Judgments

[2001] 3 F.C. 163

T-936-99

2001 FCT 137

Novartis Pharmaceuticals Canada Inc. and Novartis AG (Applicants)

v.

RhoxalPharma Inc. and The Minister of Health (Respondents)

Indexed as: Novartis Pharmaceuticals Canada Inc. v. RhoxalPharma Inc. (T.D.)

Trial Division, Tremblay-Lamer J.--Ottawa, February 5, March 1, 2001.

Patents — Infringement — Courts must adopt purposive construction of patent claims to be fair to patentee, public — No infringement if essential element different or omitted in allegedly infringing device — Patent for pharmaceutical preparations including, as active ingredient, cyclosporin in form of hydrosol for intravenous injection not infringed by cyclosporin capsule not containing hydrosol but forming hydrosol in situ after ingestion.

The applicant, Novartis AG, was the owner of a patent relating in part to pharmaceutical preparations which included, as the active ingredient, cyclosporin in the form of a hydrosol (fine dispersion of solid particles in an aqueous medium). The applicant Novartis Pharmaceuticals Canada Inc. has obtained a number of notices of compliance in respect of a number of dosage strengths of cyclosporin capsules. The respondent, RhoxalPharma Inc., has forwarded a notice of allegation to the applicants in which the respondent alleged that it would not infringe the patent by the making, using or selling of its cyclosporin capsules which did not contain a hydrosol, but which relied on the formation of a hydrosol in situ after ingestion of the capsule.

The applicants sought an order prohibiting the Minister of Health from issuing a notice of compliance to the respondent, RhoxalPharma Inc., in connection with 100 mg. capsules of the drug cyclosporin for oral administration until after the expiration of the applicants’ patent.

Held, the application should be dismissed.

The issue was whether the formation of a hydrosol after ingestion of a capsule was an infringement of the patent.

The applicants bear the initial burden of proof. Where a notice of allegation alleges non-infringement, the Court starts from the proposition that the allegations of fact in the notice of allegation are true except to the extent that the contrary has been shown by the applicant.

In Free World Trust v. Électro Santé Inc. and Whirlpool Corp. v. Camco Inc., the Supreme Court of Canada has made it clear that, in order to arrive at an interpretation of patent claims that is reasonable and fair to both the patentee and the public, the courts must adopt a purposive construction of patent claims. The Court stated that the interpretative task of a court is to distinguish a patent’s essential elements from non-essential elements on the basis of the common knowledge of a worker skilled in the art to which the patent relates as of the date the patent is published. There is no infringement if an essential element is different or omitted in an allegedly infringing device, but there may be infringement if non-essential elements are substituted or omitted. It also sent a clear message that the claims should receive only one interpretation for all purposes.

Here, on a reasonable and fair interpretation of the patent claims, the respondent’s capsules did not infringe the patent. The patent only covered pre-ingestion solutions. The disclosure of the patent clearly indicated that the invention involved a stable, pharmaceutically acceptable hydrosol preparation suited for intravenous injection of particles of cyclosporin which were small enough to avoid clogging blood vessels. Neither the disclosure nor the patent claims referred to a hydrosol formed in situ. An ingested pharmaceutical preparation which formed a hydrosol in situ was not covered by the patent. The respondent’s capsules did not perform “substantially the same function in substantially the same way to obtain substantially the same result” as the applicants’ invention.

STATUTES AND REGULATIONS JUDICIALLY CONSIDERED

Food and Drug Regulations, C.R.C., c. 870, s. C.08.004.

Patent Act, R.S.C., 1985, c. P-4, s. 55.2(4) (as enacted by S.C. 1993, c. 2, s. 4).

Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, s. 6(1) (as am. by SOR/98-166, s. 5).

CASES JUDICIALLY CONSIDERED

APPLIED:

Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302; 169 N.R. 342 (F.C.A.); Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024; (2000), 194 D.L.R. (4th) 232; 9 C.P.R. (4th) 168; 263 N.R. 150; Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067; (2000), 194 D.L.R. (4th) 193; 9 C.P.R. (4th) 129; 263 N.R. 88.

DISTINGUISHED:

Beecham Group Ltd. v. Bristol Laboratories Ltd., [1978] R.P.C. 153 (H.L.).

REFERRED TO:

Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605 (1950).

APPLICATION for an order pursuant to subsection 55.2(4) of the Patent Act and subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations prohibiting the Minister of Health from issuing a notice of compliance to RhoxalPharma Inc. in connection with 100 mg capsules of the drug cyclosporin for oral administration. Application dismissed.

APPEARANCES:

Anthony George Creber and Jennifer L. Wilkie for applicants.

Jean-François Buffoni, Marie Lafleur and Martin Sheehan for respondent RhoxalPharma Inc.

No one appearing for respondent Minister of Health.

SOLICITORS OF RECORD:

Gowling Lafleur Henderson, Ottawa, for applicants.

Fasken Martineau DuMoulin, Montréal, for respondent RhoxalPharma Inc.

Deputy Attorney General of Canada for respondent Minister of Health.

The following are the reasons for order rendered in English by

[1]        Tremblay-Lamer J.: Novartis Pharmaceuticals Canada Inc. and Novartis AG (the applicants) seek an order pursuant to subsection 55.2(4) of the Patent Act [R.S.C., 1985, c. P-4 (as enacted by S.C. 1993, c. 2, s. 4)] and subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations [SOR/93-133 (as am. by SOR/98-166, s. 5)] prohibiting the Minister of Health from issuing a notice under section C.08.004 of the Food and Drug Regulations [C.R.C., c. 870] (a notice of compliance) to RhoxalPharma Inc. (the respondent) in connection with 100 mg capsules of the drug cyclosporin for oral administration until after the expiration of Canadian Letters Patent 1,308,656 entitled “Hydrosols of Pharmacologically Active Agents and their Pharmaceutical Compositions Comprising Them” granted on October 13, 1992 (the patent).

FACTS

[2]        Cyclosporin is an immunosuppressant and is sold in Canada in relation to its application to recipients of organ transplants, e.g. kidney or heart transplants, as well as for the therapy of certain autoimmune diseases.[1] The patent on cyclosporin itself has expired.

[3]        Novartis AG is the owner of Canadian Patent 1,308,656. Novartis Pharmaceuticals Canada Inc. has obtained a number of notices of compliance in respect of a number of dosage strengths of cyclosporin capsules, including the 100 mg dosage strength. Novartis Pharmaceuticals Canada Inc. has filed patent lists in connection with its cyclosporin notices of compliance and the Minister of Health has listed the Novartis AG patents in respect of cyclosporin products of Novartis Pharmaceuticals Canada Inc.[2]

[4]        The patent relates, in part, to pharmaceutical preparations which include as the active ingredient, cyclosporin in the form of a hydrosol. Hydrosols comprise a fine dispersion of solid particles in an aqueous medium, e.g. water.

[5]        The patent claims are directed to pharmaceutical preparations in the form of hydrosols. Claim 1 of the patent refers to pharmaceutical preparations for intravenous administration:

1. A pharmaceutical preparation for intravenous administration the active agent of which comprises a cyclosporin, said preparation comprising either:

(a) a hydrosol, the particles of which comprises said active agent in solid form, have a diameter of from 1 to 10,000 nanometres, and which are stabilized whereby the particle size distribution of said particles is maintained constant; or

(b) the stabilized particulate phase of the above hydrosol in dry or isolated form.[3]

[6]        Claim 2 of the patent refers to pharmaceutical preparations without specifying the route of administration:

2. A pharmaceutical preparation the active agent of which comprises a cylosporin said preparation comprising either:

(a) a hydrosol, the particles of which comprises said active agent in solid form, have a diameter of from 1 to 10,000 nanometres, and which are stabilized whereby the particle size distribution of said particles is maintained constant; or

(b) the stabilized particulate phase of the above hydrosol in dry or isolated form.[4]

[7]        By letter dated April l2, 1999, the respondent forwarded a notice of allegation to the applicants in which the respondent alleged, amongst others, that it would not infringe the patent by the making, using or selling of its cyclosporin capsules:

We have available cyclosporine soft gel capsules which will not contain a hydrosol and, more precisely, will not contain the hydrosol as described and claimed in the patent. Accordingly, since at least one essential feature of each claim will not be found in our product, the patent will not be infringed.[5]

[8]        The notice of allegation states that the respondent’s capsules do not contain a hydrosol. This has been admitted by the applicants.[6]

SUBMISSIONS

[9]        The applicants take the position that there would be infringement of the patent either directly or indirectly by the sale of the respondent’s capsules.

[10]      The applicants argue that Claim 2 of the patent refers to pharmaceutical preparations irrespective of the route of administration, and therefore such claim covers the respondent’s capsules.

[11]      The applicants submit that a “pharmaceutical preparation” can exist in several forms obtained prior or after the ingestion. The respondent’s capsule itself need not contain a hydrosol to infringe the patent. It will infringe as long as a hydrosol is formed in aqueous medium, e.g. addition to water or gastrointestinal fluid, by following the manufacturer’s instructions, for example, through ingestion.

[12]      The applicants also allege that the respondent is infringing the patent by inducing patients and others to infringe it by virtue of complying with the instructions which will be attached to the respondent’s capsules.

[13]      The respondent takes the position that there is no infringement of the patent because, at the time of sale of its capsules, there is no hydrosol.

[14]      The respondent argue that “pharmaceutical preparation” referred to in Claim 2 of the patent does not cover a hydrosol formed in situ. Neither the disclosure nor the patent claims refer to a hydrosol formed in situ.

[15]      The respondent also allege that there can be no inducement to infringe because its capsules do not infringe the patent. In any event, the respondent argues that the applicants have not established that it would be such.

ISSUE

Are the respondent’s 100 mg capsules of cyclosporin in infringement of Claim 2 of the patent?

ANALYSIS

[16]      The sole issue in the present case is whether the formation of a hydrosol after ingestion of a capsule is an infringement of the patent.

[17]      The applicants bear the initial burden of proof. As stated by the Federal Court of Appeal in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), that burden “is a difficult one since it must be to disprove some or all of the allegations in the notice of allegation which, if left unchallenged, would allow the Minister to issue a notice of compliance.”[7]

[18]      Where a notice of allegation alleges non-infringement, the Court should start from the proposition that the allegations of fact in the notice of allegation are true except to the extent that the contrary has been shown by the applicant. In determining whether or not the allegations are justified, the Court must then decide on a balance of probabilities whether, on the basis of such facts as have been assumed or proven, the allegations would give rise in law to the conclusion that the patent would not be infringed by the respondent.[8]

[19]      In assessing infringement, the Court must first construe the applicants’ patent claims, and, second, compare the respondent’s capsules to the claims as construed to determine whether it falls within the scope of those claims.

[20]      Two recent decisions of the Supreme Court of Canada, Free World Trust v. Électro Santé Inc.[9] and Whirlpool Corp. v. Camco Inc.[10] have resolved the controversy as to whether a literal interpretation of patent claims or a more generous approach identifying the “pith and marrow” or “substance” of the invention represented the proper method of construing patent claims. It is clear now that courts must adopt a purposive construction of patent claims.

[21]      The Supreme Court emphasized that the objective of purposive construction is to arrive at an interpretation of a patent claims that is reasonable and fair to both the patentee and the public. The interpretative task of a court is to distinguish a patent essential elements from non-essential elements on the basis of the common knowledge of the worker skilled in the art to which the patent relates as of the date the patent is published.

[22]      The Supreme Court of Canada stated that there is no infringement if an essential element is different or omitted in an allegedly infringing device. There may be infringement however if non-essential elements are substituted or omitted. For a particular element to be considered non-essential, it must be shown that the skilled reader at the date of publication of the patent would have appreciated that element was clearly not intended to be essential in that it could be substituted or omitted without affecting the working of the invention.

[23]      Purposive construction properly directs itself to the words of the claims interpreted knowledgeably and in the context of the specification as a whole.[11]

[24]      With respect to the appropriateness of utilizing a method of claim construction other than purposive construction in a judicial proceeding other than an infringement action, I am of the view that the Supreme Court of Canada in Whirlpool Corp. sent a clear message that the claims received only one interpretation for all purposes:

(b) Acceptance of the appellants’ argument could result in a different claims construction for the purpose of validity than for the purpose of infringement (assuming purposeful construction is retained for infringement issues). However, it has always been a fundamental rule of claims construction that the claims receive one and the same interpretation for all purposes.[12] [Emphasis added.]

[25]      For the following reasons I find that the respondent’s capsules do not infringe the patent.

[26]      The applicants’ position is that the term pharmaceutical preparation as used in the patent covers a hydrosol formed in situ.

[27]      On a reasonable and fair interpretation of the patent claims, I am unable to agree with the applicants’ position.

[28]      Claim 2 of the patent is directed to a pharmaceutical preparation comprising the drug cyclosporin which requires either the presence of a hydrosol or a “dry or isolated form” of the hydrosol.

[29]      The disclosure of the patent clearly indicates that the invention involves a stable, pharmaceutically acceptable hydrosol preparation suited for intravenous injection of particles of cyclosporin which are small enough to avoid clogging blood vessels.

[30]      The patent specification indicates that the pharmaceutical preparation referred to in Claim 2 of the patent covers intravenous solutions:

The invention provides a hydrosol of a pharmacological active agent in an intravenous applicable, stabilised, pharmaceutically acceptable form, which form is suspended or is dry and re-suspendible in an aqueous medium.

…

The invention provides in particular a hydrosol of solid active agent particles in such a form which, when in water suspended and administered, behaves, regarding pharmacological activity, as an injectable solution.[13]

[31]      Nowhere in the patent could I find any reference to a hydrosol that could be formed after ingestion in the body. The patent teaches variations of a process, requiring human intervention, for making an intravenous solution consisting of a hydrosol:

A solution of the active agent in a solvent which is miscible with water is mixed with a comparatively large amount of water. Mixing preferably is effected rapidly to promote formation of the particles at the same time and in a narrow distribution. Rapid mixing also produces large numbers of colloidal particles. Permanent fixing of the particle size is possible if the influence of the organic solvent is in minimalised and for that reason the solvent is preferably removed. Removal may take place by evaporation, e.g. in a rotary evaporator. Evaporation can be continued so that the water of the hydrosol is also evaporated. Preferably this is effected by lyophilisation, so as to facilitate redispersibility. Upon complete evaporation of the water, a dry lyophilisate may be formed, especially with Cyclosporin A, gelatin, mannitol and acid additive.[14]

[32]      The portion of the disclosure identifying stable, solid cyclosporin particles in a “dry and re-suspendible” form as falling within the scope of the invention clearly indicates that the inventor intended such particles to be re-suspended for use in an intravenous application.

[33]      The patent provides 12 examples illustrating the invention. In each example, the hydrosol forms by a series of mechanical operations involving dissolving the active agent in an alcohol, adding water and stirring. The resulting preparation is suitable for intravenous injection. The hydrosol never spontaneously generates, and never generates in situ. The examples do not contemplate oral administration.

[34]      Neither the disclosure nor the patent claims refer to a hydrosol formed in situ. The lack of such a reference in what is otherwise a complete description of the hydrosol, its advantages, uses and the process by which it is made, leads to the conclusion that an ingested pharmaceutical preparation which forms a hydrosol in situ is not covered by the patent.

[35]      Although Claim 2 is silent with regards to the route of administration and therefore may not be limited only to pharmaceutical preparations for intravenous use, I am satisfied that a contextual examination of the patent can only lead to the conclusion that it covers pre-ingestion solutions.

[36]      The applicants cite Beecham Group Limited as determinative of the issue. In Beecham, the patent covered the medicine ampicillin. The defendant’s drug, hetacillin, converted to ampicillin on ingestion. The House of Lords held that the pith and marrow of the plaintiff’s patent had been taken since hetacillin had no antibacterial activity of its own. Its only value as an antibacterial agent arose by virtue of converting into ampicillin.[15]

[37]      The present case differs in material respects. As pointed out by the respondent, it is not the value of cyclosporin which must be considered but that of the hydrosol. The purpose of the applicants’ invention is to provide a hydrosol with small, stable pharmacologically active agent particles for intravenous use. Obviously, that is not the purpose of the respondent’s product which is administered orally. Simply, the respondent’s capsules do not perform “substantially the same function in substantially the same way to obtain substantially the same result” as the applicants’ invention.[16]

[38]      As stated by Binnie J. in Free World Trust:

… the ingenuity of the patent lies not in the identification of a desirable result but in teaching one particular means to achieve it. The claims cannot be stretched to allow the patentee to monopolize anything that achieves the desirable result.[17]

[39]      For the above reasons, the applicants have failed to show that the respondent’s capsules would infringe the patent. The notice of compliance proceedings are therefore dismissed.

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