Ottawa, Ontario, April 26, 2006
PRESENT: The Honourable Mr. Justice Harrington
BETWEEN:
and
THE MINISTER OF HEALTH
REASONS FOR ORDER AND ORDER
[1] Should Pharmascience be prohibited from marketing its version of Axcan's drug Urso® for the treatment of primary biliary cirrhosis until the latter's patent expires in 2010? That is the question, the answer to which depends on whether Pharmascience's allegation that the patent is invalid is justified.
[2] Axcan's drug Urso® contains the medicine Ursodeoxycholic Acid, commonly referred to by its shortened name, Ursodiol, or as UDCA. Axcan is permitted to market Urso® in 250 mg tablets by virtue of a Notice of Compliance issued by the Minister of Health. Axcan listed patent 1,318,590 ('590) against the drug on the Register which is maintained by the Minister in accordance with the Patented Medicine (Notice of Compliance) Regulations (PM (NOC)). Canadian Patent '590 asserts but one claim which reads as follows:
"1. Composition pharmaceutique pour le traitement de la cirrhose biliaire primitive caractérisée en ce qu'elle comprend de l'acide ursodesoxycholique ainsi qu'un véhicule et le cas échéant des excipients phamaceutiques, ladite composition étant conditionnée sous une forme permettant ledit traitement de la cirrhose biliaire primitive selon une posologie comprise entre 13 à 15 mg/kg/jour."
[3] Pharmascience submitted the following English translation which was used by the medical experts called by both parties:
"Pharmaceutical composition for the treatment of primary biliary cirrhosis, characterized in that it includes ursodeoxyscholic acid as well as a vehicle and if necessary pharmaceutical excipcients, the said composition being processed in a form allowing for the said treatment of primary biliary cirrohosis based on a dose of 13 to 15 mg/kg/day."
[4] Primary biliary cirrhosis (PBC) is an uncommon disease, the prime, but not exclusive, target of which is middle-aged women. It is a chronic cholestatic disorder. Cholestasis refers to a condition in which bile flow in or outside the liver is blocked. PBC gradually progresses to cirrhosis and liver failure. Neither its cause nor a cure (apart from a liver transplant) is currently known. Nevertheless, Ursodiol is useful in treatment of the disease.
[5] Pharmascience seeks a Notice of Compliance for its version of Ursodiol on the basis that it is bio-equivalent to Axcan's. The fact that Axcan's patent is listed on the Register maintained by the Minister prevents him from issuing Pharmascience a Notice of Compliance before the patent expires, unless Pharmascience sidesteps the patent by one of the means contemplated in the Regulations.
[6] In this case, Pharmascience served Axcan with a Notice of Allegation that patent '590 is not valid. More particularly, it alleged that the matters covered by the patent were previously known and used, were the subject of prior publications, were the object of prior public use or sale in Canada, were obvious, are invalid as a method of medical treatment which is not patentable and are broader than the invention described in the disclosure portion of the patent.
[7] Axcan responded by filing a Notice of Application with this Court on 20 May 2004. It seeks a declaration that Pharmascience's allegations are not justified and an order prohibiting the Minister of Health from issuing a Notice of Compliance until patent '590 expires in 2010. The Court application has the effect, pursuant to the details set out in the Regulations, of automatically enjoining the Minister from issuing Pharmascience a Notice of Compliance pending suit. This statutory stay, called "draconian" by Mr. Justice Iacobucci in Merck Frost Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 193 at paragraph 33, and the Regulations were described in some detail by the Supreme Court in Bristol-Myers Squibb Co. v. Canada (Attorney General), [2005] 1 S.C.R. 533.
THE NOTICE OF ALLEGATION
[8] The Regulations have been heavily litigated, and certain parameters have been clearly established.
[9] The issues before the Court were circumscribed by Pharmascience in its Notice of Allegation. It is incumbent upon Axcan to establish, on the balance of probabilities, that the allegations are not justified. Matters not alleged are not considered.
[10] Although the onus is thus on Axcan to convince the Court that Pharmascience's allegations are not justified, it benefits from the rebuttable presumption set forth in the Patent Act that the patent is valid.
[11] The decision on the application is of limited effect. It does not determine the ultimate validity of the patent or, if alleged, whether it has been infringed. The real issue in this case is not the validity of the patent. The issue is limited to whether the Minister should be prohibited from issuing Pharmascience a Notice of Compliance. Matters of validity and infringement may form part of the Court's reasoning, but are not res judicata. See, for instance Biovail Pharmaceuticals Inc. v. Canada (Minister of National Health and Welfare) 2005 FC 9, (2005) 267 F.T.R. 243, [2005] F.C.J. No. 7 (QL) at paragraphs 6-9, and Fournier Pharma Inc v. Canada (Minister of Health) 2004 FC 1718, [2004] F.C.J. No. 2149 (QL) at paragraphs 8 and 9)
SIGNIFICANT DATES
[12] The application for Canadian patent '590 was filed 18 November 1987. The patent was issued 1 June 1993. The Patent Act, R.S.C. 1985, c-P4 has been amended numerous times. The effect of transitional provisions is such that the patent is to be dealt with in accordance with the Act as it was on 30 September 1989. For ease of reference, I shall refer to the Act as it then was as the "old" Act. I shall refer to the Act as it now is as the "new" Act.
[13] Under the "old" Act, the date of patent issue and the date of publication were the same. The patent is to be construed as of 1 June 1993, the date it was publicly available to be read by the notional addressee, a person skilled in the relevant art or science of the invention. Under the "new" Act, the patent specification is "laid open" or made public 18 months after the effective date of the patent application. See Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024 at paragraph 54.
[14] Two other dates are important. The patent identifies a priority date of 20 November 1986, which was the date the inventor, Dr. Raoul Poupon, first applied for a patent for his invention. He applied in France. Absent evidence to the contrary, that is the date of the invention. However, Axcan, who called Dr. Poupon as a witness, submits that the invention goes back to no later than 31 December 1984.
[15] The date of the Canadian application is important for two reasons. The patent is invalid if the invention was described in any publication printed anywhere more than two years beforehand, i.e. before 18 November 1985. There was such a publication in Germany which describes the use of Ursodiol in the treatment of PBC, but at a different dosage.
[16] The Canadian application date is also important because the patent is invalid if the invention was in public use or on sale in Canada more than two years prior thereto. Based on evidence submitted by Pharmascience, the Court is called upon to conclude that Ursodiol was both in public use and on sale in Canada for the treatment of PBC prior to 18 November 1985.
[17] The date of the invention is important, because the patent is invalid if it was known or used by any person prior thereto in such a way that it had "become available to the public" (Sections 27(1) and 61(1)(a) of the old Patent Act).
THE PRINCIPLES OF PATENT CLAIM CONSTRUCTION
[18] It is important to ascertain exactly what is claimed in the patent. The first step is to construe the claim on a purposive construction basis. In Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, Mr. Justice Binnie stated:
"45 The key to purposive construction is therefore the identification by the court, with the assistance of the skilled reader, of the particular words or phrases in the claims that describe what the inventor considered to be the "essential" elements of his invention."
The Courts are not to read the patent through the eyes of a grammarian or etymologist. Rather, the patent should be read
"53...through the eyes and with the common knowledge of a worker of ordinary skill in the field to which the patent relates."
[19] Both parties called expert witnesses. As these proceedings took the form of an application pursuant to Federal Courts Rules 300 and following, rather than a trial, the experts did not testify in open Court. The Court was provided with their affidavits and transcripts of cross-examinations thereon.
[20] Before turning to their evidence, it should be noted that they have radically opposed views on the significance of the dosage of 13-15 mg/kg/day. The medical expert called by Axcan considers dosage to be an essential part of the patent claim, while the two medical experts called by Pharmascience do not.
[21] In Free World Trust, supra, Mr. Justice Binnie, speaking for the Court, said at paragraph 31:
" ¶ 31 The appeal thus raises the fundamental issue of how best to resolve the tension between "literal infringement" and "substantive infringement" to achieve a fair and predictable result. There has been considerable discussion of this issue in Canada and elsewhere, which I will discuss briefly in support of the following propositions:
[...]
(e) The claims language will, on a purposive construction, show that some elements of the claimed invention are essential while others are non-essential. The identification of elements as essential or non-essential is made:
(i) on the basis of the common knowledge of the worker skilled in the art to which the patent relates;
(ii) as of the date the patent is published;
(iii) having regard to whether or not it was obvious to the skilled reader at the time the patent was published that a variant of a particular element would not make a difference to the way in which the invention works; or
(iv) according to the intent of the inventor, expressed or inferred from the claims, that a particular element is essential irrespective of its practical effect;
(v) without, however, resort to extrinsic evidence of the inventor's intention."
[22] Notice the use of the word "or" between a variant and the intent of the inventor. Objectively speaking, an element of the claimed invention may not be essential but nevertheless is essential according to the intent of the inventor. The inventor will not get more than he asked for.
THE EXPERTS
[23] Axcan called on medical expert, Dr. Eldon Shaffer, currently a professor, Department of Medicine (Division of Gastroenterology), University of Calgary, who at various times in his long and distinguished career headed the Division of Gastroenterology, and has been an assistant professor of medicine at McGill University, an associate professor, professor, head of the department of medicine and associate dean at the University of Calgary. He has many years of experience in research and clinical use of Ursodiol. His pre-eminence and stature was recognized. Although he primarily focused on Pharmascience's allegations in its notice that the subject matter of the invention had been anticipated or obvious, this is what he thinks the patent claims:
"I have read and understood the translation of the '590 Patent which essentially claims a pharmaceutical composition including UDCA for the treatment of pbc based on a dose of 13 to 15 mg/kg/day."
In his opinion the development of such a pharmaceutical composition based on a dose of 13 to 15 mg/kg/day would not have been obvious to a person of ordinary skill in the art before it was invented by Dr. Poupon between 1982 and 1984.
[24] This leads us to Dr. Poupon, who was also called by Axcan, but only as a factual witness. Although obviously an expert in this field, the focus of his testimony was on the date of his invention i.e. no later than 31 December 1984.
[25] Pharsmacience called two medical experts Dr. Gregory B. Haber and Dr. Christopher Williams. They are both prominent gastroenterologists and superbly qualified to offer expert opinion to assist the Court.
[26] Unlike Dr. Shaffer, both specifically considered the attributes of the notional addressee of the patent. Dr. Haber states (although Dr. Williams says more or less the same) that in his opinion the patent is addressed to a gastroenterologist with experience in treating patients suffering from PBC, cholestatic or biliary tract diseases. This "ordinary skilled worker" would have an understanding of the physiology of liver function and bile secretions. There is no debate as to the attributes of the addressee of the patent. I accept Dr. Haber's evidence.
[27] Words must be considered in context, which is why the Supreme Court has endorsed the purposive construction approach to patents. A person familiar with the milieu which generates a document may have helpful advice to offer. As stated by Mr. Justice Binnie in Free World Trust, supra:
" ¶ 51 This point is addressed more particularly in Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, 2000 SCC 67 and Whirlpool Corp. v. Maytag Corp., [2000] 2 S.C.R. 1116, 2000 SCC 68, released concurrently. The involvement in claims construction of the skilled addressee holds out to the patentee the comfort that the claims will be read in light of the knowledge provided to the court by expert evidence on the technical meaning of the terms and concepts used in the claims. The words chosen by the inventor will be read in the sense the inventor is presumed to have intended, and in a way that is sympathetic to accomplishment of the inventor's purpose expressed or implicit in the text of the claims. However, if the inventor has misspoken or otherwise created an unnecessary or troublesome limitation in the claims, it is a self-inflicted wound. The public is entitled to rely on the words used provided the words used are interpreted fairly and knowledgeably.
[28] Yet a patent is not an ordinary writing. It meets the definition of a "regulation" in the Interpretation Act, R.S.C., 1985, c. I-21, and must be read to assure the attainment of its objects. As per Whirlpool, paragraph 61, "...claims construction is a matter of law for the judge, and he was quite entitled to adopt a construction of the claims that differed from that put forward by the parties"
WHAT DOES THE INVENTION CLAIM?
[29] It is common ground, and not in issue, that Dr. Poupon does not claim to have invented Ursodiol, which in one form or another may go back to ancient times. It was marketed by a pharmaceutical company in Japan in 1957 for the treatment of various liver ailments, but not PBC. By the 1970s, it was considered useful by many doctors in the treatment of a certain type of gallstones. Dr. Poupon claims a new use, that Ursodiol is useful in the treatment of PBC. Pharmascience agrees that Ursodiol is useful for that purpose, but disputes that this use is new.
[30] It is also common ground that Dr. Poupon claims a pharmaceutical composition. The incipients, or other ingredients, in that composition, are not in issue either. What is in issue is this:
| "...the said composition being processed in a form allowing for said treatment of primary biliary cirrhosis based on a dosage of 13 to 15 mg/kg/day." |
« ...ladite composition étant conditionnée sous une forme permettant ledit traitement de la cirrhose biliaire primitive selon une posologie comprise entre 13 à 15 mg/kg/jour. » |
[31] Pharmascience alleges that a dosage of 13 to 15 mg of Ursodiol per kilo of the patient's weight per day is not an essential part of the claim. Alternatively, if it is, the patent is invalid as it discloses a method of medical treatment. Dr. Poupon testified that he intended that the dosage be essential. The Court cannot take into account what Dr. Poupon may have intended. The Court is limited to the language of the claim, with the disclosure portion of the patent serving as an aid to understand what was meant, but neither to enlarge nor to contract (Whirlpool, paragraph 52).
[32] I have been of more than one mind as to whether the dosage claimed is an essential element of the patent. Dr. Williams almost persuaded me that the claim "...is directed to the form of the pharmaceutical (i.e. capsule) as opposed to the dosage at which it is to be administered." He went on to say:
"...physicians recognized that healthy adults have variable rates of drug absorption in the range of a six-fold difference. As a result, the administration of specific doses may not be achievable. Consequently, a physician considers a dosage recommendation of 13 - 15 mg/kg/day for ursodeoxycholic acid to be a general guide and would likely increase or decrease the dosage depending on the side-effect profile and efficacy. If the dosage form did not permit the administration to the PBC patient at a dosage of 13 - 15 mg/kg/day, a physician would adjust dosage."
[33] Dr. Williams used some basic arithmetic to justify his proposition that the specification supports this point of view. Dr. Poupon gave an example in the disclosure of the administration of a dosage of 13-15 mg/kg/day with 200 mg capsules. Capsules cannot be divided and so it is quite true, as Dr. Williams asserts, that a patient with a weight of 50 kilos would have to receive either less than 13 or more than 15 mg/kg/day.
[34] However, when it comes to grammar, and simple arithmetic, the Court does not need the expert advice of a physician. Rather, expert evidence was useful in that an ordinary skilled worker familiar with the subject would have known that capsules could be of different sizes. Material attached to Dr. Haber's affidavit, and set forth in Pharmascience's original notice of allegation, identifies 150, 250 and 300 mg capsules in addition to the 200 mg capsule given as an example by Dr. Poupon. One would be hard pressed to come up with a weight which could not be accommodated by a combination of capsules of different sizes.
[35] On reflection, I have come to the conclusion, taking into account the technical background provided by the experts, that the language of the claim should be given its plain and ordinary meaning. The dosage portion thereof i.e. 13-15 mg/kg/day is an essential element. Otherwise, what would be the point of mentioning dosage in a patent which asserts but one claim limited to a single sentence?
PRIOR PUBLICATION
[36] As aforesaid, Section 27(1)(b) of the old Patent Act provided that the inventor or his legal representative could apply for a patent for an invention which was not described in any publication printed anywhere within the two preceding years. In other words, for certain purposes, the application date of 18 November 1987 was retroactive to 18 November 1985.
[37] By 11 October 1985, the date stamp of the National Library of Medicine, David R. et al., published Die Wirkung von Ursodesoxycholsaure bei chromishchen Lebererkrankungen, Eine Pilotstudie, Z. Gastroenterologie vol. 23, 1985, page 420. This was a report from a department of gastroenterology on the effect of Ursodeoxycholic Acid on chronic liver diseases. The abstract states, in English translation, that while treating gallstones with Ursodiol, it was discovered that Hepatic Enzyme parameters improved. Consequently, 18 patients including six with PBC "...were administered ursodeoxycholic acid in the same dose as used during lysis therapy (10 mg/kg of bodyweight) of an average of 42 weeks." Certain other improvements were also noted.
[38] If I had found that a dosage of 13-15 mg/kg/day was not essential to Dr. Poupon's claim, the publication of Dr. David's study would have invalidated the patent. Had the dosage not been essential, then Dr. Poupon's claim could not be differentiated from Dr. David's study. Put another way, the patent would have taught that Ursodiol was useful for the treatment of PBC, a fact already known to the ordinary skilled worker who, being multilingual, would have been familiar with Dr. David's article. To conclude on this point, the patent is not defeated by a prior publication because of the different dosages.
DATE OF INVENTION
[39] We must now consider whether the invention was known or used by someone else before Dr. Poupon claims he invented it. Assuming a dose of 13-15 mg/kg/day to be an essential element of the patent claim, the date of the invention becomes important because Drs. Fisher and Parradine of the Liver Disease Program, Sunnybrook Medical Centre, Toronto, prepared a paper entitled "Influence of Ursodeoxycholic Acid (UDCA) on Biochemical Parameters in Cholestic Liver Disease", an abstract of which was published in the May 1986 issue of the Gastroenterology, a copy of which was date-stamped at McGill University in April 1986. Apparently, it is not unusual for abstracts to be sent out early.
[40] This paper is not relevant as a publication, because it was published within two years of the application for the Poupon patent in Canada. However, it is important because it describes the treatment of PBC with Ursodiol at dosages between 10-15 mg/kg/day. The greater dosage encompasses the lesser and so it covers off Dr. Poupon's invention if it is deemed to have been invented on the date the application was filed, i.e. 18 November 1987. While the paper as a publication is not relevant, it does serve as evidence that Dr. Fisher and Parradine had "...disclosed or used the invention in such manner that it had become available to the public" (Section 61(1)(a) of the old Patent Act). That being said, if the invention date is 18 November 1987 the patent is invalid in virtue of Sections 27(1)(a) and 61(1)(a) of the old Patent Act because it was known or used in such manner that it had become available to the public.
[41] However, I am persuaded that Dr. Poupon's invention goes back to at least 31 December 1984. He described more than two years of work in his application for his French patent, which was filed 20 November 1986. More publicly, he disclosed his work in an article published in the British medical journal The Lancet in 1987. In it, he described his work as going back to 1982. He testified as to the truth of these statements in these proceedings, and there is no reason whatever to doubt him.
METHOD OF MEDICAL TREATMENT
[42] Assuming the dosage to be an essential claim of the patent, I am of the view that the patent is invalid because it is a method of medical treatment. Methods of medical treatments are not patentable.
[43] The Supreme Court addressed the issue of medical treatment not long ago in Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153. Speaking for the Court, Mr. Justice Binnie spoke to the subject matter of the AZT patent for the treatment of AIDS. He said:
¶ 48 There is no serious challenge in this case to subject matter patentability. "[H]itherto unrecognized properties" can constitute a patentable new use for an old substance: Shell Oil, supra, at p. 549, per Wilson J. In that case, it was disclosed in the patent that known chemical compounds revealed a previously unrecognized use as plant growth regulators.
¶ 49 At trial, the present appellants argued that the patent was invalid as seeking to monopolize a method of medical treatment contrary to TennesseeEastman, supra, but this was rightly rejected. Tennessee Eastman was concerned with the patentability of a surgical method for joining incisions or wounds by applying certain compounds. The decision was based on the former s. 41 of the Patent Act, now repealed. The Court concluded that the method (apart from the compounds) was not patentable. The policy rationale, as explained by Wilson J. in Shell Oil, supra, at p. 554, was that the unpatentable claim was
|
|
essentially non-economic and unrelated to trade, industry, or commerce. It was related rather to the area of professional skills.
|
|
¶ 50 The AZT patent does not seek to "fence in" an area of medical treatment. It seeks the exclusive right to provide AZT as a commercial offering. How and when, if at all, AZT is employed is left to the professional skill and judgment of the medical profession.
[44] The reference to Tennessee Eastman is to Tennessee Eastman Co. v. Commissioner of Patents, [1974] S.C.R. 111 and the reference to Shell Oil is to Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536.
[45] Pharmascience does not dispute that a new use for an old compound is patentable, as held in Shell, supra. However, as noted by Mr. Justice Binnie in Apotex, supra, and Shell, supra, an invention relating to the area of professional skill is not patentable. This issue was considered by Mr. Justice Dubé in Visx Inc. v. Nidek Co. et al, 3 C.P.R. (4th) 417, affirmed by the Federal Court of Appeal at 16 C.P.R. (4th) 251. That case dealt with an apparatus for performing laser eye surgery. One submission was that the patent was invalid as relating to surgical procedures. The argument was that the claim did not relate to an "art or process" within the statutory definition of an invention Mr. Justice Dubé rejected the argument. He said:
[173] In my view, the Professional Skill Defence is not available to attack the validity of the three patents in issue. These patents do not teach professional skills to surgeons. They deal with an apparatus, a machine, a combination of several components. In that sense, the apparatus is similar to other medical equipment, as x-ray machines, dentist drills, scalpels, all of which are patentable if they teach an invention. The invention in the Visx patents does not pose a limitation upon the surgeons' skills. On the contrary, it is meant to assist a surgeon in his operation on the human eye. It focuses, directs and shapes the beam. It determines and controls a circular area of exposure and does the ablation. All the surgeon does is prepare the patient and enter the basic measurements into the computer. He then steps on the pedal to start the machine. Moreover, in accordance with Dr. Sher's evidence, myopia, hypermyopia and astigmatism are not diseases, they are human conditions.
[46] The invention claimed here is quite different. It is up to the physician based on his or her knowledge of the patient's rate of metabolism and other factors to determine the appropriate daily dosage. I cannot, for a moment, contemplate that Axcan could claim exclusive property in the dosage and sue a physician for prescribing Ursodiol for the treatment of PBC at a dosage less than 13 mg/kg/day or greater than 15 mg/kg/day. In fact, Dr. Shaffer, who was called by Axcan, stated during cross-examination that he has at times prescribed Ursodiol at dosages greater than those set out in the patent.
[47] A case very much on point is the decision of Mr. Justice Mosley in Merck & Co., Inc. et al. v. Apotex Inc. et al. (2005), 41 C.P.R. (4th) 35. That case also dealt with the PM (NOC) Regulations. Merck had long marketed Alendronate tablets in a 10 mg daily dosage form for the treatment of osteoporosis. This required a strict dosing regime to which a number of patients did not adhere, to their detriment. There were significant adverse side-effects. The alleged invention asserted that a larger once weekly dose had fewer adverse effects. Mr. Justice Mosley held that the invention was obvious and therefore invalid. However, he also addressed the issue of medical treatment at paragraphs 133 and following. Apotex argued that the patent was invalid as it simply provided instructions to the physician to alter the dosage regime. Merck, however, argued that the claim was for a vendable product having economic value in trade, industry and commerce, and was distinguishable from the work of the physician, which work required the exercise of specialized skill. The how and when of administration was not part of the patent.
[48] Contrary to the position taken by the U.K. Courts, Mr. Justice Mosley found that the patent was for a vendable product having real economic value, and was not for an unpatentable method of treatment. However, in this case the number of capsules to prescribe is a matter between the patient and her doctor, and does not form part of a monopoly protected by Letters Patent. Therefore, the patent is invalid because it claims a method of medical treatment.
[49] Another case of some interest is the decision of Mr. Justice Heald of the Federal Court of Appeal in Imperial Chemical Industries Ltd. v. Canada (Commissioner of Patents), [1986] 3 F.C. 40, 67 N.R. 121. The Commissioner had rejected a patent application in so far as it related to method claims. The invention claimed a method of cleaning teeth by applying an aqueous composition. The application was rejected as being a treatment of the human body not patentable in virtue of TennesseeEastman, supra. The method was not a "process" in the economic sense. The appellant argued that Tennessee Eastman only prohibited the patentability of medical methods which utilized materials produced by chemical processes as per Section 41(1) of the Patent Act, a section repealed before Dr. Poupon's application. However, Mr. Justice Heald, like the Supreme Court in Apotex v. Wellcome Foundation, supra, held that Tennessee Eastman was authority for the broader proposition that methods of medical treatments, as such, are not patentable.
[50] After analyzing the decision of Mr. Justice Kerr in first instance in Tennessee Eastman, Mr. Justice Heald said:
¶ 11 Coming now to the decision of the Supreme Court of Canada, Mr. Justice Pigeon delivered the Court's decision. He commences his reasons by setting out the agreed statement of facts and issues. At pages 114-115 S.C.R.; at page 204 of the C.P.R., he reproduces, with approval, that portion of the reasons of Kerr J. set out supra. It is true that he does discuss the impact of section 41, presumably since that case was a subsection 41(1) case. However, after that discussion, at page 119 S.C.R.; at page 207 of the C.P.R., he states:
Having come to the conclusion that methods of medical treatment are not contemplated in the definition of "invention" as a kind of "process", the same must, on the same basis, be true of a method or surgical treatment.
In my opinion, this is a clear and unequivocal statement that "methods of medical treatment are not contemplated in the definition of 'invention' as a kind of 'process', ..". That was the sole issue before the Court and it is here answered in unmistakable and unambiguous language. Accordingly, in my view, the force of that pronouncement cannot be restricted merely to factual situations where subsection 41(1) of the Act applies. It follows, therefore, that the Commissioner did not err in considering himself bound by the ratio of Tennessee Eastman.
[51] There is a distinction between the dosage in a capsule and a dosage range based on the patient's weight. As I read the claim, the emphasis is on the dosage range, and a dosage range is not a vendable product.
CONCLUSION
[52] I have found that the claimed dosage is an essential element of the patent and that therefore the patent, for the purposes of this application, is invalid as it claims a method of medical treatment. In the alternative, if the dosage is not an essential element, then the patent is still invalid because a claim for the use of Ursodiol in the treatment of primary biliary cirrhosis was reported in Dr. David's article which was published more than two years prior to the application for the Canadian patent. Given the summary nature of these proceedings, it is neither necessary nor appropriate to consider Pharmascience's other allegations. Axcan's application for a prohibition order against the Minister shall be dismissed.
COSTS
[53] Neither party had much to say except that Pharmascience asked to make subsequent submissions, if appropriate, had I commented on the sufficiency or lack of sufficiency of its Notice of Allegation. However, that point was not pertinent. As Axcan pointed out, it only claimed the Notice was insufficient in that it did not identify two pharmaceutical companies from which Ursodiol could be purchased on special ministerial permit, prior to 1985. Those sales did not figure in my reasoning as the ministerial permit authorized the sale for the treatment of gallstones, not the treatment of PBC.
[54] Pharmascience shall have its costs.
ORDER
THIS COURT ORDERS that the application is dismissed, with costs.
"Sean Harrington"
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-1005-04
STYLE OF CAUSE: AXCAN PHARMA INC. v.
PHARMASCIENCE INC. and THE MINISTER OF HEALTH
PLACE OF HEARING: Montreal, Quebec
DATE OF HEARING: March 30, 2006
APPEARANCES:
| François Grenier
|
|
| Warren Sprigings
|
SOLICITORS OF RECORD:
| Leger Robic Richard Barristers & Solicitors Montreal (Quebec)
|
|
| Hitchman & Sprigings Barristers & Solicitors Toronto (Ontario)
|
|
| John H. Sims, Q.C. Deputy Attorney General of Canada |
FOR THE RESPONDENT THE MINISTER OF HEALTH |