- Methods of medical diagnosis and/or treatment have long been patentable in Australia.
- In Europe and New Zealand methods of medical treatment and/or diagnosis have long been excluded from patentability. However, the scope of these exclusions has recently been narrowed.
The European Patent Convention and New Zealand Patents Act specifically exclude methods of medical diagnosis and/or treatment from patentability. A recent European decision and a proposal by IPONZ have narrowed the scope of these exclusions.
Whether methods of medical diagnosis and/or treatment should be patentable is a controversial question to which countries around the world have reached different conclusions.
In many jurisdictions, methods of medical diagnosis and/or treatment have long been considered unpatentable. For example, both the European Patent Convention ("EPC") and the New Zealand Patents Act 1953 ("the NZ Act") specifically exclude such methods from patentability. However, the scope of these exclusions has recently been narrowed.
In Australia, methods of medical diagnosis and/or treatment have been patentable for decades.
Under Article 52(4) of the EPC, "methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body" are excluded from patentability.1 The scope of this exclusion has long been uncertain, with various Technical Boards of Appeal of the EPO delivering inconsistent decisions. However, in December 2005, the Enlarged Board of Appeal of the European Patent Office ("EPO Board of Appeal") issued a decision http://legal.european-patent-office.org/dg3/pdf/g040001e.pdf both clarifying and narrowing this exclusion.2
The EPO Board of Appeal held that in order for the subject-matter of a claim relating to a diagnostic method practised on the human or animal body to fall under the prohibition of Article 52(4), the claim must include features relating to:
- "the diagnosis for curative purposes stricto sensu representing the deductive medical or veterinary decision phase as a purely intellectual exercise;
- the preceding steps which are constitutive for making that diagnosis; and
- the specific interactions with the human or animal body which occur when carrying those out among these preceding steps which are of a technical nature."
Whether or not a method is a diagnostic method within the meaning of Article 52(4) neither depends on the presence or participation of a medical or veterinary practitioner, nor on the fact that all method steps can also, or only, be practised by medical or technical support staff, the patient himself/herself or an automated system. Moreover, no distinction is to be made in this context between essential method steps having diagnostic character and non-essential method steps lacking it.
Stating that it is "difficult to see why applicants and inventors in the field of diagnostics should be deprived of a comprehensive patent protection", the EPO Board of Appeal took a restrictive interpretation of the patent exclusion for diagnostic methods. Inventions referring exclusively to new methods carried out during the examination phase in order to collect clinical data of a human being or animal independent from the subsequent use of these data may no longer be excluded from patentability under Article 52(4).3 As an example, methods for obtaining data, in-vitro diagnostic techniques and measurements of blood parameters are patentable.
Section 2 of the NZ Act also excludes methods of medical treatment from patentability. The New Zealand Court of Appeal in Pfizer Inc. v. The Commissioner of Patents  NZLR 362 held that methods of medical treatment of humans do not meet the definition of a patentable invention according to section 2(1) of the NZ Act and section 6 of the Statute of Monopolies 1623. However, in November 2005, the Intellectual Property Office of New Zealand ("IPONZ") issued a Proposed Patent Practice4 relating to the medical treatment of humans, which defines the scope of the exclusion in a similar manner to the EPO Board of Appeal. Although diagnostic methods are in principle excluded from patentability when practised on the human body, "in vitro diagnostic tests, performed on blood or on other samples removed from the body are patentable as it is considered to be an intellectual exercise". IPONZ further stated that a claimed method of diagnosis, which "involves a number of steps including data gathering, comparison of the data with normal values and recording any deviation, and finally attributing the deviation to a particular clinical picture" and "thereby makes it possible to decide on a particular course of treatment", is clearly unpatentable. IPONZ did not clarify, however, whether a method of diagnosis including only one step performed on a human body would necessarily constitute an unpatentable diagnostic method.
The Australian Patent Office ("APO") has accepted the patentability of methods of medical treatment since the early 1970s.5 The patentability of such methods was confirmed in 1994 by the Full Bench of the Federal Court in Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) AIPC 91-076, 28 IPR 383. That case held that there was no justification in law or logic to distinguish a process of curative treatment of the human body from that of cosmetic treatment, and that both of these forms of treatment may constitute a manner of manufacture provided they have commercial application. In 2000, the Full Bench of the Federal Court in Bristol-Myers Squibb Company v FH Faulding & Co. Ltd  FCA 316 reconsidered Rescare and affirmed that methods of medical treatment are patentable in Australia.
1. The EPO Board of Appeal has defined a diagnostic method to require the following four steps, the first three of which are identified as "preceding steps", while the fourth represents the actual diagnosis for curative purposes: (i) the examination phase involving the collection of data; (ii) the comparison of these data with standard values; (iii) the finding of any significant deviation, ie. a symptom, during the comparison; and (iv) the attribution of the deviation to a particular clinical picture, ie. the deductive medical or veterinary decision phase.
2. Case number G 0001/04 (16 December 2005):http://legal.european-patent-office.org/dg3/pdf/g040001e.pdf
3. However, the EPO Board of Appeal has made clear that where an invention does refer to a diagnostic method, rather than to a preceding method of data acquisition or data processing, the Article 52(4) patent exclusion cannot be circumvented by simply omitting one of the essential diagnostic method steps (see footnote 1), from the patent claim. Such a method claim would contravene Article 84 EPC which requires that, in order to be patentable, an independent claim must recite all the essential features which are necessary for clearly and completely defining a particular invention.
4.Guidelines on Application Relating to the Medical Treatment of Humans (16 November 2005).
5. In itsPatent Manual of Practice and Procedure the APO states that "it is now firmly established that methods of medical treatment are patentable subject matter, and there is no objection to this aspect of an invention."
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