Not just for medicaments: broadening horizons in Europe

A recent decision by the Board of Appeal (BoA) of the European Patent Office (EPO), T 2003/08, has changed the criteria for second medical use patent protection in Europe. Here we examine the implications for protection by second medical use claims, with a focus on areas that may not fit the traditional concept of a ‘medicament’.

Although it is generally not possible to patent methods of treatment of humans or animals in Europe, due to their legislative exclusion from patentability, there has been a long-established principle of allowing equivalent patent protection by reformatting ‘method of treatment’ claims as ‘medical use’ claims.

Protection is available if either an active substance or composition is used in medicine for the first time (‘first medical use’), or if it has been used in medicine previously but is now being used in a new therapy (‘second medical use’).

For many years, the accepted format of a second medical use claim in Europe was based on language explicitly approved by the EPO’s Enlarged Board of Appeal (decision G 5/83), which takes the form:

“Use of [a specified substance or composition] for the manufacture of a medicament for the treatment of a [specified therapeutic application].”

This format clearly applies to active substances or compositions that are used in the preparation of readily-recognisable ‘medicaments’. However, other forms of treatment can sometimes involve the presentation of active substances or compositions in the form of devices that are not generally regarded as a medicament.

Over the years, and despite the introduction of a new second medical use claim format that no longer explicitly uses the term ‘medicament’, there has been considerable uncertainty over the extent to which therapies not using typical medicaments can be protected by second medical use claims.

A body of case law had developed, establishing a variety of requirements for medicaments to be eligible for protection by a second medical use format claim, including:

1.    It must be administered, or used to deliver a therapeutic, to the patient’s body. A claim defining the manufacture of a blood filter for treating extracorporeal blood was not allowed (decision T 138/02), whereas the manufacture of an inhalation delivery device was (decision T 138/95).

2.    It must be consumed in use. A ‘laser surgery system’ was not allowed (decision T 227/91), because medicaments are “expended in the process of use and have only a once for all utility”, unlike surgical instruments. By contrast, the blood filter of T 138/02 (supra) was considered to be consumed because “the adsorbent is changed during its use” by binding its ligand.

3.   It must be a finished product, made by an industrial process, and ready to perform its therapeutic function without further modification. A device for use in the surgical repair of a body passageway was refused (decision T 775/97), because the manufacture of the “finished product” could occur only by bringing together multiple parts inside the patient.

4.  The therapeutic effect of the medicament must result from the substance or composition from which it is manufactured. A claim to the manufacture of a biocompatible strip for treating female urinary incontinence was not allowed (decision T 1099/09) as the therapeutic effect did not stem from the material itself but from the geometry and positioning of the strip as applied to the body.

Such case law made it generally difficult to obtain second medical use protection for medical devices at the EPO. Moreover, a precise definition of the term ‘medicament’ had not been forthcoming from the BoAs, with the risk that ever more convoluted definitions might restrict opportunities for the patenting of second medical uses without justification.

Decision T 2003/08

European patent EP 862444 was opposed, and considered by the BoA, with the following independent claim:

“1. Use of a specific ligand … in the manufacture of a column having said ligand coupled thereto for the treatment of a patient suffering from dilated cardiomyopathy (DCM) …”

At issue was whether the “column having said ligand coupled thereto” satisfied conditions 1 to 4 above—that is, whether it was a true ‘medicament’.

Although the BoA found no reasons to conclude that the column did not satisfy the established conditions to be a medicament, it was particularly striking that the BoA commented:

“… an assessment of whether or not a ‘medicament’ is used is not in fact needed.”

In arriving at this decision, the BoA explained that:

“… it is therefore of pivotal importance to establish whether or not the means used in the treatment of DCM according to the present claims constitute a ‘substance or composition’, rather than to establish whether or not it constitutes a ‘medicament’.”

Accordingly, the BoA concluded that:

“… it is decisive for determining whether or not a ‘substance’ or ‘composition’ is used in a treatment to establish (a) the means by which the therapeutic effect is achieved and (b) whether that which achieves the therapeutic effect is a chemical entity or composition of chemical entities.”

In applying the rationale to EP 862444, the BoA found that the “specific ligand” as used in the manufacture of the column was indeed a “chemical entity”, and was responsible for bringing about the therapeutic effect on the patient. The BoA judged that the claim was a valid second medical use claim, irrespective of whether the manufactured column was a true ‘medicament’.

Accordingly, the question of whether a ‘medicament’ is made is irrelevant to the validity of a second medical use claim. Rather, it is decisive that the claim relates to a therapeutic effect caused by molecular interaction between a chemical entity and a patient’s body, irrespective of whether that chemical entity is presented in the form of a medicament, or as part of a device.

Conclusion

This decision appears to release the shackles imposed by the EPO’s earlier complex case law, and opens new opportunities for second medical use claims in which active chemical entities are not formulated as ‘medicaments’.

Therefore, it is highly relevant for protecting new medical uses of columns and other devices containing active chemical (including biological) entities.

Andrew Wright is a partner in the biotechnology and pharmaceuticals group at Potter Clarkson LLP. He can be contacted at: andrew.wright@potterclarkson.com

Tom Harding is an associate in the biotechnology and pharmaceuticals group at Potter Clarkson LLP. He can be contacted at: tom.harding@potterclarkson.com