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Matched Legal Cases: ['art 11', 'UKHL ', 'EWCA ', '§103', 'EWCA ', 'EWCA ', 'UKHL ', 'EWCA ', 'EWCA ']

Apotex Inc v Sanofi-Synthelabo Canada Inc [SCC]
File No. 31881
IpsofactoJ.com: International Cases [2008] Part 11 Case 6 [SCC]
Sanofi‑Synthelabo Canada Inc.
This appeal raises questions relating to the validity of what are known as selection patents. In the context of chemical compounds, in general terms, a selection patent is one whose subject matter (compounds) is a fraction of a larger known class of compounds which was the subject matter of a prior patent.
The appellant (“Apotex”) challenges the validity of the selection patent in this case on the grounds of anticipation, obviousness and double patenting. I would dismiss the appeal.
The parties have accepted that the Sanofi respondents (“Sanofi”) are the relevant holders of patent 1,194,875 (‘875 patent). This patent disclosed a genus or class of compounds useful in inhibiting platelet aggregation activity in the blood which is important in treating coronary artery, peripheral vascular and cerebral vascular diseases. This genus patent discloses over 250,000 possible different compounds useful for this purpose. One of the compounds is a racemate described as methyl alpha–5 (4, 5, 6, 7–tetrahydro (3, 2–c)–thieno pyridyl) (2–chlorophenyl)–acetate (the “racemate”).
The parties have accepted that Sanofi is also the relevant holder of subsequent Canadian patent 1,336,777 (‘777 patent), the patent in suit. It discloses and claims clopidogrel bisulfate, which is marketed by Sanofi under the trade name of Plavix as an anti-coagulant that inhibits platelet aggregation activity in the blood.
Clopidogrel bisulfate is encompassed within the scope of the claims in the ‘875 patent. Clopidogrel is the dextro-rotatory isomer of the racemate, having beneficial properties over both the racemate and the levo-rotatory isomer. The dextro-rotatory isomer exhibits a platelet aggregation inhibiting activity and is less toxic and better tolerated than the levo-rotatory isomer and racemate. The salts of the dextro-rotatory isomer, such as clopidogrel bisulfate, have a better therapeutic index than the salts of the racemic mixture and in fact, the levo-rotatory isomer exhibits almost no platelet aggregation inhibiting activity, and its toxicity is markedly higher than that of the dextro-rotatory isomer.
On March 10, 2003, Apotex served a Notice of Allegation under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (“NOC Regulations”), on Sanofi for the purpose of obtaining a Notice of Compliance pursuant to section C.08.004 of the Food and Drug Regulations, C.R.C. 1978, c. 870, from the Minister of Health for a generic version of Plavix. The basis of Apotex’s Notice of Allegation was that it would not infringe Sanofi’s ‘777 patent for Plavix because the ‘777 patent was invalid on account of anticipation, obviousness and double patenting. On April 28, 2003, Sanofi initiated proceedings under s. 6(1) of the NOC Regulations in the Federal Court seeking an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex on the grounds that its generic version of Plavix would infringe the ‘777 patent. The Federal Court granted the order of prohibition ((2005), 271 F.T.R. 159, 2005 FC 390). The Federal Court of Appeal dismissed Apotex’s appeal ((2006), 282 D.L.R. (4th) 179, 2006 FCA 421).
This appeal requires the Court to determine whether selection patents are invalid in principle or on the facts of this case on the grounds of anticipation, obviousness and double patenting.
While not exhaustively defining a selection patent, he set out (at pp. 322-23) three conditions that must be satisfied for a selection patent to be valid.
Although much has been written about selection patents since I. G. Farbenindustrie, Maugham J.’s analysis is consistently referred to and is well accepted. I find it is a useful starting point for the analysis to be conducted in this case.
At the outset, it is appropriate to refer to the words of Judson J. for this Court in Commissioner of Patents v Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Braning, [1964] S.C.R. 49, at p. 57:
The most recent reference to the law of patents being wholly statutory are the words of Lord Walker in Synthon B.V. v SmithKline Beecham plc, [2006] 1 All E.R. 685, [2005] UKHL 59, at paras. 57-58:
The law of patents is wholly statutory, and has a surprisingly long history. In the interpretation and application of patent statutes judge-made doctrine has over the years done much to clarify the abstract generalities of the statutes and to secure uniformity in their application.
The procedure under the NOC Regulations pursuant to which a manufacturer of drugs may apply to the Minister of Health for a Notice of Compliance is well known. A manufacturer, usually a generic manufacturer, wishes to compare its drug with that of a patent holder for which a patent list has been submitted to the Minister by the patent holder. The generic manufacturer’s purpose is to establish the safety and efficacy of its drug for the purposes of securing marketing approval from the Minister. The process of comparison saves the generic competitor time and resources. However, the Minister will not issue a Notice of Compliance unless the patent on the comparator drug has expired, is invalid, or the generic’s product will not otherwise infringe the patent. Thus the NOC Regulations create a connection between government approval to market a generic drug and the issue of patent validity and infringement.
Section 5(1)(b) of the NOC Regulations states that the generic manufacturer, in its submission for a Notice of Compliance, may allege that the patent has expired, is not valid or will not be infringed. The patent holder may then apply to the Federal Court for an order prohibiting the Minister from issuing a Notice of Compliance to the generic manufacturer until after expiration of the patent that is the subject of the Notice of Allegation. The court will grant the prohibition order if it finds that the allegation of invalidity, expiry or non-infringement is not justified. If it finds the allegation justified, it will dismiss the application for prohibition and the Minister may then issue a Notice of Compliance to the generic manufacturer if all other requirements are met.
The NOC Regulations do not provide guidance about how an allegation of “not valid” as stated in s. 5(1)(b)(iii) is to be considered and determined by the court. For this purpose, reference must be made to the relevant version of the Patent Act, which is R.S.C. 1985, c. P-4, applicable to patent applications filed prior to October 1, 1989.
The application for the ‘875 patent was filed in 1983. The patent was issued in 1985 and expired in 2002. The application for the ‘777 patent was filed in 1988. The patent was issued in 1995 and unless found to be invalid, will expire in 2012.
The use of the term “not valid” in s. 5 of the NOC Regulations parallels what would otherwise be a defence to an infringement action referred to in s. 59 of the Act:
For purposes of anticipation, it is necessary to have regard to s. 27 of the Act which sets forth the basic conditions necessary for obtaining a patent. The invention must not have been previously known or used nor described in any patent or other publication printed in any country more than two years before the filing of the patent application and must not have been in public use or sale in Canada more than two years prior to the filing of the patent application. Section 27(1) provided:
may, on presentation to the Commissioner of a petition setting out the facts, in this Act, termed the filing in the application, and on compliance with all other requirements of this Act, obtain a patent granting to him an exclusive property in the invention.
It is with s. 27 in mind that the law of anticipation must be considered. Apotex’s arguments based on anticipation are not that the applications judge erred in his analysis of the law of anticipation or its application to the facts of this case. Rather, Apotex implies that the current understanding of the law sets the bar for proving anticipation too high and that the acceptance of a system of genus and selection patents necessarily, or at least on the facts of this case, involves anticipation and therefore invalidity. I would reject the broader objection. A system of genus and selection patents is acceptable in principle, on the line of authority stemming from I. G. Farbenindustrie. The real question is whether, on the facts of this case, the particular selection patent has been anticipated.
In his reasons after referring to s. 27(1) of the Act, the applications judge defined anticipation as meaning “that the exact invention has already been made and publicly disclosed” (para. 55). Shore J. cited this Court’s decision in Free World Trust v —lectro Sant— Inc., [2000] 2 S.C.R. 1024, 2000 SCC 66, at para. 26, which approved of the test for anticipation described in Beloit Canada Ltd. v Valmet OY (1986), 8 C.P.R. (3d) 289 (F.C.A.), at p. 297:
One must, in effect, be able to look at a prior, single publication and find in it all the information which for practical purposes, is needed to produce the claimed invention without the exercise of any inventive skill. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and without possibility of error be lead to the claimed invention.
[emphasis added by the applications judge]
The applications judge noted that the English Court of Appeal stated in General Tire & Rubber Co. v Firestone Tyre & Rubber Co., [1972] R.P.C. 457, at p. 486:
If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated, although it may fail on the ground of obviousness. To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented.
He then noted that in Free World, at para. 26, this Court approved the following statement from General Tire (p. 486):
The law of anticipation as explained in Beloit and General Tire has been accepted in Canada without reservation: see Free World, at para. 26. In his application of the law to the facts, there is no doubt that Shore J. was using the test as set out in Beloit when he stated, at para. 57:
In the 2005 decision of the House of Lords in Synthon, Lord Hoffmann has brought some further clarity to the law of anticipation as understood since General Tire. His reference at para. 20 to the “unquestionable authority” of Lord Westbury in Hills v Evans (1862), 31 L.J. Ch. (N.S.) 457, at p. 463, makes it plain that his analysis does not depend on any change on English law flowing from the enactment of the Patents Act 1977 (U.K.), 1977, c. 37, or the U.K.’s adoption of the Convention on the Grant of European Patents, 1065 U.N.T.S. 199 (entered into force October 7, 1977). He distinguishes between two requirements for anticipation that were not theretofore expressly considered separately, prior disclosure and enablement.
He explains that the requirement of prior disclosure means that the prior patent must disclose subject matter which, if performed, would necessarily result in infringement of that patent, and states, at para. 22:
If I may summarise the effect of these two well-known statements [from General Tire and Hills v Evans], the matter relied upon as prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent .... It follows that, whether or not it would be apparent to anyone at the time, whenever subject matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied.
If the disclosure requirement is satisfied, the second requirement to prove anticipation is “enablement” which means that the person skilled in the art would have been able to perform the invention (para. 26). Lord Hoffmann held that the test for enablement for purposes of anticipation was the same as the test for sufficiency under the relevant United Kingdom legislation. (Enablement for the purposes of sufficiency of the patent specification under the Canadian Patent Act, s. 34(1)(b) of the pre-October 1, 1989 Act, now s. 27(3)(b), is not an issue to be decided in this case and my analysis of enablement is solely related to the test for anticipation. The question of whether enablement for purposes of sufficiency is identical in Canada is better left to another day.)
The Beloit decision by which the applications judge rightly felt bound dealt with only one aspect of anticipation, that is, whether or not the invention in a patent had been disclosed in a single prior publication or patent. In that decision, Hugessen J.A. held that it had not. He had no need to consider the further point whether or not, had there been such a clear disclosure, the working of the invention was also enabled by that disclosure. That point was not in issue in Beloit. Explicitly separating disclosure and enablement is a refinement of the approach set out in Beloit. It explains the process a person skilled in the art would follow if the original patent anticipated the invention of the subsequent patent. I would adopt this approach.
Subject to any limitations expressed in the Patent Act, I see no reason why the discussion of anticipation should not apply to other prior art than merely genus patents. Again, subject to limitations in the Patent Act, the discussion of anticipation and obviousness would seem applicable to patents generally.
Two questions now must be answered:
what constitutes disclosure at the first stage of the test for anticipation, and
how much trial and error or experimentation is permitted at the enablement stage?
Section 27(1) of the Act requires as a condition for obtaining a patent that the invention was not “known or used” and was not “described” in any patent or any publication more than two years before the patent application was filed. In the context of genus and selection patents, in E. I. Du Pont de Nemours & Co. (Witsiepe’s) Application, [1982] F.S.R. 303 (H.L.), Lord Wilberforce stated, at p. 311:
In the context of disclosure as explained in Synthon, “the absence of the discovery of the special advantages” to which Lord Wilberforce was referring in Witsiepe’s means that the genus patent does not disclose the special advantages of the invention covered by the selection patent. Where there is no such disclosure, there is no discovery of the special advantages of the selection patent as compared to the genus patent, and the disclosure requirement to prove anticipation fails. At this stage, the person skilled in the art is reading the prior patent to understand whether it discloses the special advantages of the second invention. No trial and error is permitted. If in reading the genus patent the special advantages of the invention of the selection patent are not disclosed, the genus patent does not anticipate the selection patent.
What amount of trial and error or experimentation is permitted before a prior disclosure will not constitute enabling disclosure? Certainly, if the applications judge finds that an inventive step was required to get to the invention of the second patent, the specification of the first patent will not have provided enabling disclosure. But even if no inventive step is required, the skilled person must still be able to perform or make the invention of the second patent without undue burden.
Two recent United Kingdom decisions are of assistance. In Halliburton Energy Services Inc. v Smith International (North Sea) Ltd., [2006] EWCA Civ 1715, Jacob L.J., a highly experienced patent judge, states at para. 18:
Patents are meant to teach people how to do things. If what is “taught” involves just too much [work] to be reasonable allowing for all the circumstances including the nature of the art, then the patent cannot be regarded as an “enabling disclosure.” .... The setting of a gigantic project, even if merely routine, will not do.
Jacob L.J. characterizes the problem at para. 20 as: “[H]ow is one to say when the work involved to perform the invention is too much?” The determination of how much work is too much is inevitably a line-drawing exercise. His answer to the problem is at para. 21:
A more extensive review of the law of enablement as defined in Synthon is contained in a decision of Kitchin J. in Wobben v Vestas-Celtic Wind Technology Ltd., [2007] EWHC 2636 (Pat.), at paras. 196-97. Although Wobben was a case in which the alleged infringer raised as one of its defences insufficiency under the United Kingdom legislation, I think guidance is provided as to what will or will not constitute enablement for purposes of anticipation.
The ‘875 genus patent covered over 250,000 possible different compounds. Obviously, every compound was not made or tested. The patent covering those compounds was based on sound prediction. From the specification, it is apparent that 21 examples were made and tested, one of which was the racemate relevant in this case. According to the applications judge, there was no disclosure in the ‘875 patent of the specific beneficial properties associated with the dextro-rotatory isomer of this racemate, nor was there disclosure of any advantages which flow from using the bisulfate salt in combination with the dextro-rotatory isomer (para. 71).
It was open to Shore J. on the record before him to conclude that a person skilled in the art and reading the ‘875 patent would not be able to come up with the invention of the ‘777 patent. Nothing in the ‘875 patent distinguished this dextro-rotatory isomer as having beneficial properties different from the racemate or the levo-rotatory isomer or from any of the other compounds made and tested and referred to in the ‘875 patent, let alone the compounds based only on sound prediction. At para. 72 of his reasons, he found:
There was no evidence that the person skilled in the art would know from reading the ‘875 patent that the more active dextro-rotatory isomer would be less toxic than the racemate or levo-rotatory isomer or any of the other compounds made and tested. Indeed, Dr. McClelland’s evidence was that while you “often” get more activity by separating isomers, the answer to the question whether this increased activity was to be found in the levo‑rotatory isomer or the dextro‑rotatory isomer was unknown. (Affidavit, at para. 42, and cross-examination, at pp. 928-30 and question 322).
Since the ‘875 patent did not disclose the special advantages of the dextro-rotatory isomer and of its bisulfate salt, as compared to the levo-rotatory isomer or the racemate and their salts, or the other compounds made and tested or otherwise referred to in the ‘875 patent, the invention of the ‘777 patent cannot be said to have been disclosed and therefore it cannot be said to have been anticipated.
It is not strictly necessary to discuss enablement since anticipation requires proof of both disclosure and enablement, and disclosure has not been proven. However, for future guidance, I would make the following few observations about enablement on the facts of this case.
The applications judge was of the opinion that “the skilled reader following the prior art must be able to arrive at the invention claimed in the impugned patent the first time he or she tries and every time thereafter” (para. 65 (emphasis in original)). However, under the test for enablement as described in these reasons, some trial and error is permitted.
However, Apotex argues that the methods for separating the isomers were well known to persons skilled in the art at the time of the invention. According to Apotex, such a person could eventually obtain the isomer through what amounts to routine tests.
In determining whether the enablement step for proving anticipation has been met, it is important to note that routine trials are acceptable but inventive steps are not permitted. Also, reasonable skill and knowledge of the art is expected in order to correct omissions in the original patent if a means of determining what is missing can readily be found. The skilled person may use his or her common general knowledge to supplement information contained in the patent.
Even though Shore J. referred to the excessively stringent anticipation test “in every case”, his findings are relevant to trial and error. He found that the evidence with respect to the methods of separation, including the evidence of the inventor, shows that the identification of clopidogrel, its bisulfate salt and their advantageous properties required extensive investigation over a period of months (paras. 68-70).
One might infer that, had the applications judge been asked to decide if these investigations constituted an undue burden for the skilled person, he would have held that they did. However, in view of my earlier conclusion on disclosure, it is unnecessary for me to pursue this point further.
As indicated above, in the context of anticipation, the two-step approach, disclosure and enablement, is a refinement of the approach set out in Beloit and should be adopted.
In the case at bar, the invention of the ‘777 patent was not disclosed by the ‘875 patent and was therefore not anticipated. The allegation of anticipation has not been justified.
The definition of invention in s. 2 of the Act is relevant because at the time the pre-October 1, 1989 version of the Act was in force, there was no statutory provision expressly providing that obvious inventions were unpatentable. As explained by Professor D. Vaver in Intellectual Property Law: Copyright, Patents, Trade-marks (1997), at p. 136:
“invention” means any new and useful .... composition of matter, or any new and useful improvement in any .... composition of matter.
Shore J. first correctly observed that at the relevant time obviousness was not mentioned expressly in the Act. He then (para. 75) cited the well-known test for obviousness in Beloit (at p. 294):
The applications judge accepted that there were five well-known separation techniques in order to obtain the dextro-rotatory isomer of the racemate. At para. 80, he stated:
.... what the experts are really saying from a legal perspective is that separating the racemate was worth a try. Having to try different methods, though they be well-known, in order to discover which one will yield the desired result cannot mean that the desired result, in this case, the compounds in claims 1 and 3 and their pharmaceutical compositions, was obvious.
He further held that the dextro-rotatory isomer and its salts had to be tested for their beneficial properties to be discovered and that the isomer and its beneficial properties were therefore not known before the racemate was separated into its isomers. He stated, at para. 81:
Apotex says that the Beloit approach is excessively rigid and is out of step with the tests for obviousness in the United Kingdom and the United States, where “worth a try” has been accepted.
Generally, in the United States, it appears that at the Court of Appeals level, the “obvious to try” test had not been accepted. In Application of Tomlinson, 363 F.2d 928 (C.C.P.A. 1966), Rich J. wrote, at p. 931:
Slight reflection suggests, we think, that there is usually an element of “obviousness to try” in any research endeavour, that is not undertaken with complete blindness but rather with some semblance of a chance of success, and that patentability determinations based on that as the test would not only be contrary to statute but result in a marked deterioration of the entire patent system as an incentive to invest in those efforts and attempts which go by the name of “research”.
However, in KSR International Co. v Teleflex Inc., 127 S. Ct. 1727 (2007), Kennedy J., for a unanimous court, rejected the restrictive approach that the Court of Appeals had taken in that case. He stated, at p. 1739:
Throughout this Court’s engagement with the question of obviousness, our cases have set forth an expansive and flexible approach inconsistent with the way the Court of Appeals applied its TSM [Teaching-Suggestion-Motivation] test here. To be sure, Graham recognized the need for “uniformity and definiteness”. Yet the principles laid down in Graham reaffirmed the “functional approach” of Hotchkiss. To this end, Graham set forth a broad inquiry and invited courts, where appropriate, to look at any secondary considerations that would prove instructive.
At p. 1742, he was clear that “obvious to try” could be a relevant test in an obviousness inquiry:
The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”. .... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.
In the United Kingdom the “obvious to try” test has been accepted since at least 1967: see Johns‑Manville Corporation’s Patent, [1967] R.P.C. 479 (C.A.). The current state of the law in the United Kingdom was summarized in Generics (UK) Ltd. v H. Lundbeck A/S, [2008] R.P.C. 19, [2008] EWCA Civ 311. Lord Hoffmann stated the following, at paras. 24-25, in response to the argument that the trial judge in that case, Kitchin J., had refused to consider the “obvious to try” test:
[The trial judge] cited from Angiotech Pharmaceuticals Inc. v Conor Medsystems Inc. [2007] R.P.C. 20, which represents this [Court of Appeal’s] last word on the extent to which the notion of some step being obvious to try is helpful in deciding whether an invention is obvious. The judge then summed up (at para. 72) the current state of the law:
No criticism has been made of this statement of principle ....
See also Angiotech Pharmaceuticals Inc. v Conor Medsystems Inc., [2007] R.P.C. 20, [2007] EWCA Civ 5, at para. 45, rev’d [2008] R.P.C. 28, [2008] UKHL 49. The passage at para. 45 in the decision of the Court of Appeal remains relevant and uncontested.
There is a similarity between the current state of the law in the United Kingdom and the United States in respect of “obvious to try”. It is now clear that both jurisdictions accept that an “obvious to try” test can be relevant in an obviousness inquiry. The United States Supreme Court has now stated so explicitly in KSR. The convergence of the United Kingdom and the United States law on this issue suggests that the restrictiveness with which the Beloit test has been interpreted in Canada should be re-examined.
I take as a starting point the words of Diplock L.J. in Johns-Manville, at pp. 493-94:
Although we are not here dealing with obviousness provided by an express statutory test, but rather by necessary implication based on the requirement for invention in the Patent Act, the words of Diplock L.J. are nonetheless apt because the courts have often tended to treat the word formulation of Beloit as if it were a statutory prescription that limits the obviousness inquiry.
I do not think that Hugessen J.A. in Beloit intended that the rather colourful description of obviousness that he coined be applied in an acontextual manner applicable to all classes of claims. I note particularly that “obvious to try” is not a mandatory test in the United Kingdom or in the United States. It is one factor of a number that should be considered, having regard to the context and the nature of the invention.
In KSR, Kennedy J. warns against an overly rigid rule that limits the obviousness inquiry. Rather, an expansive and flexible approach that would include “any secondary considerations that [will] prove instructive” will be useful (p. 1739). I read KSR as teaching that as in most matters in which a judge or a jury is called upon to make a factual determination, rigid rules are inappropriate unless mandated by statute.
While I do not think the list is exhaustive, the factors set forth by Kitchin J. and adopted by Lord Hoffmann in Lundbeck, referred to at para. 59 of these reasons, are useful guides in deciding whether a particular step was “obvious to try”. However, the “obvious to try” test must be approached cautiously. It is only one factor to assist in the obviousness inquiry. It is not a panacea for alleged infringers. The patent system is intended to provide an economic encouragement for research and development. It is well known that this is particularly important in the field of pharmaceuticals and biotechnology.
In Saint-Gobain PAM SA v Fusion Provida Ltd., [2005] EWCA Civ 177, Jacob L.J. stated, at para. 35:
It will be useful in an obviousness inquiry to follow the four-step approach first outlined by Oliver L.J. in Windsurfing International Inc. v Tabur Marine (Great Britain) Ltd., [1985] R.P.C. 59 (C.A.). This approach should bring better structure to the obviousness inquiry and more objectivity and clarity to the analysis. The Windsurfing approach was recently updated by Jacob L.J. in Pozzoli SPA v BDMO SA, [2007] F.S.R. 37, [2007] EWCA Civ 588, at para. 23:
In areas of endeavour where advances are often won by experimentation, an “obvious to try” test might be appropriate. In such areas, there may be numerous interrelated variables with which to experiment. For example, some inventions in the pharmaceutical industry might warrant an “obvious to try” test since there may be many chemically similar structures that can elicit different biological responses and offer the potential for significant therapeutic advances.
If an “obvious to try” test is warranted, the following factors should be taken into consideration at the fourth step of the obviousness inquiry. As with anticipation, this list is not exhaustive. The factors will apply in accordance with the evidence in each case.
For example, if the inventor and his or her team reached the invention quickly, easily, directly and relatively inexpensively, in light of the prior art and common general knowledge, that may be evidence supporting a finding of obviousness, unless the level at which they worked and their knowledge base was above what should be attributed to the skilled person. Their course of conduct would suggest that a skilled person, using his/her common general knowledge and the prior art, would have acted similarly and come up with the same result. On the other hand, if time, money and effort was expended in research looking for the result the invention ultimately provided before the inventor turned or was instructed to turn to search for the invention, including what turned out to be fruitless “wild goose chases”, that evidence may support a finding of non-obviousness. It would suggest that the skilled person, using his/her common general knowledge and the prior art, would have done no better. Indeed, where those involved including the inventor and his or her team were highly skilled in the particular technology involved, the evidence may suggest that the skilled person would have done a lot worse and would not likely have managed to find the invention. It would not have been obvious to him/her to try the course that led to the invention.
Applying the four steps of Windsurfing/Pozzoli, I accept the applications judge’s findings of fact where they are unaffected by his rejection of the “obvious to try” test. Where application of the obvious to try test requires further consideration of the evidence, it will be necessary for this Court to make some findings of fact. In this case, I think it is preferable to remitting the matter to the trial judge for redetermination and subjecting his decision to further possible appeals.
Apotex filed its Notice of Allegation in 2002. It is now some six years later. If the ‘777 patent is invalid, and provided all other requirements are met, Apotex should be entitled to a Notice of Compliance from the Minister without any further delay. Indeed, the NOC Regulations are intended to be a summary procedure. I think it is time that this matter finally be resolved. I would conduct the following analysis:
Both parties agreed that a trained pharmachemist is that person.
Apotex reiterates its submissions made with respect to anticipation, insisting that, since the methods of separation were well known, the claimed invention and its advantages would have been obvious to the person skilled in the art. Shore J. found on the evidence before him that there were five well-known methods to separate this racemate into its isomers. However, he did not find that the relative advantage of the dextro-rotatory isomer would have been known by the skilled person.
The construction of the claims in the ‘777 patent is not an issue. It is agreed that they constitute the dextro-rotatory isomer of the racemate and its pharmaceutically acceptable salts and processes for obtaining them.
In the present case, it is apparent that the inventive concept of the claims in the ‘777 patent is a compound useful in inhibiting platelet aggregation which has greater therapeutic effect and less toxicity than the other compounds of the ‘875 patent and the methods for obtaining that compound.
The ‘875 patent disclosed over 250,000 possible different compounds predicted to inhibit platelet aggregation. Twenty-one compounds were made and tested. Nothing distinguishes the racemate in this case from other compounds disclosed or tested in terms of therapeutic effect or toxicity. As stated above, there is no disclosure in the ‘875 patent of the specific beneficial properties associated with the dextro‑rotatory isomer of this racemate in isolation; nor was there disclosure of any advantages which flow from using the bisulfate salt of the dextro‑rotatory isomer. The ‘875 patent did not differentiate between the properties of the racemate, its dextro-rotatory isomer and levo-rotatory isomer or indeed the other compounds made and tested or predicted to work.
On the other hand, the ‘777 patent claims that the invention of the dextro‑rotatory isomer of the racemate, clopidogrel, and its bisulfate salt discloses their beneficial properties over the levo‑rotatory isomer and the racemate and expressly describes how to separate the racemate into its isomers.
At this stage, it must be determined whether the nature of the invention in this case is such as to warrant an “obvious to try” test. The discovery of the dextro-rotary isomer and its bisulfate salt came after experimentation. There were interrelated variables with which Mr. Badorc had to experiment. An “obvious to try” test in this case would recognize the evidence of the expert witnesses as to the discovery of the beneficial properties of the dextro-rotary isomer and its bisulfate salt and the methods for finding them.
The applications judge cannot be faulted for the analysis he conducted as far as it went. However, he erred in not allowing for the application of the “obvious to try” test, which is warranted in this case.
The following factors are therefore relevant at this fourth step of the obviousness inquiry:
As I have observed earlier, Shore J. found that the skilled person would not know, before separating this particular racemate into its isomers and then testing the separated isomers, that the properties of the dextro‑rotatory isomer would be different from the properties of the racemate or the levo‑rotatory isomer (para. 81). Similarly, he found that the person skilled in the art would not know before trying the different salts in combination with the dextro‑rotatory isomer what the bisulfate salt’s beneficial properties would be (para. 82).
Just because there are known methods of separating a racemate into its isomers does not mean that a person skilled in the art would necessarily apply them. The fact that there are such known methods of separation will be of no account if the evidence does not prove that it was more or less self-evident to try them. It is true that at the relevant time there was evidence that a skilled person would know that the properties of a racemate and its isomers might be different. However, a possibility of finding the invention is not enough. The invention must be self-evident from the prior art and common general knowledge in order to satisfy the “obvious to try” test. That is not the evidence in this case.
As indicated, the applications judge found that there were five well-known techniques for separating this racemate into its isomers. He also found that there was no evidence that at the relevant time, a person skilled in the art would know which one would work with the racemate at issue in this case. The evidence was that a skilled person would eventually find the right technique.
As earlier indicated, Shore J. also found that there was no evidence that at the relevant time a person skilled in the art would know before separating the racemate and testing the isomers what their properties would be, although the specific properties of the isomers could be discovered. There was evidence that, using known techniques, the properties of different pharmaceutically acceptable salts to be used with the dextro-rotatory isomer could be discovered.
However, in considering whether it was “obvious to try” to find the invention, once it was decided to isolate the dextro-rotatory isomer, the methods for doing so were known, the methods for testing the properties of the isomers were known and the method for determining the beneficial properties of the salts to be used with the isomer would also have been known.
According to Mr. Badorc’s affidavit, it took from November 1985 to April 1986 to find the ‘777 invention, and he was already familiar with the ‘875 invention. Potentially five different methods to separate the racemate would have had to have been tried and tested before determining the properties of the dextro-rotatory isomer. As in the case of anticipation, one might infer that the applications judge, if asked to decide this question, would have held that the investigation here was not routine, but rather was prolonged and arduous. In any event, on the facts of this case, this factor would assume small significance in view of the finding I make with respect to the whole course of conduct discussed at para. 91 below.
It is well known that the pharmaceutical industry is intensely competitive. Market participants are continuously in search of new and improved medications and want to reach the market with them as soon as possible. So demand for an effective and non-toxic product to inhibit platelet aggregation might be assumed to exist. However, nothing in the ‘875 patent or common general knowledge provided a specific motivation for the skilled person to pursue the ‘777 invention. The prior patent was a genus patent, and selection might be expected. However, the prior patent did not differentiate between the efficacy and the toxicity of any of the compounds it covered. This suggests that what to select or omit was not then self-evident to the person skilled in the art.
Mr. Badorc’s affidavit reveals that for several years prior to November 1985, Sanofi was in the process of developing the racemate in its salified form. In November 1985, the racemate was being tested in preliminary human clinical trials. It was at that time that Mr. Badorc was asked to separate the racemate into its isomers. After he discovered that the dextro-rotatory isomer was active and non-toxic and that the levo-rotatory isomer was non-active and toxic, Sanofi decided to develop the dextro-rotatory isomer and abandon its work on the racemate. However, this was after it had “spent millions of dollars and several years developing [the racemate] up to the point of preliminary human clinic trials” without at least trying to see if the dextro‑rotatory isomer had advantageous properties to those of the racemate (Affidavit of Mr. Badorc, at para. 25). This evidence was uncontradicted.
The methods to obtain the invention of the ‘777 patent were common general knowledge. It can be assumed that there was a motive to find a non-toxic efficacious product to inhibit platelet aggregation in the blood. However, it was not self-evident from the ‘875 patent or common general knowledge what the properties of the dextro-rotatory isomer of this racemate would be or what the bisulfate salt’s beneficial properties would be and therefore that what was being tried ought to work. The course of conduct and the time involved throughout demonstrate that the advantage of the dextro-rotatory isomer was not quickly or easily predictable. Had the dextro-rotatory isomer been “obvious to try”, it is difficult to believe that Sanofi would not have opted for it before unnecessary time and investment were spent on the racemate. I conclude that the prior art and common general knowledge of persons skilled in the art at the relevant time were not sufficient for it to be more or less self-evident to try to find the dextro-rotatory isomer.
As I have earlier explained, there was a significant difference between the ‘875 genus patent and the ‘777 selection patent. The difference was not obvious. Having regard to the foregoing analysis, I conclude that the allegation of obviousness is not justified.
Apotex also bases its challenge to the validity of the ‘777 patent on double patenting. Apotex also challenges the validity of the doctrine of selection patents itself on this basis.
There may only be one patent covering an invention (Whirlpool Corp. v Camco Inc., [2000] 2 S.C.R. 1067, 2000 SCC 67, at para. 63). Apotex says that a selection patent claims the same invention as the original class or genus patent and as a result, the selection patent cannot be valid.
The concern expressed by Apotex is that the doctrine of selection patents allows a patent holder to “evergreen” an invention. The original genus patent is granted for a finite period of years. If a selection patent is later obtained by the owner of the genus patent covering the same invention as the genus patent, the number of years the owner is entitled to exclude others from making or using the invention is extended, contrary to the limited period of exclusivity provided by the original patent.
Evergreening is a legitimate concern and, depending on the circumstances, strategies that attempt to extend the time limit of exclusivity of a patent may be contrary to the objectives of the Patent Act. The Act aims to promote inventiveness by conferring exclusivity for a limited period of time while providing for public disclosure of the invention to enable others to make or use it after expiry of the period of exclusivity.
However, a generalized concern about evergreening is not a justification for an attack on the doctrine of selection patents for two reasons. First, a selection patent may be sought by a party other than the inventor or owner of the original genus patent. In such a case, anticipation or obviousness may be an issue, but evergreening does not arise.
At the hearing, counsel for Apotex submitted that, in the pharmaceutical industry, the only party that would ever attempt to obtain a selection patent would be the genus patent holder. This is a highly competitive industry and a market participant who is able to develop a more effective product might be expected to be anxious to do so and seek patent protection through a selection patent even if it requires the making of an agreement with the holder of the genus patent to allow for the marketing of the selected product. However, even if counsel is correct, the doctrine of genus and selection patents is not restricted to the pharmaceutical industry. It is of general applicability.
Second and more importantly, selection patents encourage improvements by selection. The inventor selects only a bit of the subject matter of the original genus patent because that bit does something better than and different from what was claimed in the genus patent.
The applications judge found that the claims of the ‘777 and ‘875 patents were not identical or coterminous. I agree with him. Apotex’s factum compares claims 1, 8, 14 and 15 of the ‘875 patent with claims 1 and 3 of the ‘777 patent.
[‘875 Patent]
“A process for the preparation of derivatives of general formula (I): .... as well as the 2 enantiomers or their mixture [racemate] of these compounds of formula (I); wherein: .... if desired, its enantiomers are separated and/or it is salified by mineral or organic acid action; ....” (page 14)
“Process according to claim 1 for the preparation of methyl ∝ [4, 5, 6, 7‑tetrahydro‑thieno[3,2‑c]‑5‑pyridyl]‑o.chlorophenylacetate, wherein the 4,5,6,7‑tetrahydro thieno[3,2‑c]pyridine is condensed over the methyl 2‑chloro‑o.chlorophenylacetate, and the derivative sought, which is isolated, is obtained.” (page 15)
“Derivatives of general formula (I): .... as well as the 2 enantiomers or their mixture of these compounds of formula (I)....”
“Methyl ∝‑[4, 5, 6, 7‑tetrahydro‑thieno[3,2‑c]‑5‑pyridyl]‑o. chlorophenylacetate, each time it is obtained by the process of claim 8 or its manifest chemical equivalents.” (page 16)
[underlined text in trial reasons; italics added by Apotex]
[‘777 Patent]
Dextro‑rotatory isomer of methyl alpha‑5(4, 5, 6, 7‑tetrahydro (3, 2‑c) thieno pyridyl) (2‑chlorophenyl)‑acetate and its pharmaceutically acceptable salts.
Hydrogen sulfate of the dextro‑rotatory isomer of methyl alpha‑5 (4, 5, 6, 7‑tetrahydro (3, 2‑c) thieno pyridyl) (2‑chlorophenyl)‑acetate.
Although Apotex does not expressly state which of the ‘875 and ‘777 claims it is comparing, it is apparent, for double patenting purposes, that there is no identity between the product claims 1 and 5 of the ‘777 patent and claims 1, 8 and 15 of the ‘875 patent because claims 1 and 8 are process claims and claim 15 is a product by process claim. The only comparison that need be considered is between claim 14 of the ‘875 patent and claim 1 of the ‘777 patent. Claim 3 of the ‘777 patent reflects the hydrogen sulfate of claim 1 of the ‘777 patent, so that if claim 1 is not invalid, claim 3 will not be invalid either.
Claim 14 of the ‘875 patent claims all derivatives of general formula 1 as well as the 2 isomers and the racemic mixture. It is a broad claim for a class or genus. Claim 1 of the ‘777 patent is specific. It claims only the dextro‑rotatory isomer of the racemate. This is a typical selection patent.
Sound prediction was the basis for granting the original genus patent. That had to be the case when the genus involved over 250,000 possible compounds. Not every compound would itself have been tested. But there was, to the satisfaction of the Commissioner of Patents, sound prediction that what was included in the original genus patent was new, useful and not obvious. It was later determined that some of the subject matter of the original genus patent did not work or did not work as well as the subject matter of the selection patent. That information is valuable.
The doctrine of “sound prediction”, explicitly adopted by this Court in Monsanto Co. v Commissioner of Patents, [1979] 2 S.C.R. 1108, 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 misinformation: see Apotex Inc. v Wellcome Foundation Ltd., [2002] 4 S.C.R. 153, 2002 SCC 77, at para. 66. In Monsanto, Pigeon J., writing for the majority, drew the following conclusion, at p. 1117:
I have quoted again the passage quoted by the [Patent Appeal] Board because I consider the last sentence of the paragraph of some importance as it does clearly indicate what is meant by a “sound prediction”. It cannot mean a certainty since it does not exclude all risk that some of the area covered may prove devoid of utility. It thus appears to me that the test formulated by Graham J. [in Olin Mathieson Chemical Corp. v Biorex Laboratories Ltd., [1970] R.P.C. 157 (Ch. D.)] involves just two possible reasons for rejecting claims such as those in issue.
This approach has been consistently accepted by courts in Canada (see for example Ciba‑Geigy AG v Commissioner of Patents (1982), 65 C.P.R. (2d) 73 (F.C.A.)).
In the present case, it was found that the levo-rotatory isomer did not work at all and was toxic. The racemate did not work as well as the dextro-rotatory isomer. Isolating the dextro-rotatory isomer as being more effective and less toxic than other compounds of the genus patent is a valuable advance to be encouraged as a matter of patent policy.
It is true that the sound prediction of the ‘875 patent that the racemate and the levo-rotatory isomer produced the same results as the dextro-rotatory isomer was not borne out. That may leave parts of the original genus patent open to challenge. But it does not affect the validity of the selection patent.
I agree with Apotex that a challenge to patent validity based on double patenting does not require the existence of identical language in the two patent claims. Even so, the wording of the claims, however different, must claim the same invention.
The invention defined by claim 14 of the ‘875 patent is not the same as the invention claimed by claim 1 of the ‘777 patent because the former is broader than the latter. Although not a selection patent case, there is a striking passage in the judgment of Lord Simonds in May & Baker Ltd. v Boots Pure Drug Co. (1950), 67 R.P.C. 23 (H.L.), at p. 32. It describes a scenario very much the same as in the case at bar.
To this point, the issue has been what is sometimes called “same invention” double patenting. This is the main thrust of Apotex’s double patenting argument. The applications judge found that the claims in the ‘777 and ‘875 patents were not identical or coterminous, requirements to prove same invention double patenting: see Whirlpool, at paras. 64-65.
Apotex also relies on “obviousness” double patenting. Binnie J. explains in Whirlpool, at para. 66, that “obviousness” double patenting
is a more flexible and less literal test that prohibits the issuance of a second patent with claims that are not “patently distinct” from those of the earlier patent.
In Commissioner of Patents v Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, it was held that even though the claims were not identical nor coterminous, the dilution of a new substance once its medical uses were established in the first patent did not result in a further invention justifying a second patent. Even though the claims were not identical or coterminous, the subsequent patent was found to be invalid.
A selection patent that claims a compound that is patentably distinct from the genus patent will not be invalid for obviousness double patenting. Here, out of the many compounds predicted to be effective as exhibiting platelet aggregation inhibiting activity in the ‘875 patent, it was found that the dextro-rotatory isomer of the racemate relevant in this case had beneficial properties over both the racemate and the levo-rotatory isomer. As I have explained above, the claims in the ‘777 patent reflect a patentably distinct compound from the compounds in the ‘875 patent. As a result, there is no basis for a challenge based on “obviousness” double patenting.
While double patenting requires a comparison of the claims of a genus and selection patent, it is necessary that the specification of the selection patent define in clear terms the nature of the characteristic which the patentee alleges to be possessed by the selection for which he claims a monopoly. See I. G. Farbenindustrie, at p. 323. Here the ‘777 specification satisfies this requirement by providing, at p. 1 (A.R., at p. 156):
For these reasons, I do not find Apotex’s challenge to selection patents on the grounds of double patenting, and in particular that Sanofi has engaged in double patenting in the case of the ‘777 and ‘875 patents, to be well founded.
It follows from the findings above that claims 1 and 3 of the ‘777 patent are neither anticipated nor obvious. The composition claims 10 and 11 of the ‘777 patent are therefore also neither anticipated nor obvious. Finally, I find that Apotex’s arguments in respect of double patenting are not well founded. In the result, the allegations that the ‘777 patent is invalid for anticipation, obviousness and double patenting are not justified.
Harry B. Radomski, Richard Naiberg, Andew R. Brodkin and Miles Hastie (m/s Goodmans, Toronto), for the appellant.
Anthony G. Creber and Cristin A. Wagner (m/s Gowling Lafleur Henderson, Ottawa), for the respondents Sanofi‑Synthelabo Canada Inc. and Sanofi‑Synthelabo.