(a) Patentability of humans, human cloning, and the biological processes involved in their generation.
Under section 16(1) of the Patents Act “[h]uman beings, and biological processes for their generation, are not patentable inventions.” As noted above, patents for human cloning are also excluded under the grounds of public order or morality. In addition, pursuant to Section 33(a) of the AIA, human beings are not patentable in the United States.227
(b) Methods of medical treatment by surgery or therapy
The patentability of methods of medical treatments by surgery or therapy is controversial, as it is argued they could interfere with a doctor’s freedom to provide the best treatment to their patients due to the fear of infringement.228 Under Article 27(3)(a) of TRIPS, WTO member countries are permitted to exclude methods of medical treatment from patentability.229
Section 16(2) of the Patents Act specifically excludes methods of medical treatment by surgery or therapy practised on human beings from the definition of patentable invention,230 which reflects the position at common law.231 Under Pfizer Inc v The Commissioner of Patents232 the Court of Appeal held that methods of medical treatment are not patentable inventions, due to being “generally inconvenient”233 in terms of the so-called ‘proviso’ in section 6 of the Statute of
227 Leahy-Smith America Invents Act, s 33(a):‘Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.’ See also MPEP § 2105.
228 See O Mitnovetski and D Nicol “Are patents for methods of medical treatment contrary to the ordre public and morality or ‘generally inconvenient’?” (2004) 30 Journal of Medical Ethics 470 at 473. It should be noted that patents over medicines also impact on a doctor’s choice of treatment, by preventing access to cheap medicines where the patient or government cannot afford the monopoly price.
229 TRIPS, art 27(3).
230 Patents Act 2013, s 16(2).
231 Pfizer Inc v The Commissioner of Patents [2005] NZLR 362 at [7]. Compare the position in Australia, which allows patents over methods of medical treatment at common law. See Anaesthetic Supplies Pty Ltd v Rescare Ltd (Rescare) (1994) 50 FCR 1.
232 Pfizer at [7].
233 At [7] per Anderson P: ‘…this Court once more unanimously holds that in terms of the present law, methods of medical treatment of humans are not patentable. Such methods may be inventions, but in terms of longstanding authority it is generally inconvenient to protect them with letters patent or grants of privilege.’
Monopolies.234 Notably, medical treatments which are deemed ‘non therapeutic’, such as cosmetic treatments, are still patentable in New Zealand.235
In the United States, claims over methods of medical treatment have been permitted since 1954.236 Nonetheless, under 35 USC § 287(c), there is a specific exclusion in the definition of patent infringement for medical practitioners that perform ‘medical activity’ on a human or animal. This exclusion is limited to ‘purely’
surgical or diagnostic methods which do not involve the use of a patented device, medicine or biotechnology process.237
Summary
As noted above, there are various categories of invention related to medical therapies that are excluded from patentability. Although patents over methods of medical treatment by therapy are permitted in the United States, patents over methods of medical treatment by surgery are unavailable and unenforceable, in New Zealand and the United States respectively. The possible effect of these exclusions on private incentives for development of socially valuable medical therapies will be discussed further in Chapter Three.
In recognition of the adverse policy implications of patentability exclusions to methods of medical treatment on private incentives for medical research, there has been a development of judicial inroads that overcome these exclusions in New Zealand. This will be discussed in the next section.
F Judicial Inroads into Exclusions of Methods of Medical Treatment
Judicial commentators have noted how excluding patents over methods of medical treatment may disincentivise medical research.238 The following sections will discuss various exceptions that have developed to overcome the exclusions of methods of
234 Statute of Monopolies 1623, s 6. The proviso reads: “so they be not contrary to the Law, nor mischievous to the State, by raising prices of commodities at home, or hurt of trade, or generally inconvenient.” See also Frankel, above n 9, at 405-407 and 409-412.
235 Re Handleman’s Application PO P02/1993, 23 February 1993. See also Joos v Commissioner of Patents [1973] RPC 59.
236 Ex Parte Scherer 103 USPQ (BNA) 107 (Pat Off Bd App 1954) at 109.
237 35 USC S 287(c)(2)(A).
238 See dicta of Jacob J in Merck & Co Inc’s Patents [2003] FSR 29 at [80]: ‘I conclude that the claim is in substance to a method of treatment of the human body by therapy. I do so with regret. For patents are provided to encourage research. If new and non-obvious improved methods of administration of known drugs for known diseases are not patentable in principle…there will be less of a research incentive to find such methods.’
medical treatment from patentability, namely, ‘Swiss’ claims, novel dosage regimens, methods of administration, and patient groups.
1 ‘Swiss’ claims
Because methods of medical treatment per se are not patentable in most Commonwealth and European jurisdictions, a dilemma arose in respect of known compounds for treating a different or new disease. If a compound was known, it would be unpatentable for lack of novelty under the General Tyre test for anticipation.
In addition, the ‘use’ of a known compound to treat a disease would be an unpatentable method of medical treatment.
This dilemma was overcome in the landmark case, ESAI/Second medical indication G0005/83, when the Enlarged Board of Appeal of the European Patent Office (EPO) first allowed so-called ‘Swiss claims’.239 Swiss claims are directed to the ‘manufacture of a medicament’, a substance used for a particular treatment, which avoids a claim over the method of treatment itself.240 Such claims allow the patent holder to sue a pharmaceutical company that manufactures a drug for an infringing use, but preserves the exemption for the doctor or pharmacist who prescribes the drug for that use.241
The patentability of ‘Swiss’ claims was upheld in New Zealand pursuant to the landmark decision of the Court of Appeal in Pharmaceutical Management Agency Ltd v Commissioner of Patents.242 There is a subtle difference between Swiss claims and second medical use claims,243 whereby the latter may be interpreted as having a slightly broader scope of coverage.244 Despite this, second medical use claims are deemed an unpatentable method of medical treatment in New Zealand.245 By contrast,
239 ESAI/Second medical indication G 0005/83 [1985] OJ EPO 64. ‘Swiss claims’ originated from the practice of the Swiss Intellectual Property Office to allow claims over the use of a known compound
‘in the manufacture of a medicament’ for a novel and inventive therapeutic use. The terms ‘Swiss claims’ and ‘Swiss-type’ claims are used interchangeably.
240 An example of a Swiss claim format is as follows: ‘Use of [drug X] in the manufacture of a medicament for the treatment of [disease Y].’
241 In any case, the difficulty with enforcing a patent against doctors or pharmacists is a characteristic of an unmonopolisable therapy, as will be discussed in Chapter Three.
242Pharmaceutical Management Agency Ltd v Commissioner of Patents [2000] 2 NZLR 529 [PHARMAC].
243 An example of a second medical use claim format is as follows: ‘Use of [drug X] for the treatment of [disease Y]’.
244 See ESAI/Second medical indication, above n 238. Notably, the European Union has now approved second medical use claims pursuant to amendments to article 52(4) and article 53(c) under the EPC 2000. The EPO will no longer accept claims in the ‘Swiss-type’ format: see ABBOTT RESPIRATORY/Dosage regime G 02/08 [2010] OJ EPO 456.
245 See Pfizer Inc v The Commissioner of Patents [2005] 1 NZLR 362 at [7]. See also discussion of s 16(2) Patents Act 2013, above n 229.
in the United States, under 35 USC § 100(b) specifically allows a patentable ‘process’
to include “a new use of a known process”.246