A risky launch at risk

Launching at risk is not a business for those who have a weak stomach.

Once a generic drug company has decided that it will go on the market despite the existence of an IP threat – e.g. because they have determined that the IP right at stake is probably invalid or unenforceable – then anything can happen, and it may happen really fast.

Today’s decision illustrates the risks of a launch at risk.

GD Searle LLC owns European patent No. EP 0810209 filed on August 24, 1993. The patent is directed to a family of antiretroviral drugs, more precisely protease inhibitors, useful for the treatment of HIV infection.

On May 9, 2008, Searle obtained a Supplementary Protection Certificate (SPC) from the French patent office (INPI), under No. FR 07C0034. This SPC is based on the EP’209 patent and relates to “darunavir or one of its pharmaceutically acceptable salts, esters or precursors“.

An exclusive license to the SPC was granted to Janssen Sciences Ireland Unlimited Company and then a sub-license was granted to its French affiliate Janssen-Cilag SAS. Janssen (Johnson & Johnson group) markets a drug known as Prezista®, the active compound of which is darunavir.

SAS Sandoz is a French affiliate of the Sandoz group (affiliated to Novartis). As readers have probably already guessed by now, Sandoz launched a generic version of Prezista® before the expiry of the French SPC – which is set to take place on February 23, 2019.

Another form of launch at risk.

The parties have been entangled in pan-European litigation over the darunavir SPCs. This litigation actually hit the headlines when, on January 25, 2018, the British Court of Appeal referred a question to the CJEU in relation with the validity of the British SPC.

The case is still pending and was allocated number C-114/18.

The issue at stake is the following.

Claim 1 of the EP’209 patent is a so-called Markush claim.

A Markush claim covers a large class of chemical compounds by way of a generic formula, without reciting them individually. In this case, the generic formula contained in claim 1 is the following:

Each group among P1, P2, R2, R3 and R4 is defined as being selected among of list of possible options. I will spare you the complete lists here. But it may be important to note that each list itself recites generic classes of groups, rather than individualized groups. For instance P1 and P2 can be alkoxycarbonyl groups, aralkoxycarbonyl groups, alkylcarbonyl groups, etc. Each of these options encompasses an unknown number of individual possibilities. In the end, the array of choices falling under the generic formula is practically unlimited.

Well, not quite. In fact the number of theoretical possibilities was estimated in the British litigation to be from 7 x 10135 to 1 x 10377. Not a very accurate estimate, but let’s not skimp on a couple hundred zeros.

Now, darunavir has the following structure:

It turns out to be one of the zillion compounds covered by claim 1

Several other claims of the patent also cover darunavir, but always in a generic way. Darunavir is not cited in the patent, not exemplified, nor singled out in any other manner.

Now, according to famous / infamous article 3(a) of the so-called SPC Regulation (Regulation (EC) No. 469/2009):

A certificate shall be granted if, in the Member State in which the application referred to in Article 7 is submitted and at the date of that application:

(a) the product is protected by a basic patent in force […].

As regular readers of this blog are well aware, people have been arguing, fighting and spending millions and millions of euros for a number of years over what it means for a product to be protected by a basic patent.

Some (limited) guidance has been offered by the CJEU over time.

For instance, this is from the Medeva judgment (C-322/10):

Article 3(a) of [the SPC Regulation] must be interpreted as precluding the [grant on an] SPC relating to active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application.

Then there is the Eli Lilly judgment (C-493/12):

Article 3(a) of [the SPC Regulation] must be interpreted as meaning that, in order for an active ingredient to be regarded as ‘protected by a basic patent in force’ within the meaning of that provision, it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Where the active ingredient is covered by a functional formula in the claims of a patent issued by the EPO, Article 3(a) of that regulation does not, in principle, preclude the grant of an SPC for that active ingredient, on condition that it is possible to reach the conclusion on the basis of those claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 of the EPC and the Protocol on the interpretation of that provision, that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question […].

And let’s not forget about Teva (C-121/17):

Article 3(a) of [the SPC Regulation] 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.

And there are a few other relevant ones.

But the thing is, the CJEU has never ruled so far on how article 3(a) should be applied with respect to a Markush claim. So, in this case, should darunavir be considered as being “specified in the wording of the claims” (as per Medeva)? Is it possible to conclude that the claim “relates, implicitly but necessarily and specifically“, to darunavir (as per Eli Lilly)? Or is this not a relevant question as the claim should not be considered as a functional claim? Or maybe a combination of substituents in a Markush formula should be treated like a combination of active compounds, so that it should be investigated whether, “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“, each of the substituents is “specifically identifiable, in the light of all the information disclosed by that patent” (as per Teva)?

Of particular interest in this case is that, not only was darunavir not known as a compound at the filing date and was only made available several years later; but group P1 of the generic formula, when the formula applies to darunavir, can be considered as an unusual group at the filing date, which does not form part of common general knowledge.

The British Court of appeal thus proposed the following question for the CJEU:

Where the sole active ingredient the subject of [an SPC] issued under [the SPC Regulation] is a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?

And this now brings us to France.

Sandoz obtained a Marketing authorization (MA) for the generic version of Prezista® on December 15, 2017. Searle and Janssen issued multiple warnings to Sandoz and then discovered in December 2018 that the generic drug (Darunavir Sandoz) was on the French market.

On December 14, 2018, they filed a complaint against Sandoz in urgency proceedings (référé d’heure à heure) for infringement of their SPC No. FR’034 – after getting an authorization to do so from the court.

Sandoz’ sole defense relied on the invalidity of the SPC for non-compliance with art. 3(a) the SPC Regulation. 

The hearing took place one week only after the filing of the complaint, on December 21, 2018. Then the judge Ms. Lignières took the case home during the Christmas break and issued her decision on January 11, 2019, ruling against Sandoz.

In the decision, the judge analyzed the CJEU case law and came to the conclusion that the Eli Lilly test is not applicable to a Markush claim:

It should be noted that, in the Eli Lilly decision, the case related to a functional claim, so that the CJEU insisted on a double condition of necessity and specificity. In the present case, the claims of the basic patent are structural and better allow the skilled person to determined in view of the claims whether the active compound protected by the SPC was covered by the basic patent. 

Then, after analyzing the formula of claim 1 of the patent and the various meanings of the variable groups in this claim and some of the dependent claims, the court concluded that:

Therefore darunavir is identified by the skilled person as being implicitly but necessarily and specifically protected by the EP’209 patent in view of the substituents identified in the claims, in keeping with the requirements of article 3(a) of the EC Regulation and of the CJEU case law.

The judge thus considered that the defendant did not prove that the SPC was manifestly invalid.

Accordingly, a preliminary injunction was ordered, under a 50,000 euro-penalty per violation of the injunction. The judge also ordered a seizure of the infringing drugs, as well as a product recall.

I don’t have an exhaustive view of the pan-European Searle v. Sandoz litigation, but at least in the Netherlands a similar preliminary ruling was issued a couple of months earlier: see here.

In a recent post I wondered whether there was a surge in preliminary injunctions in France these days. The darunavir case seems to provide a confirmation. 

We will have to wait for the CJEU ruling to know whether the French judge correctly guessed which way the Luxembourg winds will finally blow.

But at any rate this decision should reassure IP right holders. A very quick preliminary decision can be issued in France when time is of the essence. Therefore, launching a generic drug a couple of months before the expiry of the IP at stake does not curtail the injunctive risk.


CASE REFERENCE: TGI Paris, ordonnance de référé, January 11, 2019, GD Searle LLC et al. v. SAS Sandoz, RG No. 18/60334

The new patent frontier

Out of sheer laziness, I am usually reluctant to report on bills that are still in the legislative process.

After all, you never know whether your report will still be consistent with what comes out of the process in the end. You may call that the UPC syndrome.

But the reform of the French patent granting procedure currently in gestation represents such an upheaval of the world as we French patent attorneys know it that it is getting more and more difficult to ignore it on this blog.

So, today, I will update readers on the “Projet de loi relatif à la croissance et la transformation des entreprises“, also known as the PACTE bill. Don’t ask me what the A in the acronym stands for. It is probably just easier to pronounce than “PLRCTE“, that’s all.

This is a very complex and long (some would say catch-all) bill that spans labor law, tax law, commercial law, etc. And there are a few provisions on patent law, which are rather far-reaching.

The bill, updated as of today, can be found here. All provisions have now been approved by the Assemblée nationale (the lower chamber of our parliament), which prompted today’s post. Please bear in mind that these provisions can still be modified during the rest of the legislative process though, but by now it is more likely than not that they will indeed become law.

The first relevant part of the bill is article 40, which deals with utility certificates. That’s the local name for utility models. These are seldom used in this country and probably not very well known. The three current main features of the utility certificate are the following:

  • no search report is established for a utility certificate;
  • the maximum duration of the utility certificate is 6 years from the filing date; and
  • a patent application can be converted into a utility certificate application but not the other way around.

In order to make the utility certificate a more attractive option for innovators, the maximum duration of the certificate will be brought to 10 years instead of 6. Its duration will thus be on a par with that of utility models in foreign countries, notably Germany.

A second change is that it will now be possible to convert a utility certificate application into a patent application. The conditions for this conversion will be further specified by way of an executive order.

If we assume that flexibility is always appreciated by applicants, these changes will indeed make the utility certificate more palatable to them. While we are at looking at what the Germans do, we might as well have imported the “Abzweigung“, i.e. the possibility to file a utility model application as a split-off from a patent (including European) application. This can be quite a powerful tool for applicants. Maybe next time – together with a (much awaited) re-opening of the French national phase PCT route?

The second topic addressed in the bill is a much bigger prize, though.

Article 42 authorizes the government to create national opposition proceedings, so as to allow third parties to request the revocation or modification of a French patent, by way of an “ordonnance”. 

An “ordonnance” is a special kind of executive order which has the same effect as a law passed by the parliament, provided that it is later ratified by the parliament.

There are absolutely no details as to this future opposition in the bill, as the parliament has precisely surrendered its prerogative to set rules on this matter to the government, by way of this article 42. So we will have to wait until we see the “ordonnance”. 

For what it is worth, a survey was conducted by the French patent and trademark office (INPI) on this topic a few months ago. Among the questions which were addressed in the survey, were the following:

  • Should any person be allowed to file an opposition, like at the EPO, or should an opposition be reserved to persons and entities having standing? (And, boy, we know that the appraisal of standing in nullity suits can be tricky.)
  • Should the opposition period be set to 6, 9, or 12 months?
  • What should the grounds for opposition be?
  • Should it be possible to file an opposition against a granted utility certificate?
  • Should the decision on the opposition be open to appeal in front of the Paris Tribunal de grande instance (first instance court) or in front of the Paris Cour d’appel (appeal court)?
  • What should the effect of an opposition be on parallel litigation, in particular concerning a possible stay of proceedings?
  • Should oral proceedings be summoned?
  • Should an accused infringer be able to intervene in opposition proceedings?
  • Should the examiner who granted the patent be part of the panel of three examiners who will decide on the opposition?
  • Etc.

As you can see, things were (still are?) very open. Rumor has it that the INPI is contemplating a rather extensive alignment of the future French opposition proceedings on the EPO model.

As a side note, article 42 of the bill specifies that the future “ordonnance” should make sure to prevent abusive oppositions. I have no idea what they mean by this, but I do hope that there will be no standing required to oppose a patent. This would certainly lead to useless complexity and legal uncertainty.

PACTE, the final frontier?

Now, the third topic of interest in the bill is as big as the second one – if not bigger.

At present, the INPI has limited power to refuse a patent application. Basically, a French examiner can raise objections (such as lack of clarity or unity) before the issuance of the search report. Then the search report and a complete written opinion are drafted, either by the EPO or directly by the French examiner. Then the applicant files observations as a response – which can very well be very brief. And a refusal can only take place in exceptional circumstances, e.g. if it is “blatant” that the application relates to subject-matter which is not an invention (such as discoveries, aesthetic creations, etc.); or if there is a “blatant” lack of novelty.

There are further (more minor) grounds for refusal, such as lack of unity. But the major fact is that lack of inventive step is not a ground for refusal – although of course it is a ground for nullity of the issued patent in front of a court. And lack of novelty or lack of patentability are grounds for refusal only insofar as the objection is crystal clear and there is no possible defense.

Well, it seems like this fundamental peculiarity of French patent law is about to become a thing of the past.

Article 42bis of the bill will make it possible for the INPI to refuse an application for lack of novelty or non-patentability, period (i.e. the objection will no longer need to be blatant); and also for lack of inventive step.

A huge change indeed. Hailed by some, as it is believed to increase the value of French patents. Lambasted by others, as applicants (especially local ones) may be less incentivized to file national applications if the local granting procedure becomes similar to the European one.

To me, the success or failure of the above reforms will mostly depend on their implementation by the INPI.

Tremendous efforts will have to be undertaken to hire and properly train new examiners to perform these tasks. Let’s hope that this aspect has not been underestimated by the government and that sufficient funding will be available to support these efforts.

One good point is that the new, beefed up, granting procedure will only come into force two years from the entry into force of the PACTE law. This transition period will certainly be necessary in order for everyone to get ready for this new enterprise, in other words “to explore strange new worlds, […] to boldly go where no man has gone before“.

And by the way, who said the unitary patent and the UPC would be the kiss of death for national patent rights?

PS: for those eager to know everything about the debates that took place in the Assemblée in connection with the above provisions, here is the link to the full transcript. Don’t hold your breath though, it is fairly high level and there was no discussion on the nuts and bolts of the new system.

Getting ready

Little by little, everything seems to finally come into place for the kick off of the UPC – pending the outcome of the constitutional complaint in Germany.

A major step has now been taken in France, with a modification of the Code de la propriété intellectuelle (CPI) to make national law ready for the UPC, by way of an executive order dated May 9.

And one of the most important amendments thus introduced… well in fact has little do with the UPC, and everything to do with this very French debate on the statute of limitations applicable to patent nullity actions.

Indeed, a new article L. 615-8-1 is introduced, per which the statute of imitations is simply not applicable to patent nullity actions. So, back to the situation that everyone took for granted ten years ago, and back into line with the practice of other European countries. Very good news indeed.

But, there is a but, or actually two.

First, this new provision will only come into force when the UPC agreement comes into force – since the overall purpose of the order is the application of the UPC agreement. Second, the new provision will not be applicable to nullity actions which are already time-barred at the time the provision comes into force.

So you can still expect a lot of discussion for a few more years on how the statute of limitations should be applied and how the limitation period should be computed, before this really becomes history.

Waiting for the entry into force.

Now, back to the other, truly UPC-related provisions. One important aspect is how double protection by a French patent and a European patent for the same invention is handled.

The current situation is that, when a French patent and a European patent granted to the same inventor or successor in title cover the same invention and have the same priority date, the French patent ceases to be in force at the expiry of the 9-month European opposition period (if no opposition is filed) or when the opposition proceedings are closed, the patent being “maintained” (either in amended form or as granted).

Under the new version of article L 614-13 CPI, this remains the case, but only for European patents that have been opted out from the exclusive competence of the UPC (under article 83 of the Agreement). For non-opted out European patents (including of course unitary patents) on the contrary, there will no longer be any such so-called substitution. Thus, applicants will be able to secure both a national patent, enforceable in front of our national courts, and a European patent enforceable in front of the UPC, for the same invention. This is of course primarily of interest for French applicants who do their first filings at the INPI and then file at the EPO. But of course foreign applicants could also use this tool, for super-important inventions, by filing at the EPO and then in France, or simultaneously at the EPO and in France.

Now, what happens if a European patent is opted out at a late stage, for instance after the 9-month opposition period? The answer provided in the new law is that double protection then ends at the time of the opt out, i.e. the French patent ceases to be in force on the date of the opt out.

By the way, any substitution is irreversible. If a European patent is invalidated or lapses or if the opt out is withdrawn after a substitution has taken place, the corresponding French patent does not come back to life.

Another amendment relates to the prohibition to transfer, or to grant rights on, a French patent or application independently from a European patent or application, for the same invention, having the same priority date, and filed by the same inventor or successor in title.

This prohibition remains in place for all non-opted out European patents (including unitary patents), as well as opted out European patents (before the substitution takes place). In addition, the recordal of a transfer at the French national patent register is only effective if a parallel recordal has taken place at the European national patent register.

Next topic, a particular procedural rule in connection with patent litigation.

Currently, if a French patent is asserted and there is a corresponding European patent or application, the court stays the proceedings as of right until the substitution takes place, or until the European patent or application disappears (by way of a withdrawal, refusal, revocation, etc.) before any substitution takes place. This rule will remain in place but solely for opted out European patents. When a non-opted out European patent / application is present, an action based on the French patent will be able to proceed independently of the fate of the European patent / application. It remains to be seen how this will play out in practice. The court will still have the possibility to order a stay anyway, under the general rules of civil procedure, if they deem that a stay is appropriate for a good administration of justice.

On a few other aspects, French law has been harmonized with the UPC Agreement.

This is especially the case regarding the wording used to define the acts of infringement and exhaustion of rights. Besides, non-exclusive licensees will now be allowed to assert a patent if this is expressly authorized by the license agreement, and provided that the patent proprietor is given prior notice. This is a new possibility under French law, which mirrors article 47(3) of the UPC Agreement.

The limitation period for infringement damages remains five years but the starting point will now be the date on which the applicant became aware, or had reasonable grounds to become aware, of the last fact justifying the action, in keeping with article 72 of the Agreement. In the current version of article L. 615-8 CPI, the starting point is “the facts” on which the action is based. The effect of this significant modification will be twofold: right holders will in some cases be able to claim more damages; and more complex debates regarding the determination of the starting point of the limitation period can be expected, as the new definition is more fuzzy than the traditional one.

Last but not least, new article L. 615-18 CPI clarifies that the UPC shall have exclusive jurisdiction over unitary patents and non-opted out traditional European patents.

So, now that the rules of the game are known, all readers can start looking for potential loopholes or ambiguities, and imagining unusual scenarios. Isn’t this what new laws are primarily for?

Biological patents: an endangered species

Last August, while most of the patent profession was enjoying well-earned holidays, the Code de la propriété intellectuelle (CPI) was amended in a way that may significantly alter the fate of patents on biological materials.

So much so that my colleague Lionel Vial wonders whether France may become a safe haven for copies of patented plants.

Here are his thoughts on the subject.

The so-called law for the recovery of biodiversity, nature and landscape dated August 8, 2016, which entered into force on August 9, 2016, has introduced two amendments into the Code de la propriété intellectuelle (CPI).

The first amendment is the addition of a new paragraph in article L. 611-19 CPI:

I – The following shall be unpatentable:

1° Animal varieties;

2° Plant varieties as defined in Article 5 of Regulation (EC) No. 873/2004 […];

3° Essentially biological processes for the production of plants and animals. A process that exclusively consists of natural phenomena such as crossing or selection shall be regarded as such;

3° bis Products exclusively obtained by the essentially biological processes defined in 3°, including the elements constituting these products and the genetic information they contain;

4° Processes for modifying the genetic identity of animals which are likely to cause them suffering without substantial medical benefit to man or animal, as well as animals resulting from such processes.

II – Notwithstanding the provisions of (I), inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.

III – The provisions of I (3°) shall be without prejudice to the patentability of inventions which concern a technical process, in particular a microbiological one, or a product obtained by means of such a process; any process involving or resulting in or performed upon a microbiological material shall be regarded as a microbiological process.

According to parliamentary discussions during the lawmaking process, this amendment was essentially triggered by decisions G 2/12 (Tomatoes II) and G 2/13 (Broccoli II) of the Enlarged board of appeal of the EPO. As a reminder, these two decisions provided that the exclusion of essentially biological processes for the production of plants from patentability in article 53(b) EPC does not extend to product claims directed to plants or plant materials such as plant parts.

The idea was also to push for a modification of European Union law, in particular of Directive 98/44/EC, after similar amendments were made in German and Dutch national laws (see Patentabilty of Plants in epi information 4/15:156-168).

However, the French version of this new exclusion from patentability is broader than a prohibition of patents on products exclusively obtained by essentially biological processes, like in Germany and the Netherlands. Indeed, the exclusion also encompasses elements constituting these products and the genetic information they contain.

According to statements made by members of parliament promoting this amendment, the aim was to further prevent native traits of plants from being patented.

As a consequence, the exact scope of this new exclusion from patentability is not simple to delimit. Indeed, from a teleological point of view, it appears that elements from plants previously occurring in nature are also intended to be excluded from patentability by this provision. In contrast, based on a literal approach, only elements from plants exclusively obtained by essentially biological processes, and thus obtained by human action, should be excluded from patentability. This would also be consistent with article 3.2. of Directive 98/44/EC per which

Biological material which is isolated from its natural environment may be the subject of an invention even if it previously occurred in nature.

The impact of the amendment of article L. 611-19 CPI should nevertheless be relatively limited, as it applies only to French patents. Besides, the INPI (French patent and trademark office) had already decided, before the entry into force of the new law, that it would not apply G 2/12 and G 2/13 and that it would refuse to grant French patents pertaining to biological material obtained by essentially biological processes.

But lawmakers also added a third paragraph in article L. 613-2-3 CPI which defines the protection conferred by a patent on biological material and which applies both to European and French patents (possibly including those already granted before the entry into force of the new law):

The protection conferred by a patent on a biological material having specific characteristics as a result of the invention shall extend to any biological material derived from that biological material through propagation or multiplication and having the same characteristics.

The protection conferred by a patent on a process for producing a biological material having specific characteristics as a result of the invention shall extend to biological material directly obtained through that process and to any other biological material, derived therefrom, by reproduction or multiplication and having the same characteristics.

The protection conferred by a patent relating to a biological material having specific characteristics as a result of the invention does not extend to biological materials having these specific characteristics, obtained independently from the patented biological material and by an essentially biological process, nor to biological materials obtained therefrom, by reproduction or multiplication.

Our readers may have difficulties determining the exact scope of this exclusion from patent protection. If so, we would be inclined to think that this is not entirely due to the translation, as the French text itself is quite cryptic.

Let’s try to get things straight.

The aim of this amendment is mainly to prevent seed makers who use essentially biological processes to generate genetic diversity when producing new seeds from being prohibited to use or sell the new seeds thus obtained because of existing patent rights.

An enlightening example for understanding the motives of the lawmakers in this regard relates to the aphid-resistant lettuce case which was referred to by several members of parliament during the debates.

In this case, the French seed maker Gautier Semences, a family business, was allegedly forced into a license agreement with Rijk Zwaan in respect of European patent EP 0921720, to be able to continue to market the aphid-resistant lettuce seeds it had been selling before the patent was filed.

As a side note, claim 1 of the patent as maintained in amended form after opposition proceedings reads as follows:

Lettuce plants of the species Latuca sativa L. which are resistant to the aphid Nasonovia ribisnigri due to presence in the genome of the Nr resistance gene, characterized in that the genetic information responsible for the CRA phenotype is absent from the genome of the plant at least to such an extent that in the presence of the Nr gene in homozygous condition the CRA phenotype is not expressed.

But how on earth could this patent be enforced against Gautier Semences, as they should benefit from prior user rights? In addition, shouldn’t there be a serious novelty issue in view of the seeds marketed by Gautier Semences?

The response is that in theory Gautier Semences should indeed have been immunized against the effects of Rijk Zwaan’s patent. However, evidence of prior user rights or of public prior use may be difficult to provide, especially for an SME.

The new provision should therefore facilitate the defense of those marketing biological materials covered by a patent, when the materials were obtained by an essentially biological process. However, it will probably still be necessary for those wishing to take advantage of this provision to prove the latter fact.

Besides, it should be noted that the new provision goes beyond simply addressing situations such as the above aphid-resistant lettuce case, as it applies to any biological material obtained by an essentially biological process, irrespective of whether it was obtained before or after the patent was filed.

Now that we have a better view of the aim of the new provision, let’s examine two interesting consequences.

The first one is in relation to the meaning of the expression “essentially biological processes”.

At least we can tell that this plant material was not obtained by an essentially biological process.
At least we can tell that this plant material was not obtained by an essentially biological process.

This expression is not defined as such in the rest of the statute. Reference is made to “essentially biological processes for the production of plants and animals” in Article L. 611-19 3° CPI. The same article also provides that “processes that exclusively consist of natural phenomena such as crossing or selection shall be regarded as [biological processes]”.

Accordingly, it is possible that the expression “essentially biological processes” in Article L. 631-2-3 CPI could be construed as not being limited to processes exclusively consisting of natural phenomena such as crossing or selection.

This may be apparent from the parliamentary history of the new provision which, until the last round of amendments and vote (out of 7!) still recited:

The protection defined in the first paragraph of the present article does not extend to the biological materials exclusively obtained by the essentially processes defined in the third paragraph of part I of article L. 611-19 CPI.

The result of this last minute amendment, the justification of which was to protect the French seed industry, was to cancel any explicit reference to a process that exclusively consists of natural phenomena such as crossing or selection being regarded as a biological process.

A consequence could therefore be that plants obtained by a process involving, among steps of a biological nature such as crossing or selection, a step of random mutagenesis, and having properties similar to a plant covered by a patent, could be considered as being obtained by an essentially biological process and would thus be excluded from patent protection.

Indeed, the French union of seed makers (Union Française des Semenciers) for instance considers that random mutagenesis, e.g. by the use of chemical agents or ionizing radiations, yields native traits, i.e. traits that could be obtained through natural processes

It will be interesting to see how case law will develop in this regard, especially in view of new mutagenesis techniques, such as the superstar CRISPR/Cas9 technique for which Monsanto has just secured a non-exclusive license.

Another consequence of this last minute amendment, which might be seen as a huge side effect, is that the exclusion from patent protection set by the new provision in article L. 613-2-3 CPI is not confined to plants and animals but now encompasses all biological materials and potentially microorganisms.

Again, it remains to be seen how patents pertaining to isolated microorganisms endowed having specific characteristics, e.g. food transformation or health properties, will be enforced against microorganisms having these characteristics but which were isolated independently from the patented microorganisms.

At present, there is no way for patentees to escape the new provision. However, there might be one in the future owing to the Agreement on a Unified Patent Court. Indeed, the limitations of the effects of a non-opted out European patent will be defined by Article 27 of the Agreement… and not by the French statute. That is, if the agreement ever enters into force…

Many thanks, Lionel. Struggling to figure out what a new legal provision exactly means, and guessing about unintended fallout are probably the perks of every single patent law reform.

Conformity of the new provisions to the biotech directive 98/44/EC could also be an interesting and tricky question. All the more so that the European Commission released a notice which was published in the Official Journal of the European Union a few days ago.

The notice addresses a number of aspects of the biotech directive. It is in particular stated that:

The Commission takes the view that the EU legislator’s intention when adopting Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes.

The Commission’s view is thus contrary to the position taken by the Enlarged Board of Appeal and on the face of it consistent with at least part of the recent amendment of French law.

Clearly, patentability of biological materials in Europe is on moving grounds right now. I would not be surprised if there were more episodes of a tomato, brocoli or lettuce saga coming up in the near future.