Abbott Laboratories v. Canada (Minister of Health)

Abbott Laboratories v. Canada (Minister of Health)
Court (s) Database
Federal Court Decisions
Date
2005-08-10
Neutral citation
2005 FC 1093
File numbers
T-1656-03
Decision Content
Date: 20050810
Docket:T-1656-03
Citation: 2005 FC 1093
Ottawa, Ontario, this 10th day of August, 2005
Present: THE HONOURABLE JUSTICE von FINCKENSTEIN
BETWEEN:
ABBOTT LABORATORIES
and ABBOTT LABORATORIES LIMITED
Applicants
and
THE MINISTER OF HEALTH
and RATIOPHARM, A DIVISION OF RATIOPHARM INC.
Respondents
REASONS FOR ORDER AND ORDER
(Public Version)
[1] This is an application brought by Abbott for an order prohibiting the Minister of Health from issuing a Notice of Compliance (ANOC@) to Ratiopharm for Clarithromycin 250 mg and 500 mg tablets because it infringes Canadian Patent Nos. 2,258,606 (A > 606 Patent@), 2,386,527( A > 527 Patent@ ) 2,277,274 (A > 274 Patent@ ) 2,386,534 (A > 534 Patent@), 2,387,361 (A > 361 Patent@) and 2,387,356 (A > 356 Patent@) held by Abbott. Prior to the hearing, Abbott abandoned any claims regarding the 534 Patent and during the hearing, Abbott abandoned any claims for an application based on the > 527 or the > 356 Patent. Accordingly, these reasons will only deal with the > 606 Patent, > 274 Patent and > 361 Patent.
[2] Abbott also brought a separate application (Court File T-1847-02) for an order prohibiting the Minister of Health from issuing a NOC to Ratiopharm for the production of Clarithromycin Form II because it infringes Canadian Patent No. 2,261,732 (A > 732 Patent@). While these two applications were heard together, they are based on different records and therefore separate reasons were issued with respect to the application based on the > 732 Patent.
Nature of Proceedings
[3] These proceedings were initiated under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the ANOC Regulations@). The nature of these proceedings was summarized by Layden Stevenson J. in Fournier Pharma Inc. v. Canada (Minister of Health), 2004 FC 1718 as follows:
6 As noted, this proceeding is brought under the Regulations. The history and scheme of the Regulations have been delineated in various decisions of the Federal Court of Appeal and need not be repeated here. See: Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.); AB Hassle v. Canada (Minister of National Health and Welfare) (2000), 7 C.P.R. (4th) 272 (F.C.A.); Novartis AG et al. v. Abbott Laboratories Ltd. et al. (2000), 7 C.P.R. (4th) 264 (F.C.A.). Basically, issues of non-infringement and validity between the patent holder (first person) and the person seeking a NOC from the Minister (second person) originate with a NOA, served on the first person by the second person, setting out the second person's allegations, including the legal and factual basis in support. The first person may disagree and apply to the court for an order prohibiting the Minister from issuing a NOC to the second person until after expiration of the patent (...)
8 Section 6 proceedings are not to be likened to actions for determining validity or infringement. They are proceedings in judicial review, to be held expeditiously, whose aim is to determine whether the Minister is free to issue the requested NOC. Their scope is confined to administrative purposes: Apotex Inc. v. Canada (Minister of National Health and Welfare) (1997), 76 C.P.R. (3d) 1 (F.C.A.). The determination must turn on whether there are allegations by the second person sufficiently substantiated to support a conclusion for administrative purposes (the issuance of a NOC) that an applicant's patent would not be infringed if the second person's product is put on the market: Pharmacia Inc. v. Canada (Minister of National Health and Welfare) (1994), 58 C.P.R. (3d) 209 (F.C.A.).
9 By merely commencing the proceeding, the applicant obtains what is tantamount to an interlocutory injunction without having satisfied any of the criteria a court would require before enjoining issuance of a NOC: Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1998), 80 C.P.R. (3d) 368 (S.C.C.); Bristol-Myers Squibb Canada Inc. v. Canada (Attorney General) (2001), 11 C.P.R. (4th) 539 (F.C.A.). The Regulations allow a court to determine summarily, on the basis of the evidence adduced, whether the allegations are justified. Section 6 proceedings are not adjudicative and cannot be treated as res judicata. The patentee is in no way deprived of all the recourses normally available to enable it to enforce its rights. If a full trial of validity or infringement issues is required, this can be obtained in the usual way by commencing an action: Pfizer Canada Inc. v. Apotex Inc. (2001), 11 C.P.R. (4th) 245 (F.C.A.); SmithKline Beecham Pharma Inc. v. Apotex Inc. (2001), 14 C.P.R. (4th) 76 (F.C.T.D.) aff'd. (2002), 21 C.P.R. (4th) 129 (F.C.A.); Novatis A.G. v. Apotex Inc. (2002), 22 C.P.R. (4th) 450 (F.C.A.)
[4] As to the findings the court must make, these were succinctly stated by Harrington J. in Biovail Pharmaceuticals Inc. v. Canada (Minister of National Health and Welfare), [2005] F.C.J. No. 7 at paragraph 10 as:
The only question is whether the Court should grant an order prohibiting the Minister from issuing Novopharm an NOC until after the expiration of one or both of the two underlying patents. Subject to the comment above as to the limited nature of the proceeding, it is inherent in a decision to grant a prohibition order that the Court form the view that Novopharm's allegations are not justified, i.e. the Court must form the view that the patents are valid and that Novopharm would infringe them. There must be a finding on both points. However, if the Court refuses to grant a prohibition order, it must have formed the view that Novopharm would not infringe or that the patents are invalid. It is not necessary to find on both points. (Underlining added)
[5] In this case, Ratiopharm served Abbott with a Notice of Allegation (ANOA@), which delimits the scope of the issues to be decided. Abbott, as the Applicant, must prove that Ratiopharm=s allegation ( that the > 606, > 274 and > 361 Patents are invalid) is not justified and that Ratiopharm=s allegation that its production of Clarithromycin Form II will not infringe any of these four patents is not justified.
Experts
[6] As in all litigation under the NOC Regulations, there were several expert opinions in evidence throughout the hearing of this matter. Harrington J. described the role of expert witnesses in Biovail Pharmaceuticals, supra, at paragraph 16 as follows:
Expert evidence presented to a court should be the independent product of the expert uninfluenced as to form or content by the exigencies of litigation. The expert should provide independent assistance to the Court (National Justice Companion Riviera SA v. Prudential Assurance Co. Ltd. [1993] 2 Lloyd's Rep. 68, reversed on other grounds, [1995] 1 Lloyd's Rep. 455, and Merck Frosst Canada Inc. v. Apotex Inc. and Minister of Health, [2004] F.C.J. No. 684, 2004 FC 567, at paragraph 16.)
Abbott Experts
Dr. Atwood is a professor and Chairman of the Department of Chemistry at the University of Missouri-Columbia. He holds a Ph.D. in chemistry from the University of Illinois and has held and holds numerous editorial positions. He has published over 500 articles in refereed journals and has authored nine patents. The Court recognized him as an expert in the fields of crystal growth, crystal engineering and polymer chemistry.
Dr. Myerson is a professor of chemical engineering and Provost and Senior Vice-President at the Illinois Institute of Technology in Chicago. Previous to that, he served as Professor of Chemical Engineering and Dean of the Armour College of Engineering and Science at the Illinois Institute of Technology. He holds a Ph.D. in chemical engineering from the University of Virginia and has edited five books and published approximately 120 papers in refereed journals, many of which deal with crystallization and related subjects. The Court recognized him as an expert in the fields of chemical engineering and crystallization, including industrial crystallization and polymorphism.
Dr. Byrn is the Head of the Department of Industrial and Physical Pharmacy at Purdue. He holds a Ph.D. in chemistry from the University of Illinois and has authored over 100 peer-reviewed publications in technical journals on topics relating to solid-state chemistry and is co-author of a book entitled Solid Chemistry of Drugs. The Court recognized him as an expert in pharmaceutical chemistry, sold-state chemistry, industrial pharmacy, polymorphism, analytical techniques and crystallization.
Ratiopharm Experts
Dr. Hollingsworth is an Associate Professor of chemistry at Kansas State University. He holds a Ph.D. in organic chemistry at Yale University where he used infrared (AIR@) spectroscopy to study different organic crystal forms. He completed his postdoctoral studies at the University of Cambridge where he focussed on characterizing chemical reactions of crystalline materials including polymorphs. The Court recognized him as an expert in the study of crystal forms and transformations between them and he has published extensively in the field of organic synthesis of crystal forms.
Dr. Eckhardt is a faculty member of the physical chemistry division of the Department of Chemistry at the University of Nebraska at Lincoln. He holds a Ph.D in physical chemistry from Yale University and has worked in the areas of single crystal X-ray diffraction settings, IR measurements, and crystal growth and characterization. The Court recognized him as an expert on the transformation of individual molecular properties into the bulk properties of a crystal. He has authored or co-authored 111 publications and two book chapters.
Dr. Petrov is a research associate at the Department of Chemistry, University of Toronto who has been involved in crystallography for the past 30 years. He holds a Ph.D. in mineralogy and crystallography from Sofia University in Bulgaria. He explains that as crystallography often entails the use of x-ray powder diffraction (XRPD) as a method of analysis, he has developed considerable experience in this analytical method. The Court recognized him as an expert in the field of crystallography.
The qualification of both parties= experts was not in issue, however the varying weight to be assigned to their testimony was argued by both sides and will be dealt with in these reasons.
Burden of Proof
[7] The burden of proof as to validity was succinctly set out in Biovail, supra, where Harrington J. stated at paragraph 12:
Much has been said with respect to the burden of proof as to patent validity. The burden is on Biovail to disprove Novopharm's assertions as set forth in its Notice of Allegation. Like any plaintiff or applicant, Biovail has the overall legal burden of proof. However, since the purpose of the application is to disprove Novopharm's allegations, rather than to prove its own allegations, Novopharm, as respondent, has an obligation to put the allegations set out in its notice "in play". Obviously, it knows better than Biovail what it intends to do and how it will go about it. There is also a rebuttable presumption that a patent is valid. See for example Merck Frosst Canada Inc. v. Canada (Minister of National Health & Welfare), [1994] 55 C.P.R. (3d) 302 FCA, and the recent commentary thereon by Mosley J. in Janssen - Ortho Inc. et al. v. Novopharm Ltd., et al., [2004] F.C.J. No. 1968, 2004 FC 1631, at paragraphs 13 and following, as well as Pfizer Canada Inc. v. Canada (Minister of Health), 2004 FCA 402, [2004] F.C.J. No. 2033 (QL) per Sharlow J.A. at paragraph 8.
[8] With respect to the rebuttable presumption that a patent is valid, Rothstein J.A. stated in Procter & Gamble Pharmaceuticals Canada Inc. v. Canada (Minister of Health), [2004] F.C.J. No. 1973 at paragraphs 15 and 16:
Noël J., in Glaxo, relied on this Court's decision in Bayer v. Canada (Minister of National Health and Welfare) (2000), 6 C.P.R. (4th) 285 (F.C.A.) which, on this point, is the governing authority. In Bayer, Sharlow J.A. dealt with the burdens of proof on the patentee and the generic in proceedings under the Regulations. She explained that the patentee, being the applicant for the order of prohibition, bears the burden of establishing its entitlement to the order sought. Subsection 43(2) of the Patent Act, R.S., c. P-4, s. 1, as amended, provides that, "After the patent is issued, it shall, in the absence of any evidence to the contrary, be valid and avail the patentee..." Sharlow J.A. observed that because of that presumption of validity, the generic, as the party responding to the application for a prohibition order, has the burden of proof to displace the presumption.
As to the standard of proof, at paragraph 9, she wrote:
The operation of the statutory presumption in the face of evidence of invalidity depends upon the strength of the evidence. If the evidence proves, on a balance of probabilities that the patent is invalid, the presumption is rebutted and is no longer relevant. [Emphasis added.]
Therefore, the standard of proof applicable to proving invalidity has been found to be proof on a balance of probabilities.
[9] With regard to the burden of proof for non-infringement, Gauthier J. precisely summarized the issue in AstraZeneca v. Apotex [2004] F.C.J. No 1078 at paragraphs 72 and 73:
A proceeding under subsection 6(1) of the Regulations is not an action for infringement. In the present case, the Court does not have to determine whether or not the second person's product would infringe a valid patent. It only needs to determine whether the facts assumed or proven and the legal assertions made justify the specific allegation of non-infringement made by Apotex. (Hoffmann-La Roche Ltd. v. Canada (1996), 70 C.P.R (3d) 206 (F.C.A.) and Merck Frosst Canada Inc. v. Canada (Minister of National Health and Welfare) (1994), 55 C.P.R. (3d) 302 (F.C.A.) at p. 302).
This means that Astrazeneca has the burden of convincing the Court that the specific allegation of non-infringement contained in the NOA is unjustified. It need not otherwise prove that Apotex' tablet would infringe the '377 Patent because it contains all the essential elements of a claim in the said patent.
Patent Construction
[10] In Biovail, supra, Harrington J. succinctly summarized the rules for patent construction as laid down by the jurisprudence:
15 It is a pre-requisite to considerations of both patent validity and infringement that the language of what is claimed in the patent be properly considered. The Court can do no better than to take the same approach in an NOC proceeding, keeping in mind the restricted purpose of the proceeding. The Supreme Court has done much to codify and clarify patent claim construction in two recent cases handed down the same day: 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. The reasons in both were given by Mr. Justice Binnie. I take the following principles as having particular relevance to this case:
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. (More will be said about this skilled reader.)
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. This lies at the heart of Biovail's position that Novopharm's allegation that it will not infringe the '320 patent is not justified. Put another way, was it obvious at the time the patent was published that the substitution of a variant would make a difference?
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, para. 52.)
[11] The person skilled in the art has been described by Binnie J. in Free World Trust v. Electro Sante Inc. (2000) 9 C.P.R. (4th) 168 at paragraph 44 as follows:
The courts have traditionally protected a patentee from the effects of excessive literalism. The patent is not addressed to an ordinary member of the public, but to a worker skilled in the art described by Dr. Fox as:
a hypothetical person possessing the ordinary skill and knowledge of the particular art to which the invention relates, and a mind willing to understand a specification that is addressed to him. This hypothetical person has sometimes been equated with the "reasonable man" used as a standard in negligence cases. He is assumed to be a man who is going to try to achieve success and not one who is looking for difficulties or seeking failure. [Fox, H.G. The Canadian Patent Law and Practice relating to Letters Patent for Inventions 4th ed Toronto: Carswell 169 at 184]
[12] In this case the parties agree that a person skilled in the art on the priority date of the patents would have a B.Sc. degree in chemistry or chemical engineering and two to five years experience in pharmaceutical crystallization processes. The Court also accepts Ratiopharm=s contention that a person skilled in the art can be a team of individuals.
Construction of the > 606 Patent
[13] In every patent case, the first step the court must take is to construe the patent. With respect to the > 606 Patent, all claims are in issue and thus this Court must construe claims 1 to 4. Attached hereto as Annex A are:
a) Relevant portions of the patent disclosure, entitled Summary of the Invention (ASummary@), and
b) Claims 1, 2, 3 and 4.
[14] Applying the provisions set out in paragraphs 10 and 11 above to the > 606 Patent and reading claims 1 to 4 as a person skilled in the art, informed by the disclosure of the patent would, the Court notes that:
1. The claims are directed to a product per se. The product in claims 1 and 2 is Clarithromycin (also known as 6-O-methylerythromycin A) Form II. It is characterized by its XRPD pattern, (also known as PXRD). The XRPD pattern in claim 2 is the same as that of claim 1, it is merely stated more precisely to two digits after the decimal point instead of one digit.
2. Claims 3 and 4 claim Clarithromycin Form II substantially free of Form I. Again, it is characterized by its XRPD pattern. The XRPD pattern in claim 4 is the same as that of claim 3, it is merely stated more precisely to two digits after the decimal point, instead of one digit.
3. The disclosure informs one that Clarithromycin Form II has known therapeutic effect as an antibacterial treatment for infections of the upper respiratory tract. No argument was raised before me regarding the eligibility of this patent as a claim for a medicine or the use of a medicine within the meaning of the NOC Regulations.
[15] Abbott urged me to interpret the term AForm II@ in the patent as it appears in each claim as referring to the identity of Clarithromycin defined by reference to the IR spectrum, the XRPD pattern and the differential scanning calorimetric (ADSC@). Abbott referred to lines 1 to 4 of the Summary which state[1]:
We have discovered that 6-O-methylerythromycin A can exist in at least two distinct crystalline forms, which for the sake of identification are designated AForm I@ and AForm II@. The crystal forms are identified by their infrared spectrum, differential scanning calorimetric thermogram and powder x-ray diffraction pattern.
In Abbott=s view, the word Form II is superfluous unless it is interpreted as incorporating the IR, XRPD and DSC identifiers.
[16] I cannot accept this interpretation for the following reasons:
a) The claims themselves only refer to the XRPD pattern. There is no reference at all in the claims to either IR or DSC.
b) Lines 19 to 26 of the Summary provide the characteristics of Clarithromycin Form II by providing A(t)his novel crystalline antibiotic may be characterized by peaks in the powder x-ray diffraction pattern having the following 2θ [theta] values: (...)@ Again, there is no reference to IR or DSC.
c) Lines 1 to 4 of the Summary referred to by Abbott=s counsel refer to both Clarithromycin Form I and Clarithromycin Form II. This first paragraph of the Summary gives background to both these forms but it does not provide the characteristics of Clarithromycin Form II. To find the characteristics of Clarithromycin Form II, one needs to look at lines 19 to 26 of the Summary and in the claims themselves (where one finds no mention of IR or DSC). It would be an improper expansion of the claims to read this background information (relating to both forms of Clarithromycin) as characteristics of Clarithromycin Form II and import such a reading into the claims.
d) Example 1 on page 13 of the Patent deals with the preparation of Clarithromycin Form I. It provides in lines 9 to 11:
6-O methylerythromycin A Form I is characterized by its infrared spectrum, the differential scanning calorimetric (DSC) thermogram and the powder x-ray diffraction pattern.
Surely if the drafter had meant to characterize Clarithromycin Form II by the IR and DSC as well as the XRPD he would have used the same language in the claims as was used in respect of Form I in Example 1.
e) While a court should look at the disclosure to understand the patent, the disclosure should not be used to enlarge or contract the scope of the claim. As Binnie J. stated in Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067 at paragraph 52:
More recently, Hayhurst, supra, at p. 190, cautioned that "[t]erms must be read in context, and it is therefore unsafe in many instances to conclude that a term is plain and unambiguous without a careful review of the specification". In my view, it was perfectly permissible for the trial judge to look at the rest of the specification, including the drawing, to understand what was meant by the word "vane" in the claims, but not to enlarge or contract the scope of the claim as written and thus understood. (Underlining added)
f) The word AForm II@ is the name Abbott assigned to this particular polymorph of clarithromycin. It is does not have any meaning per se, nor is it a defined term of art.
[17] Accordingly, I will proceed on the basis that the > 606 Patent describes the invention of a new polymorph of Clarithromycin. This new polymorph is designated Form II and is characterized by specific 2 theta values. Claims 1 and 2 refer to Clarithromycin Form II, while claims 3 and 4 refer to Clarithromycin Form II, substantially free of Clarithromycin Form I. The 2 theta values for claims 1 and 3 are given at the one decimal level, while claims 2 and 4 are given at the two decimal level. While drawings of the IR and the DSC patterns are annexed to the patent and referred to in the disclosure they are provided for illustration only and do not form part of the invention as claimed in any of claims 1 to 4.
Ratiopharm=s NOA
[18] Ratiopharm in its NOA questions the validity of the > 606 Patent on the basis of invalidity claiming:
a) it was anticipated by Salem;
b) it was anticipated by Iwasaki;
c) it was anticipated by the prior sale of BIAXIN; and
d) it was obvious.
[19] The issue for this Court to decide is if any of Ratiopharm=s allegations are justified. If so, Abbott will not succeed in its application for a prohibition order. The Court will examine these issues in the order listed above.
Invalidity - Anticipation by Salem
[20] Ratiopharm alleges that the invention set out in the > 606 Patent was anticipated by an article by I.I. Salem entitled AClarithromycin found in analytical profiles of drug substances and excipients@, Volume 24, published by Academic Press Inc., San Diego in 1996. The > 606 Patent was filed on July 25, 1997 and has a claim date of July 29, 1996.
[21] Ratiopharm alleges that the Salem article anticipates the claim date of the > 606 Patent. The exact allegations in the NOA state:
Claims 1 to 4 BDescribed in or obvious in view of prior publications
Compositions comprising clarithromycin Form II and their uses as claimed in each of claims 1 to 4 of CA > 606 were described in patents, patent applications and printed publications that were published more than one year before the filing date or prior to the claim date of CA > 606 and clarithromycin Form II and processes for its preparation were obvious in view of such references. Ratiopharm relies on the disclosures contained in the documents listed in Schedule 1 hereto. By way of example, the reference to Salem (document 43) discloses clarithromycin in which the powder X-ray diffraction (PXRD) pattern (Figure 4) and the differential scanning calorimetry (DSC) thermogram (figure 6) are the PXRD pattern and DSC thermogram of clarithromycin crystal Form II).
The Schedule 1 referred to in the above quote lists the Salem article as no. 43 but merely gives 1996 as the publication date.
[22] There is no dispute that Salem describes crystalline Clarithromycin and that the Clarithromycin analyzed and reported by Salem has XRPD 2 theta values that are identical to the ones set out in claim 1 of the > 606 Patent.
[23] To be successful with this argument, Ratiopharm has to produce evidence to satisfy subsections 28.2(1)(a) and (b) of the Patent Act, R.S.C. 1985, c. P-4:
28.2 (1) The subject-matter defined by a claim in an application for a patent in Canada (the "pending application") must not have been disclosed
(a) more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant, in such a manner that the subject-matter became available to the public in Canada or elsewhere;
(b) before the claim date by a person not mentioned in paragraph (a) in such a manner that the subject-matter became available to the public in Canada or elsewhere;
[24] Ratiopharm produced no other evidence. Abbott produced the affidavit of one Daniel Artola, a lawyer with the firm representing Abbott. This affidavit purports to establish that the book Analytical Profiles of Drug Substances and Excipients, Volume 24 (in which the Salem article appears) has, according to the publisher=s record, a publication date of July 25, 1996. The publisher=s records also show that the first order for the book was placed on that date. There is no evidence provided as to who ordered the book, when it was shipped or when it was delivered. There is merely some conjecture that its normal deliveries were shipped through UPS and that its delivery would have taken 5 to 7 business days. (Artola Affidavit, Applicant=s Record, Volume 7, Tab 32, paras 5 to 9.)
[25] However, this evidence was obtained by phone from an employee of the publisher. The publisher refused to let the employee appear as a witness or swear an affidavit. The Artola affidavit, being based on information relayed over the telephone from an employee who has no personal knowledge and is not prepared to swear an affidavit, is of no probative value to this Court. Accordingly, it will be disregarded.
[26] In any NOC proceedings, the NOA has to set out a detailed statement of law and facts the person making the allegations intends to rely upon. As stated by Stone J.A. in AB Hassle v. Canada (Minister of National Health and Welfare) [2000] F.C.J. No. 855 at paragraphs 20 and 21:
While it is true that the detailed statement is not filed in a section 6 proceeding, it nevertheless casts a long shadow over that proceeding. Indeed, it is upon the content of that statement that the patentee must decide whether or not to commence a section 6 proceeding and to assess its chances of success or failure. In this sense the allegation and detailed statement assist in an important way in framing the issues and facts to be determined in the section 6 proceedings for in seeking prohibition the patentee is obliged to show that, contrary to what is stated in the detailed statement, the patentee's patent right will be infringed if an NOC for the drug is issued prior to the expiration of the listed patent.
In my view, all of these considerations suggest that a second person must do what, in fact, paragraph 5(3)(a) requires, i.e. set forth in the detailed statement "the legal and factual basis" for the paragraph 5(1)(b) allegation and to do so in a sufficiently complete manner as to enable the patentee to assess its course of action in response to the allegation.
[27] I do not see how this standard has been met in this case. On the basis of the NOA, the date of the publication of Salem is not known. In my view, Ratiopharm failed to set out any facts in its NOA on which it relies to assert the Salem article was available prior to the filing or claim date of the > 732 Patent. There is no need for Abbott to disprove this allegation.
[28] I would note that this application in respect of the > 606, > 274, > 527, > 356, > 534 and > 361 patents is separate from the application in respect of the > 732 Patent. Although the two applications were heard contemporaneously, they are each governed by their separate records. However, the conclusion reached on this record is no different than the conclusion reached on the basis of the evidence contained in the record related to the > 732 Patent.
Invalidity - Anticipation by Iwasaki
[29] Ratiopharm also alleges that the > 606 Patent was anticipated by the article of H. Iwasaki published June 15, 1993 in ACrystal structure communications@, Volume 49, Part 6.
[30] That article clearly predates the filing of the > 606 Patent. It describes the molecular structure of 6-O methylerythromycin A (Clarithromycin). Under the heading AExperimental@, it sets out the crystal data as C38H69NO13.CH40. The dot (.) before the CH40 denotes that this is a solvate.
[31] Dr. Hollingsworth, Ratiopharm=s expert, testified that the 2 theta values of the Iwasaki molecule can be readily calculated from its crystal structure. He states in his affidavit:
It is evident from the foregoing that the 6-O-methylerythromycin A analyzed and reported by Iwasaki has the identical PXRD 2 theta values as claimed in claim 1 of the > 606 Patent. Although Iwasaki=s 2 theta value of 19.23 would appear to lie outside of the claimed range of 19.0__0.2 (number 15) in claim 1, it is, in fact, within this range when rounded to one decimal place, consistent with the manner in which the values in claim 1 are reported. The Iwasaki 2 theta values also fall within the more precise 2 theta values listed in claim 2 of the > 606 Patent. It is also evident that there is no detectable Form I in the Iwasaki sample, and so it also falls within the scope of claims 3 and 4 of the > 606 Patent, which require the Form II to be substantially free of Form I.
(Respondent=s Record, Volume 9, Tab 14, para 133)
[32] Similarly, Abbott=s expert Dr. Byrn states in his affidavit:
For the reasons set out above, Iwasaki discloses a methanol solvate structure that it not claimed in any of the Abbott Patents, which is indistinguishable (to examination of the powder xray diffraction pattern) from Form II but which is very clearly not Form II (Byrn Affidavit, Applicant=s Record, Volume 12, Tab 41, para 59). (Underlining added)
Conclusion regarding the > 606 Patent
[33] Abbott maintains that Clarithromycin Form II is not a solvate and therefore cannot have been anticipated by Iwasaki. While I found in the > 732 Patent proceedings that Clarithromycin Form II as referred to in that patent does not include a solvate, that is irrelevant for this application. Here we are dealing with the > 606 Patent which I have construed to be solely characterized by its XRPD pattern. The experts for both sides agree that the XRPD pattern which can be calculated from the Iwasaki molecule is identical to that of the > 606 Patent. Since the > 606 Patent did not claim any characteristics other than the XRPD pattern and as this pattern was already available to the public due to the Iwasaki publication, the > 606 Patent is anticipated by Iwasaki.
[34] Given my findings regarding anticipation by Iwasaki, I see no necessity to deal with Ratiopharm=s allegation regarding invalidity due to the prior sale of BIAXIN or invalidity based on obviousness. In my view, Abbott has failed to disprove Ratiopharm=s allegations of invalidity, based on anticipation by Iwasaki.
> 274 Patent
Patent Construction
[35] As noted previously, in every patent dispute, the first step the court must take is to construe the patent. Both sides agree that with respect to the > 274 Patent, only claims 1, 4, 5 and 16 are in issue. For ease of reference, Annex B attached hereto sets out:
a) the portion of the disclosure entitled Summary of the Invention, and
b) claims 1, 4, 5, and 16.
[36] Applying the provisions set out in paragraphs 10 and 11 above to the > 274 Patent and reading the disclosure and claims 1, 4, 5 and 16 together as would a person skilled in the art, the Court notes that:
1. This is a product per se patent. The invention in claim 1 is the crystalline structure of an antibiotic designated as Clarithromycin Form 0. It is a solvate with the solvating molecule selected from the group consisting of ethanol, isopropyl acetate, isopropanol and tetrahydrofuran.
2. Claim 16 is identical to claim 1 except that it claims Apure@ Clarithromycin Form 0, i.e. Form 0 substantially free of Form I or Form II.
3. Claims 4 and 5 are dependent on claim 1 and describe Clarithromycin Form 0, solvated from ethanol, by providing its XRPD pattern which shows 16 peaks in 2 theta values to one decimal and two decimals points respectively.
4. Claims 1 and 16 cover Clarithromycin Form 0 made from four solvents.
5. All the claims in issue are for an antibiotic. In reading the disclosure, we know that this is an antibiotic that has therapeutic utility to fight infections of the upper respiratory tract in children and adults. However, no claims regarding the use of this antibiotic are made and one has to refer to the disclosure to understand what is meant by the word Aantibiotic@.
[37] Ratiopharm made four allegations at the hearing, namely:
1. All the claims in issue are for Form 0 used as an intermediate in the manufacture of Clarithromycin Form II, they are not a claim for the medicine itself, nor for the use of the medicine and therefore are not eligible under the NOC Regulations.
2. In the alternative, if the claims in issue are claims for Form 0 as the medicine itself, or for the use of the medicine, they cannot be asserted against an intermediate under the NOC Regulations.
3. Its manufacturing process (called CLX) does not involve the use, complex or suspension of Clarithromycin Form 0 as claimed.
4. The discovery of Clarithromycin Form 0 was inherent and obvious in light of the prior art.
Allegation 1 - Claim for the medicine
[38] Ratiopharm alleges that the claims in issue regarding the > 274 Patent are claims for an intermediate and not claims for a medicine and thus, pursuant to Eli Lilly v. Apotex (1995) 63 C.P.R. (3d) 245, are not eligible for listing under the NOC Regulations. Abbott asserts that they are claims for a medicine within the meaning of the NOC Regulations.
[39] Abbott=s expert, Dr. Byrn stated the following regarding Form 0 as a medicine in one of affidavits:
161. However, after the invention of Form 0 and Form I, Abbott determined and disclosed in the Abbott Patents that Form 0 and Form I are less thermodynamically stable than Form II (see page 2, lines 12 and 13 of the > 606 Patent and lines 22 to 24, page 1 of the > 274 Patent).
162. The fact that Form II is the most thermo-dynamically stable crystal form of
clarithromycin known at the date of the Abbott Patents necessarily entails that it is the least soluble of the three solid forms invented and claimed by Abbott in the patents.
163. Once the antibiotic activity of the clarithromycin molecule in known, but only after they are determined to be less thermodynamically stable, it then follows that Form 0 and Form I must be useful as medicines to treat infections in the same way that Form II has been demonstrated to be useful.
164. Once the crystals were identified and their thermodynamic stability relative to Form II was ascertained, one could conclude, with certainty, that crystal Form 0 and Crystal Form I of clarithromycin would be useful as medicines themselves.
165. ratiopharm is incorrect to assert that Form 0 and Form I are anything but the medicine in issue in this case.
166. The medicine in BIAXIN7 is clarithromycin and each Form 0, Form I and Form II are useful forms of the medicine in BIAXIN7. (Underlining added)
(Applicant=s Record, Volume 12, Tab 41, paras 161-166)
[40] Abbott=s expert Dr. Atwood observed in his affidavit:
136. The > 606 Patent identifies Form II as an antibiotic. An antibiotic is a medicine. The medicine is clarithromycin. Abbott has invented three crystal forms [forms 0, I and II] which are all an antibiotic medicine. (Underlining added)
(Applicant=s Record, Volume 10, Tab 35, para 136)
[41] Ratiopharm=s own expert Dr. Hollingsworth went further and suggested the word antibiotic signified that the > 274 Patent is a claim for Form 0 when used as a medicine. He stated:
57. Furthermore, in my opinion, a person skilled in the art would construe claim 1 as being directed to clarithromycin Form 0 when used as an antibiotic therapeutic agent. The wording of claim 1 is not directed to A6-O-methylerythromycin A Form 0" per se, but is instead directed to a Acrystalline antibiotic desig