Patentability in small doses

Dosage regimen inventions are one of those subjects wherein French law tends to be unique in the European patent law landscape.

By way of a reminder, patent eligibility of claims directed to dosage regimen inventions was denied in a number of court decisions. In the finasteride litigation, the Paris Cour d’appel finally seemed to align with the principles set out in decision G2/08 of the EPO’s Enlarged Board of Appeal, as it acknowledged that posology features are allowed in further medical use claims. See a summary in a previous post here.

However, first instance judges did not seem willing to follow this case law, as shown by two further decisions from the Paris tribunal de grande instance (TGI) reported on at the beginning of this other post.

In December 2017, the Cour de cassation issued its ruling on the finasteride case. The main topic of the decision however is sufficiency of disclosure, as explained in this post. Some have argued that this decision from the supreme court implicitly “acknowledged the patentability of dosage regime claims“. I tend to disagree, as it seems to me that this was simply not decided upon by the cassation judges.

A few months later, we now have a clear confirmation that the issue of patent eligibility of dosage regimen inventions is absolutely not settled.

The case at hand relates to European patent No. EP 1448207 owned by Hungarian company Richter Gedeon Vegyeszeti Gyar RT (Richter) and licensed to French company Laboratoire HRA Pharma (HRA). In June 2013, the generic drug manufacturer Mylan initiated nullity proceedings in front of the Paris TGI. Mylan launched a generic drug in early 2014. Richter tried to get a preliminary injunction against Mylan, which was denied in June 2014.

The French part of the European patent was voluntarily limited in front of the Institut National de la Propriété Industrielle in October 2014, by turning product claim 1 into an EPC 2000-type therapeutic use claim; and by merging Swiss-type claims 2 and 3 together.

On June 9, 2015, the TGI handed down its decision on the merits, revoking the patent. Richter and HRA appealed.

On March 2, 2018, the Cour d’appel confirmed the first instance decision.

The drug at stake in this lawsuit is levonorgestrel, a hormonal substance used as an emergency birth control medicine.

Claim 1 of the patent as limited reads as follows:

Pharmaceutical composition as single application dose, containing 1.5 ± 0.2 mg of levonorgestrel as active ingredient in admixture with known excipients, diluents, flavoring or aromatising agents, stabilizers, as well as formulation-promoting or formulation-providing additives, commonly used in the pharmaceutical practice, for use in emergency contraception by administering a single application dose up to 72 hours after the coitus.

Claim 2 of the patent, also modified by way of the national limitation, is the following:

Use of 1.5 ± 0.2 mg levonorgestrel for the preparation of a pharmaceutical for emergency contraception by administration of a single application dose up to 72 hours after the coitus.

At the priority date of the patent, levonorgestrel was already widely known and used for emergency contraception. It was administered in two doses of 0.75 mg each. The invention thus consisted in replacing these two doses by a single dose of 1.5 mg.

Dosage regimen patents in France are like a game of Hide & Seek.

The court noted the following:

The invention neither modifies the sought contraceptive purpose, nor the used substance (levonorgestrel), nor the total dose of 1.5 mg, nor the administration of the product within 72 hours of non-protected coitus. 

Indeed, it is not challenged that taking two doses of 0.75 mg levonorgestrel is tantamount to one dose of 1.5 mg levonorgestrel, as the additives are not the subject-matter of the invention and anyway are identical for Noverlo 1.5 mg and for Noverlo 0.75 mg.

The court then further held:

Besides, the description of the patent does not contend that the invention makes it possible to obtain better results to avoid pregnancies, or to reduce side effects, but that its purpose is to solve the problem of the difficulty for patients to comply with the taking of the second dose within a period of twelve hours from the first one, while achieving at least the same results without additional side effects. 

Thus, and insofar as the sole contribution of the ‘207 patent consists in taking the product which is identical in its substance, in its total dosage and for the same indication, in one take instead of two without any novel technical contribution or benefit other than the comfort of a single take, the first instance court rightly held that the invention is not patentable under article 53(c) of the European patent convention. 

There you have it, dosage regimen inventions can still be held non-patentable as relating to mere methods of treatment.

This applied similarly to purpose-limited composition claim 1 and to Swiss-type claim 2. This is not surprising as French courts do not typically attach importance to the exact manner in which claims are drafted. They focus on what the invention really is about.

As a further comment, we should never read too much in any given court decision.

In particular, I do not believe the present decision to be a complete reversal relative to MSD v. Actavis. In the present ruling, the court insisted on the fact that there was absolutely no technical contribution, in their opinion: same total dosage, no reduction in side effects, no efficacy improvement. In a different context, with a new dosage providing for instance improved efficacy or fewer side effects, the court might have come to a different conclusion, based on the existence of an actual technical contribution to the art.

As if one deadly wound were not enough, the court inflicted two additional ones to the patent, in a clear effort to make Richter’s way to a cassation appeal as difficult as possible.

The court thus held that the claims of EP’207 lacked novelty over clinical trials on the 1.5 mg dosage which were publicly reported on by the World Health Organization before the priority date.

And the court finally held that the claims lacked inventive step, also in view of the clinical trial reports.

As a final remark, it is somewhat paradoxical that the patent was revoked as relating to a method of treatment, whereas a method of contraception is in principle not considered at least by the EPO as a method of treatment – as pregnancy is not a disease. See example 3 in section G-VI, 7.1.2 of the Guidelines for examination. I do not know whether the argument was raised during litigation or not.

That said, if one adopts this approach, it then means that perhaps the EPO should not have granted claim 2 of the patent at least in this specific form, as the exceptional Swiss-type claim drafting format is not applicable to non-medical uses (so that the claim would or should have been found to lack novelty).


CASE REFERENCE: Cour d’appel de Paris, pôle 5 chambre 2, March 2, 2018, Richter Gedeon Vegyeszetu Gyar RT & SAS Laboratoire HRA Pharma v. SAS Mylan, RG No. 15/16651.

A skinned patent

Prevailing as a patentee in France when your patent belongs to the chemical or pharmaceutical field is extremely difficult. I will in fact provide some figures on this matter soon.

More often than not, patents are skinned alive by the court – and, bad pun intended, even dermatology is not spared, as the present case shows.

Dermaconcept JMC is a French company active in the pharma / cosmetology business. It owns a French patent No. FR 2823671 as well as a European patent No. EP 1404327 claiming the priority of the French patent. Noreva-Led is their exclusive licensee, which markets the brand of products Actipur, for the treatment of acne skin and atopic dermatitis.

Together, they initiated legal proceedings against Laboratoire Bioderma in December 2014. Laboratoire Bioderma, later merged into Naos, was accused of infringing the above patents through their product Atoderm Intensive.

In May 2016, both patents were limited at the INPI (Institut National de la Propriété Industrielle) after record-breaking 8-day long proceedings. It is reasonable to assume that this limitation came as a reaction to Naos’ initial invalidity arguments.

The limitation was however apparently not good enough for the Paris Tribunal de grande instance (TGI), as the asserted claims were found invalid in spite.

The court started by throwing out claim 9 of the French patent.

In principle, when there are both a French patent and a European patent claiming the priority of the French patent, the effects of the former cease at the end of the opposition period (assuming that no opposition is filed against the European patent, as was the case here). See article L. 614-13 Code de la propriété intellectuelle (CPI). But this is traditionally believed to be true only insofar as both patents cover the same invention.

Here, claim 9 of the French patent is directed to

A method of cosmetic treatment characterized in that it consists in applying a composition based on nicotinic acid or nicotinic acid amide, and a sphingoid base according to any one of claims 2 to 7 on exposed areas, the composition being of the emulsion type.

As this claim is not present in the European patent, it survives in the French patent. Or rather, survived – until it got revoked by the court, that is.

Article L. 611-16 CPI is worded in a manner very similar to article 53(c) EPC, and it inter alia prohibits patents on methods of therapeutic treatment.

Referring to the description of the patent, the court noted that the composition at stake is meant to treat acne and atopic dermatitis, which are diseases of the skin.

Therefore, the method is not merely cosmetic but also therapeutic, since it does entail a therapeutic effect:

In this respect, the mere mention that the field of the claim is intended to cover only the cosmetic effect is not sufficient to shield this claim from the prohibition of article L.611-16 CPI, since the therapeutic effect is in fact inseparable, and actually is expressly presented as one of the advantages of the invention in the patent description. Therefore, the fact that this method produces an aesthetic effect on the skin, namely a fairer and smoother skin, is not sufficient to shield it from the prohibition of abovementioned article L.611-16 since this effect is only the consequence of the therapeutic treatment of the composition which reduces the presence of blackheads on the skin. 

The court also noted that a very similar claim was deleted from the European application before grant, as the European examiner had raised the same objection. I emphasize this, as it is not everyday that a French court feels bolstered by the opinion of an EPO examiner.

A butterfly batch – the ideal treatment for skin disorders.

Next up were claims 1 and 10 of the French part of the European patent – as limited in front of the INPI – which are respectively a product claim and a Swiss-type claim.

Claim 1 reads as follows:

A dermatological composition useful for the treatment of atopic dermatitis, characterized in that it comprises, in combination, nicotinamide (vitamin PP), and at least one sphingoid base selected from phytosphingosine, tetraacetylphytosphingosine, N-acetylphytosphingosine, and phytosphingosine hydrochloride. 

Claim 10 is directed to:

The use of nicotinamide (vitamin PP), and of a sphingoid base according to claim 1, for preparing a medicinal product for the treatment of atopic dermatitis.

Both claims fell for lack of inventive step.

The closest prior art was found to be a Procter and Gamble (“P&G“) PCT application No. WO 99/47114. Claim 1 of the P&G reference discloses a skin moisturizing composition comprising a vitamin B3 compound and a ceramide pathway intermediate or precursor thereof. Other passages of the document disclose that the vitamin B3 compound can be selected from a list comprising nicotinamide, and that the ceramide intermediate or precursor can be selected from a list comprising some sphingoid bases, including e.g. sphingosine.

Interestingly, the P&G reference does not explicitly mention phytosphingosine or its derivatives, recited in claim 1 of the European patent. As far as I understand, phytosphingosine is a compound which is different from sphingosine.

But the P&G reference contains the following statement:

Ceramide pathway intermediates or precursors are discussed in detail in U. S. Patent 5,578,641 to Simon et al. and U. S. Patent 5,610,040 to Smeets et al., both of which are herein incorporated by reference. 

And it turns out that phytosphingosine is recited as a preferred ceramide pathway intermediate in US 5,578,641.

The court considered that the teaching of this U.S. patent completes the explicit teaching of the P&G reference, so that:

The [P&G reference], the purpose of which is to provide a composition activating and increasing the rate of ceramide synthesis and to provide improved methods of skin moisturizing […] already discloses the composition mentioned in claim 1 of the EP’327 patent, with the additional remark that […] the synergistic effect of the combination was already known. 

In other words, the court relied on the incorporation by reference of US 5,578,641 in the P&G reference in order to determine its overall teaching.

As a next step, the court stated:

It remains to be determined if it was obvious for the skilled person to use this combination to solve the problem at stake, i.e. treat atopic dermatitis.

Thus, the only difference between the claims at stake and the teaching of P&G was the fact that the composition is used for treating atopic dermatitis.

This means that the court fully took into account the therapeutic purpose recited in product claim 1 (“a dermatological composition useful for the treatment of atopic dermatitis“) as well as in Swiss-type claim 10 (“for preparing a medicinal product for the treatment of atopic dermatitis“). 

This finding is rather logical but not so straightforward given the (past?) tendency of French courts to come up with unconventional claim constructions especially when therapeutic inventions are at stake.

Going back to the final step of the inventive step reasoning, the court noted that atopic dermatitis, as set forth in the patent in suit, is known as being related to an alteration of the barrier function of the skin.

The P&G reference itself mentions that the composition improves said barrier function.

The court then turned to a secondary reference, Korean patent application No. KR 2000-0024485, specifically concerned with the treatment of atopic dermatitis. It is explained in the document that atopic dermatitis is related to skin dryness, wherein skin moisturizing is significantly reduced, which impairs the barrier function. The Korean document adds that nicotinamide increases lipid synthesis in the skin, therefore supporting the barrier function of the skin and curbing atopic dermatitis.

The court thus concluded:

It can be derived from this that the skilled person, knowing the effects of the combination comprising a vitamin B3 compound and a ceramide precursor on skin moisturizing, looking for a way to alleviate the effects of atopic dermatitis, and knowing that the latter is characterized by skin dryness and impairs the barrier function thereof, but also that nicotinamide strengthens this barrier function and that its combination with an intermediate or precursor of ceramide synthesis produces an amplified effect on the ceramide synthesis properties of vitamin B3 compounds, would use this same combination for the treatment of atopic dermatitis without exercising any inventive step. 

Claims 1 and 10 were thus declared invalid, and the infringement claims were not examined.

Whether the judges got it right or not, at least the decision looks well reasoned and in line with European case law.  

One reservation, though, is that there is no discussion in the judgment as to whether P&G was a proper starting point for the inventive step reasoning at all, despite the fact that the claimed therapeutic purpose was not mentioned in the document.

This point may not have been raised by the nullity defendants. And it may not be a big deal anyhow. It can be surmised that a similar reasoning of lack of inventive step could have been made starting from the Korean application (which is concerned with atopic dermatitis) and combining it with P&G.


CASE REFERENCE: Tribunal de grande instance de Paris, 3ème chambre 2ème section, July 7, 2017, Dermaconcept JMC & Laboratoires Nora-Led v. Naos, RG No. 15/00069.

Summertime

It is this time of year when some readers of this blog may still be enjoying what is left of the summer, albeit the back-to-work frenzy is looming – and is in fact already upon a number of us.

What we need in such a moment of transition is probably a gentle reintroduction to the delights and torment of patent law.

Matthieu Dhenne, attorney at law at Cabinet Schertenleib offers us just that, as he kindly accepted to share some comments with us regarding two decisions recently discussed on the blog.

The typical year of a patent attorney.

The first decision is B/E Aerospace Inc. & B/E Aerospace Systems GmbH v. Zodiac Aerotechnics, reported here. At stake is the hotly debated question of the limitation period for patent nullity actions in France. I may have already mentioned that the recent case law on this issue has drawn a lot of criticisms. It turns out that Matthieu is one of the vocal critics of the new trend.

Having looked in detail at what the essence of a limitation period is, Matthieu writes:

The Paris Tribunal de grande instance states (once again) that the limitation period under ordinary law (i.e. 5 years) applies to an action for patent revocation.

It is an error of law. Two brief explanations hereafter.

First, it does not comply with article 2224 of the Code civil. Article 2224 provides a limitation period for both actions in personam and actions in rem. Yet the action for patent revocation is neither one nor the other. It is not based on a debt obligation (action in personam), nor on a thing (action in rem). It is based on the defense of free competition. In this regard, we should remind that a patent right, as an exclusivity to operate an invention during a certain period of time, constitutes an exception to free competition. Therefore, as an exception, this right is only justified for patentable inventions. Rather, it is not justified for non-patentable inventions. In other words: the purpose of an action for revocation is mainly to avoid unjustified patents that will negatively affect competition.

Then, the purpose of a limitation period does not apply to it. Such a deadline aims at strengthening legal certainty. Thus, a right holder must act within a strict deadline when his right is infringed. Similarly, a right may be created over time, when a defect originally affecting it disappears. For instance, a trademark can acquire distinctiveness through use. However, on the contrary, in patent law, time may only be harmful. An invention which is not novel or inventive at the date of filing will not become novel or inventive afterwards. Rather, one could discover prior art that was not discussed during the examination phase.

Eventually, a limitation period in patent nullity suits will only introduce uncertainty. On the one hand, there are still doubts concerning the starting point of the deadline. According to the case law: date of filing, date of grant or date of formal notice. There is no strict trend concerning this question. Besides, in any event, the plaintiff must prove he was unaware of the existence of the patent: the burden of proof is upon the plaintiff. On the other hand, the defect that originally affects the patent right will not disappear over time. To the contrary, one could discover after grant that a patent is void due to prior art which was not discussed during the examination phase. Therefore, legal protection is not needed and thus not justified because it strengthens situations of facts that will never comply with the legal system. Worse: potentially, a patentee will still be able to use a patent against someone else even after it is found to be invalid.

The above case law obviously deserves much more comments. But, for now, I think there is an urgent need to stress out the fundamental legal issues at stake, hoping that the Courts will quickly remedy them.

Another important decision previously discussed by my partner Aujain Eghbali on this blog is Xaga Network v. Ewalia, in which a patent was revoked because the main claim at stake was held to relate to software as such (the programming activity field not constituting a patentable technical activity), and to actually describe “an abstract scheme which does not offer any technical solution to the application management facilitation problem it pretends to solve since it is not made explicit how the proposed management system effectively helps the user”.

Aujain said he was rather impressed by how French judges seem to have taken over the typical EPO reasoning in connection with computer-implemented inventions – even if the legal basis is not the same – as he explained in his post.

Matthieu, as far as he is concerned, has three remarks:

The Court refers to the “activity of programming” to assess technicity under article 52 EPC. However, only the invention should be technical. The question whether an activity is able (or not) to give birth to an invention exclusively falls under the inventive step assessment under article 56 EPC.

The Court states that claim 1 aims at an abstract scheme which is not explained. I think it is interesting to point out that abstraction is opposed to explanation. Two lessons. On the one hand, technicity does not require a transformation of nature (i.e. material production). On the other hand, further explanations in the description could, in fine, justify technicity. In other words: French judges are bringing the requirements of technicity and sufficiency closer together.

Eventually, the Court evokes the technical effect requirement. Nonetheless, in doing so, the Court unavoidably evokes a further technical effect, to the extent that any software already produces a first technical effect in the machine (i.e. electric current).

Speaking of computer-implemented inventions, those interested in this topic may want to mark their calendars. Indeed, Matthieu is happy to announce that an exciting full-day seminar dedicated to this very topic and put together by the AACEIPI (Association des Anciens du Centre d’Etudes Internationales de la Propriété Intellectuelle) will take place on November 24, 2017, in the prestigious premises of the Cour de cassation.

You can inquire about the seminar and register (by November 10) with Aristide Tenan, at at@schertenleib-avocats.com. Several top speakers are announced, including professors, IP judges and last but not least my partner Patrick Trabé.

Summertime, and the livin’ is easy” – this will just be a memory by the time the seminar kicks off. A belated happy August to all readers!

A new hope

Biotech and IT are complex areas, not only on the technical standpoint, but also in terms of patent law.

Reading about U-turns on plant patents or about the tricky transposition of the EPO’s software concepts into French national practice, one could be tempted to once and for all switch DNA sequences and algorithms for braking mechanisms and meat mincers. But one might be wrong. It turns out that even the most difficult of topics are not hopeless.

Today, Aujain Eghbali tells us about a new hope for patent software applicants. All sci-fi geeks will agree that a new hope can be a great beginning. But in order to find out what today’s hope is really about, you may have to read through the entire post.

Aujain reports.

Decision T 1227/05 (Circuit simulation I/Infineon Technologies) of December 13, 2006 has become a major reference for EPO examiners who need to assess the inventive step of computer-implemented mathematical methods.

The invention in Infineon related to the simulation of a circuit subject to 1/f noise. After establishing the principle that, beyond its implementation, a procedural step may contribute to the technical character of a method only to the extent that it serves a technical purpose of the method, the Board chaired by Mr. Steinbrener considered that:

  • The simulation of a circuit subject to 1/f noise constitutes an adequately defined technical purpose for a computer-implemented method, provided that the method is functionally limited to that technical purpose.
  • The metaspecification of an (undefined) technical purpose (simulation of a “technical system” as in original claim 4), on the other hand, could not be considered adequate, as the purpose of a claim in this context is not to quote the technical character requirement, but to identify clear features supported by the description which meet that requirement (Article 84 EPC).
  • A circuit with input channels, noise input channels and output channels the performance of which is described by differential equations does indeed constitute an adequately defined class of technical items, the simulation of which may be a functional technical feature.
  • Specific technical applications of computer-implemented simulation methods are themselves to be regarded as modern technical methods which form an essential part of the fabrication process and precede actual production, mostly as an intermediate step. In that light, such simulation methods cannot be denied a technical effect merely on the ground that they do not yet incorporate the physical end product.

Based upon these considerations, most EPO examiners seem to nowadays apply the following standard:

If claimed mathematical steps form a method functionally limited to an adequately defined technical purpose and related to an adequately defined class of technical items, then these mathematical steps can be taken into account in the assessment of inventive step, otherwise they cannot.

Obviously, this standard is not self-explanatory. Not only because it relies on the notion of “technical” items and purposes, and we know that the Boards of appeal are careful not to provide a generic definition of the term “technical”. But also because the standard refers to the unspecified notions of “functional limitations” of methods and of “adequate definitions” of purposes and classes of items.

A secret method for properly drafting software patent applications.

Probably without any such aim in mind, Board 3.4.01 has now expressed what could be construed as a liberal view on these notions, in decision T 0625/11 of January 19, 2017.

The decision was issued further to an appeal during examination by French nuclear power company AREVA NP. Areva

had filed European patent application No. 03775483.5 broadly relating to the use of a “transitional operation simulation” to calculate a “limit value of at least a first operating parameter of a nuclear reactor” in view of the subsequent safe operation of the nuclear reactor. Areva argued that limit values of operating parameters in the prior art were empirically determined without using a transitional operation simulation and the invention was therefore in total breach of normal practice and involved an inventive step. The application was however refused by the Examining division on the ground that the claims related to method steps without any technical character going beyond their normal interactions with a computer.

Claim 1 of the main request read:

A method for determining by a computer system at least one limit value of at least a first operating parameter of a nuclear reactor comprising a core in which fuel assemblies are charged, the fuel assemblies comprising fuel rods each having nuclear fuel pellets and a sheath surrounding the pellets,

characterized in that it comprises the steps of:

b) simulating at least one transitional operation of the nuclear reactor,

c) calculating the value reached by a physical quantity during the transitional operation in at least one sheath of a fuel rod,

d) determining, as a limit value, the value of the first operating parameter at the time when the value calculated in step c) corresponds to a value of the physical quantity characterizing a rupture of the sheath.

In its refusal decision, the Examining division held that the Infineon decision did not apply since Areva’s claim 1 was not limited to the simulation of a nuclear reactor.

The first instance examiners considered in particular that:

  • In Infineon, the invention related to a numerical simulation procedure to test an already designed circuit subject to noise.
  • Claim 1 did not have a concrete technical application of a computer-aided numerical simulation method.
  • Claim 1 did not relate to the use of a simulation step in a very specific and eminently practical and technical application.
  • Claim 1 did not define simulation steps, but a very general step of simulating a transitional operation in order to subsequently calculate values.
  • Transitional operation simulations were well known at the priority date of the application. And anyway claim 1 did not define specific characteristics of the transitional operation simulation, but a very general step of simulating a transitional operation in order to subsequently calculate values. Thus, there were no steps going beyond what was common practice for the person skilled in the art at the priority date.

During the appeal procedure, the Board first followed this reasoning but later changed its mind and admitted the main request. From a procedural point of view, it is worth noting that Areva asked in an auxiliary request introduced during the oral proceedings that two questions be referred to the Enlarged Board of Appeal. The Board actually did not consider this request lightly. They even suggested a rewording of the questions and did not reach a decision during the oral proceedings, such that the procedure was resumed in writing. But after all, the case was resolved without any referral.

The Board compared at length the Infineon liberal approach and the opposite approach which consists in ruling out method claims which do not incorporate the alleged technical goal (such as via a final step of operating a nuclear reactor). And the Board decided to follow Infineon. Furthermore, the Board considered that the fact the claimed method merely recited the calculation of a limit value did not prevent one from applying the Infineon approach to the present case.

The Board notably noted that the calculation of the value and the later use of this value were performed by different economic actors in different geographic locations, such that requiring the integration of said later use in the claim would reduce the efficiency of the patent, given the specificity of contributory infringement rules.

T 0625/11 thus constitutes a confirmation of Infineon’s principles and of its taking industrial evolution into account. But considering how Infineon is widely followed by EPO examiners, it is questionable whether such thoroughly reasoned confirmation was even needed in the first place.

But T 0625/11 is of particular interest for yet another reason.

As readers may have noted, claim 1 of the main request eventually granted by the Board is very broad. I bet drafters used to prosecuting software applications are counting the number of clarity-related objections they could raise.

The Board itself conceded:

The terminology used in claim 1 leads to the recognition of a very broad scope for the claimed process. This observation stems from the fact that a transitional operation of the nuclear reactor is reported without specifying its parameters. Similarly, the reference to the notion of “physical quantity” and “first operational parameter”, without specifying its nature, permits an in-depth interpretation of the claimed process.

But then:

The Board notes that the skilled person would have immediately recognized that the problem posed is in no way limited by the nature of the parameters chosen. Similarly, whatever the degree of sophistication of the transitional mode of operation selected, its modeling will only involve well-known operating principles, which finite element calculation algorithms can account for.

The fact that the principles we are discussing incorporate a complex set of laws relating to nuclear physics, to the resistance of materials, to thermal physics, to thermodynamics does not affect this observation. In this respect, the teaching of the initial application, combined with the general knowledge of a person skilled in the art, justifies the degree of generalization resulting from the formulation adopted for the application.

Regarding sufficiency of disclosure, the Board held:

With regard to the disclosure of the invention, the Board deems that the broad scope of the claims does not in any way impede the achievement of the invention over the entire area claimed. The laws of physics mentioned above are in fact able to account for the evolution of the relevant parameters, in spite of the complexity of the phenomena at hand, since the transitional operation and the operating conditions and parameters are sufficiently defined.

And regarding clarity issues when assessing inventive step:

In this case, the definition of the technical problem adopted by the applicant appears realistic. The invention aims at determining at least one limit value of an operating parameter of a nuclear reactor in order to allow better exploitation of the capacities of the latter.

Similarly, the nature of the parameters involved in the simulation (constraints, temperatures, heat capacity, pressures, dimensions, etc.) also confers a technical character to the claimed invention.

The bar on clarity at the EPO has always been high for software inventions in general and computer-implemented mathematical methods in particular, leading to a number of issues. It can of course be very costly for applicants in this field to ensure that all implementation details are included in the application in case there is a clarity objection. But there is also a specific issue related to the way Infineon is applied by examiners in practice: if a method claim is broad or unclear, it is easy for them to hold that the method is not “functionally limited” to a technical purpose or that said purpose is not “adequately defined”.

The generosity of Board 3.4.01 in decision T 0625/11 might constitute a source of hope for applicants who had become desperate because of this difficulty.


CASE REFERENCE: T 0625/11, Board 3.4.01, January 19, 2017, AREVA NP.

U-turn at the EPO

Who said patent law is boring? Sometimes, it can be as hectic as an episode of 24.

Look at the unitary patent package. One day it is supposed to enter into force anytime soon, then a UK referendum creates mayhem. In the following episode, the project is back on tracks. Next thing you know, bang, a constitutional challenge in Germany pops up in the season’s finale, and this is your cliffhanger until the next season.

These days, the same seems to be true of the issue of patentability of plants and animals obtained by essentially biological processes. Lionel Vial reports.

Some news regarding the patent eligibility of plants or animals obtained by essentially biological processes, which was previously discussed here and there on this blog.

On June 29, 2017, the Administrative Council of the EPO took a decision amending Rules 27 and 28 of the Implementing Regulations to the EPC.

Here are the amended Rules (with the amendments underlined):

Rule 27 – Patentable biotechnological inventions

Biotechnological inventions shall also be patentable if they concern:

(a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;

(b) without prejudice to Rule 28, paragraph 2, plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety;

(c) a microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.

Rule 28 – Exceptions to patentability

(1) Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:

(a) processes for cloning human beings;

(b) processes for modifying the germ line genetic identity of human beings;

(c) uses of human embryos for industrial or commercial purposes;

(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.

(2) Under Article 53(b), European patents shall not be granted in respect of plants or animals exclusively obtained by means of an essentially biological process.

Breaking news: Archie Asparagus and Charlie Carrot remain patentable.

The decision also provides that amended Rules 27 and 28 entered into force on July 1, 2017 and that they apply to European patent applications filed on or after this date, as well as to European patent applications and European patents pending at that time.

The interpretation of the amendments appears to be quite straightforward: plants or animals which are exclusively obtained by means of an essentially biological process are not patent eligible.

To make a long story short, this decision aims at putting an end to a story which began with decisions G 2/12 (Tomatoes II) and G 2/13 (Broccoli II) of March 25, 2015 of the Enlarged board of appeal (EBA) of the EPO. These decisions held that the exclusion of essentially biological processes for the production of plants in Article 53(b) EPC does not have a negative effect on the allowability of a product claim directed to a plant or plant material such as a fruit or plant part. The EBA decisions caused a certain turmoil in Europe, triggering fears among the public that producers and growers of plants obtained by essentially biological processes might be patent barred from practicing their activity.

As a consequence, France excluded from patentability products exclusively obtained by essentially biological processes for the production of plants and animals on August 8, 2016 (the Netherlands and Germany had already done so in 2010 and 2013).

Furthermore, the European Commission issued a notice on November 8, 2016 taking the view that the EU legislator’s intention in the so-called Biotech Directive 98/44/EC was to exclude from patentability products (plants/animals and plant/animal parts) that are obtained by means of essentially biological processes.

Eventually, a notice from the EPO dated November 24, 2016 informed the public that follow-up measures further to the Commission’s notice were under discussion with representatives of the member states of the European Patent Organisation. Pending this discussion, proceedings before EPO examining and opposition divisions in which the decision entirely depended on the patentability of a plant or animal obtained by an essentially biological process were stayed ex officio.

So, is the decision of the Administrative Council of June 29, 2017 the end of the story?

Well, we are not so sure.

Indeed, there are at least two points which will require some clarification in our opinion.

The first point regards the interpretation of the word “exclusively”, which happens to be found nowhere in the EPC nor in the Biotech Directive. Besides, to our knowledge, no guidance has been offered by the legislator either (the Administrative Council in this case) on its intent when using that word.

Let’s try by ourselves then.

The first interpretation which comes to mind is that “exclusively” is merely meant to emphasize that plants or animals which are obtained by means of a mix of an essentially biological process and a non-essentially biological process are not excluded from patentability.

In that case, “exclusively” may seem a little superfluous, as simply providing that European patents shall not be granted in respect of plants or animals obtained by means of an essentially biological process would probably also have made the job.

The second interpretation is that “exclusively” relates to the different ways the plant or the animal can be obtained. According to that interpretation, European patents would be denied only for plants or animals which at the filing date could only be obtained by an essentially biological process, whereas plants or animals which at the filing date could be obtained by an essentially biological process but also by an independent non-essentially biological process would still be patentable.

As readers will surely have noticed, this interpretation is reminiscent of decision G 2/06 of the EBA according to which, with respect to Rule 28(c) which prohibits the patentability of uses of human embryos for industrial or commercial purposes, the prohibition only concerns claims directed to products which – as described in the application – at the filing date could exclusively be prepared by a method which necessarily involved the destruction of the human embryos from which said products are derived (even if said method is not part of the claims).

It could thus be possible, under this interpretation, that a European patent could still be granted for a claim pertaining to a plant or an animal, which is only described in the application as being obtained by means of an essentially biological process, provided this plant or animal could also have been obtained by a non-essentially biological process at the filing date.

The second point to be clarified regards the application of amended Rules 27 and 28 EPC to European patent applications and European patents pending on July 1, 2017, i.e. filed before their entry into force, which in our opinion does not follow as evidently from the decision of the Administrative Council as the latter may consider.

Here again, G 2/06 offers some guidance.

The EBA further decided in that case that Rule 28(c) EPC (formerly Rule 23d(c) EPC), which was introduced by decision of June 16, 1999 of the Administrative Council of the EPO, applied to all pending applications, including those filed before the entry into force of the rule. It seems quite clear.

However, in point 13 of the decision the EBA notes that:

The introduction of this new chapter without any transitional provisions, can only be taken as meaning that this detailed guidance on what was patentable and unpatentable was to be applied as a whole to all then pending applications. It has not been argued that Rule 28 (formerly 23d) EPC took away the possibility to patent anything which had previously been regarded as patentable under Article 53(a) EPC, nor that the Directive did so (see in this respect the reference in Art. 6(1) to what is contained in Article 53(a) EPC as well as the reference to the TRIPS Agreement in Article 1(2)). Already by 1984 (see Dolder, Mitteilungen der Deutschen Patentanwälte, 1984, 1, “Barriers to patentability of biotechnological inventions under the EPC”), instrumentalization of the human body (as opposed to parts of it), thus degrading it to an object of technology, had been considered as a barrier to patentability. There is no indication that the commercial exploitation of human embryos was ever regarded as patentable.

Well, in the case at hand, it appears that plants or animals obtained by means of essentially biological processes were indeed previously regarded as patentable under Article 53(b) of the EPC (remember G 2/12 and G 2/13?).

Accordingly, there does appear to be a ground to challenge the application of amended Rules 27 and 28 EPC to applications and patents filed before July 1, 2017 before the boards of appeal of the EPO.

In fact, clarifications will surely be brought to the above points, as the agriculture industry is not deprived of deep-pocketed applicants who will fiercely defend their applications before the examination/opposition divisions and boards of appeal of the EPO.

Thank you Lionel. Let’s wait for the next episode then. But, dear readers, don’t hold your breath, though. 24 hours is not exactly the kind of time scale we are talking about in the patent law saga.