A travel back in time

Regular readers of this blog are probably aware that Lionel Vial is a frequent contributor.

I am grateful for his thorough reporting on pharma / biotech case law. Today, he once again keeps us apprised of the latest SPC tidbit. As he even provided the illustration, I really have nothing to add but say thanks!

While we are all waiting for the decision of the CJEU in the Santen case (C-673/18) to finally know if, in application of the Neurim (C-130/11) case law, a patented novel medical use in humans of a product having already been authorized for a previous different medical use in humans deserves a supplementary protection certificate (SPC), the decision discussed today will take us back to the pre-Neurim era, a time of uncertainty as we will see.

At that time, the prevailing case law regarding further medical use consisted in Pharmacia Italia SpA (C-31/03) rendered on October 19, 2004, and Yissum (C-202/05) rendered on April 17, 2007.

According to the judgment in Pharmacia Italia SpA:

The grant of a supplementary protection certificate in a Member State of the Community on the basis of a medicinal product for human use authorised in that Member State is precluded by an authorisation to place the product on the market as a veterinary medicinal product granted in another Member State of the Community before the date specified in Article 19(1) of Council Regulation No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products.

On the other hand, the order in Yissum reads:

Article 1(b) of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products […] is to be interpreted as meaning that in a case where a basic patent protects a second medical use of an active ingredient, that use does not form an integral part of the definition of the product.

The DeLorean remains the best way to travel in time with style.

The Regents of the University of Colorado (hereafter the University) was granted European patent No. 1658858 on November 18, 2009 for the use of a botulinum toxin, in particular botulinum toxin type A, in the preparation of a pharmaceutical composition for treating a recalcitrant voiding dysfunction, in particular urinary incontinence.

A corresponding marketing authorization was then granted on August 22, 2011.

The University had six month (that is until February 22, 2012) to file an SPC application. However, since botulinum toxin type A had benefited of previous marketing authorizations and in view of the then prevailing case law, the University considered it impossible to have an SPC granted and therefore no SPC application was filed.

Then the Neurim judgment was rendered on July 19, 2012. It notably provides that:

Articles 3 and 4 of Regulation (EC) 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, in a case such as that in the main proceedings, the mere existence of an earlier marketing authorisation obtained for a veterinary medicinal product does not preclude the grant of a supplementary protection certificate for a different application of the same product for which a marketing authorisation has been granted, provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

Neurim has often been considered as a complete reversal of the previous case law.

Besides, for many commentators, it opened the door to SPCs for novel medical uses in humans of products having already been authorized for a previous different medical use in humans.

The University therefore filed an SPC application on September 19, 2012, i.e. within 2 months of the publication of the Neurim judgment, but about 7 months after the end of the deadline for doing so.

The University sought to benefit from the provisions of Article L. 612-16 of the Code de la propriété intellectuelle, according to which:

Where an applicant has not complied with a time limit as regards the Institut National de la Propriété Industrielle, it may submit an appeal for reinstatement of it rights if it is able to give a legitimate reason and if the direct consequence of the hindrance has been refusal of its patent application or of a request or the loss of any other right or means of appeal.

The appeal must be submitted to the Director of the Institut National de la Propriété Industrielle within two months of the cessation of the hindrance. The act that has not been carried out must be accomplished within that period. The appeal shall only be admissible within a period of one year from expiry of the time limit not complied with. […]

However, the INPI (French patent office) was not convinced and rejected the appeal for reinstatement on June 30, 2015.

The University and Allergan (to whom the SPC application and the basic patent had then been assigned) appealed the decision of the Director of the INPI before the Paris Cour d’appel on September 18, 2015.

In a first decision dated September 16, 2016 the Cour d’appel confirmed the decision of the INPI. However, the decision was invalidated by the Cour de cassation, the French Supreme court, on April 5, 2018, for procedural reasons, as the Cour d’appel had neglected notifying observations made by the INPI to the University and Allergan.

The case then came back in front of the Paris Cour d’appel which, albeit with different judges, again confirmed the decision of the INPI on February 12, 2019 in the following terms:

However, according to the terms of article L. 612-16 of the intellectual property code, the legitimate reason must be understood as a “hindrance”;

Even considering that the case law of the CJEU, before the Neurim judgement, did not allow the University to expect obtaining an SPC and could therefore discourage it to file an SPC application, the director of the INPI rightly observes that this situation does not characterize a hindrance according to the previously cited provision, given that the case law, be it that of the Court of justice, evolves, that even with the Pharmacia Italia and Yissum case law other operators have indeed filed SPC applications in relation to further medical uses, one of which having given rise to the Neurim judgment, and that the lack of filing of an SPC application by the University was the result of its free appreciation of the latter and not of an objective impossibility, independent of its will.

In any case, pursuant to article 7 of regulation No. 469/2009 concerning the supplementary protection certificate for medicinal products, the University had a six-month period expiring on February 22, 2012 to file its SPC application; the reference for preliminary ruling to the Court of justice of the European Union was received at the Court on March 16, 2011 and published in the OJEU on June 18, 2011; under these conditions, as is rightly observed by the director of the INPI, the University had to consider a possible reversal of the case law of the Court of justice;

As such, the decision of the director of the INPI is exempt from criticism in having retained that the lack of respect of the deadline imparted to the University for filing its SPC application was not due to a hindrance for which it would benefit from a legitimate reason, but to its will not to proceed with a filing that it did not consider appropriate and this in spite of the reference for a preliminary ruling submitted to the Court of justice duly published on June 18, 2011.

Perhaps, this case is an illustration that too much knowledge is sometimes dangerous, and that we, as counsels, should always be careful when giving opinions on the likely outcome of a filing on the basis of our knowledge of established case law, bearing in mind that there is always a possibility, even a remote one, that a case law can be overturned.

In any case, the University and Allergan should refrain from nourishing regrets on their missed filing at least until the result of the Santen referral (C-673/18) is known, as this latter case precisely arises from a decision of rejection of an SPC application by the INPI in relation to a further medical use.

Well, the way I see it, getting SPC law 100% right is a little bit like having to hit a wire with a connecting hook at precisely eighty-eight miles per hour the instant a lightning strikes a tower. Everything will be fine.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, February 12, 2019, The Regents of the University of Colorado & Allergan Inc. v. Directeur de l’Institut National de la Propriété Industrielle, RG No. 18/14291.

Representatives don’t count

Being a representative myself, my feelings tend to get hurt when I am told that representatives do not matter. Except, that is, when this is in the best common interest of attorneys and their clients, as in the present case.

In December 2013, Spanish company Agromet Ejea SL filed a French utility certificate application through its local French representative.

This is already an unusual start, since utility certificates are a rare species. But wait until you hear about the rest of the facts, which are rather unusual as well.

The second renewal fee for the utility certificate was due on December 31, 2014, and was not paid in due time. It was not paid either by the end of the 6-month grace period. This led the Institut National de la Propriété Industrielle (INPI) to issue a decision of noting of lapse dated August 31, 2015. This decision was notified to the French representative on September 3, 2015.

When the INPI sends you flowers.

A request for restoration of right was filed on November 16, 2015. The INPI rejected this request as inadmissible as it was filed too late.

The French provision on restoration of right is article L. 612-16 of the Code de la propriété intellectuelle. It is very similar to article 122 and rule 136 EPC. In particular, it is specified in the French provision that the request for restoration must be filed within two months of the removal of the cause of non-compliance.

The INPI considered that the cause of non-compliance had been removed upon notification of the decision of noting of lapse to the French representative on September 3, 2015. Therefore, according to the position of the office, the request for restoration should have been filed by November 3, 2015 at the latest.

The owner of the utility certificate appealed the decision in front of the Paris Cour d’appel.

They did well, as the court set aside the decision of the INPI and offered a different computation of the time limit for filing the request for restoration:

Contrary to the position of the [INPI], the legitimate excuse and the removal of the cause of non-compliance […] are appraised with respect to the owner of the IP right and not their representative

In the present case, Agromet Ejea SL stated that they entrusted a Spanish patent law firm with the filing and handling of the utility certificate […], which appointed firm [X] for France. They proved the deficiencies of their representatives in their submissions and with their exhibits, which led to the non-payment of the renewal fee […]. In December 2014, the email reminders of the French representative to the Spanish representative did not reach their destination due to an error of electronic address. In 2015, the IP portfolio management software of the French representative broke, preventing a reminder of the time limit for late payment. The employee of the French firm in charge of the file made several mistakes, leading to the termination of her employment agreement on September 9, 2015, with an effective departure on October 20, 2015. Finally, the decision of noting of lapse of August 31, 2015, notified on September 3, 2015 to the French representative was only communicated to the Spanish representative on October 12 and 16, 2015. The latter only informed the right owner on October 19, 2015. 

Besides, Agromet Ejea SL established that they inquired about the status of their right. Their Spanish representative asked the [French] representative about this by email on July 6, 2015. In view of the above, it can be derived, on the one hand, that Agromet Ejea SL could rely on a legitimate excuse for not paying the renewal fees of its IP right within the prescribed time limits, due to its representatives’ faults; and on the other hand that the cause of non-compliance was only removed on October 19, 2015, when they were made aware of the decision of lapse, or at the earliest when it was published in the BOPI on September 25, 2015

Thus, on November 16, 2015, since the two-month time limit had not yet expired and the payment of the surcharge was made on the same day, the request for restoration of Agromet Ejea SL was admissible.

In summary, the court held that the request for restoration was admissible and well-founded.

It is well known that the notion of legitimate excuse is assessed in a much more lenient manner in France than at the EPO.

In fact, a mistake made by a representative is a legitimate excuse per se, as illustrated by the present case. There is no need to demonstrate that the omission was the result of an isolated mistake within a satisfactory system for monitoring time limits, as demanded by the EPO. Fortunately so for the applicant in the present case, in view of the large number of deficiencies noted by the court…

But today’s decision illustrates that this different perspective also extends to the computation of deadlines.

According to established case law of the Boards of appeal, “the removal of the cause of non-compliance is a matter of fact which has to be determined in the individual circumstances of each case“. More particularly, “the removal of the cause of non-compliance occurs […] on the date on which the person responsible for the application (the patent applicant or his professional representative) is made aware of the fact that a time limit has not been observed“.

Usually, the receipt of a noting of loss of rights or negative decision is considered by the EPO as making the person in charge aware of the non-observance. In most cases, the relevant person is the European representative; but in other cases, it can be the applicant, or even a foreign patent attorney (see here), depending on the specifics of the case.

In contrast, the position of the Cour d’appel seems to be that only the receipt by the applicant can be relevant. Interestingly, the Cour d’appel also offered another possible starting point for the time limit, namely the publication of lapse in the BOPI (Bulletin officiel de la propriété industrielle), which is the local equivalent of the European patent bulletin.

In this case, the time limit was found to have been complied with irrespective of the exact starting point. But if the request for restoration had been filed e.g. on December 1, 2015, it would then have made a world of a difference whether the starting point was October 19 or September 25. So, it is somewhat strange that the court did not more clearly state its position.

The one unfortunate thing about this case though is that one of the very few advantages of utility certificates as opposed to patents is their reduced cost. But in this instance, I would not bet that any money at all was ultimately saved, in view of all the efforts necessary to keep the certificate alive.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 1, April 25, 2017, Agromet Ejea SL v. Directeur général de l’INPI, RG No. 16/11489.

Time goes by so slowly

The U.S. used to have submarine patents staying under water as pending applications for many years without getting published and suddenly emerging upon grant and awarding 17 years of protection to their owners.

We in France have had a similarly exotic and frightening species of IP rights, that one could call zombie patents:  patents that have apparently been dead for years but that are in fact quietly waiting in their graves for an awakening – which can be triggered e.g. by a decision from the highest court in the country.

European patent No. EP 0984773 to Astrazeneca AB, directed to a pharmaceutical formulation of omeprazole, was such a zombie patent. The patent was filed in 1998 and granted in 2003, and the French translation of the granted patent was duly filed at the Institut National de la Propriété Industrielle (INPI) as was required in those pre-London days. Unfortunately, the sixth renewal fee which was due in 2003 was not paid in due time – nor within the 6-month grace period.

As a result, a formal decision of lapse was issued by the INPI on January 30, 2004 and a mention of this decision was published in the official bulletin (Bulletin Officiel de la Propriété Industrielle or BOPI) on February 27, 2004.

Several pharmaceutical companies apparently relied on this lapse and started marketing generic drugs, such as Ethypharm, which launched its formulation in April 2004.

Five years went by, until one day in April 2009 Astrazeneca filed a request for restoration of right at the INPI. One would think that the request would be expediently dealt with but, as is often the case, one would be wrong. It took the INPI four years to issue its decision on the case, which was… positive. And therefore, in 2013, the patent woke up from the dead.

Obviously Ethypharm was not too happy about this turn of events and filed an appeal against the decision. The Cour d’appel de Paris had sympathy for the generic manufacturer’s case and canceled the decision from the INPI in a judgment dated January 15, 2014 – a swifter process than the proceedings in front of the INPI.

Quite predictably, Astrazeneca filed an appeal on points of law with the Cour de cassation, which brings us to the ruling issued on April 12, 2016, in which the highest court set aside the judgment of the Cour d’appel and therefore reinstated the 2013 INPI decision – and thus revived the patent for the two additional years that are left until it expires.

At this stage there are two questions any puzzled reader would be entitled to ask:

  • Why such a mess?
  • How can a patent possibly be reinstated by a request for restoration of right filed five years after the loss of right occurred?

I think there are two main factors which can help answer these questions:

Let’s first look at the old pre-2008 statute. At that time, the restoration of right further to a lapse due to non-payment of a renewal fee was handled differently from a restoration of right further to non-compliance with another type of time limit.

The former version of article L.613-22 CPI (Code de la propriété intellectuelle) provided in its second paragraph that:

The patent proprietor can file a request for restoration of right within three months from the notification of the decision [of lapse] if it had a legitimate excuse for not paying the renewal fee. 

In the omeprazole case, the decision of lapse having been issued in January 2004, the three month-deadline should have been long expired by the time the request for restoration was filed, and also by the time the law changed in 2008, right?

Well, no, and this is because of the pravastatin case law. It was decided in this famous case (which involved a zombie SPC) that when a decision of lapse is notified to the wrong recipient (i.e. to a recipient who was not entitled to receive the decision), the time limit of article L. 613-22 does not start. Since it does not start, it cannot expire.

This is exactly what happened in the present case. The decision of lapse was not notified to the patent proprietor in Finland. It was not notified to a representative of the patent proprietor either. Instead, I understand from the decision of the Cour de cassation, or rather from the statement of grounds of appeal annexed to the decision, that the 2004 decision of lapse was notified to… the annuity provider:

[…] The director of the INPI states that the notification was made to Mrs Caroline C, who is not an employee of Astrazeneca AB, nor a patent attorney, nor an attorney at law, nor a representative registered with the INPI, and therefore this notification was not made to a person who would be entitled due to the annuity provider, RWS group. Thus, this illegal notification did not trigger the three-month time limit for the restoration, and the request filed by Astrazeneca AB was not outside the time limit. 

OK. But what about the change of law which took place in 2008? How does this come into play?

By way of an executive order dated December 13, 2008, the statute was amended in such a way that paragraph 2 of article L.613-22 CPI was canceled. As a result, the system of restoration of right further to a lapse was aligned with the normal system of restoration of right further to non-compliance with other types of deadlines.

The new relevant provision is article L.612-16 CPI, which will look familiar to European practitioners as it is similarly drafted as the restitutio in integrum provisions in the EPC:

The applicant who does not comply with a time limit set by the [INPI] may file a request for restoration of right if they have a legitimate excuse and if the failure to comply with the time limit directly results in the refusal of the patent application or of a request, in the lapse of the application or the patent or in the loss of any other right. 

The request must be filed with the director of the [INPI] within a deadline of two months from the removal of the cause of non-compliance. The omitted act shall be accomplished within this deadline. The request is only admissible within a deadline of one year from the expiry of the unobserved time limit. 

When the request relates to a failure of payment of a renewal fee, the unobserved time limit is the end of the grace period […].

So, in the new system, the deadline of three months from the notification of the decision of lapse has been replaced by the usual double deadline: two months from the removal of the cause of non-compliance and one year from the expiry of the unobserved time limit.

Since this second deadline is an absolute time bar and is independent from any actions taken or not taken by the patent proprietor and the patent office, it seems that there can no longer be zombie patents in this new system. If this provision had been in place before, Astrazeneca would have been barred from filing a request for restoration of right on the first of December, 2004 (one year after the six-month grace period following the due date for the sixth renewal fee, on the first of June, 2003).

The illustrated device is useful for store clerks: it displays the minimum birth date for an individual who is entitled to purchase alcohol or tobacco. I suggest a variant for patent office clerks displaying the maximum date of lapse of a patent for a patentee who is entitled to restoration of right.

The illustrated device is useful for store clerks: it displays the minimum birth date for an individual who is entitled to purchase alcohol or tobacco. I suggest a variant for patent office clerks displaying the maximum date of lapse of a patent for a patentee who is entitled to restoration of right.

The new provision came into force a few months before Astrazeneca filed its request for restoration. How did this affect the request? As the Cour de cassation summarizes it:

[…] in order to set aside the decision [to restore the patent], the judgment [by the Cour d’appel] stated that the executive order […] entered into force on December 2008 and deleted the second paragraph of article L.613-22 CPI so as to replace it with article L.612-16; and that this was a procedural law and thus was immediately applicable; that Astrazeneca was subjected, in order to benefit from a restoration of right, to the time limit of two months from the removal of the cause of non-compliance in the new provision; that the publication in the BOPI of the decision [of lapse] removed the circumstance which had prevented Astrazeneca to pay the sixth renewal fee when the new article L.612-16 came into force, so that the request filed on April 6, 2009 was late and inadmissible. 

So, in summary, for the Cour d’appel, the time limit of two months came into force with the new law, and since the cause of non-compliance had long been removed, this deadline started on the day the new provision came into force, and was expired by the time Astrazeneca filed its request – so that the restoration could not be granted.

On appeal in front of the Cour de cassation, Astrazeneca criticized the computation of the two-month deadline. They said that a law cannot have a retroactive effect, and that the judgment by the Cour d’appel amounted to such a retroactive effect because the publication of the mention of the decision of lapse in the Bulletin in 2004 retroactively acquired a legal effect in 2008. Also, they explained that this publication was not an actual removal of cause of non-compliance.

But very interestingly, the Cour de cassation set aside the judgment on another ground, that the court came up with on its own – I am not sure I have ever seen this before. Namely, the court ruled that the former pre-2008 rule in fact still applied to the request for restoration filed in 2009. Said the supreme court:

[…] legal remedies against a decision are determined by the law which is in force on the day the decision is issued; 

[…] the decision of lapse of patent right was open to restoration of right under article L.613-22 [CPI] second paragraph, within a time limit of three months from the notification, and since the notification was illegal, the deadline did not start running, and thus the Cour d’appel violated the law […]. 

As a side remark, Ethypharm was not the only third party involved in this dispute. Parallel cases involved Actavis, and therefore there are two other judgments by the Cour de cassation of the same date with substantially the same content.

All in all, this is a rather spectacular result which does seem to make sense on a legal standpoint. The real aberration is probably the error made by the INPI. Why on earth a decision of lapse was notified to someone else than the representative is puzzling – and I guess there must have been a representative actually appointed since the patent was validated by filing a French translation.

Fortunately this kind of fiasco would no longer be possible nowadays – or could it?


CASE REFERENCE: Cour de cassation, ch. com., April 12, 2016, Astrazeneca AB v. Ethypharm & Directeur général de l’INPI, pourvoi No. V 14-17.439.