Smells like revocation

Believe it or not, it is somewhat difficult for this blogger to know what his readers are most interested in. Do they yearn for complex legal discussions? Are they rather keen on getting their hands dirty with an insight into actual patents and prior art documents?

The good thing is that today’s post will contain a little bit of both – hoping that the answer to my question is not “none of the above“.

Reckitt-Benckiser owns European patent No. EP 1891197 which is entitled “Process for manufacturing improved dispensing devices“. This patent owner is no small fish, but rather a giant in the hygiene industry. Think of the brands Air Wick, Calgon, Clearasil, Cillit Bang, Durex. But today, Harpic is the type of products we are talking about.

In June 2013, two companies of the Bolton group, namely the Italian Bolton Manitoba and the French Bolton Solitaire, filed a nullity suit against the French part of the European patent.

On March 13, 2015, the Paris Tribunal de grande instance (TGI) dismissed the nullity claim. Bolton appealed, and the Paris Cour d’appel issued its judgment a couple of weeks ago.

The first interesting aspect in the appeal judgment is… the application of the statute of limitations to the nullity claim.

One would think that we have heard enough about this topic on this blog lately, and one would be wrong.

As is usual now in a patent nullity lawsuit, the admissibility of the request for revocation was challenged by the patent proprietor. The proprietor deemed that the limitation period for the nullity claim started running from the publication date of the application.

In the present case, the application had been published before the amended statute of limitations entered into force on June 19, 2008 (as discussed here, this amended statute brought the default limitation period from 30 years down to 5 years, which initially created the legal mess that we are now in). Therefore, the patentee said, the starting point was postponed to June 19, 2008, when the amended statute entered into force; and the limitation period expired on June 19, 2013, i.e. five days before the nullity complaint was served.

On the other hand, the nullity plaintiff argued that the five-year limitation period only started from the publication of the grant of the patent, namely August 27, 2008, so that the nullity action was timely filed and admissible.

The court ruled that

[…] the limitation period can only start running from the date on which the person against whom [the patent] is asserted can validly act; pursuant to article 64 EPC, a European patent confers rights as from the publication of the mention of grant, so that a nullity action against a European patent application does not exist. The limitation period for the action can thus only start running, in the present case, from the publication of the patent grant at the earliest

There is a lot to digest in this single sentence:

  • It is a good thing that the publication of the application was not upheld as a valid starting point – this is the last thing we need right now.
  • The choice of the patent grant as the starting point is consistent with the recent ruling by the same panel of the Cour d’appel in Halgand v. RP Nicoll, discussed here.
  • The court did not perform an in concreto assessment, which currently continues to be applied by the judges in the TGI (see the discussion here).
  • However, the wording used by the court, i.e. can thus only start running in the present case, from the publication of the patent grant at the earliest“, does not fully contradict the in concreto approach. Here, the nullity plaintiff seems to have taken the position that the starting point did not need to be accurately determined, as it could anyway not be before the publication of the patent grant, which thus ensured the admissibility of the action in any case. And the appeal judges fully followed this approach.

Therefore, all in all, this new ruling does not change much relative to the previous situation. Or, as they say in every good mystery novel, the plot thickens.

Having found the nullity action admissible, the court turned to the merits of the case, and more particularly to the contention that claim 1 of the patent did not involve an inventive step.

This is the second interesting aspect in the judgment, since the Cour d’appel reversed the decision under appeal in this respect, and declared claim 1 invalid although it had survived the first instance proceedings.

The patent in suit is directed to a manufacturing process for a sanitizing toilet block. Claim 1 reads as follows:

A process for the manufacture of a lavatory dispensing device useful for the delivery of at least one treatment composition, preferably a cleaning composition and/or a sanitizing composition to a sanitary appliance, preferably a toilet bowl which method comprises the steps of: 

– providing a composition to an extruder,
– forming an extrudate from said composition;
– inserting part of a hanger into said extrudate;
– compressing the extrudate to encase or enrobe said part of a hanger thereby forming said lavatory dispensing device.

The next generation sanitary appliance for your toilets.

I understand that the relevant prior art was the following:

  • Some prior art references taught the manufacturing of toilet blocks by placing a hanger in a composition comprising paradichlorobenzene, and compressing the composition onto the lower end of the hanger. These blocks are “cageless”, that is they are provided on their own and not in a plastic cage.
  • Other prior art references disclosed the manufacturing of toilet blocks by an extrusion process, and their inclusion into cages.

In the first instance judgment, claim 1 was found to be inventive. The TGI commented on the teaching of the prior art as follows:

– the process of fixing a hanger to a cageless device only concerns compositions containing paradichlorobenzene, known for its low solubility, which has now been prohibited since it is considered as a dangerous material; 

– the insertion of the hanger occurs when the block is molded; 

– none of the […] patents suggests a compression after an extrusion, to attach the hanger; 

– compositions containing at least one surfactant (which leads to the block breaking off) are in the prior art always placed in a support. 

Therefore, the skilled person was not naturally prompted by this prior art to contemplate a toilet block containing surfactants, to be used without a cage, by inserting a hanger into a block obtained by extrusion, and then compressing the extrudate to encase the hanger. 

The existing prejudice that cages were required to support and contain sanitary treatment blocks was overcome, since it is now possible to make cageless devices which comprise a suspending hanger and a composition as a compressed full block tied to the suspending hanger, said solid block compositions comprising one or more chemical compounds, preferably at least one surfactant composition. 

It is remarkable that the first instance court did not apply the problem and solution approach. Though this reasoning “made in EPO” is more and more often relied upon by litigants and judges in France, it is by no means mandatory.

It is also noteworthy that the TGI, when discussing why the skilled person would not have achieved the invention in an obvious manner, made reference to a number of features which are actually not present in claim 1.

For example, the court seemed to consider that the composition of the block comprises surfactants and does not comprise paradichlorobenzene. According to the court, this is very important, as only paradichlorobenzene-based blocks were disclosed as being compressively tied to a hanger – in view of the particularly low solubility of this chemical. But claim 1 does not explicitly exclude the presence of paradichlorobenzene, and does not specifically call for the presence of surfactants (which are recited in dependent claim 10). Claim 1 merely mentions a “treatment composition, preferably a cleaning and/or a sanitizing composition“.

Furthermore, the court considered that there was a prejudice against cageless devices comprising a sanitary composition (as opposed to a merely deodorizing, paradichlorobenzene-based composition). But claim 1 does not explicitly exclude the presence of a cage in addition to the hanger. This is in fact the subject-matter of dependent claim 8.

As for the appeal judges, they did not follow the problem and solution approach either. But they did reach a different conclusion: 

In the end, at the priority date of European patent No. 1891197, in view of the teaching of the above documents, the skilled person […] knew processes for making blocks for toilet bowls suspended by hangers; desirous of making a cageless suspended lavatory block, not based on molded paradichlorobenzene (deemed toxic) but on treatment compositions comprising surfactants, obtained by extrusion, he could use the same process starting from an extruded composition as taught in [a couple of patents]; he also knew from the teaching of [another patent] that it was possible to compress an extrudated block to give it a shape or to close the opening resulting from the insertion of the hanger.   

It is striking that the Cour d’appel shared the TGI’s appraisal of the crux of the invention, namely providing a cageless device for a block comprising surfactants.

The TGI was thus not blamed for its extremely extensive interpretation of claim 1 in view of the description of the patent. 

As far as I can tell, the different conclusion was in fact reached due to a new prior art citation, namely a reference disclosing the compression “of an extrudated block to give it a shape or to close the opening resulting from the insertion of the hanger” – whereas the first instance judges had noted that “none of the […] patents suggests a compression after an extrusion, to attach the hanger”. 

First instance judgments are very often confirmed on appeal in France. One exception to this general trend is when new facts arise, such as a new prior art document like in the present case.


CASE REFERENCE: Cour d’appel de Paris, Pôle 5 chambre 2, October 20, 2017, Bolton Manitoba & SASU Bolton Solitaire v. Reckitt Benckiser LLC, RG No. 15/09777.

Beware, drafters!

This may well be the fourth post almost in a row on a pharma case. Although pharma patent litigation is typically not hyperactive in France, each single case usually generates many interesting questions.

Today is no exception, not only from the litigation perspective but also from the viewpoint of a patent drafter. There are in fact at least two aspects in the decision of the Paris Tribunal de grande instance (TGI) which can be taken as significant warnings for patent attorneys.

The patent in suit is EP 0984957, owned by Swedish company AstraZeneca AB, and it looks quite simple and straightforward.

Claim 1 of the patent simply reads: “the magnesium salt of S-omeprazole trihydrate“.

S-omeprazole, also known as esomeprazole, is a blockbuster drug used in the treatment of gastric ailments. The patent is directed to a specific form of the drug.

Claims 2-4 further specify the form of the drug. Claims 5-8 relate to a process for the preparation of the drug. Claim 9 relates to a pharmaceutical composition comprising the drug of claim 1 and another one. Finally, claim 10 is a Swiss-type claim mentioning the treatment of a gastric acid-related condition.

In July 2011, AstraZeneca initiated infringement proceedings against Ethypharm based on this patent in view of the exploitation by this French company of generic esomeprazole.

Ethypharm of course filed a counterclaim for nullity in due time. But things did not go smoothly, and the lawsuit seemed to drag on forever.

First, an expertise was ordered so as to sort out the documents seized during an infringement seizure. Second, the parties discussed and initially agreed to the designation of another expert, as far as I understand in order to weigh on whether there was an infringement or not. Third, this expert was finally not designated, as AstraZeneca admitted that the generic esomeprazole on the market no longer infringed the patent (while maintaining that there had been infringement in the past). Fourth, AstraZeneca was compelled to file the experimental evidence based on which the above admission was made.

In summary, the judge in charge of case management certainly had her work cut out for her. And this leads us to the judgment issued by the TGI on June 23, 2017.

The first aspect of the decision that deserves a discussion is claim interpretation.

The patent proprietor stated that claim 1 covered any magnesium salt of S-omeprazole trihydrate. But, according to the defendant, claim 1 only protects a specific form of magnesium salt of S-omeprazole trihydrate.

The court went for the latter interpretation.

The court referred to article 69 EPC and the protocol on the interpretation, and remarked that “the judge must not make any interpretation if the claim is self-sufficient and should not denature the claim on the pretext of claim interpretation“.

One may wonder if the court did not do just that, i.e. interpret a claim based on the description, although the claim seemed quite self-sufficient.

At least from an EPO perspective, I have little doubt that a claim simply entitled “the magnesium salt of S-omeprazole trihydrate” would be seen as covering any magnesium salt of S-omeprazole trihydrate based on its plain wording.

But this is not the option that the court used. Instead, the court had a close look at the description of the patent and noted inter alia the following:

Since the wording of claim 1 does not comprise any determiner, one should refer to the description and drawings to interpret it, with respect to the skilled person […]. 

It is also specified that omeprazole and its salts as well as the R and S enantiomers of omeprazole and their salts are known from the art […] and that the magnesium salt of the S enantiomer of omeprazole exists in different forms. 

As mentioned in the description, the field of the invention does not relate to a “novel form of S-omeprazole” as suggested by the title of the patent, since this molecule was already identified, but a “novel form  of trihydrate of the magnesium salt of the S-omeprazole” […], which implies that it is a trihydrate form other than known from the art, with specific features such as “substantially pure” […], devoid of magnesium salts of R-omeprazole […] and devoid of other forms of magnesium salts of S-omeprazole (including the dihydrate form used for the preparation of the composition). 

This product is said to be “highly crystalline” […] since it has a larger crystallinity than any other form of magnesium salt of S-omeprazole, including trihydrate forms […]. 

This compound is characterized by an X-ray powder diffractogram [XRD] which shows main peak positions and intensities […], or by spectroscopy […]. 

Crystalline forms at their best

In support of its proposed interpretation, AstraZeneca filed an affidavit by a doctor Byrn, as well as a judgment by the New Jersey district court on a corresponding U.S. patent, per which the magnesium salt of esomeprazole trihydrate was novel at the time the invention was made and the patent was to be interpreted in a broad manner.

By the court was not convinced and noted that

the prior art previously disclosed a non-pure form a magnesium salt of S-omeprazole trihydrate, as can be derived from the laboratory tests performed on molecules recited in previous patents […]. [And] it can be deduced from the aforementioned elements in the description (notably the very title of the patent and the wording of the claims, the use of determiners in the text of the description such as “A” or “This” […] to mention the product […]) that the invention does not relate to any trihydrate of magnesium salt of S-omeprazole as suggested by AstraZeneca, but to a specific trihydrate having defined features (substantially pure, crystalline, with specific peaks) […]. 

The court repeatedly stated in the judgment that some magnesium salts of esomeprazole trihydrate were known from the art. But it does not seem to me to clearly stem from the patent itself. It is possible that the recreation of prior art esomeprazole could show that this particular salt form was already present, but isn’t this rather an issue of novelty of the claim?

Also, it is extremely striking that the court placed so much emphasis on how the description was drafted.

Here is the thing, I think. Paragraph [0009] of the patent for instance starts with: “the magnesium salt of S-omeprazole trihydrate obtained according to the present invention is substantially free from magnesium salts of R-omeprazole“. Then paragraph [0010] starts with: “the compound of the invention is characterized by the positions and intensities of the major peaks […]“.

If my understanding is correct, it could have made a world of a difference if these paragraphs had mentioned that the compound “according to some embodiments” is substantially free from other salts, or that the compound of the invention “may be” characterized by certain positions and intensities of peaks.

Therefore, beware drafters! Even if you get what you consider a broad claim granted, it may be interpreted by a court in a much narrower manner if the description gives the impression that the invention has a number of other essential features.

Surprising? Well, with Munich eyes, certainly. But not really if you are familiar with French case law.

Today’s decision is for instance very reminiscent of the approach recently taken in the rosuvastatin case. Even electronics cases are handled in a similar manner, as illustrated here.

The TGI’s comment on dependent claims 2-4 is enlightening in this respect. Claim 2 mentions that the compound is highly crystalline. Claim 3 mentions that it is stable. Claim 4 mentions that it has a certain XRD pattern. A common way of looking at this would be to state that claim 1 is broader than claims 2-4 and thus is precisely not limited to the specific XRD pattern, or to a highly crystalline form, etc. But the court reached the exact opposite conclusion and noted that

these claims define the specific features of the compound mentioned in claim 1.

Now, one may criticize the court’s rewriting of straightforward claim 1 and the challenge this presents to legal certainty. 

But there may nevertheless be a possible justification for this bold approach.

As the patent only discloses one very specific crystalline form of trihydrate, it could be argued that the protection should be limited to this specific form and should not extend to other forms of trihydrate which were not actually made available to the public by the patent. Maybe this is what the judges had in mind.

After this section on claim interpretation, the judgment contains a section on sufficiency of disclosure and novelty.

Both grounds of nullity were discarded by the court. In fact, the objection of lack of novelty was put forward only in case the patentee’s broad interpretation prevailed – and this was not the case.

And then comes the other important point in the judgment, namely inventive step.

At this point, the patent was revoked, based on a very brief justification.

The court generally made reference to the problem and solution approach. The dihydrate form of the compound was the closest prior art. According to the patent, the new form is more stable and easier to characterize and synthesize.

But the court refused to take this statement of a technical problem into account:

Yet, beside the disclosure of the molecule on a new form (trihydrate) and the presentation of preparation and identification methods of this product, whereas the pharmaceutical industry wants to find further forms of an active, even if the properties to be expected from the new molecular forms are not known, the patent does not define any problem. It just mentions that the product is more stable, easier to synthesize and handle and identify, without however supporting this statement in the patent itself, by studies and researches and results. Thus, the patent does not mention a problem to be solved let alone demonstrate the resolution of this technical problem. 

Moreover, it is acknowledged that in front of the EPO or in litigation the patentee may refer to posterior tests, but these must consolidate results already contained in the patent […]. 

Therefore, claim 1 is invalid for lack of inventive step as it does not solve a technical problem.

To summarize: the patent does mention a technical problem solved by the invention. But in the absence of any experimental evidence in the patent that this problem is indeed solved, the problem is not taken into account. Post-published evidence is considered to the extent that it can merely supplement data already contained in the patent, but not replace it entirely.

So far so good, and the approach taken by the court seems consistent with EPO case law. See in this respect the catchword of oft-quoted T 1329/04:

The definition of an invention as being a contribution to the art, i.e. as solving a technical problem and not merely putting forward one, requires that it is at least made plausible by the disclosure in the application that its teaching solves indeed the problem it purports to solve. Therefore, even if supplementary post-published evidence may in the proper circumstances also be taken into consideration, it may not serve as the sole basis to establish that the application solves indeed the problem it purports to solve.

However, directly jumping to the conclusion that the claims lack inventive step, as the court did, is something a Board of appeal would probably not do.

Instead, they would likely reformulate the technical problem in a less ambitious manner, e.g. in this case as providing an alternative form of esomeprazole, and would then investigate whether it was obvious for the skilled person to achieve the claimed invention with this unambitious technical problem in mind.

Let’s assume for instance that it was technically difficult to make the trihydrate form. In this case, a Board could arrive at a finding of inventive step. In France, the absence of an ambitious technical problem is in itself indicative of a lack of inventive step.

This confirms that French courts are more severe in the appraisal of inventive step.

At any rate, here comes the second advice for drafters is: beware of the plausibility of the technical effects of the invention!

My understanding is that it is kind of a hot topic at the EPO these days. Well, it is an even more serious matter in this country.

And this does not just apply to “therapeutic” effects.

In this case, the alleged technical effect was not related to the treatment of an illness but rather to physical characteristics of the drug (stability, ease of handling…).

So, we are all doubly warned, I guess.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 3ème section, June 23, 2017, AstraZeneca AB v. Ethypharm, RG No. 11/11460.

The problem with the problem

Over the years, the Boards of appeal of the EPO have developed a number of rules which are now set in stone. The so-called “gold standard“, used for appraising whether any extension of subject-matter has occurred and whether priority is valid, is a famous one. An even more famous one is the “problem and solution approach” for appraising inventive step.

The problem and solution approach is a very clear reasoning framework which has two fantastic advantages:

  • avoiding an ex post finding artificially ignoring the actual contribution of the invention to the art; and
  • enhancing the predictability of the inventive step assessment, and thus improving legal certainty for all stakeholders, patent applicants and third parties alike.

Make no mistake: I love the problem and solution approach. Especially when I compare it with the Russian roulette of the obviousness rejections that you tend to randomly get at the USPTO.

However, one downside of a clear reasoning framework is that everyone learns how to make the best of it.

Clever patent drafting and sophisticated argumentation can thus sometimes make up for the relatively low inventive merit of some inventions. Correlatively, a number of patent professionals have noted that, for better or worse, the inventive step threshold et the EPO is generally rather low.

In fact, more often than not, whether an application or patent passes the article 56 test mostly depends on the selection of the closest prior art, and on what kind of technical problem you can possibly come up with – and these considerations may sometimes be remote from technical reality.

In such a context, I think it is a good thing when the Boards of appeal remind us that the problem and solution approach should be followed with some flexibility, in order to avoid any artificial outcome which would be unfair to third parties.

The problem and solution game.

I will take two examples of how things can get somewhat skewed in the problem and solution approach; and how some Board decisions can nevertheless offer a way to achieve a right balance.

The first example is taken from T 2123/14, already discussed on Laurent’s blog.

The initial step of the approach is the selection of the closest prior art. As summarized in section G-VII, 5.1 of the Guidelines, “in selecting the closest prior art, the first consideration is that it should be directed to a similar purpose or effect as the invention or at least belong to the same or a closely related technical field as the claimed invention“.

It is therefore a classical strategy to insert a number of goals or purposes in the description of the application, and then argue that any prior art reference which does not address one of these goals or purposes is unsuitable for being selected as the closest prior art. This is especially helpful when it is indeed difficult to establish the existence of an inventive step starting from a reference sought to be discarded.

Now, such a strategy may be curtailed by following the reasoning used in T 2123/14. As a disclaimer, please note that I have formed no personal opinion as to whether the claims at stake were actually inventive or not, I will just focus on the principles established by the Board, which seem quite relevant.

In this case, the examining division had refused the application, relating to a cosmetic composition for the hair, for lack of inventive step based on D3 as the closest prior art. But the appellant argued that the closest prior art was not D3 but rather D8, so that inventive step should be assessed only based on D8 as a starting point.

The appellant’s argument, as summarized by the Board, was that:

D8 indeed mentioned as a technical purpose, beside the improvement of untangling, volume, lightness, softness, flexibility and tidiness, also the improvement of smoothing while avoiding a greasy feel […], unlike D3 which did not mention the problem of the hair’s greasy feel or heaviness, and which merely focused on a conditioning effect, on making hair soft and flexible, improving volume, brightness and smoothness of wet and dry hair […].  (Reasons, 1.2.1, translated from the French language).

The Board did not accept this and noted the following:

[…] The claimed subject-matter must involve an inventive step relative to each prior art document. Nothing prevents the relevance relative to D3 from being examined first. If, on the face of it, the skilled person can choose between several prior art documents as reasonable starting points, inventive step can thus be effectively acknowledged only after applying the problem and solution approach to each of the options (T967/97, T21/08). If one of the options reveals obviousness, then there is no inventive step. The problem and solution approach may therefore need to be repeated for each of these options (T710/97). (Reasons, 1.2.2.1).

This is a helpful reminder. A relevant document cannot be swept under the rug by pointing to an allegedly better document. All “reasonable” starting points may have to be investigated. Of course what is “reasonable” and what is not is a matter of case by case analysis.

The decision then goes on by recalling the criterion of the “similar purpose or effect” for the closest prior art. But the Board then adds:

This does however not mean that, when an invention purports to solve a list of specific problems, said closest prior art must necessarily specifically disclose or mention all of these specific problems or more particularly only one of these problems taken in isolation. This is in particular the case for the objective technical problem, which is only established in the second step of the problem and solution approach […]. This is also the case for a technical problem which is solved in an implicit and inherent manner by the closest prior art, although this is not expressly stated in said prior art. 

Thus, simply inserting a purpose or even more so a list/series of specific purposes in the description does not allow the applicant to oppose any objection of lack of inventive step raised in view of a document which does not mention one of the abovementioned specific purposes, if this document was concerned with a similar use(Reasons 1.2.2.3).

In other terms, in order to qualify as a closest prior art (possibly among others), a reference needs to relate to a similar use. But it is not necessary for the document to explicitly address all the purposes that the drafter included in the description of the application or patent.

To me, this is a significant clarification, as the strategy consisting in inflating the number of purposes set out in the description in order to discard possible closest prior arts has certainly been quite effective for a number of applicants / patent proprietors to date.

In the case at hand, the Board found that D3 was indeed a possible closest prior art to take into consideration:

[…] Even if D3 does not explicitly mention the purposes of the claimed subject-matter, it cannot be denied that both documents D3 and D8 show compositions designed for the same goal and belong to the exact same technical field as the present application, namely conditioning shampoos, and therefore have a similar use and the same actions and effects on the hair, in particular in terms of smoothing. 

It can thus be legitimately expected that the type of cosmetic composition disclosed in D3 and D8 generally involves the same technical problems, or technical problems necessarily deriving from the similar use. Besides, even if the properties relating to the absence of a greasy feel or heavy hair are not explicitly recited in D3, it remains that example 5 of D3 does contain said non-silicone fatty components responsible for a possible greasy feel and possible heavy hair. In the absence of any specific indication or remark in example 5 of D3 regarding these properties, it is immediately apparent and obvious for the skilled person that the properties and abilities of the compositions disclosed in D3 are prima facie satisfactory, including regarding a greasy feel or heavy hair. (Reasons 1.2.2.3).

To summarize this latter point: even if a very specific technical problem is not expressly addressed in a reference, the skilled person can sometimes derive from the context that this technical problem is indeed taken into account in the document.

Here is now a second example of a possible flaw in the problem and solution approach favoring the applicant / patentee, and a possible remedy taught in T 2456/13 (decision initially reported on Peter de Lange’s blog).

The issue here is the second step of the problem and solution approach, namely the formulation of the objective technical problem. Sometimes, several technical effects relative to the closest prior art can be possibly contemplated. Depending on which technical effect(s) is/are retained, the solution may or may not be obvious for the skilled person.

The usual strategy for the applicant / patentee is to focus on one or more very specific technical effects, seldom addressed in the art, so as to more easily arrive at a finding of non-obviousness. But in some instances, this may be considered as artificial (and, if I may add, ex post) if, already based on another, less sophisticated technical effect, it would be obvious for the skilled person to arrive at the claimed invention.

The way the EPO may deal with this situation is addressed in section I.D.10.8 of what is commonly referred to as the Case law book. It is called the “bonus effect“:

[…] If, having regard to the state of the art, it would already have been obvious for a skilled person to arrive at something falling within the terms of a claim, because an advantageous effect could be expected to result from the combination of the teachings of the prior art documents, such claim lacked inventive step, irrespective of the circumstance that an extra effect (possibly unforeseen) was obtained. […] An unexpected bonus effect does not confer inventiveness on an obvious solution.

However, my subjective impression is that the bonus effect objection is seldom effective in practice.

One difficulty is how to distinguish a technical effect which is merely a bonus effect from one which absolutely must be taken into account in the formulation of the objective technical problem.

In some decisions, reference was made to “one-way street” situations, in which there is a lack of alternatives for the skilled person, as opposed to situations wherein “the use of means leading to some expected improvements might well be patentable in relying on an additional effect, provided this involved a choice from a multiplicity of possibilities” (see the above section of the Case law book). Clearly, this is a restrictive approach, as I do not think that there are generally many one-way streets in technology.

In T 2456/13, the patent proprietor argued that a secondary reference D3 would not be taken into account by the skilled person as it did not address a certain technical effect, namely the reduction in the tendency to caking.

But the Board considered this effect as a mere bonus effect. The Board did not hold that this was a one-way street situation but adopted another approach:

D3 discloses a generic process for the preparation of sodium percarbonate particles which are coated by spraying on a solution of sodium sulfate and sodium carbonate. […] According to D3, the coating improves storage stability […]. In view of the partial task of improving storage stability, the skilled person would, in the opinion of the board, refer to the relevant document D3, even if no improvement in the tendency to caking is explicitly shown. The person skilled in the art is in fact taught by D3 that, with a coating in the composition range between 82:18 and 69:31 parts by weight of sodium sulfate to sodium carbonate, particularly stable percarbonate particles can be obtained. […] He would try to adjust the advantageous ratio indicated in D3 and thus reach the claimed article.

A (slight) improvement in the tendency to caking is necessarily also obtained. In the opinion of the board, it constitutes an additional or bonus effect, which cannot justify an inventive step. The board takes into account that the improvement in the tendency to caking is only slight […] and possibly for this reason not mentioned in D3. (Reasons 4.9, translated from the German language).

This decision thus provides a possible criterion for establishing that a technical effect is merely a bonus effect, namely the relative low magnitude of the effect.

Of course, we should bear in mind that this is only one factor among others that may have to be taken into account.

All in all, these two decisions may helpfully contribute to containing some of the possible abuses of the problem and solution approach leading to artificial non-obviousness findings.


CASE REFERENCES:

T 2123/14, Board 3.3.07, October 27, 2016, L’Oréal.

T 2456/13, Board 3.3.05, March 7, 2017, Evonik Treibacher v. Kemira Oyj.

Clean sweep

There are at least three interesting aspects in today’s decision, as well as a sort of infuriating one. The interesting points are limitation, public prior use and inventive step. The infuriating one is a mistake made by the court, which stumbled over dependent claims – despite vocal criticisms of this type of mistakes made by various commentators over the years.

But before I address these points in turn, a few words on the background. The claimant in this case is Concept Microfibre, a French company specialized in microfiber textiles, as its name suggests. They own two French patents filed on the same day, FR 2926204 (FR’204) and FR 2926205 (FR’205).

In 2012, Concept Microfibre sued another French company Distribution de Matériel Européen (DME) as well as its Italian mother company, Filmop, for infringement of the two French patents. Further to the classical nullity counter strikes, the Paris Tribunal de grande instance (TGI) revoked claims 1, 2 and 3 of FR’205 (which were relied upon by the patent proprietor) in its judgment dated July 3, 2014; but the other patent FR’204 was upheld, and the defendants were found liable for infringement.

They appealed, which leads us to the judgment of September 27, 2016 by the Paris Cour d’appel.

On appeal, the patentee did not fight the revocation of claims 1, 2 and 3 of FR’205 by the TGI. So, this was quite easy to deal with for the appeal judges, and this part of the TGI decision was confirmed. What was more challenging for the court was to handle the other patent FR’204.

The first challenge was that the FR’204 patent was limited during the appeal proceedings, or more precisely at the onset of the appeal proceedings. The appeal was lodged on August 27, 2014, and a request for limitation of FR’204 was filed less than 2 months later, on October 16, 2014, at the INPI (French patent and trademark office). The limitation was accepted by the INPI on January 9, 2015.

The limitation consisted in combining claim 1 with claims 2 and 4.

The alleged infringers claimed that this limitation was invalid, because the limitation was requested “in order to adapt the right so as to escape a looming revocation” (uh, yes, that’s kind of the whole point of limitation proceedings) “and so as to harmonize it with the features of the products that they market” (right, too bad the patentee did not add a feature clearly not present in the alleged infringing products).

The alleged legal basis for the invalidity of the limitation was the legal principle “fraus omnia corrumpit“.

As much as I like Latin phrases, especially when I happen to know what they mean, the argument was clearly a long shot. The court easily concluded that the limitation was neither fraudulent nor improper, and that the defendants had had enough time to challenge the validity of the limited claims.

What I do find puzzling in this limitation case, though, is why the claims were limited in the first place. Usually, claims are limited on appeal when the patent is revoked in first instance (see a recent example in the Orange v. Free litigation). But in this case the patent was upheld in first instance.

Did the appellants immediately file submissions together with their appeal of August 27, 2014, and did these submissions contain new arguments which appeared more serious and threatening to the patentee? It is possible, but we cannot know for sure as the file wrapper is not part of the public record.

As far as I can tell, no new prior art was cited on appeal.

On the other hand, it seems that the appellants developed a proper argumentation of lack of inventive step, which was not the case in first instance.

In first instance, it looks like the defendants were so confident with their lack of novelty attack that they did not really focus on inventive step. Thus, the TGI simply discarded the inventive step attack by noting that:

regarding the first part of the characterizing portion [of the claim], the defendants did not make any observation on its inventive character and on the approach that the skilled person would have to make this composition and its particular structure. 

So I can only speculate that a convincing argument of lack of inventive step was newly introduced very early on appeal, which led to the limitation – unless readers have other ideas?

Anyway, the proprietor may actually have underestimated the new argument in spite, as the main claim as limited was ultimately found not to be inventive by the court!

The claim at stake was the following:

Cleaning cloth, in particular for cleaning the floor, intended to be carried by a broom, said cloth having a cleaning surface intended to come into contact with the floor, said cleaning surface comprising a textile composition made of polyolefine, and a textile composition made of hydrophilic microfibers, characterized in that:

– each of said textile composition made of polyolefine and said textile composition made of hydrophilic microfibers comprises a thread extending towards the cleaning surface, 

– the titer of the thread of said textile composition made of polyolefine is greater than the titer of the thread of said textile composition made of hydrophilic microfibers, 

– the first textile composition defines scrubbing areas and the second textile composition defines absorption areas, and

– on the cleaning surface, the textile composition made of polyolefine is slightly below the textile composition made of hydrophilic microfibers.

Brooms are not just useful for scrubbing and absorbing fluids.
Brooms are not just useful for scrubbing and absorbing fluids.

The court relied on an EPO-like approach to assess inventive step, in particular with respect to the definition of the closest prior art:

the closest prior art which is selected must be relevant, that is it must correspond to a similar use and must require the fewest structural and functional modifications to arrive at the claimed invention; said closest prior art must therefore have the same purpose or effect as the invention or at least belong to the same technical field as the claimed invention or a closely related field. 

The court identified the technical problem addressed in the patent as improving the efficacy of cleaning cloths both for scrubbing dirt and for absorbing fluids, owing to the two textile compositions. Then, the court identified three relevant documents which could represent the closest prior art, without really singling out one among the three. They all belonged to the same technical field although their purpose was slightly different (namely, the prior art cloths were intended for sweeping, not scrubbing).

The court then held that all claimed features could be found in various prior art documents. As far as I understand:

  • Two Korean documents both taught two textile compositions, one made of hard polyolefine fibers (suitable for scrubbing) and one made of hydrophilic fibers (suitable for absorbing fluids), the titer of the former being greater than the titer of the latter.
  • A PCT application disclosed distinct areas, with fibers made of a single thread extending towards the cleaning surface.
  • Finally, a U.S. patent disclosed a cloth made of fabric comprising thread loops of different lengths depending on their purpose (absorption of dirt for the longer loops and absorption of liquid for the shorter ones).

The court did not explicitly state that all these documents could be combined due to a “partial problem” approach, but this is probably what they more or less had in mind. At any rate, they noted that the claimed invention:

does not contravene any prejudice, does not represent any breakthrough relative to the methods already taught, does not overcome any technical difficulty and does not provide any unexpected or surprising result. 

On the face of it, and with the important caveat that I have not examined the prior art nor the submissions of the parties (which are not public), this conclusion seems to make sense.

On the other hand, what makes absolutely no sense is that one of the dependent claims was then revoked for lack of novelty:

Claim 5 recites that the polyolefine is polypropylene, but this claim lacks novelty, since claim 1 of Korean patent 10-0718962 already discloses fibers areas made of polypropylene. 

It is unfortunately relatively common for our judges to get dependent claims wrong. Here, the court apparently focused only on the features contained in claim 5, without realizing that these features should be read in combination with those of claim 1. If claim 1 is novel, then claim 5 is also novel. It can at best lack inventive step, like claim 1.

By the way, the frequency of this type of error regarding dependent claims is probably a factor to be taken into account by patent proprietors when determining their litigation strategy. If you know that your main claim is weak, it is probably better to amend it by way of a limitation rather than assume that a stronger dependent claim will survive if the main claim is revoked. Of course, that can happen, but you’d better not count on it.

As mentioned at the beginning of the post, the way the court handled the public prior use defense was also interesting, I will try to address it in another post.


CASE REFERENCE: Cour d’appel de Paris, pôle 5, chambre 1, September 27, 2016, Filmop Srl & SASU Distribution de Matériel Européen v. SAS Concept Microfibre, RG No. 14/18000.

Patent gone quiet

AstraZeneca holds European patent No. EP 0907364 directed to a sustained release formulation of the drug quetiapine, which is useful in the treatment of schizophrenia. This patent has been litigated for years in a number of EPC contracting states. As far as I understand, in the majority of (but not all) cases, the patent was found invalid by national courts (see by way of example relevant blog posts here and there).

With a ruling issued on July 1, 2016, France has just joined the list of countries in which the quetiapine patent has gone quiet.

U.S.-based generics company Mylan filed a nullity complaint in front of the Paris Tribunal de grande instance (TGI) on April 28, 2015, requesting revocation of the EP’364 patent. This was part of Mylan’s preparation for the launch at risk of their generic version of AstraZeneca’s patented drug, Xeroquel LP. The first boxes of generic quetiapine were marketed during the week of September 14, 2015. By that time, AstraZeneca had already counterclaimed for infringement of the patent.

On October 6, 2015, AstraZeneca boldly requested a preliminary injunction (PI) in front of a different court, namely the Lyon Tribunal de commerce, on unfair competition grounds. They were initially successful. The injunction was in place for a little bit more than one month, before being lifted by the Cour d’appel. This interesting aspect of the litigation was already discussed in detail in a previous post.

Finally (at least for now), in a judgment handed down on July 1, 2016, the Paris TGI revoked the French part of EP’364 for lack of inventive step. This is 14 months after the filing of the complaint, which from a timing standpoint is a great outcome.

Another great outcome is that, whether you agree with it or not, the court’s inventive step reasoning is very thorough and well argued.

Quetiapine as a drug for treating schizophrenia was known from the prior art, and in particular from an earlier AstraZeneca patent EP 0240228. Mylan’s case was that it was obvious for the skilled person starting from this earlier EP’228 patent to come up with a sustained release formulation of the drug, in view of the well-known advantages of this type of formulation, such as a more controlled diffusion of the active and a reduction in the number of daily doses to be taken.

AstraZeneca developed a number of arguments as a defense. First off, they said the court should apply the problem-and-solution approach. Accordingly, the closest prior art was not the EP’228 patent but rather a scientific paper by Hirsch & Casey describing clinical trials conducted with an immediate release formulation of quetiapine. As a result, the objective technical problem was not the provision of a sustained release version of quetiapine, but more broadly the provision of an efficient anti-psychotic drug treatment.

This did not fly with the court:

However, the problem-and-solution approach is only one method of reasoning which can be used, but not the only one, to assess the validity of a patent with respect to the inventive step requirement. In the present case, the reformulation of the technical problem suggested by the defendants relates to an artificial approach, the purpose of which, by broadening the scope of the technical problem, is to make the patent’s choice to look at a sustained release quetiapine formulation appear inventive. 

The court’s statement on the problem-and-solution approach is a reminder as a matter of principle that French courts are not bound by the EPO guidelines and case law. That being said, in practice, most judgments issued nowadays draw inspiration from the problem-and-solution approach: a starting point and a technical problem are defined, and the question of obviousness is analyzed through the lens of this technical problem – which is the very framework of the problem-and-solution approach. The present case is no exception.

It is well known that the formulation of the technical problem is critical in the assessment of inventive step. AstraZeneca proposed to get rid of the notion of sustained release in the formulation of the technical problem. To some extent, this makes sense as we are not supposed to include any pointer to the solution in the formulated problem.

But the issue was that the patent at stake itself formulated the technical problem as providing a sustained release formulation of quetiapine. The reformulation proposed by AstraZeneca was thus considered self-serving and ex post by the court. To put it otherwise, by arguing that the closest prior art should be a document concerned with an immediate release quetiapine formulation, the patent proprietor attempted to focus on a starting point suggesting a different direction from the one chosen in the patent, and therefore one that would almost necessarily lead to a finding of inventive step.

The court did not agree. First, an “efficient anti-psychotic drug treatment” (i.e. the problem offered by AstraZeneca) already existed at the priority date. Second, a press release by the patentee before the priority date implicitly suggested that sustained release formulations of quetiapine were being investigated.

Therefore, the realistic technical problem was the one originally mentioned in the patent, namely the provision of a sustained release formulation of quetiapine.

With that in mind, the prior art was replete with descriptions of sustained release formulations of other drugs similar to the sustained release formulation of the EP’364 patent.

Nevertheless, the proprietor argued that clinical studies at the priority date rather oriented the skilled person towards a regimen of one or two daily doses of an immediate release formulation, possibly with an increase in dosage. They added that the skilled person was not in a position to predict:

  • Whether satisfactory bioavailability could be achieved with a sustained release formulation.
  • Whether the size of a sustained release quetiapine tablet or pill would be acceptable or too large, leading to improper absorption and travel through the gastrointestinal tract.

Based on a report authored by two pharmacology experts, AstraZeneca more specifically argued that

the travel of a sustained release drug through the gastrointestinal tract is very different since the extended delivery time results in the delivery taking place in downstream areas of the digestive system, with different pH, metabolic and bacterial environment conditions, which has an impact on the release of the active substance, its metabolism, and the permeation of the active substance through the intestinal wall. 

Sometimes things can get messy in the GI tract.
Sometimes things can get messy in the GI tract.

All of these arguments were rejected by the court, either because they were not substantiated by evidence, or because they were contradicted by some of the documents on the record:

  • The necessity to increase the dose of quetiapine when switching from an immediate release formulation to a sustained release formulation was not proven. In fact the opposite was generally true based on pharmacology textbooks. Even if a larger size tablet had to be achieved, it was also possible to divide a single dose into two doses to be taken simultaneously.
  • The half-life of quetiapine was already documented at the priority date and was compatible with a sustained release formulation.
  • The undesired effect of pH on the release of the active substance was only shown in a post published document (which would not have been taken into account by the skilled person). The extent of the undesired effect was debatable in view of the declarations of the patentee’s own expert in the British litigation. And it was known by the skilled person how to thwart this pH effect by adjusting the drug formulation.
  • The prior art taught that quetiapine bioavailability increased linearly with an immediate release formulation. It could be concluded from this finding that the disruptive effect of first pass metabolism emphasized in AstraZeneca’s submissions was at best limited and was not an obstacle to a sustained release formulation.

In other terms, there was no prejudice against a sustained release formulation of quetiapine, which the skilled person was able to achieve with routine testing. It can be derived from the judgment that the court at least partly based its findings on the British litigation, and in particular on the statements of an expert who took part in that lawsuit.

One last argument dealt with in the judgment is that clinical trials performed after the patent grant showed an improved bioavailability and broader therapeutic indications with the sustained release formulation than with the immediate release formulation. But the court held that the improved bioavailability resulted from routine optimization and was not surprising; and that the broader therapeutic indications could not be relied on as they were not addressed in the patent.

The take home message is probably that if inventive step rests on obstacles or prejudices, those have to be very fully and convincingly demonstrated. The burden of proof lies on the patentee and based on the decision at stake it is a relatively heavy one.

There are two interesting side issues in the judgment.

First, Mylan claimed that AstraZeneca was guilty of unfair competition because they had warned customers about risks of infringement related to the generic version of Xeroquel LP. The court rejected the claim because AstraZeneca’s communication was deliberate and objective.

Here are some interesting comments by the court which seem to be generally applicable to similar situations in the pharmaceutical field:

When it comes to competition between an original drug and a generic one, infringement can hardly be challenged. It disappears if the patent is held invalid, but until the invalidity judgment, it is legitimate for the patent proprietor to defend its patent monopoly. Besides, the circular letter sent to stakeholders mentioned the existence of a validity challenge in objective terms. 

A generic drug manufacturer that decides to launch its product at risk before the patent on the original drug expires or is invalidated cannot blame the patent proprietor for defending its monopoly with its customers. Besides, the fact that the patent was finally revoked in other European countries does not result in a lesser legal scope for the French part of the patent as long as it is valid. 

The second point of interest relates to the PI obtained and enforced by AstraZeneca during approximately one month. Mylan claimed and obtained damages in relation with the PI, pursuant to article L. 110-10 of the Code des procédures civiles d’exécution.

The damages award amounted to approximately 200,000 euros – which was however much less than Mylan had requested.

Part of the award was calculated based on an evaluation of lost sales, to which a margin of 30% was applied.

The other part corresponded to a loss of opportunity in relation with a public tender from which Mylan had been excluded due to the PI.

On the other hand, the court did not take into account the alleged harm suffered in terms of sales of other products or in terms of image injury, in the absence of convincing supporting evidence.

Finally, reimbursement of 300,000 euros of attorney’s fees were requested by Mylan. The court granted half of it.

It remains to be seen whether there will be an appeal decision, given that it may prove difficult for AstraZeneca to obtain it before the expiry of the patent on May 27, 2017 (no SPC was filed, as the judgment tells us).


CASE REFERENCE : Tribunal de grande instance de Paris, 3ème chambre 3ème section, July 1, 2016, Mylan v. AstraZeneca, RG No. 15/05880.