Clarifying priority

Pharma cases are among the most complex of patent cases. Take the zoledronic acid infringement and nullity litigation for instance. No sooner than two weeks ago, I reported on a creative preliminary objection defense raised by the manufacturer Sanochemia Pharmazutika AG – which was rejected by the Paris Tribunal de grande instance (TGI), with a confirmation on appeal.

At the end of the post, I said that the case was worth watching for further developments, and that the decision reported on was just an amuse-bouche. Well, after the amuse-bouche, we now have a starter to feed on. For the main course, i.e. the judgment on the merits, we will have to wait a little bit longer.

Patent pending on an tray configured for accommodating amuse-bouche.

As always, a few words of context should be helpful.

The Novartis group owns European patent No. EP 1296689 on a further therapeutic indication of the drug zoledronic acid, for the treatment of osteoporosis. According to Novartis, their drug Aclasta® is covered by this patent. The Teva group on the one hand and Biogaran on the other hand hold marketing authorizations for a generic version of Aclasta®.

In January 2014, Novartis initiated proceedings against Teva alleging infringement of the EP’689 patent. In March 2014, Biogaran filed a nullity action in relation with this patent. Finally, in December 2014 and January 2015, Novartis initiated proceedings against Biogaran and two other companies alleging again infringement of the EP’689 patent. All of these proceedings have now been linked together in front of the TGI.

The validity of a divisional patent, EP 1591122, was later also challenged by Biogaran. Turns out this divisional patent is currently undergoing opposition proceedings at the EPO. The patent was maintained in amended form in first instance, and the outcome of the appeal should be known any time soon (more on this aspect below).

The French trial date was initially set on April 26, 2017, but the parties agreed to a postponement to Q1 2018, i.e. after the decision of the Board of appeal.

Meanwhile, motions were filed both by Teva and Biogaran in front of the judge in charge of case management. These motions gave rise to two parallel orders dated June 8, 2017, which I am reporting on today.

The issue raised by these motions is the following. The EP’689 patent, and therefore also the divisional EP’122 patent, are based on a PCT application filed on June 18, 2001, claiming priority from two U.S. applications of June 20, 2000 and February 9, 2001 respectively. It seems that the validity of the priority claims may be critical for the validity of the patent. I assume that this is because relevant prior art was published between the priority date and the filing date of the PCT.

Both priority applications were filed in the name of the inventors, as was mandatory at the time under U.S. law. But the PCT application was filed in the name of Novartis AG for all designated states except Austria, where the applicant is a local Novartis company.

In such a (common) situation, it is a frequent line of attack by nullity claimants to question the entitlement of the applicant(s) of the subsequent application to claim priority.

This line of attack is based on the wording of article 4.A.1 of the Paris Convention:

Any person who has duly filed an application for a patent, or for the registration of a utility model, or of an industrial design, or of a trademark, in one of the countries of the Union, or his successor in title, shall enjoy, for the purpose of filing in the other countries, a right of priority during the periods hereinafter fixed.

Article 87(1) EPC contains a similar provision. It is established case law that, when the applicant of the subsequent filing is not the same as the applicant of the first filing, a valid transfer of the right to claim priority to the first filing must have taken place before the date of the subsequent filing. Otherwise, the priority claim is invalid.

In the present case, Biogaran and Teva challenged that the inventors and original applicants have properly transferred the right to claim priority to the original filings to Novartis AG (the applicant for France in the PCT filing). They therefore deemed that the priority is invalid.

Novartis of course maintained that the priority was validly claimed and offered some justifications without however providing all of the underlying agreements.

As a consequence, Biogaran and Teva requested that Novartis should be ordered to supply copies of these underlying agreements. This encompasses the employment agreements of the three inventors, as well as relevant agreements between different entities of the Novartis group. The inventors themselves should be ordered to supply copies of their employment agreements to Novartis, to the extent that this would be necessary, asked Biogaran and Teva.

As could be expected, Novartis requested that the judge in charge of case management should reject these requests.

Based on the two orders issued on June 8, 2017, the judge was apparently quite sensitive to the arguments developed by the nullity claimants. At the very least, the judge noted that serious doubts have been raised regarding the entitlement of Novartis AG to claim priority to the two U.S. applications.

Let’s have a closer look at the arguments. Quoting from the Biogaran order:

For Biogaran, there is no evidence that the inventors held the rights that they allegedly assigned to Novartis on the day of the alleged assignment of May 2, 2001. 

As far as I understand from this passage, there was an alleged assignment from the inventors to Novartis AG before the filing date, but the question was whether the inventors still held the rights on the invention (and thus the right to claim priority) on that date.

The judge further explained:

Biogaran states that in many countries, and notably in the U.S., Switzerland and France, the right of the employer to claim inventions made by employees in the course of their employment agreement derives from the law or from the employment agreement. 

Regarding the Swiss inventor Trechsel who is said to reside in Switzerland, in the country of the applicant Novartis AG, Biogaran mentions that his employer is the Swiss company Novartis Pharma AG. 

They state that the employer of the inventors Richardson and Horowitz who reside in the USA was Novartis Pharmaceuticals Corporation and that therefore their employment was regulated under U.S. law and that it is necessary to determine if Horowitz and Richardson, according to the applicable U.S. law, assigned their invention (including the right to claim priority) to their employer. 

We thus have the complex picture of a multinational team of inventors having two different employers, both of which are different from the company that filed the PCT application.

Novartis, on the other hand, denied that any challenge against the entitlement to priority can be validly raised by third parties to the relevant agreements, such as Biogaran and Teva.

On the merits, Novartis’ response relied on an affidavit of a manager, who explained that there was a general policy in the Novartis group to the effect that Novartis AG was the applicant of all PCT applications, so that the rights on this invention were necessarily assigned to this company.

Here is what the judge had to say in this respect:

However, even if this affidavit makes it possible to understand that the wish of the Novartis group was that Novartis AG should own all the patents of the group, it does not provide any indication on the fate of an employee’s invention with respect to his direct employer. 

Novartis does not clearly explain the status of the three inventors and even more so does not provide the court with any information in order to make sure that at the time of filing the U.S. applications or between these U.S. applications and the assignment to Novartis AG of May 2, 2001, they indeed owned the inventions, and these had not been assigned to their respective employers due to their agreements or under U.S. or Swiss law. 

It is important for Novartis AG to take a position on this issue by supporting its argumentation on any useful communications. Therefore, the case management judge invites their counsel under article 765 of the Code de procédure civile to do this as further stated in the order below. Nevertheless, at present the judge does not have to specifically issue an order regarding the three employment agreements, the existence of which is not proven, and which at any rate are supposed to have been executed by third parties to the present litigation; nor regarding the other evidence requested by Biogaran. 

The court will rule on the merits in view of the arguments and evidence provided by the parties, on the admissibility […] of a challenge of the priorities and, if necessary, on Novartis AG’s right to claim priority in its patent application to the U.S. applications […]. 

As a result, the judge refused to issue any specific orders for the production of documents. But on the other hand she did invite Novartis to provide further information and evidence.

This looks like a mixed outcome. On the one hand, the nullity claimants (infringement defendants) did not get the specific orders that they requested. This is not very surprising as French judges are traditionally reluctant to issue such orders unless relatively strict conditions are met, especially when third parties are involved. Discovery is definitely not a part of French legal culture.

On the other hand, the patentee was explicitly invited to provide further information and evidence, which may mean that their case is currently viewed as incomplete and thus weak.

Clarifying the priority has thus been flagged a priority by the judge.

Another important step for this lawsuit was certainly the oral proceedings concerning the divisional patent which took place on September 13 and 14, 2017 in front of Board of appeal 3.3.01. That’s case T 0239/16.

If any reader has information on the outcome of these oral proceedings, you are more than welcome to post a comment. At the time I am drafting this post, there is no news on the EPO website.

The outcome of these oral proceedings will be most interesting for two reasons. First, the Board’s decision will necessarily impact the French litigation. Especially if the divisional patent is revoked.

Second, priority has also been (quite understandably) discussed in depth in front of the Board. Quite frankly I did not have the courage to really delve into the thick file wrapper. The link is here. But based on the communication issued by the Board on June 9, 2017, it seems that priority is the big topic.

According to the Board’s rapporteur, first, the validity of the priority claim has to be assessed in terms of claimed subject-matter (under G 2/98). Second, if the priority holds after this assessment, entitlement to priority must be discussed. A complex legal discussion can be expected, especially on the key and preliminary issue of whether the EPO has the power at all to decide on the legal entitlement to the right of priority. In fact, the rapporteur seems to have some sympathy with Novartis’ arguments in this connection, according to the above communication.

The issues raised in the Board’s communication are too complex to be addressed here. In fact, one of Novartis’ requests is a referral to the Enlarged Board of Appeal.

Again, I look forward to hearing about what actually happened in Munich last week.

And at any rate, this is definitely a case to keep on the watch list.


CASE REFERENCES: Tribunal de grande instance de Paris, 3ème chambre 4ème section, ordonnance du juge de la mise en état, June 8, 2017, Novartis AG et al. v. Teva BV et al., RG No. 14/01134. Tribunal de grande instance de Paris, 3ème chambre 4ème section, ordonnance du juge de la mise en état, June 8, 2017, Biogaran SAS v. Novartis AG et al., RG No. 16/10894.

A true vade mecum to SPC law

A few days ago, a very interesting decision on the blockbuster drug Truvada® landed on my laptop courtesy of Matthieu Dhenne. According to the decision, Gilead’s request for preliminary injunction to halt the distribution of Mylan’s generic version of Truvada® on the French territory was denied on September 5, 2017.

Soon thereafter, a most interesting report on the decision reached my inbox courtesy of Lionel Vial.

Owing to both of them, my main remaining task was to find a title and a patent illustration for the post. So, if those are neither apt nor witty, that’s on me.

As you will see, this decision is a good opportunity to revisit the CJEU case law on combo SPCs, since there is a UK-based pending reference to the CJEU in connection with the Truvada® litigation.

I will now leave the floor to Lionel.

Today we report about France’s contribution to the ongoing pan-European litigation over generics of Truvada®.

Truvada® (Gilead) is an anti-HIV drug comprised of the combination of Tenofovir Disoproxyl Fumarate (TDF) and Emtricitabine (FTC). It has received a relatively important media exposure since it became, in 2012, the first drug to be approved by the Federal Drug Agency (FDA) for Pre-exposure Prophylaxy (PreP) of HIV infection. As such, the TDF/FTC combination can be used to reduce the risk of sexually acquired HIV-1 infection in adults who do not have HIV but are at high risk of becoming infected. By way of example, the so-called IPERGAY clinical study has evidenced that this combination allowed for a reduction of 86% of the risk of being infected by HIV.

Truvada® was covered until 25 July 2017 by European patent EP0915894. The effects of the patent have been extended by supplementary protection certificates (SPCs) which will expire between 21 and 24 February 2020 depending on the countries.

The SPCs are based on European Union marketing authorization EU/1/04/305/001 and on claim 27 of the basic patent, which reads as follows:

A pharmaceutical composition comprising a compound according to any one of claims 1-25 [N.B. tenofovir disoproxil is claimed in claim 25] together with a pharmaceutical carrier and optionally other therapeutic ingredients.

As will be readily spotted by our trained readers, the main question of law arising from this wording is whether the use of the expression “other therapeutic ingredients” to refer to emtricitabine (FTC) is indeed sufficient to protect the TDF/FTC combination pursuant to Article 3(a) of Regulation (EC) No. 469/2009 of the European Parliament and of the Council (hereafter the « SPC regulation »).

Intense litigation over the validity of the SPCs has ensued, which has notably led Justice Arnold of the High Court of England and Wales to request a preliminary ruling of the CJEU on the question of knowing “What are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?” (yes, again). The case is pending as C-121/17.

The current status of selected SPCs is summarized in the following table:

Country Decision of the patent Office Validity status
Belgium Granted Ruling on the merits pending
Germany Granted Ruling on the merits pending
Great-Britain Granted Ruling of the High Court stayed pending C-121/17
Ireland Granted Ruling on the merits pending
Italy Granted Ruling on the merits pending
The Netherlands Rejected Ruling of the Court of Appeal stayed pending C-121/17
Spain Rejected Rejection overturned by the Administrative Court of Madrid
Sweden Rejected Rejection upheld by the Court of Appeal

It is now France’s turn to take position on the validity of the SPC.

French SPC No. 05C0032 was granted on December 21, 2006 and will expire on February 24, 2020. Mylan obtained a generic marketing authorization for the TDF/FTC combination on December 16, 2016. On July 13, 2017, Gilead requested a preliminary injunction under urgency proceedings to prohibit the sale of Mylan’s generic. The case was heard on August 11, 2017. Meanwhile, Mylan offered its generic for sale on July 26, 2017, i.e. one day after the term of the basic patent. The ruling was rendered on September 5, 2017.

As could be expected, the judge performed a quite thorough appraisal of the case law of the CJEU regarding Article 3(a) of the SPC regulation as applied to this case, notably:

  • C-322/10 (Medeva): active ingredients have to be specified in the wording of the claims;
  • C-443/12 (Actavis v. Sanofi): the basic objective of the SPC regulation is to compensate for the delay to the marketing of what constitutes the core inventive advance [i.e. the technical contribution] that is the subject of the basic patent;
  • C-493/12 (Eli Lilly): where the active ingredient is covered by a functional formula in the claims, Article 3(a) does not preclude the grant of a supplementary protection certificate for that active ingredient, on condition that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question.

The French judge also noted that in cases C-443/12 and C-577/13 (Actavis v. Boehringer), the CJEU had considered that the core inventive advance forming the subject of the respective basic patents was limited to the compound the invention of which was sought to be protected, even though combinations with other compounds (which invention did not form the subject of the patent) were mentioned.

A patented robot to help you find your way through SPC case law.

In the case at hand, the French judge thus considered that the SPC was “in all likelihood invalid”, because none of the conditions defined the case law of the CJEU were apparently fulfilled.

Here is the relevant part of the decision (based on the English translation distributed by cabinet Schertenleib):

It appears that claim number 27 is drafted so broadly that it does not describe any specific active ingredient that should be combined with tenofovir disproxil [NB: this a reference to C-322/10]; it thus does not protect a combination that is likely to result in entitlement to the grant of a patent.

Moreover, the combination claimed as active ingredient “tenofovir disoproxyl + emtricibatine” is not implicitly but necessarily and specifically taught in the description [NB: this is a reference to C-493/12], there is no indication whatsoever that would enable the person skilled in the art to choose emtricibatine and it quite evidently does not constitute the core of the invention [NB: this is a reference to C-443/12].

If tenofovir disoproxil indeed constitutes the subject matter of the basic patent, the combination of tenofovir disoproxil with any other therapeutic ingredient cannot constitute a separate invention.

On the one hand, this combination as claimed in claim No. 27 is not a functional claim because it does not describe the structure that should be produced and the function that the second product should fulfill in order to build this structure. [NB: this is a reference to C-493/12]. On the other hand, assuming that this claim was functional, the steps defined by the Dutch Patent office in order to determine whether emtricibatine was sufficiently taught by the patent as being the necessary therapeutic ingredient of claim number 27 are relevant:

1 – Upon reading the phrase formulation in the context of the patent and in the light of their general knowledge, would the person skilled in the art think of the active therapeutic ingredient (biological)?

2 – Would the person skilled in the art think immediately of antiviral agents?

3 – Would the person skilled in the art immediately deduce that these antiviral agents designate anti-HIV agents?

4 – At the priority date, would the person skilled in the art have immediately thought of emtricitabine as anti-HIV agent?

Based on the description and as was perfectly highlighted by the Dutch Office of Industrial Property, no specific combination has been claimed, no relevant element has been reported so as to induce the person skilled in the art to select emtricitabine especially as there is no indication leading one to select a second antiviral agent as the “other therapeutic ingredient” let alone an antiviral anti–HIV agent.

As a consequence, Gilead’s request for preliminary injunction was refused. It now remains to be seen if this preliminary conclusion will be upheld when the case will be tried on the merits.

Finally, we would like to go back to Justice Arnold’s request for further guidance of the CJEU on the question “what are the criteria for deciding whether ‘the product is protected by a basic patent in force’ in Article 3(a) of the SPC Regulation?”. Apparently, Justice Arnold’s goal was to get a ruling establishing that, pursuant to Article 3(a), SPCs for combinations of active ingredients should be reserved for cases where the combination, as distinct from one of the active ingredients, embodies the inventive advance of the basic patent. But perhaps the Truvada® case was not the best one for such a reference to the CJEU.

Indeed, as emtricitabine is only purported to be specified by the expression “other therapeutic ingredients”, there is a chance the CJEU will not feel it necessary to go beyond its previous ruling according to which active ingredients have to be specified in the wording of the claims.

Well, to Lionel’s latter point, UK courts have always been quite prolific in asking SPC-related questions to the CJEU. As we know, this will probably soon come to an end. So maybe this was something of a last chance for them to try and get a final answer to a longtime puzzle?


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance de référé, September 5, 2017, Gilead Sciences Inc. et al. v. SAS Mylan, RG No. 17/57112.

Swiss-type exception

Today, I would like to provide a brief report on some ongoing pharma litigation in France, in connection with zoledronic acid.

Novartis AG is the proprietor of the French part of European patent No. EP1296689. This Swiss-type company was granted Swiss-type claims by the EPO.

More specifically, independent claim 1 is the following:

Use of 1-hydroxy-2-(imidazol-1-yl)ethane-1, 1-diphosphonic acid, or a pharmaceutically acceptable salt thereof, or any hydrate thereof in the preparation of a medicament for the treatment of osteoporosis in which the 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid, or a pharmaceutically acceptable salt thereof, or any hydrate thereof is administered intravenously and intermittently and in which the period between administrations is at least about 6 months.

There is also an independent claim 5:

Use of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid, or a pharmaceutically acceptable salt thereof, or any hydrate thereof for the preparation of a medicament for the treatment of osteoporosis wherein said medicament is adapted for intravenous administration in a unit dosage form which comprises from about 1 up to about 10 mg of 1-hydroxy-2-(imidazol-1-yl)ethane-1,1-diphosphonic acid, or a pharmaceutically acceptable salt thereof, or any hydrate thereof, wherein the period between administrations of bisphosphonate is at least about 6 months.

I wonder how these claims are going to fare at the Paris Tribunal de grande instance (TGI) validity-wise, given the historical dislike of such claims by this court. But this is not today’s topic.

When looking for a patent on Swiss-type cheese, I stumbled on this remarkable invention on a cheese-flavored cigarette filter. Hard cheese as exemplified by Parmesan, Romano or Swiss cheese is preferred. So sad that camembert was not cited.

In December 2014, Novartis started patent infringement proceedings against Biogaran, Agila Specialties Polska SP and Sanochemia Pharmazutika AG. The exploitation of the generic Aclasta in France was considered by Novartis as an infringement of the patent.

The lawsuit was linked with other pending lawsuits, namely infringement proceedings against several Teva companies, as well as nullity proceedings initiated by Biogaran.

The decision discussed today is not a judgment on the merits, but rather a judgment on two preliminary objections filed by the defendant Sanochemia.

One of the preliminary objections was an alleged nullity of Novartis’ writ of summons. The other one was an alleged lack of jurisdiction of the Paris TGI. Such preliminary objections, or “exceptions” as they are called in French procedural law, are dealt with by the judge in charge of case management, before the trial in front of the full court. In this case, both were a bit of a long shot, and they were rejected by the judge on January 28, 2016. Sanochemia appealed, but the first instance decision was confirmed by the Cour d’appel de Paris on May 12, 2017.

Readers may be curious to know how the Paris TGI could possibly be considered as having no jurisdiction – according to the defendant. After all, we are talking about the alleged infringement of the French part part of a European patent, and this is the daily bread of the 3rd chamber of the Paris TGI.

Well, the argument presented by Sanochemia was very creative – although a long shot, as I mentioned.

Sanochemia is the manufacturer of the generic drug. The drug is manufactured in Austria. Then, it is imported into France and marketed in this country, and Sanochemia may or may not be directly involved in such activities – hard to tell based on the court’s ruling. At any rate, Sanochemia stated that it did not have any marketing authorization in France.

Now, remember that the patent at stake is a Swiss-type patent, and that the patent claims are accordingly directed to the use of an active substance for the preparation of a medicament for a particular treatment modality. My understanding is that Sanochemia considered that these claims exclusively protect a manufacturing process.

Since the manufacturing process was not carried out in France, Sanochemia argued that the alleged infringement in fact took place in Austria, and not in France. Sanochemia’s case was that they did not commit any act on the French territory. Therefore, they said, the Austrian courts had exclusive jurisdiction under the Brussels I jurisdiction.

As could be expected, the Paris Cour d’appel held that this theory did not hold water:

As noted by the judge in charge of case management, regulation No. EC 44/2011 of December 22, 2000 on jurisdiction provides that a person residing on the territory of a member state can be sued in another member state, and, in matters relating to delict or quasi-delict, in the courts for the place where the harmful event occurred.

Even if the act of manufacturing the product took place in Austria, the court for the place where the harmful event occurred is however not in Austria, since the drug alleged to be infringing is said to have been imported into France by Sanochemia. Therefore, the arguments presented by Sanochemia pertain to a defense on the merits and need to be examined on the merits. The judge in charge of case management thus rightfully rejected the exception of lack of jurisdiction filed by Sanochemia. 

In summary, Sanochemia argued that they did not commit any act of infringement in France. However, the mere fact that infringement in France is alleged by Novartis implies that this question must be decided by French courts.

Whether Sanochemia is ultimately found to be guilty of infringement (assuming that the patent passes the validity hurdle) will be very interesting to watch, given the particular claims at stake, namely Swiss-type, dosage regimen claims.

According to article 64(2) EPC, “if the subject-matter of the European patent is a process, the protection conferred by the patent shall extend to the products directly obtained by such process“. Thus, typically, a company that manufactures a product abroad according to a patented process and imports it into France can be declared guilty of infringement of the patent at stake.

But in the present case, the claims are not classical manufacturing process claims. The main part of the invention, or to be more precise the contribution of the invention to the art, lies in the dosage regimen (namely “administered intravenously and intermittently and in which the period between administrations is at least about 6 months” if we focus on claim 1), and this has in principle nothing to do with the manufacturing process.

In fact, one of Sanochemia’s arguments regarding the alleged nullity of Novartis’ writ of summons was that it was not clear from the writ whether the alleged infringement related to the manufacture of the drug or the manufacture of the leaflet, which contained dosage indications. The court found that the writ of summons was sufficiently clear – and the decision does not contain further details. But I would add that even the mere importation of a drug into France without any label or leaflet could possibly be an act of contributory infringement of a dosage regimen claim.

So, definitely a case to keep watching – today’s discussion being just an amuse-bouche.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, May 12, 2017, Sanochemia Pharmazutika AG v. Novartis AG et al., RG No. 16/05608.