Alcon Canada Inc. v. Cobalt Pharmaceuticals Company

Alcon Canada Inc. v. Cobalt Pharmaceuticals Company
Court (s) Database
Federal Court Decisions
Date
2014-02-14
Neutral citation
2014 FC 149
File numbers
T-504-12
Decision Content
Date: 20140214
Docket:
T-504-12
Citation: 2014 FC 149
Ottawa, Ontario, February 14, 2014
PRESENT: The Honourable Madam Justice Gleason
BETWEEN:
ALCON CANADA INC., ALCON RESEARCH, LTD., ALCON PHARMACEUTICALS, LTD., AND KYOWA HAKKO KIRIN CO., LTD.
Applicants
and
COBALT PHARMACEUTICALS COMPANY AND THE MINISTER OF HEALTH
Respondents
REASONS FOR JUDGMENT AND JUDGMENT
[1] This case involves an application for an order in the nature of prohibition to restrain the Minister of Health from issuing a Notice of Compliance [NOC] under the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 [the NOC Regulations] to the respondent, Cobalt Pharmaceuticals Company [Cobalt], for approval to sell its generic version of an eye drop in which the active pharmaceutical ingredient [API] is a 0.2% concentration of olopatadine.
[2] Alcon Canada Inc. and Alcon Pharmaceuticals Ltd., two of the applicants in this matter, distribute and sell both a 0.1% and a 0.2% olopatadine eye drop solution. The 0.1% solution was developed first and is marketed under the name “PATANOL”, and the 0.2% solution is marketed as “PATADAY”. Both are available in Canada through prescription and are used to treat allergic and inflammatory eye reactions. Olopatadine, the active ingredient in the two products, is a known compound, and its usefulness in the treatment of allergic and inflammatory eye reactions has likewise been known for several years.
[3] Both PATANOL and PATADAY are listed on the Patent Register, established under s. 3(2) of the NOC Regulations. The applicants (collectively termed “Alcon”) own or are licensed to use three patents that are (or were) listed against the PATANOL and PATADAY products on the Register. Canadian Patent No. 2,195,094 [the 094 Patent] is listed against both products, and Canadian Patent No. 2,447,924 [the 924 Patent] is listed against PATADAY. In addition, Canadian Patent No. 1,337,603 [the 603 Patent] was previously listed against both the 0.2% and 0.1% products but that patent expired on November 21, 2012.
[4] Cobalt applied to the Minister of Health under the NOC Regulations for approval to sell its generic version of a 0.1% and 0.2% olopatadine eye drop in Canada and, as is required by the NOC Regulations, served Alcon with Notices of Allegation [NOAs] in respect of each concentration. In its NOAs, Cobalt contests the validity of both the 094 and the 924 Patents (but not the now-expired 603 Patent).
[5] In response, Alcon commenced prohibition proceedings in this Court, pursuant to subsection 6(1) of the NOC Regulations, seeking to restrain the Minister of Health from issuing NOCs to Cobalt, thereby hoping to prevent Cobalt from distributing and selling its version of 0.1% and 0.2% olopatadine eye drops in Canada until the 094 and 924 Patents expire, respectively, in 2016 and 2022.
[6] The present application deals with the 0.2% concentration and was commenced on March 8, 2012. As originally pleaded, Alcon relied on both the 094 and 924 Patents in support of its claimed right to exclusively market and distribute 0.2% olopatadine eye drops. However, it now relies solely on the 924 Patent in support of its position in this application.
[7] In this regard, the issues between the parties in respect of the 0.1% concentration eye drops (with the exception of costs) have been resolved, as Alcon discontinued its application involving Cobalt’s 0.1% product following the decision in Alcon Canada Inc v Apotex Inc, 2012 FC 410 [Apotex v Alcon]. In addition, in respect of the 0.2% olopatadine product, Alcon advised that it no longer asserts the 094 Patent and accordingly now relies solely on the 924 Patent in support of its claim to a continued right to exclusively sell and distribute the 0.2% olopatadine product in Canada.
[8] In Apotex v Alcon, my colleague, Justice Barnes, dismissed Alcon’s prohibition application, which was based on the 094 Patent, finding that Alcon had not substantiated that the 094 Patent is valid. More specifically, Justice Barnes determined that the 094 patent merely claimed a known use for an old product and accordingly held that the 094 patent failed on the ground of obviousness. In light of Alcon’s acceptance of these findings, only the 924 Patent is at issue in the present application.
[9] The 924 Patent is directed in relevant part towards particular combinations of olopatadine and polyvinylpyrrolidone [PVP], a known excipient (or ingredient) often present in pharmaceutical formulations. As is more fully discussed below, the 924 Patent claims an invention centred on the alleged ability of PVP to stabilize a solution containing olopatadine. Alcon alleges that this ability of PVP to stabilize olopatadine solutions was unknown before it was disclosed in the 924 Patent.
[10] Alcon relies in this application on only two of the 32 claims made in the 924 Patent, namely Claims 2 and 7 (the “asserted claims”), which are both composition claims. Cobalt does not allege that it does not infringe these claims, and thus infringement is not at issue.
[11] Cobalt instead asserts that the 924 Patent is invalid: it raises several alternate arguments in support of its claim of invalidity. More particularly, Cobalt first asserts that the 924 Patent lacks inventiveness and is therefore invalid due to obviousness. Second, Cobalt alleges that the promised utility of the 924 Patent was neither demonstrated nor soundly predicted by Alcon, which likewise results in its invalidity. Third, Cobalt argues that the relevant claims made in the 924 Patent are broader than the invention allegedly made, and that this, likewise, leads to invalidity. Finally, Cobalt claims that the 924 Patent is ambiguous and that disclosure contained in the patent is insufficient, which would similarly lead to its being found invalid. If Cobalt is correct in any one of these assertions, this application must be dismissed.
[12] For the reasons set out below, I agree with Cobalt’s assertions regarding the lack of demonstrated utility and lack of sound prediction as well as overbreadth of Claims 2 and 7 of the 924 Patent and accordingly am dismissing this application, with costs.
I. General principles applicable to NOC proceedings
[13] Prior to examining the issues raised by the parties regarding the alleged invalidity of the 924 Patent, it is perhaps useful to briefly summarise the context in which the present application arises. As Justice Sharlow noted in Wyeth Canada v Ratiopharm Inc, 2007 FCA 264, 60 CPR (4th) 375 [Ratiopharm] at para 14, the Patent Register maintained by the Minister of Health is the “linchpin” of the NOC Regulations, which operate in the following fashion. Where an innovator’s drug is listed on the Patent Register, another drug manufacturer (typically a generic manufacturer) who wishes to produce a similar product (and who lists the innovator’s drug as a reference product in its Abbreviated New Drug Submission) may seek an NOC to authorise it to distribute and sell its generic version of the drug in Canada (see s. 5(1) of the NOC Regulations). When it does so, the generic drug manufacturer (or “second person”) must serve the innovator (or “first person”) with an NOA, setting out its position as to why the generic product either will not infringe the innovator’s patent or as to why it believes that such patent is invalid (see s. 5(3) of the NOC Regulations).
[14] The jurisprudence recognises that an NOA must contain a detailed statement of the factual and legal bases for such allegations, which must be sufficiently particularized so as to allow the innovator to appreciate the case it has to meet (see e.g. AB Hassle v Canada (Minister of National Health & Welfare) (2000), 256 NR 172, 7 CPR (4th) 272 (FCA) at paras 21-24; Procter & Gamble Pharmaceuticals Canada Inc v Canada (Minister of Health), 2002 FCA 290 at paras 21-25, 20 CPR (4th) 1 [Procter & Gamble]; Bayer Inc v Cobalt Pharmaceuticals Co, 2013 FC 1061 at paras 34-37 [Bayer]). The NOA thus functions much like a pleading and circumscribes the issues and to a large extent the evidence that the generic manufacturer may raise in the context of an application like the present. As my colleague, Justice Hughes, recently stated in Bayer at para 37: “… the Notice of Allegation must set forth the legal and factual bases for the allegations in a sufficiently complete manner so as to enable the first person … to assess its course of action in response to the allegations.”
[15] An innovator who receives an NOA may choose to not contest it, in which event the NOC will be issued to the generic company, which will then be permitted to enter the Canadian market with its competing product. Or, conversely, the innovator may, like Alcon has done here, choose to seek an order of prohibition under subsection 6(1) of the NOC Regulations. Where this occurs, the Minister of Health is precluded from issuing an NOC to the second company for 24 months following the date the Notice of Application is filed or for a shorter period if the prohibition application is dismissed, withdrawn or discontinued before the 24 months have elapsed. The filing of an application for prohibition therefore functions like an injunction, preventing the second company from entering the market for up to 24 months.
[16] Proceedings such as the present do not determine issues of patent validity or infringement, but rather, are limited to making determinations in respect of the ability of the Minister of Health to issue an NOC. As Justice Sharlow noted in Ratiopharm at para 21,
The NOC Regulations operate in addition to the patent enforcement regime in the Patent Act. Regardless of the outcome of a prohibition application, the innovator has the right to sue a generic drug manufacturer for infringement, and a generic drug manufacturer has the right to impeach the patent.
[17] The structure of the NOC Regulations (as well as the presumption of validity of a patent set out in subsection 43(2) of the Patent Act, RSC 1985, c P-4 [Patent Act]) affect the burden of proof in an application such as the present. In this regard, provided the party seeking the NOC files evidence that is capable of establishing invalidity, the burden shifts to the applicant to establish the validity of the patent in respect of the points in issue (see e.g. Lundbeck Canada Inc v Ratiopharm Inc, 2009 FC 1102 at paras 24-25, 79 CPR (4th) 243; Abbott Laboratories v Canada (Minister of Health), 2007 FCA 153 at paras 9-10, 59 CPR (4th) 30; Pfizer Canada Inc v Canada (Minister of Health), 2007 FCA 209 at paras 109-10, 60 CPR (4th) 81; Allergan Inc v Canada (Minister of Health), 2012 FC 767 at para 42, 103 CPR (4th) 155; Pfizer Canada Inc v Pharmascience Inc, 2013 FC 120 at paras 24-26, 111 CPR (4th) 88). In this case, Cobalt has filed sufficient evidence in respect of each of the points it raises to put them in issue and, therefore, Alcon has the burden, on the balance of probabilities, of establishing the validity of the 924 Patent. However, this case does not turn on the issue of burden as the most salient evidence in respect of lack of utility and over-breadth is contained in the 924 Patent, itself.
II. Construction of relevant claims of the 924 patent and determination of the inventive concept and the promise of the patent
[18] Bearing these general principles in mind, I turn to the first issue that arises, namely, review of the relevant claims in the 924 Patent and construction of what those claims mean. The case law recognises that in a prohibition application the first step is the construction of the claims, as it is the claims which establish the scope of the protected monopoly guaranteed by the patent, and both validity and infringement must be analyzed with reference to the claims (see e.g. Whirlpool Corp v Camco Inc, 2000 SCC 67 at para 43, [2000] 2 SCR 1067 [Whirlpool]; Free World Trust c Électro Santé Inc, 2000 SCC 66 at para 31, [2000] 2 SCR 1024 [Free World Trust]). Here, Alcon asserts only Claims 2 and 7 of the 924 Patent. Thus, I must commence by construing Claims 2 and 7, which I do in this section of my reasons.
[19] In this section, I also set out my findings on the inventive concept of the claims and the promise of the 924 Patent, which are relevant to Cobalt’s allegations of obviousness and inutility, because it is convenient to address claim construction, inventive concept and the promise of the patent at the outset.
(a) Principles applicable to claim construction
[20] The principles generally applicable to claims construction are well-settled and not disputed by the parties. Briefly in this regard, the claims of a patent must be construed in a purposive as opposed to a literal fashion and must be interpreted from the point of view of a notional ordinary person skilled in the art to which the patent applies (see e.g. Whirlpool at para 45; Free World Trust at paras 44, 51). In a patent such as this, filed after October 1, 1989, the claims are construed as of the date of publication (see e.g. Whirlpool at paras 55-56; Free World Trust at paras 53-54), which in this case is January 9, 2003. While construction is a matter of law to be determined by the Court, regard should be given to the expert evidence tendered concerning the meaning the skilled person would ascribe to the wording used in the patent, especially where some of its terms are technical (see e.g. Whirlpool at para 45). Where this is the case, the rest of the patent specification may be used to assist in interpreting the claims (Whirlpool at para 48), but the disclosure must not be used to either expand or contract the scope of the claims (see e.g. Whirlpool at para 52; Dimplex North America Ltd v CFM Corp, 2006 FC 586 at para 51, 54 CPR (4th) 435; Pfizer Canada Inc v Canada (Minister of Health), 2007 FCA 209 at para 39, 60 CPR (4th) 81; Pfizer Canada Inc v Canada (Minister of Health), 2005 FC 1725 at paras 32-53, 46 CPR (4th) 244 [Pfizer]).
(b) Relevant provisions in the 924 patent
[21] Here, as noted, Alcon relies on only Claims 2 and 7 in the 924 Patent. As both are dependent on or are impacted by other claims in the patent, I reproduce below all of the relevant claims, namely, Claims 1, 2, 4, 5, 6 and 7. They provide as follows:
1. A topically administrable solution composition for treating allergic or inflammatory disorders of the eye and nose comprising 0.17 – 0.62% (w/v) olopatadine and a polymeric physical stability-enhancing ingredient consisting essentially of polyvinylpyrrolidone or polystyrene sulfonic acid in an amount sufficient to enhance the physical stability of the solution, wherein the composition does not contain polyvinyl alcohol, polyvinyl acrylic acid, hydroxypropylmethyl cellulose, sodium carboxymethyl cellulose or xanthan gum.
2. The solution of Claim 1 wherein the solution comprises 0.18 – 0.22% (w/v) olopatadine.
4. The solution of Claim 1 wherein the solution comprises polyvinylpyrrolidone having a weight average molecular weight of 5000 – 1,600,000.
5. The solution of Claim 4 wherein the polyvinylpyrrolidone has a weight average molecular weight of 50,000 – 60,000.
6. The solution of Claim 4 wherein the solution comprises 0.1 – 3% (w/v) polyvinylpyrrolidone.
7. The solution of Claim 6 wherein the solution comprises 1.5 – 2% (w/v) polyvinylpyrrolidone.
[22] Cobalt’s generic product does not contain polystyrene sulfonic acid [PSSA] but, rather, only PVP. Thus, the portions of Claims 2 and 7 that are relevant in this application may be rephrased as follows:
2. A topically administrable solution composition for treating allergic or inflammatory disorders of the eye and nose comprising 0.18 – 0.22% (w/v) olopatadine and PVP in an amount sufficient to enhance the physical stability of the solution, wherein the composition does not contain polyvinyl alcohol, polyvinyl acrylic acid, hydroxypropylmethyl cellulose, sodium carboxymethyl cellulose or xanthan gum.
7. A topically administrable solution composition for treating allergic or inflammatory disorders of the eye and nose comprising 0.17 – 0.62% (w/v) olopatadine wherein the solution comprises 1.5 – 2% (w/v) PVP having a weight average molecular weight of 5000 – 1,600,000, wherein the composition does not contain polyvinyl alcohol, polyvinyl acrylic acid, hydroxypropylmethyl cellulose, sodium carboxymethyl cellulose or xanthan gum.
[23] Both asserted claims teach compositions that do not contain polyvinyl alcohol [PVA], polyvinyl acrylic acid (which is also called “polyvinyl acrylic acid carborner 974P” or “Carbopol 974P”), hydroxypropylmethyl cellulose [HPMC], sodium carboxymethyl cellulose and xanthan gum. I refer to these excluded substances collectively as the “five excluded excipients” or “the excluded excipients”.
[24] The 924 Patent, under the heading “Summary of the Invention”, provides as follows:
Among other factors, the present invention is based on the finding that [PVP] and [PSSA], unlike polyvinyl alcohol and the polyacrylic acid carborner 974P, enhance the physical stability of solutions containing approximately 0.2 – 0.6% olopatadine.
[25] The next section of the patent, under the heading “Detailed Description of the Invention” notes that both olopatadine and PVP are known compounds and then sets out the concentrations and, in the case of PVP, the molecular weights claimed in the 924 Patent in respect of these two compounds. As concerns olopatadine, the patent notes that “the solution formulations of the present invention contain 0.17 – 0.62 olopatadine”. It goes on to state that the preferable solution formulation for use in the eye contains 0.17 – 0.25% olopatadine and most preferably 0.18 – 0.22% of the substance. As concerns PVP, the patent states that PVP “included in the solution compositions of the present invention has an average molecular weight of 5000 – 1,600,000.” The description then goes on to indicate that the most preferred molecular weight of PVP is 50,000 to 60,000. In addition, this portion of the patent provides that the amount of PVP “contained in the compositions of the present invention will be 0.1 – 3%, preferably 0.2 – 2%, and most preferably 1.5 – 2%”.
[26] The detailed description section of the 924 Patent also provides indications as to the viscosity and pH of the solutions intended for use as eye drops. With respect to viscosity the patent states:
The compositions of the present invention have a viscosity of 0.5 – 10 cps, preferably 0.5 – 5 cps and most preferably 1 –2 cps. This relatively low viscosity insures [sic] that the product is comfortable, does not cause blurring, and is easily processed during the manufacturing, transfer and filling operations.
[27] As concerns the pH of the solutions for use in the eye, the disclosure indicates that “compositions of the present invention preferably have a pH of 4 – 8, preferably pH of 6.5 – 7.5, and most preferably a pH of 6.8 – 7.2”. The patent then goes on to provide lower preferred pH numbers for compositions intended for use in the nose, the most preferable of which is indicated to be a pH of 3.8 – 4.4.
[28] The 924 Patent also contains a number of examples, several of which provide results of experiments conducted by Alcon, which are more fully discussed in the section dealing with utility, below.
(c) The expert witnesses
[29] Each of the parties filed evidence from a single expert in respect of the issues that must be determined in this application. Alcon’s expert, Dr. Roland Bodmeier, is a Professor in the Department of Pharmaceutical Technology at the College of Pharmacy at the Freie Universität in Berlin, Germany. He has published widely, is an associate editor of the European Journal of Pharmaceutical Sciences and is on the editorial boards of several other scholarly journals in the pharmaceutical area. He teaches a course in ophthalmic formulation and has experience with ophthalmic solutions, although he has never worked as a formulator. Cobalt’s expert, Dr. Paul Laskar, has a Ph.D. in Pharmaceutical Sciences from Oregon State University, has taught in the schools of pharmacy of two American universities and has several years experience working as a formulator and at a senior managerial level in companies engaged in the development and production of ophthalmic solutions. He has published several articles in peer-reviewed journals and now works as a consultant.
[30] To a lesser or greater extent, both Alcon and Cobalt attack the credibility or expertise of the other party’s expert. Cobalt claims that Dr. Bodmeier lacks the practical expertise of working as a formulator and exhibited a lack of knowledge in signing an affidavit directed to the infringement issues without setting out his construction of the 094 and 924 Patents in that affidavit, which Cobalt argues tends to show Dr. Bodmeier lacks expertise in Canadian patent construction. Alcon, on the other hand, claims that Dr. Laskar’s opinion should be given lesser weight as he was provided copies of all the prior art by counsel for Cobalt as opposed to locating such materials for himself for use in formulating his opinion on obviousness and was therefore improperly influenced by counsel.
[31] In my view, neither of these arguments has merit. Both Dr. Bodmeier and Dr. Laskar possess expertise relevant to the points in issue in this application and are thus qualified to provide opinion evidence. I have found the evidence of both to be relevant and of assistance. Where I prefer the evidence of one over the other, I have done so based on the contents of the evidence given by them as opposed to counsel’s generalised comments regarding the opposing party’s expert.
(d) Construction of the relevant claims
[32] Turning, then, to the parties’ positions on construction, they are in substantial agreement as to the attributes of the notional ordinary person skilled in the art through whose eyes Claims 2 and 7 of Patent 924 are to be construed. They agree that the skilled person is someone with a background in pharmacy, pharmacology, chemistry, chemical engineering or biological sciences, who likely has a Ph.D. in one of those fields or a Bachelor or Masters degree, supplemented by relevant industrial experience, and who is knowledgeable in pharmaceutical formulation. I accept that the foregoing aptly describes the characteristics of the notional ordinary person skilled in the art, given the subject matter to which the 924 Patent pertains, and believe that the two experts possess knowledge similar to that which would be possessed by the skilled person.
[33] As concerns the parties’ differing views as to the construction to be given to Claims 2 and 7 of the 924 Patent, it is useful to commence by recalling the claims (as I have paraphrased them). They provide:
2. A topically administrable solution composition for treating allergic or inflammatory disorders of the eye and nose comprising 0.18 – 0.22% (w/v) olopatadine and PVP in an amount sufficient to enhance the physical stability of the solution, wherein the composition does not contain PVA, polyvinyl acrylic acid, HPMC, sodium carboxymethyl cellulose or xanthan gum.
7. A topically administrable solution composition for treating allergic or inflammatory disorders of the eye and nose comprising 0.17 – 0.62% (w/v) olopatadine wherein the solution comprises 1.5 – 2% (w/v) PVP having a weight average molecular weight of 5000 – 1,600,000, wherein the composition does not contain PVA, polyvinyl acrylic acid, HPMC, sodium carboxymethyl cellulose or xanthan gum.
[34] While both parties’ submissions indicate they concur with this paraphrasing (which indeed is merely a summary of the relevant portions of the two asserted claims and the claims they depend on), Alcon and Cobalt differ on three points in respect of the interpretation to be given to Claim 2. The first difference concerns what grade of PVP is included in Claim 2. The second centres on what is meant by the words “amount sufficient” and the third on what is meant by the word “enhance”.
i. Grade of PVP
[35] Turning, first, to the positions of the parties concerning how one interprets “PVP” in Claim 2, there is a difference of opinion as to whether PVP should be interpreted to mean to an average molecular weight of 50,000 to 60,000 (or 50K to 60K), the weight range of 5000 to 1,600,000 (1600K), or all molecular weights of PVP. The parties raise this point as part of their arguments on utility; however, it is actually a matter of construction.
[36] On one hand, Alcon argues that the utility of PVP in enhancing the stability of olopatadine solutions of Claim 2 should be evaluated primarily with reference to solutions containing PVP in molecular weights of between 50K to 60K as this is indicated in the disclosure section of the patent as being the most preferred range. In response, Cobalt asserts that in so arguing Alcon is improperly seeking to limit the scope of Claim 2 to that lower molecular weight range, which it argues is an impermissible use of the disclosure to limit the scope of Claim 2. It points out that Claim 4 and the other claims which depend on it (which include Claim 7) are a narrowing of Claim 1 and that Claim 5 is likewise a narrowing of Claim 1. It will be recalled that Claim 4 limits the molecular weight of PVP to be used in the solution from between 5000 to 1600K and that Claim 5 limits the PVP molecular weight further from 50K to 60K. Cobalt argues that Claim 1 must therefore be interpreted as including at the very least molecular weights of PVP from between 5000 to 1600K if not, indeed, all molecular weights of PVP. Cobalt further asserts that Claim 2 of the 924 Patent must be interpreted as including all these molecular weights of PVP because Claim 2 depends on Claim 1 and therefore incorporates Claim 1’s non-limitation of the molecular weight of PVP.
[37] Although Dr. Bodmeier did not address this issue directly in his affidavit, he did discuss the issue obliquely in his opinion on utility (at para 202 of his affidavit):
Some of the claims of the 924 Patent specify a molecular weight of PVP, e.g. claim 5 covers a molecular weight of 50,000 – 60,000. For the other claims, unless stated otherwise, they refer to the molecular weight range specified in the disclosure, namely 5000 – 1,600,000 [i.e. 5000 to 1600K].
Dr. Laskar concurs and notes at para 25 of his affidavit that the inventors of the 924 Patent stated in the patent that “the invention of the 924 Patent includes PVP with a weight of [5000 to 1600K]”.
[38] In cross-examination, however, Dr. Bodmeier was much more direct (at page 131, lines 3-5):
Q. And claim 1 covers a range of at least 5,000 [to] 1.6 million?
A. That’s correct…
Thus, the evidence of both experts indicates that Claim 1 encompasses a PVP range of at least 5000 to1600K. I agree that Claim 2 must therefore be construed as including a PVP range of at least 5000 to 1600K, because Claim 1 is specifically narrowed in Claims 4 and 5 and this makes it impossible to interpret Claim 2 as being limited to the narrowest molecular weight of PVP that is set out in Claim 5. In short, Claim 2 must include at least 5000 to 1600K PVP and not only 50K to 60K PVP because the narrower claims circumscribe the breadth of weights of PVP that are included in Claim 2.
[39] This interpretation is supported by Rule 87 of the Patent Rules, SOR/96-423, which provides:
87. (1) Subject to subsection (2), any claim that includes all the features of one or more other claims (in this section referred to as a “dependent claim”) shall refer by number to the other claim or claims and shall state the additional features claimed.
(2) A dependent claim may only refer to a preceding claim or claims.
(3) Any dependent claim shall be understood as including all the limitations contained in the claim to which it refers or, if the dependent claim refers to more than one other claim, all the limitations contained in the particular claim or claims in relation to which it is considered. [emphasis added]
87. (1) Sous réserve du paragraphe (2), la revendication qui inclut toutes les caractéristiques d’une ou de plusieurs autres revendications (appelée « revendication dépendante » au présent article) renvoie au numéro de ces autres revendications et précise les caractéristiques additionnelles revendiquées.
(2) La revendication dépendante peut seulement renvoyer à une ou plusieurs revendications antérieures.
(3) La revendication dépendante comporte toutes les restrictions contenues dans la revendication à laquelle elle renvoie ou, si elle renvoie à plusieurs revendications, toutes les restrictions figurant dans la revendications ou les revendications avec lesquelles elle est prise en considération. [Je souligne]
As Justice Pelletier noted in Halford v Seed Hawk Inc, 2004 FC 88 at para 91, 31 CPR (4th) 434, “[i]t is clear from section 87 of the Patent Rules that a dependent claim includes all the features and limitations of the claim which it incorporates by reference”.
[40] Thus, “PVP” as used in Claim 2 must include the weights encompassed in Claim 1 and therefore be construed to mean molecular weights of PVP from at least 5000 to 1600K. Claim 2, therefore, cannot be narrowed to mean only PVP in the 50K to 60K weight range.
ii. Meaning of “amount sufficient”
[41] Turning, next, to the meaning to be ascribed to the term “amount sufficient”, Alcon and Dr. Bodmeier assert that this phrase would be understood by the ordinary person skilled in the art to mean such amount of PVP as is sufficient to enhance the physical stability of the solution as compared to an identical solution not containing PVP. Cobalt, on the other hand, argues that this wording is impermissibly vague, but Dr. Laskar interpreted the phrase to mean that the solution of Claim 2 would contain an amount of PVP and would be more stable than an identical solution lacking PVP, which is a similar position to that advanced by Dr. Bodmeier. Given Dr. Laskar’s evidence, I agree with Alcon that a skilled person would interpret the term “amount sufficient” to mean such amount of PVP as is sufficient to enhance the physical stability of the solution as compared to an identical solution not containing PVP. Moreover, regard may be given to the disclosure section of the patent to determine this amount, which, as noted, indicates the most preferred amount falls within the range of 1.5 to 2% (w/v) of PVP.
iii. Meaning of “enhance”
[42] As concerns the interpretation of “enhance”, Alcon and Dr. Bodmeier submit that a person skilled in the art would interpret the term as essentially meaning “tends to enhance” and that the asserted claims teach that PVP will tend to make olopatadine solutions more stable than solutions not containing PVP. Dr. Bodmeier expresses the opinion that a skilled person would know that physical stability, as opposed to chemical stability, is more difficult to predict and, hence, that a skilled person would understand the asserted claims do not guarantee that the addition of PVP always results in olopatadine solutions that are stable. He states in this regard at paragraphs 194 to 196 of his affidavit:
194. The skilled person would be aware that the promise of the 924 Patent is a relative assurance, namely that PVP enhances physical stability, as compared to those solutions with no PVP. The skilled person would not read the 924 Patent as promising that the presence of PVP guarantees that no particles will ever form in solution, or alternatively, that particles will always form in solutions without PVP.
195. The skilled person would also be aware of the sporadic mechanisms which result in physical instability. The skilled person would therefore expect the data to reflect a degree of arbitrariness. That is, the skilled person would expect that in certain instances, a solution with a stability-enhancing agent would nonetheless exhibit the formation of particles, and conversely, solutions with no stability-enhancing agent would nonetheless show no particles.
196. Of course, the skilled person would not expect the results to be completely arbitrary, but would look for a general trend in the results in the data. And when the results of the experiments in the 924 Patent are examined, they exhibit a clear trend demonstrating that solutions containing PVP (or PSSA), in amounts specified in the patent, exhibit enhanced physical stability when compared to those solutions without PVP (or PSSA).
Even though these comments were made in the context of Dr. Bodmeier discussing the promise of the 924 Patent (which is further addressed below), they are equally applicable to his interpretation of “enhance” in the context of claims construction.
[43] Dr. Laskar and Cobalt, on the other hand, offer a slightly different view and indicate that “enhance” effectively means “improve”. At paragraph 65 of his affidavit Dr. Laskar indicates that “‘Enhance the Physical Stability of the Solution’ refers to a reduction in the extent of haze or particulate matter development during storage when compared to a component lacking such an ingredient”.
[44] I find there to be relatively little difference between the two positions because Dr. Laskar confirmed during cross-examination that “enhancement” is not a “surefire” prediction of physical stability and that a skilled person would recognise this and would also recognise that it is possible that under certain conditions a solution without PVP might be stable (at page 20, line 15 – page 21, line 8).
[45] Therefore, based on the evidence of the experts, I interpret the term “enhance” as meaning “to improve” but underscore that what is taught in the 924 Patent is that addition of the required amount of PVP will improve the physical stability of the relevant solution in most instances, as compared to solutions that are PVP-free but otherwise identical.
[46] Thus, in light of the foregoing, I find that Claims 2 and 7 of the 924 Patent should be construed as setting out two different formulations for a solution and that in describing the solution in Claim 2, PVP is included in molecular weights of at least 5000 to 1600K. (The solution of Claim 7 specifically includes PVP in the molecular weights of 5000 to 1600K). I also find that the amount of PVP to be included in the solution of Claim 2 is an amount sufficient to enhance the physical stability of the solution as compared to an identical solution not containing PVP. (Claim 7 specifically lists the amount of PVP required to be between 1.5 – 2% (w/v).) I further find that “enhancement” means improve, which is not a teaching that the additional amount of PVP will necessarily always guarantee a stable solution or that its exclusion will always necessarily result in an instable solution, but, rather, a teaching that addition of the required amount of PVP will improve the physical stability of the relevant solution in most instances.
[47] In light of the above, Claims 2 and 7 of the 924 Patent may be rephrased as follows to incorporate the construction I have found appropriate:
2. A topically administrable solution composition for treating allergic or inflammatory disorders of the eye and nose comprising 0.18 – 0.22% (w/v) olopatadine and PVP having an average molecular weight of 5000 to 1600K and in an amount sufficient to improve the physical stability of the solution, wherein the composition does not contain PVA, polyvinyl acrylic acid, HPMC, sodium carboxymethyl cellulose or xanthan gum.
7. A topically administrable solution composition for treating allergic or inflammatory disorders of the eye and nose comprising 0.17 – 0.62% (w/v) olopatadine wherein the solution comprises 1.5 – 2% (w/v) PVP having an average molecular weight of 5000 to 1600K, wherein the composition does not contain PVA, polyvinyl acrylic acid, HPMC, sodium carboxymethyl cellulose or xanthan gum.
(e) Inventive concept
[48] The inventive concept of the claims forms part of the obviousness analysis established by the Supreme Court in Sanofi-Synthelabo Canada Inc v Apotex Inc, 2008 SCC 61, [2008] 3 SCR 265 [Sanofi-Synthelabo]. The inventive concept is a statement of the claims of the patent as properly construed, but “stripped of unnecessary verbiage” (Allergan Inc v Canada (Minister of Health), 2012 FC 767 at para 137, 103 CPR (4th) 155). Where the inventive concept of the claims is not apparent from the claims themselves, as may be the case with claims for chemical formulas, the Court is free to determine the inventive concept based on the remainder of the specification. In this regard, the Supreme Court held in Sanofi-Synthelabo, at para 77:
The inventive concept of the claims is not readily discernable from the claims themselves. A bare chemical formula in a patent claim may not be sufficient to determine its inventiveness. In such cases, I think it must be acceptable to read the specification in the patent to determine the inventive concept of the claims. Of course, it is not permissible to read the specification in order to construe the claims more narrowly or widely than the text will allow.
This approach has been followed by this Court on several occasions (see e.g. Allergan Inc v Canada (Minister of Health), 2011 FC 1316 at para 51, 97 CPR (4th) 331; Fournier Pharma Inc v Canada (Minister of Health), 2012 FC 741 at paras 106-08, 107 CPR (4th) 32).
[49] Alcon takes the position that the inventive concept of the claims is that PVP can be used to enhance the physical stability of relatively higher concentration solutions of olopatadine (para 72 of its memorandum). However, the evidence of its expert, Dr. Bodmeier, goes further. He states, at para 111 of his affidavit:
The inventive concept of the claims is that PVP and PSSA can be used to enhance the physical stability of a higher-concentration solution of olopatadine and that certain specified agents (such as HPMC) do not do so. [emphasis added]
[50] Dr. Laskar for his part deposes at para 23 of his affidavit that his “…understanding of the 924 Patent is that the presence of PVP or [PSSA] and the exclusion of the other named polymers from the formulation is the inventive concept”.
[51] In my view, both experts’ evidence is to the effect that the inventive concept of the relevant claims in the 924 Patent is that PVP enhances the physical stability of olopatadine solutions, while the five excluded excipients do not. I agree that this is the inventive concept. Indeed, the inventors state at page 3 of the 924 Patent that “the present invention is based on the finding that [PVP] and [PSSA], unlike polyvinyl alcohol and the polyacrylic acid carborner 974P, enhance the physical stability of solutions containing approximately 0.2 – 0.6% olopatadine.”
[52] Therefore, I find that the inventive concept of Claims 2 and 7 of the 924 Patent is that PVP at sufficient concentrations improves the physical stability of higher concentration (0.2% to 0.6%) olopatadine solutions in most instances, whereas the five excluded excipients do not.
(f) Promise of the patent
[53] The promise of the patent is a concept developed in the context of utility. A patent need not make a promise, but where it does so, the patent’s usefulness will be measured against that promise (see e.g. Apotex Inc v Sanofi-Aventis Canada Inc, 2013 FCA 186 at paras 48-49, 447 NR 313 [Sanofi-Aventis]).
[54] My findings above under claims construction regarding the molecular weights of PVP, the amounts of PVP, and meaning of “enhance” are equally applicable to the promise of the asserted claims. Therefore, I find that the 924 Patent promises that PVP at sufficient concentrations improves the physical stability of olopatadine solutions in most instances. Specifically, Claim 2 promises that PVP having an average molecular weight of 5000 to 1600K (and most preferably 50K – 60K), and at sufficient concentrations will e