Docket: T-2437-03
Ottawa, Ontario, August 31, 2005
PRESENT: THE HONOURABLE MR. JUSTICE BEAUDRY
BETWEEN:
and
MAYNE PHARMA (CANADA) INC. and
THE MINISTER OF HEALTH and
AVENTIS PHARMA, S.A.
REASONS FOR ORDER AND ORDER
[1] This is an application pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, amended by SOR/98-166 and SOR/99-379 (Regulations) by which the Applicant (AVENTIS or the First Person) seeks an order prohibiting the Minister of Health (MINISTER) from issuing a notice of compliance (NOC) to the Respondent (MAYNE or the Second Person) in respect of the drug cefotaxime sodium, until after the expiration of the Canadian patent number 1,319,682 ('682 patent).
ISSUES
[2] The issue can be summarized as follows:
1. Are the allegations of Mayne on invalidity of the '682 patent justified?
[3] For the following reasons, I must answer that question negatively. Therefore, the application shall be allowed.
BACKGROUND
[4] On January 21, 1977, the predecessor of AVENTIS applied for the '682 patent. The patent was issued on June 29, 1993, and its term will expire on June 29, 2010. It contains 93 claims and was disclosed for the preparation of a new family of cephalosporins.
[5] MAYNE served a Notice of Allegation (NOA) on AVENTIS alleging non-infringement and invalidity of the '682 patent on November 13, 2003 pursuant to the regulatory scheme procedure established under the Regulations.
[6] On December 22, 2003, AVENTIS filed a Notice of Application before this Court pursuant to section 6 of the Regulations seeking an order prohibiting the MINISTER from issuing the NOC to MAYNE.
[7] On July 5, 2004, Mr. Justice Noël of the Federal Court allowed a motion from AVENTIS to strike paragraphs 22 to 25 and paragraphs 71 to 75 of the June 7, 2004, affidavit of MAYNE's expert, Dr. Tony Durst.
[8] On appeal of that decision, the Federal Court of Appeal allowed the appeal in part. It permitted MAYNE to rely on paragraphs 22 to 25 as it was satisfied that it did not raise facts which have not been disclosed in the detailed statement. On the other hand, it dismissed MAYNE's appeal with regard to paragraphs 71 to 75 as it concluded that this information was not disclosed in the NOA.
APPLICANT'S SUBMISSIONS
[9] AVENTIS argues that the making, constructing, using and selling of the MAYNE's product would infringe its patent. Based on its expert's affidavit, the Applicant argues that the letters R, R' and A of the cephalosporins' structure represent substituents that can be changed without altering the compounds shown in claim 1 of the '682 patent (formula I). In other words, MAYNE's product has the same structural chemical formula (compound) as the one protected by the '682 patent. Therefore, AVENTIS is of the opinion that the cefotaxime sodium falls within the scope of the formula I and MAYNE consequently infringing their patent.
[10] As mentioned above, AVENTIS relies on the expert evidence submitted by Professor James D. Wuest, a professor of the University of Montreal since 1986. Mr. Wuest studied chemistry and mathematics at Cornell University and completed graduate work in organic chemistry at Harvard University, where he also was, until 1980, an Assistant Professor of Chemistry.
[11] AVENTIS also asked Mr. Jean H. Dubuc to comment on the exchange of correspondence between the Canadian Intellectual Property Office and Robic, the applicant's patent agent, to evaluate whether any undue delay had occurred during the prosecution of the application. Mr. Jean H. Dubuc, was admitted as a patent agent in 1971 following completion of an engineering degree at l'École Polytechnique of Montréal in 1964. Mr. Dubuc has been a registered patent agent for 30 years and is now practising with the firm Goudreau Gage Dubuc.
[12] Mr. Dubuc concluded that the sixteen year delay between the filing of the patent application in 1977 and its issuance in 1993 is largely attributable to the fact that the application was conflicting with other co-pending applications in the Patent Office. The subject matters of those patents overlapped, and the issue was not resolved until 1993. In his numerous years of practice, Mr. Dubuc noted that it is common for an applicant to occasionally request an extension of time, especially where conflict proceedings are underway. Therefore, he was of the opinion that there was no unreasonable delay caused by the applicant or its agent.
Professor Wuest's Affidavit
[13] Professor Wuest was asked to comment on whether the compound having the chemical formula described in paragraph 6 of MAYNE's NOA is the same as the compound claimed in at least claims 30, 31, 32, 33, 34, 35, 36 and 50 of the '682 patent.
[14] He explained that the specific compound in paragraph 6 of MAYNE's NOA is literally identical to the compound claimed in claims 33 and 34 of the '682 patent. He began his analysis by illustrating the structural chemical formula of the cefotaxime sodium as set out in the Merck Index. He indicated that both of claims 33 and 34 specifically identify the geometry of the methoxyimino group as "syn". The well-established rules of nomenclature in organic chemistry confirm that this description is equivalent to the expression "(Z)", which specifies the orientation of the methoxyimino such as used by MAYNE in paragraph 6 of its NOA.
[15] Moreover, he underlined that claims 33 and 34 both place the claimed compound in the family of cephems by explicitly using cephem nomenclature. In this nomenclature, the configuration of the centres at position 6 and 7 is understood to be that set out in the structural formula of cefotaxime sodium such as identified in the Merck Index.
[16] AVENTIS also requested Professor Wuest to comment on whether the process described in paragraph 7 of MAYNE's NOA falls within the scope of the process claimed in claim 49 of the '682 patent. Professor Wuest concluded that the process described by MAYNE is the same process as the one used for the '682 patent.
[17] The process to obtain the desired compound CIII is characterized by the reaction of 7-aminocephalosphoranic acid (7-ACA) with an aminothiazole acid (CIa) or a functional derivative thereof. This reaction between an acid and an amine produces an amide bond (CO-NH) which is required to form compound CIII.
[18] According to Professor Wuest, MAYNE uses diethylthiophosphoryl (Z) (2-aminothiazol-4-yl) (methoxyimino) acetate (DAMA) to react with 7-ACA to form an amide link (CO-NH). The DAMA is a functional derivative of the CIa used in claim 49 of AVENTIS' '682 patent. Professor Wuest mentioned that a chemist of normal skill in the art of organic synthesis would understand that the DAMA is included in the scope of the functional derivatives of claim 49.
Professor Wuest's Cross-Examination
[19] During the cross-examination, Professor Wuest mentioned that a normal chemist skilled in the art would understand, from the reading of claim 49, that for the acid to react with the amine, an intermediate activation step is necessary. The problem with the intermediate activation step is that it is not selective of the group it will react with and could therefore form unwanted side reactions.
[20] In order to successfully carry out the reaction, a chemist does not necessarily need to use a protective group. Professor Wuest explained that when a protective group is added to the reaction scheme it subsequently needs to be removed. Even though the use of a protective group would ensure that no undesired side reactions occurred and that a higher "yield" of the desired compound be formed, it might be more advantageous not to use a protective group if it gets too complicated to remove it after the reaction is completed. Consequently, the formation of a smaller "yield" of the desired compound which can easily be separated can be a better option.
[21] In addition, Professor Wuest opined that the '682 patent at page 6 (pp. 0024 and 0025 of the Applicant's Record, Vol.1 of 8) does not gives specific instruction to use DCC as a reagent. Professor Wuest's understanding of this passage is that DCC is only an example of the use of a reagent and that other equivalent reagents would be understood to be candidates for this type of coupling reaction.
RESPONDENT SUBMISSIONS
[22] In the NOA, MAYNE maintained that no claim for the medicine itself and no claim for the use of the medicine, would be infringed by the making, constructing, using or selling by MAYNE of sterile cefotaxime sodium for injection (MAYNE's product).
[23] MAYNE contended that the reaction scheme described by the '682 patent was not new in 1977 and that it had been used well prior to that date to produce a very large number of penicillin and cephalosporin.
[24] In order to obtain a NOC from the MINISTER, MAYNE submitted a detailed statement, pursuant to section 5 of the Regulations, which provided an extensive, claim by claim explanation as to why each claim of the '682 patent would not be infringed.
[25] The crux of MAYNE's allegation is that the process used to make its product differs from the process claimed and described by the '682 patent. More particularly, instead of using the compound 7-ACA with the general formula IIc, it uses DAMA.
[26] Its allegations are based on the affidavit of Dr. Tony Durst, who is presently Professor Emeritus and Visiting Professor of Chemistry and Director of Biopharmaceutical Sciences at the University of Ottawa. He obtained a Bachelor of Science in chemistry in 1961 and a Ph.D. in chemistry in 1964 from the University of Western Ontario. After doing post-doctoral work at the University of Munich in Germany and at Harvard University, he joined the Department of Chemistry at the University of Ottawa in 1967.
[27] In the alternative, MAYNE alleged that certain product and process claim of the '682 patent were not infringed due to the claims being invalid, unenforceable or void, as they were previously disclosed and claimed in two Canadian patents.
Dr. Durst's Affidavit
[28] Dr. Durst was asked to comment on whether:
a) the compound cefotaxime sodium is encompassed by any of the claims of the '682, '284 or '343 patents;
b) the process described in the NOA, more particularly in paragraph 7, is within the scope of the process of claim 49 of the '682 patent, and to comment on the conclusions expressed by Professor Wuest in this regard;
c) the processes of the '682 patent and the '284 patent pertain to the preparation of cefotaxime sodium, and if so, whether those processes are identical or obvious chemical equivalents;
d) the process of the '343 patent pertains to the preparation of cefotaxime sodium, and if so, whether that process is identical to, or would be obvious, having regard to the claims of the '682 and '284 patents.
[29] Dr. Durst arrived at the following conclusion: the compound of cefotaxime sodium, as described in paragraph 6 of the NOA, is disclosed in the claims of the '682, '284 and '343 patents.
[30] Dr. Durst disagreed with the conclusion expressed by Professor Wuest to the effect that the process described in paragraph 7 of the NOA falls within the scope of the process of claim 49 of the '682 patent.
[31] Dr. Durst explained that the process for preparing compound CIII is characterized by the reaction of 7-ACA with an aminothiazole acid (CIa) or a functional derivative thereof. It involves the reaction of an acid with an amine to produce an amide bond. In order to allow the amide bond to be formed under relatively mild conditions, the acid needs to be activated by a reagent. Since the reagent is not selective, Dr. Durst mentioned that a protective group of the amino group of the CIa needs to be used to ensure that the "yield" of the desired reaction is not compromised or reduced by undesirable side reactions.
[32] The use of a protective group involves additional steps in a reaction sequence: one step to attach and one step to detach the protective group. Dr. Durst opined that a skilled chemist would recognize that activation step would consequently necessitate the use of an amino protective group to prevent unwanted side reactions.
[33] The two reactants prescribed by claim 49 each have an amino group and a carboxylic acid group. This means that there are two sites on each of the two reactants at which an amino group and a carboxylic group may react. Thus there are four possible amide bond-forming reactions, only one of which will "yield" the desired compound.
[34] Therefore, the skilled person would recognize that the claim which states that the amino group "may" be protected in a conventional manner is for practical purposes mandatory and not discretionary in order to efficiently carry out the process of claim 49.
[35] Dr. Durst indicated that the specification of the '682 patent does not teach any other method, besides the use of an activating reagent and of a protective group. There is no indication of any particular process that is used to activate the carboxylic acid derivative and to allow efficient formation of the desired amide bond without the necessity of having a protective group. There is also no indication that the inventors of the '682 patent were aware of an activating group with the specific properties that would eliminate the need for use of a protective group.
[36] The discovery of an efficient process in which the amine of the acid does not require protection prior to activation would have been advantageous. If the inventors of the '682 patent had contemplated the reaction scheme to be viable without a protective group, the skilled person would have expected an explicit teaching to this effect.
[37] In order to produce compound CIII, Mayne's process involves the reaction of a reactant referred to in the NOA as "DAMA". Dr. Durst is of the opinion that DAMA is a different compound than the reactant CIa, as it does not feature a carboxylic acid group. Instead, the hydrogen of the carboxylic acid group in DAMA is replaced by a diethylthiophosphoryl group.
[38] The process used by MAYNE eliminates the need to employ a protective group. Dr. Durst explained that the reaction described by the inventors of the '682 patent would probably result in unwanted side reactions if a suitable amino protective group was not used. Such an approach would significantly reduce the "yield", and greatly increase the cost of the desired product. The use of a protective group prevents side reaction from occurring and ensures that the desired reaction proceeds in an efficient manner.
[39] Dr. Durst believed that a person skilled in the art would have understood, upon reading claim 49 in the context of the '682 patent, that the use of a protective group would be necessary in order to successfully carry out the process of claim 49. As opposed to the '682 patent, MAYNE's process uses a reactant that does not require the use of a protective group.
[40] Dr. Durst specified that the goal of all synthetic chemists is to carry out reactions without the use of a protective group. The discovery of procedures that permit this is usually considered novel and worthy of publication as new research. Dr. Durst indicated that, if this had been the case, it would have been featured and taught by examples and brought to practice. It would not have been considered to be an obvious chemical equivalent.
Dr. Durst's Cross-Examination
[41] During his cross-examination, Dr. Durst confirmed that he does not speak French very well but that he can read scientific French (especially chemistry) reasonably well. Moreover, he indicated that he did not read every word of the '682 patent but read what he thought were relevant parts of it.
[42] Dr. Durst mentioned that he did not understand how patents '682 and '284 could have both been granted, as they cover very similar compounds. Furthermore, he was not informed that there was a conflict between patent '682 and '284. He was also not aware that patent '343 led to the issuance of patent '682.
[43] Dr. Durst acknowledged that the use of a protective group is not necessary to obtain the formation of compound CIII. However, he explained that the use of a protective group increases the efficiency of the process and the yield of the desired compound. Therefore, from a practical point of view, the use of a protective group is mandatory.
[44] He indicated that he did not give much weight to the word "may" used in claim 49 with regard to the protective group after having taken into consideration the whole claim. He justified his reasoning by underlining that the use of an activating reagent is not even discussed in Claim 49 even though it is necessary to successfully carry out the reaction. In fact, the only other way to carry out the reaction between 7-ACA and CIa, without the use of an activating reagent, is by elevating the temperature over 200 degrees. This method is not a viable option as the desired compound decomposes. Therefore, even if the use of a reagent is not discussed in claim 49, it is mandatory from a practical point of view.
[45] He alleged that in the pharmaceutical industry the minimum purity has now to be 99.5 per cent. If unwanted side compounds are created as a result of the reaction, a chemist may have to work very hard to purify the desired compound and to reach the level of purity required. This additional step can reasonably be assumed to be difficult and costly. Consequently, it would make that process undesirable and almost impossible to be economically viable.
ANALYSIS
Are the allegations of Mayne on invalidity of the'682 patent justified?
[46] As a preliminary argument, AVENTIS alleges that MAYNE did not address the issue of invalidity in its NOA in a sufficient manner as required under section 5 of the Regulations and that this inadequacy should be enough to issue a prohibition order.
[47] In the alternative, AVENTIS submits that it possesses a valid patent that confers upon it a statutory monopoly over the compound cefotaxime sodium until 2010. AVENTIS argues that the compound formula having the structural formula described in paragraph 6 of the NOA is the same as the compound claimed in at least claims 30 to 36 and 50 of the '682 patent and that MAYNE would be infringing its patent.
[48] In this regard, AVENTIS outlines the fact that MAYNE admitted that the compound described in its NOA is the same as the compound disclosed in claim 30 to 36 and 50 of the '682 patent.
[49] On the other hand, MAYNE argued that the product claims (30 to 36 and 50) are invalid as the substance described in those claims has been in the public domain since 1999 following the expiration of the '343 patent. It alleged that the '682 and '343 patents constitute a double patenting of the cefotaxime sodium.
a) Historical background of the Patent Act
[50] Substantial amendments to the Patent Act were proclaimed effective October 1, 1989. The transitional provisions provided that all applications for a patent having an effective filing date after October 1, 1989 will be treated under the new system and all patents granted prior to October 1989 and all applications filed prior to October 1, 1989 will be treated under the Patent Act as it existed prior to the amendments proclaimed on that date.
[51] Since AVENTIS' application was filed before October 1989, it is to be dealt with under the "old" Patent Act commonly referred to as the "Pre-1989 Patent Act". Under the Pre-1989 Patent Act, there were several important exceptions as to what may be patented. One of those exceptions provided that no patent could be issued for substances that are intended for food or medicine and are prepared by microbiological processes except that the substance may be patented only when prepared by the disclosed method (s.39). (Hughes and Woodley on Patents, (2nd edition), LexisNexis Butterworths, binder 1, section 5, p. 125). Section 39 of the Pre-1989 Patent Act reads as follows:
39. NATURALY OCCURRING SUBSTANCES INTENDED FOR FOOD OR MEDICINE
(1) In the case of inventions relating to naturally occurring substances prepared or produced by, or significantly derived from, microbiological processes and intended for food or medicine, the specification shall not include claims for the resulting food or medicine itself, except when prepared or produced by or significantly derived from the methods or processes of manufacture particularly described and claimed. [1987, c. 41, s.14]
[52] Technically, it means that it would only have been possible for AVENTIS to obtain a patent on the process that leads to the production of cefotaxime sodium and not on the medicine itself.
[53] However, the provisions precluding a patentee from obtaining a patent on a medicine under the Pre-1989 Patent Act were amended on November 19, 1987 to provide, among other things, that these provisions would cease to have effect after November 19, 1991. In other words, after November 19, 1991, it became possible for a patentee to obtain a patent on a medicinal substance.
[54] In this regard, the Patent Appeal Board decided that any patent issued after November 19, 1991, regardless of when it was filed, will be allowed to contain claims to naturally occurring substances with no process limitations (Hughes and Woodley on Patents, (2nd edition), LexisNexis Butterworths, binder 1, section 22, page 181). Therefore, since AVENTIS' patent had not yet been issued in 1991, it was allowed to modify its application in order for it to contain claims of the substance per se. By letter dated January 21, 1993, the Applicant modified its application to include product claims on cefotaxime and its derivatives (Applicant's Record, Vol. 5, p. 1188).
b) Onus of proof
[55] Subsection 43(2) of the Patent Act provides that every patent is granted a statutory presumption that it is valid in the absence of evidence to the contrary. In order to rebut this presumption, the second person needs to adduce evidence to support its invalidity allegations whereupon the first person bears the onus of proving that the allegation of invalidity are, on the balance of probabilities, not justified. In other words, the first person can rely on the presumption of validity until the second person adduces evidence to support its allegation of invalidity; it is only then that the onus of proof "shifts" to the first person (SmithKline Beecham Pharma Inc. v. Apotex Inc., [2001] 4 F.C. 518 at paragraphs 12 to 15, aff'd, [2003] 1 F.C. 118 (C.A.)).
c) Sufficiency of the NOA
[56] The purpose of the Regulations was described by the Federal Court of Appeal in AB Hassle v. Canada (Minister of National Health and Welfare), [2000] F.C.J. No. 855 (QL) at paragraph 16, citing Apotex Inc. v. Canada (Minister of National Health and Welfare) (1997), 76 C.P.R. (3d) 1 (F.C.A.), at paragraph 11:
[¼] The basis purpose of the Regulations is to provide a means by which patents are noted and protected from possible infringement at the instance of the patent-holder. The Regulations thus ensure that an NOC is not issued without a patent-holder having the opportunity to defend its patent. [¼]
[57] Reiterating the comments of Justice Stone in Ab Hassle, supra, Justice Snider in Aventis Pharma Inc. v. Pharmascience Inc., [2005] F.C.J. No. 511 (T.D.) (QL) at paragraph 30, outlined that the purpose of the NOA is to provide sufficient information to the patentee so that it can decide whether to commence an application under the Regulations to prevent the issuance of a NOC. The NOA must be sufficiently detailed to make the patentee fully aware of the grounds upon which the second person claims that there will be no infringement.
[58] In this regard, subsection 5(1) and paragraph 5(3)(a) of the Regulations provide a mechanism for compulsory disclosure. To comply with its statutory obligations, the second person needs to set out the legal and factual basis for its allegation.
[59] This statutory obligation originates from the somewhat unusual procedural scheme established by the Regulations. The Regulations provide that the allegations are to be framed by the second person but that the application for prohibition is to be brought by the first person. Consequently, the first person has to build its application so as to demonstrate that none of the allegations made by the second person is justified. In other words, the first person is forced to deal with the allegations made in the detailed statement provided by the second person (Mayne Pharma (Canada) Inc. v. Aventis Pharma Inc. et al (2005), 38 C.P.R. (4th) 1 (F.C.A.)).
[60] Therefore, if the first person has to plead to the grounds raised in the detailed statement, even though other grounds of infringement or invalidity may exist, it is unfair to allow the second person to raise different grounds in its evidence in reply to the application for prohibition. The second person set the parameters of the dispute in its detailed statement. It cannot then change those parameters after the first person has framed its application to address the issues raised by the detailed statement (Mayne Pharma (Canada) Inc. v. Aventis Pharma Inc. et al (2005), 38 C.P.R. (4th) 1 (F.C.A.)).
[61] In the case at hand, the inadequacy of the NOA is raised by the Applicant as it argues that the Respondent did not clearly indicate that the invalidity of the product claims would be at issue.
[62] In support of its allegations, AVENTIS referred the Court at page 2 of the "Form V: Declaration Re Patent List" (Applicant's Record, Vol.7, p. 1585) where no "X" is marked in the third row besides the allegation of invalidity. Moreover, AVENTIS points to paragraph 4 of the Detailed Statement that accompanies Form V in which it is possible to read that MAYNE's allegations are made pursuant to subparagraph 5(1)(iv) of the Regulations referring to non-infringement. It contends that no reference was made to subparagraph 5(1)(iii) of the Regulations referring to invalidity.
[63] In order to determine if the information provided by the second person is sufficient, the Court must consider the NOA as a whole and must not isolate certain sections or paragraphs to draw its conclusions. After a careful review of the NOA, the Court was able to ascertain that invalidity allegations were made in paragraphs 72 to 83 with respect to claim 30 and that the same arguments were reiterated for claims 31 to 38 and 50 (Applicant's Record, Vol. 7, pages 1617 to 1624 and pages 1636 and 1637). The invalidity allegations read as follows:
71. Claim 30 is directed to a compound of the formula I
(illustration)
dans laquelle R représente un atome d'hydrogène, R' représente un atome d'hydrogène ou un radical alkyle saturé ou insaturé ayant de 1 à 4 atomes de carbone, A représente soit un atome d'hydrogène soit un équivalent de métal alcalin, alcalino terreux, de magnésium ou d'une base organique aminée, le trait ondulésignifie que le groupement OR' se trouve dans la position syn. [emphasis in the original]
72. If formula I includes the compound cefotaxime sodium, then claim 30 must be read to incorporate the process restrictions of claim 1, namely to extend to cefotaxime sodium only when prepared by the process of claim 1. Otherwise, claim 30 is not infringed by reason of being invalid, void or unenforceable, for the reasons set out below.
73. The compound cefotaxime and its salts (including cefotaxime sodium), are in the public domain.
74. By way of example, cefotaxime and cefotaxime sodium were disclosed by, and enjoyed patent protection under Canadian patent 1,121,343 ('343 patent) which issued April 6, 1982 to Roussel-Uclaf. Roussel-Uclaf is likewise the original patentee of the '682 patent, subject to this allegation.
75. Pursuant to the Patent Act as it then was, the term of the '343 patent was seventeen (17) years from the date of its issue. The '343 patent thus expired in 1999. As a consequence, the compound cefotaxime and its sodium salts, passed into the public domain as of the date. The process for making such compounds, as disclosed by the '343 patent, likewise passed into the public domain. The content of the '343 patent is incorporated herein by reference.
76. The application (no. 270,375) that eventually matured as the '682 patent was filed January 21, 1977 and issued to patent June 29, 1993. Its term is seventeen years and will expire in 2010.
77. As of the filing date of the aforesaid application 270,375, chemical compounds having medical or therapeutic usefulness (such as the compounds disclosed and claimed by the '682 patent) could not be claimed per se. Any patent protection for such compounds was restricted to claiming such compounds when prepared by a particular process.
78. The '682 patent disclosed and claims processes to make compounds, including cefotaxime and its salts. The processes of the '682 patent and those of the now expired '343 patent are not identical.
79. By virtue of the expiry of the '343 patent in 1999, the Canadian public became entitled to practice the process taught and claimed by the '343 patent to make compounds including cefotaxime and cefotaxime sodium.
80. If cefotaxime and cefotaxime sodium may be lawfully made using the process of the now expired '343, then it must also be lawful to make such compounds using a process which does not infringe the '682 patent. For the reasons set forth herein, the Mayne Process does not infringe the '682 patent.
81. If the situation is otherwise, a molecule that became public property in 1999 will be effectively removed from the public domain and become subject to an artificial extension of patent monopoly. Such "recapture" is a result which is not contemplated by the purpose and scheme of the Patent Act, nor its underlying public policy.
82. As the cefotaxime sodium made by the Mayne Process does not infringe the processes claimed by the '682 patent, Mayne's cefotaxime sodium must lie outside the scope of claim 30 and will not infringe. If the situation is otherwise, then claim 30 is not infringed by reason of being invalid, or otherwise void and unenforceable. (emphasis added)
83. Moreover, having obtained patent protection for the molecule cefotaxime and its salts when prepared by the process disclosed and claimed by the '343 patent, Roussel-Uclaf cannot obtain subsequent protection for the molecule cefotaxime (and/or its salts) per se. Otherwise, if claim 30 is construed as protecting the compound cefotaxime sodium) (sic) regardless of the process used to make it, then claim 30 is further invalid for double patenting. (emphasis added)
[64] That being said, I am of the opinion that AVENTIS' allegation regarding the insufficiency of the NOA is not justified. When it decided to contest MAYNE's claim construction of the '682 patent, AVENTIS knew that MAYNE was going to argue invalidity for double patenting. It had more than enough information to disprove MAYNE's allegation.
d) Claim Construction
[65] The first step in a patent suit is to construe the claims as they would be interpreted by a person skilled in the art. This "purposive construction" approach is adopted as an antecedent to consideration of both validity and infringement issues. In a recent decision of the Supreme Court of Canada, Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, Binnie, J. reiterated the comments of Lord Diplock in Catnic Components Limited v. Hill & Smith Limited, [1982] R.P.C. 183, at paragraph 44. Lord Diplock described the purpose of claim construction as follows:
My Lords, a patent specification is a unilateral statement by the patentee, in words of his own choosing, addressed to those likely to have a practical interest in the subject matter of his invention (i.e. "skilled in the art"), by which he informs them what he claims to be the essential features of the new product or process for which the letters patent grant him a monopoly. It is those novel features only that he claims to be essential that constitute the so-called "pith and marrow" of the claim. A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. The question in each case is: whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked. [My emphasis]
[66] In Whirlpool Corp., supra, Binnie J. also made the following statement on purposive construction at paragraphs 45 and 48:
The key to purposive construction is therefore the identification by the court, with the assistance of the skilled reader, of the particular words or phrases in the claims that describe what the inventor considered to be the "essential" elements of his invention. [¼]
[...]
[¼] In Catnic, as in the earlier case law, the scope of the monopoly remains a function of the written claims but, as before, flexibility and fairness is achieved by differentiating the essential features ("the pith and marrow") from the unessential, based on a knowledgeable reading of the whole specification through the eyes of the skilled addresses rather than on the basis of "the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge" (Catnic, supra, p. 243).
[67] The above comments underscore the importance of distinguishing essential elements from non-essential elements because there will be no infringement if an essential element is different or omitted, while infringement will still be possible if non-essential elements are substituted or omitted.
[68] The question that consequently lies with the Court is whether the '682 patent is constructed in a way that a person skilled in the art would conclude that it contains a claim on the substance per se or if it only provides a statutory monopoly on the process it describes. In other words, are claims 30 to 36 and 50 defined in a way that captures cefotaxime sodium per se as part of the monopoly?
[69] The scope of the exclusive right is determined by the claims of the patent. The claim is what describes the element of the invention and defines the monopoly the patentee seeks in the application. As mentioned inHughes and Woodley on Patents at page 313, the claims define the scope of the monopoly and may be read in conjunction with the disclosure. The disclosure outlines the nature of the invention for which a monopoly is claimed. The claim may not be broader than the invention disclosed and cannot be used to expand the invention as described in the disclosure.
[70] After a thorough analysis of the '682 patent, the Court is of the opinion that the claims are constructed in a way that provides AVENTIS with statutory monopoly on the compound of cefotaxime and its derivatives. This opinion is supported by Dr. Durst and Professor Wuest, who both agreed and confirmed that the compound cefotaxime sodium as described in paragraph 6 of the NOS falls within the scope of claim 32 to 36 and 50 of the '682 patent.
Professor Wuest
11. The specific compound set out in Paragraph 6 as the active ingredient in the Mayne product, identified unambiguously as outlined above, is within the scope of compounds claimed in Claims 30, 31, 33, 34, 35, 36 and 50 of the '682 patent (Applicant's Record, Vol.6, p. 1249)
Dr. Durst
Is the compound cefotaxime sodium, as described in paragraph 6 of the notice of allegation defined by the claims of the '682 patent?
12. My answer to this question is "yes". I have reviewed the claims of Canadian Patent 1,319,682 ('682 patent) and the declaration of James Wuest. I agree with the conclusions expressed by Prof. Wuest in paragraphs 7 through 11 that the compound described in paragraph 6 of Mayne's notice of allegation is cefotaxime sodium (Applicant's Record, Vol. 7, p. 1528)
[71] Here are some parts of the relevant sections of the '682 patent product claims (Applicant's Record, Vol. 1, pages 108, 118, 155 to 157):
Dans la divulgation principale, la Société demanderesse a décrit et revendique des produits conformes à la formule I, un procédé de préparation de ces produits, leur application comme médicaments, ainsi que des produits industriels nouveaux nécessaires pour la préparation de ces produits.
La Société demanderesse a également décrit et revendiqué des produits conformes à la formule I, un procédé de préparation de ces produits, leur application comme médicaments, les produits industriels nouveaux nécessaires pour la préparation de ces produits, ainsi que des variantes du procédé décrit dans la divulgation principale.
La Société demanderesse a décrit et revendiqué des produits conformes à la formule I, leur application comme médicaments, des produits industriels nouveaux nécessaires pour la préparation des produits de formule IB ainsi que des variantes du procédé décrit dans la divulgation principale.
[...]
La présente divulgation supplémentaire a donc également pour objet, à titre de médicaments et notamment de médicaments antibiotiques, les produits de formule I suivants :[...]
[...]
30. Un produit de formule (I) :
(illustration)
[...]
31. Un produit de formule (IB) :
(illustration )
[...]
50. Un composé de formule (CIII):
(illustration)
[...]
e) Double patenting
[72] MAYNE alleges that AVENTIS' patent protection does not extend to the cefotaxime sodium per se. It alleges that the '682 patent only provides monopoly on the process used to produce cefotaxime and that all claims extending the monopoly to the substance per se are invalid as the cefotaxime sodium has been in the public domain since 1999 with the expiration of the '343 patent. It argues that all claims pertaining to the substance itself are invalid for double patenting.
[73] The principle behind the patent system is that of a bargain between the patentee and the public by which the patentee obtains full monopoly for a period of 20 years over the subject of the claims in exchange for a complete disclosure of how to perform the invention so that the public can freely use it on expiry of the patent term. As a consequence of such a bargain, a patentee cannot "evergreen" or prolong its monopoly beyond what the public has agreed to through successive obvious patents. The double patenting prohibition relates to this "evergreen" problem. A patentee is only entitled to one patent per invention (Whirlpool Corp., supra, at pages 1086 and 1104).
[74] It is trite law that different types of claims exist in the pharmaceutical industry, namely product claims and process claims. Once a patent is obtained for a substance per se, no additional protection may be obtained for the same substance. However, it is nevertheless possible to obtain a patent for the process by which the substance is made independently of the patent on the substance per se. This type of patent is a valid patent and does not extend the statutory monopoly of the patent on the substance per se.
[75] Therefore, if a patentee, different from the one who possesses a patent on the substance per se, obtains a patent on a process, it may own rights on the process but it may not be possible for it to use its process without infringing the patent on the substance per se. In such a case, it needs to get the approval of the other patentee to produce the substance for which it developed a new process of fabrication (if that patent is not already expired).
[76] In the case at hand, MAYNE alleges that cefotaxime sodium was already claimed in patent '343 and that its expiration caused the substance to fall within the public domain. However, a closer look at patent '343 permits the Court to notice that the '343 patent was issued in 1982. Since it was not possible in 1982 to obtain a patent on medicine per se, patent '343 could not have provided statutory monopoly on the cefotaxime sodium. Patent '343 could only have provided protection for the process used to produce cefotaxime sodium. Since it is widely recognized that two patents can exist in parallel, one on the medicine per se and one on the process used to produce that medicine, the argument on double patenting cannot stand as patent '343 never provided monopoly on the substance per se.
CONCLUSION
[77] After a thorough review of all the evidence adduced before the Court, I conclude that Aventis obtained by '682 patent, a monopoly on the product per se (cefotaxime sodium) and that the NOA's allegations on invalidity are not justified. Since MAYNE wants to use the process it described in its NOA to produce cefotaxime sodium, a product covered by the '682 patent, on that basis only, the NOC cannot be issued.
[78] In view of the above conclusions, I do not believe it is necessary to analyseanother issue raised by this application as to whether the process for preparing sterile cefotaxime sodium for injection infringed patent '682.
ORDER
THIS COURT ORDERS that:
1. The application is allowed with costs to the applicant.
2. The Minister of Health is prohibited from issuing a Notice of Compliance to Mayne Pharma (Canada) Inc. in respect of the drug cefotaxime sodium until after the expiration of the Canadian patent number 1,319,682 has expired.
3. The parties asked for a timetable to make written submissions on the matter of costs. The applicant shall serve and file its written representations no later than September 15, 2005. The respondent shall serve and file its written representations no later than September 30, 2005. The applicant shall have until October 11, 2005 to serve and file its reply.
4. An order on costs will follow.
"Michel Beaudry"
JUDGE
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
STYLE OF CAUSE: AVENTIS PHARMA INC.
and
MAYNE PHARMA (CANADA) INC.
and THE MINISTER OF HEALTH and
AVENTIS PHARMA S.A.
John H. Sims, Q.C. FOR RESPONDENT
Deputy Attorney General THE MINISTER OF HEALTH
Montreal, Quebec