Arrow v Novartis – Assessing Common General Knowledge for Patents.


The Delegate’s decision in Arrow Pharmaceuticals Pty Ltd v Novartis AG [2019] APO 22 regarding whether the claimed invention involves an inventive step in view of the common general knowledge provides an interesting study as to how the Australian Patent Office should assess common general knowledge for patents.

Australian Patent Application 2013204752 is broadly directed to compositions and methods including S1P receptor modulators. S1P is a natural serum lipid. Binding of S1P antagonists to the S1P receptor in lymph nodes leads to immunosuppression. Independent claims 1 and 15 are directed to a solid pharmaceutical composition (namely a tablet or a capsule) comprising the S1P receptor modulator fingolimod at a concentration between 0.1% to 10% by weight and microcrystalline cellulose (MCC), either in the absence of a sugar alcohol (claim 1) or in the absence of both a sugar and a sugar alcohol (claim 15). MCC is a known diluent, filler, binder, or carrier for use in pharmaceutical compositions. Claim 1 defines the concentration of MCC between 75% to 99% by weight, whereas claim 15 has no such limitation suggesting use of MCC as a binder in the context of a composition as claimed in claim 15. The remaining claims include the conventional claim types for pharmaceutical patents, including methods of preparing the compositions, Swiss-style claims, methods of medical treatment claims. Fingolimod is an immunomodulatory agent that has particular therapeutic application in the treatment of autoimmune diseases and multiple sclerosis.

The test for inventive step in Australia is “whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.” (Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12; 148 CLR 262 at 286)

Under subsections 7(2) and (3) of the Patent Act 1990, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed before the priority date of the claim, whether that knowledge is considered separately or together with a single piece of prior art information, or a combination of any 2 or more pieces of prior art information. Prior to the Raising the Bar Act 2012, the existence of common general knowledge for patents was restricted to Australia. Under the Raising the Bar Act 2012, this restriction was broadened to include common general knowledge within and outside Australia. The opposed application falls under the provisions of the Act as it existed prior to the amendments of the Raising the Bar Act 2012, and as such the assessment of inventive step is in relation to common general knowledge as it existed in Australia before 26 September 2006, the earliest priority date of the application.

Assessment of inventive step requires consideration of the common general knowledge as a threshold issue. In the present opposition, Arrow Pharmaceuticals argued that claims 1 to 15 lacked an inventive step in light of the common general knowledge alone and in view of the common general knowledge combined with s7(3) documents. This article discusses the Delegate’s assessment of inventive step in light of the common general knowledge alone.

It is often overlooked during prosecution that determining the common general knowledge before the priority date of the claim is a factual enquiry to be made with the assistance of a person of skill in the art. The Courts have set down the approach to be followed when determining what is part of the common general knowledge. As a starting point, common general knowledge “forms the background knowledge and experience which is available to all in the trade” (Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd [1980] HCA 9; 144 CLR 253 at 2922). For a document purported to form part of the common general knowledge for patents, there must be evidence of its general acceptance and assimilation by the skilled addressee; mere public availability is not sufficient (Aktiebolaget Hässle v Alphapharm Pty Ltd [2002] HCA 59). The following passage from British Acoustic Films Ltd v Nettlefold Productions (1936) RPC 221 at 250 conveniently sets out how a disclosure is elevated to the common general knowledge:

In my judgement it is not sufficient to prove common general knowledge that a particular disclosure is made in an article, or a series of articles, in a scientific journal, no matter how wide the circulation of that journal may be, in the absence of any evidence that the disclosure is accepted generally by those who are engaged in the art to which the disclosure relates.  A piece of particular knowledge as disclosed in a scientific paper does not become common general knowledge merely because it is widely read, and still less merely because it is widely circulated.  Such a piece of knowledge only becomes common general knowledge when it is generally known and accepted without question by the bulk of those who are engaged in the particular art; in other words, when it becomes part of their common stock of knowledge relating to the art.

When assessing whether the claimed invention is obvious in light of the common general knowledge alone, the starting point for the Delegate’s assessment was the problem to be solved by the invention. In the Delegate’s view, the problem was the provision of a stable oral dosage form of an S1P receptor modulator. Fingolimod was not part of the starting point or the problem identified by the Delegate, which lead to the question whether fingolimod formed part of the common general knowledge before the earliest priority date and thus can be taken to be part of the starting point.

Based on the evidence before the Delegate, the answer is no. Before the priority date, evidence adduced by the experts showed that fingolimod was known as an S1P receptor modulator and appeared in several hundred peer-reviewed literature and patent documents. The compound was also mentioned in the pharmacology textbook Goodman & Gilman, which according to the Opponent’s expert witness suggested that the compound was “rising in prominence”. The Applicant adduced evidence that the Goodman & Gilman fingolimod entry was made publicly available 17 days before the priority date, which is insufficient time to be generally accepted and assimilated.

According to the Delegate, the evidence from Goodman & Gilman suggested that fingolimod attracted interest as an immunosuppressant and that the compound was being tested in clinical trials, but there was an absence of evidence establishing that fingolimod had become part of the common general knowledge before the priority date. The Delegate agreed that, before the priority date, fingolimod was merely “rising in prominence” and as such the skilled addressee may have taken more than “an ephemeral interest in the disclosure”. On this basis, the Delegate concluded fingolimod was not common general knowledge and as such, claims 1 to 15 are inventive in light of the common general knowledge alone.

Although the Applicant was victorious on this point, the Delegate ultimately found that claims 1 to 15 lack inventive step in light of the common general knowledge plus two separate pieces of prior art.

Common general knowledge is the basis of an inventive step assessment, whether or not s7(3) documents are also considered. However, Australian examiners rarely particularise the common general knowledge component of an objection. Indeed, one should argue that an examiner is unable and unqualified to make such determinations since an assessment of the common general knowledge is a factual enquiry supported by evidence of a person of skill in the art. This decision is informative as to the approach that should be taken by the Australian Patent Office for considering common general knowledge for patents, and the means by which such arguments can be refuted.