Glaxosmithkline Inc. v. Canada (Attorney General), 2004 FC 1725

Date: 20041210

Docket: T-834-04

Citation: 2004 FC 1725

Ottawa, Ontario, this 10^th day of December, 2004

Present:           THE HONOURABLE MR. JUSTICE von FINCKENSTEIN       

BETWEEN:

                                                      GLAXOSMITHKLINE INC.

                                                                                                                                            Applicant

                                                                           and

ATTORNEY GENERAL OF CANADA AND

THE MINISTER OF HEALTH

                                                                                                                                      Respondents

                                            REASONS FOR ORDER AND ORDER

[1]                The Applicant, GlaxoSmithKline Inc. ("GSK") has brought this application for a judicial review of a decision of the Minister of Health who decided that two patents held by GSK did not meet the prescribed requirements and were therefore, not eligible for inclusion on the Patent Register (the "Register").

[2]                Pursuant to Division 8, Part C of the Food and Drug Regulations, C.R.C., c. 870, any drug manufacturer who wishes to advertise or sell a new drug in Canada must first obtain a Notice of Compliance ("NOC") permitting such advertising and sale. To obtain an NOC, the manufacturer files a drug submission with the Minister of Health, (the "Minister"). Under the Patented Medicines (NOC) Regulations, ("PMNOC Regulations") a manufacturer who files a drug submission for a NOC or has been previously granted an NOC may submit a list of eligible patents to be added to the Register against the drug for which the NOC is sought or issued. Under section 3(1) of the PMNOC Regulations, the Minister may refuse to add or may delete a patent submitted by a manufacturer if the submitted patent is ineligible for inclusion on the Register according to the requirements of section 4 of the PMNOC Regulations.

[3]                On March 29, 2004, the Minister decided that Canadian Patents 1,298,479 (the "479 patent") and 2,031,393 (the "393 patent") submitted by GSK are ineligible for listing on the Patent Register with regard to PAXIL CR, a drug containing controlled release tablets of paroxetine hydrochloride. The 479 patent relates to a system for controlled rate release of active substances while the 393 patent relates to tablets with controlled rate release of active substances.

Issue

[4]                Do the 393 patent and the 479 patent comply with s. 4(2)(b) of the PMNOC Regulations?

Standard Of Review

[5]                Both sides agree that the standard of review is correctness. See Ely Lilly Canada Inc v. Canada (2003), 300 N.R. 76.

Statutory Provisions

[6]                The relevant statutory provisions are sections 3 and 4 (2)(b) of the PMNOC Regulations which provide as follows:

Analysis

[7]                Before deciding whether the patents in issue comply with the PMNOC Regulations, it is first necessary to construe the patents. Both sides agree that such construction must be guided by the principle stated in Whirlpool Corp. v. Camco Inc. 9 C.P.R. (4^th) 129 where Binnie J., quoting Diplock J from Catnic Components Ltd. v. Hill and Smith Ltd., [1982] RPC 183, stated:

... Lord Diplock's description of purposive construction was as follows, at pp. 242-43:

My Lords, a patent specification is a unilateral statement by the patentee, in words of his own choosing, addressed to those likely to have a practical interest in the subject matter of his invention (i.e. "skilled in the art"), by which he informs them what he claims to be the essential features of the new product or process for which the letters patent grant him a monopoly. It is those novel features only that he claims to be essential that constitute the so-called "pith and marrow" of the claim. A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. The question in each case is: whether persons with practical knowledge and experience of the kind of work in which the invention was intended to be used, would understand that strict compliance with a particular descriptive word or phrase appearing in a claim was intended by the patentee to be an essential requirement of the invention so that any variant would fall outside the monopoly claimed, even though it could have no material effect upon the way the invention worked. [Emphasis in original.]

[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. ...

[8]                The expert witness for GSK, one Dr. James McGinity, a professor of pharmacy at the University of Texas at Austin, Texas also appended as Exhibit B to his affidavit a document neatly setting out the principles of patent construction that he was told to employ. I attach at Annex A said principles as in my view they succinctly enunciate all principles applicable to patent interpretation.

[9]                Dr. McGinity, the only person skilled in the art of constructing patents put forward, stated in relation to the patents in issue:

Generally, the '479 Patent and the '393 Patent relate to controlled-release pharmaceutical tablet preparations or formulations.

[10]            The 393 patent makes claims with respect to tablets containing active substances. In Dr. McGinity's view as stated in his affidavit:

... one skilled in the art of pharmaceutical formulation would conclude that any active substance appropriate for use in a controlled-release tablet formulation could fall within the scope of these claims.

21. I understand that GSK markets controlled-release tablets of paroxetine hydrochloride in association with the trade-mark PAXIL CR. As such, it is clear that the medicine paroxetine hydrochloride is an active substance suitable for the formulation in a controlled-release tablet such as that claimed in the claims of the '479 Patent.

22. As a result, it is clear that Claims 1-7 of the '393 Patent include within their scope controlled-release tablets of the medicine paroxetine hydrochloride. Indeed, a second entry manufacturer wishing to market controlled-release tablets of paroxetine hydrochloride could look to the claims of the '393 Patent to develop its own formulation or preparation for marketing such tablets.

[11]            The 479 patent makes claims for a system of controlled released active substances. The Respondent concedes that system does include tablets. The 479 patent specifies that the active substance to be released can consist of medicaments. Thus, Dr McGinity concludes at paragraph 26:

As a result, one skilled in the art of pharmaceutical formulation with a mind willing to understand the invention will conclude that the term "system" includes within its scope controlled-release tablet formulations or preparations. Indeed, the claims of the '479 Patent simply relate to a different geomatrix controlled-release tablet formulation than the one claimed in the '393 Patent.

[12]            Thus, both patents deal with processes for the controlled release of active substances. As Dr. McGinity summarizes at paragraph 35):

Both the 393 Patent and the 479 Patent include within the scope of their respective claims controlled release tablets of the medicine paroxetine hydrochloride.

[13]            Section 4(2)(b) however, requires a patent to be listed to contain a "claim for the medicine itself" or a "claim for the use of the medicine". Both of these terms are defined in the PMNOC regulations:

[14]            Within the claims of either patent, there is, however, no explicit claim to either the medicine paroxetine hydrochloride or its use.

[15]            The Applicant pointed to a long line of cases drawing the distinction between the medicine itself and a system or method for administering the medicine. In Glaxo Group Ltd v. Novopharm Ltd., (1998) 87 CPR (3^rd) 525 it was held that an inhaler used to administer a medicament to patients does not contain claims to the medicine itself. Similarly, it has been held that transdermal patches (See Novartis Pharmaceuticals Canada Inc v. Canada ( Minister of Health), 2003 FCA 299) or a mechanical capsule forced into the stomach of a cow (see Ely Lilly v. Canada 2003 FCT 676) are not claims to the medicine itself but for administering the medicine.

[16]            The Pfizer Canada Inc v. Canada 2004 FC 370 case involved a patent that describes the construction of a tablet that would allow for controlled release of the drug formulation to the patient after a certain time interval had passed following ingestion. Mosley J. held that the patent in issue dealt with the delivery system for the adminstration of any one of 27 listed drugs not with the drug itself (verapamil hydrochloride). Consequently, he upheld the Minister's decision not to list the patent.

[17]            While these cases clearly establish that patents for the application of a medicine cannot be registered under section 4(2)(b) they are not helpful in determining whether the patents here in issue contain a "claim for the medicine itself" or a "claim for the use of the medicine". There is, however, a line of cases where patents have been held to qualify for registration under s. 4(2)(b).

[18]            Hoffman-LaRoche Ltd v. Canada (1995) 62 CPR (3d) 58 involved four patents involving the medicine flunisolide; namely claims for Form A flunisolide, for the crystalline form of flunisolide, for pharmaceutical formulations containing Form A flunisolide and claims for a process for the preparation of Form A flunisolide itself.

[19]            Similiarly, it was raised as a side issue in Apotex v. Minister of Health (1999) 87 CPR (3d) 271 that the patent in issue No 2178637 did not comply with section 4(2) of the PMNOC Regulations. However, McGillis J. noted at paragraph 47 that "the 637 patent was issued for paroxetine tablets and a process to prepare them, and includes claims to novel paroxetine formulations prepared in the absence of water." Paroxetine being the actual medicine in issue in that case.

[20]            Lastly, in Ely Lilly (2003) 23 CPR 4^th 289 Sharlow J.A. upheld the registration of a patent for an alternate process for the production of ceftazidime pentahydrate (marketed by Ely Lilly under the drug name 'Tazidime'). The patent in issue made claims to a formulation of ceftazidime (held to be a medicine) and amorphous lactose used to defeat the toxicity inherent in ceftazidime. Thus, again, the particular medicine was referred to in the patent in issue.

[21]            By contrast, both the 393 patent and the 479 patent refer to "active substances". There is no mention of paroxetine hydrochloride, the medicine in question. The line of case referred to above makes it clear that patents which can be registered (i.e. that qualify under s. 4 (2)(b)) must have a claim involving the medicine in question in the patent. One skilled in the art of patent interpretation can properly find (as Dr. McGinity did) that active substances, as referrred to in the 393 patent and the 479 patent, include within their scope paroxetine hydrochloride. However, even one skilled in the art of patent interpretation cannot equate active substance with paroxetine hydrochloride. Yet the provisions of s. 4(2)(b) require that the patent contain a claim for the medicine itself i.e. a claim in the patent for the medicine itself when prepared or produced by the methods or processes of manufacture particularly described and claimed. That is not the case with the 393 patent and the 479 patent.

[22]            Both the 393 patent and the 479 patent are process patents as defined by Deprenyl Research Ltd v. Apotex Inc (1994) 55 CPR (3d) 171 at 175. They constitute a new way to effect the controlled release of paroxetine hydrochloride, but they do not make claims for the medicine itself (paroxetine hydrochloride). These processes can be used for medicine but also for other products. Patent 479, for instance, mentions that the active substances can be herbicides; fertilizers and room deodorants.

[23]            Consequently, the logic of Deprenyl (supra) applies. As stated by Jerome A.C.J. at paragraph 17:

the phrase "claim for the medicine itself", in the Patented Medicines (Notice of Compliance) Regulations means a claim for the medicine itself, in the ordinary and natural sense of the words, and a claim for the medicine when prepared by a particular process, in the ordinary and natural sense of the words used in section 2. There is nothing in the language of the legislation which suggests the phrase also covers a claim for a particular process used to produce a medicine. Such an interpretation would, in my view, be an unwarranted enlargement of the natural sense of the words used in the Regulations

[24]            Accordingly, I find that patent 393 and patent 476 do not qualify for registration under s. 4(2)(b) of the PMNOC Regulations. For these reasons, this application cannot succeed.

                                               ORDER

THIS COURT ORDERS that:

1.         This application be dismissed, and

2.         Costs be awarded in favour of the Respondents

"K. von Finckenstein"

                                                                                                   Judge                       

ANNEX A

LEGAL PRINCIPLES OF PATENT CONSTRUCTION

Purposive Construction

In construing a patent, and to give effect to the true inventions, the patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge.

Whirlpool, supra at 148.

Catnic Components Ltd. V. Hill & Smith Ltd., [1982] R.P.C. 183 at 243 (H.L.).

Furthermore, the Supreme Court has held that:

it has always been a fundamental rule of claims construction that the claims receive one and the same interpretation for all purposes.

Whirlpool, supra at 149.

Thus, the same construction used for determining matters of infringement and validity should be used in determining whether a patent contains a claim to the medicine, itself, and as such, is listable on the Patent Register in respect fo a drug containing a medicine.

The key to purposive construction is the identification of the essential elements of the invention. Construction of a patent is a question of law for the Court. However, it should be undertaken with the knowledge of a person skilled in the art, to the extent that such knowledge is revealed by expert evidence at trial.

Whirlpool, supra at 147

Free World Trust v. Électro Santé Inc. (2000), 9 C.P.R. (4^th) 168 (S.C.C.) At 192

[hereinafter Free World].

Beecham Canada Ltd. v. Proctor & Gamble Co. (1982), 61 C.P.R. (2d) 1 at 9 (F.C.A.).

Non-essential elements may be substituted or omitted without having a material effect on the structure or operation of the invention as described in the claim, while essential elements must be present in order fo the device to work as contemplated and claimed by the inventor.

Free World, supra at 193.

To reject purposeful construction would imply embracing a purposeful construction would imply embracing a purposeless approach that ignores the context and use to which the words are being put.

Whirlpool, supra at 149.

Purposive construction does not go outside the four corners of the specification. It is permissible for the trial judge to look at the rest of the specification, including the drawing, to understand what is meant by [a particular word] in the claim, but not to enlarge or contract the scope of the claim as written and thus understood.

Whirlpool, supra at 153.

Person Skilled in the Art

A person skilled in the art has been defined as:

a hypothetical person possessing the ordinary skill and knowledge of the particular art to which the invention relates, and a mind willing to understand a specification that is addressed to him. This hypothetical person has sometimes been equated with the "reasonable man" used as a standard in negligence cases. He is assumed to be a man who is going to try to achieve success and not one who is looking for difficulties or seeking failure.

Free World Trust, supra at 189; citing Fox, H.G. The Canadian Patent Law and Practice Relating to Letters Patent for Inventions, 4^th ed. (Toronto: Carswell, 1969) at 184.

Further General Principles for Claim Construction

A patent is an enactment within the definition of "regulation" under the Interpretation Act, and must accordingly be given an interpretation as best ensures the obtainment of its objects.

Whirlpool, supra at 150.

The construction of a patent must be neither benevolent nor harsh, but rather should be reasonable and fair to both the public and the patentee. A patent must be read by a mind willing to understand, not a mind desirous of misunderstanding. This necessarily means that close attention must be paid to the purpose and intent of the author. The Court should not apply and overly technical or astute approach, and should endeavour to give effect to the construction which will give the inventor protection for that which he has in good faith invented.

Whirlpool, supra at 149.

Consolboard Inc., v. MacMillan Bloedel (1981), 56 C.P.R. (2d) 145 at 157 (S.C.C.).

A dictionary approach is not to be used in construing claims. This would be using evidence from outside the four corners of the specification. Furthermore, looking at the claims of a patent using a dictionary approach is equivalent to looking at the words thorough the eyes of a grammarian or etymologist, rather then through the eyes of and with the knowledge of a person skilled in the art.

Whirlpool, supra at 153.

                          FEDERAL COURT OF APPEAL

    NAMES OF COUNSEL AND SOLICITORS OF RECORD

DOCKET:                  T-834-04

STYLE OF CAUSE: Glaxosmithkline Inc. v. Attorney General of Canada and

The Minister of Health

PLACE OF HEARING:                                 Ottawa

DATE OF HEARING:                                   December 6, 2004

REASONS FOR ORDER:                            The Honourable Mr. Justice von Finckenstein

DATED:                     December 10, 2004

APPEARANCES:

SOLICITORS OF RECORD: