Both chambers of the parliament, the Assemblée nationale and the Sénat, get to debate on, amend and vote bills. But if they fail to agree on the same version of a bill, in the end the Assemblée nationale has the last word.
And so it is with the so-called “Loi Pacte“, first discussed on this blog post. There was some suspense as to what the bill would finally contain, as it bounced back and forth, being amended and dis-amended from one chamber to the other. But now the suspense has come to an end as the bill has been finally adopted and will become the law of the land.
Well, unless there is a last minute surprise, as the constitutionality of the bill will likely be challenged in front of the Conseil constitutionnel (our constitutional supreme court) by disgruntled members of parliament.
The final text is here and it is 408 pages long (yes, that is some packed Pacte). It has many different aspects, including some controversial ones – like the privatization of ADP (the company that runs Paris’ airports). It also contains some provisions on IP, including just a few ones on patent law – but they are very important provisions indeed.
Basically, the report that I previously made on the draft still stands, although the articles have been renumbered:
The maximum duration of utility certificates will be brought from 6 years to 10 years (article 118).
It will be possible to convert a utility certificate application into a patent application within a deadline which still needs to be determined, whereas only the opposite is possible as of today (article 118).
The government is authorized to rule by way of an ordonnance in order to set up a procedure for third parties to oppose a granted patent (article 121).
The INPI (French patent office) will be able to refuse a patent application if its subject-matter is not an invention or is excluded from patentability, in contrast with the current formulation, per which its subject-matter is “manifestly” not an invention or is “manifestly” excluded from patentability (article 122).
The INPI will be able to refuse a patent application if its subject-matter is not novel or not inventive, in contrast with the current formulation, per which an application may be refused if it was not modified despite a “manifest” lack of novelty (article 122).
Infringement actions will be time-barredfive years after the day the right owner knew or should have known the last fact allowing them to act, as opposed to the current formulation, which is five years “from the facts” (article 124).
The statute of limitations will no longer apply to patent nullity actions (article 124).
So, there you have it, I don’t know if it is spring or winter, but a new season is definitely coming.
So what next? Well, first we will have to carefully look at transitional provisions.
In this respect, I have noted the following:
The new provisions on utility certificates shall enter into force when the implementing decree is published, or one year from the publication of the law at the latest.
The timeline for the introduction of the opposition proceedings is still unclear, as it will depend on the regulations (ordonnance) that the government will issue.
Provisions extending the scope of examination of patent applications by the INPI shall enter into force one year from the publication of the law.
The new provision on the statute of limitations for nullity actions will immediately enter into force – but will have no effect on decisions that have become res judicata. It remains to be seen how this will be interpreted in practice.
The bottom line is that, regarding the biggest changes for patent applicants, patent attorneys and the patent office, we have some time to get prepared – but we all know how that usually flies.
The nitty-gritty of the new system is still unclear and will require our full attention.
Moreover, another question mark is how the INPI will adapt to this upheaval.
Based on a report on a meeting between the INPI management and representatives of the patent profession a few weeks ago, the following seems to be contemplated at present:
The projected date of entry into force of the patent opposition proceedings is January 1, 2020 (this is quite ambitious).
The projected start of the examination of inventive step is mid-2021 (this is because the new law will only apply to newly filed applications, I presume).
In terms of HR efforts, 15 patent examiners currently working on a backlog of national search reports will be redeployed to deal with opposition cases, and 16 new patent examiners will be hired to deal in particular with the increased workload related to the examination proceedings.
We also learn from this report that the new French “provisional patent application“, that we have heard of a number of times, is not dead. It should be created soon by way of a government decree.
I am curious to know what such a provisional application will look like. So far, patent professionals have been extremely skeptical about this – to put it mildly.
According to one apocryphal anecdote, President Macron was told by a French start-upper a few years ago that U.S. law is much more favorable to innovators than French law, because they have provisional applications in the U.S.
As a reminder, filing a French patent application without claims and without paying any taxes gives you a filing date, which is all you need to later claim priority. So, if there is any truth to this anecdote, it probably means that our President never met a French patent attorney – or at least that such a meeting did not leave as strong an impression as the ones he had with start-up folks. Which, let’s face it, is quite understandable.
This is the second part of my interview of Ms. Marie-Christine Courboulay, former judge at the Paris Tribunal de grande instance (TGI), in charge of IP matters and especially patent litigation.
The first part of the interview can be found here.
In today’s part, Ms. Courboulay reflects on the strengths and weaknesses of the French judicial system. She explains how French judges interact with their foreign counterparts, and tells us about the role of case law – French case law, foreign case law, and most interestingly EPO case law, as the rift between the approach of the Boards of appeal and the approach of French courts has not really been reduced over the past few years. The interview would not be complete without some words on the UPC, and you will see that Ms. Courboulay is very optimistic regarding the attractiveness of the Paris local division of the court.
Again, a big thank-you to Ms. Courboulay for sharing her views on this blog.
What do you see as the main strengths and weaknesses of the French judicial system, particularly regarding patents, compared to our European neighbors?
The French judicial system has several advantages, in the field of patents:
In the case of provisional measures, an adversarial decision can be issued in an extremely short amount of time, namely within a few days: for example summons may be authorized by a judge on Monday, the oral argument may be heard on Wednesday, and the decision issued on Friday. This is perfectly compliant with the standard set by the CJEU, which intends to favor the adversarial principle even at this stage.
Infringement seizure, which provides evidence of alleged infringement through an ex parte request. It should be mentioned that this is the only ex parte order for which the judge does not have to justify the reasons why the adversarial principle does not apply.
Judgments on the merits that are now issued within a timeframe which is comparable to those of other European courts which base their decisions on continental law and not on common law, and which rule both on the validity of the patent and on infringement, since there is no bifurcation in French law.
A single court (the Paris TGI and the Paris Cour d’appel) which therefore concentrates the entire litigation, so that the judges handle many patents and develop their expertise.
As for the weaknesses: the main one is the judges’ turnover, and sometimes their level of English proficiency.
Do French IP judges have regular exchanges with their counterparts in other European countries? What do they get out of these exchanges? Do they strive for harmonization with the practice of neighboring countries? If so, what are the limits of this desire for harmonization?
French judges have regular exchanges with their European and even American colleagues at European or international conferences, but also at workshops organized by the EPO or by the EUIPO on trademarks and designs.
These exchanges are important because they make it possible to understand how the same text (when it is a regulation) can be interpreted differently from one country to the next, to understand nuances or consequences evaluated one way or another, and why certain specificities are preserved, when a directive is transposed.
These exchanges make it possible to learn about solutions found by other judges based on a same text and / or a same case, and to discuss future developments or modifications to be considered in the different areas of IP.
There is indeed a desire to harmonize IP case law; it is mandatory in the trademark and design area, and by extension, it is sought in the patent area as well, even if this not legally required. This is less true of copyright, except in the case of private copying, which has been the subject of numerous decisions by the CJEU.
However, the decisions of the CJEU which are meant to ensure harmonization are read by all European judges and should also lead to harmonization, including for example concerning SPCs or FRAND licensing.
There is one limit which is the applicable national law, when there is a difference between a directive and its transposition law.
For instance, regarding infringement, the notion of good or bad faith was not incorporated into the French statute, whereas it exists in other European countries, where a bona fide infringer and a pirate are not handled in the same manner. The French judge cannot make any prima facie difference based on the notion of good faith, which should not be taken into account when it comes to infringement.
On the other hand, French judges, due to the harmonization desire, and after discussing with other European judges who regretted an excessive difference relative to other national rights, introduced the requirement for the person who requests an infringement seizure to provide a reasonably accessible beginning of proof. This is taken from the non-transposed part of the directive, but the judge may add a criterion for assessing the grant of the order, i.e. a condition which preserves equal rights before the court dealing with the merits, and which especially preserves the rights of the alleged infringer.
If the Code de la propriété intellectuelle provides that the infringement seizure is a right, it should be borne in mind that there is no absolute right, that this right is subject to the appreciation of a judge who must in his/her decision weigh the grounds on which the request is based, and those which could lead him/her to refuse the infringement seizure or to limit it in its scope. This is in view of a concern, acknowledged by the CJEU, of proportionality of the rights of litigants, which must more particularly be taken into account in ex parte proceedings that lead to a particularly intrusive measure before any judgment.
In the context of multinational patent litigation, how important are foreign decisions in the eyes of French judges?
I know that there was a time when French magistrates said that they were not bound by foreign decisions, and that they did not even read them.
But that time is over.
If it is true that we are not bound by the decision of a court of another member state in the procedural sense of the term. But, when a decision is issued in the same litigation by a foreign court and it is submitted to the court, it is part of the file wrapper. Decisions are read and analyzed, first to ensure that they indeed relate to the same dispute, and especially that the arguments under discussion are the same, which is not always the case. Second, if the grounds relied on are the same in the dispute between the same parties, the decision will be very carefully read to understand and analyze the reasoning followed by the foreign court, because in general the same causes lead to the same legal grounds, which lead to the same consequences.
I would say that the judge will determine whether he/she is convinced by the reasoning of his/her colleague. At any rate, as far as I am concerned, these decisions are of a special importance, which is greater than that of a legal opinion for example, even if I also pay close attention to such opinions.
Or we can find food for thought in other decisions, and we can take a hold of criteria developed by another court or another office to assess the validity of an SPC for example, if these criteria appear to be relevant.
I would add that in case of a disagreement with the foreign court, it will be necessary to try to provide an even clearer and more precise reasoning, so that the parties can understand and follow the reasoning proposed by the French judges.
In fact, there may be disagreements of analysis and interpretation with foreign colleagues which are similar to those which may exist with French colleagues.
How is the case law developed by the EPO boards of appeal on the validity of patents considered by French judges? In particular, French courts have sometimes explicitly discarded some decisions of the EPO’s Enlarged board of appeal (for example on computer programs, or on claims to dosage regimens). Some observers were surprised at such differences in practice between Munich and Paris, which do not seem to be found to the same extent in other European countries. Is there a French distinctive identity in this respect?
The case law of the boards of appeal and of the Enlarged board of appeal are known to the 3rd chamber and to the Cour de Cassation, that expressly referred to it in its judgment of December 6, 2017. But they come from an office and not from a court; they do not have the same value for French judges as judgments from another court.
The other point is that the boards of appeal of the EPO have a tendency to interpret the texts on which they base their decisions in an extremely extensive manner. They try to grant patents (which is their primary objective and the source of their financing) even when the conditions are not met.
This is the reason why the European Commission has taken up the subject in the broccoli cases, or why the Paris Cour d’appel has referred a preliminary question to the CJEU as to whether a new molecule already known for an already known treatment could be considered as a second therapeutic application.
Lastly, German judges who are presented with an action for nullity of a patent must stay the proceedings as long as the decision by the EPO on the patent is final, which is not our case. This difference necessarily affects the influence of EPO decisions on French courts, as they will validate or revoke a patent without waiting for the EPO decision, when the patent is still under opposition.
So, I do not know if French judges are more reluctant than others to follow the decisions of the EPO boards of appeal, but they are in any case cautious about how they should be analyzed.
The French legal tradition differs from common law, which is centered on precedent. Apart from the main judgments of the Cour de cassation, do you think that there is a French patent case law which courts strive to follow? Or do the judgments of the TGI and of the Cour d’appel only represent specific decisions without any general influence on judges in other cases? Mention can be made for example of the different approaches which have recently been noted between the Paris TGI and Cour d’appel concerning the application of the statute of limitations to patent nullity suits.
There is no need for a tradition of precedent to create a consistent case law that attempts to develop a set of universally understandable enforcement rules. In France, the Cour de cassation carries out the necessary harmonization between the different courts and thus indicates the direction that future decisions will have to follow.
While of course each judgment is a case in point, it is clear that case law reveals major trends and defines interpretations of the legal bases proposed by the parties in their submissions.
Concerning the statute of limitations, the first instance court has proposed an interpretation of the rule which has not been followed by the Cour d’appel and it will be up to the Cour de cassation to provide the interpretative framework that the courts will have to follow.
So, as always, the rule and its interpretation will be general and elaborated by the Cour de cassation or the CJEU, which also provides an interpretative framework or “instructions for use” of a law, and which leaves it to national courts to apply the rule thus interpreted to the case at hand.
In your opinion, does patent law in its current state offer a satisfactory balance between the interests of right holders and third parties? Do you wish for some legislative changes, either in terms of substantive or procedural law?
I would say that there is a certain balance between right holders and third-party competitors as long as patents are not granted too loosely, and as long as they reward investments actually made for research and innovation by a 20-year monopoly, as the CJEU always reminds us. That’s why I’m not at all in favor of theories per which patents may have other purposes than the reward of an invention, notably a communication to the public when a particular product is advertised as being patented. To me, this benefit is a form of lie, when it is not based on a real invention (so-called blocking patents that distort competition) and that is why I am in favor of a real examination of French patents by the INPI (with the human and financial resources that should go with it as I said above).
Turning to consumers who are also third parties, I would like the concept of public interest, particularly in the area of medicines, to be more fully taken into account and even integrated into the statute.
This public interest concern is in line with the senators’ concern, as they have debated the notion of “essential drugs”, and have taken interest in drug shortages, or in new therapies that are burdened by an exceedingly high price.
The same considerations apply to standard essential patents and the resulting consequences on the market, the price of IT products, the monopolies thus created and the extra cost to the consumer. This is the field of so-called FRAND licenses and the necessary balance that must be achieved between licensees, competitors, start-ups and consumers.
You have been involved in extensive preparatory work regarding the unified patent court. If this court does come into force soon, which position do you think French courts will have in the future?
I still am involved. I think that if the UPC fulfils the objective assigned to it, which is to issue decisions on infringement and validity of unified and European patents throughout the members states of the European Union that have ratified the Agreement, within an extremely short timeframe (one year), then, after the 7-year transition period during which there will be shared jurisdiction over European patents between the UPC and national courts, national courts will then only have to deal with national patents.
On the other hand, the Paris local division should be able to attract a larger share of the European patent litigation than the one currently handled by the 3rd chamber because it will be possible to plead in the three languages of the European patent. Two French judges will be part of the three-judge panel, and the proximity of the central division will have a great attractive force in favor of the local division.
Today, Patent my French! features a special post. Indeed, I had the honor and privilege to interview Marie-Christine Courboulay.
Ms. Courboulay recently retired after serving for almost 13 years as a judge in the 3rd chamber of the Paris Tribunal de grande instance (TGI), namely the chamber in charge of IP litigation. You can see her name on the front page of a number of prominent patent judgments issued over the years.
Ms. Courboulay was probably the single most senior and experienced patent judge in France in the recent past – given that, and this was one of the subjects we discussed, the turnover of IP judges in this country is usually very high.
Thus, my understanding is that she took a major part in framing recent case law on some of our favorite hot topics here on the blog, such as exclusion from patentability, or the application of the statute of limitations to patent nullity suits.
Therefore, I am sure that her views on the French legal system and on the current state of patent law will be of interest to all readers.
So I am very grateful that Ms. Courboulay accepted to (electronically) sit and have this chat.
In the first part of the interview, Ms. Courboulay tells us a little bit about her career; then she provides some insider’s perspective on how the 3rd chamber of the TGI operates; she also offers some advice to litigants and their attorneys, gives her opinion on the quality of patents. The last bit of today’s installment focuses on the more specific issue of prosecution file history – is there or isn’t there a notion of estoppel in this respect?
One final note: I translated the questions and answers into English, therefore any residual error despite the usual extensive proofreading would be entirely on me.
Can you briefly recount your career? What positions did you hold as a magistrate? How long were you in charge of IP cases at the 3rd chamber of the Paris Tribunal de grande instance (TGI)?
I joined the magistracy in January 1982, after a master’s degree in business law at the University of Paris I. I was a trainee judge for two years, and I did my internship in a court in Bobigny.
Then, I was appointed judge (juge d’instance) from March 1985 to September 1996, first in a small court in Coulommiers, then in the Tribunal d’instance (TI) of the 19th arrondissement in Paris, and finally in the TI of the 13th arrondissement.
During this period of time, I worked a lot on the then new laws relating to over-indebtedness and I got to train the members of the over-indebtedness commissions in a program set up by the Banque de France.
I joined the Paris TGI in September 1996 and I worked for three years in the 18th chamber (specialized in commercial leases) and another three years from September 1999 to September 2002 in the 9th chamber (specialized in banking law). At that time, I worked on the start of electronic contracting and on the proof of consent, when the first agreements were executed online.
I was also in charge, like all judges of the 9th chamber, of the execution of international letters rogatory assigned to the Paris TGI, and I took a lot of interest in this work, which required a knowledge of the law applicable in the countries making the requests.
In September 2002, I joined the 1st chamber of the Nanterre TGI as a vice-president, and I discovered literary and artistic property on this occasion.
I came back to the Paris TGI in September 2005, in the 3rd chamber, and I did not leave it for the rest of my career, as I did not want to be deprived of such beautiful litigation, open to the world.
How many different cases does a judge of the 3rd chamber of the Paris TGI handle per year, on average?
At least two judgments on the merits per week, or eighty per year.
Approximately twenty-five case management orders per year.
Approximately thirty urgency judgments (“référés”) each year, plus extreme urgency judgments (“référés d’heure à heure”).
Among these cases, what is the approximate distribution between copyright, trademark, design and patent cases?
I cannot precisely answer this question because I do not have the statistics.
I would say that half of the cases are trademark cases, 10% are design cases, 25% to 30% are copyright cases (including copyright on clothing) and 10 to 15% are patent cases.
How much time does a judge have to devote to a patent case, on average?
It depends on the complexity of the patent and the level of expertise of the judge. Between three and ten full days.
Do you think that the training of judges is sufficient for handling patent cases, or that it should be improved?
The training of judges to deal with patents, but also IP as a whole (because an artistic copyright case is at least as complicated as a patent case), should be improved in the sense that this function should be considered as a full-fledged specialty. Each new judge should be offered a compulsory theoretical training from one week to fifteen days before taking office.
For how long are judges appointed to the 3rd chamber of the Paris TGI, on average, and do you consider that this is sufficient, or too short?
Judges are appointed to the 3rd chamber for an average of three years, and this duration tends to increase.
This is much too short because judges leave when they begin to be really well trained, which creates a huge loss of value for the court. Furthermore, it requires a constant (and exhausting) effort for training newcomers, despite their generally high merits and hunger for knowledge.
At last, it seems that there may be a possibility for judges to be able to get promoted without leaving, thanks to the creation of the Economic Pole by President Hayat. This could make it possible to keep judges interested in this subject for a longer period of time, as they would be able to make part of their career there.
Is it an asset for a judge of the 3rd chamber to have held a previous magistrate position in a field other than IP, and if so why?
Of course, to understand IP law, you need to have an overview of society as a whole: its evolution, its major trends, and especially its innovations. I would say that one must take an interest in all economic sectors of society, but also have a pronounced taste for culture.
For example, if you have worked on the renewal of commercial leases, you know that the establishment of competing brands in a same sector is a factor of increase in commerciality, which in turn makes an increase in rent possible. This is a factor which can be used to reason, when it is claimed that competitors’ ads on a result page of a Google search creates a prejudice. What is true in “real” life is also valid in the so-called virtual economy (which it obviously is not).
So, yes, previous experiences of judges are useful and rewarding, as well as their personal history.
Similarly, I am very much in favor of the integration of judges who had a career in the private sector, or as independent professionals. It is again a great opportunity to have a colleague in the court who worked in another context and who can shed light on what litigants expect in this area, or on the difficulties they may have. And when this previous career was in the field of IP as was the case several times (I had colleagues who had been IP lawyers or had worked at the INPI), the benefit to be gained from their experience is even greater.
How do the different judges of the 3rd chamber work together? In particular, is there an effort of harmonization among judges to avoid discrepancies between judgments?
First, the judges of the 3rd chamber work in three-judge panels and deliberate on the cases assigned to their panel. But of course, they also discuss the various cases between them, and they try to find harmonized solutions to avoid any disorder with litigants.
All magistrates are very much aware of the fact that their decisions must comply as much as possible with the requirement of predictability. For example, they circulate the decisions that they issue when a new point is raised and a solution is provided by one of the panels (for example regarding the application of the statute of limitations to patent nullity suits, or regarding the nullity of infringement seizures).
Also, there are so-called chamber meetings with an agenda on points of law where there seem to be differences of interpretation or appreciation. There are also information meetings organized by the Cour de cassation on specific topics (trademarks, patents, etc.) to raise the awareness of judges on solutions to various current legal issues.
Patent cases are sometimes highly technically complex (e.g. in the biotech or telecom field). How do judges deal with this technical complexity? Are the explanations of the parties’ counsels in their submissions and during the hearing generally sufficient to fully understand the underlying technical issues, or would an additional effort of popularization be useful?
The hearing time, if it is well calibrated (I would say at least half a day per patent), is enough to explain the issues, and it is obviously more than necessary for the court.
However, in the case of a particularly complex lawsuit, it is possible to appoint a consultant whose main task will be to objectively explain the patent, the technology, but also the prior art.
The statute thus gives the court the necessary tools to understand the technology involved in e.g. telecom patents – which to me are the most complex ones.
In patent cases, it is not uncommon for parties’ submissions to reach several hundred pages. Is this too much? Do judges have the time needed to read and digest such large file wrappers, given their heavy workload?
Yes, this is too much, and I must unfortunately say that, often, many pages are irrelevant, since they contain repetitions in various forms.
We must remember this sentence: “sorry, I did not have time to keep it short”.
Judges from other European countries also complain about the same phenomenon and also conclude that the strength of the case does not depend on the weight of the written submissions; and I know that in the United Kingdom, on appeal, submissions are limited to 25 pages, because the court already has the first instance judgment.
Judges do not forget that this can be, in some cases, a tactic to drown them, so that they are not able to properly handle the litigation anymore, if each case reaches 200 pages without any reason.
I believe that, one day, it will be up to the case management judge to limit the number of pages allowed per case, in view of the first exchanges (complaint and defense).
What do you think is the role and use of the attorneys’ pleadings in the trial?
As far as patents are concerned, oral argument is essential to clearly explain the invention and to allow the judge rapporteur who has read the submissions and the patent to verify that he/she has properly understood what the case is about.
It is also essential for the presentation of the prior art, and the voice of each party sheds a different light on the topic.
Finally, it is essential for presenting the comparison between the invention and the alleged infringement by the patent proprietor and by the defendant.
On the other hand, for the determination of damages, clear written submissions with convincing supporting documents are more than enough.
Is there any advice you could give to parties and their counsels to improve their chances of convincing the court in patent litigation?
A clear presentation of the invention, optionally with the help of diagrams or slides.
A debate limited to the real issues at stake.
Avoid raising quibbles instead of arguments and avoid raising inadmissibility pleas and other motions on the communication of exhibits that pollute the real debate and sometimes weaken the position of those who raise such objections without any serious reason.
Do you consider that patents granted by the INPI or the EPO are generally of a good quality? Or is this quality insufficient in your opinion?
In the midst of a debate on the granting procedure of French patents, I can only say that the French patents that were submitted to me often suffered from a lack of quality, and I have some oddities in mind which were worthy of a cabinet of wonders.
I am in favor of a better control of French patents by the INPI, in particular by not focusing on the sole criterion of novelty, which is totally insufficient and puts us in a miserable position compared to other European offices. However, it seems to me that, in order for this reform to make sense and not give rise to other criticisms on the process of granting French patents, it will be necessary to hire many examiners trained in the analysis of inventive step, sufficiency of disclosure and extension of subject-matter beyond the application as filed, and also trained in discussing with the applicant and then with possible opponents, in full compliance with the adversarial principle.
With regard to European patents, their quality often depends on the technical field. Despite a more in-depth analysis of the various criteria mentioned above, there is a significant invalidity rate in French courts, but also in German, Dutch or English courts, of the order of 60 to 70%, which is still a lot.
I would say that the other criticism that can be made against European patents is the extreme length of the proceedings before the examining division and then the opposition division.
What is the role of the modifications made by the patent proprietor during examination proceedings, as well as of their statements in front of the patent office concerned, at the litigation stage? In your opinion, should the proprietor be bound by the strategy and the procedural choices adopted during examination?
Both French case law and Dutch case law take into account the amendments made during examination proceedings and the statements made to the patent office, when they are submitted to the court, because they are then elements of the dispute.
And the patent proprietor is bound by the modifications, which are in any case enshrined in the patent as granted, which is the very basis of the case, but also by its statements, insofar as they make it possible to understand what the proprietor itself considers as the perimeter of its invention, as the proprietor specifies the limits thereof (what is part of it and what is not part of it).
That said, the proprietor may take another position, but the new interpretation will be read in the light of the modifications made and ratified by the patent office in the granted patent, and of the reasons for which the modifications were agreed to be made.
It seems that the German Supreme Court in Düsseldorf has now slightly opened the door to this possibility, which it had long refused, even though some regional courts, including the one in Munich, already took statements before the patent office into account.
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.
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 Medevajudgment (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.
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 […].
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.
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?
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.
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.