Abbott Laboratories Limited. v. Canada (Ministry of National Health and Welfare), 2006 FC 1411

 

 

 

 

 

 

Date: 20061121

Docket: T-214-05

Citation: 2006 FC 1411

OTTAWA, ONTARIO, November 21, 2006

PRESENT:     The Honourable Mr. Justice von Finckenstein

 

BETWEEN:

ABBOTT LABORATORIES LIMITED

TAP PHARMACEUTICALS INC.

Applicants

and

 

THE MINISTER OF HEALTH, NOVOPHARM LIMITED

and TAKEDA PHARMACEUTICAL COMPANY LIMITED

Respondents

 

 

REASONS FOR ORDER AND ORDER

 

 

[1]               This is an application pursuant to s. 6(1) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (“NOC Regulations”), for an Order prohibiting the Minister of Health  from issuing a Notice of Compliance (“NOC”) under the Food and Drug Regulations, C.R.C. c. 870, to the Respondent, Novopharm Limited (“Novopharm”), with respect to Lansoprazole, 15 mg or 30 mg delayed-release capsules for oral administration until after the expiration of Canadian Patent 2,009,741 (the “741 Patent”).

[2]               The Applicant, Abbot Laboratories Limited is a Canadian pharmaceutical company. TAP Pharmaceuticals Inc. (“TAP”), also an Applicant (collectively, “Abbott”), is a joint venture between Abbott and Takeda Pharmaceuticals Company Limited (“Takeda”). Takeda is the owner of the 741 Patent and TAP is a licensee of the patent. Abbott manufactures and markets a Lansoprazole composition under the trade name “PREVACID”.

 

[3]               Lansoprazole itself is a known compound used to treat excess gastric acid secretions. The patent for the Lansoprazole compound, Canadian Patent 1,255,314, (the “314 Patent”), was also owned by Takeda but, expired on June 6, 2006.  The use of Lansoprazole to treat excess gastric secretions is referred to as the “old use”.

 

[4]               The 714 patent is a patent for the use of Lansoprazole as an antibacterial agent to treat and prevent infectious diseases caused by a bacterium now called Helicobacter pylori (also known as H. pylori) (formerly called Campylobacter pylori) which hereinafter is referred to as the “new use”.  The NOC for the new use of Lansoprazole under the brand name PREVACID was issued to Abbott on April 7, 1998.

 

[5]               Novopharm seeks the issuance of a NOC to allow it to produce a generic version of the 15 mg and 30 mg Lansoprazole. Novopharm intends to market the capsules under the name of “Novo-Lansoprazole”, a drug that is bioequivalent and therapeutically equivalent to PREVACID, but it will be marketed for the old uses only.

 

[6]               To that end Novopharm in its Notice of Allegation (“NOA”),  dated December 21, 2004, states:

The Novopharm Formulation will not infringe any of the claims of the ‘741 Patent because it will not be made, constructed, used or sold as an antibacterial composition or for the treatment or prevention of Helicobacter pylori infections. Novopharm is not seeking approval for the use of the Novopharm Formulation as an antibacterial composition or for the treatment or prevention of Helicobacter pylori infections and no such use will be included in our labeling and Product Monograph.

 

(Affidavit of Sonia Atwell, AR, Vol. 1, Exhibit “D”)

 

 

[7]               Abbott in response started this application alleging, in essence, that infringement will occur as:

(a)    Novopharm’s Product Monograph (“PM”)  for Novo-Lansoprazole will encourage and promote the use of Novo-Lansoprazole for the treatment of ulcers caused by H. pylori;

 

(b)   Novopharm’s labelling advocates a dosage regime that can only be used for the treatment of ulcers caused by H. pylori; and

 

(c)    Novopharm’s sales and marketing strategy is designed to encourage and promote the use of Novo-Lansoprazole for the treatment of ulcers caused by H. pylori.

 

Issue

[8]               There is no allegation of invalidity in this case, accordingly there is only one issue in this case, namely:

Is Novopharm’s allegation (that its proposed product Novo-Lansoprazole will not be “used or sold as an antibacterial composition or for the treatment or prevention of Helicobacter pylori infections”) justified?

 

 

 

Applicable Jurisprudence

[9]               The jurisprudence regarding NOC’s is extensive. It is best set out by Justice Stone in Hoffman-La Roche Ltd. v. Canada (Minister of National Health & Welfare) (1996), 205 N.R. 331 at paragraph 8:

It seems to me that the core guidance of these decisions, insofar as it is applicable to the case at bar, may be summarized as follows:

1. Applications made pursuant to subsection 6(1) of the Regulations are governed by the procedural rules contained in Part V.1 of the Federal Court Rules, C.R.C. 1978, c. 663 -- "Applications for Judicial Review". Bayer AG, supra, per Mahoney J.A., at page 336;

2. The initiator of a section 6 proceeding, being the person having the carriage of the litigation, bears "the initial burden of proof" which is a difficult burden because "it must be to disprove some or all of the allegations in the notice of allegation which, if left unchallenged, would have allowed the Minister to issue a notice of compliance". Merck Frosst, supra, per Hugessen J.A., at page 319;

3. This burden, known in a civil case as either the "persuasive burden" or the "legal burden", is the burden of establishing a case to the civil standard of proof. By contrast, the "evidential burden" consists of the burden of putting an issue in play and means that a party has the responsibility to ensure that there is sufficient evidence of the existence or non-existence of a fact or an issue on the record to pass the threshold for that particular fact or issue. Nu-Pharm, supra, per Stone J.A., at page 33 [p. 16].

4. Where the notice of compliance of a second person 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". Merck Frosst, supra, per Hugessen J.A., at page 319;

5. In determining whether or not the allegations are "justified" "the court must then decide 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". Merck Frosst, supra, per Hugessen J.A., at page 319;

6. The Minister's decision of whether to issue a notice of compliance must turn on whether the allegations of the second person are "sufficiently substantiated to support a conclusion for administrative purposes ... that the applicant's patent would not be infringed if the generic's product is put on the market". Pharmacia, (Court File No. A-332-94) supra, per Strayer J.A., at page 216;

7. Where second persons fail to file notices of allegation or adequate notices of allegation they "must assume their own risk when it comes to attacks on the adequacy of such allegations once prohibition proceedings are commenced". Bayer AG, (Court File No. A-669-93) supra, per Strayer J.A., at page 134.

8. The requirement in paragraph 5(3)(a) of the Regulations that a second person provide a detailed statement "seems intended ... [to make] the patentee ... fully aware of the grounds on which the applicant seeks issuance of a NOC [that will not lead to infringement of the patent] before the patentee decides [page456] whether or not to apply to a court for a determination. Such disclosure would define the issues at a very early stage." Bayer AG, (Court File No. A-389-93) supra, per Mahoney J.A., at pages 337-338;

9. A bald statement of non-infringement in a detailed statement without any factual assertion in support thereof does not meet the requirements of subparagraph 5(1)(b)(iv) of the Regulations. Nu-Pharm, supra, per Stone J.A., at pages 41-42 [pp. 19-20];

10. A common law presumption that a second person's process would infringe the patent applies where: that person has asserted no facts to support his allegation of non-infringement; the evidence of non-infringement lay peculiarly within his knowledge; no evidence of non-infringement has been presented by that person; and the first person has no other available means of accessing such evidence. Nu-Pharm, supra, per Stone J.A., at page 45 [p. 20].

 

 

 

 

 

Findings Required

[10]           As Novopharm made allegations of non-infringement in this case, it is inherent in a decision to grant a prohibition order that the Court form the view that Novopharm's allegations are not justified.  Conversely, if the Court refuses to grant a prohibition order, it must have come to the conclusion that Novopharm’s activities would not infringe.

 

[11]           Abbott’s allegation of infringement are based on subparagraph 5(1)(b)(iv) of the NOC Regulations which reads as follows:

 

[12]           There has been considerable jurisprudence about the meaning of subparagraph (iv) and whether infringement by third parties can be attributed to the generic producer (the second person) or whether it has to be induced, procured or otherwise be linked to the generic producer.  The recent case of Pharmascience Inc v. Sanofi-Adventis Canada Inc., [2006] F.C.A. 229 puts an end to that debate when Madame Justice Sharlow stated:

 

54     The interpretive principle from Biolyse weighs against an interpretation of the NOC Regulations that assumes that they are intended to prevent all patent infringement. Biolyse is more consistent with an interpretation of the NOC Regulations that assumes that they are intended to prevent only infringement by (or infringement induced or procured by) generic drug producers who make abbreviated new drug submissions containing one of the stipulated comparisons to an existing drug product.

 

55     I turn now to the relevant words of subparagraph 5(1)(b)(iv) of the NOC Regulations, which sets out the required contents of a non-infringement allegation. It states that in a non-infringement allegation, the generic drug producer must allege that:

 

o           ... 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.

* * *

o           ... 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.

 

56     Pharmascience argues that the words "by that person" means that this provision refers only to acts of Pharmascience that would constitute infringement of the 457 patent (which I understand would include acts of Pharmascience that induce or procure infringement by others). Aventis argues that subparagraph 5(1)(b)(iv) is capable of being read more broadly, and should be read more broadly, so that it includes any infringement by anyone of the 457 patent that results in any way from the issuance of a notice of compliance to Pharmascience.

 

57     In my view, the interpretation proposed by Pharmascience is more consistent with the ordinary grammatical meaning of subparagraph 5(1)(b)(iv) of the NOC Regulations, and is also more consistent with the legislative scheme and purpose. Subsection 55.2(4) of the Patent Act and by extension the NOC Regulations are intended to prevent patent infringement by Pharmascience, not by patients.

 

58     The narrower interpretation proposed by Pharmascience is also more consistent with the general scheme of the Patent Act. The bargain represented by the 087 patent permits anyone to use the patented invention (that is, to make ramipril using one of the claimed processes) once the term of that patent expired in November of 2002. If Pharmascience is now prevented from obtaining a notice of compliance for its ramipril capsules for use in the treatment of hypertension only because the inevitable result is infringement of the 457 patent by patients who use the Pharmascience product for the treatment of cardiac insufficiency, the practical result will be an artificial extension of the monopoly represented by the now expired 087 patent. I do not believe that Parliament intended the NOC Regulations to permit such a result.

 

(Underlining added)

 

[13]           From this I take it that in order for Abbott to succeed it has to prove on a balance of probabilities that infringement (by Novopharm or infringement by others induced or procured by Novopharm) will occur.

 

[14]           In addition the NOC Regulations have been recently revised and came into force on October 5, 2006. The new subparagraph now reads:

 

 

[15]           With this jurisprudence in mind I will now address the facts of this case.

 

Construction of Patent

[16]           The first step in a case dealing with alleged infringement is a construction of the patent in issue. The patent at issue is the 741 patent. The 741 Patent, entitled “Selective Antibacterial Agent”, contains 34 claims and concerns a new use of the Lansoprazole compound. It was issued on March 23, 1999, and will expire February 9, 2010. The parties agree that the only claims in issue here are claims 1 and 16.

 

[17]           Claim 1 reads:

An antibacterial composition which contains an antibacterial effective amount of compound of the formula:

(wherein R1 stands for hydrogen, methoxy or trifluoromethyl; R2 and R3, being the same or different from each other, stand for hydrogen or methyl; and R4 stands for optionally substituted hydrocarbon residue and n denotes 0 or 1), or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier.

 

Claim 16 reads:

 

A use for preventing or treating infectious diseases caused by the genus Campylobacter, of a compound of the formula:

 

(wherein R1 stands for hydrogen, methoxy or trifluoromethyl; R2 and R3, being the same or different from each other, stand for hydrogen or methyl; and R4 stands for optionally substituted hydrocarbon residue and n denotes 0 or 1), or a pharmaceutically acceptable salt thereof.

 

[18]           The principles of patent claim construction have been stated by Justice Binnie in Free World Trust v. Électro-Santé Inc., [2000] 2 S.C.R. 1024 and Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067. These principles have been succinctly summarized by Harrington J. in Biovail Pharmaceuticals Inc. v. Canada (Minister of National Health and Welfare), 2005 FC 9 at paragraph 15, 267 F.T.R. 243:

1.  A patent is construed as a bargain between the inventor and the public. In consideration of disclosing the invention, the inventor is given a temporary monopoly to exploit it.

 

2.  It is a statutory requirement that the patent contain a specification and end with a claim or claims "defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege or property is claimed". The specification must be sufficiently full, clear, concise and exact "as to enable any person skilled in the art or science to which it pertains, or to which it is most closely connected, to make, construct, compound or use it". (Patent Act, R.S.C. 1985, c. P-4, as amended, s. 27)

 

3.  The patent is notionally addressed to a person skilled in the art or science of the subject-matter and is to be read as such a person would have read it when it first became public. …

 

4.  The claims are to be read in an informed and purposive way to permit fairness and predictability and to define the limits of the monopoly "[I]ngenuity of the patent lies not in the identification of the desired 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 desired result" (Free World Trust, paras. 31, 32).

 

5.  The claim portion of the patent specification takes precedence over the disclosure portion in the sense that the disclosure is read to understand what was meant by a word in the claims "but not to enlarge or contract the scope of the claim as written and thus understood" (Whirlpool, para. 52).

 

6.  It is only such novel features that the inventor claims to be essential that constitute the "pith and marrow" of the claim. "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" (Whirlpool, para. 45).

 

7.  Some elements of the claimed invention are essential and others are not, based either on common knowledge when the patent was published or according to the intent of the inventor, expressed or inferred from the claims. …

 

8.  To overclaim is to lose everything. If the inventor underclaims, the court will not broaden the monopoly in the interests of the "spirit" thereof. This often, as in this case, results in layers of claims, each limitation serving as a potential safety net so that if the broadest claims fall, the monopoly may be saved in part by the more modest claims.

 

9.  Yet a patent is not an ordinary writing. It meets the definition of a "regulation" in the Interpretation Act, and must be read to assure the attainment of its objects. "Claims construction is a matter of law for the judge, and he was quite entitled to adopt a construction of the claims that differed from that put forward by the parties." (Whirlpool, supra, paragraph 52 [61].)

 

 

[19]           There is no dispute between the parties that the patent should be interpreted by reference to the state of the art as it existed in 1990. Further, the parties agree that the appropriate person skilled in the art would be a physician; someone who has an undergraduate level understanding of chemistry, has a medical degree and has completed an internship, with some exposure to clinical gastroenterology.

 

[20]           As experts, the parties put forward the witnesses listed in Annex 1. None of the experts have been challenged as to their expertise and I see no reason to question their credentials.  I accept their testimony except to the extent qualified in these Reasons.

 

[21]           There is no dispute as to claim 1. It is simply a claim for a new use of the old Lansoprazole composition, namely as an effective antibacterial compound. This is different from the 314 patent which claimed the use of Lansoprazole as an inhibitor against excess acid secretions.

 

 

[22]           However with respect to claim 16 Novopharm contends that it should be read:

(a)    as a new use for Lansoprazole as an antibacterial agent against H. pylori; and

 

(b)   as a claim for the use Lansoprazole alone. It should not be constructed to include a claim for the use of Lansoprazole in combination with other drugs.

 

Abbott on the other hand contends that it should be read as:

(a)   a claim for the use of Lansoprazole against infectious diseases caused by H. pylori, and

 

(b)   a claim for Lansoprazole alone or in conjunction with other drugs.  

 

[23]           Point a) is conclusively dealt with by the testimony of Abbott’s witness, Dr. Armstrong, who observed:

27. In 1990 there were no data, and there are none today, to support any suggestion that taking Lansoprazole can prevent a patient from acquiring an H. pylori infection.  This is an important medical fact which given background to the meaning of “treating and preventing”.  No person of ordinary skill in the art, reading the patent in 1990, would have concluded that Lansoprazole was being described for use in preventing an H. pylori infection.  For this reason, among others, such a person would also understand, necessarily, that claim 16 cannot be directed at preventing or treating H. pylori infections (as Dr. Graham has it) but is clearly directed at preventing the diseases that such infections cause – ulcers.

 

28. A person with ordinary skill in the art reading the patent as a whole would understand that the invention relates to the antibacterial ability of Lansoprazole to prevent the diseases caused by H. pylori and that it is not limited to eradication of H. pylori or directed to the prevention of H. pylori infections from occurring.

 

(Reply Affidavit of Dr. David Armstrong, AR, Vol III at 527.)

 

[24]           This interpretation is also supported by the plain meaning of the claim and gives significance to the words “diseases caused by” used in claim 16 while the interpretation put forward by Dr. Graham, Novopharm’s expert ignores them.  Further support for this interpretation can also be found in Lilly ICOS LLC v. Pfizer Ltd. 59 BMLR 123 at paragraph 43.  The Court will therefore adopt Dr. Armstrong’s interpretation.  The significance of the reference to diseases will become obvious during the following discussion of the product monogram (“PM”) for Novo-Lansoprazole.

 

[25]           As to point b) I see nothing in either claim that imports a limitation that Lansoprazole has to be used alone. We know from Whirlpool, supra as quoted in Biovail, supra that:

The claim portion of the patent specification takes precedence over the disclosure portion in the sense that the disclosure is read to understand what was meant by a word in the claims "but not to enlarge or contract the scope of the claim as written and thus understood" (Whirlpool, paragraph 52 [61]).

 

[26]           Thus, even if there was a limitation implicit or explicit in the disclosure, it could not be imported into the claims.  Drugs often are not administered in a pure state but mixed with an excipient or other drugs and the use of such drugs would be highly restricted if the mention of a use of a drug would be read as implying it has to be used alone.  Unless the use claimed specifically employs such words as “alone” or “not in conjunction with other compounds” it would be improper to read such a limitation into the claim. Abbott’s expert, Dr. Fass stated:

55. The disclosure of the patent teaches the Lansoprazole exhibits antibacterial activity against H. pylori and can therefore be used to treat or prevent infectious diseases caused by H. pylori.  This would be understood by a person skilled in the art (as defined below) to refer to the use of Lansoprazole either alone or in combination to treat or prevent the infectious diseases caused by H. pylori.

 

(Affidavit of Ronnie Fass, M.D., Applicant’s Record, Vol. III.)

 

 

[27]           And more explicitly under cross-examination, Novopharm’s expert, Dr. Fred Saibil, stated:

Q.  There is nothing in the patent claims that would exclude the use of Lansoprazole in patients who are taking other medications at the same time?

 

A.  That’s correct.

 

(Cross-examination of Dr. Fred Saibil, Respondent’s Record, Vol. VI at 1136)

 

 

[28]           Only Novopharm’s expert  Dr. Graham suggested in paragraph 92 of his affidavit:

92. As at the Relevant Date, a person skilled in the art would understand the ‘741 Patent to be claiming the use of Lansoprazole, on its own, for the intentional eradication of H. pylori infectious diseases.

 

(Affidavit of Dr. David Y. Graham, Respondent’s Record, Vol. I.)

 

[29]           Other than Dr. Graham, there was no evidence presented to contradict the contentions of Dr. Fass and Dr. Saibil.  While Dr. Graham may be a great expert on H. pylori, the Court is not persuaded by his approach to patent construction.  Accordingly, the Court will not read any limitation into claim 16. With this interpretation of claim 16, as suggested by Abbott, in mind let us then turn to the three contentions of Abbott.

 

Uncontested facts

[30]           After reading the affidavits of both sides and the relevant cross-examinations the Court found that the experts of both sides basically agree on the following facts:

-  Lansoprazole is a proton pump inhibitor (PPI) and is used for the prevention or treatment of patients with H. pylori infections among other indications. It is sometimes used either by itself (“monotherapy”) or with another medicine (“dual therapy”) or as a part of a combination therapy along with two antibiotics for eradicating H. pylori (“triple therapy”). Triple therapy is the gold standard in the treatment of infectious diseases caused by H. pylori. (See Affidavit of Dr Armstrong, AR, Vol III at paragraph 100, Affidavit of Dr Graham, RR, Vol. I at paragraph 69.)

 

-  PREVACID, Abbott’s trade name for Lansoprazole, is used in Canada roughly in the following percentages:

 

 

(a)    GERD – 52%

 

(b)   Dyspepsia/Heartburn – 29%

 

(c)    Peptic Ulcer – 4%

 

(d)   NSAID – induced ulcer – 3%

 

(e)    Other – 12%

 

(Affidavit of Dr. Armstrong, AR, Vol. III at paragraph 91.)

 

-  There are three major causes of ulcers:

 

o       H. pylori , causes  approximately  90% of duodenal ulcers and approximately 80% of gastric ulcers ,

o       Nosteroidal Anti-inflammatory Drugs ( NSAID); and

o       Zollinger-Ellison Syndrome and other hypersecretroy states.

 

Other causes of ulcers, while extremely rare, exist.

 

(See Affidavit of Ronnie Fass, M.D., Affidavit of Dr. David Y. Graham, Affidavit of Dr. David Armstrong, Compendium of the Applicants; and the Transcript on Cross-examination of David Y. Graham dated June 2, 2006, Compendium of the Respondent, Novopharm Limited.)

 

Product Monograph

[31]           Abbott contends there will be infringement of claim 16 as the PM of the proposed Novo-Lansoprazole will induce physicians to prescribe Novo-Lansoprazole for triple therapy.

 

 

[32]           The product monograph (“PM”) for Novo-Lansoprazole provides:

SUMMARY PRODUCT INFORMATION

 

 

INDICATIONS AND CLINICAL USE

 

Adults

 

NOVO-LANSOPRAZOLE (Lansoprazole delayed-release capsules) is indicated in the treatment of the following conditions where a reduction of gastric acid secretion is required:

 

·        Duodenal ulcer

·        Gastric ulcer

·        Reflux esophagitis including patients with Barrett’s esophagus, and patients poorly responsive to an adequate course of therapy with histamine H₂-receptor antagonists.

·        Healing of NSAID-Associated Gastric Ulcer, treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. (Controlled studies did not extend beyond 8 weeks).

·        Reduction of Risk of NSAID-Associated Gastric Ulcers in patients with a history of gastric ulcers who require to continue taking a NSAID. (A controlled study did not extend beyond 12 weeks).

·        Gastroesophageal reflux disease (GERD); treatment of heartburn and other symptoms associated with GERD.

·        Pathological hypersecretory conditions including Zollinger-Ellison Syndrome.

(See DOSAGE AND ADMINISTRATION)

 

[33]           While the record does not contain a PM of PREVACID, the Canadian Compendium of Pharmaceuticals Specialties 2006 (“CCPS”) provides the following reference for PREVACID:

 

SUMMARY PRODUCT INFORMATION

 

 

Indications and Clinical Use:  Note:  When used in combination with antimicrobials for the eradication of H. pylori, the product monograph for those agents should be consulted.

 

Oral Administration:  Adults: PREVACID (Lansoprazole delayed-release capsules), and PREVACID Fas Tab (Lansoprazole delayed-release tablets) are indicated in the treatment of conditions where a reduction of gastric acid secretion is required, such as:

 

1.                   Duodenal ulcer;

2.                   Gastric ulcer;

3.                   Reflux esophagitis including patients with Barrett’s esophagus, and patients poorly responsive to an adequate course of therapy with histamine H₂ receptor antagonists;

4.                   Healing of NSAID-Associated Gastric Ulcer, treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. (Controlled studies did not extend beyond 8 weeks).

5.                   Reduction of Risk of NSAID-Associated Gastric Ulcers in patients with a history of gastric ulcers who require to continue taking a NSAID. (A controlled study did not extend beyond 12 weeks).

6.                   Symptomatic Gastroesophageal reflux disease (GERD); treatment of heartburn and other symptoms associated with GERD.

7.                   Pathological hypersecretory conditions including Zollinger-Ellison Syndrome. (See Dosage and Administration)

8.                   Eradication of H. pylori.

(AR Vol VIII p.1737)

 

The PM for Novo-Lansoprazole evidently mirrors the indication and clinical use of PREVACID’s as found in the CCPS, except for the addition of number 8 in PREVACID (“Eradication of H. pylori”).

 

[34]           Novopharm argues that:

(a)    there is no reference to H. pylori in its PM and therefore it does not induce or encourage infringement of the 741 patent;

 

(b)   The Novopharm PM reflects the fact that Novopharm is only asking for an NOC regarding the old use of Lansoprazole; and

 

(c)    The reference to H. pylori was deliberately left out. While H. pylori may cause 90% or duodenal ulcers and 80 % of gastric ulcers there are other causes of duodenal or gastric cancers and these are the ulcers the first two bullets refer to. They can’t be read to refer to H. pylori caused infections as these were specifically referred to in the last bullet of the CCPS reference for PREVACID, which was dropped from Novo-Lansoprazole’s PM.

 

[35]           Abbott points out that Novopharm’s PM is, for all intents and purposes, identical to the reference for PREVACID in the CCPS.  Like PREVACID’s reference, it refers to duodenal and gastric ulcers. Most duodenal or gastric ulcers are caused by H. pylori. The treatment for ulcers caused by H. pylori is triple therapy (a PPI (such as Lansoprazole) and 2 antibiotics). The Novopharm PM, given its prominent reference to duodenal and gastric ulcers will encourage or induce physicians to prescribe Novo-Lansoprazole for triple therapy. If Novopharm really intended to only target the old use market for Lansoprazole, i.e. gastric acid secretions, GERD and ulcers caused by Zollinger-Ellison Syndrome, NSAID’s or extremely rare other causes, it would have either left out the first two bullets or added after the first two bullets the words “other than ulcers caused by H. pylori”.

 

[36]           The case law establishes that the PM ‘plays a key role …by providing the Court with an indication of the intentions of the generic company and the likelihood of infringement’ (see A.B Hassle v. Canada (Minister of Health and Welfare) (2002), 22 C.P.R. (4th) 1 at paragraph 55 per Sexton J.A).

 

[37]           The experts from both sides agree that the ‘gold standard for treating ulcers caused by H. pylori would be triple therapy. Dr. Graham, the star witness for Novopharm, in his affidavit even went so far as to point out the dangers of monotherapy for H. pylori caused ulcers.

 

123. As at the Relevant Date, in context of the ‘741 Patent, the person skilled in the art knew that “preventing and treating” an H. pylori infection meant eradicating the H. pylori and that “an antibacterial effective amount” meant an amount that would eradicate the H. pylori.

 

124. Lansoprazole monotherapy does not eradicate H. pylori in vivo.

 

125. Due to the potential increased risk of gastric cancer, and the known lack of success, it would be foolish, dangerous and potentially negligent to prescribe Lansoprazole monotherapy to treat H. pylori.

 

                                    (Affidavit of Dr. David Y. Graham, RR, Vol. I at 151.)

 

[38]            Physicians prescribing medication for triple therapy can do so by either prescribing what is called an HpPAC (a separately identified package of drugs having its own Drug Identification Number and containing a PPI and two antibiotics) or prescribing the three compounds separately. The practice depends on the individual physician. The PM, which is addressed at physicians and pharmacists, has to be read through their eyes.  The issues raised in this application only come into play when the three drugs are prescribed separately.

 

[39]           Under cross-examination regarding the Novopharm PM and how a physician would interpret it in a situation where he had diagnosed an ulcer caused by H. pylori, Dr Graham observed the following:   

Q.  All right. If they look at the monograph which Novopharm wants to have approved by Health Canada, they would find that the Lansoprazole product is approved to treat a gastric ulcer. Correct?

 

A.  They would find that.

 

Q.  And the monograph says to the physician reading it that they can treat this ulcer with Lansoprazole monotherapy. Correct?

 

A.  Well, that would hopefully not be what the physician would come away with.

 

Q.  They would come away with some different conclusion?

 

A.  Well, they have just diagnosed the presence of H. pylori infection –

 

Q.  Okay.

 

A.  – and an ulcer.  They would make the presumptive diagnosis that that ulcer was caused by the H. pylori – may or may not be – and their next decision would be how to treat the H. pylori infection, so the ulcer would become less important or irrelevant, so they could chose any therapy for that.  And then afterwards, because it’s a gastric ulcer, then they may decide to continue treatment until complete heal –

 

Q.  All right.

 

A.  – or may not.

 

Q.  According to your view of the matter, they would be obliged, though having diagnosed the H. pylori, to treat it.  Correct?

 

A.  To treat the H. pylori.

 

Q.  And the only acceptable treatment, in your view, would be eradication.  Correct?

 

A.  Well, that’s how you treat H. pylori.

 

Q.  And so the person who looks at the Lansoprazole – Novo-Lansoprazole monograph wants to treat this ulcer, wants to treat this patient, would understand that in addition to the use of Lansoprazole, they would have to use probably two other antibiotics.

 

A.  They would use some – Yeah.  They would use probably –

 

Q.  Gold standard.

 

A.  – or four drugs, right.

 

Q.  The first line treatment gold standard today would probably be two other antibiotic drugs.  Correct?

 

A.  That would be one of the options, yes.

 

Q.  So a person reading that monograph, although they see the treatment of the ulcer as indicated for Novo-Lansoprazole, would understand that they have to actually use the Novo-Lansoprazole with two antibiotic drugs.

 

A.  They would recognize that they would have to – They would use – If they’d chose that PPI –

 

Q.  Right.

 

A.  – for whatever reason –

 

Q.  Assume that.

 

A.  – that that would then be given with two other antibiotics.

 

(Cross-examination of Dr. David Y. Graham, AR, Vol. VI at 1030-32)

 

 

[40]           Admittedly, Dr. Graham also points out that: a) physicians rarely look at a PM when making a prescription; and b) that a pharmacist might, when filling out the prescription, note that Novo-Lansoprazole has no indication for triple therapy use. This however, does not detract from the fact that the Novopharm PM is set up in such a way that, by his own admission, it can be seen to be a prescription of Novo-Lansoprazole for triple therapy which would be an encouragement to infringe claim 16 of the 741 patent.

 

[41]           Given the expert testimony that ulcers caused by something other than H. pylori, NSAID’s or Zollinger-Ellison Syndrome are extremely rare, it is hard to understand why the reference to duodenal and gastric cancer is on the Novopharm PM and why it occupies the first two bullets.

 

[42]           Accordingly, I find, based on the testimony of Novopharm’s most renowned witness, that on a balance of probabilities the Novopharm PM would induce a physician to prescribe Novo-Lansoprazole for a triple therapy to fight H. pylori-caused infections.

 

Label

[43]           The proposed label for Novo-Lansoprazole has the following side panel:

Side Panel

 

[44]           The Adult dosage displayed “15 mg to 30 mg once or twice daily, for one to eight weeks” includes the standard dosage for triple therapy against ulcers caused by H. pylori, namely “30 mg twice daily for one week”.  (See Affidavit of Dr. Arni Sekar, RR, Vol. II at 420; Affidavit of Dr. Fred Saibil, RR, Vol. II at 305.)

 

[45]           Dr. Sekar, Novopharm’s expert witness under cross-examination admitted the following:

Q.  And you understand that the dosing in the HpPAC is 30 milligrams of Lansoprazole b.i.d.?

 

A.  That is right.

 

Q.  For one week?

 

A.  Yes.

 

Q.  And you know of no other use of Lansoprazole which is clinically indicated for a single week; correct?

 

A.  Correct.

 

Q.  You know of no other use of Lansoprazole, according to the statements in the monograph anyway, requiring 30-milligram dosing b.i.d.; right?

 

A.  You are talking about the monograph…

 

Q.  Yes.

 

A.  …or my opinion?

 

Q.  The monograph.

 

A.  Yes.  It is different with the investigation of NCCP, which we maybe should go into it right now, non-cardiac chest pain.  It is well-established practice that if you are not too sure whether the pain is coming from the esophagus or not, you put them on a b.i.d. regime of the PPI for a week at least, and see what happens to the patient’s chest pain.  So that is actually considered to be a PPI diagnostic test.  So that is another indication…

 

Q.  Got it.

 

A.  …which I often use in practice.

 

Q.  It is called NCCP?

 

A.  Non-cardiac chest pain, NCCP.

 

Q.  Okay.

 

A.  And it is called a PPI trial therapy.  It used to be called the omeprazole trial therapy, and now it is called PPI therapy.

 

Q.  That is not a regime which is specifically described in the Novopharm monograph; fair?

 

A.  I don’t see it here, no.

 

(Cross-examination of Dr. Arni S.C. Sekar, RR, Vol. IV at 1295.)

 

[46]           The NCCP that Dr. Sekar suggests, that one might prescribe Lansoprazole, 30 mg twice a day for a week, is (a) a diagnostic test, not a treatment; and (b) would be a use of Novo-Lansoprazole that is not indicated in the NOC. It would be an “off label use” of Novo-Lansoprazole and thus, not relevant when discussing uses authorized by the NOC and which is reflected on the PM and the label.

 

[47]           The Court is driven to the conclusion that the inclusion of the amount, the frequency and the duration of the dosage for triple therapy on the label for Novo-Lansoprazole under the rubric ‘Adult dosage’ and the absence of any other clinically indicated use for that dosage, on the balance of probabilities, will have the effect of inducing or encouraging physicians to prescribe Novo-Lansoprazole for triple therapy.

 

Novopharm’s marketing strategy.

[48]           Sexton J.A. in A. B. Hassle, supra observed at paragraph 35:

[35] As stated in Hoffmann-La Roche v. Canada (Minister of National Health and Welfare) (1996), 70 C.P.R. (3d) 206 (F.C.A.) at 210, the initial burden of proof rests on the person having the carriage of the litigation to establish a case to a civil standard of proof. Thus, the onus for proving that Apotex’ allegations in the NOA are not justified rests upon the Appellants, on a balance of probabilities. The onus is not on Apotex to provide evidence supporting their allegations in their NOA. Rather, as stated in Hughes and Woodley on Patents, loose-leaf (July 2002, Issue 52) at 413, the Appellants must prove on a balance of probabilities that an infringements will occur if the Minister issues a NOC.

 

[49]           To discharge this onus, Abbott called a host of witnesses. It is not necessary to review the evidence of all. Scott Gavura, a pharmacist and former manager in the Ontario Ministry of Health and Long term Care who was closely involved in the Ontario Drug Benefit Formulary, stated his general opinion in his affidavit:

15.  In my opinion a generic Lansoprazole will obtain “reimbursement” and “interchangeability” designations in Ontario if a NOC issues to Novopharm in the circumstances set out as assumptions herein.

 

16.   In that event, prescriptions given to ODB beneficiaries for Lansoprazole, regardless of how the prescriptions are written, will be filled with Novopharm’s generic Lansoprazole (“Novo-Lansoprazole”) for the reasons set out herein.

 

17.  For the reasons set out below, substitution of Novo-Lansoprazole will occur in virtually each and every case where Lansoprazole or PREVACID is prescribed alone, regardless of indication, to a patient who is an ODB beneficiary.

 

18.  For the reasons set out below, substitution of Novo-Lansoprazole will occur in virtually each and every case where Lansoprazole or PREVACID is prescribed to an ODB beneficiary as one of the three drugs to be used for patients diagnosed with an H. pylori infection.

(Affidavit of Scott Gavura, AR, Vol. IV at 704.)

 

 

[50]           And specifically with respect to a restricted designation he opined;

51.  Based on my knowledge and experience, it is my personal opinion that Ontario will not make any sort of special or restricted designation of interchangeability of a Novopharm Lansoprazole product if the other requirements of listing are met. The designation of equivalence by Health Canada is equally applicable to the H. pylori indication as it is to the GERD or other proton pump inhibitor (“PPI”) indications. Even if a NOC is issued to Novopharm based upon a product monograph and submission that makes no reference to “H. pylori”, there is no realistic prospect of anything but a listing of the Novopharm product as fully interchangeable with PREVACID.

(Affidavit of Scott Gavura, AR, Vol. IV at 715.)

 

[51]           Mr. Gavura was cross-examined by Novopharm, but his testimony was not shaken and no contradictions were unearthed.

 

[52]           Novopharm did present the evidence of Mr. Luciano Tauro, an Ontario pharmacist. His testimony was limited to the effect of Novo-Lansoprazole being listed on the Ontario Drug Benefit Plan with partial interchangebility. However, his cross-examination revealed that as a mere owner of a pharmacy, he has no knowledge of the details of the Ontario Drug benefit Plan or how generic products are listed. His testimony therefore in no way detracts from that of Mr. Gavura. 

 

[53]           With respect to the private payer drug plans (plans where a third party, not being the government, pays part or all of the cost of prescription drugs) Abbot tendered the testimony of Margaret Ingram. She is a pharmacist and an expert in:

“the design, operation, management, coverage, and reimbursement schemes in plans and systems for the dispensing and reimbursement of drugs under Private Payer arrangements in Canada and their effect on generic substitution;”

 

(Affidavit of Margaret Ingram, AR, Vol. IV at 679.)

 

[54]           According to Margaret Ingram 58 % of Canadians receive benefits from a private payer. Based on her extensive knowledge and experience of the private payer market Ms Ingram observed:

(b) Triple Therapy

 

(i)                  The generic product will have to be launched and sold at a price substantially lower than PREVACID^®;

 

(ii)                If a prescriber were to order Triple Therapy by prescribing its three component drugs separately, and regardless of how the Lansoprazole component was described (e.g., by brand name or generically), pharmacists would be under a duty to advise patients of the availability of a generic alternative;

 

(iii)               In at least half and probably three quarters of the cases, Private Payer plans in Canada will not reimburse patients for the higher cost of PREVACID®;

 

(iv)              When Private Payer plans do not reimburse for the higher cost of brand products, only a tiny number of patients ever elect to pay the additional cost of a drug to obtain the brand product;

 

(v)                As a result, and regardless of how the Lansoprazole part of such a Triple Therapy prescription is written, at least half and probably three-quarters of such cases will result in the generic product being dispensed to and used by patients in the Private Payer context, when available.

 

(Affidavit of Margaret Ingram, AR, Vol. IV at 682-83)

 

[55]           Ms Ingram was cross-examined by Novopharm, but her testimony was not shaken and no contradictions were unearthed. Novopharm presented absolutely no evidence with respect to the private payer market.

 

[56]           Abbott has thus produced uncontradicted affidavit evidence by two experts as to what, in their opinion, will most probably happen under the regime of the Ontario Drug Benefit formulary and in the private payer market.

 

 

[57]           Given the extensive experience that both experts have in their fields and given that they both withstood very rigorous cross-examination,  I have no problem of finding, on the basis of their evidence, that Abbot has discharged its onus of proving ‘on a balance of probabilities that an infringements will occur if the Minister issues a NOC’.

 

[58]           There is no need for me to review the evidence of the other witnesses regarding practices in Manitoba, Alberta and British Columbia.

 

Conclusion

[59]           Given the nature of the proposed  PM, and label for Novo-Lansoprazole and in light of the evidence of likely infringement presented by Mr. Gavura and Ms. Ingram I have no hesitation in finding that the allegation of Novopharm is not justified. Consequently, a prohibition will issue ordering the Minister not to issue an NOC until expiry of the 741 patent.

 

Postscript

[60]           Subsequent to the hearing, counsel for Novopharm drew the Court’s attention to the recent Supreme Court decision of AstraZeneca Canada Ltd. v. Canada (Minister of Health), 2006 SCC 49 and argued:

15. In view of AstraZeneca, the question for the Court to ask is: did Novopharm take advantage of the early-working exception with respect to the “invention” of the ‘741 Patent in submitting its ANDS for Novo-Lansoprazole?  To answer this question, the Court must compare the invention claimed in the ‘741 Patent with the approved uses of the reference product.

 

16. As noted above, the invention claimed in the ‘741 Patent is the “new use” of Lansoprazole, namely use as an antibacterial agent.  This is not an approved use of PREVACID, which is only approved for the “old use” of Lansoprazole, namely in reducing gastric acid secretions.  Accordingly, the reference product does not and has never incorporated the invention of the ‘741 Patent.

 

[61]           This point was not raised in the NOA (nor for that matter in Novopharm’s factum).  It cannot be raised at this late stage, and the Court will therefore disregard such submissions.

 

ORDER

 

THIS COURT ORDERS that an Order of prohibition will issue.

 

(a)        The Minister of Health shall not issue a Notice of Compliance to the Respondents prior to the expiry of Canadian patent 2,009,741 with respect to 15 mg or 30 mg delayed-release capsules of Novo-Lansoprazole; and

 

(b)        Costs in favour of Abbott Laboratories Limited, Tap Pharmaceuticals Inc. and Takeda Pharmaceutical Company Limited, payable by Novopharm Limited.

 

 

“Konrad W. von Finckenstein”

 

 

 

Annex 1

 

For Abbott

 

Dr. David Armstrong: He is a specialist in gastroenterology, a subspecialty of internal medicine, a field he has been practicing, studying and teaching since 1985. Between 1982 and 1985 he was a Senior House Officer and Registrar in Internal Medicine and Gastroenterology at the Hull Royal Infirmary where he underwent three years of study and practice in internal medicine and gastroenterology. Thereafter, he spent seven years as a research fellow in gastroenterology. From 1995 to 1998 he was a Clinical Scholar in Gastroenterolgy at McMaster University and he has held an appointment as Assistant and then, Associate Professor at McMaster University since 1998. He is currently the Chief of Clinical Service in the Division of Gastroenterology for the Hamilton Health Sciences group of academic hospitals, affiliated with McMaster University. He has hundreds of peer-reviewed publications, abstracts, and has been involved with many invited lectures and symposia on gastroenterology generally and H. pylori specifically. He has been apart of the development of consensus guidelines recognized both nationally and internationally in respect of H. pylori and has conducted major research projects on other gastric ailments affected by H. pylori.

 

Dr. Ronnie Fass: He is a gastroenterologist from the University of Arizona. He is currently a tenured Associate Professor of Medicine at the University of Arizona and the Director of Motility Laboratory at the University’s Health Sciences Center. He is a staff gastroenterologist with full clinical responsibilities and he also serves as a medicine-attending physician 4-6 weeks per year. He has participated in numerous American and international committees in the medical community and is the author of more than 300 articles, commentaries, editorials, book chapters and abstracts and is a peer reviewer of over 40 journals, including the Journal of Clinical Gastroenterology, the American Journal of Gastroenterology, and the American Journal of Medicine. He teaches medical students, residents, and fellows and mentors research fellows, pre-med students, visiting scholars, medical students, residents, clinical fellows and public health students. He was a person skilled in the art at the relevant time for the construction of the 741 Patent. He has also been invited to be a participant in development of a number of consensus guidelines internationally and continues to be an active contributor to the collective medical understanding of diseases caused by H. pylori.

 

Tom Brogan: He is the President of Brogan Inc., a company that conducts economic research in the health care industry, specializing in the analysis of pharmaceutical markets. He has 30 years of experience as an economist, senior manager in public sector drug plans, and as a manager of major studies in health economics. He supervises the operation of Brogan Inc., which publishes research reports based on a detailed analysis of both private and public drug plan operations, including a landmark study of the factors affecting the cost of private drug plans. His area of expertise includes health economics, market access and corporate strategies, such as drug pricing. Through his company, Brogan Inc., he has extensive access to raw data from almost all public or provincial drug formularies. He has also been employed with the Federal government for 15 years and has gained extensive experience with the pharmaceutical industry while employed as a senior policy analysis with Consumer and Corporate Affairs Canada. Between 1982 and 1989, he was involved in policy analysis related to amending the Patent Act, including drafting portions of Bill C-22, An Act to Amend the Patent Act 1987, and in organizing the Patented Medicines Prices Review Board, acting in the position of Director, Compliance and Liaison.

 

Dr. Jerry Rosenblatt: He is a Principal of Rosenblatt-Klauber Group Inc., a firm he formed that specializes in providing marketing strategies consulting in the pharmaceutical industry focusing in the areas of new product forecasting, in-line forecasting, market size and attractiveness assessments, strategic market planning, corporate portfolio assessment, marketing science applications and marketing research support. His company has been tracking and studying the Canadian pharmaceutical market for the past 12 years and has analyzed, by province, the impact of generic entry of a number of drugs, including pravastatin, simvastatin, and sertraline. He also published a strategic analysis of the Canadian Generic Industry. His pharmaceutical industry background spans over 20 years and includes experience in management development and training. He has worked with many North American and international pharmaceutical companies as a consultant on strategic marketing planning, marketing research and sales forecasting. Between 1983 and 1985 he was an Assistant Professor with the John Molson School of Business at Concordia University and from 1985 he became an Associate Professor of Marketing, tenured in 1989. From 1989 to 2000, he was appointed the Associate Dean with various areas of responsibilities. He has conducted research for IMS Health Strategic Information Services group, an organization in the business of providing market data and analysis to the pharmaceutical industry.

 

Dr. Robert Rennie: He is a Clinical Professor in the Division of Microbiology with the Department of Laboratory Medicine & Pathology at the University of Alberta. He received his Bachelor of Science in 1967 and his Masters in 1970 from the University of Manitoba. In 1979, he became an Associate Microbiologist at the Henderson General Hospital & McMaster University Medical Centre. In 1984, he was appointed the Director of the Central Media Laboratory in the Hamilton District Programme in Laboratory Medicine. In 1989, he became a full Professor in the Department of Microbiology College of Medicine. He has also served as the Acting Head of the Department of Medical Microbiology at the Royal University Hospital at the University of Saskatchewan and also a Clinical Microbiologist and Head of the Clinical Microbiology Laboratory at the University of Alberta Hospitals. Since 1999 until the present, he has been the Divisional Director at the Medical Microbiology Laboratory at the University of Alberta Hospital in Edmonton, Alberta. From 1994 to the present, he has also been the Director of the National Centre for Mycology with the Provincial Laboratory of Public Health.

 

Margaret Ingram: She received a Bachelor of Science in Pharmacy with First Class Honours standing from the University of Strathclyde, Glasgow in 1971. From May 2004 until the present time, she has acted as a Consultant Pharmacist focusing on a variety of Private Payer issues on behalf of pharmaceutical companies. Over the course of her career, she has gained considerable experience in retail pharmacy practice. Except between 1996-1998, she has always maintained some level of retail pharmacy practice since 1984 until the present time, including the position of Manager of Drug Operations for Assure Health Inc. During the period of her employment, she has personally conducted many pharmacy audits between 1995 and 2002 and supervised the staff pharmacists and pharmacy technicians in their conduct of many pharmacy audits. From 1992 to 1995, she was also employed as a Sessional Professor at Mohawk College, Hamilton in the Pharmacy Assistant program for four winters.

 

 

Scott Gavura: He received his Bachelor of Science in Pharmacy from the University of Toronto. From 1993 to 2000 he practiced as a pharmacist in Ontario. While working as a pharmacist, he graduated with an MBA from the University of Toronto. From 2000 to 2003, he served as the Manager, Drug Submissions with the Ontario Ministry of Health and Long-Term Care Drug Programs Branch. He was involved with the management of the Ontario Drug Benefit Formulary and in particular, with the decision-making process to add drugs to the Ontario Drug Benefit Formulary. He has also acted as a representative of the Drug Programs Branch to Health Canada providing comment on federal generic drug submissions requirements. He has coordinated and attended over 30 of the Ontario’s Drug Quality and Therapeutics Committee meetings, at which decisions respecting drug listing and generic drug interchangeability were discussed and decided. At present, he serves as the Director of the Drug Information and Research Centre at the Ontario Pharmacists’ Association.

 

David J. Bougher: He received his Bachelor of Science in Pharmacy from the University of Saskatchewan in 1964. He received his Master of Health Services Administration degree from the University of Alberta. He began his pharmacy experience at the University Hospital in Saskatoon in 1964 and was the Director of Pharmaceutical Services at the Ottawa General Hospital. From 1974 to 1978 he served as Pharmacist Consultant or the Alberta Hospital Services Commission which was an agency of the Alberta Government that managed budget standards for Alberta hospitals and nursing homes. For 8 years, he served as the Director of Pharmaceutical Policy and Programs for Alberta Health and Wellness, the Branch of the Alberta Government responsible for the Alberta Health and Wellness Drug Benefit List (Alberta’s drug formulary). He was responsible for advising the Alberta Minister of Health on issues related to coverage of brand and generic drugs, including matters related to the granting of interchangeability status for drugs. Since leaving the Alberta Government in 2004, he has established a consulting practice which includes advising and assisting drug manufacturers in obtaining coverage for their drug products on government formularies.

 

Don Kyte: He received his undergraduate degree for Bachelors of Science in Pharmacy in 1973 and his MBA in 1977, both from Dalhousie University. From 1973 to 1975 he acted as the Director of Pharmacy for the Sydney City Hospital. From 1977 to 1986, he has worked at Lawton’s Drug Stores Limited and ultimately became its President in 1986. In 1987, he became the initial employee and General Manager of Pharmasave Drugs (Atlantic) Ltd. He is currently the owner and operator of three retail pharmacies in Nova Scotia.

 

For Takeda

 

Ms. Anne-Marie-Gaulin: She obtained a Bachelor of Science from the University of Montreal. From 1987 to 1991 she worked at Fisons Corporation and was responsible for planning and overseeing the execution of the marketing plan for prescription pharmaceuticals in Canada. She was the Marketing Manager for Novopharm Limited in 1991 and 1992 for 6 months in the Sales and Marketing Department. At Novopharm, she was responsible for management of Novopharm’s entire portfolio of products. From 1992 to 1995, she worked at Sandoz Canada in the over-the-counter, or non-prescription, market. She joined Rhodiapharm as its Director of Business Development and Marketing. Her work at Rhodiapharm involved launching generic versions of Rhone Poulenc drugs or other drugs licensed from an innovator. It also involved development of generic drugs that were proposed to be launched without license from the innovator.

 

For Novopharm

 

Dr. David Graham: He is a specialist in gastroenterology, a field he has been practicing and studying for the past 30 years. He received his Bachelor of Science from the University of Notre Dame in 1963 and his Medical Degree from Baylor University College of Medicine in 1966. He currently holds multiple academic appointments. He has been the Chief of Gastroenterology Section at the VA Medical Center since 1976 and the Chief of the Digestive Disease Division at Baylor College of Medicine since 1988. He has taught medicine at Baylor for over 30 years and has been fully tenured since 1983 as a Professor of Medicine, Virology, Molecular Virology and Microbiology. Along with teaching, lecturing, and researching, he also maintains a clinical practice. He has made contributions to field of gastroenterology and in particular to the treatment and understanding of H. pylori by writing papers, participating at many conferences relating to H. pylori and developing the first effective non-invasive test for active infection, the urea breath test. Along with his research team, he has made major contributions to all phases of basic and clinical research in the field of H. pylori and has been in the forefront of studies exploring new therapies. He is listed in the top 1% of all researchers in terms of citations in the field of clinical medicine. He has received numerous awards and honours for his work as a gastroenterologist. In March 1993 his paper on the effect of cure of H. pylori infection on ulcer recurrence (Ann Intern Med 1992; 116: 705-8) was recognized as one of the top ten advances in medical progress by the Harvard Health Letter. He is also listed as among the Top 50 Most Influential Gastroenterology Professionals of the 20^th Century by Vgastroenterology.com.

 

Dr. Fred Saibil: He is an Associate Professor of Medicine at the University of Toronto in the Department of Medicine, Division of Gastroenterology and he has been practicing and teaching gastroenterology at Sunnybrook & Women’s College Health Sciences Centre since 1972. He received his medical degree from McGill University in 1967. During his career, he has held various positions, including Acting Head, Division of Gastroenterology from 1973 to 1975, and Head of the Division of Gastroenterology from 1988 to 2000. From 1998 to the present, he has been a consultant at the Toronto Sunnybrook Regional Cancer Centre in the Preventive Oncology Program. During his career, he has participated in numerous research studies as a co-principal investigator. He is familiar with Canadian prescribing practices and the use of proton pump inhibitors, such as lansoprazole, for the treatment of various diseases, including those caused by H. pylori.

 

Dr. Arni Sekar: He is a practicing gastroenterologist and assistant Professor of Gastroenterology at the University of Ottawa for the past 29 years. He received his Bachelor of Medicine at the University of Mysore, India, in 1965. He is also a consultant gastroenterologist at the Ottawa Hospital and a consultant gastroenterologist at the Queensway-Carlton Hospital. He has developed the therapeutic pancreatic-biliary endoscopy section of the gastroenterology program at the University for over 20 years. He also has a large practice in clinical gastroenterology. He received the Canadian Association of Gastroenterology Research Award for the best clinical research by a Resident/Research fellow in Gastroenterology in 1977. He has also authored and co-authored a number of articles and abstracts.

 

 

Rosemary Bacovsky: She obtained a Bachelor of Science in Pharmacy with Distinction from the University of Alberta in 1977. In 1985, she obtained a Master of Pharmacy from the University of Alberta. In 1997, she obtained a Master of Health Service Administration from the University of Alberta. She has been practicing hospital pharmacy for 13 years, including being employed as the Director of Pharmacy Studies at Alberta Health. She has provided pharmaceutical policy advice to the Minister of Health and the Alberta government and served as the liaison between the Minister and the Expert Committee on Drug Evaluation and Therapeutics. This consisted of issues related to the coverage of brand and generic drugs on the Alberta Health and Wellness Drug Benefit List, including the cost-effectiveness for new drugs, bioequivalence of generic drugs, the granting of interchangeability status for drugs, and operation of Alberta’s Least Cost Alternative price policy. She has also worked as a consultant to hospitals and the pharmaceutical industry focusing on drug and health topics and has been a consultant on pharmaceutical policy, drug plans and reimbursement, and pharmacy/pharmacist issues.

 

Kenneth Brown: He obtained his Bachelor of Science in Pharmacy from the University of Manitoba in 1966. He was employed as a community pharmacist manager from 1966 to 1973 and during this time he was also a teaching assistant teaching Pharmaceutics and Manufacturing at the University of Manitoba. Between 1976 and 1979, he was an executive coordinator of the Canadian Conference on Continuing Education in Pharmacy and editor and publisher of the national Home Study Pharmacy Correspondence Program. Between 1973 to 1997, he was retained as a pharmaceutical consultant by Manitoba Health and in 1978 he was appointed secretary to the Manitoba Drug Standards and Therapeutic Committee, which is an expert advisory committee responsible for evaluating pharmaceuticals and making recommendations to the Minister of Health on those that should be considered for listing as benefits under the Manitoba Pharmacare Drug Program and those that should be designated as interchangeable in the Manitoba DBIF. He is also a pharmaceutical consultant proving policy, program and strategic advice to governments, the pharmaceutical industry, and the health professions.

 

Luciano Tauro: He received his Bachelor of Science in Pharmacy from the University of Toronto in 1982. He is a licensed pharmacist since 1983. He was the Pharmacy Manager of the Danforth Pharmacy in Toronto from 1983 to 1985. From 1986 to the present, he has been the owner and manager of the Dufferin Drug Mart in Toronto. He also continues to be a dispensing pharmacist at the Dufferin Drug Mart and has frequently dispensed the proton pump inhibitor lansoprazole either as PREVACID or as a component of the HpPAC. He has routinely dispensed other proton pump inhibitors, such as omeprazole, pantoprazole and rabeprazole.

 

FEDERAL COURT

 

SOLICITORS OF RECORD

 

DOCKET:                                          T-214-05

 

STYLE OF CAUSE:                          Abbott Laboratories et al. v. Novopharm et al.

 

PLACE OF HEARING:                    Toronto, Ontario

 

DATE OF HEARING:                      October 30 and 31, 2006

 

REASONS FOR ORDER

AND ORDER:                                   von Finckenstein, J.

 

DATED:                                             November 21, 2006

 

APPEARANCES:

 

Andrew J. Reddon Steven G. Mason

FOR THE APPLICANTS

 

Gary Morrisson Andrew Skodyn Jan Parnega

FOR THE RESPONDENT NOVOPHARM LIMITED

 

Christopher Van Barr

FOR THE RESPONDENT TAKEDA PHARMACEUTICAL CO.LTD.

 

No Appearance

FOR THE RESPONDENT THE MINISTEROF HEALTH

 

SOLICITORS OF RECORD:

 

McCarthy Tetrault, LLP Toronto, Ontario

FOR THE APPLICANTS

 

Heenan Blaikie, LLP Toronto, Ontario

FOR THE RESPONDENT NOVOPHARM LIMITED

 

Gowling Lafleur Henderson, LLP Ottawa, Ontario

FOR THE RESPONDENT TAKEDA PHARMACEUTICAL CO.LTD.

 

John H. Sims, Q.C. Deputy Attorney General of Canada

FOR THE RESPONDENT THE MINISTER OF HEALTH