Of yeast and insects

It is with great pleasure that I am hosting a new contribution by Lionel Vial on this blog. Today, Lionel asks the question whether the regulatory specificity of biological medicinal products has just been denied by French courts.

It is known that Supplementary Protection Certificates (SPCs) make up a particularly tricky part of patent law. So tricky that national courts regularly feel the need to refer questions of law in this respect to the Court of Justice of the European Union (CJEU); and so tricky that the answers provided by the CJEU in its preliminary rulings have a tendency to fuel yet further references from national courts.

But when it comes to biological medicinal products, things can get even thornier, especially since policymakers may have primarily had chemical medicinal products in mind when the SPC regulation was drafted.

So let Lionel now explain how the difference may come into play.

The decision we discuss today was rendered by the Cour d’Appel de Paris on April 12, 2016 and deals with the appeal lodged by the Government of the United States of America against the decision of the Director of the INPI (French patent and trademark office) to reject SPC application No.08C0003 covering Cervarix® (GlaxoSmithKline Biologicals).

As a side note, we will first remind our readers that appeals against decisions of the Director of the INPI, such as rejections of patent applications or SPCs, are to be lodged directly to the Cour d’Appel de Paris, i.e. the second instance court, and not to the first instance Tribunal de Grande Instance de Paris.

Back to the case at hand, Cervarix® is a vaccine intended for use in women and girls from nine years old to protect against cancer of the cervix (neck of the womb) and precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva or vagina) caused by certain types of the human papillomavirus (HPV). Cervarix® HPV-16/18 L1 AS04 vaccine contains recombinant C-terminally truncated major capsid L1 proteins of HPV types 16 and 18 as active ingredients. The L1 proteins of HPV-16 and HPV-18 are separately produced using a recombinant Baculovirus expression system and the insect cell line Hi-5 Rix4446 derived from Trichoplusia ni.

For those not versed in the biological arts, this basically means that the antigens contained in the vaccine are shortened versions of viral proteins from two different viruses (HPV-16 and HPV-18), which proteins have been produced in vitro in insect cells.

The SPC application was filed on January 18, 2008 on the basis of European patent EP 0662132 filed on September 3, 1993 and of the Marketing Authorization (MA) No.EU/1/07/49/001 of September 20, 2007. It was rejected on March 16, 2015 by the INPI.

The decision of the INPI was essentially based on the Actavis judgment C-443/12 of December 12, 2013 by the CJEU (following a reference for a preliminary ruling from the High Court of Justice of England and Wales), and more particularly on points 40 and 42 of this judgement:

40. Bearing in mind the objective of Regulation No. 469/2009 [i.e. the SPC regulation] […] – namely, to compensate the patent holder for the delay to the commercial exploitation of his invention by providing him with an additional period of exclusivity – first, the grant of the first SPC in respect of the single active ingredient irbesartan [i.e. the drug at stake in the judgment] has already afforded the holder such compensation and, second, the objective of that regulation is not to compensate the holder fully for the delay to the marketing of his invention or to compensate for such delay in connection with the marketing of that invention in all its possible forms, including in the form of combinations based on that active ingredient. […] (emphasis added) 

42. It follows that, in such a situation, Article 3(c) of Regulation No. 469/2009 precludes a patent holder from obtaining, on the basis of one and the same basic patent, more than one SPC in connection with irbesartan, since such SPCs would in fact be connected, wholly or in part, with the same product […]”

Indeed, another SPC No.07C0020 covering Gardasil® (GlaxoSmithKline Biologicals) was granted earlier on the basis of the same patent in regard of a L1 protein from HPV16. The INPI thus considered that this previous SPC also protected the C-terminally truncated form of the L1 protein, purported to be obtained by production from insect cells, and that the product for which SPC No.08C0003 was applied for had already been the subject-matter of a certificate.

As it appears from the ruling, the main argument of the appellant against the decision of the INPI was that the HPV16 L1 protein obtained from insect cells, which forms the subject-matter of SPC No.08C0003, is a different product from the HPV16 L1 protein obtained from yeast cells, which forms the subject-matter of SPC No.07C0020, because of the differences in the glycosylation pattern and amino acid chains depending on the cell type (yeast or insect) in which the protein is produced. Accordingly, the MAs of Gardasil® and Cervarix® relate to medicinal products having different active ingredients and SPC No.07C0020 and SPC application No.08C0003 relate to different products. In addition, pursuant to Articles 4 and 5 of Regulation (EC) No 1768/92 (i.e. the previous version of the SPC regulation), an SPC may not confer a protection extending to a product which is not the one related to the marketing authorization.

"How could you possibly mistake me for a yeast?" said the beetle.
“How could you possibly mistake me for a yeast?” said the beetle.

However the Court ruled that:

As is rightly pointed by the Director of the INPI, firstly, the basic patent claims (claim 1) “an isolated HPV16 capsomer structure comprising L1 capsid protein” which is not characterized by its manufacturing process and the patent does not explain the differences between the proteins asserted by the appellant, [the patent] referring to various manufacturing processes (insect cells such as for Cervarix, yeast cells such as for Gardasil, and even mammalian cells (cf. page 20 of the patent)), secondly, the asserted differences are not mentioned either in the MAs provided with the two SPC applications which relate secondarily to the manufacturing process without drawing any conclusion regarding the protein structure, and finally, SPC application No.08C0003 initially related – before the amendments brought by the applicant in relation with the forms and production methods in response to the objections from the INPI during the examination procedure of the application – to a product defined as “L1 proteins from type 16 human papillomavirus”, this definition being precisely that mentioned in SPC application No.07C0020 filed on March 20, 2007;

Article 1 of the previously cited Regulation defines the product as “the active ingredient or combination of active ingredients of a medicinal product”, without any reference to the manufacturing process of the active ingredient;

Accordingly, the HPV16 L1 protein comprised in Cervarix and that comprised in Gardasil constitute one and the same product within the meaning of the previously cited Regulation, regardless of their possible differences regarding their forms and their manufacturing processes;

It results from Articles 4 and 5 of the Regulation that the protection and the rights conferred by an SPC are framed by the basic patent and that the MA is used to determine the product forming the subject-matter of the protection; it is thus irrelevant, for assessing the regularity of the rejection of SPC application No.08C0003, whether this application is based on an MA specially obtained for Cervarix, which, even though it aims at treating the same pathologies, is different from Gardasil, which has a different MA, since the HPV16 L1 protein comprised in the two drugs is the same;

Under these conditions, the Director [of the INPI] was right in considering that SPC No.07C0020 granted on July 23, 202 also applied to the HPV16 L1 protein comprised in Cervarix, even if obtained from insect cells, and in rejecting SCP application No.08C0003 filed on June 18, 2008 by the Government of the United States of America.

Accordingly, the decision of rejection of SPC application No.08C0003 was upheld.

This decision is interesting in that the Court decided, following the INPI, that the protection conferred by an SPC extends beyond the physical product which can be found in the marketed medicinal product to encompass all products falling within the definition of the product in the SPC or SPC application.

This construction of Articles 4 and 5 of the SPC Regulation may not give rise to too much discussion for chemical medicinal products, as in addition to C-443/12 (Actavis) it could also be considered to be an application of the previous ruling of the CJEU in C-392/97 (Farmitalia) (“where a product in the form referred to in the marketing authorisation is protected by a basic patent in force, the supplementary protection certificate is capable of covering the product, as a medicinal product, in any of the forms enjoying the protection of the basic patent”). But it may give rise to more concerns as regards biological medicinal products, as in the present case.

In fact, it can be regretted that the present decision was not taken as an opportunity to discuss – and why not to request a preliminary ruling on – the question of knowing if the same standard is to be applied to chemical and biological medicinal products when applying Articles 4 and 5 of the SPC Regulation.

Indeed, the specificity of biological medicinal products has been recognized by European Union law. By way of example, Article 10 of Directive 2001/83/EC notably provides that where a biological medicinal product which is similar to a reference biological product does not meet the conditions in the definition of generic medicinal products, owing to, in particular, differences relating to raw materials or differences in manufacturing processes of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical tests or clinical trials relating to these conditions must be provided.

Accordingly, in view of the objective of the SPC Regulation which is, as was recalled above, to compensate the patent holder for the delay to the commercial exploitation of his invention by providing him with an additional period of exclusivity, it could be questioned whether biological products obtained by different manufacturing processes could not be considered as truly different products and not merely as different forms of a same product.

As a final side note, we would like to add that the above-mentioned Actavis decision of the CJEU is only one of numerous rulings following from references from the High Court of Justice of England and Wales. It is with some sadness that the commentator in us sees the Brexit taking away the most active Case Law provider in SPC matters.

Although I share Lionel’s concern regarding Britain’s major contribution to SPC case law, maybe we should not be too sad too soon; after all there are still many unknowns as to what comes next.


CASE REFERENCE: Cour d’appel de Paris, Pôle 5 chambre 1, April 12, 2016, The Government of the United States of America v. Directeur Général de l’INPI, RG No. 15/12234.

Invalidity swept under the rug

Self-represented applicants, who draft and prosecute their patent applications on their own without an extensive knowledge of patent law have a good chance of getting a French national patent granted – this is in fact not an extremely difficult task. But they also run a very high risk of getting an invalid patent granted.

One of my previous posts was dedicated to the revocation of what looked like one such patent, and today’s post is dedicated to the revocation of another one of those.

French patent No. FR 2933591 contains four claims, the first one of which reads as follows:

1. A set for praying comprising a rug, characterized in that it comprises weights at its four ends. They are made of metal or lead and are in the form of beads, or round or angular parts. The set is folded and put in a pouch. 

The three dependent claims are drafted in a similarly non-conventional manner:

2. A rug according to claim 1 characterized in that it is made of a waterproof material covered on the lower side with a silver or gold coating [I am not sure about the meaning of the French term used here] on its back. 

3. A rug according to claim 1 characterized in that it is made [sic] of a drawing indicating the direction of the prayer. 

4. A pouch according to claim 1 characterized in that it comprises adjusting seams in order to keep the rug folded. 

Globacom SARL is a company which markets Islamic products online, including prayer rugs. Globacom was sued for infringement of the above patent by the patent owner, Salmane SAS, as well as the inventor – who was the original applicant.

Globacom counterclaimed for revocation of the patent.

Their first argument was lack of novelty over an alleged public prior use of the invention. The court dismissed this argument which was insufficiently substantiated. Reference was made to a number of websites, but the contents of these websites were not submitted to the court, and the only examples actually filed did not clearly predate the filing date. Globacom also relied on prayer rugs advertised in catalogues, but these catalogues did not contain any precise description of the rugs. Lastly, Globacom mentioned the inventor’s own press releases. But the court could not identify any evidence of a disclosure before the filing date. There was a relevant publication in the issue of September 2008 of a magazine, but this was precisely the month in which the patent was filed, and the exact day on which the magazine was published was not known.

Then the defendant raised an argument of lack of inventive step, which was successful.

Unfortunately, the court did not cite in its decision specific prior art for all the claimed features. I can only assume that such specific prior art was indeed identified in the defendant’s submissions – to which the court referred to in the judgment.

The court held that

The folding, the waterproof material, the silver or gold coating and the presence of weights in order to keep the rug on the floor are indeed known functional parts. 

Besides, the folding and the drawing indicating the direction of Mecca are features introduced before the patent, as evidenced by catalogues of the Chinese company Huitai Carpet showing that as from 2005 a foldable prayer rug kept in a pouch was marketed notably under reference BT317 or BT301. 

Finally, when reading the patent it does not appear that the inventor brought any solution to a technical problem, except for transporting the rug so as to use it in any circumstance or place, which was already solved in the prior art by folding the rug and keeping it in a sleeve. 

Therefore the patent is a mere addition of juxtaposed functional means without any distinct result, so that the patent must be revoked for lack of inventive step. 

This is quite a change from the usual hyper-technical pharma or telecom cases.

The reference by the court to “juxtaposed functional means” is reminiscent of old, traditional French case law, which made a distinction between mere juxtapositions of features and combinations of features bringing a new technical effect (synergistic features if you will).

A more modern approach rather uses a reasoning akin to the EPO problem and solution approach. But this case was probably so simple that a problem and solution approach was not really necessary.

Besides, the patent itself does not contain any indication of a problem to be solved. The description is less than one page long and basically contains a copy-and-paste of the claims plus a couple of additional sentences.

So, what would have happened if the applicant had hired a professional to draft the patent application? Was there no possible patentable invention at all in this product? Could a better drafting have changed the situation? Difficult to say. Expert patent drafting is a necessary and insufficient condition for a valid patent.

As a last word on the case, Salmane SAS further argued infringement of a community design, which was also revoked by the court for lack of novelty. A copyright claim also failed as the originality of the work was not clearly defined by the plaintiff. And so did a passing-off claim.

This praying robot may be more of an invention than the foldable rug in suit.
This demo praying robot may a more sophisticated invention than the foldable rug in suit.

Some readers may wonder how on earth the foldable rug patent got to be granted by the French patent office in the first place. The answer is that the patent office is not supposed to perform an extensive screening process. It issues a search report and a written opinion, and then it is up to the applicant to decide what to do.

This does not necessarily do self-represented applicants a favor.

But for those who are fully aware of the specificity of French patent prosecution, going the national route can be really advantageous.

In fact, while everyone’s attention right now is focused on European patents with or without unitary effect, it should not be forgotten that national patents remain a valuable option.

Here is why, in my view:

  1. French patents are much easier to obtain than European patents. Applicants often have to deal with minor objections of e.g. lack of clarity. But as far as prior art objections are concerned, an application cannot be refused for lack of inventive step. It can only be refused in case there is lack of novelty, and actually only if the lack of novelty is “blatant” (i.e. there is no room for discussion).
  2. Accordingly, prosecution is much cheaper than for a European patent (even when taking into account the need for foreign applicants to provide a French translation).
  3. The lighter examination process also makes it possible for applicants to avoid making statements which could possibly constitute a form of estoppel.
  4. A search report and a written opinion (for information purposes only) either similar or exactly identical to those issued by the EPO are provided at a much lower cost.
  5. There is no pre-grant or post-grant opposition.
  6. After grant, the patent proprietor can file a limitation of the patent at any time. It is thus a possible strategy for a proprietor to get a patent granted in a form which they know is probably too broad, and then limit the patent at a later stage if and when enforcement of the patent is contemplated (or even after the patent has been asserted and subjected to an invalidity challenge).

For the sake of completeness, after this subjective list of pros, here is an equally subjective list of cons (leaving aside the scope of geographical coverage, which is an obvious point):

  1. Applicants have to take their full responsibilities when drafting and prosecuting a French patent application. They should not count on the patent office to make them amend the claims and they should not consider a patent grant as an indication that they have obtained the right scope of protection – as the case discussed above clearly shows.
  2. In terms of valuation, French patents may be perceived as weaker and thus less valuable than European patents. However, this approach is debatable; as explained above, to some extent French patents are stronger because they cannot be opposed, and they can be limited at any time if their initial scope of protection is too broad.
  3. It is not possible to enter French national phase via a PCT. Therefore, a French patent application needs to be filed either as a first filing or as a direct filing within one year from another, original filing. This is a huge handicap which puts our national patent market at a disadvantage with respect to other European countries such as Germany, where national phase entries are allowed. But that is the way it is.

In summary, I do not believe that French national patents should be considered as useless remains of the pre-EPC, pre-UPC world. Together with Unitary patents, opted-out European patents and non opted-out European patents, national patents are yet another valuable option in an ever more complex IP landscape, which requires flexible strategies… Provided that great care is brought to the drafting.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 3ème section, March 25, 2016, Salmane SA v. Globacom SARL, RG No. 13/06836.

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 pravastatine 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.

A fishy appeal?

It is not an easy task to report on case law from the EPO Boards of Appeal, as there are so many commentators in the blogosphere (and elsewhere) poised to jump on any fresh decision that being original is tricky, unless you do high frequency posting. Nevertheless, I am wondering whether decisions drafted in French might as a general rule fly a little bit more under the radar, since French is certainly the official language of the EPO which is the least spoken by the European patent profession.

With that in mind, here is a report on one of these low flying decisions, which I find noteworthy for two reasons. The first reason is that the main claim of the patent in suit was directed to a container containing precooked tuna fish, which opens up an ocean of possible aquatic puns for this blogger. And the second reason is that the decision deals with an interesting point of law regarding the burden of proof in appeal proceedings.

The patent owned by Brittany-based Etablissements Paul Paulet had been revoked by an opposition division due to insufficiency of disclosure.

Claim 1 as granted was the following:

A rigid container containing foodstuff, the container comprising a receptacle and a cover and being made of a material selected from aluminum, steel, glass, or a plastics material that is oxygen-proof, the foodstuff being constituted by pre-cooked fish that is in solid form, eventually comprising an additive, a preservative, or a small amount of water or oil, characterized in that

– the closed container presents substantially no liquid after sterilization, such that the liquid content is less than 10% of the total weight of the content, and

– the container contains only the foodstuff and a gas, wherein the volume content of dioxygen in the gas is less than 15%, the gas being nitrogen.

Both features of the characterizing part of the claim were viewed by the opposition division as raising implementation issues.

If we focus on the liquid content feature, the opposition division noted that the patent taught to place the precooked fish into the container, add liquid nitrogen which will be turned into gaseous nitrogen, then close the container and sterilize the product. Based on various statements made by the patent proprietor during the opposition proceedings and information contained in the patent itself, as well as in an experimental report referenced as T4 (filed – unfortunately – by the patent proprietor), it could be concluded that, during the sterilization step, the liquid content in the container can change, and in particular can increase or decrease. Many factors may influence this change in the liquid content, including the type of fish, the precooking procedure, the shape of the fish, the additives and the conditions of sterilization. The opposition division deemed that the patent did not teach how to control these various parameters.

A container for fish hopefully containing more than 10% of liquid
A container for fish hopefully containing more than 10% of liquid

With its statement of grounds of appeal, the patent proprietor filed a modified version of claim 1 as a main request (corresponding to one of the auxiliary requests discussed in first instance). In this modified version of claim 1, the material of the container was somewhat restricted, and the nature of the fish was further specified to be “pre-cooked tuna fish in solid form“.

With the summons to oral proceedings, the Board expressed the preliminary opinion that there was an issue of sufficiency of disclosure with the liquid content feature, although it did not share the view of the opposition division regarding the other feature of the nitrogen / oxygen content.

One month before the oral proceedings, the patent proprietor submitted a new document T18, which was an experimental report focusing on the processing of tuna fish. The admissibility of document T18 at this late stage of the proceedings was debated in front of the Board, in view of R. 13(3) of the Rules of Procedure of the Boards of Appeal.

The patent proprietor’s argument was that:

  • the first instance decision relied on experimental report T4, in which experiments were conducted on billfish product;
  • the main claim was now restricted to tuna fish, so that the first instance decision was no longer applicable;
  • the Board raised a new objection in the preliminary opinion by stating that even with precooked tuna fish the variations in liquid content were unpredictable;
  • therefore the patent proprietor had reacted in a timely manner by filing the new experimental report T18 focusing on tuna fish.

The Board rejected the argument by analyzing the first instance decision, which mentioned a number of ill-controlled parameters influencing the liquid content and not just the type of fish; and by noting that the main request in the appeal was the third auxiliary request in first instance and had thus also been rejected by the opposition division.

The most interesting part of the discussion relates to whether the admission of T18 into the proceedings would violate the opponents / respondents’ right to be heard – in view of the lateness of the filing. The appellant said no, because the respondents had failed to provided detailed justifications and evidence in their response to the statement of grounds of appeal; on the other hand, the appellant did not have to file additional evidence with its statement of grounds of appeal since:

the burden of proof of insufficiency of disclosure lies exclusively with the opponents, in all circumstances. This also applies on appeal further to a decision revoking the patent for insufficiency of disclosure, notably when the grounds of the decision at stake no longer adversely affect the appellant due to a modification of the claimed subject-matter (reasons, 1.4.1).

The Board rejected the argument in view of the very nature of the appeal proceedings.

The respondents brought forward elements during the opposition proceedings which were apparently sufficiently credible as to the impossibility to carry out the invention in a systematic and reproducible manner by relying on the information contained in the patent; moreover, this information would be too limited and contradictory. This led the opposition division to hand down the decision at stake, which was duly reasoned. This decision not only brings an end to the opposition proceedings, but also as a consequence assigns different roles to the parties for the appeal stage. Once the patent has been revoked, it is up to the patent proprietor as the appellant to take a more active part and present, firstly, a detailed argumentation in its statement of grounds of appeal, even if by filing a new set of claims the grounds for the challenged decision seem to be overcome. The appellant cannot simply wait for the respondents to demonstrate the invalidity of the patent.

The patent proprietor, as the appellant, must therefore act against the challenged decision, that is, must, in the present case, demonstrate that common general knowledge does make it possible to carry out the invention based on the patent. This demonstration must be complete and not selective, without waiting for the Board or the parties to invite it to develop it more. In this respect, the appeal proceedings are not a continuation of the opposition proceedings but a new procedure instituted by the appellant. Therefore, the principles which initially governed the opposition proceedings are no longer necessarily applicable at the appeal stage, and those stated in the Rules of Procedure of the Boards of Appeal replace them, notably the duty to provide the complete means in view of which the decision cannot be maintained. A patent proprietor who thinks that they can discard the basis for the challenged decision owing to grounds of appeal limited to only one aspect of said decision runs the risk of later being in a situation where the filing of additional grounds or evidence during the appeal proceedings may be considered late under articles 13(1) and/or 13(3) RPBA (reasons 1.4.2).

I think it is fair to say that the burden of proof of insufficiency of disclosure on the opponents is a very heavy one in opposition proceedings.

However, according to the present decision, the onus shifts on appeal, if the patent is revoked by the opposition division. More generally, it can be derived from the Board’s comments that the first instance decision is presumed valid until the contrary is proven – although I am not sure that this has often been stated in this way in the case law.

On the merits, the Board reached a similar conclusion as the opposition division regarding the unpredictability of the liquid content in the container after sterilization, and therefore dismissed the appeal.

The parties will have the opportunity to continue the discussion and fish for further arguments on the liquid content feature, since there are opposition proceedings pending in connection with the divisional patent, and since the same feature is present in the independent claims. My guess is it will be an uphill battle for the patent proprietor but at least they can hope to be able to rely on the additional evidence that the Board has refused to take into account in this case.


CASE REFERENCE: Board of Appeal 3.2.07, T 30/15, Etablissements Paul Paulet v. Princes Limited & Bolton Alimentari S.P.A, January 20, 2016.

Getting a handle on limitation

Last week’s post was about a famous chemical case which found its way up to the Cour de cassation twice, due to a tricky limitation issue combined with a tricky SPC issue.

Today, I would like to reassure readers versed in the mechanical arts. Yes, they too are entitled to get some fun with fancy limitation questions.

The case at hand relates to French patent No. FR 2843372 (FR’372), which is concerned with a sales display pack for door or window handles. The patent proprietor Société de Fonderie du Centre (SOFOC) has apparently had a complicated relationship with DIY store chain Bricorama over the past twenty years. A recent episode of their hectic partnership is an infringement lawsuit brought by SOFOC against Bricorama based on FR’372.

Interestingly, the legal action was started only one month after a limitation of the patent was granted by the INPI (French patent office).

Bricorama counterclaimed for invalidity – why would they not – and my focus will be on their argument that some of the patent claims were invalid due to extension of the scope of protection after grant, further to the alleged “limitation” of the patent. Speaking EPO language, this would be an “Art.123(3) objection“.

The patent as granted comprised a main claim and seven dependent claims. Claim 1 read as follows:

Sales display pack for door or window handles comprising a finger-plate and a lever-handle, characterized in that it is composed firstly of cardboard folded on itself in two flaps, a presentation flap and a back flap, and secondly means of attachment of the said handle(s) to be presented on said cardboard fitting into cut-outs formed in said cardboard, the said cardboard comprising two fixing cut-outs formed facing each other on the two flaps, at least four cut-outs for attachment of the handle(s) to the said display pack, said cut-outs being formed facing each other in pairs in the two flaps and at least one cut-out formed on the presentation flap, in which a transparent compartment is placed for containing assembly accessories for the presented handle(s).

After the limitation, claim 1 was worded as follows (the highlighted expressions corresponding to added features):

Sales display pack for door or window handles comprising a finger-plate and a lever-handle, characterized in that it is composed firstly of cardboard folded on itself in two flaps, a presentation flap and a back flap, and secondly means of attachment of two handles to be presented on said cardboard fitting into cut-outs formed in said cardboard, so that the finger-plates rest against the presentation flap, said cardboard comprising two fixing cut-outs formed facing each other on the two flaps, at least four cut-outs for attachment of the two handles to the said display pack, said cut-outs being formed facing each other in pairs in the two flaps and at least one cut-out formed on the presentation flap, in which a transparent compartment is placed for containing assembly accessories for the presented handles.

It was not challenged that amended claim 1 was more restricted than claim 1 as granted.

The issue was that, together with the amendment of claim 1, the patent proprietor had also filed five brand new claims 9 to 13 which, they said, were merely dependent claims.

New claim 9 was worded as follows (the highlighted portions being in my view the most important ones):

A set of two door or window handles attached to a sales display pack, each handle comprising a finger-plate and a lever-handle, characterized in that the sales display pack is composed of cardboard folded on itself in two flaps, a presentation flap and a back flap, and secondly means of attachment of the two handles fitting into cut-outs formed in said cardboard, the finger-plates resting against the presentation flap, said cardboard comprising two fixing cut-outs formed facing each other on the two flaps, at least four cut-outs for attachment of the two handles to said display pack, said cut-outs being formed facing each other in pairs in the two flaps and at least one cut-out formed on the presentation flap, in which a transparent compartment is placed for containing assembly accessories for the presented handles, the sales display pack being according to one of claims 1 to 8.

The following new claims 10 to 13 were also directed to a set of handles attached to a sales display pack, making reference to claim 9. For the defendant, claim 9 was an independent claim, and not a mere dependent claim as advocated by the plaintiff. They also argued that claims 9 to 13 extended the scope of protection of the patent and were thus invalid.

Fancy handles are best displayed in their natural environment.
Fancy handles are best displayed in their natural environment.

The Tribunal de grande instance (TGI) ruled in the defendant’s favor:

It is true that claim 9 repeats the wording of claim 1 regarding the definition of the sales display pack, but it is directed to “a set of two door or window handles characterized in that the handles are attached to a sales display pack”. Now, claim 1 only relates to the sales display pack which supports the handles, and not to the set composed of these distinct elements. The scope of protection under Article L. 612-6 of the Code de la propriété intellectuelle, restricted to the sales display pack in claim 1, is extended in claim 9 to a different product made of the combination of the handles and previously characterized sales display pack. Claim 9 adds relative to the features of claim 1 and concerns a distinct subject-matter, whereas claims 10 to 13, which are mere embodiments of claim 9, depend on it. 

With this assessment of the nature of claim 9, it comes as no surprise that the TGI found that there had been an extension of the scope of protection:

[…] Article L. 613-24 of the Code de la propriété intellectuelle mentions limitation only as far as claims are modified. Per se, the addition of 5 dependent claims cannot be analyzed as a modification of preexisting claims. In fact, [SOFOC] does not contend that going from 8 to 13 claims would be the result of a mere redrafting of the initial claims 1 to 8, which remain unchanged – with the exception of the definition of the number of handles supported by the sales display pack. 

Moreover, it is now acknowledged that claim 9 does not simply repeat the features of claims 1 to 8 but includes a set made of the sales display pack and two handles in the scope of protection conferred by the patent. Even if it is clear that the description relates to a sales display pack intended for supporting door or window handles, it does absolutely not institute the combination of the two elements of the invention, and by the way the sole drawing of the patent does not show the handles. The latter are only mentioned in the description in order to understand the purpose of the sales display pack, which is the sole subject-matter of the invention. Also, the modification of claim 1 was sufficient to limit the protection to a sales display pack intended for supporting two door or window handles, without any need for the addition of 5 new claims. Thus, independent claim 9 and dependent claims 10 to 13 involve a broadening of the scope of protection conferred by the patent, which in fact would have had a significant impact on a possible damages computation, to a new object not comprised in the description and in the features of initial claims 1 to 8. They are therefore invalid.

In summary, the amendment was objectionable on two grounds.

First, limitation proceedings are not meant to add claims, but rather to modify and more precisely restrict existing claims. This seems to be in keeping with the Guidelines for examination in the EPO (section D-X, 4.3):

Likewise, adding dependent claims in limitation is not permissible if not directly caused by the limitation introduced in the claims.

In the present case, the addition of the supplemental claims seems to have been uncorrelated to the modification of claim 1 and thus unjustified.

The second ground retained by the judges is that new claim 9 and its dependent claims covered a different object from the one covered in the patent as granted. This is probably a more controversial point. For one thing, the TGI analyzed claim 9 as an independent claim, even though it explicitly refers to claims 1 to 8 and includes all the limitations of these preceding claims. This appraisal may not be fully consistent with the definition of independent and dependent claims provided in section F-IV, 3.4 of the Guidelines for examination in the EPO.

But, more importantly, the combination of a sales display pack and two handles, recited in claim 9, was considered as a different object (an aliud) in comparison with the sales display pack as such recited in claims 1 to 8. This approach is comparable to that adopted by the INPI in the Syngenta case discussed last week: the INPI considered that adding a second active substance to a claim directed to a fungicide composition comprising a first active substance resulted in a shift of the scope of protection towards a different object. As explained in the post, the Cour de cassation finally rejected the objection in Syngenta. But did they fully weigh all relevant factors? One cannot really tell based on the brief and cryptic reasons for the decision.

There are, to my mind, valuable reasons for making a distinction between (A) further restricting some features of a claimed object; and (B) adding a supplemental object in a claim. If case (A) undoubtedly corresponds to a real limitation, case (B) is not so simple, as it may in some instances pave the way for a new contributory infringement complaint, or for an increase in the amount of damages, as rightly noted by the court in the above citation – in addition to also making it theoretically possible to extend the duration of protection in the pharmaceutical or phytosanitary field, by way of an SPC application, as discussed last week.

A somewhat more indirect parallel can also be made with the Nespresso judgment discussed in a previous post. The TGI had objected to the presence of a claim directed to a device for the extraction of a capsule, plus the capsule itself, in combination, while the application as filed focused on the device without presenting the capsule as part of the invention. In this case, the nullity ground was extension of subject-matter beyond the contents of the application as filed, and not extension of the scope of protection after grant. But the underlying idea is similar.

A common feature of NespressoSyngenta and Bricorama is that the patent proprietor tried to change the focus of the invention after the filing date in order to gain a particular legal advantage. In all three cases, the judges thwarted the patentees’ strategy:

  • In Nespresso, the combination claim was introduced at a late stage during examination proceedings (after the issuance of the communication on the intent to grant by the EPO) presumably specifically in order to make it possible to sue capsule manufacturers. The combination claim was viewed by the French judges as improperly adding matter.
  • In Syngenta, a dependent claim was limited after grant in the hope of making it compliant with the Medeva standards, as a basis for a combo SPC application. The Cour de cassation validated the limitation but the SPC application was rejected all the same, and the rejection was confirmed by the Cour d’appel.
  • In Bricorama, new claims were added by way of limitation proceedings a few weeks before launching an infringement action, potentially modifying the quantum of damages. Those claims were revoked.

Could it be that courts are not that keen on too smart patentees?

As a final note, SOFOC did not have such a bad time in court after all. Having revoked claims 9 to 13, the court also revoked claims 1 to 4 (for lack of inventive step) but then held that dependent claims 5 to 8 were valid and infringed. This certainly made the judgment much easier for SOFOC to ahem… handle.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre, 1ère section, May 21, 2015, Société de Fonderie du Centre SA v. Bricorama France SAS & Bricorama SA, RG No. 2014/02007.