- Vaughan Barlow (1)

A Swiss-style or Swiss-type claim is a particular form of claim often used in jurisdictions where methods of medical treatment are unpatentable. Such claims are usually drafted as “use of [substance A] in the manufacture of a medicament for the treatment of [disease Y]”. They have long been regarded as an acceptable and useful form of claim in order to effectively secure monopoly rights for new uses of known pharmaceutical entities, otherwise known as “second indications”. Although many jurisdictions allow Swiss-style claims, New Zealand has traditionally been extremely reluctant to do so.

Summary
On 23 January 2007, the Assistant Commissioner of Patents of the Intellectual Property Office of New Zealand (IPONZ) handed down a significant decision that departs from established examination practice and which broadens the scope of allowable “Swiss style” claims in New Zealand. This decision, Genentech, Inc. and Washington University v The Commissioner of Patents (2), asserts that Swiss style claims are now allowable for a known pharmaceutical entity with a known activity used in a novel dosing regime. Such reliance on a method of administration for novelty extends the scope of allowable Swiss style claims in New Zealand. Until this decision, Swiss style claims in New Zealand were only valid for protecting a new use of a known entity.

Background to New Zealand application 539505
New Zealand patent application no. 539505 entitled “Method of administration of IGF-1” in the joint names of Genentech, Inc. and Washington University related to the use of insulin-like growth factor-1 (IGF-1) in the treatment of a range of diseases including heart failure, diabetes and renal failure. Use of IGF-1 to treat such diseases was known prior to the filing date of the application. However, the prior art also showed that treatment with IGF-1 often leads to undesirable side-effects, and that continuous IGF-1 treatment can become ineffective.

Application 539505 was therefore directed to an allegedly novel and inventive (non-obvious) dosing regime which was asserted by the applicant to maximize IGF-1 activity whilst minimizing side-effects. This was achieved by administering IGF-1 intermittently.

Due to the unpatentability of methods of medical treatment of humans in New Zealand(3), the claims sought under application 539505 were drafted in an unconventional “Swiss style” format.

Claim 1 read, in part:

“1.      Use of insulin-like growth factor-1 (IGF-1) in the preparation of a medicament for administering to a mammal so as to sustain its biological response in the treatment of a chronic disorder in the mammal wherein the medicament is formulated for administration according to a dosing regime … to provide an exposure to IGF-1 that is continuous or at least once a day consecutively over a period of days … then discontinuing said administration … then administering … IGF-1 to the mammal that is continuous or at least once a day consecutively over a period of days … then discontinuing said administration … and repeating this pattern …” (4)

Claim 1 (and all 56 claims) of application 539505 therefore differed from conventional Swiss style claims in that the claimed activity of the pharmaceutical composition was already known in the art, with the alleged novelty of the claims residing in the particular dosing regime used for administration.

Background to Swiss style claims in New Zealand
Swiss style claims were first formally allowed in New Zealand on 7 January 1997 when IPONZ published a Practice Note (5) advising of the allowance of Swiss style claims of the general form:

Use of [compound] in the manufacture of a medicament for the treatment of [disease].

The terms of the Practice Note were ultimately upheld by the New Zealand Court of Appeal in Pharmaceutical Management Agency Ltd v The Commissioner of Patents (6) (the “ Pharmac” case) where the court aligned itself with the European Patent Convention as interpreted in Re Eisai Co Ltd. (7)

After a number of apparently conflicting IPONZ decisions, a paper entitled “Guidelines for the Examination of Swiss-type claims” was issued by IPONZ on 16 November 2006,(8) wherein it was asserted that claiming the use of a known compound in the manufacture of a medicament with a known activity did not comply with the definition of a Swiss-style claim as per the Pharmac case. These guidelines made it clear that:

“[i]f the novelty of a Swiss-style claim resides in a subsequent use of the medicament rather than the new pharmaceutical activity, such as the mode of administration, or the quantity, frequency or timing of dosage, a section 2 objection shall be raised, as the claim is not a valid Swiss-type claim.” (9)

The 2006 Guidelines therefore consolidated a relatively narrow interpretation of case law on Swiss style claims, with preference given for the conservative approach taken in Bristol-Myers Squibb v Baker Norton Pharmaceuticals (10), where Swiss style claims relying on a faster administration rate for novelty were refused. This decision was later followed by IPONZ in Abbott Laboratories (11). Accordingly, the 2006 Guidelines required a novel activity for a known entity in order for a Swiss style claim to be valid.

The conservative position taken in the 2006 Guidelines was contrary to that of the European Patent Office in Genentech Inc (12), which interestingly was later followed by IPONZ in Merck & Co v Arrow Pharmaceuticals (13), where a Swiss style claim specifying a novel dosage regime overcoming low bioavailability in respect of a known pharmaceutical entity with a known activity was allowed.

In the present case, it was clear that the Swiss style claims of application 539505 did not meet the requirements for a valid Swiss style claim as set out in the 2006 Guidelines. The claims of application 539505 were therefore refused during examination, at which point the applicants requested a hearing on the matter.

The decision on New Zealand application 539505
Assistant Commissioner Popplewell (who was also the IPONZ hearing officer responsible for the Abbott Laboratories decision) reviewed previous UK and EPO decisions in detail, as well as several previous contradictory IPONZ decisions. In doing so, the Assistant Commissioner reasoned that the decision in Abbott Laboratories was:

“concerned with the particular case of novelty being claimed solely in the fact of co-administration and is not intended to be authority for a general principle. Further, it was decided without the benefit of the reasoning in … Bristol-Myers ... or the later … Genentech case”. (14)

In further attempting to distance the present case from the precedent set in Abbott Laboratories and then consolidated in the 2006 Guidelines, the Assistant Commissioner went on to review the 2006 Guidelines, stating:

“I appreciate the concerns of IPONZ which led to … the Guidelines. However, particularly after considering the arguments put forward in the cases (both British and Eurpoean, and the two IPONZ cases) discussed above, I do not agree with the statement in the Guidelines that claims such as those in suit in the present case are not valid Swiss-type claims. … As I see it the claims are not claims to medical treatment or an attempt to monopolize a new method of treatment any more than are normal Swiss-type claims.” (15)

In coming to the conclusion that earlier cases (as reflected in the 2006 Guidelines) were overly restrictive, the Assistant Commissioner purported to rely on the principles outlined by the IPONZ Assistant Commissioner in Merck & Co v Arrow Pharmaceuticals and the Pharmac decision, in which the Court noted the similarity between New Zealand and European law. Although the contrary reasoning in Bristol-Myers Squibb v Baker Norton Pharmaceuticals was acknowledged as persuasive, the Assistant Commissioner regarded it as non-binding, and further noted that it had not been followed by later European cases. The claims of application 539505 were therefore allowed, being regarded by the Assistant Commissioner as indistinguishable from conventional Swiss style claims in terms of the monopoly thereby created.

Conclusion
This decision is significant for the pharmaceutical industry, as it represents an acknowledgement by IPONZ of the need for broader patent protection in circumstances where particular dosing regimes confer important clinical benefits. More broadly, it may also indicate an increasing acknowledgement by IPONZ of the greater need for ancillary protection of second indication inventions in a jurisdiction where methods of medical treatment of human beings remains unpatentable.

- Vaughan Barlow, Pizzeys Patent and Trade Mark Attorneys (vbarlow@pizzeys.com.au)

(1) BSc(Hons) PhD LLB LLM(Hons). Vaughan is a legal practitioner admitted to the Supreme Court of New South Wales and a patent attorney registered to practice before the Australian Patent Office and the Intellectual Property Office of New Zealand. Vaughan is also a trade marks attorney registered to practice before the Australian Trade Marks Office. Vaughan practices with Pizzeys Patent and Trade Mark Attorneys: www.pizzeys.com.au
(2) IPONZ hearing decision P1/2007.
(3) Pfizer v Commissioner of Patents [2005] 1 NZLR 362.
(4) NZ patent application no. 539505
(5) ìPatent Office Practice Note ìSwissî type patent claimsî 1997/2 appearing in the New Zealand Journal of Patents issue no. 1412, page 2942 (January 1997) and issue no. 1413, page 2 (January 1997).
(6) [2000] RPC 857.
(7) Gr 05/83 of the Enlarged Board of Appeal of the European Patent Office.
(8)  IPONZ proposed practices: ìGuidelines on Applications Relating to Swiss-type claimsî released 16 November 2006. See http://www.iponz.govt.nz/pls/web/dbssiten.main.
(9) Ibid n 8 paragraph 016.
(10) [2001] RPC 1.
(11) IPONZ hearing decision (P16/2003).
(12) (T1020/03).
(13) IPONZ hearing decision (P3/2006).
(14) Genentech, Inc. and Washington University v Commissioner of Patents P1/2007 at page 14.
(15)  Ibid at page 16.