Eli Lilly Canada Inc. v. Apotex Inc.

Eli Lilly Canada Inc. v. Apotex Inc.
Court (s) Database
Federal Court Decisions
Date
2008-02-05
Neutral citation
2008 FC 142
File numbers
T-1364-05
Decision Content
Date: 20080205
Docket: T-1364-05
Citation: 2008 FC 142
Ottawa, Ontario, February 5, 2008
PRESENT: The Honourable Mr. Justice Hughes
BETWEEN:
ELI LILLY CANADA INC.
Applicant
and
APOTEX INC. and
THE MINISTER OF HEALTH
Respondents
and
ELI LILLY AND COMPANY LIMITED
Respondent
REASONS FOR JUDGMENT AND JUDGMENT
[1] This is an application made by Eli Lilly Canada Inc. under the provisions of the Patented Medicines (Notice of Compliance) Regulations, S.O.R./93-133 (NOC Regulations). It seeks to prohibit the Minister of Health from issuing a Notice of Compliance (NOC) to Apotex Inc. in respect of a drug containing as an active ingredient a medicine commonly called raloxifene for a particular use being the treatment and prevention of osteoporosis, particularly in post menopausal women, until the expiry of Canadian Letters Patent No. 2,101,356 (the ’356 patent). For the reasons that follow, I find that the application is dismissed.
GENERAL BACKGROUND
[2] Eli Lilly has previously received from the Minister a Notice of Compliance to sell its drug containing raloxifene (as raloxifene hydrochloride) in Canada, for use in the prevention and treatment of osteoporosis, particularly in postmenopausal women. This drug is sold in tablet form for oral administration, 60mg strength, under the brand name EVISTA.
[3] Under the provisions of the NOC Regulations, Eli Lilly listed the ’356 patent. As a result, Apotex in seeking to obtain its own Notice of Compliance to market its generic version of the drug, served a Notice of Allegation on Eli Lilly on June 16, 2005 in which it alleged that the ’356 patent was invalid and, would not be infringed by its generic version, particularly having regard to the so-called Gillette Defence. Consequently, Eli Lilly instituted these proceedings on August 5, 2005 seeking to prohibit the Minister from issuing the Notice of Compliance that Apotex is seeking on the basis that the allegations aforesaid are not justified.
[4] NOC proceedings such as this one must be heard and judgment issued within 24 months from their institution unless that period is extended. By an Order of this Court dated March 14, 2007 that time period has been extended by a period to expire three months from the date that the hearing of the matter was commenced. The hearing was originally scheduled to commence January 14, 2008 but was rescheduled and commenced on January 21, 2008 thus the time for rendering judgment expires April 21, 2008.
WITNESSES
[5] The parties tendered in evidence the affidavits of 19 witnesses in all, many of whom were cross-examined.
[6] Eli Lilly tendered the evidence of nine witnesses. The following eight witnesses were asserted to be expert witnesses. All of these witnesses except for Thisted, Stewart and Azzarello were cross-examined by Apotex. They are:
1. Dr. Russell: Dr. Russell is the Norman Collisson Professor of Musculoskeletal Sciences and the Department Head of the Nuffield Department of Orthopaedic Surgery at the University of Oxford. He is a medical doctor and has published extensively on topics related to calcium metabolism and bone diseases.
2. Dr. Turner: Dr. Turner is a medical doctor and Professor of Nutrition and Exercise Sciences at Oregon State University, Co-Director of the Musculoskeletal Core of the Centre for Health Aging and the Director of the Bone Research Laboratory Faculty. He has published in the fields of bone disease and osteoporosis.
3. Dr. Lindsay: Dr. Lindsay is the Chief of Internal Medicine at Helen Hayes Hospital in West Haverstraw, New York and a Professor of Clinical Medicine at Columbia University. He has extensive clinical experience in treating patients who suffer from bone diseases and has authored articles on osteoporosis and its pathophysiology and treatment including the use of estrogens and estrogen-like substances.
4. Dr. Chalmers: Dr. Chalmers is a Professor in the Department of Medicine (Rheumatology) at the University of British Columbia. His research focuses on clinical epidemiology, specifically complex rheumatoid arthritis.
5. Dr. Thisted: Dr. Thisted is a Professor and the Chairman of the Department of Health Studies at the University of Chicago, which is part of the Pritzker School of Medicine. He teaches medical students, residents and fellows on clinical epidemiology, including interpretation of clinical diagnostic tests, risk factors for disease and the design and analysis of clinical studies. Dr. Thisted is also a member of the University of Chicago’s Department of Statistics and has published in the area of statistical computation.
6. Dr. Draper: Dr. Draper is a Clinical Endocrinologist who has been employed with Eli Lilly and Company since 1984. He holds both Ph.D. and M.D. degrees. Since 1984, he has been responsible for various clinical investigations and was the principal endocrinologist involved in the human clinical trials for raloxifene.
7. Mr. Stewart: Mr. Stewart is a registered patent agent and partner at Sim & McBurney. He has been practicing as a patent agent in Canada and the United States since 1967.
8. Ms. Azzarello: Ms. Azzarello is a licensed Ontario pharmacist who has worked in the pharmaceutical industry since 1983. She has held the position of Director of Regulatory Affairs at a major Canadian pharmaceutical company and since 1996 has served as President of Market Access Strategic Regulatory Services Inc. In that capacity, she represents Canadian and American companies in the federal drug approval process and drug formulary listing of both generic and innovative products.
[7] In addition, Eli Lilly tendered the affidavit of Larry John Black, one of the two named inventors of the ’356 patent. He was cross-examined. No evidence from the other named inventor George Joseph Cullinan was put in evidence by any party.
[8] Apotex led the evidence of nine witnesses who were asserted to be expert witnesses. All were cross-examined. They are:
1. Dr. Roos: Dr. Roos is the Director of the Division of Gerontology and Geriatric Medicine, the Executive Director of the Geriatric Institute and a Professor of Medicine at the University of Miami’s Miller School of Medicine. His research interests include osteoporosis and endocrine metabolic studies of aging.
2. Dr. Hollis: Dr. Hollis is a Professor of Pediatrics, Biochemistry and Molecular Biology, and Director of Pediatric Nutritional Sciences at the Medical University of South Carolina in Charleston. He has published extensively on calcium metabolism, vitamin D metabolism and animal models of ovarian hormone deficiency bone loss.
3. Dr. Klibanov: Dr. Klibanov is a Professor of Chemistry and of Bioengineering at the Massachusetts Institute of Technology and is on the editorial boards of eight scientific journals. He specializes in medicinal chemistry and has studied treatments for and animal models of osteoporosis.
4. Dr. Dordick: Dr. Dordick is a Professor in the Departments of Biology and Chemical and Biological Engineering at Rensselaer Polytechnic Institute. He co-founded a drug discovery company, Solidus Biosciences, that focuses on developing early stage human metabolism and toxicology testing.
5. Dr. O’Keefe: Dr. O’Keefe is the Dean’s Professor of Orthopaedics and Director of the Center for Musculoskeletal Research at the University of Rochester. He oversees a range of research programs including programs focussed on bone metabolism and regulation of osteoblast and osteoclast activities and specializes in musculoskeletal oncology and metabolic bone disease.
6. Dr. Vieth: Dr. Vieth is a Professor in the Department of Nutritional Sciences and the Department of Laboratory Medicine and Pathobiology at the University of Toronto and the Director of the Bone Mineral Laboratory with the University of Toronto and Mount Sinai Hospital. He teaches a biostatistics class and maintains a clinical laboratory service that focuses on markers of bone formation and bone resorption.
7. Dr. Dziak: Dr. Dziak is a Professor of Oral Biology at the University of Buffalo. Her research focuses on bone cell biology, specifically metabolism, and she is the Director of a graduate course that focuses on dynamics of the skeleton.
8. Dr. Bloch: Dr. Bloch is a Research Professor in the Department of Health Research and Policy, Division of Biostatistics at Stanford University. His research involves applying mathematical statistics to scientific studies and advancing biostatistical research methodology.
9. Mr Oyen: My Oyen is a partner and patent agent at Oyen Wiggs Green & Mutala LLP who has practiced in intellectual property law, including patent law, since 1967.
[9] In addition, Apotex tendered the affidavit of Megan Ellis which served to put in evidence Apotex’s Notice of Allegation and many pieces of prior art. Ellis was not cross-examined.
[10] Each of Eli Lilly and Apotex has tendered the evidence of more than five expert witnesses without seeking leave of the Court to do so. Recent jurisprudence of this Court makes it clear that leave of the Court must be sought when a party seeks to introduce the evidence of more than five expert witnesses. I appreciate that this jurisprudence is more recent than the date upon which evidence was tendered thus I will not reject any of it, since no party has asked me to do so, but I will refer to it in respect of an award of costs.
THE ’356 PATENT
[11] Canadian Letters Patent 2,101,356 were issued and granted to the Respondent Eli Lilly and Company of the United States of America on November 17, 1998. The Applicant Eli Lilly Canada Inc. is a licensee under that patent. The application for that patent was filed in the Canadian Patent Office on July 27, 1993 thus the provisions of the “new” post-October 1989 Patent Act, R.S.C. 1985, c.P-4 apply. The patent claims priority from an application number 07/920,933 filed in the United States Patent Office on July 28, 1992 (the priority date). The Canadian Patent application was laid open for public inspection on January 29, 1994.
[12] The ’356 patent names Larry John Black and George Joseph Cullinan as inventors. As noted above, the evidence of Black but not Cullinan was tendered in this application.
[13] The patent will expire 20 years from the date of filing of the application with the Canadian Patent Office, that is, it will expire July 27, 2013, unless earlier held to be invalid in an appropriate action. This is not such a proceeding.
[14] The ’356 patent contains 17 claims; all drafted in the “Swiss” form.
[15] The parties by Counsel at the pre-trial conference held January 14, 2008 agreed that the only claims requiring consideration by the Court are claims 1, 3, 15 (as it depends on 14), and 17 of the ’356 patent. These claims (including 14) state:
1. The use of a compound of formula (I):
Wherein
n is 0, 1 or 2;
R are R1, independently, are hydrogen, hydroxyl, C1-C6-alkoxyl, C1-C6-acyloxy, C1-C6- alkoxy-C2--C6-acyloxy, R3-substituted aroyloxy, R4-substituted carbonyloxy, chloro, or bromo;
R2 is a heterocyclic ring selected from the group consisting of pyrrolidino, piperidino, or hexamethyleneimino;
R3 is C1-C3-alkyl, C1-C3-alkoxy, hydrogen, or halo; and
R4 is C1-C6-alkoxy or aryloxy; or
a pharmaceutically acceptable salt thereof, in the preparation of a medicament useful for treating or preventing osteoporosis in a human.
. . .
3. The use of raloxifene hydrochloride in the preparation of a medicament useful for inhibiting bone loss in a human.
…
14. The use of any one of claims 1-3 wherein the medicament is for the treatment of an aging human.
15. The use of claim 14 wherein the medicament is for the treatment of a post-menopausal female.
. . .
17. The use of any one of claims 1-3 wherein the medicament is for the treatment of a patient without eliciting significant estrogenic responses in the primary sex tissues.
[16] The group of compounds depicted by formula (I) in claim 1 are within a family of chemicals commonly referred to as benzothiophenes. There is no dispute that among such benzothiophenes is that known as raloxifene. Earlier literature uses the name keoxifene instead of raloxifene; they are the same thing.
[17] To simplify the claims for purposes of these reasons, including incorporating the reference to claim 14 in claim 15, and including the reference to claims 1-3 in claim 14 and claim 17, claims 1, 3, 15 and 17 can be restated:
1. The use of a member of a group of benzothiophenes (such as raloxifene) in the preparation of a medicament useful for treating or preventing osteoporosis in a human.
…
3. The use of raloxifene hydrochloride in the preparation of a medicament useful for inhibiting bone loss in a human.
…
15. The use of a member of a group of benzothiophenes (such as raloxifene or raloxifene hydrochloride) for the preparation of a medicament useful for treating or preventing osteoporosis or for inhibiting bone loss in a post-menopausal female.
…
17. The use of a member of a group of benzothiophenes (such as raloxifene or raloxifene hydrochloride) in the preparation of a medicament useful for treating or preventing osteoporosis or for inhibiting bone loss for the treatment of a patient without eliciting significant estrogenic responses in primary sex tissues.
[18] All 17 claims of the ’356 patent, not only claims 1, 3, 15 and 17, are drafted in the “Swiss” style that is to say in a style which says:
The use of [an old compound] in the manufacture of a medicament for the treatment of [a new disorder].
[19] Claims in a patent directed in one way or another to medicines, to make them and how to use them have at various times and in various jurisdictions, been the subject of certain restrictions and limitations. At one time for instance, Canada as well as some other countries did not permit claims for a medicine per se. As a result claims became structured in certain ways so that, indirectly, some monopoly protection could be claimed. A good brief analysis of the history of such claims in Canada was given by the late Jerome A.C.J. in Deprenyl Research Ltd. v. Apotex Inc. (1994), 55 C.P.R. (3d) 171 (aff’d (1995), 60 C.P.R. (3d) 501 (F.C.A.)) at page 175:
… Until very recently, a medicine itself could not be patented, except when prepared by a particularly described process. Even then, however, it was essential that the medicine so produced be new or novel. If the medicine was not new, but the process producing it was, only the process could be patented. Though medicines themselves can now be patented as products, clearly a large number of patents still exist in relation to medicines when prepared by a particular process. Accordingly, there are three types of claims which can be made in a medicine patent. There may be a claim for the medicine itself, known as a “product” claim; a claim for the medicine when prepared by a particular process, known as a “process-dependent” product claim; and, a claim for the particular process that produces a medicine, known as a “process” claim.
[20] In Europe, claims that were “susceptible of industrial application” were quite permissible but “methods of treatment of the human body…by surgery or therapy and diagnostic methods” were not, with the saving provision that “substances or compositions, for use in any of these methods” were permitted to be claimed. Thus a new medicine could be claimed, but not a new use for an old medicine. The Swiss developed a way around this issue of claiming a new use for an old medicine by characterizing the manufacture of a pill for a new use as something that was “susceptible of industrial application” thus this type of claim became known as a “Swiss claim”.
[21] Jacob J. as he then was explained Swiss claims clearly in his decision in the English Chancery (Patents) Division in Bristol-Myers Squibb Co. v. Baker Norton Pharmaceuticals Inc., [1998] EWHC Patents 300 (aff’d [2000] EWCA Civ. 169 (CA)), at paragraph 43 and following:
43. Before going further I must now say something about the general structure of the claim. I daresay that an ordinary skilled man (to whom it is notionally addressed) would find it puzzling, unless he had been initiated in some of the Byzantine logic of patent law and jurisprudence. The explanation lies in Art. 54(4) of the EPC and the decided cases. The material parts of Art.54 read:
"(1) European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step.
(4) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods."
[22] Thus the “Swiss claim” is an additional structural form of a claim that can be added to the structures discussed in Deprenyl, supra so that presently, in Canada, claims directed to a medicine, and in particular to a previously known medicine can be structured in a variety of ways such as:
· The use of an old medicine for the treatment of a new disorder (new use claim)
· The process for making an old medicine that is to be used in the treatment of a new disorder (process claim)
· The use of an old medicine when prepared by a certain process for the treatment of a new disorder (process-dependent claim)
· The use of an old medicine for the manufacture of a medicament for the treatment of a new disorder (Swiss claim)
[23] Each of these claims could arguably be said in “spirit” or “essence” to be directed to the new use of a known medicine, but each is structured differently.
[24] At the pre-trial conference held on January 14, 2008, counsel for Apotex stated that Apotex would not be arguing whether “Swiss” type claims are appropriate for listing under the NOC Regulations nor would it be arguing whether such claims are directed to a method of medical treatment. To the extent that such arguments were raised in Apotex’s Notice of Allegation or Memorandum of Argument, they have been abandoned.
CONSTRUCTION OF THE CLAIMS
[25] The Court, in proceedings such as this, must place a construction on the claims at issue. Construction of the claims is to be made by the Court before consideration is given to issues of validity and infringement (Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067 at para. 43). This applies to the whole of the patent, where necessary, and not only to the claims (Burton Parsons Chemicals, Inc. v. Hewlett-Packard (Canada) Ltd., [1976] 1 S.C.R. 555 at page 563; Western Electric Co. v. Baldwin International Radio of Canada, [1934] S.C.R. 570 at page 572).
[26] Construction is a task for the Court alone (Whirlpool, supra; Burton Parsons, supra) the role of an expert, if required, is limited to assisting the Court in putting the Court in the position of a person skilled in the art as of the relevant time (Halford v. Seed Hawk Inc., 2006 FCA 275 at para. 11). In Dableh v. Ontario Hydro, [1996] 3 F.C. 751 at paragraph 33, the Federal Court of Appeal stated what the role of the expert is:
It is a matter of accepted law that the task of construing a patent’s claim lies within the exclusive domain of the trial judge. In strict legal theory it is the role of expert witnesses, that is those skilled in the art, to provide the judge with the technical knowledge necessary to construe a patent as though he or she were so skilled. Where the experts disagree, it is incumbent on the trial judge to make a binding determination.
[27] The parties focused only on certain claims as requiring consideration by the Court. They are claims 1, 3, 15 and 17. To repeat those claims in simplified format:
1. The use of a member of a group of benzothiophenes (such as raloxifene) in the preparation of a medicament useful for treating or preventing osteoporosis in a human.
…
3. The use of raloxifene hydrochloride in the preparation of a medicament useful for inhibiting bone loss in a human.
…
15. The use of a member of a group of benzothiophenes (such as raloxifene or raloxifene hydrochloride) for the preparation of a medicament useful for treating or preventing osteoporosis or for inhibiting bone loss in an aging human, namely a post-menopausal female.
…
17. The use of a member of a group of benzothiophenes (such as raloxifene or raloxifene hydrochloride) in the preparation of a medicament useful for treating or preventing osteoporosis or for inhibiting bone loss for the treatment of a patient without eliciting significant estrogenic responses in primary sex tissues.
[28] Apotex argues that the claims say just what they say and that the “plain meaning” of “osteoporosis” is any form of osteoporosis, however caused and the “plain meaning” of “bone loss” is any form of bone loss however caused.
[29] Eli Lilly argues that, when read in the context of the patent as a whole the terms “osteoporosis” and “bone loss” referred to in these claims is “that which arises from a lack of estrogen”.
[30] The Court must approach the matter of claim construction in an informed and purposive manner. Information is to be gained from the patent as a whole in order to determine the context in which the claims are to be considered, and from experts whose role is to provide assistance, if necessary, in respect of the technical meaning of the terms and concepts used in the claims. This is what the Supreme Court said in Free World Trust v. Electro Santé Inc., [2000] 2 S.C.R. 1024 at paragraphs 51 and 52:
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.
(ii) What Constitutes an "Essential" Element Is to Be Interpreted in Light of the Knowledge of the Art at the Date of the Publication of the Patent Specification
52 The substitutability of non-essential elements derives from an informed interpretation of the language of the claims at the time they are revealed to the target audience of persons skilled in the relevant art. Thus Dickson J., in Consolboard, supra, spoke at p. 523 of "what a competent workman reading the specification at its date would have understood it to have disclosed and claimed" (emphasis added). See also Fox, supra, at p. 204. The date of publication was identified by Lord Diplock in Catnic, supra, and picked up by Hoffmann J. (as he then was) in Improver Corp. v. Remington Consumer Products Ltd., [1990] F.S.R. 181 (Pat. Ct.), at p. 182:
Would this (i.e.: that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. [Emphasis added.]
[31] The Court, so informed, must construe the claims in a “purposive” manner paying close attention to the purpose and intent of the inventors as expressed in the patent document, including the whole of the specification being neither benevolent nor harsh. As the Supreme Court said in Whirlpool, supra at paragraph 49(c):
(c) The orthodox rule is that a patent "must be read by a mind willing to understand, not by a mind desirous of misunderstanding", per Chitty J. in Lister v. Norton Brothers and Co. (1886), 3 R.P.C. 199 (Ch. D.), at p. 203. A "mind willing to understand" necessarily pays close attention to the purpose and intent of the author.
[32] And as the same Court said earlier in Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504 at pages 520-521:
We must look to the whole of the disclosure and the claims to ascertain the nature of the invention and methods of its performance (Noranda Mines Limited v. Minerals Separation North American Corporation), being neither benevolent nor harsh, but rather seeking a construction which is reasonable and fair to both patentee and public. There is no occasion for being too astute or technical in the matter of objections to either title or specification for, as Duff C.J.C. said, giving the judgment of the Court in Western Electric Company, Incorporated, and Northern Electric Company v. Baldwin International Radio of Canada Limited at p. 574: “where the language of the specification, upon a reasonable view of it, can be so read as to afford the inventor protection for that which he has actually in good faith invented, the court, as a rule, will endeavour to give effect to that construction”. Sir George Jessel spoke to like effect at a much earlier date in Hinks & Son v. Safety Lightning Company (1876), 4 Ch.D. 607. He said the patent should be approached “with a judicial anxiety to support a really useful invention”.
[33] This exercise in construction does not mean, however, that a patentee, through argument by counsel at a trial, can rewrite a claim. To repeat what the Supreme Court said in Free World, supra., at paragraph 51:
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.
[34] With this jurisprudence in mind, together with evidence presented by the experts, where needed, I will consider the claims at issue. First, there is no doubt that the claims simply say “osteoporosis” and “bone loss”. These terms are not modified in any way in claim 1 or claim 3.
[35] Then, I turn to the specification of the ’356 patent. The specification begins at page 1, over to page 2, by stating that the invention relates to a class of benzothiophene compounds useful in the prevention of bone loss, that the mechanism of bone loss is not well understood, that bone loss occurs in a wide range of subjects and, if unchecked, leads to osteoporosis. To quote in part from page 1:
This invention relates to the discovery that a group of 2-phenyl-3-aroylbenzothiophenes is useful in the prevention of bone loss.
The mechanism of bone loss is not well understood…
…
Bone loss occurs in a wide range of subjects…
…
Unchecked bone loss can lead to osteoporosis…
[36] At page 2 and over to page 3 the specification states that one of the most common types of osteoporosis is found in post-menopausal women and that estrogen therapy has been used with beneficial effects; however there are undesirable side effects which support the need to develop alternative therapy. To quote in part:
One of the most common types of osteoporosis is found in post-menopausal women…A significant feature of post-menopausal osteoporosis is the large and rapid loss of bone mass due to the cessation of estrogen production by the ovaries. Indeed, data clearly support the ability of estrogens to limit the progression of osteoporotic bone loss, and estrogen replacement is a recognized treatment for post-menopausal osteoporosis in the United States and many other countries. However, although estrogens have beneficial effects on bone, given even at very low levels, long-term estrogen therapy has been implicated in a variety of disorders…Concerns over the significant undesirable effects associated with estrogen therapy, and the limited ability of estrogens to reverse existing bone loss, support the need to develop alternative therapy for bone loss that generates the desirable effects on bone but does not cause undesirable effects.
[37] At the top of page 3 the specification describes several known alternatives. In the middle of page 3 there is a statement that the invention provides methods for inhibiting bone loss without the adverse effects of estrogen therapy:
The current invention provides methods for inhibiting the loss of bone without the associated adverse effects of estrogen therapy, and thus serves as an effective and acceptable treatment for osteoporosis.
[38] The benzothiophene compounds are then discussed at pages 3 and 4. It is acknowledged that these compounds were previously known including the compound of interest here, which is raloxifene (previously known as keoxifene).
[39] At pages 4 to 7 the invention is summarized. At pages 4 and 5 it is stated that the invention provides for the use of the known benzothiophene compounds “…in the treatment or prevention of osteoporosis in a human” and that it also provides for a formulation of such benzothiophene and a carrier in an amount such as to increase or retain bone density.
[40] At pages 5 to 7 the invention and how it is understood to work is described. The invention is that a group of benzothiophenes is useful in the treatment of osteoporosis. The way that the compounds are understood to work is that they inhibit bone loss that results from a lack of endogenous estrogen caused by certain things. At page 6 the specification states that the “real benefit” is that the compounds inhibit bone loss without eliciting estrogenic responses. Thus the use of the compounds is to be in an amount that does not significantly affect the primary sex target tissues. To quote in part:
… the real benefit of the current discovery is that the benzothiophenes of formula I inhibit the loss of bone but do not elicit significant estrogenic responses in the primary sex target tissues. Thus, the current invention provides the use of a compound of formula I as defined previously for inhibiting bone loss in a human in need of treatment, in an amount that inhibits bone loss but which does not significantly affect the primary sex target tissues.
[41] At pages 7 and 8 of the specification, the biological action of the compounds is discussed. At pages 9 and 10 some of the chemical substituents of various compounds within the group are defined. At page 11 the specification identifies raloxifene as “most preferred” and acknowledges that the method of making these compounds is already known. To quote in part from page 11:
The most preferred embodiment of the invention involves the use of raloxifene, especially when administered as the hydrochloride salt.
All of the compounds used in the methods of the current invention can be made according to established procedures…
[42] Pages 11 to 35 of the specification are directed to the preparation of some of the benzothiophene compounds such as raloxifene, and their formulation for preparing capsules and tablets.
[43] The balance of the descriptive part of the specification from pages 36 to 47 is directed to experiments on rats and one, example 5, to a contemplated experiment on humans, in particular, post-menopausal women. The rat studies (conducted on 75-day old Sprague Dawley rats) involve comparisons between female rats with ovaries removed and those that are intact. The human studies contemplate involvement of women who would normally be considered candidates for estrogen replacement in treatment for osteoporosis. As stated for instance by Dr. Lindsay at paragraphs 32 and 33 of his affidavit, all these examples are directed to bone loss due to lack of estrogen.
[44] Example 5 appears to be directed to a human study which, at the time, appears only to have been in contemplation. Pages 45 to the first half of page 47 discuss how one hundred and sixty patients are selected, blood and urine samples are taken, that there was a control group and a group to whom certain medicines were to be administered in certain dosages and baseline measurements that were to be made. No results of the study are given. At page 47 the descriptive portion of the patent concludes with the following two paragraphs which speak of what is “expected” and anticipates “subsequent longer term studies”:
During subsequent visits to the investigating physician, measurements of the above parameters in response to treatment are repeated. The biochemical markers listed above that are associated with bone resorption have all been shown to be inhibited by the administration of estrogen as compared to an untreated individual. Raloxifene is also expected to inhibit the markers in estrogen deficient individuals as an indication that raloxifene is effective in inhibiting bone loss from the time that treatment is begun.
Subsequent longer term studies can incorporate the direct measurement of bone density by the use of a photon absorptiometry and the measurement of fracture rates associated with therapy.
[45] The words “bone loss” and “osteoporosis” themselves do not appear in the specification in a way that could be said to be ambiguous if considered on their own. The evidence demonstrates for instance in the cross-examinations of Dr. Russell at questions 180 to 195, Dr. Turner at questions on pages 24 to 30, Dr. Chalmers at questions 191 to 199 and Dr. Lindsay at questions 191 to 198 that those words “osteoporosis” and “bone loss” on their own are not ambiguous and that causes other than estrogen related causes were known as of 1992 to cause bone loss and osteoporosis.
THE CLAIMS
[46] Turning to the claims, in particular claims 1, 3, 15 and 17 which were the focus of the parties’ arguments, I repeat them in their simplified form (which has nothing to do with construction, it simply makes them easier to read):
1. The use of a member of a group of benzothiophenes (such as raloxifene) in the preparation of a medicament useful for treating or preventing osteoporosis in a human.
…
3. The use of raloxifene hydrochloride in the preparation of a medicament useful for inhibiting bone loss in a human.
…
15. The use of a member of a group of benzothiophenes (such as raloxifene or raloxifene hydrochloride) for the treatment of an aging human, namely a post-menopausal female.
…
17. The use of a member of a group of benzothiophenes (such as raloxifene or raloxifene hydrochloride) in the preparation of a medicament for the treatment of a patient without eliciting significant estrogenic responses in primary sex tissues.
[47] Claim 1 is an independent claim and refers simply to “osteoporosis in a human”. Claim 3 is an independent claim and refers simply to “inhibiting bone loss in a human”. The words “osteoporosis” or “bone loss” are not qualified.
[48] Claim 15 is a dependent claim; it depends on claim 14 which in turn depends on any of claims 1, 2 or 3. The treatment is for osteoporosis (claim 1) or bone loss (claim 3) in an aging human (claim 14) and in particular “for treatment of a post-menopausal female” (claim 15). Again the type of osteoporosis or bone loss is not qualified.
[49] Claim 17 depends on any of claims 1, 2 or 3 that is, treatment for osteoporosis (claim 1) or bone loss (claim 3) in which the treatment occurs “without eliciting significant estrogenic responses in the primary sex tissues”.
[50] Eli Lilly urges that the claims, even claims 1 and 3, must be limited to only bone loss and osteoporosis caused by an estrogen deficiency. I repeat paragraph 61 of its memorandum:
61. When read with a mind willing to understand, and when read in view of the context provided by the specification, the claims in the ’356 Patent are clearly concerned only with bone loss and osteoporosis caused by an estrogen deficiency. To conclude otherwise would fail to give effect to the principles of construction endorsed by the Supreme Court of Canada.
[51] I reject that submission. The Federal Court of Appeal in Dableh, supra particularly at paragraphs 29 to 39 expressly warned against restricting plain and unambiguous language of a claim. A claim was not to be restricted for instance to preferred embodiments. At paragraph 30 the Court said:
30 It is a matter of settled law that recourse to the disclosure portion of the specification is: (1) permissible to assist in understanding the terms used in the claims; (2) unnecessary where the words are plain and unambiguous; and (3) improper to vary the scope or ambit of the claims.11 It is equally clear that where the words used in the claims are clear and unambiguous, they must not be narrowed or limited to a patent's preferred embodiment.12 Against this legal framework, the issue is whether the terms "varying electric current" and "electromagnetic coil" were found to be ambiguous and, therefore, the Trial Judge was justified in resorting to the disclosure to resolve any ambiguity. In our view, the evidence clearly establishes that no ambiguity existed and that claim 1 is worded broadly enough to cover an AC source of electricity and coils other than Bitter or near Bitter coils.
[52] More recently Pelletier J. (sitting as a Trial Judge) in Halford v. Seek Hawk Inc., 2004 FC 88 (aff’d 2006 FCA 275 at paras. 28-33) reviewed the question of claim construction at paragraphs 90 to 97 when dealing with independent and dependent claims. He stated at paragraph 93:
In its simplest form, claim differentiation requires that “limitations of one claim not be ‘read into’ a general claim”.
[53] Here we have limitations in clams 15 and 17. Claim 15 limits the treatment to aging post-menopausal females. Claim 17 limits the treatment to that which does not elicit significant estrogenic responses in the primary sex tissues. It cannot be said that claims 1 or 3 incorporate the limitations of claims 15 or 17.
[54] Unlike the claims in Nekoosa Packaging Corp. v. United Dominion Industries Ltd. (1994), 56 C.P.R. (3d) 470 (F.C.A.) which used simply the word “processing” when describing what a machine did with trees which required the Court of Appeal to review the specification so as to conclude that “processing” meant reducing the trees to wood chips and not just logs, there is no equivocation as to what “osteoporosis” or “bone loss” mean in the patent at issue here.
[55] Eli Lilly argues that the result of an “unlimited” interpretation of “osteoporosis” or “bone loss” would mean that the claims would, to quote from paragraph 60 of its memorandum:
…include within their scope, bone loss caused by amputation or that associated with tooth decay.
[56] This is to introduce an absurdity of the kind rejected by the Supreme Court of Canada in Burton Parsons Chemicals Ltd., supra where a claim to a skin cream preparation containing salt was not read so broadly so as to include salts that would kill or injure the person to whom the cream was applied. Pigeon J. for the Court at page 563 said:
In my view, the rights of patentees should not be defeated by such technicalities. While the construction of a patent is for the Court, like that of any other le