Un sou est un sou” – every penny counts. Thus, the French part of the patent was declared lapsed on May 31, 2016.

There are two ways to challenge a declaration of lapse. One is a request for restoration of rights. The other one is a “recours gracieux which I would probably not translate into a gracious appeal, but rather a petition for reconsideration.

The INPI dismissed this petition for reconsideration in a decision dated February 6, 2018. It is against this decision that Mr. F filed an appeal with the Paris Cour d’appel.

And then what?

For starters, the INPI argued that the appeal was inadmissible because the notice of appeal neither specified the date and object of the decision under appeal, nor the professional occupation and birthplace of the appellant. As you can guess, Mr. F did not hire an attorney at the appeal stage either. Usually, this is not a good idea, but in this case the court was satisfied that the decision under appeal could be properly identified by the mention “I hereby appeal the INPI decision for the lapse of my patent“, and the appellant was allowed to simply provide the missing information at the hearing.

On the merits, the INPI argued that the procedure had been clean. Admittedly, no reminder of the grace period was issued after the due date for the renewal fee – but the INPI is not required to send such a reminder.

As for Mr. F, he claimed that he was never informed that his payment was insufficient; that he moved in 2012; and that, although he duly received all correspondence from the INPI, as an exception he did not receive the communication on the declaration of lapse and he only became aware of it more than one year and a half afterwards.

By the way, this is reminiscent of the infamous pravastatin case, in which an SPC was considered lapsed and then had to be reinstated due to a correspondence problem.

Here is now the court’s position:

The court notes that, based on the patent datasheet submitted by the INPI, Mr. F residing in Palluau is mentioned as the patent proprietor, but Mr. F residing in Le Pallet is indicated as the representative. It is at this “representative” address that the INPI sent him each year from 2012 to 2018 the renewal fee receipts, including that of November 12, 2015 for the amount of 170 euros.  

However, it has been established that the decision of declaration of lapse of May 31, 2016 was not sent to Mr. F at his address in Le Pallet, but at the one in Palluau; and that the registered letter came back with the mention “unknown recipient at this address”; and that these circumstances have prevented him to exert his rights to maintain or restore the patent in time.

It can be deduced from all of this that Mr. F’s appeal must be granted so that the decision to reject his petition for reconsideration is set aside. 

A rescue operation by the Cour d’appel.

Let me now express some conflicting observations.

First, the court’s reasoning may rest on shaky legal grounds.

Even if the declaration of lapse had been properly notified to Mr. F, it would still have been too late for him to pay the missing amount. Actually, declarations of lapse are only issued after the grace period is over, i.e. when it is already too late to redress the situation. A proper notification of this declaration of lapse would have enabled him to file a request for restoration – but it would not per se have entitled him to a reconsideration of his case.

Second, despite this somewhat shaky reasoning, I have a lot of sympathy for Mr. F – and thus for this judgment.

What happened to this inventor strikes me as mostly unfair. The INPI did not take any step to let him know that a minor amount of the recently increased renewal fee was still due, then messed up with the patentee’s contact information (how and why being unclear based on the judgment), and finally, as far as I understand, continued to bank the following renewal fees for several years despite the lapse.

Third, I assume that one of the reasons why the INPI stood its ground when Mr. F finally complained is the protection of the interests of third parties.

This is a very legitimate concern. It is true that reinstating a patent further to a procedure initiated a couple of years after the lapse (and thus initiated after the one-year restoration time bar) can also be very unfair – to third parties.

But I think one way to address this concern would be to make the office’s records more fully and readily available to the public, so that third parties can make their own assessment of the actual situation of any patent or application.

Progress has recently been made, but this is still not enough. If you look up the patent in suit on the INPI’s website, you will see that the only documents available for download are… the publication of the PCT application, and the B1 patent!

The declaration of lapse cannot be downloaded – let alone the no-delivery mailing receipt. The full renewal fee records cannot be checked – so that third parties cannot see that the patentee paid the major part of the 9th renewal fees and continued to pay the following ones. Last but not least, the “datasheet” mentioned by the court, in which the “representative address” is supposed to be indicated, can also not be retrieved from the website.

Some documents can probably be more or less easily obtained upon request – at least the communication on the declaration of lapse and hopefully the patentee’s petition for reconsideration and the INPI’s decision to refuse this petition. But I am pretty sure that not all of the relevant information can be obtained. Besides, this is 2020 – everything should be made available online.

Anyway, congratulations to Mr. F, and let’s hope he gets the next steps right when his patent is reinstated, especially regarding the payment of the various renewal fees.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, June 19, 2020, Mr. F v. Directeur général de l’INPI, RG No. 19/06949.