Bristol-Myers Squibb Company v FH Faulding & Co Ltd
[1998] FCA 860
•22 JULY 1998
FEDERAL COURT OF AUSTRALIA
PATENTS – petty patents for administration of anti-cancer drug in specified range of dosage over specified periods – drug naturally occurring compound with known anti-cancer properties – whether invention – whether method of medical treatment of human body patentable – whether “generally inconvenient” – whether novel – whether obvious – whether fairly based – supply to doctors and hospitals with instructions as to dosage – whether authorisation of use – whether infringement
N V Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 applied
Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232 applied
W R Grace & Co v Asahi Kasei Kogyo Kabushiki Kaisha (1993) 25 IPR 481 applied
Van der Lely NV v Bamfords Ltd [1963] RPC 61 followed
Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 applied
Sharp & Dohme Inc v Boots Pure Drug Company Ltd (1927) 44 RPC 367 followed
Re I G Farbenindustrie A G’s Patent [1930] 42 RPC 289 followed
Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1 discussed
Anaesthetic Supplies Pty Ltd v Rescare Ltd (1992) 25 IPR 119 followed
Maeder v Busch (1938) 59 CLR 684 mentioned
National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 52 mentioned
Joos v Commissioner of Patents (1972) 126 CLR 611 mentioned
Advanced Building Systems Pty Ltd v Ramset Fastners (Aust) Pty Ltd (1998) 152 ALR 604 mentioned
Wellcome Foundation Ltd v Commissioner of Patents [1983] NZLR 385 followed
Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 235 applied
Hill v Evans (1862) 31 LJ Ch 457 at 453,4 De G F & J 288, 45 ER 1195 applied
Martin and Biro Swan Ltd v H Millwood Ltd [1956] RPC 125 applied
Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 mentioned
The Australian Gas Light Company v The Valuer-General (1940) 40 SR (NSW) 126 mentioned
CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 applied
Falcon v Famous Players Film Co [1926] 2 KB 474 discussed
Walker v Alemite Corporation (1933) 49 CLR 643 applied
CCOM Pty Ltd v Jeijing Pty Ltd (1993) 27 IPR 577 followed
Firth Industries v Polyglas Engineering Pty Ltd (1975) 132 CLR 489 mentioned
Ryan v Lum (1989) 14 IPR 513 followed
Monckton v Pathé Frères Pathephone Ltd [1914] 1 KB 395 discussed
Evans v Hulton & Co Ltd [1924] WN 30 mentioned
Patents Act 1990 (Cth) ss 13(1), 18(1), 40, 117
Statute of Monopolies 1623 (Imp) s 6
BRISTOL-MYERS SQUIBB COMPANY v F H FAULDING & CO LIMITED
NO. VG 109 OF 1995
JUDGE: HEEREY J
DATE: 22 JULY 1998
PLACE: MELBOURNE
IN THE FEDERAL COURT OF AUSTRALIA
VICTORIA DISTRICT REGISTRY
VG 109 of 1995
BETWEEN:
BRISTOL-MYERS SQUIBB COMPANY
APPLICANTAND:
AND:
AND:
F H FAULDING & CO LIMITED
RESPONDENTF H FAULDING & CO LIMITED
CROSS-CLAIMANTBRISTOL-MYERS SQUIBB COMPANY
CROSS-RESPONDENTJUDGE:
HEEREY J
DATE OF ORDER:
22 JULY 1998
WHERE MADE:
MELBOURNE
THE COURT ORDERS THAT:
The application is dismissed.
Petty patents Nos 641894 and 651307 are revoked.
Bristol-Myers Squibb Company pay the costs of F H Faulding Co Ltd of the application and cross-claim, including reserved costs.
Note:Settlement and entry of orders is dealt with in Order 36 of the Federal Court Rules.
IN THE FEDERAL COURT OF AUSTRALIA
VICTORIA DISTRICT REGISTRY
VG 109 of 1995
BETWEEN:
BRISTOL-MYERS SQUIBB COMPANY
APPLICANTAND:
AND:
AND:
F H FAULDING & CO LIMITED
RESPONDENTF H FAULDING & CO LIMITED
CROSS-CLAIMANTBRISTOL-MYERS SQUIBB COMPANY
CROSS-RESPONDENT
JUDGE:
HEEREY J
DATE:
22 JULY 1998
PLACE:
MELBOURNE
REASONS FOR JUDGMENT
Introduction
This proceeding concerns two petty patents which claim a method of administering the drug taxol in the treatment of cancer.
The claims of petty patent no. 641894 (the first petty patent) are:
“1.A method for administration of taxol to a patient suffering from cancer comprising infusing from 135 to 175 mg/m2 of taxol over a duration not exceeding 6 hours.
2.The method of claim 1, wherein said administration comprises infusion of 135 mg/m2 of taxol.
3.The method of claim 2, wherein the duration of said infusion is not greater than 3 hours.”
The claims of petty patent no. 651307 (the second petty patent) are:
“1.A method for treating cancer in a patient suffering therefrom including infusing from 135 to 175 mg/m2 of taxol over a duration less than 6 hours, wherein said method results in a reduction of hematological toxicity and neurotoxicity compared with infusing greater than 170 mg/m2 of taxol over a duration of 24 hours.
2.A method according to claim 1 wherein said method includes infusing 175 mg/m2 of taxol.
3.A method according to claim 1 or claim 2 wherein said method includes infusing said taxol over a duration not exceeding 3 hours.”
The dosage mg/m2 refers to milligrams per square metre of body surface. The latter figure is calculated by reference to the height and weight of the patient.
The priority date is 3 August 1992. The applicable law is the Patents Act 1990 (Cth) (the Act).
The patentee is Bristol-Myers Squibb Company (Bristol-Myers). In August 1994 F H Faulding & Co Limited (Faulding) commenced proceeding VG 267 of 1994 against Bristol-Myers seeking revocation of each of the petty patents. In February 1995 Bristol-Myers commenced proceeding VG 109 of 1995 against Faulding alleging infringement of each of the petty patents. Faulding denied infringement and by a cross-claim sought revocation on the same grounds as in VG 267 of 1994. That latter proceeding has been discontinued.
By the time of final submissions the grounds of invalidity relied on by Faulding were:
(a) not an invention (s 18(1), opening words);
(b)not a manner of manufacture (s 18(1)(a)) because the petty patents were for a method of medical treatment of the human body and thus “generally inconvenient” within the meaning of s 6 of the Statute of Monopolies;
(c) lack of novelty (s 18(1)(b)(i) and s 7(1));
(d) lack of inventive step (s 18(1)(b)(ii) and s 7(2) and (3));
(e) not fairly based (s 40).
The foregoing sequence was not the order in which the issues were dealt with by counsel. However the majority judgment of the High Court in N V Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655 necessarily requires that a court address first the threshold issue as to whether, within the meaning of the opening words of s 18(1), there is an “invention”. If the answer is negative, “one need go no further”: 183 CLR at 664. Of course it is often desirable that a trial judge make findings in respect of all contested issues. I propose to do so in the present case. As to Mirabella, see generally David Brennan and Andrew Christie, “Patent Claims for Analogous Use and the Threshold Requirement of Inventiveness” (1997) 25 Federal Law Review 237 and James Cherry, “Standard of Inventiveness for Australian Patents” [1996] 6 European Intellectual Property Review 365.
Taxol
Taxol is a naturally occurring compound extracted from the bark of the small evergreen Taxus brevifolia, variously referred to as the western or Pacific yew, which grows in the Pacific Northwest region of the United States. It was found to have anti-cancer effectiveness in the late 1960s. The mechanism of action of taxol was discovered in 1979. Like some other anti-cancer agents, taxol inhibits the uncontrolled division of cancer cells by affecting sub-cellular structures known as microtubules. These are microscopic tubular structures which are built up or broken down and reassembled depending on the needs of the cell. While many other drugs inhibit microtubule assembly, taxol promotes assembly and inhibits disassembly, the cells becoming crowded with the thread-like structures. Taxol thus prevents the breakdown of spindles. Cell division is frozen. The spread of cancer - the uncontrolled proliferation of cells - is thereby inhibited.
Clinical trials of taxol commenced in 1983, but major problems with toxicity were encountered and initial studies were abandoned. The toxic effects included very severe hypersensitivity reaction, blood toxicity and damage to the nervous system (neurotoxicity).
Taxol has always been administered intravenously. Because it is relatively insoluble in water it is administered with a mixture of Cremophor EL and dehydrated ethanol. This vehicle also created problems.
Another problem is shortage of supply. Extraction from the bark of the western yew is a lengthy process taking about two years. Production of one kilogram of taxol requires 9,000 kilograms of bark collected from 2,000 to 3,000 trees. The equivalent of at least three trees is needed to treat a single patient.
Trials for new drugs
In medical science today there is a path which must be followed before drugs can be generally released for human treatment. The drug is first tested in the laboratory and with animals. Then follow clinical trials involving the administration of the drug to patients. These follow an internationally recognised sequence.
Phase I trials are conducted to determine the safe dose limit, referred to as the maximum tolerated dose. Phase I trials are not designed to show the efficacy of a drug, but rather what amount can be delivered safely and what type or types of toxicity set a limit to the amount of the drug that can be safely administered (dose limiting toxicity).
Phase II trials apply the safe level established in Phase I and test for efficacy under particular regimes of treatment involving variables such as dosage and time.
Phase III trials test and compare the drug with existing forms of medication.
Before a trial (in whatever phase) is commenced the investigators will prepare a protocol. This is a document setting out the relevant state of knowledge, the objectives of the trial and the methods proposed to be followed. The protocol will usually need to be approved by the ethics committee of the hospital or research institution where the trial is to be conducted. The cost of the trial may be met by a drug company, in which case the protocol will be submitted to it.
After the trial is completed the results will often be published in an appropriate learned journal. Sometimes there will also be presentation of the results at a conference. As well as articles giving detailed results of a trial, there may also be abstracts, which provide a brief summary. Sometimes these are published before the trial is completed. The fact that trials are proposed or being conducted may arouse general interest within the relevant area of medical science. Learned journals may publish editorials and other comments on the trials and generally on the current state of knowledge and future prospects for improved treatments.
The field of cancer medicine is a global one. A number of eminent Australian specialists gave evidence in this case. It is apparent from their evidence that they travel regularly to attend overseas conferences and have access to overseas journals.
The NCIC European study
The application for the petty patents in suit resulted from a study conducted under the auspices of the National Cancer Institute of Canada (NCIC) in a number of centres in Canada and Europe, and in particular in the Netherlands. It was funded by the NCIC and Bristol-Myers. The object of the study was to test taxol as a treatment for patients with ovarian cancer. In a protocol dated 14 June 1991 the investigators stated (CB 8/2315):
“It is clear that taxol is a drug with major potential in the treatment of ovarian cancer. However the optimal dose and infusion duration have not yet been defined. There is no evidence to suggest that higher doses yield better rates of tumor regression, nor is there data to conclude that the more cumbersome 24-hour infusion (which is currently considered the ‘standard’ recommended by NCI [National Cancer Institute of the United States]) is any afer than a shorter, more convenient infusion preceded by premedication.
We propose to study, with a bifactorial design, the impact of dosage as well as of time of infusion (in presence of premedication) upon efficacy and safety of the drug. Moreover, we plan to correlate both aspects with patient quality of life during treatment.”
The patients who were to participate in the trial would receive certain premedication (CB 8/2326) and then be allotted to one of four different arms for treatment as follows:
Arm A 175 mg/m2 over 24 hours
Arm B175 mg/m2 over 3 hours
Arm C135 mg/m2 over 24 hours
Arm D135 mg/m2 over 3 hours
Trials commenced in July 1991.
Some of the results of the NCIC European study were announced to an International Oncology Conference held in Amsterdam on 17-20 March 1992. An abstract by one of the investigators, Dr W W ten Bokkel Huinink, entitled “Taxol the First Available of Taxanes, a New Class of Anti Cancer Drugs” (Ex 10(L)) was circulated at the conference and published in the same month’s issue of Annals of Oncology, the journal of the European Society for Medical Oncology. It will be necessary to return later to the Huinink abstract. Suffice to note at the moment that it stated amongst other things that the three hours infusion time administration schedule “proved to be feasible”. A paper on that topic was presented to the conference by Dr Winograd. The paper (CB 15/4833) gave more details of the study.
In September 1992 further preliminary data was published (CB 9/3375). The final results were published in December 1994 (CB 5/1425).
In summary the report showed that response (reduction in tumour size) was slightly higher at 175 mg/m2 (20 per cent) as against 135 mg/m2 (15 per cent), but this was said to be not statistically significant given the size of the trial. As for progression free survival (the period until regression), there was a statistically significant difference for the 175 mg/m2 dose (19 weeks) versus the 135 mg/m2 dose (14 weeks). The three hour infusion was found to be safe and indeed associated with less neutropenia (a form of haematological toxicity).
It will be seen that the publication of information concerning the NCIC European study extended over a period which includes the priority date.
The petty patents in suit
The first petty patent is entitled “Methods for Administration of Taxol”. After reviewing the history of the drug and the literature the specification states (p 6):
“The conflicting recommendations in the prior art concerning whether premedication should be used to avoid hypersensitivity reactions when using prolonged infusion durations, and the lack of efficacy data for infusions done over a six hour period has led to the use of a 24-hour infusion of high doses (above 170 mg/m2) of taxol in a Cremaphor EL emulsion as an accepted cancer treatment protocol.”
The specification goes on to note the expense and inconvenience of 24 infusion durations, including the fact that an overnight stay of the patient is required. It is suggested that it is “highly desirable” that the infusion duration not exceed six hours so that the patient could be treated on an outpatient basis while providing sufficient dosage to have an anti-neoplastic (anti-cancer) effect not exceeding dose limiting toxicities. The specification continues (p 8):
“Thus, there is a need for a new method of administration of taxol which utilizes less taxol and/or requires less infusion time.
Therefore, it is a primary object of the present invention to provide a new method for administering taxol over a shorter period of time than the present 6 to 24-hour infusion protocols, while minimizing toxic effects induced by the administration of taxol.
It is another object of the present invention to provide a new method for administration of taxol which reduces the amount of taxol administered to a patient, without sacrificing the anti-neoplastic effects desired by administering taxol.
It is yet a further object of the present invention to provide a new method for administration of taxol which utilizes both lower dosages of taxol and shorter infusion periods, without sacrificing the anti-neoplastic benefits of the administration of taxol.”
Under the heading “Detailed Description of the Invention” it is stated (p 10):
“The surprising discovery that taxol could be safely administered via a short infusion (e.g., less than six hours and preferably over about 3 hours) means that it will now be possible to administer taxol on an outpatient basis, saving patients the time and expense of yet another hospitalization while improving patient quality of life.
It has also been surprisingly discovered that lower taxol dosages, such as about 135 mg/m2 can be administered via infusions lasting about 3-hours to 28-hours, and still be antineoplastically effective.”
The specification then goes on to detail the trials and the results of the NCIC European study, including incidence of toxic effects. It is stated (p 34):
“From the above teachings, it is readily apparent that many modifications and variations of the present invention are possible. It is to be therefore understood that the invention may be practiced [sic] than as otherwise specifically described.”
The specification of the second petty patent is in terms which are not significantly different. The petty patents conclude with the claims already mentioned.
Earlier Taxol trials
Phase I trials began in the 1980s. A range of dosages and infusion schedules were used. They included infusions at between 135 and 175 mg/m2 over three and six hours: Kris 1986 (Ex 10(C)), Longnecker 1987 (Ex 10(D)), Wiernik 1987 (Ex 10(E)), Donehower 1987 (Ex 10(F)), Lipton 1989 (Ex 10 (G)). (Papers referred to in these reasons were in all instances written by more than one author. As a mater of convenience the first author only is named.) Taxol was infused in solution with Cremaphor EL and alcohol. The three toxicities of the drug were haematological toxicity, neurotoxicity and hypersensitivity reactions. Haematological toxicity and neurotoxicity were found to be dose related: Rowinsky 1992 (Ex 10(M)). Doses of 200-250 mg/m2 were found to be safe for untreated or minimally pre-treated patients and were thus taken into Phase II trials: Rowinsky 1992 (Ex 10(M)). At least two of the trials, using a 6 hour infusion schedule, showed tumour response: Wiernik 1987 (Ex 10(E)), Donehower 1987 (Ex 10(F)).
The early problems encountered with taxol precluded conventional broad Phase II trials covering all types of cancer. Instead Phase II trials were initially limited to melanoma, renal and ovarian cancers. The Phase II trials in the late 1980s showed significant efficacy against a number of cancers including advanced ovarian cancer.
A trial of particular importance was McGuire 1989 (Ex 10(H)) at the Johns Hopkins Oncology Center. The subjects of the study were patients with ovarian cancer that had proved drug-refractory (unresponsive to previous drug therapy - in this case usually platinum based drugs). A 30 per cent response rate occurred.
By the priority date the optimal dosage and infusion schedule for taxol as a single agent treatment against platinum refractory ovarian cancer was a dose of 135-175 mg/m2 infused over 24 hours. The lower dose was the dose appropriate for heavily pre-treated patients, the higher dose for less heavily pre-treated patients: T 452, 485.
Significant hypersensitivity reactions had been encountered in early Phase I trials with an infusion schedule of three hours and no pre-medication: Kris 1986 (Ex 10(C)). It was unclear whether these were induced by the taxol itself or the Cremaphor EL and alcohol vehicle: Rowinsky 1990 (Ex 10(I)) p 1253. The United States NCI recommended that pre-medication be given and the infusion schedule be extended to 24 hours: Rowinsky 1991 (Ex 10(K)) p 1778, CB 9/3019. Accordingly, all Phase II trials were conducted using a 24 hour infusion schedule with known prophylactic anti allergic pre-medications including steroids and antihistamines: Rowinsky 1990 (Ex 10(I)) p 1253. These measures substantially reduced the incidence and severity of hypersensitivity reactions. Because the longer infusion schedule and the pre-medication were adopted together it was not clear what their relative merits were in controlling hypersensitivity reactions: T250-252, 496.
A study of hypersensitivity reactions had been conducted by Weiss in 1990: CB 5/1342, 8/2945. It surveyed earlier studies and set out their results in a table. It observed amongst other things that “prolonging the infusion by three hours [from three to six hours] is sufficient to reduce the incidence” of hypersensitivity reactions. It also observed (p 1266):
“Although prolonging the drug infusion to 6 or 24 hours might have reduced the risk for an acute reaction, this also may not be the case because 78% of the reactions occurred within 10 minutes of initiating the drug infusion, and the length of time planned for the total infusion would have no bearing.”
A 1987 Phase I trial by Donehower (Ex 10(F)) had commenced infusing taxol on a one hour infusion schedule without pre-medication. Significant hypersensitivity reactions were encountered. Fourteen patients were then given a total of 43 courses of taxol over six hours after pre-medication. Only three minor reactions occurred in this group. In 1991 a Phase I trial was conducted by Brown: (Ex 10(J)). Thirty one patients received 64 assessable courses of taxol (without premedication) administered as a six hour infusion every 21 days. One patient had a hypersensitivity reaction which was easily controlled using routine measures.
Thus clinical data existed which supported the proposition that taxol could be reasonably safely administered over six hours especially if pre-medication was given: CB 5/1113-4, T458-9, 499.
In December 1991 an editorial by Rowinsky and Donehower was published in the Journal of the National Cancer Institute entitled “Taxol: 20 Years Later, the Story Unfolds” (Ex 10(K)). It reviewed the development of taxol until that time and disclosed all the above matters other than the Brown trial. This was an important review article written by respected authors. It would have been read with interest by the hypothetical skilled addressee in early 1992 and regarded as reliable: CB 5/1117, CB 6/1461, T306-7, T407, T 446, T482.
After discussing hypersensitivity reactions the editorial said (p 1778):
“Both addition of the premedication regimen and the schedule change, however, were carried out at the same time. Therefore, the relative merits of each manoeuver are not entirely known. Further clinical trials should examine whether the 24-hour infusion which mandates hospitalization, is necessary when the pre-medication regimen is given. This is one of the questions being evaluated in a European-Canadian study with a bifactorial design which is comparing 3- and 24-hour infusions at doses of 135 and 175 mg/m2 in patients with ovarian cancer.”
Following a reference to maximum tolerated doses, the authors commented (p 1779):
“Nevertheless we are still in the dark at this juncture regarding the optimal therapeutic doses and the importance of a dose-response effect for taxol. The pivotal European-Canadian study mentioned above with a bifactorial design is currently attempting to address this issue in ovarian cancer by randomly assigning patients who have received previous platinum therapy to one of two different taxol doses (135 and 175 mg/m2) and one of two different schedules (24- and 3-hour infusions). Still, the discrepancy between the two doses used in this trial may not be wide enough to detect a significant dose-response effect in a heavily pre-treated and overall drug refractory patient population.”
The Rowinsky editorial also refers to a GOG (Gynecologic Oncology Group) Phase III randomised trial then in progress in which a taxol/cisplatin combination was being compared with the standard cisplatin/cyclophosphamide combination.
Statutory provisions
It is convenient to set out at this stage provisions of the Act which affect issues of invalidity in this case. Section 18 defines a patentable invention as follows:
“18 (1) Subject to subsection (2), a patentable invention is an invention that, so far as claimed in any claim:
(a) is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and
(b) when compared with the prior art base as it existed before the priority date of that claim:
(i)is novel; and
(ii)involves an inventive step; and
(c) is useful; and
(d) was not secretly used in the patent area before the priority date of that claim by, or on behalf of, or with the authority of, the patentee or nominated person or the patentee’s or nominated person’s predecessor in title to the invention.
(2) Human beings, and the biological processes for their generation, are not patentable inventions.
The requirements of novelty and inventive step are further dealt with in s 7:
“7. (1) For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:
(a)prior art information (other than that mentioned in paragraph (c)) made publicly available in a single document or through doing a single act;
(b)prior art information (other than that mentioned in paragraph (c)) made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art in the patent area would treat them as a single source of that information;
(c)prior art information contained in a single specification of the kind mentioned in subparagraph (b)(ii) of the definition of ‘prior art base’ in Schedule 1.
(2) For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim, whether that knowledge is considered separately or together with either of the kinds of information mentioned in subsection (3), each of which must be considered separately.
(3) For the purposes of subsection (2), the kinds of information are:
(a)prior art information made publicly available in a single document or through doing a single act; and
(b)prior art information made publicly available in 2 or more related documents, or through doing 2 or more related acts, if the relationship between the documents or acts is such that a person skilled in the relevant art in the patent area would treat them as a single source of that information;
being information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant to work in the relevant art in the patent area.”
The terms “prior art base” and “prior art information” are defined in Schedule 1 as follows:
“‘Prior art base’ means:
(a)in relation to deciding whether an invention does or does not involve an inventive step:
(i)information in a document, being a document publicly available anywhere in the patent area; and
(ii)information made publicly available through doing an act anywhere in the patent area; and
‘Prior art information’ means:
(a)for the purposes of subsection 7(1) - information that is part of the prior art base in relation to deciding whether an invention is or is not novel; and
(b)for the purposes of subsection 7(3) - information that is part of the prior art base in relation to deciding whether an invention does or does not involve an inventive step”.
Schedule 1 provides that “invention” means:
“any manner of new manufacture the subject of letters patent and grant of privilege within section 6 of the Statute of Monopolies, and includes an alleged invention”
and that “patentable invention” means:
“an invention of the kind mentioned in section 18.”
Section 6 of the Statute of Monopolies 1623 (Imp) declared that monopolies in general were bad, but saved
“... grants of privilege for the term of fourteen years or under, hereafter to be made of the sole working or making of any manner of new manufacture within this Realm, to the true and first inventor and inventors of such manufactures, which others at the time of making such Letters Patent and Grants shall not use, so as also they be not contrary to the law nor mischievous to the State, by raising prices of commodities at home, or hurt of trade or generally inconvenient.”
Section 40 of the Act provides:
40.(1) A provisional specification must describe the invention.
(2)A complete specification must:
(a)describe the invention fully, including the best method known to the applicant of performing the invention; and
(b)where it relates to an application for a standard patent – end with a claim or claims defining the invention; and
(c)where it relates to an application for a petty patent – end with a single claim, or a single indepenent claim and not more than 2 dependent claims, defining the invention.
(2)The claim or claims must be clear and succinct and fairly based on the matter described in the specification.
(4) The claim or claims must relate to one invention only.”
Invention
Mirabella, 183 CLR at 660-661, affirms the applicability under the Act of the principle which denies patentability to an alleged patent which is “nothing but a claim for the use of a known material in the manufacture of known articles for the purpose of which its known properties make that material suitable”: Commissioner of Patents v Microcell Ltd (1959) 102 CLR 232 at 251. If the specification on its face answers that description, the necessary quality of inventiveness is lacking.
The present case for invalidity seems to me stronger. At the priority date the material (taxol) had been known for many years. It is a naturally-occurring compound and thus in itself unpatentable. In the words of the specification, taxol had “shown great promise as an anti-cancer drug” and “been found to be an active agent against drug-refractory ovarian cancer” (p 1a). The properties which made taxol effective against cancer, that is to say its biological mechanism, were well known. They had been discussed in the articles referred to in the specification which were “incorporated by reference as if reproduced in full below” (p 1a), for example Brown 1991 (Ex 10(J)). Thus the specification is not merely a claim of “a new use of an old substance” (Re BA’s Application (1915) 32 RPC 348 at 349, Mirabella, 183 CLR at 661) but a claim for the same use for an old substance. Further, the specifications disclose that the claimed inventions were the product of routine testing which merely verified a hypothesis arising from analysis of reports of earlier trials: see W R Grace & Co v Asahi Kasei Kogyo Kabushiki Kaisha (1993) 25 IPR 481 at 497-498.
By using the term “routine” I do not wish to be taken as in any way disparaging the skill and effort which obviously went into the NCIC European study. But the petty patents in suit do not claim any method of scientific investigation or analysis. On their face they claim a particular dosage over a particular period of a substance known to be effective, in a known way, for the treatment of cancer, a dosage and period arrived at by the “ordinary methods of trial and error which involve no inventive step ... ”: Van der Lely NV v Bamfords Ltd [1963] RPC 61 at 71 per Lord Reid, cited with approval in Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 91 ALR 513 at 530 per Gummow J (with whom Jenkinson J agreed).
Immediately after the passage just quoted Lord Reid goes on to speak of such methods being “generally necessary in applying any discovery to produce a practical result”. The present case is even less an invention because in no sense could it be said that as at the priority date taxol was a “discovery” for the treatment of cancer.
The concepts of routine testing and trial and error were discussed (although not described as such in terms) by Astbury J in Sharp & Dohme Inc v Boots Pure Drug Company Ltd (1927) 44 RPC 367. The following passages are of assistance not only as to the invention issue but to the later issue of novelty. Much of Bristol-Myers’ case revolved around the proposition that use of taxol over a three hour infusion period had not, at the priority date, been sufficiently tested so as to be regarded as safe and effective for ordinary clinical use.
Sharp concerned an alleged invention relating to the production of new alkyl resorcinals. Astbury J said (at 387-388):
“It was Sir James Dewar who has constantly said in this Court that there is no prevision in chemistry. In a limited sense that is, of course, absolutely true. One cannot be definitely certain in chemistry that a process or a reaction which has followed up to a certain point will necessarily go the next step. In a large number of these cases one can have very, very little idea as to whether it will or not: in many cases one can be pretty sure that it will, and in others one can have very little doubt that up to some point beyond what was already reached there will be a successful result if the previously-known reaction is tried with a higher body. But really what the Plaintiffs’ witnesses are saying, and saying perfectly accurately, is that there is no certainty of knowledge until the fact is ascertained. There are many, many of these questions, but I think they all in substance come to the same thing. ... As we proceed in this case it will be found that the Plaintiffs have tried, in my judgment, to make a great deal too much of what they describe as research. Supposing the fact be that a chemist had, in a simple, or more or less simple series, and with a more or less simple reaction, gone four steps up in the series and had indicated that that process or that reaction would be a wise thing if one desired to go higher up in the series, it seems to me idle to say that it would involve invention for a chemist, knowing that to say: ‘Although I cannot say whether I shall get to the fifth or sixth step, still I will do what the man says and try.’ The Plaintiffs have suggested that that is research. Mr Ballantyne calls it investigation. I do not care what word is used. In my opinion that, and that alone, would not in any reasonable sense at all form valid subject-matter for taking out a patent to verify the anticipations of an earlier chemist.”
And later, in referring to an earlier paper by one Clemmensen, his Lordship said (at 393):
“I accept from them [the plaintiffs’ witnesses] without demur that, notwithstanding what they read here, they are entitled to say, and to say honestly, that unless and until they had put into practice with regard to any particular body this process of Clemmensen’s result as he states it would occur. But it is a different matter altogether to say that it is subject-matter for a patent for a person to come up into this Court and say: ‘Because I did not ‘know, in the sense of final knowledge, that Clemmensen’s statement was ‘accurate, I can then take out a patent for proving that what he said was ‘true.’ That, in my opinion, is a complete disclosure of the principle under-lying the plaintiffs’ so-called invention.”
As Maughan J noted in Re I G Farbenindustrie A G’s Patent [1930] 42 RPC 289 at 322, the court is not concerned with the state of mind of the inventor. His Lordship said:
“Patents may be granted for inventions which have been the result of profound research or of some sudden and lucky thought or of mere accident, and also for inventions imported from abroad without the knowledge of the inventor. ... The Court is concerned, so far as subject-matter is concerned, only with the results. The invention must, of course, add something of a substantial character to existing knowledge; but the Courts do not inquire into the way in which the conquest was achieved. If the language of metaphor may be used, the citadel 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.”
Thus the alleged inventions in the present case have to be judged on the inventive merit involved in a stipulation of a particular dosage over a particular period of a known anti-cancer drug used for that very purpose. In my opinion no invention is disclosed.
Manner of manufacture
The issue which falls to be considered under this heading is whether the monopolies claimed in the petty patents in suit are “generally inconvenient” within the meaning of s 6 of the Statute of Monopolies. In particular it is said that a method of medical treatment of the human body is not patentable.
This question was discussed extensively by members of the Full Court in Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1. Lockhart J (at 6-19) reviewed authorities in Australia, New Zealand, the United Kingdom, Canada, the United States, Germany and Israel. His Honour concluded that a method of treatment was not inherently unpatentable. Wilcox J (at 42-45) was of the same view. Sheppard J (at 32-41) was to the contrary.
Since the passages referred to take up some 26 pages of the Federal Court Reports I think the more convenient course will be to incorporate them by reference.
As to authority on this issue, the following can be said:
The views in Rescare itself were obiter. The patentee failed on the fair basing issue. Senior counsel for Bristol-Myers in the present case conceded this, although he said that the remarks were obiter only “at the most technical level”. I do not understand this qualification. For the purposes of the doctrine of precedent, a decision of a higher court is either binding or not.
There is no other authority suggested to be binding on a single judge of the Federal Court .
Such obiter as there is in High Court decisions tends against patentability for methods of medical treatment of the human body: Maeder v Busch (1938) 59 CLR 684 at 699, 706-707, National Research Development Corporation v Commissioner of Patents (1959) 102 CLR 252 at 270, Joos v Commissioner of Patents (1972) 126 CLR 611 at 616-619, 622-623. Subsequent to Rescare, Brennan CJ, Gaudron, McHugh and Gummow JJ said in Advanced Building Systems Pty Ltd v Ramset Fastners (Aust) Pty Ltd (1998) 152 ALR 604 at 614:
“The classification of certain methods of treatment of the human body as an inappropriate subject for grants under the Act appears to rest on this footing” [i.e. the exclusion in s 6 of methods of manufacture which are “contrary to the law” or “generally inconvenient”].
In a footnote to this passage their Honours refer only to Joos and Rolls-Royce Ltd’s Application (Manner of Manufacture) [1963] RPC 251 at 255. However it is hardly likely that their Honours were unaware of Rescare.
The New Zealand Court of Appeal in Wellcome Foundation Ltd v Commissioner of Patents [1983] NZLR 385 has decided against patentability.
Australia and New Zealand have close historical, geographical and social ties. Under the Australia New Zealand Closer Economic Relations Trade Agreement (Treaty Series 1983 No 2) there is a high degree of integration of the two nations’ economies. The Trade Practices Act 1974 (Cth) provides by ss 5, 46A and 46B for the regulation of a “trans-Tasman Market” and for the enforcement of some of the competition law of each country in the other. It is therefore a desirable policy objective in itself that in important areas of commercial law the laws of the two countries be consistent.
As a matter of principle, I would respectfully agree with and adopt the observations of Sheppard J in Rescare, 50 FCR at 40-41 as follows:
“Australia is one of a large number of countries which are fortunate enough to be served by extremely competent physicians and surgeons whose task it is to maintain and improve the health of the community. Leading members of the medical profession are usually members of one or more of the distinguished colleges of physicians or surgeons which exist in the United Kingdom, the United States, the European countries and in this country. Not infrequently - this case provides an example - they are also members of a faculty of medicine within one of the universities. The hospital in which they practise medicine is allied with the university and, for this reason, is known as a teaching hospital.
It is well known that the work of the medical colleges involves both research and teaching. It is probably true to say that all professions, using that expression in its true sense, develop by research and by teaching. There is a willingness on the part of members to share information about new discoveries and new methods of treatment. This is particularly so in relation to surgical procedures of innumerable kinds and in relation to the management of people who are suffering from serious disease. Whether that treatment consists of the way a patient is managed in hospital, the selection of particular drugs and the dosages of them to be administered or the subjection of patients to particular treatment, for instance by radiotherapy or chemotherapy, the process is an on-going one in which members of the medical profession and those associated with them learn as they go along and thus develop and improve the quality of medical treatment in the community. Commonly, important research or discoveries become the subject of learned papers or articles or even text books which are published throughout the medical world. That was done in this case. In this way there is a wide dissemination of knowledge. This occurs also when doctors, as they commonly do, travel from one country to another to attend conferences or witness methods of treatment and surgical techniques which may help them in their treatment of patients in their own countries. Not infrequently knowledge is disseminated to medical practitioners in countries less fortunate than our own. These are sometimes visited by doctors so that they may teach local practitioners about these matters and many others.
The subject matter of all this, although it may have its commercial elements, is the treatment and relief of human suffering It has a direct bearing on the well being of the nation. Medical research and treatment have a long history which is replete with distinguished examples afforded by a great many dedicated men and women.
The disease in question here [obstructive sleep apnoea] is life-threatening. The evidence shows that, if it is not relieved, it may lead to heart failure and death. The treatment for which letters patent are sought in claims 9 and 11 is treatment which may cure or at least relieve symptoms and signs which are highly dangerous to the human body. I think the question which one needs to ask is whether the grant of a patent in these circumstances is generally inconvenient. That was the way that the matter was approached by Barwick CJ in Joos and by Somers J and, to a degree, Cooke J, in the Wellcome Foundation case (supra) in New Zealand. My own view is that there can be only one answer to that question. The grant of a patent in these circumstances seems to me to be generally inconvenient. It is not going too far, I think, to say that the Court should not contemplate the grant of letters patent which would give to one medical practitioner, or perhaps a group of medical practitioners, a monopoly over, for example, a surgical procedure which might be greatly beneficial to mankind. Its denial might mean the death or unnecessary suffering of countless people. I cannot think that this is really what the medical profession as a whole would seek to achieve. Its whole history is a denial of the proposition.”
His Honour’s comments are equally applicable to the present case, involving as it does the treatment of a deadly disease which causes such pain and distress.
The present case shows in acute form the harmful effects which would follow from the granting of monopolies in respect of forms of medical treatment. As senior counsel for Faulding pointed out, a doctor who chose to administer 200 mg/m2 to a patient over a period of up to six hours, but who formed the clinical judgment that the dose should be reduced by 25 per cent to accommodate emerging toxic reactions, would have to discontinue treatment or obtain the approval of the patentee.
Further, the petty patents, if valid, would create a penumbra of uncertainty as to any treatment which came close to the claims. No doubt use of an infusion period of six hours and one minute would infringe the claim (see Nicaro, 91 ALR at 528), but would a further five, ten or twenty minutes remove the risk of infringement proceedings against the treating physician?
Similar considerations moved Lloyd-Jacob J, sitting as the Appeal Tribunal in Rolls-Royce Ltd’s Application [1963] RPC 251, to treat as “generally inconvenient” a patent for operating jet aircraft in a particular way so as to minimise noise during take-off. His Lordship said (at 255):
“The responsibility of a pilot of an aircraft in flight carrying scores of passengers is already sufficiently onerous without adding to his burden the task of avoiding infringement of a statutory monopoly in the operation of his standard engine controls unless the justification for grant is reasonably manifest.”
Moreover, if a patent for the method of human treatment is to be available, there is no reason why a surgeon could not obtain a patent for making an incision at a location or angle which differed from the generally accepted practice. Having discovered that such a procedure was effective, the surgeon would be careful not to discuss it with professional colleagues or students for fear of providing anticipation of a commercially valuable patent. The danger of this inhibiting effect on the sharing of knowledge by medical practitioners and scientists is in my respectful opinion convincingly argued by Sheppard J in the passage from Rescare already quoted.
It is said that the lack of monopoly patent protection will be a disincentive to investment in medical research. However, it was not suggested in argument that there is empirical evidence to support this proposition. Advances in medical science, unimaginable at the commencement of the twentieth century, have been made under regimes which do not provide monopoly protection for methods of treatment.
Moreover, in medical science there are powerful non-economic factors at work: the excitement of the search for knowledge for its own sake, hope for the betterment of mankind, and the human motivation of professional advancement and personal satisfaction.
To the argument that it is illogical to grant patents for surgical, medical and pharmaceutical products but not for methods of treatment I would call in aid the observation of Oliver Wendell Holmes Jnr that the life of the law has not been logic, it has been experience. As Cooke J said in Wellcome [1983] NZLR at 388.
“... there remains … a deep-seated sense that the art of the physician or the surgeon in alleviating human suffering does not belong to the area of economic endeavour or trade or commerce.”
The limitations of strict logic in this area are shown by an American supporter of patentability who argues in effect that since there are inequities in the delivery of health care anyway, the possibility of reducing the general availability of medical treatments by reason of allowing their patenting should not be singled out for prohibition: T McCory, “Medical Process Patents” (1992) 13 Journal of Legal Medicine 501 and 510-511 cited by Patricia Loughlan, “Of Patents and Patients: New Monopolies in Medical Methods” (1995) 6 Australian Intellectual Property Journal 5 at 13. (The latter article contains a particularly valuable discussion of this issue.)
I uphold this ground of invalidity.
Novelty
It was not suggested that the Act had altered the basic test for anticipation or want of novelty, which is
“... whether the alleged anticipation would, if the patent were valid, constitute an infringement.”
Meyers Taylor Pty Ltd v Vicarr Industries Ltd (1977) 137 CLR 228 at 235 per Aickin J.
A document relied on to establish anticipation must satisfy the test in Hill v Evans (1862) 31 LJ Ch 457 at 453, 4 De G F & J 288 at 301, 45 ER 1195 at 1200:
“... the information as to the alleged invention given by the prior publication must, for the purposes of practical utility, be equal to that given by the subsequent patent. The invention must be shewn to have been before made known. Whatever, therefore, is essential to the invention must be read out of the prior publication.”
See also Martin and Biro Swan Ltd v H Millwood Ltd [1956] RPC 125 at 133 per Viscount Simons.
As Lockhart J said in Nicaro, 91 ALR 513 at 517:
“The prior art must enable the notional skilled addressee at once to perceive and understand and be able practically to apply the discovery without the necessity of making further experiments. Whatever is essential to the invention must be read out of or gleaned from the prior publication.”
In the present case there was evidence of a number of publications which in my opinion satisfied the Hill v Evans test. Before going to them I would make some observations. First, each of the publications in my view was an anticipation in its own right. Each conveyed the essential information. There is no question of mosaic or cross-reference; as to which see Minnesota Mining and Manufacturing Co v Beiersdorf (Australia) Ltd (1980) 144 CLR 253 at 292 per Aickin J, Nicaro at 532-539 per Gummow J.
Secondly, this case was so much taken up with extensive evidence by eminent oncologists that there is a risk of overlooking a simple fact. In terms of practical application, the administration of taxol, in whatever dose and over whatever period, is a routine medical procedure. As mentioned, the drug is always administered intravenously. A device in everyday clinical use enables a measured dose of the drug to be released into the patient’s body over a pre-selected period. Thus an instruction to administer x mg/m2 of taxol over y hours can be followed by any competent medical practitioner or nurse. No question of “workshop improvement” arises. Nor is there any lack of clarity.
Thirdly, it is not to the point that the information in the prior publication does not recommend to the skilled reader the utility of the method disclosed. The test is not whether such a reader would be persuaded by what is disclosed in the prior publication to work the invention. As already noted, there was much evidence from Bristol-Myers’ witnesses to the effect that there was not enough data publicly available at the priority date to confirm that a three hour infusion period of taxol was safe. But disclosure of an invention is not a matter of scientific proof, nor warranty of effectiveness.
Fourthly, publication of a method of medical treatment is none the less a disclosure because it takes the form of a report of clinical trials. Such trials are not solely experiments. It is to be assumed that the medical practitioners involved are also treating their patients with a rational and ethical objective of alleviating their condition and would only continue treatment if there was a reasonable prospect of success. (The side effects of taxol are at the very least unpleasant.)
Turning to the evidence, I find that each of the following reports of Phase I trials disclosed the use of the claimed method. It was not disputed that they were contained in publications available in Australia before the priority date.
Dosage mg/m2 Period
(i) Kris 1985 (Ex 10(C)) 135 and 160 3 hours
(ii) Longnecker 1987 (Ex 10(D)) 135 and 175 6 hours
(iii) Wiernik 1987 (Ex 10(E)) 135 and 175 6 hours
(iv) Donehower 1987 (Ex 10(F)) 135 and 170 6 hours
(v) Lipton 1989 (Ex 10(G)) 175 6 hours
There was also an editorial in a prestigious medical journal which disclosed the use of the claimed method in its description of the NCIC European study and disclosed it as appropriate: (vi) “Taxol: Twenty Years Later, the Story Unfolds” by Rowinsky and Donehower in the Journal of the National Cancer Institute, December 1991 (Ex 10(K)). Reference has already been made to passages in that editorial.
Finally there is the Huinink abstract already referred to: (vii) “Taxol the First Available of Taxanes, a New Class of Anticancer Drugs” (Ex 10(L)). After describing the source and mechanism of taxol, the author states:
“Toxicity of taxol so far consists of dose limiting neutropenia, general malaise, muscle cramps, alopecia and hypersensitivity reactions, maybe related to the carrier in so far used formulations: Cremophor. Due to these side effects and based on preclinical screening antitumor continues [sic] infusions of 24 hours have been used so far. Phase I and II studies revealed activity against cisplatin refractory ovarian cancer, breast cancer and lung cancer. Further studies to evaluate the feasibility of shorter infusion time, 3 hours versus 24 hours and a lower 135 mg/m2 versus a maximum tolerated dose of 175 mg/m2 are now in progress in relapsing ovarian cancer patients both in Canada and in Europe. Already more than 200 patients have entered into this four-arm randomized, NCIC guided international study. Indeed, the 3 hours infusion time administration schedule proved to be feasible, if given concomitantly to profylactic [sic] measures as high dose dexamethasone, cimetidine and difenhydramine. This makes even outpatient treatment with this first available representative of this new class of antitumor agents possible. Major steps forward in medical oncology are rare. After doxorubicine in the seventies, and cisplatin and carboplatin in the eighties, taxol and its European pendant Taxotere ranks high to become the outstanding drugs of the nineties.” (Emphasis added)
A number of Bristol-Myers witnesses argued that the word “feasible” in the abstract would only convey to a skilled reader that a three hour infusion period was safe; it would say nothing as to efficacy. However there was no suggestion, nor could there be, that “feasible” is a technical term. Strictly speaking such evidence may have been inadmissible: The Australian Gas Light Company v The Valuer-General (1940) 40 SR (NSW) 126.
In any event the Huinink abstract would in my opinion convey at least that a three hour infusion had been found to be, in the trial conducted thus far, reasonably efficacious as well as safe. The Shorter Oxford Dictionary gives as one meaning of “feasible”:
“Capable of being done, carried out, or dealt with successfully in any way; possible, practicable.”
The Macquarie Dictionary gives the meaning:
“Capable of being done, effected, or accomplished: a feasible plan.”
Read as a whole, I think the Huinink abstract is using “feasible” in this sense.
Thus safety is included within the concept of feasibility, but is not coincident therewith. To be feasible, a procedure must be safe, but also reasonably likely to be effective. There would be no point in a procedure which was safe but useless.
The context here is that 200 cancer patients were being treated in an international study conducted on an ethical basis with a drug known to have anti-cancer effectiveness. The abstract concludes with an enthusiastic prediction for the future of taxol as an anti-cancer drug. I do not think a reasonable reading of the abstract is “The three hour infusion period is safe but we have no idea whether it has any beneficial effect.”
It is noteworthy that the abstract says:
“This [i.e. the 3 hours infusion time administration schedule] makes even outpatient treatment with this first available representative of this new class of antitumour agents possible.”
Outpatient treatment is not “possible” if one has no expectation of efficacy. This is the language of the specification itself which states (p 10-11):
“The surprising discovery that taxol could be safely administered via a short infusion (e.g., that it will now be possible to administer taxol on an out-patient basis, saving less than six hours and preferably over about 3 hours) means that it will now be possible to administer taxol on an out-patient basis, saving patients the time and expense of yet another hospitalization while improving patient quality of life.”
I conclude that both petty patents are invalid for want of novelty.
Lack of inventive step
There is a considerable, perhaps entire, overlap between the evidence on this issue and that on the issue of invention. Comparison with the prior art base referred to in the specifications discloses a lack of an inventive step, for the reasons already discussed.
I uphold this ground of invalidity.
Fair basing
The law as to fair basing is expounded by the Full Court in CCOM Pty Ltd v Jiejing Pty Ltd (1994) 51 FCR 260 at 275-282.
I find that in the following respects the petty patents in suit contravene s 40.
First, the method claimed is for a method of administration of taxol to “a patient suffering from cancer”, that is to say all types of cancer. The trial work was done on patients “suffering from ovarian cancer which had been pretreated with platinum” (p 11). It would be surprising if a drug treatment regime tested only on patients with one type of cancer (and indeed a patient population further restricted to those who had already been unsuccessfully treated with another specified drug) could be administered with equal confidence to patients suffering any type of cancer. If this were so, why would the investigators in the NCIC European study go to all the trouble to recruit 400 patients suffering from the same type of cancer?
There is evidence supporting this intuitive reaction. For example in the Rowinsky and Donehower editorial “Taxol: Twenty Years later, the Story Unfolds” (Ex 10 (K)) the authors, after discussing a study by Holmes 1991 on breast cancer, comment (at p 1779):
“Nevertheless, unlike the situation in ovarian cancer, in which initial phase II trials were performed in a population essentially drug (platinum) resistant, it is much more difficult at this time to predict the ultimate role of taxol in breast cancer on the basis of a single positive study in patients who received a maximum of one prior regimen. The strategy for the subsequent development of this disease may well need to be different from that evolving in ovarian cancer.”
Also in an editorial in “The Lancet” for June 1992 (Ex 10 (N)) after referring to McGuire 1989 (Ex 10(H)) it is said (at p 1447):
“If taxol is active in advanced ovarian carcinoma, what about other tumours? Results of phase II trials, which have been limited owing to problems with drug supply, have shown low activity in renal cell carcinoma, moderate response rates in melanoma and non-small-cell lung cancer, and promising activity in breast cancer.” [Footnotes omitted.]
Secondly, the only short infusion trialed was a three hour infusion, yet there are claims for administration of an infusion
· not exceeding six hours (first petty patent claims 1 and 2); and
· less than six hours (second petty patent claims 1 and 2).
The selection of six hours would appear not to be related to any scientific criteria but to the commercial and marketing consideration that this is the outer limit for outpatient treatment.
Thirdly, the method claimed is defined as “comprising” (first petty patent) and “including” (second petty patent) infusing a specified dosage of taxol over a specified infusion period. It therefore includes taxol used in that manner in combination with other drugs. No such combination is disclosed.
Thus, having regard to the three features already mentioned, the petty patents effectively claim a monopoly for the use of taxol in any dosage in the range 135 to 175 mg/m2 in combination with any other drug in the treatment of any cancer in any outpatient treatment.
The petty patents in my opinion contravene s 40.
Infringement
The evidence relied on by Bristol-Myers to establish infringement was constituted mainly by a statement of agreed facts dated 27 February 1996.
Those facts concern Faulding’s conduct in Australia in relation to a drug it marketed under the name Anzatax. The active ingredient of that drug is admitted to be taxol, which is also referred to as paclitaxel. To avoid confusion I shall continue to use the term “taxol”, except for direct quotation from documents.
Since 23 January 1995 Faulding sold and supplied taxol to doctors and hospitals in Australia, together with a product information guide. The guide, consisting of fourteen A4 pages, commences with information as to the properties of taxol. There is reference to the various forms of toxic reactions. Under the heading “Dosage and administration” details are given as to premedication and the following is stated (CB 4/1079):
“For the treatment of metastatic ovarian cancer or metastatic breast cancer, it is recommended that paclitaxel be used as a single agent at a dose of 175mg/m2. Paclitaxel should be administered as an intravenous infusion over 3 hours. The infusion should be repeated every 3 weeks as tolerated. Patients have tolerated treatment with up to 9 cycles of paclitaxel therapy, but the optimal course of therapy remains to be established.”
As at the date of the agreed statement of facts, taxol was approved under the Therapeutic Goods Act 1989 (Cth) in Australia only for use in the treatment of metastatic ovarian cancer and metastatic breast cancer, after failure of standard therapy.
Also, in March 1993 Faulding publicly announced that it would supply taxol under the Special Access Scheme (SAS). Under the scheme, introduced in December 1992, it is possible for a patient with a prescription from his or her treating medical practitioner to gain access to a drug that has not yet received marketing approval from the Australian Therapeutic Goods Administration. If a practitioner forms a view that the patient is terminally ill, or seriously ill with a life threatening condition, the practitioner may, upon receiving the informed consent of the patient, advise the patient that the drug is not registered for marketing in Australia and complete an authority to supply form. This form identifies the drug, the patient, the dosage and duration of infusion. Faulding then supplies the hospital with taxol under SAS. There were 39 hospitals identified for the purposes of SAS. They are situated in every State and in the Australian Capital Territory.
The agreed statement of facts states (par 5) that Faulding:
“… undertook the supply of paclitaxel to hospitals under the SAS in conjunction with so-called ‘protocols’, although those were not clinical protocols.”
The protocols are annexed to the agreed statement of facts. It is not quite clear who prepared them. They typically refer to a named “principal physician” and a “treatment centre” such as the Peter McCallum Cancer Institute in Melbourne. The “drug sponsor” is a named company which is said to be a division of Faulding. In any event they include the statement:
“Taxol will be given as 135mg/m2 or 175mg/m2 as a continuous intravenous infusion for three hours every three weeks for a maximum nine courses.”
It is also stated in the agreed statement of facts that Faulding “arranged” two clinical trials in Australia in 1992 and two further clinical trials in 1994 in which taxol was administered. Faulding supplied taxol to various named centres “so as to enable them to take part in the trials”. Clinical trial protocols were prepared. The protocols provided for a dose of 175mg/m2 and an infusion duration of three hours.
Bristol-Myers’ final submissions included the assertion that the protocols for the two clinical trials in 1994 “were prepared by Faulding”. Paragraph 1 of the agreed statement of facts is cited as authority for that proposition but I doubt if the language of par 1 supports the assertion.
There was also reference in the agreed statement of facts to Faulding sending letters in February 1995 to medical practitioners “announc(ing) the launch of new ANZATAX (paclitaxel)” and inviting the recipient to “celebrate the launch of ANZATAX and Faulding’s 150th anniversary with your complimentary compact disc … featuring the inspiring works of the extraordinary Australian poet, Henry Lawson”. This particular alleged infringement was not pressed in final submissions.
The relevant statutory provisions are as follows.
Section 13(1) of the Act provides:
“13. (1) Subject to this Act, a patent gives the patentee the exclusive rights, during the term of the patent, to exploit the invention and to authorise another person to exploit the invention.”
The dictionary in Schedule 1 contains the following definition:
“exploit”, in relation to an invention, includes:
(a)where the invention is a product – make, hire, sell or otherwise dispose of the product, offer to make, sell, hire or otherwise dispose of it, use or import it, or keep it for the purpose of doing any of those things; or
(b)where the invention is a method or process – use the method or process or do any act mentioned in paragraph (a) in respect of a product resulting from such use.”
Section 117 provides:
“117. (1) If the use of a product by a person would infringe a patent, the supply of that product by one person to another is an infringement of the patent by the supplier unless the supplier is the patentee or licensee of the patent.
(2) A reference in subsection (1) to the use of a product by a person is a reference to:(a)if the product is capable of only one reasonable use, having regard to its nature or design – that use; or
(b)if the product is not a staple commercial product – any use of the product, if the supplier had reason to believe that the person would put it to that use; or
(c)in any case – the use of the product in accordance with any instructions for the use of the product, or any inducement to use the product, given to the person by the supplier or contained in an advertisement published by or with the authority of the supplier.
Two questions arise:
Does any of Faulding’s conduct amount to “exploiting” the invention disclosed in the petty patents?
If not, has Faulding authorised any other person to “exploit” the invention?
As to the first question, the invention here is a method or process. There is no basis for a finding that, within the meaning of part (b) of the definition of “exploit”, Faulding has used the method or process disclosed. There is no suggestion that Faulding itself has administered taxol to cancer patients in the dosages and over the periods referred to in the claims, or indeed at all. The method or process disclosed by the invention does not result in any product. Therefore Faulding has not done any act mentioned in par (a) in respect of a product resulting from such use: see Rescare (1992) 25 IPR 119 at 154 per Gummow J. His Honour’s judgment on this issue was upheld by the Full Court: 50 FCR 1 at 24 (per Lockhart J, with whom Wilcox J agreed).
Counsel for Bristol-Myers sought to rely on s 117 but as Gummow J pointed out in Rescare it is a precondition to the operation of s 117 in relation to a method claim that there is a product, the use of which by Faulding would infringe the claim. His Honour said (at 154):
“… where the invention relevantly claims a method or process, exploitation occurs, other than by use of the method or process, only by the doing of an act mentioned in para (a) of the definition of ‘exploit’. There must be an act done ‘in respect of a product resulting from such use.’”
Here Faulding argues, and I agree, that there is no such product with the result that s 117 has no operation.
As to the question of authorisation, Gummow J in Rescare, 25 IPR at 155, dealt with submissions to the effect that recourse should be had by way of analogy to the body of case law interpreting the concept of authorisation in copyright law. His Honour noted the decision of the English Court of Appeal in Falcon v Famous Players Film Co [1926] 2 KB 474. Banks LJ said (at 491) that to authorise means to “sanction, approve, and countenance”. Aitkin LJ said (at 499) that to authorise means to “grant or purport to grant to a third person the right to do the act complained of”. At first blush there might appear to be a difference, at least in emphasis, between the two definitions. However Banks LJ and Aitkin LJ probably had in mind the same concept because both referred with approval to the dicta of Buckley LJ in Monckton v Pathé Frères Pathephone Ltd [1914] 1 KB 395 at 403 and Tomlin J in Evans v Hulton & Co Ltd [1924] WN 130. In the former case Buckley LJ said in reference to s 1(2) of the Copyright Act 1911 (Imp):
“… copyright includes the sole right to authorize the performance of the work. The seller of a record authorizes, I conceive, the use of the record, and such use will be a performance of the musical work. This consideration seems to show that sub-s 2 itself is not confined to making but extends to sale.”
In the latter case Tomlin J held that a person who sold to a publisher serial rights in stories written by the plaintiff authorized the printing and publication of them.
But patent law and copyright law differ in many respects. It cannot be assumed that concepts from one can always be transplanted into the other. For the purposes of the Act, and in the particular circumstances of the present case, I do not think it can be said that Faulding “authorised” another person to “exploit” the invention in the sense of “using the method or process”. The Macquarie Dictionary gives as one meaning of “authorise”
“to give authority or legal power to; empower (to do something).”
In the Shorter Oxford Dictionary the equivalent meaning is
“To give legal or formal warrant to (a person) to do; to empower, permit authoritatively.”
I think “authorise” is used in s 13(1) of the Act in this sense. It would be apt for example to cover the situation where A owns a factory containing a machine which is within the claims of B’s patent. If A were to lease the factory, including plant, to C, he would be authorising the use of the machine by C and hence infringing B’s patent.
But the present case does not disclose an authorisation in that sense. Faulding is not selling, licensing, or otherwise making available for reward, a particular method of administering taxol. The transactions complained of are ones in which Faulding is supplying taxol to doctors and hospitals, as it is perfectly entitled to do. The accompanying instructions are no more than recommendations that the recipient (persons skilled in the art) are free to follow or not. Where a consumer buys a new camera or washing machine or car and the manufacturer’s operating instructions are provided, one would not normally say that he or she was “authorised” by the manufacturer or retailer to follow those instructions.
If Faulding is not liable as an authoriser, within the meaning of the Act, is it liable on common law principles? I shall assume, without deciding, that the provisions of the Act have not excluded the possibility of such liability.
Generally speaking patent law has imposed a high threshold on making persons liable as what might be called secondary infringers. Thus in Walker v Alemite Corporation (1933) 49 CLR 643 at 658 Dixon J said:
“… sale with a knowledge that the purchaser will use the articles for infringement is not itself an infringement although the vendor gives the purchaser an indemnity: the vendor must have made himself a party to the act of infringement (per Mellish L.J., Townsend v. Haworth (1875) 48 L.J. Ch., at p. 773(n); Dunlop Pneumatic Tyre Co. v. David Moseley & Sons Ltd. (1904) 1 Ch., at pp. 616, 620. Further, in the opinion of Vaughan Williams L.J. it is not enough that the article sold has no other use than a use in the course of what amounts to infringement ((1904) 1 Ch., at pp 616, 618, 619). The basis upon which these rules rest is that whatever is not included in the monopoly granted is publici juris and may be freely used as of common right. Narrow as this view of what constitutes participation in infringement may appear, it requires us, in my opinion, to hold that the claims 4 to 11 of the specification were not infringed.”
In CCOM Pty Ltd v Jeijing Pty Ltd (1993) 27 IPR 577 at 626-627 Cooper J held that the mere sale of a computer program with a book of instructions does not establish the necessary doing of an act in furtherance of a common design that is necessary to constitute the buyer and seller of the program and instructions joint tortfeasors. Likewise his Honour doubted
“… that the mere sale of the program with instructions goes beyond the facilitating of the doing of an act to become the procuring of the doing of the act.”
His Honour referred to English authorities as authority for the proposition that
“there must be a procuring in the sense of persuading a party to commit the tort of infringing the patent: Dow Chemical AG v Spence Bryson & Co Ltd (1992) FSR 397 at 403-4; Kalman v PCL Packaging (UK) Ltd [1982] FSR 406 at 423-4.”
His Honour also referred to Firth Industries v Polyglas Engineering Pty Ltd (1975) 132 CLR 489 at 497 where Stephen J, citing cases including Townsend v Haworth and Walker v Alemite Corporation, thought that it was “a matter open to some doubt” that selling infringing bins together with instruction folders as to their use amounted to an infringement. Cooper J’s findings as to infringement were upheld by the Full Court: 51 FCR 272-275.
In Ryan v Lum (1989) 14 IPR 513 at 522, 86 ALR 670 at 679 Young J said, although finding it unnecessary to finally determine the matter:
“It seems to me, however, in the light of analogous uses and copyright such as CBS Songs Ltd v Amstrad Consumer Electronics plc [1988] AC 1013; (1958) 11 IPR 1 that it would need a lot more than mere instructions of use on a product to enable a court to find the seller procured the tort.”
In CBS Lord Templeman said (at 1058):
“Generally speaking, inducement, incitement or persuasion to infringe must be by a defendant to an individual infringer and must identifiably procure a particular infringement in order to make the defendant liable as a joint infringer.”
In the present case Bristol-Myers cannot complain of Faulding persuading anybody to use taxol. Taxol is not the subject of any patent. In providing suggested methods of administration Faulding is doing so in a context where the drug is to be administered by skilled professionals whose paramount duty is to act ethically and skilfully in the interests of their patients. Read in that context, the information guide can amount to no more than a recommendation.
I find that even if the petty patents were valid, no infringement has been established.
Orders
There will be orders that the application is dismissed, that petty patents Nos 641894 and 651307 are revoked and that Bristol-Myers pay the costs of Faulding of the application and cross-claim, including reserved costs.
I certify that this and the preceding thirty four (34) pages are a true copy of the Reasons for Judgment herein of the Honourable Justice Heerey
Associate:
Dated: 22 July 1998
Counsel for the Applicant: Dr J McL Emmerson QC with Mr B N Caine Solicitors for the Applicant: Minter Ellison Counsel for the Respondent: Mr R C Macaw QC with Mr B J Hess Solicitors for the Respondent: Freehill Hollingdale & Page Date of Hearing: 9-12, 15-19, 22, 24 and 25 June 1998 Date of Judgment: 22 July 1998
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