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The NOC Regulations - Two Issues to Consider:
(1) What goes on the Patent List?

(2) What is the scope of a product by process claim?
(1) What goes on the Patent List?
The Patented Medicines (Notice of Compliance) Regulations (the "NOC Regulations") combine two separate regimes, one the regulatory regime and the other, the patent regime. One of the problems with this combination is the concept of the Patent List. What should be listed and how should patents be listed? The Regulatory Framework: The NOC Regulations
The NOC Regulations provide for a Patent List under Section 4 as follows: 4(1) A person who files, or has filed a submission for, or has been issued, a notice of compliance in respect of a drug that contains a medicine may
submit to the Minister a patent list certified in accordance with subsection
(7) in respect of the drug.
A patent list submitted in respect of a drug must: (a) indicate the dosage form, strength and route of administrations of set out any Canadian patent that is owned by the person.that contains a claim for the medicine itself or a claim for the use of the medicine and that the person wishes to have included on the register; Subject to subsection (4), a person who submits a patent list must do so at
the time the person files a submission for a notice of compliance.
[Where the patent has issued at the time of filing of a new drug submission: the patentee files its new drug submission and its patent list at the same time.] A first person may, after the date of filing of a submission for a notice of
compliance and within 30 days after the issuance of a patent that was
issued on the basis of an application that has a filing date that precedes
the date of filing of the submission, submit a patent list, or an amendment
to an existing patent list, that includes the information referred to in
subsection (2).
[Where the patent has not yet issued at the time of filing of a new drug submission, the sequence of events must be: File patent, file drug submission, obtain patent and file against submission within 30 days of the patent issuing.] When a first person submits a patent list or an amendment to an existing patent list in accordance with subsection (4), the first person must identify the submission to which the patent list or the amendment relates, including the date on which the submission was filed. A person who submits a patent list must keep the list up to date but may not add a patent to an existing patent list except in accordance with subsection (4). 5. (1) Where a person files or has filed a submission for a notice of compliance in respect of a drug and compares that drug with, or makes reference to,
another drug for the purpose of demonstrating bioequivalence .and that
other drug has been marketed in Canada pursuant to a notice of
compliance issued to a first person and in respect of which a patent list
has been submitted, .[file a notice of allegation]
The NOC Regulations do not define the term "drug". However, the term "medicine" is "a substance capable of being used for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof" The Regulatory Framework: The Food and Drugs Act and Regulations

The Food and Drugs Act does provide a definition of "drug":
"drug" includes any substance or mixture of substances manufacture, sold, or represented for use in the diagnosis, treatment, mitigation or prevention of disease, disorder, abnormal physical state, or its symptoms, in human beings or animals; restoring, correcting or modifying organic functions in human beings or disinfection in premises in which food in manufactured, prepared or kept." Under the Food and Drug Act and Regulations, a "new drug" means a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish the safety and effectiveness of that substance for use as a drug; a drug that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug for sufficient time etc. a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration, or duration of action and that has not been sold for that use or condition of use in Canada, for sufficient time etc. Under the Food and Drug Regulations, the generic compares its drug to the "Canadian reference product". The Canadian reference product is defined to mean a drug in respect of which a notice of compliance (NOC) has issued and which is marketed in Canada by the innovator of the drug, or a drug acceptable to the Minister that can be used for the purpose of demonstrating bioequivalence where the drug is no longer marketed in Canada. Thus, the Canadian reference product is the "drug" referred to in Section 5(1) The innovator drug companies will file a new drug submission (or "NDS") including tests to show that the drug is safe and efficacious. A generic drug company can file an abbreviated new drug submission (or "ANDS") for a new drug where its new drug is "equivalent" to that of the innovator. Showing that the drugs are bioequivalent proves this equivalence, and this is generally shown by means of bioequivalency studies (where the two drugs are administered to people, and the blood levels of the two drugs are measured to ensure that they are taken up in the body in the same way). After reviewing the ANDS, the Minister must be satisfied that the drug is safe and efficacious for human
The Patent List : What are the Issues?

The focus of the NOC Regulations would appear to be the submission for a Notice of Compliance. The "drug" that is referred to Section 4(1) is tied to the submission and the NOC. Furthermore, the time limits provided for in Section 4(4) are directly related to the timing of the submission for the NOC. Thus, if a patent is filed after a submission is made, it cannot be listed against that submission/NOC. In cases where a new patent comes along after an NOC is granted, the patentee can still list the new patent against a new drug submission that results in a new NOC. However, due to the timing restrictions, such a patent should not be listed against an NOC based on a submission filed before the Accordingly, one would expect to see a patent list that was organized by NOC, as However, the Patent List is in fact maintained by reference to the medicine, and its Drug Information Number (or "DIN"). There is no reference on the Patent List to the NOC. This can cause problems since the same "medicine" may have more than one NOC, but have only one DIN. A case in point is etidronate disodium, which has two NOCs for different indications, but only one listing on the patent register. Hence its listing is as A further complication is the fact that the Patent List includes patents that may relate to the "medicine" or active ingredient, but not to the actual drug that is marketed in Canada. The patent could, for example, relate to a sustained release version of the medicine, while the actual marketed product is an immediate release product. This results in a generic being faced with patents on the list that are unrelated to the actual product that the generic The focus of the cases has been on whether or not a patent contains a claim for the medicine or a use of the medicine, even though it may not be related to the preliminary requirements of section 4(1), namely a medicine that is contained in a drug for which a In the case of Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare)1, the court considered whether patents on the list were properly there, i.e. did they contain a claim for the medicine or a use of a medicine. In one of the patents, the claim included naproxen and another substance. (Naproxen is a medicine.) The patentee led evidence to the effect that the consumption of a mixture that contains naproxen results in consumption of a naproxen. The court found that this evidence was insufficient to establish that the patent covered a "medicine". The medicine must also be one that has been used as a medicine or approved or recommended by an authority as a medicine. This is consistent with the requirements of Section 4(1), which contemplates an NOC being granted, or at least a submission for an NOC having been filed. The Case Law:
1 (1999), 86 C.P.R. (3d) 303 (F.C.T.D.) Novopharm v. Canada (Minister of Health and Welfare) 2
In this case, Abbott Laboratories had obtained NOCs for 1, 2, 5 and 10 mg tablets of terazosin hydrochloride. The patents listed against these tablets expired in 1997. In 1995, Abbott filed a new drug submission for a "starter pack" consisting of 1, 2 and 5 mg tablets packed together in such a way that the patient would take gradually increasing doses of the drug over a four-week period. Abbott obtained new patents covering terazosin in June of 1997. These patents had been filed before the 1995 starter pack submission and so could be listed against the starter pack. However, the new patents were filed after the submissions relating to the 1, 2, 5 and 10 mg tablets, and as a result could not be listed with respect to the individual tablets. Abbott applied to amend its patent lists filed in respect of the NOCs earlier issued to it for the individual dosages (1, 2, 5 and 10 mg). The Minister accepted the new lists and had the new patents listed against the NOCs for the individual tablets. Novopharm then filed an ANDS and compared its drugs to the drugs covered by the NOCs for 1, 2, 5 and 10 mg tablets. It did not compare its drugs to the NOC for the starter pack, and was not seeking approval to market the starter pack in Canada. However, it was unable to obtain an NOC on the basis of the Patent List, which included the newer patents. Novopharm brought an application to have the newer patents removed from the list relating to the individual tablets. The court found that the Minister had erred in listing the newer patents against the older NOCs. In his decision, Mr. Justice Hugessen pointed out that patent lists are filed in respect of "drugs covered by either an NDS or by the NOC which results therefrom". The NOC Regulations refer to a "drug that has been marketed in Canada pursuant to a Notice of Compliance issued to a first person in respect of which a patent list has been submitted". Thus, he concluded that it is the "subject of the NDS (the "drug") and not the subject of the patent (the "medicine") which constitutes the critical link". Furthermore, since the "drug" is the subject of the NOC, while the "medicine" is the subject of the patent claim, it is possible for there to be multiple NOCs issuing with respect to the same patented "medicine" and this results in different "drugs" corresponding to the different subjects of the NOCs. This analysis is consistent with the NOC Regulations, which provide that a person is required to submit a patent list at the time of the filing of the As a result, in the Novopharm case, the court found that the new patents that were listed against the starter pack (containing 1, 2 and 5 milligram tablets) could not be listed against the NOCs for the individual tablets. The new patents had been filed after the submission for the NOCs for the individual tablets (and could not be listed under Section 4(4) of the NOC Regulations). (due to the timing restrictions in the regulations). Thus, the Minister was not prohibited from issuing an NOC to Novopharm. What follows from this case law, is that a generic should only be met with patents listed against the "drug" to which it is compared. However, the patent list, as it is currently maintained, is not listed by NOC, but by active ingredient or "medicine" and by drug identification number ("DIN number"). (Attached to this paper are some sample pages from the Patent Register.) This has created problems for generics wishing to compare their drug to the "drug" for which a particular NOC was granted, but being met with a list of patents listed against the "medicine". Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General)3
In the Bristol-Myers case, Bristol-Myers filed a submission for an NOC in respect of the medicine nefazadone hydrochloride in 50, 100, 150, 200 and 300 mg strengths on April 30, 1992 under the brand name SERZONE. Bristol-Myers submitted a patent list for these tablets, as required, within 30 days of the coming into force of the NOC Regulations. However, Bristol-Myers omitted from its list Canadian Patent 1,198,436 ("the '436 Patent"). Bristol-Myers made attempts to have the 436 Patent added to the list, In January of 2000, Bristol-Myers submitted a supplementary new drug submission where the only change made to the "drug" was a change of brand name from SERZONE to SERZONE-5HT2. Bristol-Myers had requested, and the government had agreed, that the DIN numbers remain the same for the various dosage forms. When the NOC was issued for the new brand name, the '436 Patent was listed on the patent register. The Minister advised Bristol-Myers that it would be removing the '436 Patent from the Patent list. In its letter to Bristol-Myers, the Minister stated: "Notably, SERZONE and SERZONE-5HT2 are the same drug, and retain the same DINs. The drug cannot be treated as a different set of products under sections 4 and 5 of the PM(NOC) Regulations. The patent list is added to the patent register on the basis of an individual submission. Thus, under section 5, the second person does not address patents listed for SERZONE separately from those listed for SERZONE-5HT2. Otherwise, a second person using SERZONE as the Canadian Reference Product would arguably not be required to address a patent listed for SERZONE-5HT2 pursuant to subsection 5(1), when the drug is known to be identical except for the brand name." This interpretation of the NOC Regulations does not appear to be consistent with the decision of Mr. Justice Hugessen in the Novopharm case. In fact, if the list is maintained by the NOCs, and a new NOC is listed for the new brand name, the old NOCs should still be on the list, and a generic (or second person) should be able to compare only to the old NOCs. Instead, the Minister appears to be focusing on the "drug" in the sense of the active ingredient or medicine, and not the various separate "drugs" (relating to the separate NOCs) under sections 4 and 5 of the NOC Regulations. In the Bristol-Myers case, the court concluded that the Minister was correct. The court considered the effect of Section 4(6) of the NOC Regulations. It was submitted by the Minister of the Attorney General that Section 4(6) had been added in order to address the very concern that innovator companies would add patents to the patent lists with the effect of inhibiting the entry of generics into the market place. The court found that to 3 [2001] F.C.J. No. 51, Court File T-1768-00, decision of Mr. Justice Campbell, dated January 19, 2001 allow the use of the Food and Drug Regulations in this case would allow innovative companies to circumvent the timing requirements of NOC Regulation Section 4 by changing brand names in order to put patents on the Patent Register that were not there before, for which the time lines had not been complied with originally. Apotex Inc. v. Canada (Minister of Health)4
The case of Apotex Inc. v. Canada (Minister of Health) considered an issue similar to the one in the Bristol-Myers case. In the Apotex case, the patentee, SmithKline Beecham Pharma Inc., had obtained an NOC in 1993 for paroxetine for 10 mg, 20 mg 30 mg and 50 mg for use in the treatment of depression. The "medicine" listed in the NOC was SmithKline filed two supplements to a new drug submission for "new indications". SmithKline obtained two additional NOCs for paroxetine 20 mg and 30 mg tablets in 1995 for therapeutic use as an antidepressant, anti-obsessional and antipanic agent, based on the supplemental submissions. The Minister permitted SmithKline to add a patent (the '637 Patent) that had been filed in 1993 and issued in 1995 to the list for paroxetine 20 mg and 30 mg, but not for the 50 mg. The '637 Patent was filed after the date that the original submissions for the NOCs for the 20, 30 and 50 mg had been filed. The new patent could not be filed against the 50 mg, due to the provisions of Section 4(4) of the NOC Regulations. However, the new patent was listed against the 20 and 30 mg strengths, regardless of the NOC. What that means is that the '637 patent was listed even though the original NOCs granted for the 20 and 30 mg were filed before the '637 Patent "As a result, in or about February 1998, the Minister added the '637 Patent to the Register for the medicine paroxetine in 20 mg and 30 mg tablets." [Emphasis added] This type of listing does not take into account the fact that there were earlier NOCs granted for paroxetine in these dosage forms. Instead, the new patent was added to the patents already listed with respect to these two dosage amounts, regardless of the NOCs that had been issued. In essence, the new patent was listed against the "medicine" paroxetine and not the "drug", that which had received an NOC. Furthermore, the time The issue before the court in the Apotex case was whether or not a supplement to a new drug submission was a "submission for a notice of compliance" within the meaning of Section 4 of the NOC Regulations. Madam Justice McGillis found that it was. Under Section C.08.003 of the Food and Drug Regulations, a new NOC can be granted where there is a supplement to a drug submission and there is a "significant difference" in the new drug in relation to the matters specified in the regulations, such as the ingredients, indication or the method of manufacture. The NOC Regulations require the submission to be one that can result in a NOC , and the Food and Drug Regulations are clear that a new Of note, is that Madam Justice McGillis went on to point out that: 4 (1999), 87 C.P.R. (3d) 271 (F.C.T.D.) ".a supplement does not vitiate or supplant the new or abbreviated new drug submission, but rather constitutes an independent submission by the manufacturer in relation to certain specified matters which differ in significant respects from the information or material in the new or the abbreviated new drug submission. The independent or "stand alone" characteristic of a supplement to a new or to an abbreviated new drug submission is reinforced by paragraphs C.08.003(1)(b) and C.08.004(1)(a) which provide for the issuance of a notice of compliance in response to a supplement." [Emphasis added] The court also stated that the patentee in this case filed its amended patent list "in relation to" the two later NOCs. This is not, however, the way these patents are listed. On the Patent Register (obtained from the Health Canada Web Site and attached as a schedule to this paper), there is no reference to the NOCs, and the '637 Patent is simply listed as against the two dosage forms for paroxetine hydrochloride. Counsel for Apotex raised a second issue in this case, and that was the fact that the '637 Patent was not properly included in the Patent Register since it was not relevant. The basis for this argument was that SmithKline had applied for, but not yet obtained an NOC to market tablets containing paroxetine in the dry formulation method covered by the '637 The court found that the '637 Patent was issued for paroxetine tablets and a process to prepare them, and includes claims to novel paroxetine formulations prepared in the absence of water. The '637 patent therefore contains a claim for the medicine paroxetine or a claim for the use of the medicine paroxetine, within the meaning of subsection 4(2). As SmithKline was the person who had been issued an NOC for paroxetine tablets, it was entitled to submit a patent list and to amend the patent list. The court noted that the argument advanced by Apotex would lead to the incongruous result that the newest patented formulation of the medicine paroxetine would not receive the protection accorded by the procedures provided in the NOC Regulations. It is to be noted that there is also an incongruous result for the generic or second person, when they compare themselves to the innovator. The innovator uses a certain process/product. The generic must contend with the patents on the patent list. The patents may have no bearing to the actual product to which the generic makes its comparison if the innovator has not yet received a notice of compliance. In this case, while the medicine was paroxetine, there were different methods of making it (with and without water) and only the method of making paroxetine with water had been approved by Health Canada. However, a generic comparing its paroxetine made with water would be obliged to file a Notice of Allegation for a patent for making paroxetine without water. This is a case where the regulations could be better worded. Section 4(1) is limited to drugs (e.g. pills) that contain medicines (e.g. ASA) for which a submission has been made. The requirement under section 4(2)(b) (i.e. listing a patent that contains a medicine or use of a medicine) should mean that the patent has some relevance to the drug for which approval is being sought, not just that it has the same "medicine". If that were the case, the patentee would then have some additional time to file patents on the list (as the patent list would match the filing of the submission) and the generics would Procter & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health)5
In the case of Procter & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health), the court considered a request for documents. Of note, is the fact that the court recites that P&G had obtained NOCs with respect to two products, Didronel and Didrocal. Didrocal is approved for use in the treatment of osteoporosis while Didronel is approved for use in the treatment of Paget's disease and hypercalcemia of malignancy. However, in both cases the active ingredient is etidronate disodium. While one would expect to see two listings for this drug on the Patent Register, there is only one, for the "medicine" etidronate disodium 400 mg. There is thus room for some clarification with respect to the Patent Register. The NOC Regulations and the cases appear to suggest that the list should be maintained by NOC. This is not however what is being done. This is an example of the clash between the regulatory framework, as Health Canada maintains the list, and the NOC Regulations, which are under the Patent Act. The fact that the list is so crucial in this area makes the matter one that the courts should seriously consider.
(2) What is the scope of a product by process claim?

In reviewing patents under the NOC Regulations, one of the issues that has surfaced is
the question of patents that contain "product by process" claims, when claiming a "medicine" or "use of a medicine". 5 (2000), 7 C.P.R. (4th) 264 (F.C.T.D.) The Statutory Framework
Under the Patent Act, prior to the revisions of October 1989 (the "Old Patent Act"), Section 41 of the Old Patent Act provided: "In the case of inventions relating to substances prepared or produced by chemical processes and intended for food or medicine, the specification shall not include claims for the substance itself, except where prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents." [Section 41(1)] This provision allowed for patents on processes for making medicines and for medicines as made by such processes, but not for the actual medicine itself. As a balance against this, the Old Patent Act also provided for a presumption of infringement. That is, if a defendant made the new substance, it was deemed to have been produced by the patented process, unless the defendant could prove to the contrary. [Section 41(2)] This section has since been repealed. It does, however, still apply to those patents issued prior to October of 1989. Section 78.1 of the current Patent Act provides as follows: "(2) Subject to section 78.5, any matter arising on or after October 1, 1989, in respect of a patent issued before that date shall be dealt with and disposed of in accordance with the provisions of this Act as it read immediately before that date and section 38.1 (deposit of biological material) as it read immediately after this section came into force." The Jurisprudence Relating to Product by Process Claims
In Canada (Commissioner of Patents) v. Winthrop Chemical Co.6, the Supreme Court of Canada held that the requirements of Section 41(1) (then section 40(1)) meant that the applicant's specification should describe the method or process and claim a patent therefor in the manner required under the Patent Act. The court considered that an application under Section 41(1) could not include claims for the substance as made by a chemical process, without also including claims for the process alone. The court noted that this was the only logical interpretation, given that subsection (2) referred to the "patented process", and subsection (3) referred to the granting of compulsory licenses for the "use of the invention for the preparation or production" of the food or medicine. The section was not intended to cover substances that were made by old processes. The underlying public policy behind this section was explained by the Supreme Court of Canada in Dairy Foods, Inc. v. Co-operative Agricole de Granby7. The court stated that the section was to free invented substances intended for medicine which are prepared or produced by chemical processes from the control that the inventor of the substance would have had (but for the section in the Patent Act) on the substance itself. The Supreme Court quoted with approval Mr. Justice Noel: "The object of section 41(1) is to prevent a patentee from monopolizing a food or a medicine. He indeed must be content with a monopoly for his way of making it. If someone else develops a different process which will result in a similar product, then he is free to use it." [Emphasis added] 6 [1948] S.C.R. 46 7 [1976] 2 S.C.R. 651 Similarly, in the case of Commissioner of Patents v. Ciba Ltd.8, the Supreme Court found ".although the methods are known and the materials are known yet the application of those methods to those materials to produce those new substances may amount to a true invention, because of the discovery that those particular known materials when combined by those methods not merely produce those new substances but produce, in the shape of those new substances, drugs of remarkable value. I think it necessarily follows that the identity of the materials chosen (by luck or good management) by the supposed inventor for the production of his new substances is of the essence of his invention." [Emphasis added] Furthermore, patents that are covered by this section can be challenged as being invalid when they do not have the necessary "product by process" limitation in the claims. In C.H. Boehringer Sohn v. Bell Craig Ltd9, the court found that one of the patent claims was invalid, as it was not limited by a process for the production of the claimed The Cases under the NOC Regulations
Pfizer Canada Inc. v. Apotex Inc.10
Under the NOC Regulations, there have been a number of cases dealing with "product by process" claims. In Pfizer Canada Inc. v. Apotex Inc., the court considered a patent for fluconazole. Apotex asserted in its Notice of Allegation that the Pfizer Patent claims were limited to fluconazole made in accordance with a certain process or processes, and 8 (1959), 30 C.P.R. 135 at 141 (S.C.C.) 9 (1962), 39 C.P.R. 201, appeal to S.C.C. dismissed at 41 C.P.R. 1 10 (1997), 77 C.P.R. (3d) 547 (F.C.T.D.) that the fluconazole to be made by Apotex would be made by a process that would not The court noted that the Pfizer Patent had been granted in accordance with the requirements of Section 41(1) of the Patent Act. The court noted: "But for Section 41(1), the patentee would have been entitled to a product per se claim to the compound fluconazole when made by any process. The types of reactions included in the claims were general reactions known at the time of the Pfizer Patent and there was nothing inventive in the idea of using these reactions. These were only included to comply with section 41(1) in order that the claims of the patent include process limitations. Therefore, these features are not essential features. This conclusion is supported by the fact that the underlying invention is fluconazole and not the claimed process." The court then applied the test from Catnic Components Ltd. v. Hill & Smith Ltd.11 in considering the question of infringement. In so doing the court found that the patentee did not intend to exclude variations from the scope of the invention claimed. The court stated: "The process requirements were prescribed by law and not intended by the patentee to be essential limitations to the invention." The court went on to find that the variations in the Apotex process were well known to those skilled in the art and were therefore obvious variants. One of the factors the court considered in concluding that the Apotex process fell within the claims of the patent was the fact that is achieved the same result (i.e. fluconazole). This is of course the very thing that Pfizer was not permitted to It would appear that the court read out the process limitations in the claims, in a way that was not contemplated by the requirements of the Patent Act or by the case law. According to the recent decision of the Supreme Court of Canada in Whirlpool Corp. v. Camco Inc.12, the role of the court, in applying a purposive construction, is to determine the scope of the monopoly by reviewing the written claims, with flexibility and fairness achieved by differentiating the essential features from the unessential, based on a knowledgeable reading of the whole specification through the eyes of the skilled addressee rather than on the basis of the "kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge". Pfizer Canada Inc. v. Apotex Inc.13
In a case involving the same parties and the same drug, Pfizer Canada Inc. v. Apotex Inc., the court considered the issue once again. The court noted that the Pfizer Patent had been issued at a time when section 41(1) was in place. The court stated that the phrase "obvious chemical equivalent" as used in section 41 ensured that a purposive and not a literal interpretation was applied to the process claims on which the patent protection depended. The court noted that in the earlier Pfizer decision, the court had considered these words to afford broader protection than merely a purposive interpretation approach In this case, the court found that the Apotex process was not a chemical equivalent of the Pfizer patented process. The court noted that while the end result is fluconazole, the individual steps in the Apotex process all act and function in a different way from the individual steps in the Pfizer patent. The court had earlier found that the essence of the 12 [2000] S.C.J. No. 68 13 (1997), 78 C.P.R. (3d) 3 (F.C.T.D.) invention was not merely fluconazole, but the formulation of fluconazole by a process that adds the second triazole to the pre-existing molecular structure by an epoxide ring opening with the simultaneous completion of the fluconazole molecule by formation of Pfizer Canada Inc. v. Nu-Pharm Inc. 14
The fluconazole patent was the subject of a further case involving Nu-Pharm. In this case, the court noted that Pfizer argued that the essence of the patent was the product fluconazole and its properties. The court noted, however, that the claims of the patent were all limited by statute to the disclosed processes or obvious chemical equivalents. The court considered both of the previous Pfizer decisions, noting that the second one was in complete conformity with the statute. In this Pfizer case, the Apotex process was also in issue. The court followed the second Pfizer decision finding that this process was not a chemical equivalent to the Pfizer patented process. The court noted that while the final result is the same, the processes operate in totally different manners: "Generally speaking, the starting compounds are different; they are used to produce different intermediates; and the steps used to produce the intermediates are different and perform different functions." Janssen Pharmaceutica Inc. et al. v. Apotex Inc. et al.15
14 Pfizer Canada Inc. v. Nu-Pharm Inc. (1998), 83 C.P.R. (3d) 1 (F.C.T.D.) 15 (2000), 5 C.P.R. (4th) 53 (F.C.T.D.) More recently, this issue was considered in Janssen Pharmaceutica Inc. et al. v. Apotex Inc. et al. In this case, the patent covered cisapride. The court noted that: "But for these limitations [i.e. Section 41], the patent would have covered cisapride regardless of the process by which it was made." The court considered the first Pfizer decision, and noted that in the case before it the patent claims covered general reactions and that there was nothing inventive in the idea of using these reactions. The court found that: ".the patentee did not intend to be limited to the specific processes of claim 1 since the process limitation were only included so as to comply with subsection 41(1) of the Patent Act. Claim 5 of the '847 Patent includes the processes of claim 1 and all other obvious chemical equivalent processes. In that light, it cannot, in my view, be said that the process limitations are essential features." This is to be contrasted with the quote from the Supreme Court of Canada that: "the identity of the materials chosen (by luck or good management) by the supposed inventor for the production of his new substances is of the essence of his invention."16 The court then concluded in the Janssen case that on a purposive construction, the '847 Patent covers the making of cisapride by the formation of the amide bond and optionally 0-methylation and/or preparing the cis isomer, and by all other obvious chemical equivalents. The Apotex memorandum, which is quoted in the case, stated that the Janssen process used an intermolecular reaction of two molecules to make cisapride. However, the Apotex process employed an intramolecular reaction. None of the intermediates or process steps employed in the Apotex process were explicitly or implicitly disclosed in the '847 Patent. Thus, Apotex argued, its process was not an The court considered that the Apotex expert witness had not construed the patent with a "mind willing to understand" since he focused upon the differences between the processes used in the patent and by Apotex. The Janssen expert, the court found, had properly construed the patent, by examining the synthetic pathway of the '847 Patent "so as to discover what the patentee really wanted to achieve and the means thereto". The court noted that it had been known for quite some time that a synthetic organic chemist should consider intramolecular versions of an intermolecular reaction when planning a synthetic pathway. Even though such reactions were not specifically referred to in the patent, the court found that the Apotex process was an obvious chemical Novartis AG et al. v. Apotex Inc. et al17
In the case of Novartis AG et al. v. Apotex Inc. et al., the issue of Section 41 was raised in relation to the drug, terbinafine hydrochloride. The court noted that the doctrine of equivalence has long been a feature of patent law. It was also included in Section 41 in the words "or obvious chemical equivalents". In this case, the claims also included the term "obvious chemical equivalents". The patentee filed evidence that it was the compounds and not the processes for making them that are the essence of the '023 Patent. The experts further stated that they were aware that at the relevant time the Canadian patent law required process claims to be included. The argument by the patentee was that the invention was the compound itself and thus any change to the process by which it was made is a change to a non-essential aspect. This argument, the court noted, carried to its logical conclusion undercuts the "If the processes are non-essential elements, then the inventor is being allowed to claim the substance itself - the result that section 41 was designed to prevent." In this case, the court noted that "the fact that some of the end components are the same does not assist the analysis. If they were not, there would be no litigation." Instead, what is important is the chemical strategy that is involved. On the facts of the case, the court found that the Apotex process was an original one. It was written up in a peer-reviewed journal as a new synthetic approach to making terbinafine. Furthermore, there were eight different sequences for preparing terbinafine that had been published in the literature. None of these sequences used an epoxide for joining of an amine and/or an alkyne unit, as did the Apotex process. The court concluded that it was not an obvious chemical equivalent to the claimed processes. While it is certainly possible to have processes fall within the scope of patent claims (particularly where the claims also cover obvious chemical equivalents), it would appear that the courts should not consider process limitations as being "inessential". According to the Patent Act and the case law, these limitations were necessary, and the process was to be an inventive one (not something that was old). The claims can only cover the process or processes that are disclosed, but not every process for making the substance. 17 (2000), 6 C.P.R. (4th) 129 (F.C.T.D.) Otherwise, the claims then become claims for the substance itself (and thus invalid, as It is thus, respectfully suggested, that product by process claims should not be read as
Conclusion

The courts have been placed in a very difficult position of interpreting these "linkage"
regulations, when the regulatory system and the patent system do not precisely match. Overall, it would appear that one of the places that the court can look for guidance is the patent law jurisprudence. It can, hopefully, assist in putting some of the issues in context. Schedule "1"
Excerpts from the Patent Register

Source: http://cba.org/cba/sections/pdf/NOCRegs.pdf