Glaxosmithkline Inc. v. Genpharm Inc.

Glaxosmithkline Inc. v. Genpharm Inc.
Court (s) Database
Federal Court Decisions
Date
2003-10-24
Neutral citation
2003 FC 1248
File numbers
T-1755-01
Notes
Digest
Decision Content
Date: 20031024
Docket: T-1755-01
Citation: 2003 FC 1248
BETWEEN:
GLAXOSMITHKLINE INC. and
SMITHKLINE BEECHAM P.L.C.
Applicants
and
GENPHARM INC. and
THE MINISTER OF HEALTH
Respondent
REASONS FOR ORDER
(Confidential Reasons for Order issued on October 3, 2003)
HENEGHAN J.
INTRODUCTION
[1] Glaxosmithkline Inc. and Smithkline Beecham P.L.C. ("GSK" or the "Applicants") seek an order pursuant to section 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the "NOC Regulations"), prohibiting the Minister of Health from issuing a Notice of Compliance ("NOC") pursuant to section C.08.0904 of the Food and Drug Regulations, C.R.C. 1985, c. 870 to Genpharm Inc. ("Genpharm" or the "Respondent") until after the expiry of Canadian letters patent 1,287,060 (the " '060 patent"). Genpharm seeks the issuance of a NOC relative to its tablets of paroxetine hydrochloride ("paroxetine HCL") in strengths of 10 mg, 20 mg and 30 mg.
THE PATENT
[2] The '060 patent, entitled "Crystalline Paroxetine HCL", was filed in the Canadian Patent Office on October 23, 1986. The patent claims priority from applications filed in the British Patent Office on October 25, 1985. The '060 patent was issued by the Canadian Patent Office on July 30, 1991. Since the patent was filed in Canada prior to October 1, 1989, the provisions of the Patent Act, R.S.C. 1985, c. P-4 then in effect, apply.
[3] The '060 patent relates to crystalline paroxetine hydrochloride hemihydrate, and the processes for its preparation and use as a therapeutic agent in a pharmaceutically acceptable form. In this application, GSK has taken issue only with claim 10 of that patent. Claim 10 is a composition of matter claim and reads:
10 Crystalline paroxetine hydrochloride hemihydrate
[4] The '060 patent has received prior consideration by this Court: see the decision of Justice McGillis in Smithkline Beecham Inc. v. Apotex Inc. (1999), 1 C.P.R. (4th) 99 (F.C.T.D.), affirmed (2001), 267 N.R. 101 (F.C.A.). More recently, the '060 patent was discussed in Glaxosmithkline Inc. and Smithkline Beecham P.L.C. v. Apotex Inc. and The Minister of Health, 2003 FCT 687, although the latter case dealt primarily with another patent owned by GSK, that is Canadian letters patent 2,214,575 (the " '575 patent"). This proceeding originally included the '575 patent and Canadian letters patent 2,178,637 (the " '637 patent"). GSK withdrew its application related to these two other patents at the commencement of the hearing, at least in part due to the decision Glaxosmithkline v. Apotex, supra, 2003 FCT 687, released the day before the hearing in this proceeding took place.
PAROXETINE HCL
[5] Paroxetine HCL is a serotonin reuptake inhibitor and is used in the treatment of depression and anxiety. The original patent that first disclosed the medicine paroxetine was U.S. Patent, No. 4,007,196 (the '196 U.S. patent"); that patent was issued on February 8, 1977 to a Danish company called Ferrosan. This patent disclosed a class of compounds that were 5-hydroxtryptamine (5-HT) inhibitors with a therapeutic use as anti-depressants.
[6] Two articles, written by Ferrosan's employees, Lund et al, and published in 1979 and 1982, described paroxetine hydrochloride as a new drug known to have an anti-depressant effect. These articles are attached as Exhibits to the affidavit of Dr. Story, filed in the Applicants' Application Record.
[7] In a subsequent article published in 1988, "Solid-state forms of paroxetine hydrochloride", Buxton et al. described two different forms of paroxetine in solid form:
Paroxetine HCL exists in two solid state forms, differentiated by their degree of hydration. Form I is a non-hygroscopic hemihydrate and is thermodynamically the more stable. Form II is a hygroscopic anhydrate the moisture content of which is controlled by the prevailing humidity. Form II converts to Form I, if seed crystals of Form I are present, when exposed to humid conditions or if subjected to compression.
[8] The chemical compound at issue in this proceeding is in a solid, "crystalline" form. When water is incorporated into the crystalline, it is called a "hydrate". When the ratio of number of molecules of water to the compound is 1:1, the compound is called a "monohydrate". When the ratio is 0.5:1, it is called a "hemihydrate". When no water is present as part of the crystalline structure, the compound is called an "anhydrate". Therefore, crystalline paroxetine hydrochloride hemihydrate refers to a solid crystalline form of paroxetine hydrochloride where there is a half mole of bound water for each mole of paroxetine hydrochloride as a structural part of its crystal lattice. While the anhydrate form has no bound water as part of its crystalline structure, it is hygroscopic, meaning that it has a propensity to attract moisture. The environment in which the anhydrate form of the compound is kept, therefore, can affect the moisture content of the compound. The difference between the anhydrate and hemihydrate forms of paroxetine HCL was discussed by Justice McGillis in Smithkline Beecham Inc. v. Apotex Inc., supra at paragraph 13.
[9] This description says that there is a difference in the crystalline forms of anhydrate and hemihydrate. It has been suggested that this difference is due to the dominance of a more stable form, the hemihydrate, over the less stable form, the anhydrate. This dominance has been said, in this proceeding, to give rise to the phenomenon of "disappearing crystal forms". One explanation tendered for that phenomenon is "seeding", that is the proliferation in the environment of seeds of a given crystalline form.
[10] "Seeding" can be deliberate; that is following the deliberate introduction of seeds of the crystalline form which is sought to be made into the system where the crystallization is occurring. Unintentional seeding occurs when the seeds of a particular crystalline form exist in the environment and contaminate the molecular structure, converting it to the crystalline form of the seeds. The concept of "seeding" is relevant to this proceeding since Genpharm's ability to create an anhydrate form of paroxetine HCL is a critical issue.
THE NOTICE OF ALLEGATION ("NOA")
[11] By letter dated August 17, 2001, Genpharm served a Notice of Allegation ("NOA"), upon GSK regarding the patents pursuant to section 5 of the NOC Regulations. Genpharm alleged that six patents listed by GSK with the Minister are invalid and four will not be infringed by Genpharm's product.
[12] In the NOA, Genpharm stated that it seeks to market tablets for oral administration containing paroxetine HCL in 10, 20 and 30 mg strengths. Genpharm attached two detailed statements to the NOA, one dealing with the '060 patent and the other dealing with the '637 and '575 patents. These attachments set out, in detail, the basis for the allegations contained in the NOA.
[13] Genpharm identifies its intended product as a solvated form of paroxetine hydrochloride anhydrate. Genpharm's tablets are manufactured in Australia using paroxetine HCL anhydrate as the active ingredient. This is mixed with other non-drug components of the formulation, collectively known as "excipients", using a dry compression process.
[14] Genpharm claims that its product will contain anhydrate rather than a hemihydrate form of paroxetine HCL.
[15] On October 4, 2001, the Applicants filed their application with this court for an order pursuant to section 55.2(4) of the Patent Act, R.S.C. 1985, c. P-4 (the "Act") and section 6 of the NOC Regulations prohibiting the Minister from issuing a NOC to the Respondent. In response to Genpharm's NOA, GSK claims that the '060 patent is valid and will be infringed by Genpharm's product.
EXPERT EVIDENCE
[16] Both GSK and Genpharm submitted affidavit evidence, including expert evidence, in support of their respective positions. GSK filed the affidavits from the following experts: Victor W. Jacewicz, John E. Richardson, Kurt Justin Baldwin, Thomas M. Niemczyk, Stephen Byrn and Gerald Brenner.
[17] Genpharm filed the affidavits of the following experts: Michael Story, Antony Godwin, James Durig, Dennis V. Stynes, and Elias Ndzie.
[18] GSK conducted tests of Genpharm's product, specifically of 50 mg of the bulk material manufactured in Australia, non-commercial tablets in strengths of 10 mg, 20 mg and 30 mg, and of the commercial tablets in the 20 mg strength.
[19] The bulk material was tested by Dr. Thomas Niemczyk, an expert in analytical chemistry. He used a technique called partial least squares ("PLS") and analysed infrared spectroscopic data. He concluded that the bulk material contained a detectable amount of hemihydrate, sufficient to cause seeding. In his affidavit, he said:
From my report attached as Exhibit "B", it is clear that Genpharm's bulk material contains some crystalline paroxetine hydrochloride hemihydrate as claimed in claim 10 of the '060 Patent and as described in Figure 2 of the '060 Patent. My experiments showed that crystalline paroxetine hydrochloride hemihydrate is present in the sample of Genpharm's bulk material at a level of 0.18 " 0.08% (0.08 is the standard deviation of five repeat determinations).[1]
[20] Dr. Baldwin, an analytical chemist and expert in spectroscopy, analysed samples of both the non-commercial and commercial tablets. He understood that the non-commercial tablets were quantitatively and qualitatively the same as the commercial tablets. He used the technique of Raman microscopy. He described this as a way of identifying molecular materials by reference to the vibration frequencies of molecules. He characterized this as a sensitive technique for detecting the drug within pharmaceutical tablets because there is usually a stronger Raman signal for the drug than for the typical excipients surrounding it. Identification of molecular material is made by comparing the Raman spectrum with the respective spectra recorded from already characterized and referenced molecular material.
[21] He determined that for the 10 mg non-commercial tablets, between 0.86% and 17.59% showed a "fingerprint" for paroxetine hydrochloride hemihydrate. He found a fingerprint for combined paroxetine hydrochloride hemihydrate and paroxetine hydrochloride anhydrate of between 0.86% and 21.76% in the 10 mg tablets he tested. He did not find any paroxetine hydrochloride hemihydrate in the 20 mg and 30 mg non-commercial tablets.
[22] Dr. Baldwin found paroxetine hydrochloride hemihydrate in all of the 20 mg commercial tablets tested. The amounts varied between 1.00% and 28.57% for paroxetine hydrochloride hemihydrate, and between 3.48% and 48.39% for paroxetine hydrochloride hemihydrate and paroxetine hydrochloride anhydrate.
[23] Dr. Byrn is an expert in solid state chemistry, including crystal chemistry, pharmaceutical chemistry and process, polymorphis and analytical techniques. He reviewed the reports and affidavits of Dr. Niemczyk and Dr. Baldwin who had tested the Genpharm bulk material and tablets, respectively. Dr. Byrn addressed the issue of invalidity of the '060 patent on the basis of obviousness and commented on certain publications relied on by Genpharm in that regard. He concluded that the testing techniques employed by Dr. Niemczyk and Dr. Baldwin were appropriate analytical tools.
[24] Dr. Byrn concluded that a partial presence of crystalline paroxetine hydrochloride hemihydrate in the Genpharm materials, that is the bulk material and tablets, was consistent with the phenomenon of seeding and conversion. Seeding is related to conversion of anhydrate to hemihydrate. He said that any amount present is capable of acting as a seed to promote the growth of crystals of paroxetine hydrochloride hemihydrate.
[25] Dr. Byrn dismissed the argument of invalidity on the basis of anticipation and found that prior to the first preparation of hemihydrate, a person making paroxetine hydrochloride would have produced an anhydrate or amorphous form of paroxetine hydrochloride. That is in contrast with developments after the discovery of the hemihydrate form since that later form affected the ability of the anhydrate to convert. He concluded that the '196 patent and the Lund articles did not teach the making of crystalline paroxetine hydrochloride hemihydrate.
[26] Dr. Jacewicz is a synthetic chemist employed by GSK. He has been involved as a chemist, in developing the crystallization of paroxetine hydrochloride. He addressed the issue of seeding and stated that he believed it was "extremely improbable, if not impossible" to recreate some crystalline forms due to the presence of widespread seeding.
[27] Dr. John Richardson, one of the named inventors of the '060 patent, filed an affidavit in which he described the discovery of the crystalline paroxetine hydrochloride hemihydrate in mid-December 1984. At the time, Dr. Richardson and others were preparing batches of paroxetine hydrochloride. The first 22 batches were of paroxetine hydrochloride anhydrate but batch 23 unexpectedly revealed the crystal form of the hemihydrate. This new form was found to be stable and non-hygroscopic, with a consistent water content. Subsequently, Dr. Richardson and other scientists with GSK were unable to produce the hygroscopic anhydrate since the process would only yield crystalline paroxetine hydrochloride hemihydrate.
[28] Dr. Brenner, an organic chemist with particular experience with crystalline and polymorph forms of compounds, was asked to provide an opinion about the allegations of invalidity raised by Genpharm relative to the '060 patent. In that report, he reviewed certain material including the decision of Justice McGillis in Smithkline Beecham Inc. v. Apotex, supra, the affidavits of Dr. Richardson, Dr. Jacewicz, Dr. Niemczyk and Dr. Baldwin, and Genpharm's formulation process. He commented on seeding and conversion. He interpreted claim 10 of the patent as follows:
In light of the above, I interpret Claim 10 to include crystalline paroxetine hydrochloride hemihydrate made by any process, including but not limited to, crystallization or recrystallization, with or without seeding, unintentional or otherwise, and conversion from paroxetine hydrochloride anhydrate with pressure or over time.
[29] He expressed the opinion that the '060 patent was valid, notwithstanding the '196 patent and the two Lund articles. He also concluded that the '060 patent would be infringed by Genpharm's product, on the basis that there is sufficient water in the Genpharm bulk material to permit conversion of approximately 86% of that material to crystalline paroxetine hydrochloride hemihydrate. He concluded, based on the testing done by Drs. Niemczyk and Baldwin, that Genpharm's product would infringe the '060 patent because "some" crystalline paroxetine hydrochloride hemihydrate was detected in the bulk material, as well as the non-commercial and commercial tablets.
[30] He dismissed the experiments conducted by Genpharm as set out in a document called "Investigations", dated March 29, 2001, primarily on the basis that these tests were conducted after the appearance of the new polymorph, that is the crystalline paroxetine hydrochloride hemihydrate because the new more stable polymorph, by the process of seeding, would negatively affect the ability to successfully make the older, less stable polymorph, that is the anhydrate of paroxetine hydrochloride. Dr. Brenner commented upon the opportunity for the likelihood of conversion of Genpharm's bulk material to crystalline paroxetine hydrochloride hemihydrate.
[31] Genpharm responded to the expert evidence tendered by GSK with parallel experts. In response to Dr. Niemczyk and Dr. Baldwin, it filed the affidavit of Dr. Durig, an analytical chemist with experience in infrared and Raman spectroscopy. He was asked to comment on the three tests described in the '060 patent as characterizing the paroxetine hydrochloride hemihydrate and their use at the date when the '060 patent was issued, that is July 30, 1991. As well, he commented on the technique of Raman microscopy and described it as a laboratory tool, rather than an analytical tool. He said it is less sensitive than infrared.
[32] Dr. Durig also reviewed the Drug Master File ("DMF") for paroxetine HCL anhydrate which he understood to be the raw material for the Genpharm products. He expressed the opinion that the Genpharm raw material, according to the charts in the DMF, is not paroxetine hydrochloride hemihydrate and further, that there is no evidence that the raw material contains paroxetine hydrochloride hemihydrate.
[33] Dr. Durig referred to testing of the Genpharm raw material according to all three methods described in the '060 patent, that is infrared spectroscopy, Differentiated Scanning Caliometry ("DSC") and x-ray diffraction. These results are included in Genpharm's DMF. He compared the results in the DMF with the data for the same tests according to the '060 patent and found differences between the Genpharm raw material and the material described in the '060 patent. He described the difference, in relation to the DSC, as "substantial", and in respect of the x-ray diffraction, as "huge". He concluded, on the basis of the differences noted when the methods of the '060 patent were employed on the Genpharm raw material, that the raw material being analysed was not the same as the material described in the patent.
[34] Dr. Durig also commented on the affidavits of Dr. Niemczyk and Dr. Baldwin. In the case of Dr. Niemczyk, he criticized his choice of analytical tool, that is the PLS type of infrared analysis. He said it was not suitable for micro-analysis, that is less than 1%, where there are large variants in the sample. He also criticized the conclusions of Dr. Niemczyk as to the amount of paroxetine hydrochloride hemihydrate present in the Genpharm bulk material, that is 0.18% "0.11%. Dr. Durig expressed other criticisms of Dr. Niemczyk's methodology and conclusions.
[35] Dr. Durig similarly criticized the choice of analysis made by Dr. Baldwin, that is the Raman microscopy. He says this method is not identified in the '060 patent as a means for identifying paroxetine hydrochloride hemihydrate. He also notes the difference in the results found by Dr. Baldwin in his analysis of the tablets, when some paroxetine hydrochloride hemihydrate was detected in the 10 mg non-commercial tablets, none in the 20 mg and 30 mg non-commercial tablets, and "some" in all of the 20 mg commercial tablets. Dr. Durig says these results are so different from the test results found by Dr. Niemczyk in his analysis of the bulk material that procedures of neither expert are reliable.
[36] Dr. Stynes, a chemist with expertise in organic chemistry and crystalline forms, addressed the issue of disappearing crystal forms and commented on GSK's evidence in that regard, particularly the affidavits of Dr. Jacewicz, Dr. Richardson and Dr. Brenner. He dismissed the theory of disappearing polymorphs saying that there was no scientific basis in theory or practice for that proposition. In particular, he commented on a prior publication by Dr. Jacewicz in which the author "debunked" the theory of disappearing polymorphs. Dr. Stynes also expressed the opinion that it is still possible to create the previously existing form, that is the anhydrate form of paroxetine hydrochloride and if it is not, that is due to the activities of GSK who have contaminated the environment with the hemihydrate, apparently without the possibility of containment.
[37] Dr. Story is a chemist and currently a consultant to the pharmaceutical industry. He prepared the Detailed Statement concerning the '060 patent that is attached to Genpharm's NOA. He expressed the opinion that claim 10 of the patent was anticipated by the prior art, specifically the '196 patent and the two Lund articles. He concluded that, for this reason, the '060 patent is invalid.
[38] Dr. Story also commented on the evidence of Dr. Byrn, Dr. Brenner, Dr. Jacewicz and Dr. Richardson relative to the '060 patent. He disagreed with their conclusions, especially the conclusion as to the "disappearance" of the anhydrate form.
ISSUES
1. Is the NOA deficient?
2. How should claim 10 of the '060 patent be construed?
3. Is Genpharm's allegation that the '060 patent is invalid, justified?
A) Obviousness
B) Anticipation
4. Is Genpharm's allegation that its product will not infringe the '060 patent, justified?
NATURE OF THIS PROCEEDING
[39] This application seeks to prohibit the issuance of a NOC to the Respondent for its product which contains crystalline paroxetine hydrochloride anyhydrate. The Applicants challenge the Respondent's NOA on the grounds that the allegations of invalidity and non-infringement of the '060 patent are not justified.
[40] A NOC grants marketing approval for drugs in Canada. It is issued by the Federal Government, indicating that all requirements have been met pursuant to the Food and Drug Regulations for the protection of public health and safety. The NOC Regulations authorize owners of existing patents for pharmaceutical products to file a "patent list" relative to those products for which they hold a NOC. The NOC Regulations refer to the person filing such a list as the "first person". In this case, the Applicants are the "first person".
[41] The framework of the NOC Regulations allows generic drug manufactures to rely on prior approval of related pharmaceutical products in applying for marketing approval of their generic form of the products. Manufacturers who produce the same drug may file application for a NOC that refers to and relies on the fact that prior approval has been granted for the brand- name version of the drug. Such a manufacturer is known to as the "second person" and that is the Respondent's status.
[42] The NOC Regulations prohibit the Minister of Health from issuing a NOC until all relevant product and use patents in the earlier approved medicine, as described in the patent list, have expired. Consequently, a second person must either wait until patent expiry before receiving a NOC or it may submit a NOA to the Minister with its new drug submission.
[43] The NOC Regulations require service of the NOA upon the first person. Section 5 sets out the grounds upon which an NOA is to be based. Briefly, the NOA must assert either that the first person is not the patentee, that the patent is expired or invalid, or that it would not be infringed if a NOC were issued.
[44] Following service of the NOA, the Minister may issue a NOC to the second person, unless the first person avails of its right, pursuant to section 6(1) of the NOC Regulations, to seek an order from the Federal Court of Canada prohibiting the Minister from issuing the NOC. Any such step must be taken by the first person within 45 days after receipt of the NOA and once such a proceeding is commenced, the issuance of a NOC to the second person is stayed for a maximum period of twenty-four months.
[45] Before addressing the specific aspects of this case, I will briefly address the jurisprudence applicable to the burden of proof and the question that must be answered in a NOC proceeding. It is well-established that the burden of proving that the second person's, that is, Genpharm's, allegations are not justified is on the person seeking the prohibition order, GSK. GSK must establish, on a balance of probabilities, that Genpharm's allegations are not justified. Genpharm must put its allegations "in play" through its NOA. However, once that has been done, GSK bears the burden of proving that such allegations are not justified, on a balance of probabilities: see Eli Lilly Co. v. Nu-Pharm Inc. (1996), 69 C.P.R. (3d) 1 (F.C.A.), Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.) and SmithKline Beecham Pharma Inc. v. Apotex Inc., [2001] 4 F.C. 518 (T.D.), aff'd (2002), 291 N.R. 168 (F.C.A.).
[46] Second, the Court must determine whether Genpharm's allegations of invalidity and non-infringement are justified or not. In Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 209 (F.C.A.), the Federal Court of Appeal commented upon the standard to be applied in this type of proceeding, at page 216:
..these proceedings are not actions for determining validity or infringement: rather they are proceedings to determine whether the Minister may issue a notice of compliance. That decision must turn on whether there are allegations by the generic company sufficiently substantiated to support a conclusion for administrative purposes (the issue of a notice of compliance) that the applicant's patent would not be infringed if the generic's product is put on the market....
SUFFICIENCY OF THE NOA
[47] Sections 5(1) and 5(3)(a) of the NOC Regulations provide as follows:
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 on the basis of pharmaceutical and, where applicable, bioavailability characteristics 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, the person shall, in the submission, with respect to each patent on the register in respect of the other drug,
(a) state that the person accepts that the notice of compliance will not issue until the patent expires; or
(b) allege that
(I) the statement made by the first person pursuant to paragraph 4(2)(c) is false,
(ii) the patent has expired,
(iii) the patent is not valid, or
(iv) 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 that person of the drug for which the submission for the notice of compliance is filed. ...
5. (1) Lorsqu'une personne dépose ou a déposé une demande d'avis de conformité pour une drogue et la compare, ou fait référence, à une autre drogue pour en démontrer la bioéquivalence d'après les caractéristiques pharmaceutiques et, le cas échéant, les caractéristiques en matière de biodisponibilité, cette autre drogue ayant été commercialisée au Canada aux termes d'un avis de conformité délivré à la première personne et à l'égard de laquelle une liste de brevets a été soumise, elle doit inclure dans la demande, à l'égard de chaque brevet inscrit au registre qui se rapporte à cette autre drogue :
a) soit une déclaration portant qu'elle accepte que l'avis de conformité ne sera pas délivré avant l'expiration du brevet;
b) soit une allégation portant que, selon le cas :
(I) la déclaration faite par la première personne aux termes de l'alinéa 4(2)c) est fausse,
(ii) le brevet est expiré,
(iii) le brevet n'est pas valide,
(iv) aucune revendication pour le médicament en soi ni aucune revendication pour l'utilisation du médicament ne seraient contrefaites advenant l'utilisation, la fabrication, la construction ou la vente par elle de la drogue faisant l'objet de la demande d'avis de conformité. ...
5(3) Where a person makes an allegation pursuant to paragraph (1)(b) or (1.1)(b) or subsection (2), the person shall
(a) provide a detailed statement of the legal and factual basis for the allegation; ...
5(3) Lorsqu'une personne fait une allégation visée aux alinéas (1)b) ou (1.1)b) ou au paragraphe (2), elle doit :
a) fournir un énoncé détaillé du droit et des faits sur lesquels elle se fonde; ...
[48] Does Genpharm's NOA comply with this requirement of the NOC Regulations, by setting out the legal and factual basis for its allegations of invalidity and non-infringement?
[49] The Federal Court of Appeal in AB Hassle v. Canada (Minister of National Heath and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.), stated at paragraph 23:
The respondent suggests that the list of prior art in the detailed statement was not intended to be exhaustive, hence the presence of the word "including", so that the way was left open to add to that list in the section 6 proceeding. I am of the view, however, that paragraph 5(3)(a) does not contemplate such possibility. The intent appears to be that the entire factual basis be set forth in the statement rather than be revealed piecemeal when some need happens to arise in a section 6 proceeding. This Court has cautioned persons in the position of the respondent that they assume a risk that a particular allegation may not be in compliance with the Regulations and that the deficiency cannot be cured by the Court in a section 6 proceeding....
[50] The Applicants, relying on AB Hassle, supra, as well as Hoffman-La Roche Ltd. et al. v. Apotext Inc. et al. (1997), 72 C.P.R. (3d) 480 (F.C.T.D.), aff'd (1998), 82 C.P.R. (3d) 284 (F.C.A.) say that the Respondent failed to include certain issues in the NOA, that are now raised in legal argument. Consequently, GSK argues that Genpharm should not be permitted to allege that new pieces of prior art, not mentioned in its NOA, invalidate the '060 Patent. GSK also argues that the NOA is deficient in not mentioning the sections of the legislation upon which Genpharm intended to rely.
[51] The Respondent argues that the NOA, including the detailed statement pertaining to the claims in the '060 patent, is not insufficient in the sense that GSK is not left unaware of the real grounds of the Respondent's allegations that the patent would not be infringed and that the patent is invalid. The Respondent relies on the case of Merck Frosst Canada Inc. et al. v. Minister of Health et al. (2000), 8 C.P.R. (4th) 87 (F.C.T.D.), aff'd (2001), 12 C.P.R. (4th) 447 (F.C.A.). In that case Justice Muldoon stated as follows at paragraph 10:
In response to the applicants' charge, counsel for Alcon pointed to several allegations of fact in the NOA which, he alleged, could ground a claim of non-infringement, if assumed to be true. In particular, he pointed to the following allegations: that Alcon's product contains xanthan gum, that xanthan gum does not undergo a liquid-to-gel phase transition in situ, that any gelation does not occur due to the presence of ions and that the applicants have admitted the second alleged fact. As the applicants submit, these allegations are not fraught with precision. They do, however, suit the purposes of paragraph 5(1) (a) of the Regulations. This is because they support, assuming them to be true, Alcon's claim of non-infringement. They also define the issues or the arena in which the applicants would have to fight Alcon's claim of non-infringement if they were so to choose. The claim of non-infringement, in other words, is not a mere bald assertion.
[52] The Respondent argues that once an Applicant makes arguments in a NOC proceeding, the Respondent must be allowed to file responding evidence. The evidence which the Applicants maintain is new evidence that should not be permitted should therefore be seen as evidence filed in response to the Applicants' evidence and argument. This was recognized by Justice Muldoon in Merck Frosst, supra, at paragraph 11.
[53] After a review of the NOA, which includes a detailed statement written by Dr. Story, I conclude that the NOA sufficiently sets out the factual and legal basis for the Respondent's allegations.
[54] The Detailed Statement filed by the Respondent clearly raises allegations of invalidity on the grounds of anticipation and novelty, in relation to claim 10. The Detailed Statement refers to three pieces of prior art in relation to the allegation of anticipation. The Detailed Statement refers to the same three pieces of prior art and two other U.S. patents in relation to the allegation of obviousness.
[55] As well, the Detailed Statement raises the issue of non-infringement. Although there is no specific reference to the argument about the applicability of the maxim de minimus in assessing the question of infringement, in my opinion that argument is inherent in the general allegation of non-infringement. Indeed, the Applicants have argued that any infringement is prohibited and they are not caught by surprise by the refinement represented by the de minimus argument.
[56] The Applicants devoted much argument to the alleged failure of the Respondent to address section 27(1)(a) of the pre-1989 Act. The Applicants advanced submissions to deal with this statutory provision.
[57] The Detailed Statement clearly sets forth the section 27(1) grounds for alleged anticipation of claim 10 as follows:
To determine whether an invention is novel one must ask the following questions:
a) Was the invention known or used by another, before the date that the named inventors made their invention? The date is presumably, for lack of other evidence, the Priority Date, October 25, 1985.
b) Was the invention described in any other patent or publication printed in Canada or any other country more than two years before filing of the patent application that is before October 23, 1984?
c) Was the invention used publicly or sold in Canada more than two years before the date of application, that is before October 23, 1984?
With regard to the question (b) above, in order for an invention to be anticipated by a prior published document all its essential features must be disclosed in a single document.
[58] The fact that the Detailed Statement does not specifically mention "section 27(1)" is not fatal. This criticism about the sufficiency of the NOA fails.
[59] Accordingly, I find that the NOA, including the Detailed Statement, meets the test for sufficiency as described in the relevant jurisprudence. The affidavit evidence filed by the Respondent was responding to the evidence and argument filed by the Applicants. As held in Merck Frosst, supra, this must be permitted to allow for the adversarial process to function properly.
CONSTRUCTION OF CLAIM 10 OF THE '060 PATENT
[60] The first step in determining whether Genpharm's allegations of non-infringement and invalidity are justified is to construe the disputed claim of the '060 patent. As held by the Supreme Court of Canada in Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067 and Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024, the patent claim is to be construed in a "purposive" way and the Court must look at the entire specification of the patent in order to understand the words as stated in a disputed claim.
[61] At page 1098 of Whirlpool, supra, Justice Binnie for the Supreme Court of Canada stated as follows:
I have already given my reasons for concluding that to the extent the appellants are arguing for a simple "dictionary" approach to construction of the '803 claims, it must be rejected. In Western Electric Co. v. Baldwin International Radio of Canada, [1934] S.C.R. 570, the Court cited earlier authority dealing with the word "conduit" as used in a patent claim. Duff C.J. at p. 572 accepted the proposition that "[y]ou are not to look into the dictionary to see what 'conduit' means, but you are to look at the specification in order to see the sense in which the patentees have used it". In Consolboard, supra, as mentioned, Dickson J. considered that the whole of the specification (including the disclosure and the claims) should be looked at "to ascertain the nature of the invention" (p. 520). To the same effect is the statement of Taschereau J. in Metalliflex Ltd. v. Rodi & Wienenberger Aktiengesellschaft, [1961] S.C.R. 117, at p. 122:
The claims, of course, must be construed with reference to the entire specifications, and the latter may therefore be considered in order to assist in apprehending and construing a claim, but the patentee may not be allowed to expand his monopoly specifically expressed in the claims "by borrowing this or that gloss from other parts of the specifications".
More recently, Hayhurst, supra, at p. 190, cautioned that "[t]erms must be read in context, and it is therefore unsafe in many instances to conclude that a term is plain and unambiguous without a careful review of the specification". In my view, it was perfectly permissible for the trial judge to look at the rest of the specification, including the drawing, to understand what was meant by the word "vane" in the claims, but not to enlarge or contract the scope of the claim as written and thus understood.
[62] The Applicants say that pursuant to Beecham Canada Ltd. v. Procter & Gamble Co. (1982), 61 C.P.R. (2d) 1 (F.C.A.), the meaning of claim 10 of the '060 patent is clear and unambiguous and therefore, there is no need to refer to the disclosure of the patent in order for this Court to construe the claim. In that case, Urie J.A. stated as follows at page 9:
From these general propositions it is next necessary to recall that the claims define the scope of the monopoly and may be read with the disclosure in the earlier part of the specification "in order to understand what the former says": see Noranda Mines Ltd. v. Minerals Separation North American Corp. (1949), 12 C.P.R. 99, [1950] S.C.R. 36 at p. 56, 9 Fox Pat. C. 165 [affirmed 15 C.P.R. 133, 12 Fox Pat. C. 123]. That this is the proper method to be used in construing claims is apparent from the following passage in the well-known case of Electric and Musicial Industries, Ltd. et al. v. Lissen, Ltd. et al. (1939), 56 R.P.C. 23, wherein Lord Russell of Killowen at pp. 41-2 had this to say:
But I know of no canon or principle which will justify one in departing from the unambiguous and grammatical meaning of a claim and narrowing or extending its scope by reading into it words which are not in it; or which will justify one in using stray phrases in the body of a Specification for the purpose of narrowing or widening the boundaries of the monopoly fixed by the plain words of a claim.
[63] The Applicants also rely on Whirlpool, supra, and argue that it supports their submission that claim 10 is unambiguous and the specification of the patent should not be looked at to "enlarge or contract the scope of the claim".
[64] The Respondent argues that claim 10 must be read in the context of the entire patent specification and the most recent Supreme Court of Canada jurisprudence supports this approach. If GSK's submission is accepted, the Respondent says that this would mean that claim 10 of the '060 patent would apply to any minute quantity of crystalline paroxetine hydrochloride hemihydrate found in anything, anywhere, at any time.
[65] The Respondent also argues that construing claim 10 by reference to the specification of the patent results in the conclusion that "crystalline paroxetine hydrochloride hemihydrate", as defined by claim 10, can only encompass such substance that can be found through the detection techniques that existed as of July 1991, the date the Canadian patent was granted. Otherwise, if the Applicants can rely on other testing techniques that are not mentioned in the patent specification, they are effectively relying on after-acquired knowledge to expand the scope of the patent.
[66] In construing the claim in issue, the Court must identify the essential elements of that claim. Again I refer to Whirlpool, supra, where Justice Binnie stated at paragraph 45:
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...
[67] In the present case, that task is challenging since the claim contains only four words and reads as follows: "crystalline paroxetine hydrochloride hemihydrate". The determination of the essential elements of the claim is to be done on the basis of the common kno