T-835-04
ABBOTT LABORATORIES LIMITED
and
PHARMASCIENCE INC.
REASONS FOR ORDER
HARRINGTON J.
[1] This case is yet another chapter in a struggle between two drug companies; the one which wishes to bring its product to market, and the other which wishes to keep it off.
[2] Pharmascience has sought regulatory approval from the Minister of Health for its drug PMS Clarithromycin, an antibiotic which apparently compares favourably with Abbott's drug Biaxin
Bid®. The Clarithromycin in Pharmascience's drug is in a crystal form, known as Form II. Abbott seeks a Court order prohibiting the Minister from giving approval until its patent 2,277,274 ('274) expires in 2017. That patent is for another crystalline form of Clarithromycin, known as Form 0. Although PMS Clarithromycin contains no Clarithromycin in crystal Form 0, the Form II which it uses in its final product is manufactured from Form 0. Hence, Abbott takes the position that its patent has been infringed. The Minister takes no position, leaving the companies to battle it out. The battleground is the Patented Medicines (Notice of Compliance) Regulations (the NOC Regulations).
REGULATORY BACKGROUND
[3] The Patent Act deals with "inventions", which it defines as "¼any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter": A patent grants for its term (currently 20 years) the "exclusive right, privilege and liberty of making, constructing and using the invention and selling it to others¼" (s. 42). However, by way of exception, the Act goes on to provide that it is not an infringement to make use of the patented invention if reasonably related to the development and submission of information required under any law of Canada, a province or other country. The Federal Government regulates the manufacture, construction, use and sale of pharmaceutical products, and in so doing requires information from drug manufacturers. In addition, Parliament has authorized the Governor in Council to make regulations in that regard. (s. 55.2)
[4] Section 55.2 of the Patent Act and the NOC Regulations thereunder provide for what is commonly referred to as an "Early Working Exception" to the monopoly granted by a patent. Had Pharmascience accepted that the Notice of Compliance it seeks would not issue until the patent expires, the Abbott companies, Abbott Laboratories as the American owner thereof and Abbott Laboratories Limited as its Canadian exploiter, would have had no legal recourse. The Early Working Exception allows competitors to be in position to put their product on the market as soon as the patent expires. Otherwise, since it takes two years or more to obtain regulatory approval of a drug, even if only on the basis of comparison to another, the patent would in effect create a monopoly for more than 20 years. However, Pharmascience is not prepared to wait. It wants a Notice of Compliance now.
[5] Abbott is of the view that Pharmascience is infringing at least seven patents it holds in relation to three crystal forms of Clarithromycin, their formation and their uses. It could take an ordinary civil action for alleged infringement thereof. Pharmascience would deny liability, and given the highly technical nature of patent infringement litigation, and the inevitable appeals from interlocutory orders and the trial judgment, the case would go on for years and years. More importantly, in all likelihood Pharmascience would be permitted to sell its product during that litigation. An interlocutory injunction is unlikely, as in most cases an award for damages would make the patent holder whole. This may be why Abbott has not yet taken a patent infringement action.
[6] This leaves us with the NOC Regulations which endeavour to strike a balance between the ongoing need to develop new and improved medicines against the desirability of making them available to the public at a reasonable cost. On the one hand, the development of new drugs with significant investment in time and research must be rewarded. On the other hand, "copycat" drugs foster competition and keep costs down.
[7] The NOC Regulations and the history of patented medicines in Canada were recently reviewed by the Supreme Court in Bristol-Myers Squibb Co. v. Canada (Attorney General of Canada) [2005] 1 S.C.R. 533 (Biolyse). Certainly the Regulations foster a great deal of tension between the inventors, innovative companies such as Abbott, and copycats, as generic companies, such as Pharmascience, were called in Biolyse.
NOC REGULATIONS
[8] A company, such as Abbott, which has been issued a Notice of Compliance in respect of a drug that contains a medicine, may submit a patent list which is entered into a register maintained by the Minister. Among other things, the submission must indicate the dosage form, strength and route of administration of the drug, identify any Canadian patent owned or used under licence or with the consent of the patent owner and certify that it "contains a claim for the medicine itself or a claim for the use of the medicine¼" If the patent predates the submission for a Notice of Compliance, it must be submitted for entry in the Register contemporaneously. Otherwise, it may be submitted within 30 days after issuance of the patent. Thus, the patent list is somewhat of a moving target. Although Biaxin was approved in the early 1990s, the filing date of the application for the patent in question was 1997, it was made available for public inspection in 1998, and only granted in 2003. Relevant patents may be added to the list as they are granted.
[9] At current count, Abbott has listed at least seven patents against Biaxin. That mere listing has what Mr. Justice Iacobucci termed a "draconian" effect in Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare), [1998] 2 S.C.R. 193 at paragraph 33. See also Biolyse, supra at paragraphs 21-24.
[10] The listing of the patent effectively blocks the Minister from issuing a NOC to a second company i.e. Pharmascience, which seeks a NOC on the grounds of bioequivalence. In order to get around this, the generic must serve the innovator with a Notice of Allegation, alleging among other things that the patent is not valid or was not eligible for listing or that its drug would not infringe any claim in the patent for the medicine itself or for its use. In this case, Pharmascience has limited its allegation to non-infringement.
[11] If the innovator does not respond, the Minister is no longer prevented from issuing a NOC. For instance, in this case Pharmascience served a Notice of Allegation with respect to five patents, but Abbott only took issue on one. Therefore, the other four patents, 2,386,527; 2,386,534; 2,387,356; and 2,387,361, but only as circumscribed by the Notice of Allegation, are no longer at issue.
[12] If, as in this case as regards patent '274, the innovator reacts by applying for an order to prohibit the Minister from issuing a Notice of Compliance, the Minister is prevented by operation of law from issuing a Notice of Compliance for 24 months or until the Court has declared that the patent is not valid or that no claim for the medicine itself and no claim for the use of the medicine would be infringed. In effect, Abbott has obtained an injunction before the merits of its application have been judicially considered even on a preliminary basis.
[13] The Canadian patent at issue, '274, is entitled "Crystal form 0 of Clarithromycin".
LITIGATION CONCERNING CLARITHROMYCIN
[14] Abbott does not claim to have invented Clarithromycin itself. It was first covered by a Japanese patent in 1980 and by an American patent in 1982.
[15] However, Abbott has been granted at least seven Canadian patents which it has listed against Biaxin. These patents claim three crystalline formations of Clarithromycin, their formation or their uses. Abbott calls them Form 0, Form I, and Form II.
[16] The litigation between Abbott and Pharmascience began with respect to patent 2,261,732 ('732) which claims a process for the preparation of Form II of Clarithromycin. Apparently, that was the only patent listed against Biaxin at the time. Pharmascience's Notice of Allegation was limited to an allegation that it would not infringe that patent. It did not go so far as to allege that the patent was invalid. The law permits the generic to serve more than one Notice of Allegation with respect to the same drug. As aforesaid, the patent list is not frozen by litigation, and new patents may be added on the register. However, even with respect to the same patent, separate Notices of Allegation may be served with respect to different dosages. Furthermore, one notice may be limited to infringement, and another to patent validity. Pharmascience says it limited its original Notice of Allegation with respect to the '732 patent to non-infringement in the belief it would be easier to succeed on that ground rather than on validity. It did not need to succeed on both grounds.
[17] Abbott responded by applying for a prohibition order against the Minister. It succeeded before Mr. Justice Gibson in October 2004. His decision may be found at 2004 FC 1349. His decision was upheld by the Federal Court of Appeal, without additional reasons. An application for leave to appeal to the Supreme Court is currently pending. That order, if it stands, prohibits the Minister from issuing Pharmascience an NOC until that particular patent expires in July 2017.
[18] The next step was for Pharmascience to issue another Notice of Allegation not only against the said same patent, but also against several others, including '274, the patent before me. That Notice of Allegation is to the effect that the patents so identified are invalid, or were ineligible for listing in the Register in the first place. Since one cannot infringe an invalid patent, even if Mr. Justice Gibson's decision stands, Abbott may have only obtained a pyrrhic victory.
[19] As expected, Abbott took issue with these allegations and filed a Notice of Application for a prohibition order against the Minister under Court docket no. T-1035-02. That application was heard on the merits before Mr. Justice O'Keefe, and is currently under reserve. Thus, the validity of patent '274 is before Mr. Justice O'Keefe and is not the subject matter of the applications before me.
[20] Pharmascience, not content to allege that patent '274 is invalid, alleges in the two separate Notices of Allegation before me that PMS Clarithromycin will not infringe any claim for the medicine itself or for its use. One Notice relates to the 250 mg dosage, and the other to the 500 mg dosage. Abbott filed Notices of Application for prohibition orders on each. The two applications have now been consolidated and were heard on a common record.
[21] Pharmascience is not the only generic which has sought a Notice of Compliance based on Biaxin. So has RatioPharm, which has another way of converting Form 0 to Form II. In Abbott Laboratories et al v. Minister of Health et al (2005) 42 C.P.R. (4th) 121, an application which dealt with the validity of patent '274, its eligibility for listing, and non-infringement, Mr. Justice von Finckenstein held that the patent was valid, and that crystal Form 0 of Clarithromycin was a medicine. However, he concluded that Abbott could not assert its patent under the NOC Regulations because Form 0 was only created in an intermediate step during the manufacture of Form II, and was not itself in the final product. That case is currently under appeal. He considered Form 0 a medicine because it was "¼a substance intended or capable for being used for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or the symptoms thereof."[emphasis added]
ISSUES
[22] The parties agree that what is at issue in these applications is "claims for the medicine itself". No claim for the use of the medicine is in issue.
[23] As finally argued, Pharmascience asserted three reasons why PMS Clarithromycin does not infringe any claim for medicine in patent '274:
A. The medicine in the patent is Clarithromycin as such, not crystal Form 0. Abbott cannot claim to have invented Clarithromycin, as it was invented by others. Therefore, PMS Clarithromycin cannot infringe Abbott's claims to the medicine itself.
B. If the patent does contain a medical claim for crystal Form 0 of Clarithromycin, that claim cannot stand because Form 0 is not actually a medicine. It cannot be formulated into a medicine (except when combined with a carbomer, which is not in issue) and has no therapeutic value;
C. Even if Form 0 is a medicine, no claim would be infringed because Pharmascience does not use it as a medicine. Form 0 is created as an intermediate step in the process by which its supplier makes Form II. Such medicinal properties it may have as an antibiotic, or otherwise, are irrelevant.
[24] Abbott's position on these three issues is:
A. Pharmascience is precluded from arguing that the medicine is Clarithromycin per se, rather than crystal Form 0 thereof. The scope of the proceeding was delimited by Pharmascience in its Notices of Allegation. It alleged Form 0 was not a medicine because it had no therapeutic value. It did not allege that it was not a medicine because the medicine was Clarithromycin. In any event, there is case law to the effect that patents for different crystal forms of a medicine may themselves be listed as having a claim for medicine.
B. The allegation that the patent was not validly listed on the Register because Form 0 has no therapeutic value, and thus is not a medicine, was argued before Mr. Justice O'Keefe. It should not be a subject matter of this case. In any event, Form 0 is a medicine.
C. The argument that the patent cannot be asserted on the grounds that Form 0 is an intermediate and not used in the drug PMS Clarithromycin is without merit. Form 0 is a medicine, and is used by Pharmascience, and its supplier, in the manufacturing process. Therefore, the making, constructing, using or selling of PMS Clarithromycin infringes a claim for the medicine itself.
DISPOSITION
[25] After considering the record, the opinions of the expert witnesses and the written submissions and oral argument on behalf of the parties, I have concluded as follows:
A. Since Pharmascience did not allege in its Notice of Allegation that crystal Form 0 of Clarithromycin was ineligible for listing on the Register because the medicine was Clarithromycin as such, there is nothing for Abbott to disprove. Therefore, that issue does not form part of this application. However, if I am wrong, crystal form 0 is not barred from listing on the grounds that Clarithromycin itself is the medicine. Both crystal and non-crystal forms of a substance may be considered medicines;
B. Pharmascience did allege in its Notice of Allegations with respect to non-infringement that there was no claim for medicine in Form 0 because it could not be formulated into a drug with therapeutic properties. However, it essentially made the same submission before Mr. Justice O'Keefe, and so is not permitted to make the same argument again. However, if I am wrong on that point, I find that Form 0 is a medicine because it is a substance capable of being used in the treatment of infections;
C. Nevertheless, Pharmascience's use of Form 0 does not infringe any claim for Form 0 as a medicine itself, or any claim for its use as a medicine. This is because PMS Clarithromycin contains no Form 0. The fact that Form 0 was used in the preparation of Pharmascience's Form II does not bar the Minister from issuing a Notice of Compliance. Form 0 is created and disappears in intermediate steps in the manufacturing process. The mere fact that Form 0 has medical attributes is irrelevant. It is not being used for those medical attributes. Although judicial comity would suggest that I follow the decision of Mr. Justice von Finckenstein in his Abbott Laboratories decision, supra, unless I formed the view that he was clearly wrong, I am following his decision because I think he was clearly right.
ANALYSIS
[26] The first step is to consider what is claimed in the patent. As the patent is notionally addressed to a person skilled in the art or science of the subject matter, the Court should take the advice of experts. Patent claim construction was considered in depth by the Supreme Court 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. I had occasion to consider the essentials thereof within the context of Notice of Compliance proceedings in Biovail Pharmaceuticals Inc. et al. v. Minister of National Health and Welfare et al (2005) 37 C.P.R. (4th) 487. Mr. Justice von Finckenstein took the same approach in Abbott, supra.
[27] Both parties agree that the patent is addressed to a chemist with at least two years experience in crystallization processes. However, Pharmascience argues that the person skilled in the art also has experience in pharmaceutical formulations.
[28] Abbott cries foul because that latter attribute was not suggested in the proceedings pending before Mr. Justice O'Keefe. Pharmascience responds that it was Abbott itself which raised the formulation issue through the affidavit of one of its experts, Dr. Stephen Byrn, who claims some expertise in that area. This is what led to Pharmascience obtaining an expert opinion from Dr. Robert Miller, whom it characterizes as the only witness with formulation expertise.
[29] I have come to the view that formulation is a side issue, and that appropriate opinion can be offered to the Court by a chemist with at least two years experience in crystallizing compounds. I would have thought that the patent is also addressed to a physician. I would want a drug containing a medicine prescribed to me by a medical doctor, not by a chemist. However, in this case it seems clear that Clarithromycin and the three crystal forms invented by Abbott have the same medical properties.
CANADIAN PATENT 2,277,274
[30] The Abstract for the patent entitled Crystal Form 0 of Clarithromycin states:
The present invention concerns the novel antibiotic 6-0-METHYLENYTHROMYCIN A Form 0 solvate of formula (1) a process for its preparation, pharmaceutical compositions comprising this compound and a method of use as a therapeutic agent"
[31] In the "Technical Field" portion of the disclosure it is said that the invention relates to a compound having therapeutic utility and to a method of its preparation. By way of background it is said that 6-0-Methylenythromycina Form 0 solvate commonly known as Clarithromycin is a semi-synthetic macrolide antibiotic and that two distinct crystal forms, designated Form I and Form II, were previously identified. Clarithromycin as such was said to exhibit excellent contra activity against certain bacteria. The "Summary of the Invention" declares, among other things, that Form 0 "¼is also a useful intermediate in the preparation of¼" Forms I and II. [emphasis added]
[32] In one embodiment, the invention is said to provide a process for the preparation of 6-0- Methylenythromycin A. Although usable in tablet form, it may also be used in an oral suspension which is helpful for patients who have difficulty swallowing. However, it has a pronounced bitter taste. Abbott claims a 6-0 Methylenythromycin A carbomer (acrylic acid copolymer) which provides particles sufficiently palatable for use in an oral suspension. These carbomer complexes are not at issue.
[33] Abbott makes 53 claims. It says that Claims 1, 4, 5 and 16 are in issue. Pharmascience protests that Claim 16 was not mentioned before oral argument.
[34] Clearly Claim 1 is the most important. The claim is for "a crystalline antibiotic designated 6-0 Methylenythromycin A Form 0 Solvate having a certain structure in which the solvating molecule is ethanol, isopropyl acetate, isopranol or tatrahydrofuran". The solvating molecule in Pharmascience's Form 0 is ethanol.
[35] Claims 4 and 5 are claims dependent on Claim 1 in which the solvate is characterized by certain peaks in the powder x-ray diffraction pattern. Claim 16 like Claim 1 is for the Form 0 solvate but substantially free of Form I and Form II. It was mentioned in the decision of Mr. Justice von Finckenstein. However, like Claims 4 and 5, it need not be considered separately. If Claim 1 is infringed, all four are infringed. If Claim 1 is not infringed, neither are the other three.
[36] There is no doubt that the patent discloses how to make crystal Form 0 of Clarithromycin. Abbott was also provided with the particulars of the manufacturing process by which Pharmascience's supplier, Teva, manufactures Form II. It begins with Erythromycin which following various chemical reactions is synthesized into Clarithromycin crude, which in turn is crystallized into Clarithromycin crystal Form 0. Form 0 is recrystallized in a slurry, from which Form II eventually emerges. The experiments carried out by independent experts retained by Abbott confirm that there is no Form 0 in the Form II used by Pharmascience.
[37] Although the advice of the experts called by both parties was generally helpful in explaining the underlying scientific principles of crystallization, and the fact that the crystal must dissolve within the body to have any medical value, a good deal of all their opinions was nothing more than argument in support of the propositions put forth by their respective clients. This is not the role of an expert, who is supposed to offer opinion, not argument, to the Court, indifferent to who is paying the bill. Nevertheless, having taken into consideration the advice of these experts, and indeed they are experts, and reading the NOC Regulations purposively I am satisfied that they do not cover a substance which is produced at an intermediate stage of a process, even if that substance has medical properties. Indeed it is the opinion of Abbott's experts, even before they were cross-examined, which I found to be most helpful.
WHAT IS A MEDICINE?
[38] The experts all agree that the medicine itself is the molecule Clarithromycin, which Abbott does not claim to have invented in this or any other patent. However, this point was not alleged by Pharmascience in justification of its proposition that PMS Clarithromycin would not infringe any claim for the medicine itself.
[39] Applications under the NOC Regulations are counter-intuitive. The agenda is set by the generic, Pharmascience, by what it says in its Notice of Allegation. Those allegations stand unless proved not to be justified by the innovator who takes the application to Court. The proceedings do not serve as a judgment on validity or infringement; the only issue is to determine whether the Minister is at liberty to issue the requested notice of compliance. See Biovail, supra, paragraph 9 and Fournier Pharma Inc. v. Canada (Minister of Health) (2004) 38 C.P.R. (4th) 297, [2004] F.C.J. No. 2149 (QL). The NOC order cannot be raised as res judicata in a patent infringement action.
[40] In AB Hassle v. Canada (Minister of National Health and Welfare) (2000) 10 C.P.R. (4th) 38, [2000] F.C.J. No. 2064 (QL) affirmed at 2002 FCA 147, [2002] F.C.J. No. 618 (QL), Madam Justice Tremblay-Lamer held that a party could not introduce new matters on a point not included in the Notice of Allegation. In Hoffmann-La Roche Ltd. v. Canada (Minister of National Health and Welfare) (1996) 70 C.P.R. (3rd) 1, [1996] F.C.J. No. 1334 (QL), the Federal Court of Appeal held that the Motions Judge did not err in refusing leave to file further evidence to remedy a deficiency in the Notice. In any event, a patent may be listed on the Register if it claims a drug containing the same medicine for which the Notice of Compliance was given, even though that medicine may be in a different form or crystal structure. Thus, Abbott was entitled to list patent '274 against Biaxin itself notwithstanding that no Form 0 is found in Biaxin (only Form II is), and notwithstanding that it was not entitled to list Clarithromycin itself. (GlaxoSmithKline Inc. v. Apotex Inc. (2003) 29 CPR (4th) 350, [2003] F.C.J. No. 1334 (QL), Eli Lilly Canada Inc. v. Canada (Minister of Health) (2003) 23 CPR (4th) 289, [2003] F.C.J. No. 75 (QL). Hoffmann-La Roche Ltd. et al. v. Minister of National Health and Welfare et al (1995) 62 C.P.R. (3d) 58, Glaxo Group Ltd. v. Canada (Minister of National Health and Welfare) (1995) 64 C.P.R. (3d) 65.
[41] Consequently, it is not open to Pharmascience to argue that it will not infringe any claim for the medicine itself, on the grounds that the medicine is Clarithromycin, whatever form it takes, crystalline or not.
IS FORM 0 A MEDICINE?
[42] Although Form 0 cannot be ruled out as a medicine on the grounds that the medicine is Clarithromycin itself, it does not necessarily follow that this particular crystal form is itself a medicine.
[43] Section 2 of the NOC Regulations defines medicine as meaning "a substance intended or capable of being used for the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof [emphasis added]".
[44] Abbott submits that I should not consider Pharmascience's allegation that Form 0 has no medical properties because that issue formed part of the application argued before Mr. Justice O'Keefe. It matters not that he has not yet rendered his decision. It is well established that whether one calls it abuse of process, issue estoppel, lis pendens or what you will, Courts will not allow the same point to be litigated twice on the merits.
[45] In its Notices of Allegation in the applications before me, Pharmascience alleged that patent '274 "relates to a non-therapeutically useful crystal structure (because it converts readily to Form I) that can only be used as an intermediate and is not proper subject matter under the NOC Regulations." In the invalidity proceedings before Mr. Justice O'Keefe, Pharmascience alleged that the patent only teaches Form 0 as a useful process intermediate, having no antibiotic effect and no therapeutic value because of its invalidity, storage requirements and necessarily high solvent levels. It could not be administered to a patient.
[46] Pharmascience acknowledges there is some overlapping in these allegations, but that is an unfortunate byproduct of its right to issue separate notices concerning validity and non-infringement. I say it is the same allegation. Abbott says this is an abuse of process.
[47] I consider Abbott's position to be the correct one. Pharmascience relies upon the decision of Madam Justice Tremblay-Lamer in Aventis Pharma Inc. v. Apotex Inc. 2005 FC 1504. While that case, like others before it, recognizes that more than one Notice of Allegation may be served with respect to the same patent, the allegations must be factually and legally distinct. Having already argued this point, Pharmascience cannot argue it again. Indeed, I cannot see any advantage for Pharmascience in arguing the same point twice. The more it puts this issue in play, the more it is at risk. All Abbott needs is one holding in one NOC that Form 0 is a medicine in order that a prohibition order issue against the Minister.
[48] However if I am wrong on that point, I hold that Form 0 is a medicine because, to use the language of the Regulations, it is "a substance intended or capable of being used for the diagnosis, treatment, medication or prevention of a disease, disorder or abnormal physical state, or the symptoms thereof." Pharmascience submits that Form 0 cannot be considered a medicine because 1) it would never obtain regulatory approval and 2) it could not be formulated into a drug which could actually be administered to a patient.
[49] The Regulations do not define medicine as a substance intended or capable of being the active ingredient in a drug for which a Notice of Compliance will likely be issued. As Mr. Justice Rouleau said in Glaxo Canada Inc. v. Minister of National Health & Welfare et al. (1987) 18 C.P.R. (3rd) 206, the Minister's decision to issue a Notice of Compliance is discretionary. "The Minister in exercising his discretion weighs the predicted benefit of the drug in relation to the foreseeable risk of adverse reaction to it. The Minister's determination is one made in contemplation of public health and represents the implementation of social and economic policy."
[50] It may be impractical to use Form 0 (which if allowed to dry out converts into Form I) or too expensive. I was not impressed by the argument that it would not be approved because it would have to be kept wet in ethanol, a form of alcohol. Other drug formations have been approved which use far more solvates. I am left with the impression that there is more alcohol in one liquor-filled chocolate, than in a week's worth of a prescription drug containing Form 0 as a medicine.
[51] The process of crystallization was clearly explained by Drs. Myerson and Atwood, called by Abbott. A substance may exist both in crystalline and non-crystalline form. Crystals of the same material with identical crystal structures may have very different qualities. A given material, carbon for instance, may crystallize into one or more distinct structures such as graphite and diamonds. This ability is called polymorphism.
[52] The experts agree that the broadest of the patent claims is Claim 1. I agree with Dr. Myerson who says that it is a per se claim, meaning that Abbott claims the crystal Form 0 of Clarithromycin, howsoever made, howsoever used. A person skilled in the art would know that the words "a crystalline antibiotic" in Claim 1 are meant to describe the fact that Form 0 has antibacterial activity. As to the allegation that the patent relates to a non-therapeutically useful crystal structure because it readily converts into Form I, and therefore can only be used as an intermediate, he notes that the patent states that Form 0 has the same spectrum as antibacterial activity as Form II. Indeed, as a matter of grammar, the patent provides that "Form 0 may also be used as an intermediate to make Form I or Form II." Certainly, on the language of the claim, a claim for a medicine is made out.
[53] However, the point is not only whether or not there is a claim to a medicine, the point is also whether Form 0 is a medicine. Drs. Myerson and Atwood are of the view that a person skilled in the art at the relevant time, 1998, would know that Form 0 must be kept wet as otherwise it would dry into Form I. Their evidence is persuasive.
[54] There is no doubt in my mind that given the right dosage one could take a spoonful of Form 0 out of Teva's intermediate stage and that it would be as therapeutically useful as Form II, or Clarithromycin itself. Dr. Byrn, also called by Abbott, stated that there were packaging methods and systems which could keep Form 0 from converting into Form I. He cited Blister packs and capsules as packaging which would keep Form 0 wet. Form 0 could also be suspended in an appropriate liquid containing ethanol to be used as syrup.
[55] Dr. Miller, the formulator called by Pharmascience, was not helpful on this point. In Free World Trust v. Électro Santé Inc., [2000] 2 S.C.R. 1024, in pointing out that a patent is not addressed to an ordinary member of the public, but to a worker skilled in the art, Mr. Justice Binnie relied on the following words of Dr. Fox: "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." (Fox, Harold G., The Canadian Law and Practice Relating to Letters for Patent for Inventions, 4th ed., page 184). As his cross-examination painfully brings out, Dr. Miller focused on the impracticalities of packaging Form 0, rather than whether packaging was in fact possible.
[56] However, Dr. Miller conceded "if one were to put the wet crystals into a proper package and seal it properly, I would think that at least in a moderate term drying would not occur." Drying would convert Form 0 into Form I. Dr. Rohani, another expert called by Pharmascience, agreed that if Form 0 was sealed airtight, it would not convert into Form 1.
[57] Thus, I conclude that crystal Form 0 of Clarithromycin is a medicine as it is capable of being used as such.
[58] Pharmascience correctly points out that the patent does not teach how to package Form 0. However, I agree with Abbott's experts that the problem, and the solution, are obvious. Keep Form 0 wet.
DOES PMS CLARITHROMYCIN INFRINGE?
[59] It is useful to repeat Abbott's Claim 1: "A crystalline antibiotic design 6-0-METHYLENYTHROMYCIN A Form 0 solvate having structure¼" In its effort to disprove the Notices of Allegation, Abbott argues:
a. Claim 1 is a product claim, and cannot be read down as suggested by Pharmascience to a claim for use as an antibiotic or in a carbomer complex.
b. The Regulations do not absolve an infringement of a claim for a medicine on the grounds that the medicine in the drug, in this case PSM Clarithromycin, contains the medicine in another crystal form.
I agree with Abbott on the first point, but not on the latter.
[60] I prefer the opinion of Abbott's experts that Claim 1 is a per se claim, a claim for a crystal howsoever made and howsoever used. This is the same conclusion as reached by Mr. Justice von Finckenstein in Abbott, supra. I am also fortified by the decision in Pfizer Canada Inc. v. Novapharm Ltd. 2005 FCA 270, [2005] F.C.J. No. 1318 (QL). The prime issue in that case was the sufficiency of the Notice of Allegation. Pfizer held a patent for crystalline Azithromycin Dihydrate. Novapharm was seeking a Notice of Compliance for Azithromycin Monohydrate, yet Mr. Justice Malone speaking for the Court of Appeal had no hesitation to say "Claim 1 claims crystalline azithromycin dihydrate and is a product per se claim."
[61] For the purpose of these allegations, it is not necessary to consider where Form 0 was made. I will assume in the absence of evidence to the contrary that Form 0 is made in Canada. I draw no distinction between Pharmascience and its supplier of Form 0, Teva.
[62] Pharmascience does not make, construct, use or sell Form 0 for its medicinal qualities. It uses it as a stepping stone to make Form II, which it puts in its PMS Clarithromycin tablets. The issue before me is not whether Pharmascience has infringed patent '274; rather the question is whether its drug PMS Clarithromycin infringes any claim for the medicine. Dr. Atwood points out that a substance may take on millions of crystalline forms. Although that substance may in itself be a medicine, some of the crystalline forms may not, because they cannot dissolve in the body. They may be no more beneficial than a penny swallowed by a child. Form 0 did not need to have medical value, as long as it could be converted into Form II which does.
[63] There is a clear distinction between a drug infringing a patent, and the drug's maker infringing the patent. It may be that Pharmascience and Teva are infringing patent '274, but that is not the question. An analogy may be drawn with in rem proceedings in an admiralty action or in forfeiture proceedings. For certain purposes, the res, or thing, takes on a juridical personality distinct from its owner. Just as a ship plagued with a maritime lien may be liable in rem, while her owner is not liable in personam, the manufacturers of a drug may have infringed a patent, while the drug itself does not. See Skander Tourki v. The Minister of Public Safety and Emergency Preparedness Canada 2006 FC 50 at paragraphs 40-41.
[64] As mentioned previously, RatioPharm Inc. has developed another process by which Form 0 is created at an intermediate stage in the production of Form II. In Abbott Laboratories v. Canada (Minister of Health) 2005 FC 1093, [2005] F.C.J. No. 1349 (QL), supra,Mr. Justice von Finckenstein had this to say at paragraph 53:
"This Court must determine if it is infringement under the NOC Regulations and they demand that there be infringement of the claim for the medicine itself or infringement of the claim for the use of the medicine. Clearly that is not the case here. At best, there could be infringement by the product resulting from stage 5 of Ratiopharm's CLX. However, the result of stage 5 of the CLX is not Ratiopharm's final product, but an intermediate product. This intermediate is not made, constructed, used or sold as a medicine but is merely a way station on the road to the final product. Thus, it defies logic to say the production of this intermediate product (assuming for argument's sake that it is Form 0) infringes on the claims of the '274 Patent for the medicine itself and/or for the use of the medicine."
Abbott submits his decision can no longer stand in light of the Federal Court of Appeal's decision in Pfizer Canada Inc. v. Novapharm Ltd., supra, and the Supreme Court's decision in Biolyse, supra.
[65] Judicial comity suggests that a judge of a lower court should exercise restraint when faced with a legal point previously decided by another member of that same Court. It is not an application of the rule of stare decisis, but a recognition that decisions of the Court should be consistent, so that there be some predictability. Mr. Justice Richard (as he then was) reviewed the authorities in the context of NOC proceedings in Glaxo Group Ltd. v. Minister of National Health and Welfare et al. (1995) 64 C.P.R. (3d) 65, supra, at paragraph 40. So did Madam Justice Dawson more recently in Alfred v. Canada (Minister of Citizenship and Immigration) 2005 FC 1134, [2005] F.C.J. No. 1391. She referred to Re Hansard Spruce Mills Ltd., [1954] 4 D.L.R. 590 (BCSC), where Mr. Justice Wilson said
"¼I have no power to overrule a brother Judge, I can only differ from him, and the effect of my doing so is not to settle but rather to unsettle the law, because, following such a difference of opinion, the unhappy litigant is confronted with conflicting opinions emanating from the same Court and therefore of the same legal weight."
[66] Mr. Justice Richard was of the view that previous decisions should be followed unless the Judge considered them to be clearly wrong. Madam Justice Dawson said she would only go against the decision of another Judge if a) a subsequent decisions have affected the validity of the impugned judgment; b) it has been demonstrated that some binding authority in case law and relevant Statute was not considered; or c) the judgment itself was unconsidered i.e. given where the exigencies required an immediate decision.
[67] The Federal Court of Appeal will not overrule itself even if it considers the first case was wrongly decided. The first case must be manifestly wrong in that the Court overlooked a relevant statutory provision or a case that ought to have been followed. See Kremikovtzi Trade v. Phoenix Bulk Carriers Limited 2006 FCA 1, [2006] F.C.J. No. 9 (QL). Mr. Justice Nadon stated at paragraph 35:
¶ 35 Before concluding, however, I wish to add that were I not bound by Paramount, supra, I would have been inclined to decide the issue in favour of Phoenix. Since I suspect that the issue before us is of some importance to the maritime community and, hence, that leave to appeal to the Supreme Court of Canada might be sought, it will be useful for me to elaborate as to why I believe Paramount, supra, was wrongly decided.
[68] I find myself in a complete agreement with Mr. Justice von Finckenstein that the production of an intermediate product not found in the final product does not infringe claims of the '274 patent for the medicine itself. I choose to follow him because I think he is right. Judicial comity has nothing to do with it. However, I must now consider whether his decision is a spent force in light of the two decisions cited by Abbott.
[69] Abbott submits that there is an inference in Pfizer that had there been evidence that its product was produced at an intermediate stage of the manufacturing process, then there would have been an infringement. I do not read the decision that way. I read it as stating the obvious: that it would be impossible for Pfizer to make out a case unless some of its patented product was in the intermediate. In other words, the presence of the product in the intermediate is a condition precedent to an argument that a claim for medicine would be infringed by the drug in its final form. The reasons give no hint as to what the decision would have been had there been proof that dyhydrate was produced as an intermediate.
[70] Nor do I think Biolyse assists Abbott. If one were to read more into the case than that what is said, one might argue that claims for crystal forms of a medicine are not claims for medicine at all. Mr. Justice Binnie said at paragraph 22: "generally speaking, the "second person" intends to manufacture and distribute a "copy-cat" version of the active medical ingredient [my underlining]". If the active medicinal ingredient is Clarithromycin, then Abbott has no grounds for complaint. If the active medicinal ingredient is Form 0, it has no reason to complain either.
CONCLUSION
[71] Abbott has not established on the balance of probabilities that Pharmascience's allegation that PMS Clarithromycin would not infringe any claim in patent 2,277,274 for the medicine itself or its use is not justified. Therefore, no prohibition order shall issue against the Minister. The applications shall be dismissed.
COSTS
[72] The two prime facts on which this decision turns were alleged by Pharmascience in its Notices of Allegations. They were that Form 0 was created at an intermediate step in the manufacturing process of Form II, and that the final product in PMS Clarithromycin was Form II. No Form 0 was present.
[73] Most of the court hearing dealt with whether Form 0 was a medicine, a point which should not have been before me because Pharmascience already argued it before Mr. Justice O'Keefe. I see no reason why invalidity should have been raised in an earlier NOC, and invalidity subsequently.
[74] Taking into account my discretion under Federal Court Rule 400, I am awarding 50% of the costs which would otherwise be taxed as counsel fees and reasonable disbursements, including fees and disbursements of experts. Counsel fees shall be calculated on Column III, mid-range. There shall only be one set of costs covering both applications. As the Minister did not participate, there shall be no costs for or against him.
"Sean Harrington"
Ottawa, Ontario
February 2, 2006
FEDERAL COURT
NAME OF COUNSEL AND SOLICITORS OF RECORD
DOCKETS: T-433-04 and T-835-04
STYLE OF CAUSE: ABBOTT LABORATORIES
and ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH
and PHARMASCIENCE INC.
Respondents
PLACE OF HEARING: Toronto, Ontario
DATES OF HEARING: January 9-11 and 19, 2006
REASONS FOR ORDER: HARRINGTON J.
APPEARANCES:
| Steven Mason Andrew J. Reddon Marcus Klee
|
FOR THE APPLICANTS |
| Carol Hitchman Paula Bremner
|
FOR THE RESPONDENT PHARMASCIENCE INC. |
| McCarthy T rault LLP Barristers & Solicitors Toronto, Ontario
|
FOR THE APPLICANTS |
| John H. Sims, Q.C. Deputy Attorney General of Canada
|
FOR THE RESPONDENT THE MINISTER OF HEALTH |
| Hitchman & Sprigings Barristers & Solicitors Toronto, Ontario |
FOR THE RESPONDENT PHARMASCIENCE INC. |