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.

One thought on “Patentability in small doses”

  1. Dear Renaud,

    Thank you for your (still) interesting comments.

    This is not a very surprising decision after all (coming from our Paris Court of Appeal I mean).

    In any event, I noticed a little mistake in the reasoning: the exception of Article 53 (c) EPC does not result from a lack of technical character but from the protection of the public interest (preservation of the freedom of prescription in this case).

    It is a common mistake to consider the exception of treatment methods is related to the technical character, as it was the case before. However, since the EPC 2000, the rejection of the patentability of these methods has been moved from Article 52 to Article 53, precisely to avoid that the requirement of technical character could authorize a circumvention of this rejection.

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