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Thursday, 14 February 2013

French pharma packaging, IP and generics: can you help?

The IPKat, being a community-minded mammal, is always keen to crowdsource questions in the unlikely event that neither he nor Merpel have a clue as to what the proper answer might be. Here's a question for our French friends and also for our pharmaceutical readers -- whether they are French or not -- since their part of the grapevine might have picked up information that others have missed.

The question relates to a relatively new and, at the time, fairly controversial amendment to the French Code of Public Health (article L.5121-10-3, which you can find on Legifrance if your French and your navigational skills are better than this Kat's.  Our reader asks:
"According to my understanding, this French provision purports to prohibit the enforcement of rights covering the look and texture of branded pharmaceutical products against generic pharmaceuticals that mimic the branded equivalent of the drugs.  My impression is that this is similar to the French provisions allow the makers of generic products to use the name of branded drugs on the packaging of their generic drugs. 
What I would like to know is whether there has been any litigation in which this provision has been invoked and whether, since it does seem to me to be incompatible with European harmonised trade mark law, any attempts have been made to challenge its validity.  Can the Kats and their readers help?"
Says our reader, whatever information you can give me would be great. It doesn't matter if it's in French, English or any other language.  References to articles in journals, law firm bulletins and news cuttings -- anything is better than nothing.

Says the IPKat, the best thing is for readers to post any information they have in the form of a comment on this blog post, so that everyone can share it.  If your browser or your company's or firm's IT system immobilises Blogger's comments facility, then just send your information by email here and the Kats will do the rest.

7 comments:

Anonymous said...

You can find it in

Code de la santé publique
Partie législative
Cinquième partie : Produits de santé
Livre Ier : Produits pharmaceutiques
Titre II : Médicaments à usage humain
Chapitre Ier : Dispositions générales.

The wording ofArt L5121-10-3 is:
"Le titulaire d'un droit de propriété intellectuelle protégeant l'apparence et la texture des formes pharmaceutiques orales d'une spécialité de référence au sens de l'article L. 5121-1 ne peut interdire que les formes pharmaceutiques orales d'une spécialité générique susceptible d'être substituée à cette spécialité en application de l'article L. 5125-23 présentent une apparence et une texture identiques ou similaires."

Valérie Schwalek said...

When making a tablet, a pill or other similar product, the process used for forming the tablet, pill or the like may confer thereto particular technical properties. For example, according to the pressure used for making pill, the crystallinity of the active ingredient may change. This may involve a different therapeutical effect, for example a delayed effect or a more suitable stability in vivo.
According to the French law, it is not possible for a pharmaceutical company whose active ingredient is no more covered by a patent to use patent or patent application related to the "form" of the product. The terms used in he French law are not well defined and are a bit obscure ...

Roufousse T. Fairfly said...

I had never heard about this issue before, and did a little digging.

L5121-10-3 slithered into law on 29 December 2011, after several unsuccessful attempts.

The exact same wording had initially been tacked to the 2009 social security financing bill. Opposition MPs referred the text as voted to the constitutional council, which duly canned the proposition together with many other ones on the grounds that they had little or nothing to do with the overall purpose of the bill.

Another attempt occurred in 2011 in the discussions regarding a bill respecting hospital reform. The constitutional council censored the proposed amendment for the same basic reasons as in 2009.

On 24 September 2011, backbencher Arnaud Robinet, who I don't perceive to be the sharpest tool of a chest rich in worn-out instruments, introduced an amendment to the Code de Propriété Intellectuelle. This paragraph, whose wording is very close to the litigious text (it appears to have originated at the senate in the previous episode), was voted by the chamber, but did not make it into the book. I can't find out what happened exactly.

The MD MP was also piloting at the time a bill for reinforcing the safety of medicines and health products, in which the controversial wording was sneaked in. I wonder whether the C.C. would have considered this bill an appropriate vehicle.

The law is no longer in the parliament's hands, and it can only be reviewed by the C.C. upon referral of an appropriate judicial instance. I'm not sure which law would then be reviewed: the Health Code or its amending law.

This could in any case take years, don't hold your breath waiting for case law. This legal layman thinks there isn't much to fear.

Observers generally find the text unclear (e.g.: here), but point out that community law has precedence over national law. You wouldn't necessarily need to go all the way to the C.C. .

I'm not quite sure myself what the blurb is supposed to mean exactly. I have a problem of my own: the word "présentEnt" is a glaring grammatical mistake. As an active conjugation of "présenter" (3ème personne de l'indicatif présent) it couldn't reside in the object part of the sentence, which already pivots around the verb "peut" (an inflection of "pouvoir"). The word should either be a present participle ("présentAnt"), or be preceded by a pronoun -- "QUI présentent", together with appropriate punctuation, or even "QUE SI ELLES présentent". IMO, the sentence as corrected would then take a rather tautological meaning, and the whole thing thus seems to become quite irrelevant.

This eyesore in a paragraph which had been bouncing around for more than two years is very telling about the quality of lawmaking nowadays.

Anonymous said...

I would guess that this is national legislation that needs to be brought into France following the Deroxat decision at the Supreme Court in 2011, which is nicely explained in the following article:

http://www.lexology.com/library/detail.aspx?g=6c2876fe-1bfc-4e28-90e1-629034b7df24



Roufousse T. Fairfly said...

Bing! The penny dropped (ouch)! I parsed the sentence once more and finally found the bit I was missing. Disregard the penultimate paragraph that came out of that can of Crisco I call my brain. I surely must have slept with my head on the wrong side of the pillow.

This doesn't mean that there isn't a lot to be criticized in the text.

The lawmaker appears to be concerned about building "customer" loyalty through trademarks in the period a medication enjoys patent protection.

I don't know whether this is a real problem.

If it were, a solution could be the imposition of neutral or prescribed appearances for medications which are still under patent protection? After all, the shape or colour of an oral preparation couldn't be registered if they played a functional role.

A possible precedent could be the increasingly bland or garish packaging (rightly) imposed on tobacco products.

pMdM said...

To this day, I haven't seen any court decision regarding article L.5121-10-3 (lack of jurisprudence is not a total surprise if one considers that this law has been in force since the end of December 2011).

As RT Fairfly wrote, this text is unclear and awkward. I believe that during the "elaboration" of this text, at no point the Parliament / government took into account or even realized that French TM & design laws were transposed from EU Directives and that there are such things as CTMs & RCDs.

This text was considered with a lot of scepticism among the IP practitioners when it finally was published in the Journal Officiel; at the time, newsletters from French IP law firms had the same doubts I had mentioned on Class 46 (https://www.marques.org/class46/default.asp?D_A=20120113) & pmdm.fr (http://www.pmdm.fr/wp/2012/01/04/aspect-des-medicaments-et-droits-de-pi-la-loi-publiee-au-journal-officiel/).

Valérie Schwalek said...

Regarding French law on generic, its appears that only the dessins et modèles cannot be used against a generic. However, a trademark can be used against a generic. See the “lexomil comprimés en baguette” law case.

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