Earlier this year the UK Intellectual Property Office (UK IPO) updated their “Examination Guidelines for Patent Applications relating to Medical Inventions in the Intellectual Property Office” (“the Medical Invention Guidelines”).
The document supplements the UK IPO “Manual of Patent Practice“, setting out practice in the field of Medical Inventions, including what constitutes excluded methods of treatment by therapy or surgery and methods of diagnosis, as well as considerations relating to medical use claims. The aim is to provide applicants with legal certainty, whilst providing UK IPO examiners with a reference document in this complex field.
The majority of the changes made to the Medical Invention Guidelines reflect a number of important decisions made by the EPO in this field in the last few years. As such, the changes will not be particularly surprising for those familiar with EPO practice, and indeed UK IPO examiners have already adopted many of the changes.
The following is not intended to be an exhaustive list of all the changes.
Second Medical Use Claims (paragraphs 94-102 & 154-155)
Since the implementation of the Patents Act 2004, it has been possible to draft second medical use claims in the form “substance X for use in the treatment of disease Y”. It is therefore no longer necessary to use the fancy footwork of the “Swiss-type” claim (“use of substance X in the manufacture of a medicament for the treatment of disease Y”). Following the Enlarged Board of Appeal decision in G 02/08, such “Swiss-type” claims are no longer allowable. In a difference from EPO practice, this rule applies to all pending applications; “Swiss-type” claims in pending application must be deleted, or can be replaced with appropriate second medical use claims.
The Medical Invention Guidelines have also been updated in relation to the scope of second medical use claims. A claim to a known drug for a particular use will not cover derivatives of that drug for the same use. Also, the presence of a claimed compound as an impurity in a medicament does not fall within the scope of a second medical use claim.
Medical Use Claims & Selection Inventions (paragraphs 119 & 120)
Taken from the UK Court of Appeal decision in Dr Reddy’s Laboratories v Eli Lilly and EPO Board of Appeal decision T 939/92, the following criteria should be applied to selection inventions to determine obviousness where a particular compound has been selected from a prior art disclosure: (i) the selection must not be arbitrary but must be justified by a hitherto unknown technical effect; (ii) a technical effect which justifies the selection of the claimed group must be one which can be fairly assumed to be produced by substantially all the selected members; and (iii) this technical effect can only be taken into account if it can be accepted as having been indicated in the specification as filed.
Dosage Regimes & Treatment of New Patient Groups (paragraphs 131-137 & 140-142)
As a result of the UK Court of Appeal decision in Actavis v Merck, and following the EPO Enlarged Board of Appeal decision in G 02/08, the Medical Invention Guidelines have been updated to reflect the UK IPO’s new practice regarding dosage regimes. Second medical use claims defined by a new dosage regime, or new modes of administration should not generally be objected to as being an unpatentable method of treatment. Thus, it is possible to obtain protection for a new use relating to a new method of administering a known agent to treat a known disease.
In relation to identification of new patient groups, the Medical Invention Guidelines reflect a difference between UK IPO and EPO practice. The UK IPO will find that a second medical use claim to an agent for use in the treatment of a disease in a specific patient group is not new if the agent has already been used to treat the same group of patients amongst others, with the same disease. This results from similar rationale to that applied to the situation where a second medical use claim relating to the same therapeutic use as the prior art, but claim a different mechanism of action; such a claim will be rejected as lacking novelty because the new mechanism of action is no more that a discovery.
Methods Of Treatment By Surgery (paragraphs 45-50)
The Medical Invention Guidelines have been updated to reflect the leading EPO Enlarged Board of Appeal decision G 01/07. The Enlarged Board found that a broad interpretation of this exception was not justified, but that a method should be excluded if it constitutes a non-insignificant physical intervention, which entails a substantial health risk even when carried out by a medical professional. Thus, a surgical method is should be invasive, require professional skill, and carry a potential risk. The presence of a medical practitioner is not a pre-requisite for a method to be excluded, but whether or not a surgeon is involved is an important consideration. G 01/07 also decided that surgical methods can be excluded whatever their purpose; thus, methods of surgery for cosmetic purposes will not be patentable.
Multi-Step Methods Involving A Surgical, Therapeutic Or Diagnostic Step (paragraphs 67-69)
In a change to previous UK IPO practice, the Medical Invention Guidelines have been amended in line with G 01/07, to state that any multi-step method which includes a step comprising a method of surgery or therapy step is excluded from patentability. However, for methods of diagnosis, a claim will only be excluded if it includes all the steps required for making a diagnosis (i.e. collection of data, comparison with normal values, recording deviation from norm, and attributing the deviation to a particular clinical picture).
Apparatus For Surgery, Therapy Or Diagnosis (paragraph 71)
Whilst apparatus for surgery/therapy/diagnosis are patentable, it is not possible to claim the first or second medical use of such apparatus. First and second medical use claims are restricted to substances and compositions. This mirrors existing EPO practice.
Undisclosed Disclaimers (paragraphs 25 & 29)
In line with previous UK IPO and EPO practice, it is possible to overcome a method of treatment objection by disclaiming non-patentable subject matter (e.g. “a non-therapeutic method of…” or “a cosmetic method of…”). However, the Medical Invention Guidelines have been updated to make clear that such a disclaimer is only allowed if the description provides support for the non-therapeutic method.
In addition, such a disclaimer can only be used to exclude therapeutic/surgical methods of treatment where the therapeutic and cosmetic methods are not “inevitably linked, such that each one necessarily develops together with the other and such that it is impossible to separate them”.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.