[1] Wyeth-Ayerst Canada Inc. (Wyeth-Ayerst) and American Cyanamid Company (Cyanamid), pursuant to the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 amended by SOR/98-166 and SOR/99-397 (the Regulations), seek an order prohibiting the Minister of Health (the Minister) from issuing a Notice of Compliance (NOC) to the respondent Faulding (Canada) Inc. (Faulding) with respect to the medicine piperacillin sodium (the brand name is piperacil) having a strength per unit of 2g, 3g and 4g until the expiration of Canadian Patent 1209477 (the '477 patent).
[2] Lederle-Cyanamid Canada Inc.(Lederle) submitted patent lists to the Minister that included the '477 patent. Wyeth-Ayerst is the corporate successor to Lederle and Cyanamid is the owner of the '477 patent.
[3] The issue to be determined is the extent to which the applicants can rely on the presumption set out in subsection 6(6) of the Regulations.
The Patent
[4] The '477 patent is entitled "Composition of Matter Comprising a Lyophilized Preparation of a Penicillin Derivative". It issued August 12, 1986 and expires August 12, 2003. It covers a lyophilized (freeze-dried) pharmaceutical preparation containing a penicillin derivative, known as piperacillin sodium, which has therapeutic utility as an antibacterial agent.
[5] The patent has 4 claims as follows:
1. A process for the preparation of a pharmaceutical parenteral dosage unit comprising a lyophilized penicillin derivative, said process comprising:
(a) preparing a solution of said penicillin derivative in water at a concentration of 125 mg/ml;
(b) filling said solution into a container to the desired amount; and
(c) freezing and lyophilizing said penicillin derivative in said container, thereby providing a light, fluffy lyophilized product which upon reconstitution to a concentration of 400 mg/ml with a pharmaceutically acceptable diluent will go into solution rapidly and completely.
2. The process of claim 1 wherein said penicillin derivative is 6-[2-(4-ethyl-2, 3-di-oxo-1-piperazinecarboxamido)-2-phenylacetamido]-3, 3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, sodium salt.
3. A pharmaceutical parenteral dosage unit comprising a light, fluffy lyophilized penicillin derivative which upon reconstitution to a concentration of 400 mg/ml with a pharmaceutically acceptable diluent will go into solution rapidly and completely when prepared by a process as claimed in claim 1 or an obvious chemical equivalent thereof.
4. A preparation as claimed in claim 3 wherein the penicillin derivative is 6-[2- (4-ethyl-2, 3-di-oxo-1-piperazinecarboxamido)-2-phenylacetamido]-3, 3-dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2-carboxylic acid, sodium salt when prepared by a process as claimed in claim 2 or an obvious chemical equivalent thereof.
[6] Claims 1 and 2 of the '477 patent are directed to a process for the preparation of a freeze-dried penicillin derivative (piperacillin sodium). Claims 3 and 4 are directed to a pharmaceutical parenteral (injectable) dosage unit comprising a light fluffy freeze-dried penicillin derivative (piperacillin sodium) that is prepared by the processes of claim 1 or claim 2.
The Notice of Allegation (the NOA)
[7] Faulding filed a Form V NOA dated December 29, 2000 alleging that its proposed piperacillin sodium product would not infringe the '477 patent. The NOA was accompanied by the requisite detailed statement of the legal and factual basis for the NOA. It is convenient, for ease of reference, to reproduce the detailed statement.
This is a notice of allegation pursuant to section 5 of the Patented Medicines (Notice of Compliance) Regulations.
Faulding (Canada) Inc. ("Faulding") is seeking a Notice of Compliance for Piperacil for Injection ("Faulding product") having a strength per dosage unit of 2g, 3g and 4g.
The Faulding product is a lyophilized pharmaceutical preparation wherein the active ingredient is piperacillin sodium. The preparation is administered by way of injection upon reconstitution of the lyophilizate.
The Faulding product is manufactured for Faulding by a supplier. The supplier advises that the process used for the manufacture of the Faulding product comprises the preparation of a solution of piperacillin sodium in water for injection wherein the solution has a minimum concentration of piperacillin sodium of 200 mg/ml. The solution is then filtered and lyophilized to yield dosage units in the form of a lyophilized cake.
Faulding hereby alleges that Canadian Patent 1,209,477 (" '477 patent") entitled "Composition of Matter Comprising a Lyophilized Preparation of a Penicillin Derivative" will not be infringed by issuance to Faulding of a Notice of Compliance for the Faulding product. In particular, Faulding alleges pursuant to section 5(1)(iv) of the Regulations 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 of the Faulding product.
The legal and factual bases for the allegation in the foregoing paragraph are as follows:
1. The '477 patent is directed to a pharmaceutical preparation, namely a lyophilized parenteral dosage unit of the penicillin derivative 6-[2-(4-ethyl-2, 3-di-oxo-1-piperazinecarboxamido)-2-phenylacetamido] -3,3-dimethyl-7-oxo-4-thia-1-azabicyclo [3-2-0] heptane-2-carboxylic acid, sodium salt ("piperacillin sodium") and to a process for making the aforesaid dosage unit.
2. Lyophilized parenteral dosage units of piperacillin sodium are not novel, per se. The specification of the '477 patent discloses that the conventional procedure for preparing a lyophilized parenteral dosage unit of piperacillin sodium involves preparing a 200 mg/ml aqueous solution of piperacillin sodium, filling the solution into a vial at 5 ml per vial, and then lyophilizing the contents of the vial (page 1, lines 21-27).
3. The '477 patent teaches that conventional lyophilized parenteral dosage units of piperacillin sodium as described in the foregoing paragraph have disadvantages. In particular, the '477 patent alleges that the aforesaid conventional dosage units are less convenient to administer to a patient because upon reconstitution of the lyophilizate for injection, the resultant injection volume is high and is difficult to conveniently and painlessly administer to a patient ('477 patent, page 1, line 27 - page 2, line 10).
4. The '477 patent further discloses that the foregoing difficulties with parenteral administration can be overcome by providing "a more concentrated final product". However, the patent also teaches that a more concentrated product is more time consuming to reconstitute from the lyophilizate. ('477 patent, page 2, lines 16-25).
5. The '477 patent claims to have overcome the foregoing disadvantages by providing:
". . . a lyophilized parenteral dosage unit form of piperacillin and similar penicillin derivatives which provide a highly concentrated but easily reconstituted final product" ('477 patent, page 2, lines 26-30).
6. The lyophilized parenteral dosage unit form purportedly disclosed and claimed by the '477 patent is characterized by a "loose, fluffy, expanded cake of a penicillin derivative" (i.e. piperacillin sodium). The patent specifically defines the term "expanded cake":
"The term "expanded cake" means a lyophilized cake which occupies a larger volume than that taken up by the "standard cake" of the prior art". ('477 patent, page 3, lines 1-3).
7. The '477 patent has four claims, only one of which (claim 1) is independent. Claim 1 provides:
"A process for the preparation of a pharmaceutical parenteral dosage unit comprising a lyophilized penicillin derivative, said process comprising:
(a) preparing a solution of said penicillin derivative in water at a concentration of 125 mg/ml.
(b) filling said solution into a container to the desired amount; and
(c) freezing and lyophilizing said penicillin derivatives in said container, thereby providing a light, fluffy lyophilized product which upon reconstitution to a concentration of 400 mg/ml with a pharmaceutically acceptable diluent will go into solution rapidly and completely."
8. Claim 2 is a process claim that depends from claim 1 (thereby incorporating the requirements and restrictions of claim 1) and introduces the further restriction that the penicillin derivative is piperacillin sodium.
9. Claim 3 is directed to a pharmaceutical parenteral dosage unit comprising a light, fluffy lyophilized penicillin derivative prepared by the process of claim 1 or an obvious chemical equivalent thereof.
10. Claim 4 is dependent upon claim 3, thereby incorporating its requirements and restrictions, and is directed to the pharmaceutical preparation claimed in claim 3 where the penicillin derivative is piperacillin sodium, and is prepared using the process of claim 2 or a chemical equivalent thereof.
11. Accordingly, all four claims of the '477 patent require and incorporate the process described in claim 1. The '477 patent concedes that the process steps (b) and (c) set out in claim 1 are conventional. Accordingly, any inventive aspect must reside in the first process step (a), which provides that the initial concentration of the precursor solution from which the aforesaid light, fluffy lyophilized cake is generated is 125 mg/ml and therefore lower than the concentration of the precursor solution (200 mg/ml) used to make a conventional lyophilized dosage form of piperacillin sodium.
12. The Faudling product is made using a process wherein the precursor solution of the lyophilizate has a piperacillin sodium concentration of at least 200 mg/ml, which is the concentration acknowledged by the patent to be within the prior art. The process described in the '477 patent is distinguished from the prior art because it features a precursor solution with a substantially lower starting concentration of piperacillin sodium (125mg/ml). The patent teaches that it is the use of this lower, starting concentration of piperacillin sodium that yields an expanded cake as a finished product, thereby overcoming the disadvantages of the prior art.
13. The Faulding product is made using a process that features a starting concentration of piperacillin sodium that is much higher than 125 mg/ml. Indeed, the starting concentration is at least 200 mg/ml, which is a concentration falling within the prior art and hence outside the scope of the patent. Consequently, the Faulding product does not infringe the '477 patent.
[8] The detailed statement accompanying the NOA explained that the basis for the allegation of non-infringement was, inter alia, that Faulding's proposed piperacillin product would be made using a starting concentration of at least 200 mg/ml.
The Aftermath
[9] Faulding forwarded the NOA and accompanying detailed statement to the applicants on December 29, 2000. On January 19, 2001, the applicants requested that Faulding, not later than January 26, 2001, provide to the applicants complete and detailed process information in respect of Faulding's proposed product, including a copy of the relevant documents confirming the details of the process, to enable them to evaluate Faulding's allegation with a view to possibly avoiding litigation. On January 30, 2001, Faulding responded that its detailed allegation provided the factual basis explaining why the Faulding product fell outside the patent and that it was sufficient.
[10] By correspondence dated February 2, 2001, the applicants referred Faulding to the presumption of infringement in subsection 6(6) of the Regulations and opined that in view of the presumption's application, as a practical matter, Faulding ought to produce the requested information given that it would be required to make such disclosure should a court application be filed. Faulding did not produce the requested information.
[11] The applicants commenced this proceeding under subsection 6(1) of the Regulations on February 9, 2001. The supporting affidavit of Robert McCluggage, sworn and filed February 19, 2001, attests to the facts just stated in paragraphs 9 and 10 and tenders the following exhibits as evidence: Lederle Patent Lists pertaining to piperacillin sodium for injection having a strength per unit of 2g/vial, 3 g/vial and 4 g/vial (Exhibit A); Subsequent Patent Lists submitted to identify Wyeth-Ayerst on Patent Register as the first person under the NOC Regulations (Exhibit B); Certified Copy of Canadian Patent 1,209,477 (Exhibit C); Notice of Allegation with Detailed Statement dated December 29, 2000 (Exhibit D), and correspondence between counsel with respect to requests for process information (Exhibit E). The affidavit neither addresses nor challenges the factual or legal basis of Faulding's NOA. Rather, the affiant deposes that "the applicants have no knowledge of the existence, date of filing, or contents, of any regulatory submission on behalf of Faulding in respect of the products referred to in the NOA". Mr. McCluggage was not cross-examined on his affidavit. Faulding did not file any affidavit evidence.
The Positions of the Parties
The Applicants
[12] The applicants framed the question in terms of whether Faulding's allegation of non-infringement is justified on the legal and factual basis provided, namely, that the patent covers a product made by a certain process and Faulding's product will not be made by such a process. Specifically, they identified the issue as: whether Faulding has rebutted the statutory presumption that Faulding's product is made by the process described and claimed in the '477 patent.
[13] The applicants, following an informative, general overview of the provisions of the Regulations, rely on Bayer Inc. v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 285 (F.C.A) and submit that while an applicant, as the initiator of the proceeding, generally bears the burden of proving that an allegation is not justified, a statutory presumption has the effect of displacing the burden of proof. If the second person adduces no evidence to rebut the presumption, the applicant can succeed on the basis of the statutory presumption alone.
[14] This proceeding, say the applicants, is in response to Faulding's allegation of non-infringement of the '477 patent which was granted for the medicine itself, in particular, penicillin derivatives, including piperacillin sodium, when prepared by the process of manufacture particularly described and claimed or by their obvious chemical equivalents. Pursuant to subsection 6(6) of the Regulations, in the absence of evidence to the contrary, the piperacillin sodium product proposed to be produced by Faulding is presumed to be prepared or produced by the processes described and claimed in the '477 patent or by their obvious equivalents. That statutory presumption accordingly places the onus on Faulding to prove that the '477 patent is not infringed. To rebut the presumption, Faulding must adduce evidence which proves on a balance of probabilities that the '477 patent is not infringed.
[15] Further, the applicants submit that Faulding has merely alleged that its product is made by a supplier using a process which is outside the scope of the '477 patent. That allegation is not evidence. Faulding has therefore failed to rebut the presumption of infringement. Accordingly, as Faulding has presented no evidence to the contrary, Faulding's allegation that its product is made using a process which is outside the scope of the patent is not justified.
The Respondent
[16] The respondent provided a comprehensive overview of the general principles applicable to proceedings brought pursuant to the Regulations. In essence, the respondent submits that the purpose here is to determine summarily whether Faulding should be permitted market access prior to patent expiration; the purpose is not to conclusively determine substantive issues pertaining to patent infringement and validity. It is for the applicants to rebut Faulding's allegation of non-infringement. However, there is no examination for discovery in judicial review proceedings. Hence, relying on Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.), it is submitted that the applicants cannot expect to make [their] case "out of the mouth of the respondent". Depending upon the case put forward by the applicants in refuting the respondent's allegation in the first instance, the evidential burden may shift to the respondent. If the respondent does not discharge its evidential burden, the applicants may find it easier to discharge the legal burden and obtain an order of prohibition.
[17] Here, argues the respondent, the applicants do not take issue with any of the substantive allegations made in the respondent's NOA, either in the Notice of Application or the affidavit of Robert McCluggage. The NOA sets forth the factual basis for the alleged non-infringement of the '477 patent, inter alia, as being the concentration acknowledged by the patent to be within the prior art. Rather than challenging this allegation, the applicants' case rests on the proposition that they have not seen detailed process information for the respondent's proposed piperacillin product and in particular, have no access to the respondent's new drug submission (NDS) and no knowledge of its contents.
[18] The essence of the applicants' argument, from the respondent's perspective, is that the respondents' allegation is not justified because the applicants have not obtained discovery of the respondent. By utilizing the presumption of infringement in subsection 6(6) of the Regulations, the applicants have surmised that the respondent must provide access to the aspects of its NDS for piperacillin that deal with the process for making the respondent's proposed product. The respondent says that the applicants seek to discharge their burden of proof by making a request for discovery of the respondent without any substantive response to the allegations made in the NOA.
[19] The respondent submits that the fallacy of the applicants' position is that it overlooks the threshold requirement of subsection 6(6) that the presumption applies only in the absence of proof to the contrary. Here, the NOA constitutes proof to the contrary because of the decisions in Merck Frosst Canada Inc., supra and Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996), 70 C.P.R. (3d) 206 (F.C.A.). The NOA is in evidence in these proceedings and its contents are assumed to be true. Because the respondent has stated that the starting concentration used in the process of making its piperacillin product is 200 mg/ml and the disclosure of the '477 patent concedes that the use of a starting concentration of 200 mg/ml is conventional, it thus falls to the applicants to make a substantive challenge to the respondent's allegation by putting forth an affirmative contention that the respondent may nonetheless infringe the '477 patent despite the use of a conventional starting concentration of 200 mg/ml. The applicants, argue the respondents, have not made out such a case.
[20] Next, the respondent argues that if the applicants' position is correct, the result would be an effective short-circuiting of the scheme of the Regulations. An applicant for prohibition could prima facie discharge the legal burden upon it by asserting no knowledge of the respondent's NDS and demanding discovery thereof irrespective of the substantial basis for the allegation of non-infringement made by the second person respondent. Such a position is contrary to well-established principles that require an applicant to set out grounds that make out a case for the grant of a prohibition order. Where the respondent has set out the factual basis underpinning an allegation of non-infringement in its NOA, the applicant's burden is not discharged by a refusal to accept the veracity of the facts set forth in the notice of allegation. The contents of the notice of allegation must be taken as true.
[21] Insofar as the applicants' reliance on subsection 6(6) presumption is concerned, the jurisprudence is clear that a presumption may assist an applicant in discharging its burden of proof but that does not mean that a presumption operates to displace the burden of proof, per se. Once an applicant for prohibition has made out a prima facie substantive challenge to the case for non-infringement postulated by the second person, regard may be had to a presumption for assistance in discharging the legal burden of proof to obtain a prohibition order. The presumption, applied as the applicants suggest, would be tantamount to a reversal or repeal of the established proposition that the onus lies on the applicant for prohibition to show that the order should issue.
[22] As a practical matter, the applicants' position would yield a result whereby a second person would be forced to release, in every case, the content of its NDS at the mere request of a commercial rival or else face the virtually automatic issuance of a prohibition order. Parliament did not intend such a result. The extent to which disclosure of a NDS may be compelled is, pursuant to subsection 6(7) of the Regulations, a matter of discretion for the Court. For the Court to order disclosure under subsection 6(7), an applicant must establish, on a balance of probabilities, that disclosure or production of the second person's NDS is relevant to the prohibition proceeding. To establish relevance, an applicant must take issue with facts or conclusions enunciated by the second person in its NOA, not merely refuse to accept the veracity of the NOA's content for want of NDS disclosure.
[23] In conclusion, the respondent submits that application of the proper principles for analysis of patent infringement reveals that the respondent's allegation of non-infringement is justified. A patentee's monopoly is tied to the language of the claims in the patent. A plain reading of the claims of the '477 patent required the use of a starting concentration of 125 mg/ml. The respondent has alleged that its product will be made using a starting concentration of 200 mg/ml and this is conceded by the '477 patent to be conventional. It is trite law that it is not an infringement of a patent to use an element that is within the prior art or which is outside the boundaries of the patent claim. Where a second person's product contains an ingredient or limitation that is outside the plain wording of the claim, the allegation of non-infringement is justified and an applicant cannot be heard to complain that it has not had disclosure of the NDS.
Analysis
The Regulations
[24] The history and scheme of the Regulations have been articulated in various decisions of the Federal Court of Appeal and need not be repeated here. See: Merck Frosst Canada Inc., supra; Apotex Inc. v. Canada (Minister of National Health and Welfare) (1997), 76 C.P.R. (3d) 1 (F.C.A.); AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.) The fundamental design, as stated by Rothstein J.A., is that the issue of non-infringement between the patent holder (first person) and the person seeking a notice of compliance from the Minister (second person) originates with a notice of allegation served on the first person by the second person alleging, amongst other things, non-infringement. Should the first person be of the view that the product of the second person infringes the patent, the first person may apply to the court for an order prohibiting the Minister from issuing a notice of compliance to the second person until after expiration of the patent: Novartis AG et al. v. Abbott Laboratories Ltd. et al. (2000), 7 C.P.R. (4th) 264 (F.C.A.) at 266.
[25] The basic purpose of the Regulations is to prevent patent infringement: Merck Frosst Canada Inc., supra; Apotex Inc. supra; ICN Pharmaceuticals, Inc. v. Canada (Patented Medicine Prices Review Board) (1996), 68 C.P.R. (3d) 417 (F.C.A.); Bayer AG v. Canada (Minister of National Health and Welfare) (1993), 51 C.P.R. (3d) 329 (F.C.A.) However, the section 6 proceedings should not be likened to actions for determining validity or infringement. They are proceedings in judicial review, to be held expeditiously, whose aim is to determine whether the Minister is free to issue the requested notice of compliance. Their scope is confined to administrative purposes: Apotex Inc., supra. The determination must turn on whether there are allegations by the second person sufficiently substantiated to support a conclusion for administrative purposes (the issue of a notice of compliance) that an applicant's patent would not be infringed if the second person's product is put on the market: Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 209 (F.C.A.) By merely commencing the proceeding, the applicant obtains what is tantamount to an interlocutory injunction for up to 24 months without having satisfied any of the criteria a court would require before enjoining issuance of a notice of compliance: Bayer AG, supra; Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) (2001), 11 C.P.R. (4th) 539 (F.C.A.)
[26] In summary, the Regulations simply provide a certain protection to a patent holder by allowing a court to determine summarily, on the basis of the evidence adduced, whether the allegation is justified. An applicant is, in no way, deprived of all the recourses normally available to a patent holder to enable it to enforce its rights: Apotex Inc., supra. If a full trial of validity or infringement issues is required this can be obtained in the usual way by commencing an action: Pharmacia Inc., supra.
The Presumption
[27] Until the enactment of subsection 6(6), the Regulations did not include a presumption of infringement. Subsection 6(6) came into force, along with other changes to the Regulations, on March 12, 1998 and provides as follows:
| 6(6) For the purposes of an application referred to in subsection (1) [request for order of prohibition], where a second person has made an allegation under subparagraph 5(1)(b)(iv) or (1.1)(b)(iv) [allegation of non-infringement] . . . in respect of a patent and where that patent was granted for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents, it shall be considered that the drug proposed to be produced by the second person is, in the absence of proof to the contrary, prepared or produced by those methods or processes.
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6(6) Aux fins de la demande visée au paragraphe (1), lorsque la seconde personne a fait une allégation aux termes des sous-alinéas 5(1)b)(iv) ou (1.1)b)(iv) à l'égard d'un brevet et que ce brevet a été accordé pour le médicament en soi préparé ou produit selon les modes ou procédés de fabrication décrits en détail et revendiqués ou selon leurs équivalents chimiques manifestes, la drogue que la seconde personne projette de produire est, en l'absence d'une preuve contraire, réputée préparée ou produite selon ces modes ou procédés.
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[28] The Regulatory Impact Analysis Statement, SOR/98-166, Canada Gazette Part II, Vol. 132 No. 7 at 1055-1059 (RIAS), accompanies but does not form part of the Regulations. It is prepared as part of the regulatory process and reveals the intention of the government and contains information as to the purpose and effect of the proposed regulation: SmithKline Beecham Pharma Inc. v. Apotex Inc. (1999), 3 C.P.R. (4th) 22 (F.C.T.D.), Hoffman-Laroche Ltd. et al. v. Canada (Minister of National Health and Welfare) (1999), 87 C.P.R. (3d) 251 (F.C.T.D.).
[29] The RIAS indicates that the changes to the Regulations respond to the April, 1997 report of the Standing Committee on Industry reviewing the Patent Act Amendment Act, 1992, which called for changes to the regulatory framework to address stakeholder concerns regarding fairness, effectiveness, and reduction of unnecessary litigation. The amendments (as stated in the RIAS) reinforce the balance between providing a mechanism for the effective enforcement of patent rights and ensuring that generic drug products enter the market as soon as possible. Changes introduced in furtherance of the objectives of reducing unnecessary litigation and
streamlining the litigation process include, among other things: placing the burden of proof on manufacturers seeking to produce a generic version of a drug covered by a product-by-process patent; permitting the Court to order disclosure portions of a generic manufacturer's notice of compliance submission if it is relevant to resolving the issues by the Court (the information must be treated confidentially), and requiring more specificity with a notice of allegation.
Patent Construction
[30] Claims construction is antecedent to consideration of both validity and infringement issues. Claims construction is a matter of law. Whether the [respondent's] activities fall within the scope of the monopoly is a question of fact. It is the claims that define the monopoly: Whirlpool Corp. v. Camco Inc. (2000), 9 C.P.R. (4th) 129 (S.C.C.).
[31] The Patent Act requires the letters patent granting a patent monopoly to include a specification which sets out a correct and full disclosure of the invention. The disclosure is followed by a claim or claims stating distinctly and in explicit terms the things or combinations that the applicant regards as new and in which he claims an exclusive property or privilege. It is the invention thus claimed to which the patentee receives the exclusive right, privilege and liberty of exploitation: Free World Trust v. Électro Santé Inc. (2000), 9 C.P.R. (4th) 168 (S.C.C.).
[32] The disclosure is the quid provided by an inventor in exchange for the quo of a monopoly on the exploitation of the invention. It is important to know what is prohibited and where it is safe to go while the patent is still in existence. The public notice function is performed by the claims that conclude the specification. An inventor is not obliged to claim a monopoly on everything new, ingenious and useful disclosed in the specification. The usual rule is that what is not claimed is considered disclaimed: Whirlpool Corp., supra.
[33] There is a high economic cost attached to uncertainty and it is the proper policy of patent law to keep it to a minimum. Predictability is achieved by tying the patentee to its claims; fairness is achieved by interpreting those claims in an informed and purposive way. A purely literal application of the text of the claims would allow a person skilled in the art to make minor and inconsequential variations and appropriate the substance of the invention with a copycat while staying just outside of the monopoly. A broader interpretation risks conferring on the patentee the benefit of inventions that he had not in fact made but which could be deemed with hindsight to be equivalent to what in fact was invented. This would be unfair to the public and unfair to competitors: Free World Trust, supra.
[34] In Free World Trust, supra, Binnie J. identified the principles to be applied to resolve the tension between "literal infringement" and "substantive infringement" to achieve a fair and predictable result. The principles are:
(a) The Patent Act promotes adherence to the language of the claims.
(b) Adherence to the language of the claims in turn promotes both fairness and predictability.
(c) The claims language must, however, be read in an informed and purposive way.
(d) The language of the claims thus construed defines the monopoly. There is no recourse to such vague notions as the "spirit of the invention" to expand it further.
(e) The claims language will, on a purposive construction, show that some elements of the claimed invention are essential while other are non essential.
(f) There is no infringement if an essential element is different or omitted. There may still be infringement, however, if non essential elements are substituted or omitted.
Decision
[35] It is within the context of the foregoing that I must determine whether an order for prohibition should issue. Because the applicants have put all their eggs in one basket and relied exclusively on the presumption contained in subsection 6(6) of the Regulations, the result will ultimately turn on the extent to which the presumption applies.
[36] As stated at the outset under the heading entitled "The Patent", the '477 patent covers a lyophilized (freeze dried) pharmaceutical preparation containing a penicillin derivative known as piperacillin sodium. Claims 1 and 2 of the patent are directed to a process for the preparation of a lyophilized penicillin derivative (piperacillin sodium). Claims 3 and 4 are directed to a pharmaceutical parenteral (injectable) dosage unit comprising a light, fluffy lyophilized penicillin derivative (piperacillin sodium) that is prepared by the processes of claim 1 or claim 2.
[37] Faulding's NOA alleged that its proposed piperacillin sodium would not infringe the '477 patent. The detailed statement accompanying the NOA explained that the basis for the allegation of non-infringement was, inter alia, that its proposed piperacillin product would be made using a starting concentration of at least 200 mg/ml. The allegation, in proceedings for an order of prohibition, is presumed to be true...except to the extent that the contrary has been shown...:Merck Frosst Canada Inc., supra; Pharmacia Inc., supra; Hoffmann-La Roche Ltd. (1996), supra; SmithKline Beecham Pharma Inc. v. Apotex Inc. (1999), 1 C.P.R. (4th) 99 (F.C.T.D.), aff'd (2001), 10 C.P.R. (4th) 338 (F.C.A.).
[38] The disclosure of the '477 patent indicates that lyophilized preparations of piperacillin sodium are known, but there are certain disadvantages when reconstituting the freeze-dried powder to make an injectable solution. The '477 patent seeks to overcome these disadvantages.
Excerpts from the disclosure state:
The conventional procedure for preparing a lyophilized parenteral
dosage form of a penicillin derivative involves preparing a 200 mg/ml
aqueous solution of the derivative, filling the solution in a vial at 5 ml.
per vial and then lyophilizing the contents; the dried cake representing
one gram of the derivative...
The 4 millilitre dosage of the prior art thus necessitates the less
convenient procedure of giving injections in the buttocks. Even
with injection in the buttocks, the large 4 millilitre dosage means
that distribution time is increased...
It is a purpose of this invention to provide a parenteral dosage
unit form of piperacillin and similar penicillin derivatives which
decreases the injection volume from that known in the prior
art by providing a more concentrated final product...
It is therefore another goal of this invention to provide a
lyophilized parenteral dosage form of piperacillin and
similar penicillin derivatives which provide a highly concentrated
but easily reconstituted final product.
[39] These stated objectives of the '477 patent are said to be fulfilled by the provision of a parenteral dosage unit comprising a lose, fluffy expanded cake of a lyophilized penicillin derivative that is prepared by a process comprising:
(a) preparing a solution of the penicillin derivative in water at a concentration of 125 mg/ml;
(b) filling the solution into a container to the desired amount; and
(c) freezing and lyophilizing the penicillin derivative in the container.
[40] Construction of a patent is always engaged by an assertion of non-infringement in any proceeding: AB Hassle v. Apotex Inc. (2001), 12 C.P.R. (4th) 289 (F.C.T.D.). See also: Glaxo Group Ltd. v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 73 (F.C.T.D.) aff'd (2001), 11 C.P.R. (4th) 417 (F.C.A.). Applying the principles of patent construction articulated in Whirlpool Corp, supra and Free World Trust, supra, I find that although the disclosure refers to a desirable result, the '477 patent inventive claims do not cover the identification of a desirable result but a particular process to achieve it. The claim is not for the chemical composition of the medicine itself but for that composition as made by a process claimed in the patent. That process, as described in the claims, defines the monopoly. As in Free World Trust, the claims "...cannot be stretched to allow the patentee to monopolize anything that achieves the desirable result..." The claims define a process of preparing a solution of the penicillin derivative in water at a concentration of 125 mg/ml. As noted at the outset of these reasons, claims 1 and 2 of the '477 patent are directed to a process for the preparation of the freeze-dried penicillin derivative (piperacillin sodium) and claims 3 and 4 are directed to a parenteral (injectable) dosage unit comprising a light fluffy freeze-dried penicillin derivative (piperacillin sodium) that is prepared by the processes of claim 1 or 2.
[41] Faulding's proposed piperacillin product is to be made using a starting concentration of at least 200 mg/ml. Reference to Faulding's detailed statement (reproduced in its entirety at the outset of these reasons) at paragraphs 11, 12 and 13 reveals its basis for the allegation of non-infringement, i.e. all 4 claims of the '477 patent require and incorporate the process described in claim 1. The patent concedes that the process steps (b) and (c) of claim 1 are conventional. Accordingly, any inventive aspect must reside in the first process step (a) which provides that the initial concentration of the precursor solution from which the light, fluffy lyophilized cake is generated is 125 mg/ml. The Faulding product is made by a process using a precursor solution of at least 200 mg which is the concentration acknowledged by the patent to be within the prior art. The '477 patent teaches that it is the use of the lower starting concentration of piperacillin sodium (125 mg/ml) that yields an expanded cake as a finished product thereby overcoming the disadvantages of the prior art. Since the Faulding starting concentration is at least 200 mg/ml, which is prior art, it is outside the scope of the patent and does not infringe the '477 patent.
[42] The notice of allegation and detailed statement describe a process that could not possibly infringe the '477 patent given its language and construction. The '477 patent cannot be infringed by a process that falls within what is conceded to be prior art therefore Faulding's process falls outside the scope of the patent. Where a second person proposes to manufacture a medicine by a process that falls within prior art and outside the scope of the patent, and files a notice of allegation saying so, a patent holder cannot succeed in an application to prohibit the issuance of a notice of compliance on the basis that the notice of allegation is not sufficiently detailed, or that the allegation is not justified.
[43] Does the presumption in subsection 6(6) of the Regulations operate to alter this result? I think not. The principles set out in Rizzo and Rizzo Shoes Ltd. (Re), [1998] 1 S.C.R. 27 and subsequent decisions dictate a purposive approach to statutory construction requiring that regard be had to the purpose of the enactment and the intention of Parliament. These factors have been discussed earlier under the heading "The Presumption". In determining purpose and intent, the Rizzo decision mandates consideration of section 12 of the Interpretation Act, R.S.C. 1985, c. I-21, which provides that every enactment be deemed remedial and be given such fair, large and liberal construction and interpretation as best ensures the attainment of its objects. My task is to identify the interpretation of subsection 6(6) that best furthers the goals of the Regulations.
[44] It is my view, that for the presumption to apply here, three conditions must be met. The first is that there must exist an application for an order for prohibition as described in subsection 6(1). The second is that the second person must have made an allegation under subparagraph 5(1)(b)(iv) in respect of a patent, i.e. an allegation of non-infringement. The third condition is that the patent in question was granted for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents, i.e. a product by process patent. If all three conditions are met, it shall be considered that the drug proposed to be produced by the second person is, in the absence of proof to the contrary, prepared or produced by those methods or processes. In short, the presumption does not become operative unless all three conditions have been met.
[45] It is common ground that the first and second conditions have been met in this case. The requirement of the third condition bears repeating. The patent in question must have been granted for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed or by their obvious chemical equivalents. The Supreme Court of Canada in the Whirlpool Corp andFree World Trust decisions has enunciated that claims construction is antecedent to consideration of infringement issues. I have determined that the process of manufacture particularly described and claimed in the '477 patent is a process of preparing a solution of the penicillin derivative in water at a concentration of 125 mg/ml. I am prepared to assume, for purposes of this application, that the third condition has been satisfied but only to the extent that the patent was granted for the medicine itself when prepared or produced by the method or process of preparing a solution of the penicillin derivative in water at a concentration of 125 mg/ml.
[46] Applying the presumption of subsection 6(6), the drug proposed to be produced by the second person is, in the absence of proof to the contrary, prepared or produced by that method or process. Faulding has served and filed an NOA and detailed statement. The law is settled that the facts advanced by a second person in support of a notice of allegation are presumed to be true. Additionally, the second person must set forth in the detailed statement the "legal and factual basis" for the paragraph 5(1)(b) allegation and do so in a sufficiently complete manner as to enable the patentee to assess its course of action in response to the allegation...The intent of paragraph 5(3)(a) appears to be that the entire factual basis be set forth in the statement...A second person cannot in a section 6 proceeding add to the facts that were set forth in its detailed statement: AB Hassle v. Canada, supra.
[47] Thus, I find that, for purposes of subsection 6(6), the NOA and detailed statement constitute proof to the contrary, in situations where, as here, it is clear from the NOA and detailed statement that the second person proposes to manufacture a medicine by a process not covered by the claims and therefore outside the scope of the patent. There is no requirement that a second person file an affidavit: Merck Frosst Canada Inc., supra; Hoffmann-La Roche (1996), supra. Faulding's NOA and detailed statement were put into evidence by the applicants and are part of the record.
[48] In my view, this construction best attains the purpose and intent of the Regulations specified to be: reducing unnecessary litigation and streamlining the process. Parliament could not have intended that those objectives would be met by the creation of a conclusive presumption notwithstanding that the second person's allegation falls outside the methods or processes of manufacture particularly described and claimed in the patent. I am reinforced in my reasoning by subsection 6(7), also one of the 1998 amendments to the Regulations. That subsection permits a first person to apply to the Court to compel production of any relevant portions of a second person's new drug submission (NDS). That avenue was not pursued by the applicants despite the fact that, as deposed by Robert McCluggage, the applicants had "no knowledge of the existence, date of filing or contents, of any regulatory submission on behalf of Faulding, in respect of the products referred to in the NOA". An applicant does not bear a heavy burden with respect to obtaining production: Novartis AG et al., supra; Glaxo Group Ltd., supra.
[49] I do not view Bayer Inc., supra, as standing for the proposition set forth by the applicants. It is correct that the Court, in addressing the statutory presumption, stated that if the second party had adduced no evidence that was capable of establishing the invalidity of the patent, the applicant could have succeeded on the basis of the statutory presumption alone. That case was an action for patent invalidity. That is not the situation here. The Court did not say that an NOA and detailed statement, in judicial review proceedings which are to be dealt with summarily, could not be regarded as evidence or taken as proof to the contrary for purposes of subsection 6(6) of the Regulations. The applicants would extend the comments of the Court beyond the context in which they were made. I am not so inclined.
[50] At the outset of the "Decision" portion of these reasons, I stated that the applicants have put all their eggs in one basket and relied exclusively on the subsection 6(6) presumption. Upon receipt of Faulding's NOA and detailed statement, the applicants requested voluntary full disclosure of the detailed process information for Faulding's proposed piperacillin product. When the disclosure was not forthcoming, the applicants initiated this proceeding. Although one year and three months less a day transpired between the date of filing and the date of hearing, the applicants did not seek disclosure pursuant to subsection 6(7) of the Regulations.
[51] The applicants had Faulding's NOA and detailed statement on December 29, 2000. They did not challenge the factual basis for the alleged non-infringement. They have not taken issue with any of the substantive allegations and have not challenged Faulding's construction of the '477 patent. Rather, the applicants state that they have not seen the detailed process information and have no access to Faulding's NDS or knowledge of its contents. They then rely on subsection 6(6) and postulate that the presumption can be rebutted only by access to the aspect of Faulding's NDS for piperacillin that deals with the processes for making the proposed product. The applicants rely solely on the provisions of subsection 6(6) to justify their refusal to accept the veracity of the facts set forth in the NOA. The result is that the NOA and disclosure statement stand uncontradicted.
[52] I have determined that, in the present circumstances, Faulding's NOA and detailed statement constitute proof to the contrary for the purposes of the presumption in subsection 6(6) of the Regulations. The only evidence relating to the issue of infringement is Faulding's. That evidence must therefore be put into balance against the evidence of the applicants, which is no evidence at all.
[53] The application for an order for prohibition is dismissed with costs to the respondent.
___________________________________
Judge
Ottawa, Ontario
September 13, 2002
FEDERAL COURT OF CANADA
TRIAL DIVISION
NAMES OF COUNSEL AND SOLICITORS OF RECORD
DOCKET: T-234-01
STYLE OF CAUSE: Wyeth-Ayerst Canada Inc. and American Cyanamid Co.
v Faulding (Canada) Inc. and The Minister of Health
PLACE OF HEARING: Toronto, Ontario
DATE OF HEARING: May 8, 2002
REASONS FOR ORDER: The Honourable Madam Justice Layden-Stevenson
DATED: September 13, 2002
APPEARANCES:
Mr. Gunars A. Gaikis FOR APPLICANT
Mr. J. Sheldon Hamilton
Ms. Susan D. Beaubien FOR RESPONDENT
SOLICITORS OF RECORD:
Mr. Gunars A. Gaikis FOR APPLICANT
Mr. J. Sheldon Hamilton
Smart & Biggar
Toronto
Ms. Susan D. Beaubien FOR RESPONDENT
Borden Ladner Gervais LLP
Ottawa
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