Apotex Inc. v. Wellcome Foundation Ltd.

Apotex Inc. v. Wellcome Foundation Ltd.
Collection
Supreme Court Judgments
Date
2002-12-05
Neutral citation
2002 SCC 77
Report
[2002] 4 SCR 153
Case number
28287
Judges
McLachlin, Beverley; L'Heureux-Dubé, Claire; Gonthier, Charles Doherty; Iacobucci, Frank; Major, John C.; Bastarache, Michel; Binnie, William Ian Corneil; Arbour, Louise; LeBel, Louis
On appeal from
Federal Court of Appeal
Subjects
Intellectual property
Notes
SCC Case Information: 28287
Decision Content
Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, 2002 SCC 77
Apotex Inc. and Novopharm Ltd. Appellants
v.
Wellcome Foundation Limited, Glaxo Wellcome Inc.,
Interpharm Inc. and Allen Barry Shechtman Respondents
Indexed as: Apotex Inc. v. Wellcome Foundation Ltd.
Neutral citation: 2002 SCC 77.
File No.: 28287.
2002: February 14; 2002: December 5.
Present: McLachlin C.J. and L’Heureux‑Dubé, Gonthier, Iacobucci, Major, Bastarache, Binnie, Arbour and LeBel JJ.
on appeal from the federal court of appeal
Patents — Validity — Standard of review — Appropriate standard of review of patent issues of mixed fact and law.
Patents — Validity — Biotechnology — New use for old compound — Statutory requirement for invention — Utility — Doctrine of sound prediction — Patent holder identifying new use for compound in treatment and prophylaxis of AIDS — Whether patent valid — Whether doctrine of sound prediction applies — Patent Act, R.S.C. 1985, c. P‑4, ss. 2 “invention”, 27, 34(1).
Patents — Validity — Covetous claiming — Patent holder claiming prophylactic as well as treatment properties for AZT — Whether claim exceeds disclosure.
Patents — Inventorship — Inventors and verifiers — Patent holder identifying new use for compound in treatment and prophylaxis of AIDS — Whether verifiers who performed critical testing co‑inventors — Whether omission to name them “wilfully made for the purpose of misleading” — Patent Act, R.S.C. 1985, c. P‑4, s. 53(1) .
AIDS is one of the great health scourges of the modern world. AZT was one of the earliest and is still one of the most effective drugs for its treatment. The respondents (collectively referred to as “Glaxo/Wellcome”) identified a new use for an old compound. They conceived the idea that AZT would work in humans against the HIV retrovirus. Since Glaxo/Wellcome was not equipped to undertake the required testing, it turned to a number of outside laboratories. One of these was the National Institutes of Health (NIH), where two scientists performed critical blind testing on the AZT and other compounds (none of which was identified) supplied by Glaxo/Wellcome. In mid‑February 1985, the NIH scientists found that AZT did indeed inhibit HIV replication in their in vitro HIV assay system and so advised the respondents. Thereafter, on March 16, 1985, Glaxo/Wellcome filed in the United Kingdom the patent application from which the Canadian patent claims priority.
The appellants, generic drug manufacturers, challenged the validity of Glaxo/Wellcome’s patent on the basis that the necessary utility had not been established as of the priority date of the patent, that the claims covered more than the invention (prophylactic properties as well as treatment properties), and that the disclosure was misleading because it omitted any reference to the NIH “co‑inventors”. The trial judge rejected the substance of this attack, and declared certain of the claims to be valid and infringed. The Federal Court of Appeal, with a minor variation, dismissed the appeal.
Held: The appeals should be dismissed.
The evidence accepted by the trial judge showed that by the date the U.K. patent was applied for, March 16, 1985, Glaxo/Wellcome had sufficient information about AZT and its activity against HIV in human cells to make a sound prediction that AZT would be useful in the treatment and prophylaxis of HIV/AIDS in human beings. To the extent its claims went beyond the limits within which the prediction remained sound, the Federal Court properly struck them out.
The doctrine of “sound prediction” balances the public interest in early disclosure of new and useful inventions, even before their utility has been fully verified by tests, and the public interest in avoiding cluttering the public domain with useless patents and granting monopoly rights in exchange for speculation or misinformation. While allowing a patent based on speculation would have been unfair to the public, requiring Glaxo/Wellcome to demonstrate AZT’s efficacy through the clinical tests required for approval of a new drug for medical prescription would have been unfair to Glaxo/Wellcome. The disclosure made in the patent was and is of real use and benefit and Glaxo/Wellcome, by making the disclosure, fulfilled its side of the bargain with the public. It was therefore entitled to legal protection for what it disclosed.
The Commissioner’s decision in this case largely raises mixed questions of law and fact. The Patent Act has no privative clause and provides an unfettered right of appeal to the Federal Court. The statutory presumption of the patent’s validity in s. 45 is weakly worded and adds little to the usual onus already resting on the attacking party. Nevertheless, fact finding by the Commissioner, who has considerable expertise in these matters, generally commands deference. In these circumstances, the appropriate standard of review is reasonableness simpliciter.
Utility is an essential part of the statutory definition of an “invention”. The inventor must be in a position to establish utility as of the date the patent is applied for, on the basis of either demonstration or sound prediction based on the information and expertise then available. Where the subject matter of the patent is a new use for an old chemical compound, it is not enough that the invention is reduced to a definite and practical shape by the formulation of a written or oral description. Nor is it enough for a patent owner to be able to buttress speculation with post‑patent proof. If a patent sought to be supported on the basis of sound prediction is subsequently challenged, the challenge will succeed if the prediction at the date of application was not sound, or, irrespective of the soundness of the prediction, there is evidence of lack of utility in respect of some of the area covered.
The doctrine of sound prediction has three components. Firstly, there must be a factual basis for the prediction. Secondly, the inventor must have at the date of the patent application an articulable and “sound” line of reasoning from which the desired result can be inferred from the factual basis. Thirdly, there must be proper disclosure. The soundness (or otherwise) of the prediction is a question of fact. The doctrine of sound prediction, in its nature, presupposes that further work remains to be done. Care must be taken, however, that the doctrine is not abused, and that sound prediction is not diluted to include a lucky guess or mere speculation.
With regard to covetous claiming, it was open to the respondents to claim prophylactic as well as treatment properties. The patent disclosure includes some information described as “Preventing Infection by AIDV”, which describes an experiment which showed “decreased infection” of cells in the presence of AZT. The patent then identifies the mechanism by which AZT prevents “the development of signs and symptoms” of AIDS (and is thus prophylactic to AIDS). HIV offers an incubation period in which the virus is present but vulnerable to attack. It is this specific feature that was targeted by the “chain termination” effect known and disclosed by Glaxo/Wellcome at the time of the patent application, and which afforded the basis for its prediction that AZT had prophylactic properties. In these circumstances, the appellants have not demonstrated any palpable and overriding error with respect to this finding by the trial judge.
The appellants contend that the NIH scientists were “co‑inventors” and ought to have been so identified in the patent. In the steps leading from conception to patentability, the inventor(s) may utilize the services of others, who may be highly skilled, but those others will not be co‑inventors unless they participated in the inventive concept as opposed to its verification. If Glaxo/Wellcome had soundly predicted that AZT could cure nausea in the weightlessness of space for example, it might require NASA and all its rocket ship expertise to “establish” the utility, but NASA would not on that account become a co‑inventor. Despite the contribution of the NIH scientists, therefore, they were not co‑inventors of the patent in suit.
Moreover, a patent is only void pursuant to s. 53(1) of the Patent Act if it contains a “material” misstatement that is “wilfully made for the purpose of misleading”. Here, there was no evidence whatsoever that the omission to name the NIH scientists was “wilfully made for the purpose of misleading”.
Cases Cited
Considered: Monsanto Co. v. Commissioner of Patents, [1979] 2 S.C.R. 1108; Olin Mathieson Chemical Corp. v. Biorex Laboratories Ltd., [1970] R.P.C. 157; Ciba‑Geigy AG v. Commissioner of Patents (1982), 65 C.P.R. (2d) 73; Beecham Group Ltd. v. Bristol Laboratories International S.A., [1978] R.P.C. 521; distinguished: Harvard College v. Canada (Commissioner of Patents), [2002] 4 S.C.R. 45, 2002 SCC 76; Ernest Scragg & Sons Ltd. v. Leesona Corp., [1964] Ex. C.R. 649; Koehring Canada Ltd. v. Owens‑Illinois Inc. (1980), 52 C.P.R. (2d) 1, leave to appeal refused, [1980] 2 S.C.R. ix; Permutit Co. v. Borrowman, [1926] 4 D.L.R. 285; C.G.E. Co. v. Fada Radio Ltd., [1930] 1 D.L.R. 449; referred to: Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536; Tennessee Eastman Co. v. Commissioner of Patents, [1974] S.C.R. 111; Burroughs Wellcome Co. v. Barr Laboratories Inc., 32 U.S.P.Q. 2d 1915 (1994); Travis v. Baker, 137 F.2d 109 (1943); Rubbermaid (Canada) Ltd. v. Tucker Plastic Products Ltd. (1972), 8 C.P.R. (2d) 6; Canada (Director of Investigation and Research) v. Southam Inc., [1997] 1 S.C.R. 748; Procter & Gamble Co. v. Bristol‑Myers Canada Ltd. (1979), 42 C.P.R. (2d) 33, aff’g (1978), 39 C.P.R. (2d) 145; Christiani v. Rice, [1930] S.C.R. 443; May & Baker Ltd. v. Boots Pure Drug Co. (1950), 67 R.P.C. 23; In re I. G. Farbenindustrie A. G.’s Patents (1930), 47 R.P.C. 289; Biogen Inc. v. Medeva PLC, [1997] R.P.C. 1; Mullard Radio Valve Co. v. Philco Radio and Television Corp. (1936), 53 R.P.C. 323; Burton Parsons Chemicals, Inc. v. Hewlett‑Packard (Canada) Ltd., [1976] 1 S.C.R. 555; Société des usines chimiques Rhône‑Poulenc v. Jules R. Gilbert Ltd., [1968] S.C.R. 950; Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024, 2000 SCC 66; Genentech Inc.’s Patent, [1989] R.P.C. 147; Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., [1981] 1 S.C.R. 504; May & Baker Ltd. v. Ciba Ltd. (1948), 65 R.P.C. 255; Henry Brothers (Magherafelt) Ltd. v. Ministry of Defence and the Northern Ireland Office, [1997] R.P.C. 693; Kellogg Co. v. Kellogg, [1942] Ex. C.R. 87; Gerrard Wire Tying Machines Co. of Canada v. Cary Manufacturing Co., [1926] Ex. C.R. 170; Jules R. Gilbert Ltd. v. Sandoz Patents Ltd. (1970), 64 C.P.R. 14, rev’d sub nom. Sandoz Patents Ltd. v. Gilcross Ltd., [1974] S.C.R. 1336.
Statutes and Regulations Cited
Food and Drug Regulations, C.R.C. 1978, c. 870, s. C.08.002(2) [am. SOR/95‑411, s. 4(2)].
Patent Act, R.S.C. 1985, c. P‑4, ss. 2 “invention”, 27(1), (3), 34(1)(a), (b), (d), (e), 40, 42, 45, 53(1), (2).
Patents Act, 1949 (U.K.), 1949, c. 87, ss. 4(3), 32(1)(i).
Authors Cited
“Agency Wants to End AIDS Drug Monopoly”, The New York Times, May 29, 1991, p. A24.
Black’s Medical Dictionary, 39th ed. Lanham: Madison Books, 1999, “prophylaxis”.
Butterworths Medical Dictionary, 2nd ed. London: Butterworths, 1978, “Clinical prophylaxis”, “Drug prophylaxis” and “Gametocidal prophylaxis”.
Case Comment, “Patent Law — Pharmaceuticals — Federal Circuit Upholds Patents for AIDS Treatment Drug — Burroughs Wellcome Co. v. Barr Laboratories, Inc., 40 F.3d 1223 (Fed. Cir. 1994)” (1995), 108 Harv. L. Rev. 2053.
Dorland’s Illustrated Medical Dictionary, 27th ed. Philadelphia: Saunders, 1988.
Fisher, Harold, and Russel S. Smart. Canadian Patent Law and Practice. Toronto: Canada Law Book, 1914.
Fox, Harold G. The Canadian Law and Practice Relating to Letters Patent for Inventions, 4th ed. Toronto: Carswell, 1969.
Godson, Richard. A Practical Treatise on the Law of Patents for Inventions, and of Copyright, 2nd ed. London: William Benning & Co., 1851.
Mitsuya, Kiroaki, et al. Letter to the editor, The New York Times, September 20, 1989.
Oxford English Dictionary, vol. XII, 2nd ed. Prepared by J. A. Simpson and E. S. C. Weiner. Oxford: Clarendon Press, 1989, “prophylaxis”.
Yardley, Jim. “Industry Giant Owns Right to AIDS Drug? N.C. Trial to Decide”, Atlanta Constitution, June 27, 1993, p. A4.
APPEALS from a judgment of the Federal Court of Appeal, [2001] 1 F.C. 495, (2000), 195 D.L.R. (4th) 641, 10 C.P.R. (4th) 65, 262 N.R. 137, allowing in part appeals and cross‑appeals from a judgment of Wetston J. (1998), 145 F.T.R. 161, 79 C.P.R. (3d) 193, [1998] F.C.J. No. 382 (QL). Appeals dismissed.
Harry B. Radomski, Richard Naiberg and David M. Scrimger, for the appellant Apotex Inc.
Carol Hitchman, Warren Sprigings and Paula Bremner, for the appellant Novopharm Ltd.
Patrick E. Kierans, Kenneth E. Sharpe, Peter J. Stanford and Brian R. Daley, for the respondents Wellcome Foundation Ltd. and Glaxo Wellcome Inc.
The judgment of the Court was delivered by
1 Binnie J. — AIDS is one of the great health scourges of the modern world. AZT was one of the earliest and is still one of the most effective drugs for its treatment. The patent on the use of AZT for HIV/AIDS treatment and prophylaxis is held by the respondents, but the appellants, Apotex and Novopharm, two “generic” drug manufacturers, say that in fact the respondents (collectively referred to as “Glaxo/Wellcome”) did not invent anything. In the alternative, if Glaxo/Wellcome can be said to have invented something, the appellants say it did so in collaboration with others whose work Glaxo/Wellcome wrongly appropriated for its own financial benefit. Moreover, there was no basis at all disclosed in the patent to claim a “prophylactic” as well as a “treatment” benefit. On any or all of these grounds, they say the patent should be declared invalid.
2 The appeals therefore require us to consider the statutory requirement for an invention in the context of a new use for an old chemical compound, and the related questions of who ought to have been included as inventors, and what is the appropriate remedy if someone who ought to have been included in the patent is left out.
3 In my view, for the reasons which follow, the inventive use of AZT was made by the five Glaxo/Wellcome scientists named in the patent on or before March 16, 1985, the priority date of the patent. It was sufficient that at that time the Glaxo/Wellcome scientists disclosed in the patent a rational basis for making a sound prediction that AZT would prove useful in the treatment and prophylaxis of AIDS, which it did. For the Commissioner of Patents to have allowed Glaxo/Wellcome a patent based on speculation would have been unfair to the public. For him to have required Glaxo/Wellcome to demonstrate AZT’s efficacy through the clinical tests required by the Minister of Health for approval of a new drug for medical prescription would have been unfair to Glaxo/Wellcome. The disclosure made in the patent was and is of real use and benefit to millions of HIV and AIDS sufferers around the world (irrespective of Glaxo/Wellcome’s pricing policy for AZT, which it must be acknowledged has generated serious controversy in some countries, particularly in the developing world). The fact remains that Glaxo/Wellcome, by making the disclosure, has fulfilled its side of the bargain with the public, and is by law entitled to legal protection for what it has disclosed.
4 The claims that have survived the rigours of administrative and judicial scrutiny to date (19 out of 78 claims) do not overreach the invention disclosed. The appellants had the onus of demonstrating the invalidity of the patent and their attack on the factual underpinnings of the trial judgment revealed no palpable and overriding error. The legal outcome was correct. I would affirm the validity of the patent and dismiss the appeals.
I. Facts
5 During the early 1980s, a deadly disease, now known as AIDS, was identified. It appeared to suppress the immune systems of those who became infected. AIDS (Acquired Immune Deficiency Syndrome) was shown to be caused, in turn, by a retrovirus, now known as the human immunodeficiency virus (“HIV”), which was first isolated at the Institut Pasteur in 1983. A virus is a type of subcellular parasite which is dependent on a cellular host to provide the machinery for its reproduction. HIV infects T-cells, which play an important part in human immune response, hijacking the T-cells to produce copies of itself, eventually destroying the T-cell and degrading the body’s immune response. At that point, HIV renders the body prone to infection, ultimately fatally, by opportunistic diseases that the diminished immune system is unable to combat. The trial judge commented that AIDS quickly became “a world-wide health crisis referred to by many as an epidemic”: (1998), 145 F.T.R. 161, at para. 8.
6 Glaxo/Wellcome had considerable experience in researching retroviruses, and in late 1983 assembled a working group to harness that expertise to the search for an anti-AIDS drug. The group included Dr. David Barry, head of the Department of Virology at Glaxo/Wellcome, Dr. Janet Rideout, who had been coordinating the various investigations involving the compound 509U81 (AZT) and the one who suggested that AZT be tested in the screens, Dr. Philip Furman, a research scientist with a Ph.D. in virology who had previously worked with anti-viral drugs, Dr. Sandra Nusinoff Lehrman, a physician with expertise in the areas of infectious disease and pediatrics, and Martha St. Clair, a virologist who worked with Dr. Furman and who had experience with retroviruses.
7 The fact that HIV attacks the T-cells, which are crucial to the functioning of the human immune system, was known in 1984. It was also known that HIV infects the T-cell by insinuating and integrating a DNA copy of its RNA genome into the genome of the T-cell using reverse transcriptase, an enzyme common to all retroviruses. As the host cell, with the viral DNA integrated into its own DNA, divides, it replicates and thereby provides a template for the further propagation of the virus.
8 The Glaxo/Wellcome scientists believed that the reverse transcription stage, unique to retroviruses, offered the best target for a drug. The growing DNA chain could be terminated by adding on a “false” nucleoside, one of the chemical building blocks of DNA. The nucleoside is said to be “false” because, while it appears to others in the chain to be a regular nucleoside, it lacks the OH group for coupling with the incoming nucleoside, which finds it has nothing to hook onto. There being no hook, the chain terminates, thereby arresting the propagation of HIV.
9 The Glaxo/Wellcome scientists, in the spring of 1984, began to screen various compounds which, they believed, based on their chemical structure, might serve as chain terminators. One of the hundreds of compounds screened eventually became known as AZT.
10 It is important to note that the respondents did not “invent” AZT. It was a known compound, synthesized and tested by Dr. Jerome Horwitz at the Detroit Institute of Cancer Research in 1964 as part of a project to find a cancer treatment for humans. That project was abandoned. Glaxo/Wellcome had more recently been researching the drug for use as an anti-bacterial treatment, though this was not its original purpose.
11 Once the Glaxo/Wellcome team had identified suitable compounds, its in-house screening methods were relatively simple. Coating the bottom of a petri dish with murine (mouse) T-cells, the laboratory technician would introduce a retrovirus. Glaxo/Wellcome used two retroviruses found in mice (not humans) because they were readily reproducible, predictable, reliable and easy to use. Using staining techniques, the laboratory technician could see if the virus spread, destroying the mouse T-cells. If the technician were then to add the candidate “remedial” compound, he or she could see whether the virus triumphed by continuing to kill the T-cells, or the compound triumphed by preserving the T-cells. In November 1984, during Glaxo/Wellcome’s multiple tests of known compounds, the AZT compound produced surprisingly good results, appearing to eradicate completely the retrovirus in the mouse T-cells. It proved more potent than any other compound tested. In argument in this Court, counsel for Glaxo/Wellcome called this a “eureka moment”, but this seems to be something of an exaggeration. There had been no testing in a human cell line (in vitro) or in humans (in vivo). The object of the exercise was to eradicate HIV in humans, not a mouse virus in a petri dish.
12 It seems clear, and was found as a fact by the trial judge, that scientists at Glaxo/Wellcome and elsewhere recognized that the immune systems of humans and mice are sufficiently different that it is not possible to predict from studies in mouse cells how a drug would work, if at all, in humans. Senior members of the Glaxo/Wellcome team readily acknowledged the problem of predictability:
Dr. David Barry:
. . . we [do not] wish to indicate that sensitivity testing in [murine retrovirus] is in any way predictive of sensitivity of the Human AIDS Virus. We have generated a considerable amount of data to show that it is extremely unpredictive.
Dr. Sandra Nusinoff Lehrman:
Recent data would indicate that human retroviruses are sufficiently different from the [murine retroviruses]. . . . [T]he use of this compound for AIDS could not be predicted.
13 However, some of the Glaxo/Wellcome scientists testified that they believed as early as November 1984 that AZT would work in humans against the HIV retrovirus. On December 5, 1984, Dr. Jane Rideout, the team member who had recommended testing AZT, sent a note to the Glaxo/Wellcome patent group stating: “Ethically the MD’s at BW [Glaxo/Wellcome] cannot suppress the activity of such a compound for very long”. By that, she meant that HIV/AIDS sufferers should not be deprived of potential relief through unnecessary delay, scientific timidity, or corporate dithering. Work on a patent application began soon afterwards.
14 Dr. Rideout shared the view that further work was essential. She added, in her note to the Glaxo/Wellcome patent group, that a patent should only be pursued “if [AZT is] active against HIV” and “if all of this holds up [i.e., if activity is shown against HIV]” (emphasis added).
15 Glaxo/Wellcome was not equipped to undertake the more sophisticated testing required, and, given the lethal nature of HIV/AIDS, may not have been anxious to do so. It turned to a number of outside laboratories for screening compounds. These included Duke University and the Sloan-Kettering Institute whose work Glaxo/Wellcome partly funded. Testing of Glaxo/Wellcome candidate compounds was also done by the U.S. Food and Drug Administration and the National Cancer Institute of the U.S. National Institutes of Health (NIH). It should be emphasized that both of these U.S. government funded agencies were working for the benefit of the public, not Glaxo/Wellcome, in the search for a drug to combat what was emerging as a national health crisis.
16 The critical testing of the AZT compound was done by Drs. Samuel Broder and Hiroaki Mitsuya, both of the NIH, who were in the forefront of efforts to find medicines that could be used as treatments for AIDS. Their mandate was to use the public funds of the NIH to make AIDS therapies available to the public on an emergency basis. As Glaxo/Wellcome was using the NIH to test AZT, so NIH was using Glaxo/Wellcome and other pharmaceutical companies as suppliers of potentially useful compounds to be tested in the NIH program. Although NIH signed confidentiality agreements with Glaxo/Wellcome, as had other outside laboratories, the NIH did not, as had the private institutions, make an assignment to Glaxo/Wellcome of any intellectual property rights generated by work on Glaxo/Wellcome-supplied compounds.
17 The NIH screening was very sophisticated. Drs. Broder and Mitsuya had developed a human cell line (ATH8) that could propagate in vitro, be infected with HIV in vitro, and provide information relevant to the ability of candidate compounds to inhibit the replication of HIV in the T-cells of living patients. At the time, normal human T-cells were very difficult to grow in vitro. This work itself required exceptional inventive ingenuity and was eventually patented by the NIH under U.S. patent number 4,704,357.
18 By February 6, 1985, Glaxo/Wellcome had prepared a draft patent application. At that point, however, AZT had not been tested against HIV in vitro (i.e., in a petri dish), let alone administered to a human being in the context of the AIDS research.
19 In mid-February 1985, Drs. Broder and Mitsuya found that AZT did indeed inhibit HIV replication in their in vitro HIV assay system, thus vindicating Glaxo/Wellcome’s confidence (justified or not at the earlier date) in the potential benefits of AZT. This result was reported to Glaxo/Wellcome on February 21, 1985. At Dr. Broder’s request, the identity of the compound was disclosed to the NIH about March 1, 1985. He was surprised. He suspected the mystery compound was probably suramin, with which he was familiar.
20 On March 16, 1985, Glaxo/Wellcome filed in the United Kingdom the patent application from which the Canadian patent claims priority. The appellants contend that because AZT had not, at that time, been administered to patients with HIV or AIDS, crucial information regarding its bioavailability, pharmacokinetics, metabolic characteristics, activity and toxicity was not known. Before it could be known whether AZT could be used as a treatment for HIV in humans, the appellants say, Glaxo/Wellcome needed to know if AZT would be absorbed into the human blood stream, make its way to the T-cells infected with HIV, enter the T-cells and inhibit the reproduction of the HIV infection without proving toxic to other cells, and demonstrate clinical improvement in the patient.
21 The argument in support of the patent’s validity is that at least by March 1, 1985, when Glaxo/Wellcome received the results from the NIH showing AZT activity in vitro against HIV-infected human T-cells, it had a sound basis to predict all of these matters, and did so predict, and has been proven correct in that prediction by subsequent clinical experience. To have withheld disclosure of this new and very important use in a gathering international health crisis would have been, as Dr. Rideout noted back in December 1984, little short of irresponsible.
II. Relevant Statutory Provisions
22 Patent Act, R.S.C. 1985, c. P-4
interpretation
. . .
“invention” means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter;
application for patents
27. (1) Subject to this section, any inventor or legal representative of an inventor of an invention that was
(a) not known or used by any other person before he invented it,
(b) not described in any patent or in any publication printed in Canada or in any other country more than two years before presentation of the petition hereunder mentioned, and
(c) not in public use or on sale in Canada for more than two years prior to his application in Canada,
may, on presentation to the Commissioner of a petition setting out the facts, in this Act termed the filing of the application, and on compliance with all other requirements of this Act, obtain a patent granting to him an exclusive property in the invention.
specifications and claims
. . .
34. (1) An applicant shall in the specification of his invention
(a) correctly and fully describe the invention and its operation or use as contemplated by the inventor;
(b) set out clearly the various steps in a process, or the method of constructing, making, compounding or using a machine, manufacture or composition of matter, in such full, clear, concise and exact terms as to enable any person skilled in the art or science to which it appertains, or with which it is most closely connected, to make, construct, compound or use it;
. . .
(d) in the case of a process, explain the necessary sequence, if any, of the various steps, so as to distinguish the invention from other inventions; and
(e) particularly indicate and distinctly claim the part, improvement or combination that he claims as his invention.
refusal of patents
40. Whenever the Commissioner is satisfied that an applicant is not by law entitled to be granted a patent, he shall refuse the application and, by registered letter addressed to the applicant or his registered agent, notify the applicant of the refusal and of the ground or reason therefor.
form and term of patents
45. Every patent granted under this Act shall be issued under the signature of the Commissioner and the seal of the Patent Office, shall bear on its face the date on which it is granted and issued and shall thereafter, in the absence of any evidence to the contrary, be valid and avail the grantee and his legal representatives for the term mentioned therein.
legal proceedings in respect
of patents
53. (1) A patent is void if any material allegation in the petition of the applicant in respect of the patent is untrue, or if the specification and drawings contain more or less than is necessary for obtaining the end for which they purport to be made, and the omission or addition is wilfully made for the purpose of misleading.
(2) Where it appears to a court that the omission or addition referred to in subsection (1) was an involuntary error and it is proved that the patentee is entitled to the remainder of his patent, the court shall render a judgment in accordance with the facts, and shall determine the costs, and the patent shall be held valid for that part of the invention described to which the patentee is so found to be entitled.
III. Case History
A. Federal Court, Trial Division (1998), 145 F.T.R. 161
23 Wetston J., in a detailed, comprehensive and thoughtful judgment, following 60 days of trial, began with the proposition that a patent is available for a new use for a known compound: Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536. Moreover, the patent in this case does not make a claim to a method of medical treatment, which would be invalid: Tennessee Eastman Co. v. Commissioner of Patents, [1974] S.C.R. 111. With respect to inventorship, Wetston J. considered the degree and type of testing required to establish utility. The “act of inventing may be different in different circumstances. . . . The range of expertise required in the pharmaceutical field, the nuances between theoretical and clinical proof, and the underlying public policy concerns of the safe and effective development of medicines, all serve to make utility in the pharmaceutical area highly complex” (para. 84).
24 Wetston J. found the insistence of Apotex and Novopharm on regulatory levels of safety to be “excessive” and “too high a standard” (para. 105). On the other hand, he rejected the applicability of the doctrine of sound prediction, which he considered was limited to the situation where inventors claim a number of untested compounds based on the proven utility of one or more compounds.
25 He concluded that utility was not shown as of the February 6, 1985 draft application date. At that time there was no more than a belief that AZT “might be useful” to treat AIDS, and the claims at that date exceeded the invention. By March 16, 1985, however, the patent met the s. 2 requirements and did not exceed the invention claimed. The Glaxo/Wellcome researchers had received the initial NIH data showing that AZT was active in arresting the HIV retrovirus in human cells.
26 On the co-inventorship issue, Wetston J. cited Burroughs Wellcome Co. v. Barr Laboratories Inc., 32 U.S.P.Q. 2d 1915 (Fed. Cir. 1994), where it was observed that Drs. Broder and Mitsuya of the NIH were not a mere “pair of hands”. They exercised “considerable skill” and were “uniquely qualified”. They were given little instruction by Glaxo/Wellcome. In fact, Glaxo/Wellcome did not have the expertise to be able to instruct the NIH researchers in this regard. Wetston J. concluded that although all the five named Glaxo/Wellcome inventors were properly included, the NIH researchers were highly skilled “collaborators” and co-inventors on the utility aspect and should not have been omitted from the application: “the utility as claimed was not established without the extensive and direct involvement of the NIH. . . . In my opinion, the work of the NIH was not ancillary to the invention and this invention would not have been complete without their investigation, skill and research” (paras. 224 and 226). Nevertheless, the failure to name co-inventors in this case was not “material” under s. 53(1) of the Patent Act , and the omission therefore did not render the patent invalid.
27 As to the claim for prophylaxis (as opposed to treatment), Wetston J. concluded that the claims were not broader than the invention or the disclosure, although the claim “for the treatment or prophylaxis of all human retroviral infections [was] overbroad” and speculative (para. 303 (emphasis added)). Wetston J. adjudged several of the claims to be invalid, but the remaining valid claims were infringed by the appellants’ manufacture and sale of the generic version of AZT (para. 377).
B. Federal Court of Appeal, [2001] 1 F.C. 495 (Rothstein, Sexton and Malone JJ.A. each writing part of a unitary set of reasons)
1. Sexton J.A.
(a) Co-Inventorship and Section 53 on Material Misrepresentation
28 Sexton J.A. reversed the trial judge’s conclusion on NIH co-inventorship and found that the facts demonstrated that Drs. Broder and Mitsuya do not satisfy the legal definition of inventorship. The subject matter of the invention was conceived without their assistance. They agreed only to test an unknown substance on Glaxo/Wellcome’s behalf. That people other than the inventors perform the tests does not make them “inventors”.
29 Sexton J.A. concluded that February 6, 1985 may be the relevant date of invention, since by that point the draft patent application had been distinctly formulated; however, he declined to choose between February 6, 1985 (draft application) or March 16, 1985 (priority date) because in either event the patent was valid.
30 Although he did not find it necessary to address s. 53 given the conclusions on co-inventorship, Sexton J.A. agreed that failure to name an inventor is not a violation of s. 53.
(b) Utility and Date of Completion of Invention
31 Sexton J.A. was of the view that the date of invention can, in effect, be backdated where speculation at the time of invention is subsequently confirmed by the time the patent is attacked. Sexton J.A. offers an analogy with the Wright brothers, suggesting that it would be “illogical” if a hypothetical patent for a heavier-than-air flying machine, considered by critics at the time to be based on an unsound prediction, could not be upheld on the basis of post-patent evidence that the invention actually works. Any other approach would require a court to close its eyes as to “continuing scientific advancements” (para. 52). The attack on the validity of the patent on this ground, too, should be rejected.
2. Malone J.A.
32 Malone J.A. upheld the trial judge on obviousness, novelty, ambiguity, and sufficiency of disclosure.
3. Rothstein J.A.
33 Rothstein J.A. agreed with the trial judge that the invention here is a new use for a known compound and not a method of medical treatment. However, only those claims relating to the use of the known compound are patentable and not those which purport to include the compound formulation itself. Accordingly, claim No. 1 and those dependent on it were struck down.
34 With respect to prophylaxis, Rothstein J.A. held that there was evidence that AZT could prevent fetal transmission of HIV from pregnant women and arrest infections received by health care workers and others stuck with contaminated needles. This, in his view, demonstrated some prophylactic properties and the fact the information was not available until years after the patent was not relevant. “[T]he time at which usefulness is to be established is when required by the Commissioner of Patents or in court proceedings when the validity of the patent is challenged on that ground. There was such evidence before Wetston J. . . .” (para. 93). Rothstein J.A. thus concluded that the claims for the prophylactic use of AZT against AIDS are valid.
IV. Analysis
35 AZT has earned for the respondents hundreds of millions of dollars in worldwide sales since its usefulness was discovered for the treatment of HIV and AIDS. In the United States alone, it is estimated that AZT earned for the patent owner a profit of $592 million between 1987 and 1993: J. Yardley, “Industry Giant Owns Right to AIDS Drug? N.C. Trial to Decide”, Atlanta Constitution, June 27, 1993, at p. A4, quoted in Case Comment, “Patent Law — Pharmaceuticals — Federal Circuit Upholds Patents for AIDS Treatment Drug — Burroughs Wellcome Co. v. Barr Laboratories, Inc., 40 F.3d 1223 (Fed. Cir. 1994)” (1995), 108 Harv. L. Rev. 2053, at note 17.
36 It is not surprising that the appellants, being generic drug manufacturers, would like to obtain at least a percentage of the AZT market in Canada. To do so they must somehow have the patent declared invalid. Yet their challenge, understandably motivated by the hope of private profit, raises broader issues of public interest.
37 A patent, as has been said many times, is not intended as an accolade or civic award for ingenuity. It is a method by which inventive solutions to practical problems are coaxed into the public domain by the promise of a limited monopoly for a limited time. Disclosure is the quid pro quo for valuable proprietary rights to exclusivity which are entirely the statutory creature of the Patent Act . Monopolies are associated in the public mind with higher prices. The public should not be expected to pay an elevated price in exchange for speculation, or for the statement of “any mere scientific principle or abstract theorem” (s. 27(3) ), or for the “discovery” of things that already exist, or are obvious. The patent monopoly should be purchased with the hard coinage of new, ingenious, useful and unobvious disclosures. The appellants’ argument here is that the identification in March of 1985 of AZT as a treatment and prophylaxis for HIV/AIDS was a shot in the dark, a speculation based on inadequate information and testing, a lottery ticket for which the public in general and HIV and AIDS sufferers in particular have paid an exorbitant price. AZT works, but for reasons both unknown and unknowable by Glaxo/Wellcome at the time it filed its patent application, the appellants argue. A lucky guess is not, they say, patentable.
38 Furthermore, if credit is to be given, the appellants argue, it should go to Drs. Broder and Mitsuya at the NIH who actually established the utility of AZT in human T-cells. If the patent on AZT was owned by the NIH or even by a co-ownership of Glaxo/Wellcome and the NIH, they say, the commercial history of AZT would have been vastly more oriented to the public interest.
39 The public interest arguments were not advanced in the