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1. Contrary to morality | Raising objections under section 17(1)

The practice note of 2008 entitled Contrary to morality | Raising objections under section 17(1) has caused some confusion with respect to the nature of what would and would not be objectionable under section 17(1) of the Patents Act 1953.

The final paragraph of the 2008 practice note was included to provide a general guide as to the subject matter which may attract an objection under section 17(1) of the Patents Act 1953.

For clarification IPONZ has revised the Practice Note as follows

"Contrary to morality | Raising objections under section 17(1)

IPONZ has reviewed its practice with regard to raising objections under s17(1) of the Patents Act 1953.

IPONZ will continue to raise objections under s17(1) where it appears that the use of the invention would be contrary to morality for New Zealand society as a whole or for a significant section of the community. In doing so, IPONZ considers that it may for any given application under consideration take the following into account: the concerns of interest groups, evidence including appropriate public polls and research, corresponding foreign legislation, caselaw and guidelines.

As a general guide, claims to the following subject matter are likely to attract an objection under s17(1): human beings, processes which give rise to human beings and biological processes for their production; methods of cloning human beings; human embryos and processes requiring their use; transformed host cells within a human and other cells and tissues within a human.”

2. Guidelines for the examination of Swiss-type claims

This document provides guidelines on applications relating to the Swiss-type claims under the Patents Act 1953 (“the Act”). These Guidelines supersede all previous practice notes, guidelines and the like. The Guidelines do not constrain the judgment and discretion of the Commissioner of Patents. Every application and patent will, as always, be considered on its own merits in light of legislation, case law, these Guidelines and any other information as may be considered relevant in view of the particular facts of each application or patent. These Guidelines are to be considered solely as a guide and should not be quoted or considered to be a legal authority. These Guidelines may become obsolete in whole or in part at any time without notice. Authority must be found in the Patents Act 1953, the Patents Regulations 1954, decisions of the Commissioner and in decisions of the New Zealand Courts.

Introduction

The exclusion to patentability of methods of medical treatment has historically caused problems for applicants and the Intellectual Property Office of New Zealand (IPONZ). Where a substance already known to treat a first medical condition is found to be useful in treating a second medical condition and this second new use has previously been unrecognised - the substance itself cannot be patented because it is not new and the method of using the substance as a medicament is not a patentable invention as confirmed by the Court of Appeal in Pfizer Inc v The Commissioner of Patents [2005] 1 NZLR 362 (Pfizer).

In Europe and the UK, where methods of medical treatment of humans are also unpatentable, the Swiss-type claim was devised to enable second medical uses to gain some patent protection. These claims were termed “Swiss-type” claims since they were allowed in a decision of the Swiss Intellectual Property Office which was subsequently followed in a corresponding decision by the European Patent Office (EPO) Enlarged Board of Appeal in G 05/83 (EISAI/Second medical use OJEPO 1985, 64). The Enlarged Board of Appeal held that claims for “the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic application” are allowable.

If the use of the compound for the therapeutic purpose is new, then such a claim is considered to be novel, even if the same substance had previously been used in medicine for a different purpose.

The protection of the second or further therapeutic use by Swiss-type claims was allowed in New Zealand by the Commissioner of Patents in a Practice note which appeared in Patent Office Journal 1412 on 7 July 1997, and was approved by the Court of Appeal inPharmaceutical Management Agency Ltd v Commissioner of Patents [2000] 2 NZLR 529 (Pharmac).

It should be noted that there is a significant lack of jurisprudence in New Zealand which considers Swiss-type claims. By far the most significant body of case law which addresses Swiss-type claims is to be found in foreign jurisdictions, most especially from the European Patent Office (EPO) and the British Courts. However, caution should be exercised before applying foreign decisions to the examination of New Zealand patent applications, as frequently the foreign decision is based upon specific parts of foreign legislation or directives which provide directly for second medical use claims and which may not have a corresponding provision in New Zealand patent legislation.

Novelty – the new use

The novelty of a Swiss-type claim is assessed using the same criteria as those applied to claims for active substances per se i.e. by application of the test recited in The General Tire & Rubber Company v The Firestone Tyre And Rubber Company and others [1972] RPC 457 (General Tire). For a Swiss-type claim to be anticipated, there should be clear and unmistakable directions found in the prior art to make or do that which is claimed in the claim in question. Therefore, the prior art should specifically disclose the use of the active substance in the purported new therapeutic application.

The decision of the Commissioner in the 7 July 1997 Practice Note, and the decision of the Court of Appeal in Pharmac, established that the use of a substance for a new and inventive therapeutic use can be protected by a Swiss-type claim. Swiss-type claims are used to effectively protect the use of an active substance or composition in the manufacture of a medicament for the treatment of a “new use”, where the substance or composition had previously been used for the treatment of a different condition i.e. a different use. Providing that the new use is not known, such claims are considered to be novel.

Swiss-type claims that are distinguished from the prior art by a novel dosage regime or mode of administration have been considered in pre-acceptance hearings, see Abbott Laboratories (P16/2003), Merck & Co v Arrow Pharmaceuticals (P3/2006) and GenentechP1/2007 . The Merck and Genentech decisions agree with one another, although a different view was reached in the earlier Abbott Laboratories decision which approved the UK caseBristol-Myers Squibb v Baker Norton Pharmaceuticals [2001] RPC 1 (Taxol).

The Merck and Genentech decisions approved and applied a corresponding European caseGenentech Inc (T1020/03). In light of the New Zealand Merck and Genentech decisions, IPONZ will accept Swiss-type claims where the purported novelty of the new use can be found in the new mode of administration or new treatment regime.

The Court of Appeal in Pharmac stated at paragraph [38] of their judgment that:

“The step necessary to render Swiss-type claims acceptable would be to recognise what is in fact the situation that the novelty as well as the inventiveness resides in the newly discovered purpose for which the medicament is to be used.”

Subsequently the Court stated at paragraph [65]:

“Once it is accepted that there can be new invention in the discovery of previously unrecognised advantageous properties in a chemical compound, the obligation to make patent protection available must apply.” (Emphasis added);

and at paragraph [66]:

“It must be emphasised that, because of the manner in which this matter has come before us, we have proceeded upon the assumptions of inventiveness in the discovery of the further pharmaceutical use and lack of anticipation of the use. Those are matters to be considered on a case by case basis” (Emphasis added)

The “previously unrecognised advantageous properties in a chemical compound” referred to in Pharmac is therefore interpreted as referring to properties of the chemical substance which makes it efficacious in the new use e.g. the treatment of a disease or condition (including a new mode of administration or treatment regime).

New mode of administration or treatment regime

As noted above, the interpretation of “previously unrecognised advantageous properties in a chemical compound” also encompasses a novel dosage regime or mode of administration, see the hearing decisions of Merck P3/2006 and Genentech P1/2007.

In Genentech, the Assistant Commissioner when discussing the allowability of Swiss-type claims (where the novelty resides in a new mode of administration or treatment regime) noted that the new method of treatment in the application under review provided a means to overcoming a problem or providing an advantage over the prior art and that it was the contribution, i.e. overcoming a disadvantage in the art, which was patentable:

“Although IGF-1 clearly has valuable therapeutic properties, there are apparently serious problems concerning observed side-effects and the fact that IGF-1 becomes ineffective with continued use. The Applicants have produced a means of overcoming or alleviating these problems by the application of a specific dosage regime and I think it proper that they should be able to obtain patent protection for their contribution” (Emphasis added).

Where the purported new use in a Swiss-type claim relates to a novel dosage regime or mode of administration then an objection generally shall not be made if the claimed subject matter overcomes a particular disadvantage or provides an advantage over the prior art (see Merck, Genentech and T1020/03 Genentech).

Mere novelty in a dosage regime or mode of administration will not automatically render a Swiss-type claim as a new invention unless the new use is a “new result”. Pharmac at [60] discusses the context of the allowability of the “new use” being an invention to the same extent as weed eradication using a novel combination of known compounds was a “new result” (see NRDC’s Application [1961] RPC 134).

“It (a Swiss-type claim) is not a product claim because a combination of the active compound and the carrier not made for the purpose of producing a cancer treatment medicine would not infringe. Nor would sale of the combination for other purposes. It is akin to a method claim by which the newly discovered properties of the active compound can be exploited and an essential element in the use is the intended end result - as it was in the application of the selective herbicide in NRDC…”

The judge in NRDC when reviewing the Elton and Leda Chemicals decision (1957 RPC 257) quoted at p145:

“It has been appreciated that although the inventor may use no newly devised mechanism or device nor produce a new substance, none the less, he may by providing some new and useful effect appropriate for himself a patent monopoly in such improved result by covering the mode or manner by which his result is secured. Seeing that the promise is some new and useful effect, there must of necessity be some product by which his promise can be tested.”

The “product” need not be a product per se where a process is concerned but should result in something upon which the promise of the claimed process can be tested.

As discussed above, the new use in a Swiss-type claim is dependant upon the discovery of a previously unrecognised property of a known chemical. The new use which is purported to be a new mode of administration or treatment regime should therefore be a new result in that it should be a “new and useful effect” in accordance with NRDC. It cannot be supported that mere novelty in the literal text of a claim is sufficient to define a patentable invention where there is not a new result or “new and useful effect” encompassed by the claimed subject matter.

New mechanism of action

The new use must be defined in clear and unambiguous terms. If a claim recites the new use in mechanistic terms, then it must be clear that the mechanistic activity itself is therapeutic or prophylactic and that it is a new use as such, rather than mere information on the mechanistic pathways involved when a known compound is used to treat a disease. For example, a Swiss-type claim for the use of a compound for the “occupation” of a receptor, or the amelioration of a condition “associated with a receptor”, may not meet the requirements of section 10(4) of the Patents Act 1953 if it does not clearly define a new use. There is no doubt that generally speaking there is a physiological interaction between the compound of interest and the receptor, but this interaction in itself is not a new use i.e. a new and useful effect. Typically, claims are framed to recite that the medicament is manufactured for the treatment of any disease for which the mechanism of action in question is active. Such claims are generally unacceptable as they do not recite a new use.

Swiss-type claims often recite the use of a group of compounds which are defined functionally; for example, as antagonists of a particular receptor. This type of claim was at issue in the UK case Pfizer’s Patent [2001] FSR 201, which included claims to the second medical use of phosphodiesterase inhibitors. Such claims are not inherently objectionable, and in this case there was no suggestion that this form of claim was unduly broad and speculative.

Although, the mere fact that a member of a functional class of compounds can be used to treat a disease does not mean that all such compounds will do so, more particularly if there is no evidence in the specification that the treatment is related to that specific activity. It was established in Pfizer’s Patent, that a claim to, for example, "the use of an inhibitor of A in the manufacture of a medicament for the treatment of disease X" is anticipated by any disclosure of the use of any compound which inhibits A in treating disease X of a compound regardless of whether the treatment is explicitly stated as being caused by the inhibition of A.

First medical use claims

Where a substance is new then it is permissible to have claims in a first medical use format, wherein the suitability for use of the substance as a medicament is claimed. Acceptable forms of claims for a first indication of a medical use of a compound are:

1. Novel Substance X for use in the treatment of medical condition Y;
2. Substance X for use as a Y-treating agent;
3. As a Y treating agent, the novel substance X; and
4. Novel Substance X for use in therapy or for use as a medicament.

Particular attention to the claim wording of first medical use claims is required. For example, terminology such as “when used” and “used” or any other similar form of wording may indicate that the substance is claimed in use in a therapy or diagnosis performed on the human body.

The form of "Swiss-type" claims

The general form of a Swiss-type claim is:

The use of [known compound X] for the manufacture of a medicament for the treatment of [new therapeutic use]]

Claims presented in the Swiss-type format may be acceptable if the active component is already known and has been used in therapy or if the active component is new. Additionally, a claim is also allowable in the Swiss-type for novel compounds or compositions.

The following claims are not valid Swiss-type claims:

1. Known substance X for use in the treatment of medical condition Y.

The claim merely indicates the suitability for use of known substance X;

2. The use of known substance X in the treatment of disease Y.

The claim recites an unpatentable method of treatment of disease Y;

3. A package containing as a pharmaceutical agent X together with instructions for using agent X ... for treating condition Y.

If the pharmaceutical use of X is already known, then the claim is only distinguished from the prior art by the content of the instructions which is considered to be a mere presentation of information and is not a patentable invention under section 2 of the Patents Act 1953.

If the pharmaceutical agent X is new, then a claim to the package is patentable so long as it contains X; and

4. A process for the manufacture of a medicament X for use in the treatment of medical condition Y, characterised by the use of substance X.

The claim does not adequately define the scope of protection desired in that it is recited as a process claim for producing a medicament X wherein the use of X is the novel feature. The claim does not adequately delimit what would or would not infringe the claim as the characterising feature is the unspecified “use” of the medicament X, which would attract a lack of clarity objection under section 10(4) of the Patents Act 1953.

Generally, if a specification discloses methods of medical treatment, then amendment or addition of claims to include Swiss-type claims will not be regarded as added matter. However, the scope of a method of medical treatment claim and a Swiss-type claim are clearly not the same as one another, see below.

Are Swiss-type claims the same as the corresponding method claims?

The scope of method of treatment claims and Swiss-type claims was considered in the Australian case Prosidion Limited v Novo Nordisk [2006] APO 6 in which the patentee sought an amendment after acceptance to add a number of method of medical treatment claims to the granted method of Swiss-type claims. The amendment was refused upon application of the “Distillers test” by the Hearing Officer (The Distillers Co Ltd's Application(1953) 70 RPC 221) and meant that what was not an infringement earlier (prior to amendment) was now an infringement post amendment i.e. that the amendment was a broadening amendment. The Hearing Officer in Distillers Application noted that a Swiss-type claim is “directed to the manufacture of the medicament with the intention of a specified medical use, but does not extend to the actual method of treatment. It is therefore limited to the preparation and sale of a product for the purpose of carrying out a specific medical treatment”.

Diagnosis

Swiss-type claims are allowable where they recite to the use of a substance in the manufacture of a medicament to treat/diagnose a disease or condition, which is otherwise not allowable in a corresponding method claim where it is excluded as being a method of medical treatment of humans or a method of diagnosis when performed directly upon the human body. It follows then that a Swiss-type claim can be used to protect the use of a known substance in the manufacture of a medicament for use in a diagnosis to be performed upon the human body (see T 958/94 THERAPEUTIQUES SUBSTITUTIVES/Anti-tumoral agent OJEPO 1997, 241).

New patient groups

The novelty of a Swiss-type claim residing in a particular patient group was considered in the pre-acceptance hearing P24/2007. The Hearing Officer decided that there could be novelty in a new patient group. The patient group should be clearly defined to ensure that there is no overlap with an existing group in the prior art.

An attempt to distinguish over the prior art merely on the basis that the prior art does not disclose the particular patient group in question is likely to attract an objection of lack of novelty if the prior art discloses the use of the same active substance(s) in the treatment of the same diseases/conditions as those in the subject claim. Generally, for a Swiss-type claim to rely on novelty residing in the “new” patient group, it must be shown that the “new” patient group clearly possesses a distinct physiological or pathological difference which is neither arbitrary nor overlapping with a known patient group, i.e. the known compound is to be manufactured for the purpose of achieving a new use, that is a new result. In determining whether or not the difference is arbitrary, consideration will be given to whether there is a functional relationship between the particular physiological/pathological status of the patient group and the therapeutic/physiological effect achieved (MEDCO RESEARCH, T233/96). If there is no functional relationship, then the claim is likely to be rejected as relating to a mere discovery of a new property of a known medicament (section 2) and/or lacking in novelty.

Fair basis for the therapeutic use in Swiss-type claims

Swiss-type claims like all other claimed subject matter should be fairly based on the disclosure of the specification. The specification as filed should therefore provide at least an indication that the claimed subject matter is fairly based. The claimed subject matter must meet the well-known test for fair basis as set out in Mond Nickel (Mond Nickel Co. Ltd.'s Application 65 RPC 123).

“Particularly described” and that the ‘best mode” in Swiss-type claims

For a claim to be avoid an objection under section 10(3)(a) it is insufficient to merely recite the use of the known compound in the manufacture of a medicament for the new use, such as treatment of a disease or condition not previously treated by the known compound and repeat the text of the claim in the description. As noted in Vidal Dyes Syndicate Ltd. v Levinstein Ltd. and Read Holliday & Sons Ltd. 29 RPC 245:

“Two duties are incumbent upon a patentee in preparing his Complete Specification. In the first place, he must "particularly describe and ascertain the nature of the invention," and, in the second place, he must particularly describe and ascertain "in what manner the same is to be performed". These two duties are distinct and have distinct objects. The first is to ensure that the monopoly granted by the Patent extends no further than the invention which the applicant for the patent has made. The second is to ensure that the public shall, in return for the grant of the monopoly, be put in full possession of the way to carry out the invention, in order that, after the Patent has expired, they may enjoy the benefit of the invention.”

It is settled law that a patentee must act towards the public in good faith, and must give the best information as to how to carry out the invention. But the applicant is not limited to claiming only the best way of carrying it out.

In considering whether or not a Swiss-type claim is particularly described, consideration should be given to the points noted in IBM (International Business Machines Corporation's Application [1970] RPC 533):

“in fact the skilled addressee can from the wording of all the specification carry out the invention there described”

There is no requirement that a claimed invention be exemplified across to entire width of it scope. However, the description should place the skilled person in a position of being capable of putting the invention into effect.

Where a known compound is to be manufactured as a medicament for a specific “new use”, then it follows that the manufacturing process of the compound per se is known. Additionally, it also follows that the purpose of manufacture is not likely to require the notional skilled person to “do” anything different from what is already known in the art when manufacturing a medicament using the known compound per se.

In considering “best mode” the description should disclose the “best” embodiment of performing the invention known to the applicant.

“New” mechanism of action

Information on how a medicament works is not patentable, as the information as such is merely a discovery (section 2 Patents Act 1953). Earlier publication of the use of the medicament for the same condition will also be considered to have been prior published even if there is no mention of the specific mechanism or if a different mechanism is mentioned in the prior publication. The “new” mechanism will have been in effect as an inevitable consequence (General Tire) of using the medicament to treat the condition according to the prior art.

However, where the knowledge of the new mechanism of action is put into effect and leads to a new use (e.g. an improved therapy not anticipated by the prior art), and the new use is fairly based upon the description, then a Swiss-type claim to a new use based upon the new mechanism of action may be allowable.

Unity of invention

The novelty in a Swiss-type claim is to be found in the “new use”, whether it be a new disease or condition, or in the mode of administration or treatment regime (as noted above).

A Swiss-type claim which recites a number of new uses will generally not be viewed as being unified as there would not be common novel subject matter linking the new uses. The discovery of a mechanism of action of a known pharmaceutical in a previously known use would not generally be sufficient to allow a claim to a number of further uses including that of the known use.

Apparatus – new therapeutic or prophylactic use

The Court of Appeal in Pharmac approved Swiss-type claims for known pharmaceutical compositions or medicaments having a previously unrecognised property which would result in a new use. The mere novelty of purpose of manufacturing known apparatus for a new use will not be accepted by IPONZ as providing patentable subject matter wherein the new use is in effect a method of medical human treatment. However, where the new use or purpose of manufacture inherently necessitates a novel material difference in that product or apparatus, then the apparatus will be novel per se and therefore patentable when claimed as the apparatus.

The patentability of a known substance in the manufacture of a medicament resides in the discovery of previously unknown or unrecognised property of the substance which makes it useful in a previously unknown therapy or diagnosis i.e. the “new use”. The same condition cannot be satisfied by a known apparatus which does not exhibit a previously unknown property in the same context as was considered in Pharmac, which was limited to the consideration of Swiss-type claims relating to second medical uses of compounds/compositions, see Pharmac at [66]:

“It must be emphasised that, because of the manner in which this matter has come before us, we have proceeded upon the assumptions of inventiveness in the discovery of the further pharmaceutical use and lack of anticipation of the use. Those are matters to be considered on a case by case basis” (Emphasis added)

When discussing the Pharmac decision, the court noted at [29] that:

“The device of the Swiss claim was created in order to overcome rules prohibiting the patenting of methods of human treatment, particularly Article 52(4) of the European Patent Convention. Such a claim is typically for the use of a particular compound in the manufacture of a medicine for the treatment of a particular medical condition. As Gault J said in giving the judgement of this Court in Pharmac at para [17], the Swiss form of claim has been devised to avoid claiming the method of treatment, but to secure protection for use of the known compound in the preparation of a medicament for the new medical use.” (Emphasis added)

It would appear to be clear that both the Pharmac and Pfizer (in the very limited reference to Pharmac) did not consider the issue of patentability of known apparatus when manufactured for a specific new use, wherein the new use was in essence a method of treating humans.

Therefore, IPONZ will not accept claims to for example: use of a scalpel in the manufacture of an instrument/medicament for the treatment of condition X (or any variation thereof including where the novelty is purported to reside in the method if use of the instrument/medicament).

3. Medical treatment of humans

This is a guide to the examination of applications relating to the medical treatment of humans under the Patents Act 1953. These guidelines do not constrain the judgment and discretion of the Commissioner of Patents, and each application will be considered on its own merits.

Introduction

Section 2(1) of the Patents Act 1953 (“the Act”), defines an invention as:

Section 6 of the Statute of Monopolies 1623 says (in modern English):

The Court of Appeal in Pfizer Inc v The Commissioner of Patents [2005] NZLR 362 held that methods of medical treatment of humans do not meet this definition and are therefore not patentable subject matter.

General

Patent applications in the medical field must meet the same requirements as applications in all other fields of technology; that is, they must be novel, and the claims must clearly define the scope of the invention and be fairly based on the disclosure.

However, patenting in this field is constrained by the exclusion from patentability of methods of treatment of humans by section 2 of the Act, as confirmed by the Court of Appeal in Pfizer Inc v The Commissioner of Patents, which held such methods do not meet the definition of invention.

As such claims including methods of treatment of humans by therapy or surgery, and claims including methods of diagnosis that are performed directly on the human body, will not be accepted.

Definition of therapy

The definition of therapy includes both curative and preventative treatments. This clarifies the practice recited in Information for Clients No.3 of October 1998 that stated:

The Office currently allows claims to methods for the treatment of humans except where the treatment identified relates to surgery or to the treatment or prevention of disease.

In Unilever (Davis’s) Application [1983] RPC 219 it was stated that therapy should be construed as the medical treatment of disease, including preventative treatment as well as curative treatment. Therapy also encompasses methods of alleviating symptoms as well as curative treatments for a disease.

In Schering A.G.’s Application [1971] RPC 337 it was held that the medical treatment exception was not so broad as to extend to any treatment of the human body. In light of this decision, claims that are directed solely to non-therapeutic medical treatments will be accepted.

Typical forms of therapy claims

In John Wyeth’s and Schering’s Applications [1985] RPC 545 it was held that claims of the form "the use of X to treat Y" were unallowable as they related to medical treatment. Consequently, claims of this form and variations such as i) the treatment of (medical condition Y) with (substance X), and ii) (substance X) when used to treat (medical condition Y) will not be accepted.

Following the decision of the Court of Appeal in Pharmaceutical Management Agency Ltd. v Commissioner of Patents [2000] 2 NZLR 529, “Swiss-type” second medical use claims of the general form “Use of compound X in the manufacture of a medicament for the treatment of a particular medical condition” are acceptable. However, following the decision in Bristol-Myers Squibb Co. v Baker Norton Pharmaceuticals Inc. [2001] RPC 1, claims drafted in the Swiss format may be rejected if they also relate to mode of administration, dosage or frequency of dosage.

Guidelines for determining whether a method is "treatment by therapy"

With regard to determining whether or not a claim relates to a method of therapy, it is worth considering whether or not the proposed method would normally be carried out by, or under the supervision of, a medical professional. A rationale for the exclusion is to prevent medical professionals (or anyone else) from being restrained or hampered in providing medical treatment by way of therapy, surgery or diagnosis when performed on a human body.

Medical treatment is not considered to be limited to formal or scheduled events such as surgical procedures in a hospital operating theatre as would be performed by qualified medical professionals. The purpose and inevitable effect of the claimed method are more important. If a method has no therapeutic purpose or effect, then the fact it may be carried out by a doctor does not render it unpatentable.

Claims to both therapeutic and non-therapeutic methods

There are instances where claims may include within their scope both patentable and non-patentable methods. For example, a claim to "A method for inhibiting the coagulation of blood by contacting the blood with compounds X and Y" could include a method of treating the blood in a patient as part of a therapeutic method (not patentable), and also a method of treating stored blood in a bottle (patentable). In cases where it is unambiguously clear from the specification that the claims relate only to non-therapeutic methods, then no amendment is required.

If it is apparent from the specification that the claims could cover non-patentable embodiments of the method then amendment is required to clearly limit the claim to methods which are patentable, and if necessary to amend the description to clarify that therapeutic methods do not form part of the claimed invention. If claims are limited, either by disclaimer or otherwise, to allowable non-therapeutic methods, then there must be support in the description for a non-therapeutic method.

In ICI (Richardson’s) Application [1981] FSR 609 a claim was made to a method of producing an anti-oestrogenic effect in a human, but excluded any method of treatment by therapy. It was considered that the specification did not describe any application of the method other than in the treatment of breast cancer or infertility, and so the claim was rejected. Any disclaimer needs to exclude all possible therapeutic methods and not merely those disclosed in the specification and also leave the scope of the remaining monopoly clear.

For example, in appropriate circumstances, the word "cosmetic" in a claim to a method of treatment may be acceptable as a sufficient limitation. Of course, if a claim is amended to "cosmetic methods", there must be disclosure of such methods in the application as filed. If there is not, then the amended claim will constitute added matter, as well as being objectionable through lack of fair basis.

It must be possible to distinguish the therapeutic and non-therapeutic effects of a claimed method. If the non-therapeutic effect is inseparable from the therapeutic effect, or if it is merely a secondary consequence of the therapy, then the method is unpatentable, regardless of the wording used. For example, it has been held in the UK courts that it is not possible to claim a cosmetic method for the removal of plaque from teeth; as such a method will inevitably have therapeutic benefits in preventing tooth decay and gum disease (see ‘Oral care’ below).

Therapeutic and non-therapeutic methods: specific examples

i) Cosmetic treatments

Purely cosmetic treatments of the skin and hair are patentable. These may include cosmetic methods of strengthening hair and nails (following Joos v. Commissioner of Patents [1973] RPC 59), and cosmetic methods to prevent hair loss.

Methods of protecting the skin by simply blocking UV radiation are not considered to be therapy, but where a method includes physiological effects then the method is considered to be therapeutic. Cosmetic and therapeutic aspects of a claimed method of protecting skin would be considered to be inevitably linked, such that each one necessarily develops together with the other and such that it would be impossible to separate them.

An argument that the treatment would effectively be directed towards natural ageing of the skin, and would therefore not be therapeutic would be rejected on the grounds that a natural process of cell degeneration is that the cell loses its physiological normality when it develops in an abnormal manner, and in particular faster than its normal process. The use of a composition for the local treatment of comedones (blackheads) would be regarded as a cosmetic method of non-medical body hygiene, although when applied for the treatment of acne this would be regarded as therapeutic.

ii) Removal of parasites

Methods of treating or preventing infestation of internal parasites are regarded as therapy; the argument that the host animal is unaffected and that it is only the parasites that are being killed and that therefore this is not therapy of the animal body will not be accepted. Treatment of parasites residing on the skin of a human is considered to be therapy. Treatment of, for example, head lice, is therefore considered therapeutic, see Stafford-Millers Application [1984] FSR 258.

iii) Oral care

Methods for the removal of dental plaque, or preventing the formation of plaque are considered to be therapeutic and thus unpatentable as all such methods have the effect of treating or preventing dental caries, Oral Health Products (Halsteads) Application [1977] RPC 612, and Lee Pharmaceuticals’ Applications [1975] RPC 51 (also see ICI Ltd’s Application BL O/73/82). The inherent therapeutic effect of removing plaque could not be separated from the purely cosmetic effect of improved appearance of the teeth, and so restriction of such a claim to a cosmetic method is not possible.

iv) Pain and fatigue

The relief of pain is considered to be therapeutic, even where the pain has no pathological cause, and is therefore unpatentable.

However, reducing the perception of fatigue (for example, following exercise) is not comparable with the relief of pain, discomfort or incapacity, and could be considered to be non-therapeutic when carried out on healthy individuals, although there may be therapeutic uses of the treatment as well.

v) Obesity, appetite suppression and weight reduction

Claims to methods of treating obesity, weight reduction and suppression of appetite are considered to be prophylactic treatment of obesity and therefore not allowable.

vi) Contraception and abortion

Claims to methods of abortion, termination of pregnancy, induction of labour, control of oestrus and menstrual regulation are considered to be unpatentable treatments, as they will always be carried out under medical supervision (see UpJohn (Kirton’s) Application[1976] RPC 324). This applies regardless of the reasons for performing these methods.

Methods of contraception are generally not considered to be therapeutic, and may be patented following the decision in Schering’s Application [1971] RPC 337. Pregnancy in itself is not an illness or disorder, and so its prevention is not regarded as therapy.

vii) Methods utilising implanted devices

If a claimed method has a therapeutic purpose or effect then it is unpatentable even if the direct effect of the method is targeted on a non-living object such as an implant. For example, a method of operating a pacemaker in which its output to the heart was adjusted would be rejected as being a method of treatment by therapy. On the other hand, a method of controlling the input energy to a pacemaker, which had the effect of minimising the energy requirements of the device but did not affect the output to the heart, would be acceptable. Similarly, a method for measuring the flow of a drug from an implant, which did not actually control the flow, would be considered as non-therapeutic.

viii) Treatments performed outside the body

A therapeutic treatment of the human body is unpatentable even if the actual treatment takes place outside the body, as in an extracorporeal blood dialysis or filtration method.

However, methods of treating blood removed from the body are regarded as therapeutic where the blood is returned to the same body or to another body. Treatment of blood for storage in a blood bank is not regarded as therapeutic treatment.

Definition of "surgery"

Surgery is defined as the treatment of the body by operation or manipulation. It is not limited to cutting the body but includes manipulation such as the setting of broken bones or relocating dislocated joints (closed surgery), and also dental surgery. Furthermore, a method of implanting an embryo could still be viewed as surgery even if the method did not require incision.

The definition of surgery used relates to the nature of the treatment, and not its purpose. The exclusion of methods of surgery is not limited to therapeutic surgery; methods of surgery for cosmetic purposes, or other non-therapeutic purposes such as sterilisation, are not patentable.

Guidelines for determining whether a method is "treatment by surgery"

In general, any operation on the body which requires the skill or knowledge of a surgeon or other medical professional is regarded as being surgery, whether or not it is therapeutic. A method of embryo implantation which required the intervention of a surgeon would be held to be a surgical method, regardless of its purpose. If a method requires a surgeon for its execution then it must be surgery. However, even a method which does not require a surgeon it does not necessarily follow that the method could not be considered to be surgery – each claimed method will considered on its merits. A physical intervention which requires the medical skills of, for example, a nurse, could still be regarded as surgery. Similarly, methods of dental surgery require specialist dental skills and are not patentable. If a method does not require medical skills or knowledge, on the other hand, (such as, for example, a method for cosmetic ear-piercing, or a method of tattooing the body) then it may not be excluded as a method of surgery.

Similarly, the setting of bones is carried out by doctors and is considered to be surgical in nature (closed surgery), while making a plaster cast is normally carried out by a technician and would not be regarded as surgery. However, the application of a plaster cast to for example a broken limb, would be considered to be a method of surgery as it has a therapeutic effect.

Methods of making artificial limbs or taking measurements or making casts are also not regarded as surgery or therapy.

Use of parts of bodies in surgery

Surgical procedures used to obtain parts from a dead human body do not fall within the excluded category under section 2 of the Act. However, such methods will be considered on a case-by-case basis as to whether or not the use of the invention is contrary to morality (section 17).

Diagnosis

General

Diagnostic methods when practised on the human body are excluded from patentability. In vitro diagnostic tests, performed on blood or other samples removed from the body are patentable as it is considered to be an intellectual exercise. To be excluded from patentability, diagnostic methods must be carried out on the living human body. A method carried out on a dead body, for example to determine the cause of death, would be acceptable.

Definition of diagnosis

Diagnosis is the determination of the nature of a medical condition, usually by investigating its history and symptoms and by applying tests. Diagnosis in itself is an intellectual exercise which is not patentable. Diagnosis includes a negative finding that a particular condition can be ruled out, as well as a positive identification of a disease. However, determination of the general physical state of an individual (for example, for a fitness test) is not considered to be diagnostic if it is not intended to identify or uncover a disease or condition.

For a claim to a method of diagnosis to be clear it may be required that the claim specifically recites what constitutes a positive or negative finding of diagnosis of a disease or condition.

The meaning of "methods of diagnosis"

Typically, the process of diagnosis involves a number of steps leading towards identification of a medical condition. 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 would be considered to be a method of diagnosis of a disease or condition. If a claimed method includes all these steps, and thereby makes it possible to decide on a particular course of treatment, it clearly constitutes an unpatentable diagnostic method (provided it is performed directly on the human body).

More commonly, claims are directed towards methods which are of value in diagnosis, but which do not in isolation enable a full diagnosis to be made. Examples include methods of imaging, or methods of blood sugar determination or other chemical tests. Methods performed on the human which are solely directed towards diagnosis are considered to be unpatentable methods, regardless of whether additional steps are needed to allow a complete diagnosis. A patent to a diagnostic step performed on the body, even where other steps were needed, would still prevent the doctor from carrying out a diagnostic procedure which required that step. Where a method may be of use for diagnostic or other purposes, then it may be acceptable if restricted to exclude its use in diagnosis (and therapy or surgery, if appropriate).

Multi-step methods involving a surgical therapeutic or diagnostic step

Where a claimed method involves a number of steps, one or more of which is surgical, therapeutic or diagnostic, then the effect of the method as a whole should be considered.

Apparatus for surgery, therapy or diagnosis

Claims to medical apparatus are allowable in the same way as claims to non-medical apparatus. However, the exclusion of methods of surgery, therapy or diagnosis performed on the human body means that claims to such apparatus "when used" in such a method are not patentable. In other words, while a surgical instrument is patentable, it cannot derive novelty from the way it is intended to be used in a surgical method.

A claim to an implanted piece of apparatus, or assembly of items, which can only be constructed inside the body in a process involving a surgical step is not patentable, as such a claim is effectively a claim to a method of surgery even if it is framed as a product claim.

Compositions adapted to a particular use

Known substances may be protected by per se product claims to pharmaceutical compositions containing them, if the composition is in a form which is novel over any known products. In particular, a claim may be made to a medicament having a form of administration which is novel and distinct from the previous use. For example, an anti-eczema ointment containing X would be regarded as clearly distinct from a tablet containing X for controlling blood pressure. The ointment is new because X has never been formulated in this form before, and it would be inventive if the previous use of X would not suggest its use in topical form. However, a claim to a composition "adapted to" a specific use should be objected to on clarity grounds as being defined by its intended result, unless it would be clear to the person skilled in the art as to what is meant.

Claims to compositions with a novel physical characteristic, such as shaped forms or tablets with particular surface features may be acceptable providing the feature relates to a genuine technical effect. For example, a claim to tablet of a particular shape or structure would be acceptable if this resulted in a particularly favourable release profile for the active agent. However, if the new shape or form is merely presentational or conveys information (for example, by allowing blind patients to distinguish different types of pill), then it represents either an aesthetic creation or a mere presentation of information. As aesthetic creations and the presentation of information are not in themselves patentable, these features cannot impart novelty to the claim.

Clarity of composition claims

Composition claims of the form "a pharmaceutical composition containing compound X together with a diluent, excipient or carrier" are considered to be clear; X being a medically active compound which characterises the composition, and the diluent, excipient or carrier being any material suitable for the purpose and being selectable by knowledge of the art or by non-inventive experiment. There is no requirement for the diluent, excipient or carrier to be further characterised. A claim to a solution of the compound, where the compound was known to be water soluble, could not make a claim novel. Terms such as "therapeutically effective amount" of an active ingredient are considered to be clear. However, the purity of a product cannot be defined merely by defining the substance "as a pharmaceutical product".

Compositions with a new non-medical purpose or property

Compositions which are allegedly distinguished from the same compositions in the prior art by the discovery of a new non-therapeutic property in one of the ingredients are not considered to be novel. Claims to the use of the agent in its non-therapeutic role are also not novel if the overall composition has previously been used in the same manner and the newly discovered property already put into effect, albeit unknowingly. Toothpastes with sodium bicarbonate as a cleaning/tingling agent are known, therefore claims to the use of sodium bicarbonate as a masking agent for bitter ingredients present in the known toothpaste formulations are not novel. This follows the general principle of novelty in NZ law that once a substance or composition is known for whatever purpose then it cannot be patented again for another purpose - second medical use claims are the only accepted exception to this rule

Claims to unit dosage forms

A unit dosage form consists of a tablet, suppository, ampoule or other device, containing a definite amount of a drug, the whole of which is intended to be administered as a single dose. It is thus distinguished from a supply of an indefinite amount of a medicament, eg a bottle of medicine, from which a dose has to be measured out.

It may be possible in cases where the required dosage for a new medical use is markedly different from that for the known use, to allow a claim to a unit dosage form containing the known active ingredient in such an amount that the unit dosage form is novel and not obvious to have been made up in that amount for the prior art use. Thus if the new medical use requires a dose of, for example, ten times (or one tenth) that for the prior art use, then a claim to a unit dosage form might be judged to be novel and allowable. In assessing such claims it should be remembered that dosages required are usually related to body weight so that children's doses are smaller than those for adults. It is also well known in medicine for patients to be asked to take more than one tablet at a time and it is known for half tablets to be taken.

Claims to packs of medicaments

Claims to packs of medicaments are sometimes made in cases where an applicant has discovered a new use for a substance and in particular the use of two or more substances together. Claims to a pack or container containing a known substance with instructions for the new use should be rejected on the grounds that the only novel feature - the instructions - is merely a presentation of information and thus not a patentable invention under section 2 of the Act. However, the acceptance of "Swiss-type" second medical use claims has now made such claims redundant in the medical fields.

A new package may be new and inventive if there is some physical relationship between the new and inventive method and the package, which goes beyond merely presenting instructions for the new use. In Organon's Application [1970] RPC 235, a claim was allowed under the UK Patents Act 1949 to a pack containing two types of known contraceptive pill arranged in the order in which they were to be taken, the arrangement being novel and an invention.

Pack or "kit of parts" claims are usually used where the invention comprises the administration of two or more different drug compositions at particular time intervals, or merely simultaneously or sequentially. Claims such as these will be considered in light ofL’Oreal’s Application [1970] RPC 565. In addition there must be clear support in the description for such a pack, and a claim for a kit or pack for carrying out a method must define all the essential elements for carrying out the method:

In our view, the mere putting up of two ingredients in separate containers in one pack, the ingredients in separate containers in one pack, the ingredients being intended to be mixed together before use to produce a known compound , cannot prima facie amount to a manner of new manufacture

4. Discretionary extensions of time under section 93(

Summary

This is a guide for granting discretionary extensions during examination to accommodate delays in replying to applicants’ submissions, and for calculating the extension and extended date. This guide does not relate to granting extensions under section 93(1) if examination commences late or if new substantive objections are raised partway through the compliance period.

All extensions should be calculated and granted in accordance with Rules 1 and 2 to ensure consistency.

Rule 1

Each time an examiner replies to submissions or amendments from the applicant, the examiner should calculate an extension so that the time remaining available to the applicant at the date of receipt of their submission is not diminished by any time taken by IPONZ to process the application.

Rule 2

The examiner should grant and notify the calculated extension – unless it has previously been granted - immediately in the reply report unless both a significant period of time for the applicant remains and the time taken to respond is reasonable.

In Rule 2

“reasonable” means no more than 15 working days following receipt of the applicant’s submissions/amendments, and  “a significant period of time” means that the time period between the date of the reply report and the current deadline is more than three calendar months.

Legislation

93.Commissioner may grant extension of time—

1. Where by this Act anything is required to be done within a prescribed time, and by reason of delay in the Patent Office the thing is not so done, the Commissioner may extend the time for the doing of the thing.
2. Where, having regard to the procedure specified and the information required under sections 12 to 16 of this Act or any regulations under those sections, the Commissioner is satisfied that the circumstances warrant an extension or extensions of the period specified in subsection (1) of section 19 of this Act, the Commissioner may extend the period prescribed therein for complying with any requirement imposed on the applicant by or under this Act; and the said subsection shall then be read as if the period so extended had been substituted for the period of 15 months therein mentioned
3. Where an extension of period has been allowed under subsection (2) of this section, the period so allowed shall be extended by the Commissioner to such further period not exceeding 3 months, as may be specified in a notice given by the applicant to the Commissioner, if the notice is given and the prescribed fee is paid before the expiration of the further period so specified.
4. No fees shall be payable in respect of any extension of time granted under subsection (1) or subsection (2) of this section.
5. The powers conferred on the Commissioner by this section may be exercised notwithstanding that in any case the time limited may have expired.

Rationale

Examiners (and applicants) should be aware of the circumstances under which discretionary extensions of time accommodating IPONZ delay in replying to patent correspondence are granted and how the extensions are actually calculated.

Explanation

Where extensions are required they should be granted consistently to all patent applicants in accordance with the Rules 1 and 2 to provide the maximum opportunity and time that can be made available for applicants to prosecute their patent application. Rule 1 is the traditional “stop the clock” principle that has been IPONZ practice for many years. Rule 2 modulates the operation of Rule 1 to prevent having to unnecessarily notify extensions and change deadline dates. In all cases, the granting of these extensions is an exercise of the

Commissioner’s discretion and variations from these rules will be necessary or desirable in some cases.

Examples of the application of the rules under different circumstances are set out below.

Date calculations

Date calculations for these rules are performed using “calendar arithmetic” or calendar months and calendar days. This is the accepted method for calculating time periods and dates in patent law as prescribed in the Interpretation Act 1999 and in the Regulations Under the PCT: Rules 80.1 to 80.7. The exception is that “working day” calculations are used under the particular circumstances outlined in Information for Clients No.16 of 30 June 2001 (see Example 3 below in particular).

If a due date happens to be a weekend or holiday then the applicant has until the end of the following working day or “office open day” to comply with the requirement.

Thus time periods or date differences are expressed in months and calendar days.

For example:

1. 14 July 2004 to 15 August 2004 is one month and one day because 14 July to 14 August is one calendar month and 15 August is the one remaining day.
2. But, 15 July 2004 to 14 August 2004 is 30 days because a “whole calendar month” cannot be extracted.

Three dates are required to calculate these discretionary extensions: the previously set deadline date, the date of the receipt of the applicant’s latest submission to IPONZ; and the date of the examiner’s report in reply.

Examples

Example 1

Applicant replies in good time and examiner’s report back is timely.

Earlier set deadline date: 21 July 2004.

The applicant’s submission received 29 March 2004.

The time still remaining for the application to be placed in order is 3 months and 22 days, that is 29 March to 29 June plus 22 more calendar days to 21 July.

The examiner replies to the submission with further objections on 19 April 2004, which is exactly 13 working days after the submission was received, accounting for the intervening Easter holidays.

The calculated extension is 21 days (that is, the applicant has had to wait 21 calendar days to receive a reply), however the reply time is “reasonable” in accordance with the second rule standard and at the time of the examiner’s reply the applicant still has at least three calendar months to complete the application.

Therefore, the calculated extension is not granted and notified at this stage.

Example 2

Subsequent reply from applicant and granting of accumulated delay extension.

Continuing Example 1, but now the applicant has submitted further amendments on 19 July 2004, two days before the deadline date.

The time due the applicant at the time of submission is 2 days.

The examiner replies to the applicant on 30 July 2004, and in this response cycle grants the total extension of the 2 days plus the 21 days from the earlier response/reply cycle.

The time is extended from the date of the examiner’s letter (30 July 2004) by 23 days to 22 August 2004.

Example 3

Applicant is right on the final deadline.

In this example the final 18-month deadline is set at an earlier time to 16 October 2004.

The applicant files submissions and/or amendments on 18 October 2004. (in time because 16 October 2004 is a Saturday).

The examiner replies quickly with continuing objections on 20 October 2004.

The applicant is not entitled to any further time in this case.

Despite the fact that the examiner took 2 days to reply the applicant is not entitled to the grant of an extension under section 93(1), the first rule being applied. The applicant has left things too late if the submissions are not sufficient to place the application in order on the last day. Further time for rectification of the application is not available under the time extension provisions of the Patents Act or Regulations.

In these circumstances, the examiner has the discretion notified in the Information for Clients No.16 of 30 June 2001 to grant the applicant 5 working days from the date of the examiner’s reply report to either place the application in order, request a hearing or request a further extension under section 93(2).

Under this practice, the final generally non-extendable date will be 27 October 2004, obtained in this case by counting five working days - rather than calendar days - from the 21 October 2004, the day after the date of the examiner’s letter.

To obtain a further extension under section 93(2) the applicant will be required to file evidence explaining the circumstances and reasons for requiring an extension.

Example 4

Applicant’s response is not received until after the final deadline has expired.

In this example the final 18-month deadline is set at an earlier time to 16 October 2004

The applicant’s response is received on 19 October 2004.

The application is VOID and the applicant will either have to restore the application under section 37 or request a special extension under section 93(2) for which they will be required to file supporting evidence.

Example 5

Examiner replies after a due date has expired.

In this example a 15-month deadline date is set at 21 June 2004 under section 19(1).

The applicant’s submissions are received 18 June 2004.

The applicant’s time entitlement at the time of submissions is 3 calendar days.

The examiner’s reply report is dated 7 July 2004.

In this case the 7 July report should extend the time under section 93(1) to 10 July 2004 being 7 July 2004 plus 3 calendar days.

Though the examiner has replied smartly, the applicant, at the date of the examiner’s reply, now has less than three months to place the application in order so both of the conditions of the second rule are not met and the extension should be notified immediately.

Of course, the applicant can now request the further extension of up to three months under section 19(2) but to be calculated from the now extended date of 10 July 2004 (rather than from 21 June 2004). If this extension is notified to IPONZ then the final due date will be 10 October 2004, 3 calendar months on from 10 July 2004.

Example 6

Applicant files section 19(2) notice together with submissions.

In this example the applicant notifies the requirement for a section 19(2) extension before the examiner replies; (more usually) before or at the time of filing submissions.

Section 19(1) deadline date: 21 June 2004.

The applicant’s submissions together with a Form 13 notice of 3- month extension under section 19(2) are received on 15 July 2004.

New 18 month deadline: 21 September 2004.

The examiner’s reply report is dated 23 July 2004.

The applicant’s time entitlement extends from 15 July 2004 to 21 September 2004, which is 2 months and 6 days.

In the examiner’s reply report the time is extended under section 93(1) by 2 months and 6 days from the date of the report so that the new deadline date is 29 September 2004, which is 2 months and 6 days on from 23 July 2004.

Example 7

Applicant files submissions after a section 19(1) deadline, but initially fails to notify a section 19(2) extension.

In this example, as in examples 5 and 6, a 15-month deadline date is set at 21 June 2004 under section 19(1).

The applicant’s submissions are received on 15 July 2004 without notification of extension under s19(2).

The applicant’s submissions are 24 calendar days overdue.

Date of examiner’s reply report: 23 July 2004.

In the examiner’s reply report the time is “extended” under section 93(1) from 23 July 2004 by –24 days to 29 June 2004. No, this is not a mistake. The applicant is “out of time”.

Of course, the applicant can notify IPONZ of the requirement for a further extension under section 19(2) of up to 3 months so that the final deadline including the section 93(1) extension will then be 29 September 2004, 3 calendar months from 29 June 2004, as in example 6. The notification of extension should be received by IPONZ before the last possible deadline date of 29 September 2004. 

5. Post-dating at applicant’s request