Unraveling contributory infringement

As a change from GMOs and mathematical methods, today’s patent is about a toilet paper dispenser. Rest assured that I heroically resisted the urge to come up with an introductory pun closely related to the invention at stake – lest this blog be rated by readers as not classy enough.

That said, a relatively simple technical field does not necessarily entail a straightforward ruling. In fact, today’s decision addresses the complex issue of contributory infringement heads on.

SCA Tissue France was originally a subsidiary of the US group Georgia Pacific, a world leader in cellulose-based products. Think Lotus toilet paper. This business has now been acquired by the Swedish group SCA. Tissue France owns European patent No. EP 1799083, on a toilet paper dispenser, and markets the so-called SmartOne dispenser, together with matching toilet paper.

In March 2011, Tissue France started infringement proceedings based on the EP’083 patent against Sipinco and Global Hygiène. An opposition was filed against the patent in parallel. The patent was upheld as granted both by the opposition division and by the board of appeal.

In parallel, the Paris Tribunal de grande instance revoked the French part of EP’083 for insufficiency of disclosure, in March 2013 and therefore rejected Tissue France’s infringement claim.

However, on appeal, the first instance judgment was set aside and the patent was acknowledged as valid.

Tissue France had raised two infringement claims:

  • The defendants had committed direct infringement by putting on the market a toilet paper dispenser as well as toilet paper within the scope of EP’083.
  • The defendants had also committed contributory infringement by marketing toilet paper intended to be used with the patented SmartOne dispensers.

The appeal judges sided with the patentee on the first count but rejected the claim based on the second count. See the ruling dated November 25, 2014.

The patent proprietor did not give up on the contributory infringement count and filed an appeal on points of law. We can imagine that whether contributory infringement is established or not may have a significant impact on the computation of damages.

They did well, as the Cour de cassation has now vacated the appeal judgment and remitted the case back to the Cour d’appel, ordering them to examine again the question of contributory infringement.

In order to understand this whole discussion, it is certainly useful to have a look at the main claim of the patent:

Paper dispenser, comprising a housing in which a roll of a paper strip is housed, which comprises precuts transverse to the strip and defining rectangular paper sheets, of which the width is transverse and the length is longitudinal, the housing comprising a dispensing orifice through which the paper strip is unwound, the width of a sheet being between 125 mm and 180 mm and the ratio of the width of a sheet to its length being between 0.45 and 1, preferably between 0.5 and 0.65, characterized in that the said paper is a toilet paper and the said dispenser comprises a nozzle with the said dispensing orifice, the said nozzle and the said roll of paper being designed so that the paper sheets are unwound one at a time and emerge with less crumpling at the outlet of the nozzle, the paper being consumed in an optimum and pleasant manner.

In other terms, the claimed subject-matter is a paper dispenser which comprises a number of features (notably a housing and a nozzle) as well as a roll of paper strip in the housing.

When in the men / women’s room, always watch out for the bear.

Now, here is the relevant legal provision which defines contributory infringement under French law, namely article L.613-4 Code de la propriété intellectuelle, first paragraph:

Unless the patent proprietor consents, the supply or offer to supply, on the French territory, to another person than those entitled to work the patented invention, of means for implementing this invention on this territory, in relation with an essential element thereof, is also prohibited, when the third party knows or circumstances make it obvious that these means are suitable and intended for this implementation. 

The supreme court judges found that the Cour d’appel erred in three different respects.

First, the original appeal judgment held the following:

[…] Regarding the existence of acts of indirect, contributory infringement […], according to Tissue France […] itself, its invention lies in a new combination between, on the one hand, a specific toilet paper, and on the other hand, the use of a nozzle for dispensing sheets associated with a specific precut paper strop, in order to achieve a dispensing of sheets one at a time, with less crumpling at the outlet of the nozzle […].

[…] Therefore this is a combination invention which lies in the association of means (toilet paper and nozzle) which cooperate, notably due to their particular arrangement as described in the patent, for a common result (dispensing of the sheets one at a time, with little crumpling). Only the arrangement of the means which cooperate together for a common result is protected by the patent. 

[…] In such a case, the means in relation with an essential element of the patented invention under article L. 613-4 cannot only consist in one of the combined means, just because this means (here, the paper roll) is part of the constitution of the invention and contributes to the result that it provides. 

The Cour de cassation disagreed and held that this was a breach of article L. 613-4, because:

[…] contributory infringement of an invention consisting in a combination of means can result from the supply of a means relating to an essential element thereof […] even if it is a constitutive element thereof. 

By the way, don’t look for more detailed explanations in the ruling. There are none. It is the unfortunate tradition of cassation judgments that they have to be drafted as concisely and cryptically as possible. Basically, the cassation judges just cite relevant parts of the appeal judgment and state: “this is wrong“. Period. Sometimes, the statement of cassation appeal which is annexed to the decision provides useful additional information. But not so much in this case.

That said, I think what can be taken from this part of the ruling is that article L. 613-4 should apply in a similar manner to combination inventions and non-combinations inventions. No distinction between these two types of inventions is made in the statute.

As far as I understand, combination inventions are those where the contribution of the invention to the art lies in special features present in two different means which cooperate together. Here, the toilet paper is specially adapted to the dispenser, and the dispenser is specially adapted to the toilet paper.

To my mind, this clarification by the Cour de cassation is rather well in line with previous case law on this matter.

For instance, in at least two distinct cases related to an invention associating a dispenser with plastic bags, it was held that the supply of plastic bags was an act of contributory infringement: see Publi Embal v. Coprima and Simahee v. MultyPack. In another case where the invention related to the association of special fixing means on a digger with a special bucket intended to be placed on the fixing means, the supply of buckets was also viewed as an act of contributory infringement: see Morin v. Magsi.

The important point for contributory infringement to be established always seems to be that the means which is supplied should play an important role in how the invention works.

In contrast, if the invention lies entirely elsewhere than in the supplied means, there should be no contributory infringement. See Calor v. Filtech for an example of a demineralizing cartridge for an iron.

The second passage of the appeal judgment that the Cour de cassation did not like was the following:

[…] Besides, there can be no contributory infringement when the means which are supplied are, as in the present case, consumables which are to be integrated to the patented device, which exists independently of the consumables.  

The Cour de cassation noted that

it does not matter whether the means may consist in consumables, if they have an essential character. 

Again, it seems that the Cour d’appel imposed another criterion which is simply not present in the statute. No distinction is made depending on the nature of the supplied means. The only important thing is whether the supplied means relate to an essential element of the invention or not.

In fact, what the appeal judges probably had in mind is the second paragraph of article L. 613-4:

The provisions of [the first paragraph] are not applicable when the means for implementing [the invention] are products which are commonly on the market, unless the third party incites the person to whom the supply is made to commit the acts prohibited by article L. 613-3 [i.e. acts of direct infringement]. 

This is a special provision for products which are “commonly on the market“. But those are not the same as “consumables“. It is easy to picture consumables which have very peculiar features and are thus not really commonly on the market. Conversely, products commonly on the market certainly encompass other products than consumables (screws and nails, for instance).

So, the test applied by the Cour d’appel as to the nature of the supplied means was not the right one.

Last, the Cour d’appel had held that:

[…] no document from Sipinco mentioned that its toilet paper rolls were compatible with the dispensers marketed by Tissue France […]. 

Here is the Cour de cassation comment on this, which is slightly more detailed this time:

[…] By making this determination, whereas Tissue France argued in its appeal submissions that, due to its specific dimensions, the paper at stake did not correspond to toilet papers commonly on the market, the Cour d’appel, that did not investigate whether this was correct, and in this case whether this should be taken into consideration to examine whether Sipinco and Global Hygiene knew, or circumstances made it obvious, that these rolls were adapted and intended for implementing the invention, the Cour d’appel did not provide a legal basis for its decision.

Now, the issue is that the Cour d’appel did not find evidence that there was any incitation to customers for them to use the toilet paper at stake with the patented dispensers, which is the test under paragraph 2 of article L. 613-4.

But, before making that determination, it should have been checked whether the toilet paper was a product commonly on the market or not.

If not, then paragraph 2 should not come into play. And in this respect, the patentee’s argument was that the dimensions of the toilet paper were so specific that it could not be considered as a product commonly on the market, so that only paragraph 1 should apply. While the Cour de cassation did not formally endorse the patentee’s argument and just requested that it should be further considered by the Cour d’appel on remand, it certainly looks like they thought that it had merit.

If this is correct, then it means that a relatively cheap and commonplace product such as toilet paper is not a product “commonly on the market” if it has some specific features which make it original relative to other, similar products. 

In summary, this Tissue France decision will probably be important for future cases involving so-called combination inventions, as well as cases where a defense related to “products commonly on the market” is raised.

And now the Cour d’appel will have to dispense another judgment in this litigation.


CASE REFERENCE: Cour de cassation, ch. com., June 8, 2017, Tissue France v. Sipinco & Global Hygiène, pourvoi No. 15-29.378.

Free infringement

Infringement proceedings are a thing of many possible metaphors, and one of them may be an assault course. Invalidity defenses, non-infringement arguments, burden of proof issues, procedural traps are some of the hurdles that a plaintiff has to go over along the way.

So, after climbing up so many walls, nets and ropes, it is really too bad when the plaintiff falls into a muddy pit just before the finish line. In the case at hand, the muddy pit was the assessment of damages.

Pick your track to a judicial win.

On March 20, 2014, the Paris Tribunal de grande instance (TGI) held that the two companies Carrera and Texas de France had committed acts of infringement of European patent EP 1067822 directed to a heating element for a heating or cooking apparatus, owned by Muller & Cie.

The court pronounced a permanent injunction against the defendants and ordered that they should provide accounting information regarding the infringing devices in order to make it possible to compute damages.

This judgment was confirmed by the Paris Cour d’appel on September 6, 2016. In the meantime, in view of the accounting information filed by the defendants, the TGI issued a second judgment dated January 14, 2016, in which Carrera and Texas de France were condemned to pay Muller damages of respectively 327,733 euros and 280,130 euros for Muller’s commercial prejudice, plus 100,000 euros for its moral prejudice.

The defendants appealed, which leads us to today’s judgment, issued on December 9, 2016.

In short, the appeal judges set aside the decision of January 14, 2016 and set the total amount of damages to… zero euro. How is this even possible, since acts of infringement were indeed committed?

The answer is that the legal basis for Muller’s computation of damages was held to be incorrect, and no alternative, legally correct computation seems to have been proposed by the plaintiff.

The method for the computation of damages is set in article L. 615-7 Code de la propriété intellectuelle:

In order to set damages, the court separately takes into account:

1° Negative economic consequences of the infringement, including lost profits and losses suffered by the harmed party;

2° Moral prejudice inflicted to said party;

3° And profits made by the infringer, including savings on intellectual, material and promotional investments made owing to the infringement.

However, the court may, alternatively and upon request of the harmed party, grant a lump sum in terms of damages. This lump sum is higher than the amount of royalties or rights which would have been due if the infringer had asked for the authorization to use the right that it infringed. This sum does not exclude the further indemnification of the moral prejudice of the harmed party.  

The current wording of the article derives from the implementation of the enforcement directive 2004/48/EC, with a later modification in 2014. And it is not really crystal clear.

Computation of damages based on the “negative economic consequences” of the infringement is a conventional and well-delineated exercise.

On the other hand, how “profits made by the infringer” are to be “taken into account” by the court is not self-evident. It is also not so clear whether the plaintiff has full discretion to rely on the alternative lump sum calculation, or whether, in some circumstances, it is mandatory to rely on one assessment method or the other.

If we focus first on the issue of how infringer’s profits are to be “taken into account“, one way to interpret this provision would be to consider that the infringer’s profits may be awarded to the claimant as an alternative to loss profits damages. Another way would be to consider that the infringer’s profits are merely a modulating factor in the assessment of loss profits.

In the present case, Muller put forward a radical theory – successfully so in first instance, i.e. that the entire infringer’s profits should be awarded to the patent proprietor. However, this method was fully discarded at the appeal stage.

The Cour d’appel noted that Muller did not personally exploit the patent. The patent was exploited through six licensed subsidiaries, which tried to intervene in the infringement proceedings. However, the respective license agreements were not registered with the French patent register, so that they were not enforceable against third parties. Accordingly, the claims brought by the six licensees were previously held inadmissible in the initial 2014 judgment – and the unregistered licensees did not appeal.

In this particular context, the Cour d’appel deemed that the sole proper methodology for assessing damages was the so-called indemnifying royalty provided in the last paragraph of article L.615-7:

[Muller] does not claim the payment of the indemnifying royalty which was however rightly mentioned by the appellant, but this mode of compensation should be applied in this case. This royalty indeed corresponds to the percentage of the turnover that Muller could have claimed from the two companies sued for infringement, if the authorization to exploit the patent that it owns had been requested, with an additional penalty to take into account the existence of the wrongful acts committed against it. 

But again, Muller did specifically not claim an indemnifying royalty. Muller argued that the words “upon request of the harmed party” in article L. 615-7 meant that this mode of calculation was not mandatory. The court concurred and stated that it “could not validly impose such a mode of compensation of its economical prejudice” on Muller. But this turned out to be a self-inflicted wound, as the sole mode of compensation put forward by Muller was not acceptable according to the court, for the two following reasons:

  • first, Muller did not personally suffer any lost profits;
  • second, the infringer’s profits may not be claimed by the plaintiff in the absence of lost profits.

As to the first reason, Muller argued that, although it had not directly suffered lost profits, there were lost profits for the overall Muller group. The court replied that Muller could not possibly claim lost profits suffered by other companies, namely the six licensees, which are distinct legal entities (in fact, it seems that it was not even properly demonstrated that they were part of the same group as Muller). The licensees’ claims were held inadmissible by the TGI, and they did not appeal. Thus, only Muller’s personal lost profits could possibly be compensated.

Yet, no lost royalties were claimed by Muller. On the one hand, the six licenses were apparently royalty-less, so that Muller did not personally lose money due to the licensees’ possible lost sales. On the other hand, Muller could have relied on a depreciation of the invention’s value due to the infringement, but did not do so. Here, the court cruelly noted: “again, it is not the court’s task to compensate an item of prejudice in the absence of a claim from the owner of the right in this respect“.

Then comes the second point on the infringer’s profits. Says the court:

In addition, it is true that the law of October 29, 2007, transposing the 2004/48 directive, provides that the judge should take into account the “profits made by the infringer”. But it did not introduce a possibility to confiscate them into the statute. Said taking into account is limited to the part which may remain, once the losses related to the exploitation have been assessed, in order to achieve a full compensation of the prejudice. 

In other words, according to this court, the infringer’s profits can only be taken into account in the context of the assessment of a commercial prejudice. The confiscation of the infringer’s profits is not an alternative option which would be available to the plaintiff instead of claiming the compensation of a commercial prejudice.

Consequently, Muller’s claim for damages was simply rejected. The court noted in passing that the permanent injunction, which remains in place, is a proper sanction in this case anyway.

The last nail in the coffin was the rejection of Muller’s claim based on the moral prejudice which was said to be insufficiently substantiated.

All in all, this is a tough decision for the patentee, although we can have a feeling that the court was irritated by its behavior. For instance, there is a remark that the patentee obtained evidence of the infringement as soon as July 2009 owing to a bailiff’s report but waited until May 2011 to file its complaint.

It remains to be seen whether the Cour de cassation will have to rule on the Cour d’appel’s interpretation of the legal provision on the apportionment of the infringer’s profits.

In the meantime, one take-away message can be that the best practice for a patent proprietor is certainly to claim an indemnifying royalty, if only as an auxiliary request. Indeed, this should always be a possible option. Better safe than sorry.


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, December 9, 2016, SARL Carrera & SAS Texas de France v. SA Muller et Cie, RG No. 16/02891.

The salt of the judgment

When you are in private practice, you sometimes get to work with clients who come up with very creative legal arguments. Or you get to work with clients whose competitors are unfortunately very creative. Rating the chances of success of such creative arguments can be difficult, especially when there is not yet any case law to refer to.

Let us take one example. A patent protects a molecule M1. A competitor markets a drug containing a molecule M2. When this drug is taken up in the body of the patient, molecule M2 is converted to M1. Is this a situation of contributory infringement?

It is not so common for thought-provoking ideas such as this one to be actually tested in court. I was thus quite happy to hear about Shionigi & AstraZeneca v. Biogaran, thanks to Lionel Vial (the decision does not appear on the INPI database). So, if you would like to know the answer to the above question, you may directly go to the end of this post to find out about the guidance offered by the presiding judge of the Paris Tribunal de grande de instance, Marie-Christine Courboulay.

But not so fast, as other aspects of the case are very worth being reviewed.

The patent at stake is EP 0521471 owned by the Japanese pharmaceutical company Shionigi, and licensed to the Swedish group AstraZeneca. The patent covers a drug for the treatment of hypercholesterolemia, called rosuvastatin.

The patent is already relatively old, as it was filed in 1992 and claims a priority of 1991. It went unopposed and expired in 2012. But a Supplementary Protection Certificate (SPC) was granted in 2005 by the French Institut national de la propriété industrielle (INPI), extending the duration of protection until June 29, 2017. And then on top of that, a pediatric extension was granted in 2015, further extending the duration of protection till December 29, 2017.

The SPC was granted for the product simply identified as “rosuvastatin”, based on a Dutch Marketing Authorization (MA) for the drug Crestor, which contains a calcium salt of rosuvastatin.

Biogaran developed a generic version of rosuvastatin. In 2014, Biogaran warned AstraZeneca and Shionigi that they had applied for an MA for the zinc salt of rosuvastatin, and stated that this product did not infringe the SPC. AstraZeneca and Shionigi did not agree with the latter statement.

Two years later, Biogaran obtained its MA and announced that it intended to launch the generic drug in July 2016 – i.e. before the term of the extended SPC.

As a result, AstraZeneca and Shionigi filed a motion for preliminary injunction (PI) in front of the judge in charge of urgency proceedings (juge des référés) on April 26, 2016. The judge issued her order on July 4, 2016.

The criteria assessed by the juge des référés for deciding on the PI are whether infringement is likely, and whether there is any serious validity challenge.

In the present case, Ms. Courboulay deemed that there is no serious validity challenge; but that, on the other hand, infringement is not likely.

As a preliminary step in the reasoning, the claims of the patent were interpreted in view of the description. It is certainly a very good thing when a patent is construed as a first step, and thus in a consistent way for both validity and infringement.

In the present case, this preliminary interpretation step led to a result which may come as a shock to a number of foreign patent attorneys but which seems to be in keeping with the tradition of French patent law.

Claim 1 of the EP’471 patent reads as follows:

The compound (+)-7-[ 4-(4-fluorophenyl)-6-isopropyl-2-(N-methyl-N-methylsulfonylamino)pyrimidin-5-yl)-(3R,5S)dihydroxy-(E)-6-heptenoic acid or a non-toxic pharmaceutically acceptable salt thereof.

This is the full name of rosuvastatin, either in the form of an acid or of a salt – any possible salt, it would seem.

Dependent claims 2, 3 and 4 respectively and specifically relate to the acid form, to the calcium salt and to the sodium salt of rosuvastatin.

The judge referred to article 69 EPC and the interpretative protocol, and made the following comments as to which rosuvastatin salts are protected by the patent:

[The patent] is drafted as disclosing a new pharmaceutical active substance, rosuvastatin, and the pharmaceutically acceptable salts of this substance, and the cited examples are only indicative and do not limit the protection to the only cited examples. However, the description and notably paragraph 007 provides examples of pharmaceutically acceptable non-toxic salts of rosuvastatin and makes reference to two families of metallic ions which were commonly used in the formulation of tablets of statins already known at the priority date, and in particular alcaline metal ions and alcaline earth metal ions. […] Thus, the pharmaceutically acceptable non-toxic salts are in these two families […], as the patent does not give any indication to the skilled person to select a salt in another family. On the contrary, the description focuses on these salts because they were already commonly used for the formulation of statin tablets; it does not provide any other lead, so that the skilled person will select a salt in the families offered by the patent as being the only relevant families for statins. He/she will not try to select salts of other families as the patent does not teach anything in this respect. 

Therefore, only salts belonging to the cited families, namely alcaline metals like sodium or alcaline earth metals like calcium, or those which can be part of the most commonly used cations for the formulation of statin tablets are concerned by the patent. The other salt families are not mentioned and thus excluded from the scope of protection of the patent

In summary, claim 1, taken at face value, covers any pharmaceutically acceptable salts of rosuvastatin. But according to the judge, the actual scope of the patent is narrower, as only two families of salts are covered: alcaline metal salts (such as sodium) and alcaline earth metal salts (such as calcium).

So beware: the interpretation of the claims in view of the description can result not only in a broadening of the scope of protection relative to the literal wording of the claims, but also in a restriction of the scope.

Just to be clear, this finding does not seem to be related to the existence of an SPC. The (re)definition of the scope of the patent was made with respect to the patent, not the SPC. See in particular the following comment in the judgment:

Although the Crestor MA designates the calcium salt of rosuvastatin, the scope of the […] SPC extends to all forms of rosuvastatin as covered by the EP’471 patent.

A judgment to be taken with a grain of salt?

Again, the limitation of the patent devised by the judge may come as a surprise from a European perspective. But I think it is in keeping with traditional French practice. French judges have consistently had a large degree of discretion in defining the scope of protection based on the overall teaching of the patent – or spirit of the invention.

Maybe another way to look at this would be to consider that the invention was sufficiently disclosed in the patent only for the two salt families explicitly mentioned (and exemplified) in the patent, which, as far as I understand, were the two usual salt families for other similar drugs at the priority date. Using other salts would have required further research.

Anyway, the consequence of this interpretation of the claim is that there was no direct infringement of the patent. Indeed, the Biogaran product is a zinc form of rosuvastatin, and zinc does not belong to the alcaline or alcaline earth metal families.

And now comes the last part of the judgment, which deals with an auxiliary argument by the claimants, which was articulated as follows:

Biogaran commits acts of contributory infringement because it provides essential means for implementing the invention [….]. The salt form under which rosuvastatin is administered decomposes as follows, as soon as it reaches the gastro-intestinal system of the patient. The salt is dissolved, which leads to the separation of the cation (for example the calcium or zinc ion) and of the anion (namely rosuvastatin in anionic form). Since the pH of the stomach is low (less than the pKa of the acid group of rosuvastatin), the rosuvastatin anion surrounded by H+ protons attracts them so as to make the free acid form of rosuvastatin. […] Therefore the invention is implemented in vivo, in the patient’s stomach, after the administration of the Biogaran rosuvastatin, which thus infringes the EP’471 patent by contributory infringement. 

An interesting theory, but which did not hold water for the judge:

The act of infringement in suit can only be the supply or marketing of the drug, and not the decomposition of the drug in the patient’s body. […]

Contrary to what is argued by the plaintiffs, contributory infringement does not consist in providing means allowing the decomposition of the rosuvastatin salt in anionic rosuvastatin and salt in the human body. This is a consequence of the ingestion of the drug in the body, and of its mode of action but it is not an essential means of the invention, which only relates to the formulation of the rosuvastatin tablet. […]

[Contributory infringement] cannot be relied upon in the context of an artificial auxiliary argument […] whereas the Biogaran product is a generic of Crestor and thus clearly intended for the same therapeutic indication.

Biogaran does not supply any means but a product equivalent to the one protected by the EP’471 patent and the SPC so that contributory infringement is neither established nor likely.

The reasoning is very clear. Contributory infringement is a notion intended to target suppliers of only part of an invention. It is “artificial” and therefore wrong to try to extend this notion to the situation of a drug which undergoes a chemical transformation into a patented compound only in the patient’s body.

It is remarkable, though, that the judge noted in passing that the Biogaran product is equivalent to the claimed invention. It seems that the plaintiffs did not argue infringement under the doctrine of equivalence. Would the outcome have been different if they had? Maybe we will find out with the case on the merits (assuming it proceeds to trial).


CASE REFERENCE: Tribunal de grande instance de Paris, ordonnance de référé, July 4, 2016, Shionigi Seiyaku Kabushiki Kaisha & Astrazeneca UK Ltd v. Biogaran, RG No. 16/56067.

Of employees and drugs

No, this is not a post about employees who do drugs. In fact, contrary to what the title suggests, there is nothing in common between employees and drugs in my mind, except that I would like to briefly report on two different subjects and that it is somewhat more convenient to group both in a single article.

Drugs first, with a follow-up on the sofosbuvir case which was reported on earlier on this blog.

As readers may remember, an opposition division of the EPO maintained Gilead’s patent EP 2203462 on a blockbuster drug for the treatment of HCV infection further to the oral proceedings which took place on October 4-5, 2016. Several granted claims were deleted in the amended version of the patent due to extension of subject-matter, including a claim specifically directed to sofosbuvir. One remaining claim recited a generic formula which could be interpreted either as covering both sofosbuvir and its stereoisomer, or as covering only the mixture of sofosbuvir and its stereoisomer. This left a number of observers wondering what the amended patent is really about, and more importantly whether it sill protects Gilead’s drug.

The update is that the written decision of the opposition division was issued on October 31, 2016. It can of course be downloaded from the online register.

In this decision it seems quite clear that the opposition division has chosen the second interpretation. In other terms, they believe that the main remaining claim covers a mixture of sofosbuvir and its stereoisomer. Indeed, the term “racemate” is repeatedly used in the decision when referring to the subject-matter of the claim.

This is especially clear in the section of the decision which deals with the ground of opposition of insufficiency of disclosure. It was alleged by one of the opponents that the patent did not contain enough information to make the individual stereoisomers. The opposition division rejected the objection with the following statement:

The OD considers that claim 1 is directed to a racemate i.e. a mixture of the enantiomers and not the pure enantiomers. As indicated by the Patentee it is not contested that the racemate of claim 1 can be produced. This interpretation of claim 1 means that it is not necessary to come to a decision as to whether or not the patent in suit sufficiently discloses how to isolate and characterise the enantiomers. This issue is not relevant to claim 1. The OD considers that the auxiliary request 1 meets the requirements of Art. 83 EPC.

So, if one follows the opposition division’s interpretation, it seems that the amended patent may no longer cover Gilead’s drug, which is as far as I understand a pure isomer and not a mixture. But here is the catch: national courts are not bound by the interpretation put forward by the EPO. As regards French courts, many illustrations of this have already been provided in previous posts. So, the conundrum is still there. Also, it is all but certain that multiple appeals will be filed. So, in 2 to 5 years we will be able to read the Board’s take on this issue.

But we will not have to wait that long to comment on the case again, as new interesting developments still keep coming up. In a letter dated November 3, 2016, the proprietor’s representative requested a correction of the minutes of the oral proceedings, as well as of the decision. She stated that the minutes and decision misrepresent the patentee’s position regarding the scope of claim 1.

Indeed, the opposition division reported that the patentee had stressed that claim 1 “does not embrace individual stereoisomers“; whereas in fact, says the representative’s letter, the patentee always expressed the view that individual stereoisomers are “within the scope of claim 1” but that claim 1 “does not particularize individual stereoisomers“.

Even if the opposition division were to correct the decision and the minutes as requested by the patentee (which could be a long shot), the opposition division’s own assessment of the scope of claim 1 would remain unaltered. But the patentee’s actual statements during the oral proceedings might possibly be of relevance in front of a judge, which is the reason for this pre-appeal move.

Interestingly, the representative asked for new oral proceedings if the request for correction were to be rejected. So, make sure to grab your bucket of popcorn and to watch the comments section below for any update on this matter – all the more so that one of the opponents also made a (different) request for correction. The opposition division’s job is certainly not an easy one in such a high profile case.

As a side note, the decision of the opposition division contains a number of other interesting aspects. Entitlement to priority was challenged, which gave rise to a review of U.S. law in relation to assignments. There is also a long discussion on the public availability of a document D5 which is a university thesis. The opposition division came to the conclusion that the document was not part of the prior art because, on the balance of probabilities, there seems to have been a bar on access to the document at the relevant period of time.

The inventive step section is also noteworthy. Several starting points were taken into consideration by the opposition division, and the surviving claims were found inventive over all starting points, the technical problem being the provision of alternative HCV inhibitors.

Now, here comes the “employees” part of the post which, as I warned, is truly unrelated to the first part.

A device for employees' drug screening
A device for employees’ drug screening

The French patent and trademark office (INPI) has recently released an extensive study on compensation policy for employees’ inventions.

According to French law, all inventions made by employees in the context of a task assigned to them by their employer (be it a general task assigned in the employment agreement or a specific task assigned during the course of employment) belong to the employer. But the employer must pay a bonus to the employees – or “rémunération supplémentaire“.

The core of the INPI’s study is a survey on how businesses deal with this legal requirement. This is quite enlightening as the statute does not provide many details and leaves it open how the compensation should be calculated and when it should be paid. Case law on this topic has provided some guidelines without however setting any generally applicable rules.

There are many interesting questions in the survey, but I picked a few ones which I found particularly blog worthy:

First, the form of the compensation. 60.5% of companies offer a lump sum-only compensation. Only 1.2% provide a compensation which is entirely dependent on whether/how the invention is exploited. The rest of the surveyed rely on a combination of both. Lump sum-only systems are certainly easier to implement (and potentially cheaper). But compensation systems which somehow take into account the exploitation of the invention might be more resistant to a court challenge.

Second, the points in time at which the compensation is paid. There are many different possibilities here, and in some companies several installments are paid over time. Thus, bonuses are typically paid when the initial patent application is filed (76.5% of respondents); when patent applications are filed abroad (33.3%); when a patent is granted at the EPO or abroad (34.6%); during exploitation of the invention (33.3%); etc. Interestingly, 8.6% of the surveyed said an installment is paid as soon as the employer becomes aware of the invention.

Third, the amount of the compensation. This is of course a key aspect. The study makes a distinction between lump sum-only compensation systems and mixed compensation systems (wherein the exploitation of the invention is partly taken into account):

  • In lump sum-only systems, the median value of the minimum awarded bonus is 500 €, while the median value of the maximum awarded bonus is 2,000 €. The maximum amount reported in the entire survey is 11,000 €.
  • In mixed systems, the median value of the minimum awarded bonus is 400 €, while the median value of the maximum awarded bonus is 15,000 €. The maximum amount reported in the entire survey is 105,000 €.

In summary, the span is broader in mixed systems, with a shift towards higher compensations. I assume that the higher bonuses must be rare: they must correspond to exceptionally valuable inventions.

The study also contains a breakdown of lump sum installments, depending on the point of time at which they are paid. For instance, in the majority of cases, the bonus for the initial patent application filing is between 500 and 1,000 €. But foreign filing bonuses and patent grant bonuses are somewhat higher, with a majority of cases between 1,000 € and 2,500 €.

Fourth, the frequency of disputes between an employer and its inventors. Fortunately, 67.2% of those surveyed reported no dispute. In 10.1% of cases, the employer received at least one complaint from an inventor. In 10.1% of cases, a dispute had to be handled by the national conciliation commission (CNIS, Commission nationale des inventions de salariés). In 6.3% of cases, a dispute went as far as a lawsuit in front of the Tribunal de grande instance (TGI).

If we add the CNIS and TGI cases, this is 16.4%, which seems to me like a relatively high dispute rate.

The study contains a number of other interesting data. It offers a comparison with a similar study performed in 2008. It provides practical examples of compensation systems set up by a number of companies, such as Air Liquide. This should be most useful for those businesses which still need to set up their own compensation system. In this respect, 7.4% of those surveyed still do not have a compensation system in place, although this is required by the law. My guess is that among those not surveyed, including many IP-unaware SMEs, the proportion could be significantly higher.

The study also provides a comparison of the French legal framework with other systems abroad.

Some of the annexes are also useful. One of them provides a list of bonuses awarded by the CNIS between 2011 and 2015. The amount awarded by invention ranges from 333 € to 50,000 €, with a total amount (for all inventions in dispute) ranging from 1,000 € to 300,000 €. This broad range certainly corresponds to a large variety of inventions, from useless ones to extremely profitable ones.

Another annex provides a list of damages awarded to employees by courts of law (as a compensation for unpaid invention bonuses) in the past few years. Again, the span is broad. However, the highest amount on the table (more than 1,000,000 € for two inventions) was in fact in a case where the inventions were not made in the context of a task assigned to the employee and therefore pertained to a different legal regime – one where the employer has a right on the invention but must buy the invention from the employee.

In summary, this is a must-read in particular for in-house patent attorneys and more generally for all involved in employees’ inventions in this country.

The sofosbuvir conundrum

Few patents get famous enough to make it to the headlines of the general press. Some Apple patents are among them, such as those nicknamed “slide-to-unlock” or “rubber-banding” – especially thanks to the world war waged against Samsung. Other patent celebs include those on blockbuster pharmaceutical drugs.

In this latter category, one patent family in particular has attracted some fuss over the past few years. It is the one which covers the drug sofosbuvir, marketed under the name Sovaldi.

Blockbuster drug patents can beat even patents on blockbusters.
Blockbuster drug patents can even beat patents on blockbusters.

Sofosbuvir has markedly improved the treatment of hepatitis C virus (HCV) infection. But in many countries, in the absence of any generic version of the drug, the price of HCV treatment has skyrocketed as a result. This has aroused vocal protests by a number of NGOs (see e.g. here).

In Europe, the sofosbuvir patent (or at least one sofosbuvir patent) is EP 2203462, owned by Gilead. It was opposed after grant by ten different parties, including the NGO Médecins du monde, a number of generic manufacturers, and a number of straw men. Oral proceedings took place on October 4-5 in Munich. The only public information available as of today on the online register is that the patent was maintained in amended form. The minutes of the oral proceedings and the written decision of the opposition division have not been issued yet.

Tufty the Cat has recently made assumptions on his blog regarding the claims which were uphed by the opposition division. I have now received a confirmation by someone who attended the oral proceedings that Tufty got the claim amendment right.

But there seems to be some confusion, to say the least, after these oral proceedings. Indeed, Gilead and its opponents seem to have different views as to whether the amended patent still covers sofosbuvir or not.

In order to understand how there can be such a controversy, it is necessary to go back to some basic notions of stereochemistry.

There are many examples of chemical compounds having different 3D atom configurations although they share the same 2D chemical formula. These different configurations are referred to as stereochemical forms, or diastereomers, of a given compound.

In the pharmaceutical field, identifying the different stereochemical forms of a compound is of prime importance, as diastereomers often have different pharmacological effects. By way of example, the so-called (S) stereochemical form of ibuprofen is a hundred times more active than the so-called (R) stereochemical form.

Besides, such chemical compounds are generally not synthesized as stereochemically pure compounds, but as a mixture of diastereomers. It is often necessary to further purify this mixture in order to isolate the most active diastereomer.

Gilead’s patent as granted contains six claims, including three independent claims 1 to 3. For once, let’s start with claim 2.

Claim 2 is directed to a compound of the following formula:

sofos-claim-2

This is sofosbuvir.

Then claim 3 is directed to another compound of the following formula:

sofos-claim-3

This other compound looks very much like sofosbuvir, since it is its diastereomer. The difference between the two compounds is highlighted in yellow. In the sofosbuvir formula, the P-O bond is shaded in black and the P-N bond is hatched, which means that, in 3D, the oxygen atom is in front of the phosphorus atom, while the nitrogen atom is behind. It is exactly the opposite in the diastereomer of claim 3.

Now, here is the formula of the compound of claim 1:

sofos-claim-1

In this formula, the relevant P-N and P-O bonds are depicted as simple lines, which means that the 3D configuration is not specified.

Claims 4-6 simply recite a composition comprising the compound of one of respective claims 1-3 and a pharmaceutically acceptable medium.

According to my source, claims 2, 3, 5 and 6 were found by the opposition division to extend beyond the contents of the application as filed. As a result, the patent proprietor filed an auxiliary request in which these claims were deleted, and only granted claims 1 and 4 remained. The opposition division came to the conclusion that this auxiliary request meets all the requirements of the EPC, and made the interlocutory decision of maintaining the patent in this amended form.

The decision should soon be issued in writing, and will be open to appeal by all parties.

And now, here comes the conundrum.

The patent as amended during first instance opposition proceedings no longer contains claims 2 and 5 which were specifically directed to the sofosbuvir compound and the sofosbuvir-containing medicament. The question is whether the remaining claims 1 and 4 still protect sofosbuvir and sofosbuvir-based drugs.

One possible interpretation is that claim 1 is a generic claim which protects both diastereomers. It is broader than claim 2, and therefore the scope of the patent remains completely intact. Quite frankly, I think this is the interpretation that most patent attorneys would consider as the most logical one.

However, another possible interpretation is that claim 1 is directed to a diastereomeric mixture, i.e. a mixture of the compounds of claims 2 and 3 as granted. Arguments in favor of this interpretation could be that: claim 1 does show a 3D configuration in other parts of the molecule; thus, the absence of 3D information around the phosphorous atom means that such information cannot be provided, because both forms are present in the compound; furthermore, granted claims 2 and 3 are independent claims and do not depend on claim 1 which confirms that they are not particular embodiments of claim 1.

According to this second interpretation, a generic sofosbuvir drug would arguably no longer infringe the patent – as the drug would not contain a diastereomeric mixture.

It seems that the description of the patent does not fully clearly support one interpretation over the other.

I could very well see a French court coming to the conclusion that since the claim specifically directed to sofosbuvir was deleted, the patent may not possibly protect this molecule any longer. Maybe the written decision of the opposition division will contain a position as to what claim 1 means. But then, maybe not. And anyway, any position that they may have taken is not binding on national courts.

With that in mind, I would certainly not bet my life on either interpretation. Would readers be keen on taking a vote?

I would like to thank my source for this hot information. I have also been told that a number of interesting topics were discussed during the opposition proceedings, in connection with extension of subject-matter, priority and inventive step. So we should watch for the written decision of the opposition division when it is issued.


CASE REFERENCE: ongoing opposition proceedings against EP 2203462 to Gilead Pharmasset LLC.