HIGH COURT OF AUSTRALIA
GLEESON CJ,
GAUDRON, McHUGH, GUMMOW, KIRBY, HAYNE AND CALLINAN JJAKTIEBOLAGET HÄSSLE & ANOR APPELLANTS
AND
ALPHAPHARM PTY LIMITED RESPONDENT
Aktiebolaget Hässle v Alphapharm Pty Limited [2002] HCA 59
12 December 2002
S287/2001ORDER
1. Appeal allowed with costs.
2. Set aside orders made by the Full Court of the Federal Court on 9 October 2000.
3. Matter remitted to the Full Court for the determination of any remaining grounds on the respondent's Notice of Contention.
4. Order 2 made by Lehane J on 18 June 1999 dealing with revocation further stayed until further order of the Federal Court.
5. Costs of the whole of the proceedings in the Federal Court to be in the discretion of the Full Court.
On appeal from the Federal Court of Australia
Representation:
J McL Emmerson QC with D M Yates SC and K J Howard for the appellants (instructed by Minter Ellison)
A C Bennett SC with S C G Burley and C Dimitriadis for the respondent (instructed by Mallesons Stephen Jaques)
Notice: This copy of the Court's Reasons for Judgment is subject to formal revision prior to publication in the Commonwealth Law Reports.
CATCHWORDS
Aktiebolaget Hässle v Alphapharm Pty Limited
Patents – Revocation – Obviousness or lack of inventive step – Patent for an oral pharmaceutical preparation – Whether invention obvious and did not involve an inventive step having regard to what was known or used in Australia on or before priority date – Combination of integers – Preparation arrived at by group of pharmaceutical chemists after period of experimental research – Whether hypothetical non-inventive worker in the field would have been led directly as a matter of course to pursue one avenue in expectation that it might well produce claimed invention – Relevance of publications discoverable by "routine literature search" but not found to have been part of the common general knowledge in Australia at the priority date – Whether invention obvious if it was apparent to a non-inventive skilled worker that it would be "worthwhile to try" each of the integers that was ultimately successfully used – Relevance of attempts to replicate the process of invention by a skilled person aware of the desired result – Whether attempts futile.
Appeal – Whether decision of primary judge in respect of obviousness affected by legal error – Where conclusions of primary judge affirmed by Full Court of the Federal Court.
Patents Act 1952 (Cth), s 100(1)(e).
GLEESON CJ, GAUDRON, GUMMOW AND HAYNE JJ. The appellants appeal from a decision of the Full Court of the Federal Court[1]. They are members of the Astra pharmaceutical group which is based in Sweden. The first appellant is the patentee of Australian Standard Patent No 601,974 for an invention entitled "New Pharmaceutical Preparation for Oral Use" ("the Patent"). At the time of the grant, the Patents Act 1952 (Cth) ("the 1952 Act") was in force. The term of the Patent is for 20 years from 23 April 1987. The claimed priority date, apparently pursuant to s 141 of the 1952 Act, is 30 April 1986. This was the date of the basic application in the United Kingdom and the Australian application was made on 23 April 1987, that is to say, within the 12 months of the basic application as required by s 141. The second appellant is an Australian subsidiary of the Astra group and is the exclusive licensee of the Patent. It is convenient to refer to the appellants without distinction as "Astra".
[1]Aktiebolaget Hässle v Alphapharm Pty Ltd (2000) 51 IPR 375; [2000] AIPC ¶91‑636.
The Patent
The Patent claims an oral pharmaceutical preparation in the form of a tablet, capsule or pellet containing omeprazole as the active ingredient. Omeprazole is a compound first synthesised in 1979. When absorbed in the upper part of the small intestine it inhibits gastric fluid secretions, and is useful in the treatment of gastric and duodenal ulcers. Astra held Standard Patent No 529,654 under the 1952 Act for this compound ("the compound patent"). This patent has expired and was not in suit in the present litigation.
The discovery of omeprazole and the grant of the compound patent was not itself sufficient to bring about the commercial exploitation of the compound by oral dosage. This was because the compound was not easily formulated into a satisfactory pharmaceutical composition. There was a problem in the administration of the drug which was answered with the formulation claimed in the Patent. The problem had several aspects. In broad terms, omeprazole rapidly degrades in an acid or neutral solution and, further, its stability also is affected by moisture and organic solvents. For omeprazole to work as a drug, it must be protected from acidic gastric juice on its way through the stomach and must be released rapidly when it reaches the top of the small intestine.
The Patent has 17 claims. Claims 1‑12 are product claims, each for a pharmaceutical preparation comprising a particular combination of constituents. Claims 1‑11 are for a tablet or pellet and claim 12 is for capsules. Claims 2‑12 are dependent upon claim 1. Claims 13 and 14 are process claims and claim 15 is for a preparation obtained by the process claimed in claims 13 and 14. Claim 16 is for the use of a preparation according to any one of claims 1‑12 and 15 for the manufacture of a medicament for the treatment of gastrointestinal diseases. Claim 17 is a method claim, the method being the administration in a therapeutically effective amount to a host in need of treatment for gastrointestinal disease. However, the focus in the litigation has been upon the broadest of the product claims, claim 1, and it is to the validity of that claim that attention will be given in these reasons.
The tablet or pellet claimed in claim 1 is a combination of three integers or elements. The first is the "core material" containing omeprazole as the active ingredient with an alkaline reacting compound; an alkali is a substance which neutralises or effervesces with acids. The second is one or more inertly reacting subcoating layer(s) on the core material, and the third an outer layer which is an enteric coating. An enteric coated tablet or pellet is one which assists through the stomach unaltered the contents then released in the intestine. The inert reacting subcoating layer(s), the second integer, comprise(s) excipients, that is to say, inactive substances that serve as a vehicle or medium for the core material. The excipients are soluble or rapidly disintegrating in water or are polymeric, water soluble, film-forming compounds optionally containing pH‑buffering alkaline compounds.
The tablet or pellet thus claimed is a combination in the proper sense of that term, combining three elements which interact with each other to produce the new product; it is the interaction which is the essential requirement of invention and such a combination may be constituted by integers each of which is old or some of which are new[2]. Thus, for example, in the present case, it is not to the point that of the three integers it may be said that omeprazole was known as an acid labile compound and that it was known that enteric coatings were resistant to acids. The question for decision concerns the ingenuity of the combination, not of the employment of any one or more integers taken individually. Astra complains that this analysis by dissection is what the Patent has wrongly been subjected to by the Full Court.
[2]Commonwealth Industrial Gases Ltd v MWA Holdings Pty Ltd (1970) 180 CLR 160 at 163; Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 at 266; Firebelt Pty Ltd v Brambles Australia Ltd (2002) 76 ALJR 816 at 819‑820 [21]; 188 ALR 280 at 285.
In many parts of the world, including Australia, Astra has sold a preparation manufactured in accordance with the Patent under the trade name "Losec". Losec has been a very effective and successful product. For example, for the period 1 July 1997 to 30 June 1998, the amount paid under the Commonwealth Pharmaceutical Benefits Scheme for Losec was considerably greater than the amount paid for any other branded drug.
The litigation
The respondent ("Alphapharm") markets "generic" drug formulations. In 1998, as the term of the compound patent neared its end, Alphapharm commenced steps to import and sell in Australia a pharmaceutical preparation containing omeprazole for therapeutic use in the treatment of gastrointestinal diseases. It applied to the Therapeutic Goods Administration to import and market in Australia such a pharmaceutical preparation. However, even after the compound patent expired and even if Alphapharm otherwise secured the necessary approvals by the Australian regulatory authorities, Alphapharm would not be at liberty to proceed with its proposals without overcoming the obstacle still presented by the Patent.
In August 1998, Astra instituted a proceeding in the Federal Court to restrain apprehended infringement of each of the claims of the Patent and for other relief. In its Defence, Alphapharm admitted it proposed to import and market its product in Australia after the compound patent expired and it had received the necessary regulatory approvals. However, it denied that there would be any infringement of any claim in the Patent and by its cross-claim sought revocation of the Patent.
The primary judge (Lehane J) held[3] that, assuming validity, the acts threatened by Alphapharm would constitute infringement of several of the claims of the Patent. However, his Honour held that Alphapharm succeeded on its cross‑claim. He made an order for revocation, with the result that the claim for infringement failed. The ground upon which his Honour determined that there should be revocation was obviousness. Alphapharm had attacked validity on various additional grounds, including lack of novelty. However, Lehane J held that none of the prior publications relied upon by Alphapharm rendered any of the claims not novel in Australia on the priority date[4].
[3](1999) 44 IPR 593; [1999] AIPC ¶91‑474.
[4](1999) 44 IPR 593 at 634; [1999] AIPC ¶91‑474 at 39,448.
On or about 30 May 1997, that is to say, before suit, an amended specification of the Patent had been filed and the amendments sought had been allowed. Alphapharm made various complaints based upon the allowance of the amendments but these were rejected by the primary judge and, for present purposes, nothing turns upon them. Nor, despite the submissions by Alphapharm in this Court respecting alleged admissions by Astra against interest arising from the amendment process, does that process assist in dealing with the issues respecting obviousness with which this appeal is concerned.
An appeal by Astra to the Full Court (Wilcox, Merkel and Emmett JJ)[5] was dismissed. The Full Court upheld the finding of Lehane J as to obviousness, but its reasoning in some significant respects differed from that of his Honour. The Full Court did not consider the additional matters raised by Alphapharm in its Notice of Contention. The issue on the appeal to this Court by Astra is whether the Full Court erred in not rejecting the finding by the primary judge with respect to obviousness. Were Astra to succeed in this Court, that would leave unresolved the balance of the issues before the Full Court. It should be added that the order for revocation made by the primary judge is, by order of the Federal Court, stayed until final determination of the appeal to this Court.
[5](2000) 51 IPR 375; [2000] AIPC ¶91‑636.
The Australian legislation
Section 100(1) of the 1952 Act relevantly stated:
"A standard patent may be revoked, either wholly or in so far as it relates to any claim of the complete specification, and a petty patent may be revoked, on one or more of the following grounds, but on no other ground:
…
(e)that the invention, so far as claimed in any claim of the complete specification or in the claim of the petty patent specification, as the case may be, was obvious and did not involve an inventive step having regard to what was known or used in Australia on or before the priority date of that claim".
It should be observed immediately that the 1952 Act directed attention to what was known or used in Australia at the priority date and that for the patent in suit this is 30 April 1986. That lapse of time is sufficient, without more, to foreclose any consideration for present purposes of what information might have been available by electronic research methods since developed on an international scale.
The 1952 Act was repealed by s 230 of the Patents Act 1990 (Cth) ("the 1990 Act"). The 1990 Act commenced on 30 April 1991. The 1990 Act deals with obviousness in terms which differ from those found in the 1952 Act, a matter adverted to in Firebelt Pty Ltd v Brambles Australia Ltd[6]. However, Lehane J referred to authorities construing the transitional provisions in Ch 23 (ss 231‑240) of the 1990 Act and concluded that, whilst the Patent might now be revoked only under the 1990 Act, for Alphapharm to succeed it would have to bring its case on obviousness within the terms of that ground as expressed in s 100 of the 1952 Act[7]. That was accepted as common ground by the parties in the Full Court[8] and the appeal to this Court has been conducted on the same basis.
[6](2002) 76 ALJR 816 at 821‑823 [31]-[36]; 188 ALR 280 at 287‑289.
[7](1999) 44 IPR 593 at 601; [1999] AIPC ¶91‑474 at 39,421.
[8](2000) 51 IPR 375 at 377; [2000] AIPC ¶91‑636 at 38,164.
The distinctions between the 1952 Act and the 1990 Act in the treatment of obviousness are important for this litigation. The 1990 Act provides some relaxation of the rule established in this Court (to which further reference will be necessary) which forbade the use of prior disclosures which, whilst publicly available, were not proved to be part of common general knowledge at the priority date[9]. The further amendments by the Patents Amendment Act 2001 (Cth) appear to continue this trend. However, the scheme of the 1990 Act was to preserve the rights of patentees under the 1952 Act by not imperilling validity through use of any broader grounds provided by the 1990 Act.
[9]Firebelt Pty Ltd v Brambles Australia Ltd (2002) 76 ALJR 816 at 822‑823 [35]-[37]; 188 ALR 280 at 288‑290.
Nevertheless, the Amended Particulars of Invalidity filed by Alphapharm were framed in terms drawn from the text of the 1990 Act. Paragraph 8 of the Particulars used terms such as "prior art base" and "related documents" which a person skilled in the art "would treat … as a single source of … information". Reliance also was placed upon listed prior art documents taken alone as well as in combination and upon each of the integers of the claimed combination as forming part of the common general knowledge. Both the primary judge and the Full Court emphasised that it was the 1952 Act which was applicable. Nevertheless, as will appear, their treatment of the issues does suggest the intrusion of considerations adverse to Astra which may have had a firmer footing in the 1990 Act.
The warning by Judge Learned Hand in Lyon v Bausch & Lomb Optical Co[10] respecting "unexpressed and unacknowledged [judicial] misgiving" about the facility with which patents appear to have been granted is in point here. His Honour added[11]:
"Courts again and again shift their position; and, although they are apt to do so under cover of nice distinctions, they impose the risk of anticipating the changes upon those who may have acted upon the faith of the original."
[10]224 F 2d 530 at 536‑537 (1955).
[11]224 F 2d 530 at 537 (1955).
Obviousness or lack of inventive step
The use of terms such as "obviousness", and lack or absence of "ingenuity", "subject-matter" and "inventive step", to distinguish a ground of revocation from that involved with "lack of novelty", "prior publication", "anticipation" and "prior use", has a fairly lengthy and evolving history in the decisions on patent law before the embodiment of the distinction in modern legislation[12]. Paragraph (e) of s 100(1) of the 1952 Act, like par (f) of s 32(1) of the Patents Act 1949 (UK) ("the 1949 UK Act"), uses the expression "was [or 'is'] obvious and did [or 'does'] not involve an [or 'any'] inventive step having regard to what was known or used … before the priority date of that claim".
[12]R D Werner & Co Inc v Bailey Aluminium Products Pty Ltd (1989) 25 FCR 565 at 569‑584, 591‑601; Lyon v Bausch & Lomb Optical Co 224 F 2d 530 at 535‑536 (1955).
On the other hand, in the United States, when a requirement for inventive quality was first embodied in statutory form by §103 of the 1952 Patents Act ("the 1952 US Act")[13], this was done under a heading "Non-obvious Subject Matter" and with a text which did not refer to absence of "inventive step". Section 103 asks whether "the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains". However, with respect to the juxtaposition of the phrases "was obvious" and "did not involve an inventive step", in the United Kingdom and Australia it has been accepted, as it was put in Beecham Group Ltd's (Amoxycillin) Application[14], "[o]bviousness and inventiveness are antitheses. What is obvious cannot be inventive, and what is inventive cannot be obvious." In the present case, the Full Court made a statement to the same effect[15] and this is accepted by both parties in this Court.
[13]35 USC.
[14][1980] RPC 261 at 290; cf Genentech Inc's Patent [1989] RPC 147 at 274.
[15](2000) 51 IPR 375 at 382; [2000] AIPC ¶91‑636 at 38,168.
Hindsight and combinations
The defendant to an infringement action who cross-claims for revocation on the ground of obviousness bears the onus of establishing that case. This obliges the defendant to lead evidence looking back to the priority date, sometimes, as here, many years before trial. In those circumstances, the warnings in the authorities against the misuse of hindsight are not to be repeated as but prefatory averments and statements of trite law. The danger of such misuse will be particularly acute where what is claimed is a new and inventive combination for the interaction of integers, some or all of which are known. It is worth repeating what was said by Lord Diplock in Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd[16]:
"Once an invention has been made it is generally possible to postulate a combination of steps by which the inventor might have arrived at the invention that he claims in his specification if he started from something that was already known. But it is only because the invention has been made and has proved successful that it is possible to postulate from what starting point and by what particular combination of steps the inventor could have arrived at his invention. It may be that taken in isolation none of the steps which it is now possible to postulate, if taken in isolation, appears to call for any inventive ingenuity. It is improbable that this reconstruction a posteriori represents the mental process by which the inventor in fact arrived at his invention, but, even if it were, inventive ingenuity lay in perceiving that the final result which it was the object of the inventor to achieve was attainable from the particular starting point and in his selection of the particular combination of steps which would lead to that result."
[16][1972] RPC 346 at 362. See also Olin Corporation v Super Cartridge Co Pty Ltd (1977) 180 CLR 236 at 262‑263.
The present invention
The case presented by Astra in opposition to the attack on validity was that the formulation claimed in the Patent had been arrived at by the exercise of scientific ingenuity, based upon knowledge and experimental research[17].
[17]cf National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 at 268.
After omeprazole was first synthesised in 1979, Astra set up what was called "the Omeprazole Project Group". Its first task was to obtain a sufficiently stable dosage form for toxicological and initial human pharmacological studies. A solution of omeprazole was not practicable and the group prepared a suspension of omeprazole in alkaline aqueous phase and this was used in human tests. In late 1979, the team considered an oil formulation, but omeprazole proved unstable in oil. Early in 1980 the researchers moved to enteric coated pellets.
A complex of difficulties was encountered by the team. These arose, inter alia, because omeprazole had low solubility in water and was highly unstable, being sensitive to acid conditions, water, solvents, high temperature and light. Other problems included poor bioavailability and shelf life. In some cases, measures which might have overcome one of these problems exacerbated others. In December 1981 a "brainstorming" meeting was held at which a range of possibilities was proposed. It was one of these which eventually led to the invention, although this was not realised at the time. The evidence of Dr Pilbrant (one of the inventors named in the Patent) respecting the position reached in December 1981 was:
"The range of ideas suggested reflected the fact that we could see no clear way forward, and there was no way that we could predict that any of the possibilities which had been suggested would solve the problems we had with omeprazole."
Further experiments resulted, by March 1982, in a subcoated pellet, tests of which for degradation, acid resistance and dissolution proved "promising". Early in 1983 a formulation, substantially the same as that which was ultimately marketed, was arrived at and could be subjected to long term stability studies. Dr Pilbrant's evidence was that it was not until the results of long term stability studies were available in 1985 that Astra could be sure that the invention solved the problems.
The evidence of another Astra witness, Dr Cederberg, was concerned with the conduct of trials in humans to see if various formulations proposed in the laboratory actually worked in the body. The Astra formulation team could be sure that the formulation worked only when supplied with these results. Trials were conducted over a period of almost four years.
The judgment at trial
Before Lehane J, Alphapharm called five expert witnesses, Drs Rowe, Story, Marshall, Thiel and Ashley. The experts called by Astra included Professors Rees and Rhodes, and from its research team Drs Pilbrant and Cederberg, to whose evidence reference has been made.
The primary judge noted the evidence of Dr Thiel that an Australian undergraduate at the priority date would have appreciated that an interaction could occur between the acidic enteric coat and the acid labile omeprazole. In a significant passage, his Honour then observed[18]:
"If that is so, it may not be unfair to comment that a large scientific team at Astra spent prodigally both time and resources in stumbling towards, and finally upon, what should have been an Australian undergraduate's first thought. But, more importantly, why should it have been thought that the core and the enteric coat were incompatible? No one gave evidence that he had previously, or since, encountered such a problem; there was no evidence of any product manufactured or marketed, before the priority date, in the making of which such a problem had had to be dealt with; there was evidence that other drugs which were both acid labile and alkaline (particularly erythromycin) had been successfully, and directly, enteric coated; each of the Alphapharm witnesses who gave evidence of the approach he would have followed in formulating omeprazole would have first tried a directly enteric coated formulation and (as senior counsel for Astra pointed out) Dr Marshall had no hesitation in applying an enteric coat directly to a core containing a significant quantity of a highly alkaline excipient; and, as the witnesses called by Astra said, there was a perfectly sound scientific explanation: in summary, that interaction should not occur in the absence of any significant quantity of free water."
[18](1999) 44 IPR 593 at 625‑626; [1999] AIPC ¶91‑474 at 39,441.
To this it may be added, as Lehane J explained, that Dr Marshall had not arrived at the precise formulation claimed in the Patent even after the preparation of six reports on varying instructions from Alphapharm which developed his initial brief to formulate an appropriate dosage form of omeprazole for use by adults[19]. Dr Marshall's evidence was important because, unlike other Alphapharm experts, he was not shown the Patent[20].
[19](1999) 44 IPR 593 at 614‑617, 629‑630; [1999] AIPC ¶91‑474 at 39,431-39,435, 39,444-39,445.
[20](1999) 44 IPR 593 at 614; [1999] AIPC ¶91‑474 at 39,431.
Against that background, at first blush it is surprising that the primary judge held that Alphapharm had made out its case for revocation. It is necessary to trace the steps by which this result was reached.
Lehane J noted that there was no significant dispute as to who was to be regarded as the hypothetical non‑inventive worker in the field; this was a person (or, it would seem to have been accepted, a team of persons) experienced in the practical work of formulating drugs for therapeutic use. Such persons would be highly qualified pharmaceutical chemists with, usually, a demonstrated capacity for original research. The hypothesis which the case law required fixed upon members of that class who were not "particularly imaginative or inventive"[21]. There are conceptual difficulties in applying what is said in some of the older authorities respecting "workmen" and the like to modern conditions in the pharmaceutical and other industries. But the employment of highly skilled research teams, as a matter of course, was noted over 70 years ago, well before the 1952 Act[22]. In this respect, there is no challenge to the way Lehane J approached the case.
[21](1999) 44 IPR 593 at 604; [1999] AIPC ¶91‑474 at 39,424.
[22]In re Farbenindustrie AG's Patents (1930) 47 RPC 289 at 321‑322.
The primary judge rejected Alphapharm's submission that the common general knowledge of the skilled formulator in Australia included material which the formulator might find by conducting computer searches and the like, being means available to and used by formulators. His Honour correctly did so because the corollary of the submission was that information should be treated as part of the common general knowledge in Australia, even in the absence of evidence of its general acceptance and assimilation by what he called "the formulating community". This was a proposition which Lehane J recognised[23] was foreclosed by the authority of this Court, in particular by Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd[24].
[23](1999) 44 IPR 593 at 606; [1999] AIPC ¶91‑474 at 39,425.
[24](1980) 144 CLR 253.
However, the primary judge erred in his further identification of the legal concept of obviousness against which the facts were measured. The Full Court also fell into error in this respect. Before turning to consider the nature and extent of these false steps, it is convenient to isolate several preliminary matters concerning the statutory formulation for "obviousness" in par (e) of s 100(1) of the 1952 Act as it has been interpreted in this Court, and to compare the position in several other countries, in particular the United Kingdom and the United States.
The law respecting obviousness
The starting point is the statement by Hoffmann LJ in Société Technique de Pulverisation Step v Emson Europe Ltd[25]:
"The words 'obvious' and 'inventive step' involve questions of fact and degree which must be answered in accordance with the general policy of the Patents Act to reward and encourage inventors without inhibiting improvements of existing technology by others."
[25][1993] RPC 513 at 519.
In The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Ltd[26], the English Court of Appeal, with reference to the ground in par (f) of s 32(1) of the 1949 UK Act, said[27]:
"'Obvious' is, after all, a much‑used word and it does not seem to [us] that there is any need to go beyond the primary dictionary meaning of 'very plain'."
These words do not aid Alphapharm; to the contrary, Alphapharm relies upon the Full Court judgment which employed such terms as "worthwhile to try", a phrase not readily understood as synonymous with "obvious".
[26][1972] RPC 457.
[27][1972] RPC 457 at 497.
More recently, Aldous J said that obvious is an "ordinary English word" which in patent law does not have "any technical meaning"[28].
[28]Chiron Corporation v Murex Diagnostics Ltd [1996] RPC 535 at 557.
However, those statements in the English cases should be treated with caution. The term "obvious" first appeared in the United States, United Kingdom and Australian legislation after detailed judicial exegesis over many years. Further, "obvious" does not stand by itself in the statute to specify a ground of revocation; the reader is required to "have regard" to what was "known or used" on or before a particular date, and to a particular geographical area. The notions of meaning and construction are interdependent and the meaning of "obvious" in par (e) of s 100(1) must be affected by the other words and syntax of the whole of s 100(1)(e)[29]. Finally, the statute does not identify the characteristics of the persons with the knowledge or use in question, thus making further judicial exegesis inevitable for the operation of the provision.
[29]Collector of Customs v Agfa-Gevaert Ltd (1996) 186 CLR 389 at 396‑397.
It is at this stage that further and for this appeal acute difficulties commence. They may be introduced by observations by Diplock LJ in a passage frequently cited in the English authorities. In Johns-Manville Corporation's Patent, Diplock LJ remarked[30]:
"I have endeavoured to refrain from coining a definition of 'obviousness' which counsel may be tempted to cite in subsequent cases relating to different types of claims. Patent law can too easily be bedevilled by linguistics, and the citation of a plethora of cases about other inventions of different kinds. The correctness of a decision upon an issue of obviousness does not depend upon whether or not the decider has paraphrased the words of the Act in some particular verbal formula. I doubt whether there is any verbal formula which is appropriate to all classes of claims." (emphasis added)
[30][1967] RPC 479 at 493‑494.
This last point is borne out by a consideration of the judgment of Aickin J in Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd[31]. In the course of that judgment, his Honour emphasised[32] (i) inventions may be the result not only of long experiments and profound research but also of chance, sudden lucky thought or mere accidental discovery; (ii) not all inventions are to be classified as successful solutions to a problem which had presented a "long‑felt want"; (iii) to the contrary, inventions which are an advance of contemporary expectations and thus reveal an "unfelt want" may well involve an inventive step; and (iv) in cases falling within (iii), experiments and research would throw no light on the quality of what was claimed as an inventive step.
[31](1981) 148 CLR 262.
[32](1981) 148 CLR 262 at 272, 279, 287.
Proposition (i) certainly also represented the law under the 1949 UK Act. In Dow Corning Corporation's Application, Graham J said[33]:
"An inventor may well arrive at his invention by a flash of genius which causes him no difficulty or concentrated thought at all, but the invention may still be a most brilliant one which would never have occurred to the notional skilled man in the art at all or only after prolonged investigation and the concentrated exercise of his, perhaps lesser, inventive faculty. In such a case, though it is in a sense obvious to the inventor, nevertheless the invention is undoubtedly worthy of patent protection."
[33][1969] RPC 544 at 560.
However, propositions (ii), (iii) and (iv) may not represent the effect of the current English case law[34]. Certainly they deny the general application of the proposition expressed by Lord Hoffmann in Biogen Inc v Medeva plc[35]. This was[36]:
"A proper statement of the inventive concept needs to include some express or implied reference to the problem which it required invention to overcome."
Biogen was the first case in which the House of Lords considered obviousness under the Patents Act 1977 (UK) ("the 1977 UK Act"). What was said may reflect the "problem and solution" approach which is apparently mandated by the European Patent Convention which requires European patent applications to disclose the claimed invention "in such terms that the technical problem (even if not expressly stated as such) and its solution can be understood"[37]. It will be necessary to return to the significance of the 1977 UK Act. However, earlier, in Amoxycillin[38], decided under the 1949 UK Act, Buckley LJ had spoken of the solution of "some recognised problem" and the meeting of "some recognised need".
[34]Blanco White, Patents for Inventions, 5th ed (1983), §4‑222.
[35][1997] RPC 1.
[36][1997] RPC 1 at 45.
[37]Paterson, The European Patent System, 2nd ed (2001), §12‑04; Cole, "Inventive Step: Meaning of the EPO Problem and Solution Approach, and Implications for the United Kingdom – Part I", (1998) European Intellectual Property Review 214 at 215‑216.
[38][1980] RPC 261 at 290.
In any event, the consistory clause in the Patent states that the invention claimed therein is designed to obtain a pharmaceutical dosage form of omeprazole which answers the problems referred to earlier in the body of the specification and indicated earlier in these reasons. The claim is for a combination, the interaction between the integers of which is the essential requirement for the presence of an inventive step. It is the selection of the integers out of "perhaps many possibilities" which must be shown by Alphapharm to be obvious, bearing in mind that the selection of the integers in which the invention lies can be expected to be a process necessarily involving rejection of other possible integers. This expression of the issue follows what was said by Aickin J in Minnesota Mining[39].
[39](1980) 144 CLR 253 at 293.
Divergence between Australian and United Kingdom law
In the argument in this Court, as in the Federal Court, reliance was placed upon various decisions in the United Kingdom. Reference has already been made to some divergence between the case law concerning the 1952 Act and the United Kingdom legislation in 1949 and 1977. There are further areas of divergence, the failure in an appreciation of which was of determinative significance for the decisions both of Lehane J and the Full Court.
The first concerns "mosaics" (a term of disparagement apparently first used by James LJ in 1880[40]), and related issues. The holding for which Minnesota Mining is celebrated is the rejection, as inapplicable to the terms of the 1952 Act, of the reasoning in certain English decisions. This might have permitted the basing of an argument of obviousness upon prior publicly available publications, without evidence that they had become part of the common general knowledge at the priority date[41]. Common knowledge, Windeyer J had pointed out in Sunbeam Corporation v Morphy-Richards (Aust) Pty Ltd[42], is the correlative of subject-matter or inventiveness, and available knowledge the correlative of lack of novelty.
[40]Von Heyden v Neustadt (1880) 50 LJ Ch (NS) 126 at 128.
[41]The law in the United States also was based upon knowledge "available" to any person having ordinary skill in the art: Lipscomb's Walker on Patents, 3rd ed (1985), vol 2, §6.29.
[42](1961) 180 CLR 98 at 114.
The respondent in Minnesota Mining had relied upon a number of prior patent specifications available in Australia for public inspection to base an argument of obviousness. But the respondent led no evidence that they were part of the common general knowledge on or before the priority date. There was no evidence that those working in the field of adhesives or surgical tapes followed a practice of studying and making themselves familiar with all patent specifications as they became available for inspection in the Patents Office library. Therefore, the issue of obviousness was to be determined without reference to the prior publications[43]. A fortiori obviousness was not determined by asking whether a diligent searcher might have selected the elements of the claimed invention by taking pieces from those prior publications and putting them together[44].
[43](1980) 144 CLR 253 at 294‑295.
[44](1980) 144 CLR 253 at 293.
In accordance with this reasoning, the respondent's case in Minnesota Mining would have been no better off if the contents of the Patents Office library had been "online" and so even more readily available to search. The issue was not whether it was "obvious" to search there, but whether what a search would have disclosed had entered the body of common general knowledge. On the other hand, Aickin J did have regard to evidence relating to the use of surgical tapes in hospitals and in medical practice as indicative both of what products were the common general knowledge and of the problem awaiting solution[45].
[45](1980) 144 CLR 253 at 295‑297.
The divergence in the case law marked by Minnesota Mining has since been widened by changes in statute law. It is unnecessary to consider further the changes in Australia brought about by the 1990 Act. They were discussed to some extent in Firebelt[46]. In the United Kingdom, the 1977 UK Act caused, as Professor Cornish has put it[47], the "largest culture shock" received by the British patent system in its history.
[46](2002) 76 ALJR 816 at 821‑823 [31]-[36]; 188 ALR 280 at 287‑289.
[47]Intellectual Property: Patents, Copyright, Trade Marks and Allied Rights, 4th ed (1999), §3‑01.
Section 3 of the 1977 UK Act says that "[a]n invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2)". Section 2(2) provides:
"The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in the United Kingdom or elsewhere) by written or oral description, by use or in any other way." (emphasis added)
Section 130(7) declares that various provisions, including ss 2 and 3, "are so framed as to have, as nearly as practicable, the same effects in the United Kingdom as the corresponding provisions of the European Patent Convention [and] the Community Patent Convention".
The result has been to mandate what was foreseen as the "Europeanisation" of British law[48]. This may bring a requirement, in broad terms, of a sufficiency or level of invention to support a patent grant[49], something more than the "scintilla" spoken of in this Court[50] and earlier British authorities[51]. The distinction may be reflected in the posing by Hoffmann LJ of the issue whether the patent in suit "discloses something sufficiently inventive to deserve the grant of a monopoly"[52]. This raises the barrier for patentees and its attempted importation for the 1952 Act may be implicit in the reasoning which led to adverse outcomes for Astra in this litigation.
[48]Blanco White, Patents for Inventions, 5th ed (1983), §4‑209, fn 52.
[49]Cornish, Intellectual Property: Patents, Copyright, Trade Marks and Allied Rights, 4th ed (1999), §5‑32.
[50]For example, Woolworths Ltd v W B Davis and Son Ltd Inc (1942) 16 ALJ 57 at 59; HPM Industries Pty Ltd v Gerard Industries Ltd (1957) 98 CLR 424 at 436; Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 249.
[51]For example, by the House of Lords in Cleveland Graphite Bronze Co v Glacier Metal Co Ltd (1950) 67 RPC 149 at 156.
[52]Société Technique de Pulverisation Step v Emson Europe Ltd [1993] RPC 513 at 519.
The result in Britain of the shift in grundnorm is exemplified in the observation by Laddie J[53] that the skilled worker (identified in s 3 of the 1977 UK Act):
"is assumed to have read and understood all the available prior art". (emphasis added)
The treatment of the point by Aickin J in Minnesota Mining, as indicated above, expressly rejected any assumption as to what in such a way may be expected of and attributed to the hypothetical addressee. That distinction is important in considering the path taken by Lehane J in his judgment. It is convenient, before doing so, to refer to the notion of "routine" which also played a significant part in that reasoning.
[53]Cairnstores Ltd v Aktiebolaget Hässle [2002] EWHC 309 (Ch) at [94].
"Matter of routine"
In Wellcome Foundation, Aickin J referred to the taking of a series of routine steps and the making of a series of routine experiments and continued[54]:
"The test 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." (emphasis added)
Lehane J, in critical passages in his reasoning[55], referred to and applied what he understood to follow from this passage. Was that understanding correct? Alphapharm submits that his Honour was correct, and Astra the opposite. Both sides accept that Wellcome Foundation is binding; they differ as to its meaning.
[54](1981) 148 CLR 262 at 286.
[55](1999) 44 IPR 593 at 626, 629; [1999] AIPC ¶91‑474 at 39,442, 39,444.
What Aickin J had in mind as "routine" appears from an earlier passage in his judgment in which he was discussing the question whether evidence of the steps taken by the patentee was relevant and therefore admissible in a revocation action. His Honour said[56]:
"Evidence of what he did by way of experiment may be another matter. It might show that the experiments devised for the purpose were part of an inventive step. Alternatively it might show that the experiments were of a routine character which the uninventive worker in the field would try as a matter of course. The latter could be relevant though not decisive in every case. It may be that the perception of the true nature of the problem was the inventive step which, once taken, revealed that straightforward experiments will provide the solution. It will always be necessary to distinguish between experiments leading to an invention and subsequent experiments for checking and testing the product or process the subject of the invention. The latter would not be material to obviousness but might be material to the question of utility." (emphasis added)
[56](1981) 148 CLR 262 at 280‑281.
There are distinct strands of thought in this passage which may now be considered in terms applicable to the issues in this ligitation. First, the working trials of which Dr Cederberg gave evidence may be (it is not necessary to determine the point) an example of the "subsequent experiments for checking and testing", to which Aickin J referred at the end of the above passage. Secondly, the invention claimed in the Patent lay not in perceiving "the true nature of the problem" to which "straightforward experiments" then would provide the solution; the invention was in the interaction between the integers of the compound, to answer the known problem. Thirdly, in a case such as the present, the relevant question was that posed in the first part of the passage. Were the experiments "part of" that inventive step claimed in the Patent or were they "of a routine character" to be tried "as a matter of course"? If the latter be attributable to the hypothetical addressee of the Patent, such a finding would support a holding of obviousness.
That way of approaching the matter has an affinity with the reformulation of the "Cripps question" by Graham J in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd[57]. This Court had been referred to Olin in the argument in Wellcome Foundation[58]. Graham J had posed the question[59]:
"Would the notional research group at the relevant date, in all the circumstances, which include a knowledge of all the relevant prior art and of the facts of the nature and success of chlorpromazine, directly be led as a matter of course to try the –CF3 substitution in the '2' position in place of the –C1 atom in chlorpromazine or in any other body which, apart from the –CF3 substitution, has the other characteristics of the formula of claim 1, in the expectation that it might well produce a useful alternative to or better drug than chlorpromazine or a body useful for any other purpose?" (emphasis added)
That approach should be accepted.
[57][1970] RPC 157.
[58](1981) 148 CLR 262 at 267. See also Washex Machinery Corporation v Roy Burton & Co Pty Ltd (1974) 49 ALJR 12 at 16.
[59][1970] RPC 157 at 187‑188. The approach taken in Olin appears now to be disfavoured by the English Court of Appeal: Pharmacia Corp v Merck & Co Inc [2002] RPC 775 at 819‑820 but it still has support in the English profession: Cole, "Inventive Step: Meaning of the EPO Problem and Solution Approach, and Implications for the United Kingdom – Part II", (1998) European Intellectual Property Review 267 at 270.
The reasoning of the primary judge
Lehane J did not treat "routine" in that way. He erred by giving it an operation more favourable to Alphapharm's case. What his Honour did was in line with the position which now apparently obtains in England, that "all of the courses of action which present themselves without the exercise of invention are obvious"[60]. His Honour did not assess what was said by the expert witnesses concerning the procedures they would have followed by making findings whether they would have been led directly as a matter of course to pursue one avenue in the expectation that it might well produce the claimed compound.
[60]Pharmacia Corp v Merck & Co Inc [2002] RPC 775 at 818.
His Honour also attributed to the hypothetical addressee the assistance to be gleaned from publications which had not been found to be part of the common general knowledge in Australia at the priority date. He correctly rejected the Alphapharm submission that the common general knowledge of the skilled formulator in Australia included material the formulator might find by conducting research, even if the information thus disclosed had not been generally assimilated and accepted by formulators[61]. But Lehane J then took a wrong turning in his reasoning process. His Honour said[62]:
"It may not necessarily follow, however, that documents which would have been found on search, but do not form part of the common general knowledge, are simply irrelevant. Common general knowledge is, after all, the stock of knowledge on the basis of which one asks whether what is claimed to be an invention was obvious and did not involve an inventive step. It may be that to make use of the result of a routine literature search is no different in concept from making use of a series of routine experiments where common general knowledge would have suggested either to the hypothetical formulator attempting to formulate omeprazole." (emphasis added)
Later in his judgment, his Honour accepted Dr Story's evidence that he would have regard to the literature revealed by this process "not … only for the purpose of finding precise directions" but "for more general ideas"[63] as a step in the statement of his conclusion that the Patent was bad for obviousness. That was an error. Further, the equating in this passage of "a routine literature search" with "a series of routine experiments" as something suggested by common general knowledge to the hypothetical formulator conflated two further errors. This came about as follows.
[61](1999) 44 IPR 593 at 606; [1999] AIPC ¶91‑474 at 39,425.
[62](1999) 44 IPR 593 at 606; [1999] AIPC ¶91‑474 at 39,425.
[63](1999) 44 IPR 593 at 629; [1999] AIPC ¶91‑474 at 39,444.
Lehane J held that the claimed combination had not been obvious "considered at the commencement of a hypothetical attempt"[64] (original emphasis). However, he continued[65]:
"The question is whether the hypothetical, not particularly imaginative skilled formulator, equipped with common general knowledge and embarking on the task at that time, would be likely to have arrived at the combination by taking routine steps which such a formulator would take for the purpose of formulating a drug." (emphasis added)
After referring to Wellcome Foundation, his Honour identified the "proper role" of expert witnesses as to what was "a matter of routine", saying[66]:
"Thus, for instance, I accept the general descriptions given by Dr Story and Dr Rowe of the way in which they would go about the formulation of a new drug. Nor do I see any reason to doubt the evidence of Dr Story, Dr Rowe and Dr Thiel about the importance of the role played by manufacturers' literature or the evidence of Dr Story and Dr Rowe about the significance, to formulators in Australia, of patent searches."
This led to the finding[67]:
"I have no difficulty with the proposition that a formulator asked, in April 1986, to formulate omeprazole would have done a literature search at least in order to discover what learning there was about omeprazole itself and its characteristics. Clearly enough such a search would have uncovered the compound patent, the omeprazole salts patent and Pilbrant and Cederberg. Pilbrant and Cederberg both indicated a number of the characteristics of omeprazole and pointed the formulator in a particular direction: an enteric coated dosage form seemed most likely to be the best possibility. That being so, there can be no surprise that the witnesses would have first tried directly enteric coating an omeprazole core, or that the particular 'controlled release' dosage form that Dr Marshall would have tried was an enteric coated one. I accept that that is what the hypothetical formulator would have done."
[64](1999) 44 IPR 593 at 626; [1999] AIPC ¶91‑474 at 39,442.
[65](1999) 44 IPR 593 at 626; [1999] AIPC ¶91‑474 at 39,442.
[66](1999) 44 IPR 593 at 626‑627; [1999] AIPC ¶91‑474 at 39,442.
[67](1999) 44 IPR 593 at 627; [1999] AIPC ¶91‑474 at 39,443.
One flaw in this reasoning is that it treats what was "known or used" within the meaning of par (e) in s 100(1) of the 1952 Act as if it was directed to information which, whilst accessible, had not been assimilated into common general knowledge. The reference to "the omeprazole salts patent and Pilbrant and Cederberg" was to an article published in 1985 by Drs Pilbrant and Cederberg, and to an Astra patent claiming principally a series of compounds which are alkaline salts of omeprazole. There was no finding that what was disclosed by those documents had entered the common general knowledge of those in Australia experienced in the practical work of formulating drugs for therapeutic use. Rather, reliance was placed upon the notion, illegitimate after Minnesota Mining, of a "routine literature search".
There follows the further conclusion[68] (later endorsed by the Full Court[69]):
"I accept also that the process which would then have followed would have been a complex, detailed and laborious one, involving a good deal of trial and error, dead ends and the retracing of steps; and it is easy to fall into the twin traps of hindsight and over simplification. But there is no reason to doubt that the hypothetical formulator would, having tried the first simple formulation, have done substantially what Astra did: submitted it to appropriate tests, including tests for stability on manufacture and on storage and for acid resistance."
The tracing of a course of action which was complex and detailed, as well as laborious, with a good deal of trial and error, with dead ends and the retracing of steps is not the taking of routine steps to which the hypothetical formulator was taken as a matter of course. In In re Farbenindustrie AG's Patents[70], Maugham J had said that while "mere verification is not invention", what he likened to the citadel of invention:
"may be captured either by a brilliant coup‑de‑main or by a slow and laborious approach by sap and mine according to the rules of the art; the reward is the same".
Further, the routine, which Lehane J accepted, took as its starting point that which was attributed from the reading of information which he had not found to be part of the common general knowledge.
[68](1999) 44 IPR 593 at 627; [1999] AIPC ¶91‑474 at 39,443.
[69](2000) 51 IPR 375 at 406; [2000] AIPC ¶91‑636 at 38,189.
[70](1930) 47 RPC 289 at 322.
The result is that the reasoning by which the trial judge concluded that the Patent was to be revoked was flawed by errors of law.
The Full Court
There is a particular temptation to rely on hindsight by imprecisely identifying the issue which arises in determining an allegation of obviousness. To this, with apparent encouragement from English authorities upon which Alphapharm relies, the Full Court succumbed as support for its rejection of Astra's appeal. To this we now turn.
The Full Court was alive to the difficulty with that part of Lehane J's reasoning which fixed upon the "availability" of the omeprazole salts patent and the Pilbrant and Cederberg article as translating their contents into the body of common general knowledge. Their Honours correctly held, contrary to what had been decided by the trial judge, that it was impermissible to have regard to documents that would have been read merely for "general ideas"[71]. However, the Full Court passed around that difficulty by accepting Dr Rowe's evidence that the information in the manufacturer's literature, respecting "the basic characteristics of omeprazole", "could, and would" be readily obtained by a formulator carrying out "a series of routine tests"[72]. That would instruct the formulator that omeprazole was an acid labile compound, which would need to be stabilised, so that "[t]he first integer selects itself"[73]. In this Court, Astra disputes the statement then made by the Full Court that Astra did not dispute that proposition. It is necessary here to take that point further.
[71](2000) 51 IPR 375 at 392; [2000] AIPC ¶91‑636 at 38,176.
[72](2000) 51 IPR 375 at 392, 409‑410; [2000] AIPC ¶91‑636 at 38,176, 38,191.
[73](2000) 51 IPR 375 at 392‑393; [2000] AIPC ¶91‑636 at 38,176.
This is because, in proceeding as it did, the Full Court considered each integer separately. It went on to say that it had been obvious to use an enteric coating and then said that[74]:
"[t]he only integer whose presence raises a doubt about obviousness is the subcoat. Was it obvious, within the sense of the relevant legal authorities, for the hypothetical formulator to try out the idea of a subcoat? And, if so, was it obvious for the hypothetical formulator to try out a subcoat falling within the description contained in the patent? These are the questions critical to the claim of lack of inventive step. They overlap and may be addressed together." (emphasis added)
[74](2000) 51 IPR 375 at 393; [2000] AIPC ¶91‑636 at 38,177.
The Full Court stated as a proposition of law that, to make out a case of obviousness[75]:
"[i]t is enough that it be apparent to [a non‑inventive skilled worker] that it would be worthwhile to try each of the integers that was ultimately successfully used." (emphasis added)
Their Honours then said that this was the point made in what they identified as a classic statement by Buckley LJ in Amoxycillin[76]. That was to the effect that, for "a particular step or process" to be obvious, it will suffice if it be shown that to a person skilled in the art but lacking an inventive capacity it would appear that "to try" the step or process would be "worthwhile" in solving the recognised problem or meeting the recognised need.
[75](2000) 51 IPR 375 at 382‑383; [2000] AIPC ¶91‑636 at 38,168.
[76][1980] RPC 261 at 290.
Astra points to several errors of law in this approach which deprive the Full Court decision of any support it might otherwise give to the decision at trial. The errors are interrelated.
First, the focus upon each integer rather than the interaction between them in combination went against the teaching in authorities such as Minnesota Mining, to which reference has been made. Secondly, the reference to "worthwhile to try" led the Full Court into the following reasoning[77]:
"[W]e reject the submission made by counsel for Astra that the finding made by Lehane J[[78]] logically concluded the issue of obviousness in their clients' favour. It will be recalled that his Honour said that 'considered at the commencement of a hypothetical attempt … the combination claimed in the patent was not obvious'. That finding would dispose of the issue only if the concept of obviousness was restricted, in the case of a combination patent, to a situation where the hypothetical formulator could foresee, at the commencement of his or her task and without the necessity for testing or any process of trial and error, which particular integers (out of all those 'worth a try') would be most appropriate. However, that is not the law, as was made clear by Buckley LJ in the extract from [Amoxycillin quoted above[79]]. Once it is accepted that it is sufficient that it be obvious to the hypothetical formulator that a particular possibility is worth trying (perhaps among many possibilities), it must follow that it is incorrect to say that an invention lacks obviousness simply because the hypothetical formulator would, or might, have been unable to say in advance which (if any) of the possibilities worth trying would prove most satisfactory." (emphasis added)
The Full Court added[80]:
"This reasoning applies even where (as here) a problem unexpectedly appears during the course of routine steps undertaken for the purpose of creating a new product. Although the existence of the problem may not have been apparent at the outset, its solution (when it does appear) may be obvious, as distinct from inventive, depending on whether or not it would immediately be apparent to a skilled worker in the field to try the solution that in fact proved effective."
[77](2000) 51 IPR 375 at 393; [2000] AIPC ¶91‑636 at 38,177.
[78](1999) 44 IPR 593 at 626‑627; [1999] AIPC ¶91‑474 at 39,442.
[79](2000) 51 IPR 375 at 383; [2000] AIPC ¶91‑636 at 38,168-38,169.
[80](2000) 51 IPR 375 at 393; [2000] AIPC ¶91‑636 at 38,177.
"Obvious" or "worthwhile" to try
It is by no means apparent that what was said by Buckley LJ in Amoxycillin was adapted to the purpose to which the Full Court put it. His Lordship was concerned with a claim to a single chemical substance (a penicillin) adapted for oral administration[81], not, as was the Full Court, with the dissection of a combination into its integers. The step or process to which Buckley LJ referred was a step from the prior art to the substance claimed. This appears from the balance of the passage from his judgment set out by the Full Court[82].
[81][1980] RPC 261 at 287.
[82](2000) 51 IPR 375 at 383; [2000] AIPC ¶91‑636 at 38,168-38,169.
Further, in the event, Buckley LJ upheld the validity of the claim. His conclusion has resonances for this litigation, but to the detriment of Alphapharm's case not, as the Full Court saw it, for its advancement. The vital passage is as follows[83]:
"I am fully prepared to assume on the evidence before the court that [prior patent] 978,178 should be regarded as having made clear to one skilled in the field of penicillins that the epimers of the para‑hydroxy and the meta‑hydroxy compounds were likely to prove fruitful avenues of research, possibly the most promising avenues known to exist. I accept that the lines which that research would follow would be what [the opponent's] witnesses described as 'routine', ie well‑known. I accept that anyone experienced in penicillin research who pursued research along those avenues would probably have found what Beecham found. But with great deference to the learned judge, I do not agree that this is enough to constitute the claim to Amoxycillin as a penicillin for administration to humans obvious for the purposes of section 14(1)(e) of the [1949 UK Act]. To reach the discovery of the particular characteristics of Amoxycillin and its suitability for treating humans the research worker would have had to embark upon a voyage of discovery. It is possible now to see that his voyage would have been short and perhaps uneventfully straightforward, but where each of his two, or possibly more, vessels would make landfall and what those places would be like would not have been obvious to him at the outset. The voyage might have been clearly worth trying but not as a means of reaching a specific hoped‑for destination."
[83][1980] RPC 261 at 296.
Buckley LJ did refer, among other authorities, to what had been said by Diplock LJ in Johns‑Manville[84]. Diplock LJ, after, as indicated above, decrying the use of particular verbal formulae, had rejected a postulate of prior certainty of success before actually performing particular tests; it was enough for a case of obviousness that the person versed in the art would assess the likelihood of success "as sufficient to warrant actual trial". Later, in Technograph Printed Circuits Ltd v Mills & Rockley (Electronics) Ltd[85], Lord Reid said that the hypothetical technician there under consideration must be supposed "to try everything which would appear to him as giving any prospect of valuable results" (emphasis added).
[84][1967] RPC 479 at 494.
[85][1972] RPC 346 at 356.
On the other hand, in American Cyanamid Co v Ethicon Ltd[86], Graham J held, with reference to Johns-Manville, that it was not obvious to try a substance (the invention claimed) which had been a candidate for inclusion in a research programme, given the extent of that programme. Reference has been made to what actually was decided in Amoxycillin. In Johns-Manville, the holding had been that the use of a known, but recently developed, flocculating agent to separate water from asbestos cement in the process of manufacture of asbestos cement pipes and boards was obvious. There was no question of dissection of a combination claim.
[86][1979] RPC 215.
Later English decisions[87] applying the 1977 UK Act to chemical and biotechnological patents treat what was said by Diplock LJ in Johns-Manville as synonymous with "worth a try" and "well worth trying out". On that basis, a number of patents have been held invalid for obviousness. These cases include Genentech Inc's Patent[88] upon which Alphapharm relied. The outcome may reflect the approach in European law that "the assessment of inventive step depends upon the extent to which a skilled person would have been technically motivated towards the claimed invention"[89]. But cases such as Genentech mark a divergence from the treatment of obviousness in the decisions of this Court. The Full Court of the Federal Court recognised this in ICI Chemicals & Polymers Ltd v The Lubrizol Corporation Inc[90].
[87]See, for example, Boehringer Mannheim GmbH v Genzyme Ltd [1993] FSR 716 at 725; Chiron Corporation v Murex Diagnostics Ltd [1996] RPC 535 at 557; Brugger v Medic-Aid Ltd [1996] RPC 635 at 661. See further Pharmacia Corp v Merck & Co Inc [2002] RPC 775 at 818‑819; Lilly Icos Ltd v Pfizer Ltd [2002] EWCA Civ 1 at [57].
[88][1989] RPC 147.
[89]Paterson, The European Patent System, 2nd ed (2001), §12‑43.
[90](2000) 106 FCR 214 at 240; their Honours referred in particular to Genentech Inc's Patent [1989] RPC 147 at 278, and see further Torremans, Intellectual Property Law, 3rd ed (2001) at 68‑78.
However, in the present case, a differently constituted Full Court, after setting out the passage from Amoxycillin to which reference has been made above, noted that[91]:
"Alphapharm does not suggest that the combination of integers disclosed in the patent would have been apparent to the skilled worker in the field prior to that worker attempting to formulate omeprazole",
but stated that the critical question in relation to the appeal was whether Alphapharm was correct in its further assertion that[92]:
"each of the integers was at least worthwhile trying; therefore the combination itself was 'obvious', in the sense in which that word is used in this area of the law" (emphasis added).
[91](2000) 51 IPR 375 at 383; [2000] AIPC ¶91‑636 at 38,169.
[92](2000) 51 IPR 375 at 383; [2000] AIPC ¶91‑636 at 38,169.
In so expressing the critical question and then proceeding to answer it favourably to Alphapharm, the Full Court fell into various errors of law. Several points are to be made. First, the statute does not ask whether a particular avenue of research was obvious to try so that the result claimed therefore is obvious; the adoption of a criterion of validity expressed in terms of "worth a try" or "obvious to try" and the like begs the question presented by the statute. In a sense, any invention that would in fact have been obvious under the statute would also have been worth trying. Paragraph (e) of s 100(1) of the 1952 Act, applied to the present case, asks whether the combination claimed in claim 1 was obvious. The paragraph does not fix upon the direction to be taken in making efforts or attempts to reach that particular solution to the problem identified in the Patent. Nor does it direct an inquiry respecting each integer of the claimed combination. The paragraph asks whether "the invention … as claimed", here the combination, was obvious, not each of its integers.
In the United States, any criterion which adopts a notion of "obvious to try" has been rejected in a long series of decisions upon §103 of the 1952 US Act[93]. The judgment in a number of these was given by Judge Rich, first as a member of the United States Court of Customs and Patent Appeals and latterly as a member of the United States Court of Appeals, Federal Circuit. In 1966, in Application of Tomlinson[94], his Honour wrote:
"Slight reflection suggests, we think, that there is usually an element of 'obviousness to try' in any research endeavor, that it is not undertaken with complete blindness but rather with some semblance of a chance of success, and that patentability determinations based on that as the test would not only be contrary to statute but result in a marked deterioration of the entire patent system as an incentive to invest in those efforts and attempts which go by the name of 'research.'"
[93]Cooper, Biotechnology and the Law, (2001 rev), vol 1, §4.03[1][a][v].
[94]363 F 2d 928 at 931 (1966).
Later, in In re O'Farrell[95], a case concerned with an invention using genetic engineering, Judge Rich observed:
"[F]or many inventions that seem quite obvious, there is no absolute predictability of success until the invention is reduced to practice. There is always at least a possibility of unexpected results, that would then provide an objective basis for showing that the invention, although apparently obvious, was in law nonobvious."
[95]853 F 2d 894 at 903 (1988).
Earlier, in In re Farbenindustrie AG's Patents[96], Maugham J had dealt with an application to revoke three "selection patents" relating to the manufacture of dyestuffs. The grounds advanced included lack of subject-matter, as it was then identified. His Lordship said[97]:
"In a sense it is still true to say that there is no prevision in chemistry. Any one of the millions of dyestuffs in question might be found to possess some unexpected and distinctive properties, either of colour or fastness, or to have some other incidental advantage. There is no short cut to knowledge of this kind. A laborious and systematic investigation of a long series of combinations becomes necessary; and it is the fact that of recent years certain industrial organisations with enormous financial resources have established laboratories where numbers of chemists of high scientific attainments devote their lives to a systematic examination on scientific principles of a vast number of chemical substances."
[96](1930) 47 RPC 289.
[97](1930) 47 RPC 289 at 321‑322.
In In re O'Farrell[98], Judge Rich also said:
"The admonition that 'obvious to try' is not the standard under §103 has been directed mainly at two kinds of error. In some cases, what would have been 'obvious to try' would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful. … In others, what was 'obvious to try' was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it."
The reasoning in these and other United States authorities[99] should be accepted in preference to the path apparently taken in the English decisions, particularly after the 1977 UK Act, upon which Alphapharm relied. The United States decisions reflect an approach to the subject closer to that adopted in Minnesota Mining and Wellcome Foundation.
[98]853 F 2d 894 at 903 (1988).
[99]Including Application of Antonie 559 F 2d 618 (1977), Application of Goodwin 576 F 2d 375 (1978), In re Geiger 815 F 2d 686 (1987), In re Fine 837 F 2d 1071 (1988), Merck & Co Inc v Biocraft Laboratories Inc 874 F 2d 804 (1989), In re Vaeck 947 F 2d 488 (1991) and In re Nunberg 33 United States Patent Quarterly 2d 1953 (1994).
Conclusions
Astra complains that the Full Court denied it procedural fairness. The Full Court took the view that Lehane J may have had in mind a possible rather than a probable result of the hypothetical formulator's activity; if so, then, in the Full Court's view, Lehane J had erred[100]. The Full Court then set out on a detailed review of the expert evidence. Astra complains that it was denied the opportunity of addressing the Full Court on the findings of fact which it made and that the Full Court wrongly assumed there to have been no dispute at trial respecting the evidence of Alphapharm's experts. It does appear that express rulings were never made at trial upon a number of objections. This failure by trial judges was described as unfortunate in Firebelt[101] and this case provides another example. Parties should know, before addresses are taken, the final state of the evidence, whether the trial be by judge and jury or judge alone.
[100](2000) 51 IPR 375 at 389; [2000] AIPC ¶91‑636 at 38,174.
[101](2002) 76 ALJR 816 at 824 [42]; 188 ALR 280 at 291.
It is unnecessary, for this appeal, further to pursue Astra's submissions on this aspect of the litigation. After its review of the evidence, the Full Court concluded[102] that Astra's "development" of the formulation "was essentially an exercise in trying out various known possibilities until the correct solution emerged" (emphasis added). That view of the matter wrongly takes as the starting point the assumed result. It succumbs immediately to the seduction of hindsight. Also, the notion of trying out possibilities invites the repetition of criticisms made earlier in these reasons.
[102](2000) 51 IPR 375 at 406; [2000] AIPC ¶91‑636 at 38,189.
The result is that the Full Court erred in the grounds upon which it supported the outcome at trial. The point is made from time to time that obviousness is a "jury question" and that the answer given to it by trial judges, juries long having since departed this scene in Australia, should be treated on appeal like any other factual resolution. All that is true, as it is, for example, of trials of negligence actions; but in all these fields the criteria of principle against which the evidence is measured are supplied by the law, whether by the common law, or by statute, in this case the 1952 Act and the decisions construing its provisions. In this litigation, both at trial and in the Full Court, Alphapharm was held to have made out its case by processes which were determined by errors of law.
Alphapharm and Astra referred to litigation in a number of countries respecting the validity of the patent protection for the formulation of omeprazole. This shows that upon variously expressed laws and differing factual findings a range of outcomes has been reached.
There are obvious advantages in a substantial measure of uniformity between the patent laws of countries with which Australia maintains international arrangements under its patents legislation. But these reasons reveal that the law respecting obviousness in various jurisdictions currently diverges and that the extent of this divergence changes from time to time. There is no universal view of a matter which at bottom reflects a range of attitudes to the balance of interests at stake in patent law. Nor is it to the point that had the obviousness of the claims of the Patent fallen for decision solely under the 1990 Act, whether in its initial or amended form, the law may have favoured Alphapharm's case more than did the 1952 Act.
Orders
The appeal should be allowed with costs. The orders made by the Full Court on 9 October 2000 should be set aside. The matter is remitted to the Full Court for the determination of any remaining grounds on Alphapharm's Notice of Contention. The operation of order 2 made by Lehane J on 18 June 1999 (which dealt with revocation) should be further stayed until further order of the Federal Court. The costs of the whole of the proceedings in the Federal Court are to be in the discretion of the Full Court.
McHUGH J. The issue in this appeal is whether "the invention, so far as claimed in any claim of the complete specification ... was obvious and did not involve an inventive step having regard to what was known or used in Australia on or before the priority date of that claim"[103]. This issue raised a question of fact that had to be determined by applying a statutory expression. A summary of some of the extensive evidence adduced in the case is contained in the joint judgment of Gleeson CJ, Gaudron, Gummow and Hayne JJ.
[103]Section 100(1)(e), Patents Act 1952 (Cth).
I would dismiss the appeal on the ground that there are concurrent findings of fact by Lehane J and the Full Court of the Federal Court that should not be disturbed by this Court. They were findings that were open to them on the evidence, they involved the application of a flexible, indeterminate expression and they were not flawed by any legal error.
The meaning of ordinary English words in a statute is a question of fact. "Obvious" is an ordinary English word whose primary meaning is "very plain"[104]. The question for Lehane J, therefore, sitting as a juror, was whether the inventive step claimed was "very plain". That involved making a judgment concerning a large volume of evidence. Different minds could reasonably have come to different conclusions about the effect of the evidence. If I had been the trial judge, I suspect that I would have applied the approach to the issue of "obviousness" that Gleeson CJ, Gaudron, Gummow and Hayne JJ follow in their joint judgment and if I had done so, I would probably have reached the same result as their Honours do. But, as a matter of law, I would not have been bound to use the approach that their Honours outline. Despite the many judicial statements to which their Honours refer, the issue in this case involved a factual conclusion[105] whose resolution could legitimately give rise to a number of differing approaches and answers[106]. In Johns-Manville Corporation's Patent[107], Diplock LJ refrained from providing a definition of "obviousness" so that it could not be cited in later cases concerning different types of claims. Diplock LJ said that patent law "can too easily be bedevilled by linguistics" and that "obviousness" does not depend upon the use of a particular verbal formula or reliance upon cases about other inventions of different kinds.
[104]The General Tire & Rubber Company v The Firestone Tyre & Rubber Company Ltd [1972] RPC 457 at 497.
[105]Société Technique de Pulverisation Step v Emson Europe Ltd [1993] RPC 513 at 519 per Hoffmann LJ; Chiron Corporation v Murex Diagnostics Ltd [1996] RPC 535 at 557 per Aldous J.
[106]Johns-Manville Corporation's Patent [1967] RPC 479 at 493-494 per Diplock LJ, Willmer LJ agreeing.
[107][1967] RPC 479 at 493-494.
A judge trying the obviousness issue is not bound, as a matter of law, to determine that issue by reference to persons who are not "particularly imaginative or inventive"[108]. Nor is the judge, in a case like the present, bound to ask "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"[109]. Nor is the judge bound to ask whether a notional research group would be directly led, as a matter of course, to try the approach of the "inventor" in the expectation that it might well produce a useful result or alternative[110]. These statements, and similar ones, have been made by judges, highly experienced and eminent in patent law, and applied by many other judges. A judge faced with a situation similar to those dealt with in a judgment containing one of these statements would be well advised to follow it, reflecting as it does the collective wisdom of the judiciary on this type of situation. And to do so helps to achieve consistency in fact finding, a matter of great importance if the law is to maintain the confidence of litigants. Equal justice under the law requires that like cases should be decided alike. Nevertheless, all such judicial statements merely reflect reasoning processes concerning factual issues. They do not lay down any legal principles and they have no precedent value. They are not binding upon judges hearing future cases.
[108]Aktiebolaget Hässle v Alphapharm Pty Ltd (1999) 44 IPR 593 at 604.
[109]Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 at 286 per Aickin J.
[110]cf Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd [1970] RPC 157 at 187-188 per Graham J.
In many fields of law governed by statute, such as income taxation, workers' compensation, environmental planning and patents, judges and practitioners, who specialise in those fields, have a tendency to treat judicial statements, determinative of particular cases, as principles of law. Few of them are. Most of the time, they simply reflect how experienced judges have resolved particular factual situations. As Dixon CJ once said[111], in rejecting an argument that a departure from observations made in an earlier case warranted the grant of special leave to appeal, "it is not everything that appears in the Law Reports that is law". Some may see this statement as a cynical reference to the Law Reports containing erroneous statements of legal principle. But given its context, I think that the great Chief Justice was emphasising that many statements in the Law Reports are concerned with reasoning about factual situations. So in Conkey & Sons Ltd v Miller[112], after referring to a passage in the judgment of Fullagar J in The Commonwealth v Butler[113] with which Dixon CJ and Kitto J had agreed, Barwick CJ said:
"[Butler] does not decide any principle of law. The statute requires the death to result from work-caused injury: whether it does or does not is a matter of fact. Doubtless, in applying the concepts of causation, a statement by an eminent judge such as I have quoted is entitled to respect by those who have themselves to decide a question of fact upon the evidence of the case before them. But its persuasion rises no higher: and certainly does not bind in point of precedent."
[111]White v The Queen (1962) 107 CLR 174 at 175.
[112](1977) 51 ALJR 583 at 585; 16 ALR 479 at 485.
[113](1958) 102 CLR 465 at 471-472.
When a trial judge has made, and an intermediate court of appeal has affirmed, a finding or findings of fact, this Court will almost invariably refuse to grant special leave to appeal against that finding or those findings. Unless the lower courts have misapplied the law in making the factual findings, the case is not "special" enough to warrant the grant of special leave to appeal.
I was a party to the grant of special leave to appeal in this case. At the time, I thought that, despite the concurrent findings of fact, the case arguably raised questions of principle. But after further examining the matter, I think that the case is really concerned with factual findings and reasoning.
Without reference to the long history of the Act and the glosses that have been placed upon it, a reader might read the clause, giving all of its words meaning and effect, to mean that a patent should be revoked if, but only if, the invention, that is, its manner of manufacture was not new as appeared in and from the complete specification, it was obvious, and it involved no inventive step. And, as to the last, regard to what was known or used in Australia on or before the priority date of the claim would be necessary.
On the basis of such a meaning, on the evidence, and the trial judge's findings, the respondent's application for revocation would be bound to fail. There was no doubt that the manner of manufacture, the coating of this active agent with the layers of the particular materials used in the respective quantities, thicknesses and places, was new. Let it however be assumed that the invention was "obvious", that is, in the sense that an enteric coated omeprazole pill was such a desirable product that as a concept it was familiar, and therefore obvious to those interested in the subject. Two matters, one clearly, and the other either implicitly found or such that it should have been found by the trial judge, nevertheless necessarily established that an inventive step was involved, having regard to whatever was known or used in Australia at the relevant time, a matter itself of some controversy. The first is that the development of a process of manufacturing an enteric coated pill (after a manufacturer understood that an enteric coated dosage might be effective) which would have followed would have been "a complex, detailed and laborious one, involving a good deal of trial and error, dead ends and the retracing of steps". That such a process might be undertaken as a matter of scientific and industrial routine may readily be accepted. But what actually and precisely had to be done, and was done, by way of unravelling the complexities, identifying and correcting errors, and, in particular, in deciding which steps to retrace, and in which direction to step thereafter, must have involved one or more inventive steps.
It is not entirely clear whether the trial judge did in terms accept the uncontradicted evidence of Dr Marshall an expert called by the respondent. I summarise it. He was the only one of the respondent's experts who was not given a copy of the appellants' patent. He was, in effect, asked to devise his own manner of manufacture of an effective form of oral dosage of omeprazole for adults. In all he made six reports. After the first, he searched a database containing abstracts of various articles. At that stage he had the benefit also of a report by Pilbrant and Cederberg[252] which was provided to him by the respondent. The respondent then instructed Dr Marshall to do further work on the basis of some assumptions that the former asked him to make. Neither his research, any of the further five reports that he made, nor various other communications from the respondent, resulted in an acceptable form of manufacture. In short, Dr Marshall's failure to achieve a satisfactory result, armed as he was with the materials and suggestions that I have mentioned, argues strongly against the absence of any "inventive step". There is no reason why the trial judge should not have accepted Dr Marshall's evidence and given effect to it. Accordingly, I will take his fairly detailed reference to it as acceptance and not a mere narration of it.
[252]Pilbrant and Cederberg, "Development of an oral formulation of omeprazole", (1985) 20 (supp 108) Scandinavian Journal of Gastroenterology 113.
However, the ordinary and natural meaning of the words of s 100(1)(e) may not be read, uninstructed by long standing authority. The terms "obvious" and "inventive step" are the antitheses of each other. Buckley LJ in Beecham Group[253] said that "[w]hat is obvious cannot be inventive"[254] notwithstanding that the word "obvious" when used in the Act qualifies "invention" that is, manner of manufacture, whereas "inventive" qualifies a step or steps involved in that manner of manufacture.
[253]Beecham Group Ltd's (Amoxycillin) Application [1980] RPC 261.
[254]Beecham Group Ltd's (Amoxycillin) Application [1980] RPC 261 at 290.
The primary judge posed the question for himself in this way[255]:
"Certainly, considered at the commencement of a hypothetical attempt, immediately before the priority date, to formulate omeprazole, the combination claimed in the patent was not obvious. The question is whether the hypothetical, not particularly imaginative skilled formulator, equipped with common general knowledge and embarking on the task at that time, would be likely to have arrived at the combination by taking routine steps which such a formulator would take for the purpose of formulating a drug. The test 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[256]: In my view, each of the expert witnesses sought conscientiously to fulfil the proper role of such a witness. Thus, for instance, I accept the general descriptions given by Dr Story and Dr Rowe of the way in which they would go about the formulation of a new drug. Nor do I see any reason to doubt the evidence of Dr Story, Dr Rowe and Dr Thiel about the importance of the role played by manufacturers' literature or the evidence of Dr Story and Dr Rowe about the significance, to formulators in Australia, of patent searches. That was evidence of factual matters within the knowledge and experience of the witnesses and which no one, with experience of the practice of formulators in Australia, was called to contradict."
[255](1999) 44 IPR 593 at 626-627 [110].
[256]Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 at 286.
It seems to me, with respect, that his Honour placed too much emphasis upon the question whether the relevant steps could be regarded as "routine" or not. I do not think the use of that word in the circumstances particularly helpful, because, as I have pointed out, although the taking and retracing of steps almost certainly would be done as a matter of routine, the selection of each of the steps to be retraced and taken, and the identification of error, are by no means necessarily dictated by any particular routine. Aickin J, although he used the word "routine"[257] in his judgment in Wellcome Foundation was not in my opinion intending to substitute an exclusive test of routineness for the test posed by the statutory language. It is important to keep in mind that the attention of the Court there was focused upon an issue of discovery only, and that his Honour's remarks naturally took into account the types of activities in which researchers and manufacturers would ordinarily be concerned.
[257]Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 at 281.
It is only to be expected that an expression (now found in the definitions section of the Act[258]) "manner of new manufacture"[259] which predated the Statute of Monopolies in 1623[260] and has repeatedly been construed by courts throughout the common law world, would not have escaped the application of layers of gloss. "Obviousness" has also, naturally, received much judicial attention, for example: something which "would at once occur to anyone acquainted with the subject"[261]; "the obvious or natural suggestion of what was previously known"[262]; "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"[263]; and, simply "very plain"[264]. It is difficult to see why, with respect, any court would have gone beyond the last of the suggested meanings. Authority in the United Kingdom has however entrenched a judicial approach to par (e) of s 100(1) of the Act and its near analogues and analogues elsewhere that questions whether "the alleged inventive step [would be] obvious to a normally skilled addressee in the art"[265]. The variety of forms in which the questions have been asked on other occasions is further illustrated by some examples collected in the Manual of Practice and Procedure[266]:
[258]See definition of "invention": Patents Act 1952 (Cth), s 6; Patents Act 1990 (Cth), Sched 1.
[259]Wellcome Foundation Ltd v Commissioner of Patents (1980) 145 CLR 520 at 524-528.
[260]21 Jac I c 3. The Statute was declaratory of the pre-existing common law.
[261]cf Vickers, Sons & Co v Siddell (1890) 15 App Cas 496 at 501-502 per Lord Herschell.
[262]Savage v D B Harris and Sons (1896) 13 RPC 364 at 370 per Lopes LJ.
[263]Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 at 286 per Aickin J.
[264]General Tire & Rubber Company v Firestone Tyre and Rubber Company Ltd [1972] RPC 457 at 497 per Sachs LJ.
[265]General Tire & Rubber Company v Firestone Tyre and Rubber Company Ltd [1972] RPC 457 at 497.
[266]Australian Patent Office, Manual of Practice and Procedure, vol 2, Pt 4 at [4.1.5.1].
"'The test 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.'
Aickin J in Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd (1981) 148 CLR 262 at page 286
'was so obvious that it would at once occur to anyone acquainted with the subject, and desirous of accomplishing the end'.
Allsop Inc & Another v Bintag Ltd & Ors (1989) AIPC 90-615 at page 39,332 [per Bowen CJ, Beaumont and Burchett JJ]
'Would the notional research group at the relevant date in all the circumstances … directly be led as a matter of course to try [the invention claimed] in the expectation that it might well produce [a useful desired result].'
Olin Mathieson v Biorex [1970] RPC 157 at page 187 [per Graham J]
'In the case of a combination patent the invention will lie in the selection of integers, a process which will necessarily involve rejection of other possible integers. The prior existence of publications revealing those integers, as separate items, and other possible integers does not of itself make an alleged invention obvious. It is the selection of the integers out of, perhaps many possibilities, which must be shown to be obvious.'
Minnesota Mining & Manufacturing Co v Beiersdorf (Australia) Ltd (1979-80) 144 CLR 253 at page 293 [per Aickin J]
'so easy that any fool could do it'
Edison Bell v Smith (1894) 11 RPC 389 at page 398 [per Lord Esher MR]".
I would myself have thought, as I have indicated, that all that the language of the statute requires is three questions: was the manner of manufacture new; was the manner of manufacture obvious; and, did it involve any inventive step. Such questions might very frequently, but by no means always overlap, and elicit overlapping answers. The question, whether the "inventive step" "was obvious" could equally, in ordinary English have been asked in one of these ways: was the step obvious, or, was the step inventive, or was the step not inventive, or was the step not obvious? The questions conventionally asked transfer the adjective "obvious" from its position as a qualifier of the (alleged) manner of manufacture, the invention, to a new position, as a qualifier of the step alleged to be inventive.
In General Tire & Rubber Company Sachs LJ[267] traced some of the history of the current forms of questions, and the use in patent law of the word "obvious", to the speech of Lord Herschell in the American Braided Wire case[268]. What his Lordship was referring to however when he used the word "obvious" in that latter case was the manner of manufacture in total, the "mode" of use, application and fixation of the various components, and not, each, or any, particular step, whether inventive or not, in the achievement of the total invention.
[267]General Tire & Rubber Company v Firestone Tyre and Rubber Company Ltd [1972] RPC 457 at 497.
[268]Thomson v The American Braided Wire Company (1889) 6 RPC 518 at 528.
It is easy to see how the tension created by the competing considerations of policy, between reward and incentive for ingenuity, and the desirability of the general availability to humankind of the products of that ingenuity, has contributed to different approaches to the questions and their answers. The problems are compounded by the difficulties of assessing, after the event, what the relevant and reasonably accessible learning or art was at the material time, the complexities for lawyers of the scientific and technical matters in issue, and the fact that almost everything, particularly to people knowledgable in the field, can have an appearance of obviousness after the event. Also almost always present in these cases is the fact that those who seek the revocation of a patent are commercial competitors with like resources and goals to those of the patentee but who have not themselves been able to, or have not had the inspiration to invent the invention. Here, a skilled practitioner, Dr Marshall, armed with suggestions from the respondent, and with the desired result identified for him, was unable to replicate the appellants' pill.
I have formed the view that on any of the stated tests, having regard to Dr Marshall's uncontradicted evidence, its source, from the respondent's side, and the trial judge's apparent and necessary acceptance of it, the answer must still be in the negative. The respondent's submission in this Court that Dr Marshall may have, indeed, even probably would have arrived at the solution had he had more time for experimentation demands no different an answer. The fact alone that he was still weighing up possible alternative methods that may or may not have worked, is a clear indication of an absence of obviousness.
The particular question that authority in this country requires me to ask is the one posed by this Court in Minnesota Mining[269]: whether the pill (as a combination patent) would have been obvious to a non-inventive skilled worker in the field able to select from a possibly large range of publications, and whether it would have been obvious to that worker to select the particular combination of integers from those selected publications[270]. It is important to keep in mind what the question is not, that is, "whether a diligent searcher might find pieces from which there might have been selected the elements which make up the patent."[271]
[269]Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253.
[270]Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 at 293 per Aickin J.
[271]Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 at 293 per Aickin J.
It may be that in Australia a less rigorous test is adopted than the one currently used in England[272] as was suggested by the Full Court of the Federal Court in ICI Chemicals & Polymers Ltd v The Lubrizol Corporation Inc[273]. United States authority does not assist very much because the statutory provision there contains manifestly different language – 35 USC §103(a) provides as follows:
"A patent may not be obtained … if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made."
It is important also to remember that in Australia, a "scintilla of inventiveness"[274] will suffice: "no smallness or simplicity will prevent a patent being good"[275]. The answer to the correct question as posed and required by Minnesota Mining therefore remains no.
[272]See for example that put forth by Mustill LJ in Genentech Inc v Wellcome Foundation Ltd (1988) 15 IPR 423; [1989] RPC 147.
[273](2000) 106 FCR 214 at 240.
[274]Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 249 per Aickin J:
"It is trite law that a 'scintilla of inventiveness' is sufficient and that 'no smallness or simplicity will prevent a patent being good' (Riekmann v Thierry (1896) 14 RPC 105 at 115; and see Vickers, Sons & Co v Siddell (1890) 15 App Cas 496 at 502). I am satisfied that there was here an inventive step in the devising of a new combination of features to obtain an improved result."
[275]Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 249.
There are, it may be accepted, problems unique to combination patents in assessing obviousness and novelty. A combination patent combines known information and is therefore susceptible to allegations of obviousness and lack of novelty. A particular danger, "that a court will assume, in retrospect, that anyone would have understood the desirability of combining the individual components"[276] was acknowledged by Fletcher-Moulton LJ in British United Shoe Machinery Company Ltd v A Fussell & Sons Ltd[277]:
"When you come to a machine of this type, you have to alter very seriously the canons which influence you in deciding such questions as novelty[[278]]. In the case of operations which have to be done under normal circumstances, in the absence of any special difficulties arising from speed, small and trivial alterations in the apparatus are viewed with suspicion, as possibly being idle variants; but when you come to machines which with this demand upon them still give uniform success, I think any tribunal will be very careful before it applies its ordinary ideas of what are mere idle and trivial changes to those alterations which have resulted in a success so triumphant. So that I approach the consideration of novelty in this case, ie, of the importance of apparently slight variations in the combination, in a very humble spirit, willing to be taught by those who know the practical performance of the machine, and are able to judge of the means which render that practical performance so successful. I remember very well a machine for printing newspapers, and turning them out in a folded form, in which the whole difference between hopeless failure and most valuable commercial success depended on a trivial change in the arrangement … a matter which, if you read it on paper seemed to be perfectly trivial, but which, I have no doubt, required very long continued experiment in order to arrive at the proper arrangement and demonstrate its importance, but which, once arrived at, actually turned failure into success." (emphasis added)
[276]Lahore, Patents, Trade Marks & Related Rights, vol 1 at 13,081 [12,905].
[277](1908) 25 RPC 631 at 646. In that case the invention was a minor addition to a known machine, but one which determined the success or failure of the machine.
[278]Lahore submits that in the context of today his Lordship's references to "novelty" would be more appropriate when considering "obviousness" rather than novelty, see Lahore, Patents, Trade Marks & Related Rights, vol 1 at 13,082 [12,905].
In my opinion the primary judge erred in focusing upon, and, with respect, not only attaching too much importance to routineness, but also in failing to distinguish between an established routine, no doubt followed by experiments, of research, of trying out ideas, identifying and correcting errors, of retracing old and taking new steps on the one hand, and, on the other, of the ingenuity involved, in carrying out the routine, of finding and eliminating error and choosing which out of a multiplicity of choices, was the right one. The Full Court of the Federal Court should therefore have upheld the appeal to it.
The Full Court (Wilcox, Merkel and Emmett JJ) chose a different test from either the one that Minnesota Mining requires or the one of "routineness" that the primary judge sought to apply. The Full Court adopted the question posed by Buckley LJ in Beecham Group[279], whether "it is shown that it would appear to anyone skilled in the art but lacking in inventive capacity that to try the step or process would be worthwhile" (emphasis added). And, the Full Court did not, in any event, in applying that test, give effect to the important qualification contained in it, that the notional skilled worker be lacking in inventive capacity.
[279][1980] RPC 261 at 290-291.
It is interesting that the Full Court dealt over some fifty or so paragraphs in great detail with the evidence of all of the experts called, with one critical exception, Dr Marshall. Of his evidence the Full Court only observed, erroneously, that his "practical reactions"[280] supported the theoretical evidence of two of the respondent's experts. The primary judge's finding in relation to those two experts was no more than that their "general descriptions … of the way in which they would go about the formulation of a new drug" should be accepted[281].
[280](2000) 51 IPR 375 at 407 [143].
[281](1999) 44 IPR 593 at 626-627 [110].
I cannot leave the discussion of the evidence without some observations of my own. It is clear that at the trial, each of the parties, particularly the appellants took lengthy objections to much of the evidence, especially to parts of the affidavits of the respondent's experts upon which the primary judge did not rule. As almost always, and at this trial, that course was bound to create difficulties for the appellants in cross-examination. What was in evidence, and what was not? What could be taken to have been sufficiently challenged by the tendering of the appellants' own experts' affidavits? The difficulties stemming from his Honour's abstention from ruling were increased by the absence of clear findings as to what he relied upon and accepted.
In those circumstances the Full Court's reliance on a claimed failure of the appellants' counsel to put various matters to the respondent's experts was, with respect, misplaced. These matters strengthen my opinion that the appeal should be upheld. Trial judges should insist upon proper proof of controversial material, and limit the reception of evidence, including evidence in writing, to what is relevant and admissible, by timely rulings on it.
I do not overlook that the issue for decision under par (e) of s 100(1) of the Act has long been said to be in the nature of a jury question. Even so, for the reasons I have given, the appeal must be allowed. Not only was the right test not posed by both the primary judge and the Full Court, but also it was not posed in relation to the compelling uncontradicted evidence of the respondent's own expert, Dr Marshall, whose evidence bore much more directly on the issue than any of the other evidence in the case. And, because this is so, I would not remit the case to the Full Court for further consideration of the application of par (e) of s 100(1) of the Act. There are however other issues outstanding, and the case will need to be remitted for the resolution of these.
I would allow the appeal with costs and order that the respondent pay the appellants' costs of the trial so far, and the appeal to the Full Court. I would remit the case to the Full Court for further disposal.