Apotex Inc. v. Astrazeneca Canada Inc.

Apotex Inc. v. Astrazeneca Canada Inc.
Court (s) Database
Federal Court of Appeal Decisions
Date
2017-01-12
Neutral citation
2017 FCA 9
File numbers
A-201-15
Notes
A correction was made October 1, 2019
Decision Content
Date: 20170112
Docket: A-201-15
Citation: 2017 FCA 9
CORAM:
PELLETIER J.A.
GAUTHIER J.A.
SCOTT J.A.
BETWEEN:
APOTEX INC.
Appellant
(Defendant)
And
ASTRAZENECA CANADA INC. and AKTIEBOLAGET HÄSSLE
Respondents/Cross-Appellants
(Plaintiffs)
AND BETWEEN:
APOTEX INC.
Appellant
(Defendant)
And
ASTRAZENECA AB and
AKTIEBOLAGET HÄSSLE
Respondents/Cross-Appellants
(Plaintiffs)
Heard at Montréal, Quebec, on March 9, 2016.
Judgment delivered at Ottawa, Ontario, on January 12, 2017.
REASONS FOR JUDGMENT BY:
GAUTHIER J.A.
CONCURRED IN BY:
PELLETIER J.A.
SCOTT J.A.
Date: 20170112
Docket: A-201-15
Citation: 2017 FCA 9
CORAM:
PELLETIER J.A.
GAUTHIER J.A.
SCOTT J.A.
BETWEEN:
APOTEX INC.
Appellant
(Defendant)
And
ASTRAZENECA CANADA INC. and AKTIEBOLAGET HÄSSLE
Respondents/Cross-Appellants
(Plaintiffs)
AND BETWEEN:
APOTEX INC.
Appellant
(Defendant)
And
ASTRAZENECA AB and
AKTIEBOLAGET HÄSSLE
Respondents/Cross-Appellants
(Plaintiffs)
REASONS FOR JUDGMENT
GAUTHIER J.A.
[1] Apotex Inc. (Apotex) appeals the decision of Justice Barnes of the Federal Court (2015 FC 322) as finally amended on July 15, 2015 (2015 FC 671). In its decision, the Federal Court found that certain claims (Claims 1, 5, 6, 13 and 19) of the Canadian Patent 1,292,693 (the 693 Patent) were valid and had been infringed by Apotex.
[2] The proceedings were bifurcated, so that the decision under appeal concerns only issues relating to liability. The Federal Court reserved the issue of costs. The respondents, AstraZeneca Canada Inc., AstraZeneca AB and Aktiebolaget Hässle (collectively, Astra) cross-appealed the Federal Court’s decision on the issue of punitive damages, asserting that in the special circumstances of this case, the Federal Court should have recognized their right to claim such punitive damages.
[3] The 693 Patent in which Astra claims an interest pertains to pharmaceutical preparations containing omeprazole, a drug used in the treatment of gastrointestinal diseases. The 693 Patent has 19 claims, including 16 claims covering specific oral pharmaceutical preparations containing omeprazole, 15 of which are dependent on Claim 1. Claim 17 covers a process for making the said preparations, while Claim 18 covers a commercial package, which includes a claimed preparation (claims 1 to 16) and instructions for the use set out in Claim 19, which itself covers the use of a claimed preparation for the treatment of gastrointestinal diseases.
[4] After a 40-day trial, the Federal Court issued a 175-page decision (the Reasons) dealing with the construction of the patent, its validity (overbreadth, inutility and ambiguity), as well as infringement, the limitation period and whether it was appropriate to award punitive damages.
[5] In its appeal, Apotex does not challenge the Federal Court’s findings that the subject matter of the claims at issue is novel and inventive (i.e. non-obvious). Apotex also concedes that if the Federal Court’s construction is found to be valid, its pharmaceutical preparations containing omeprazole infringed the 693 Patent.
[6] I agree with Astra that this appeal, as well as the cross-appeal, involve no new principles of law and turn on their own facts. For the reasons that follow, in my view, the Federal Court made no reviewable errors in respect of the construction of the claims at issue and in concluding that these claims were valid. With respect to limitation period, I believe that with respect to the Federal Court file no. T 1890-11, the Federal Court erred in failing to properly consider whether a provincial time period shorter than six years did apply to some infringing activities of Apotex (see paragraphs 114-118, 125 and 126 below). Finally, I believe that the cross-appeal should be dismissed.
I. CONTEXT
[7] To provide some context, I will set out, among other things, some facts and findings of the Federal Court that are not in dispute.
[8] The 693 Patent has a priority date of April 30, 1986; the application was filed in Canada on April 29, 1987; and was issued on December 3, 1991 (Reasons at para. 12). This means that it is subject to the application of the old Patent Act, R.S.C. 1985, c. P-4, which did not have a specific section dealing with the limitation period applicable to infringement actions unlike the current version of the Patent Act (Act), where, since 1993, section 55.01 provides that a six-year time limitation applies to acts of infringement.
[9] Claim 1, which is at the heart of the construction argument raised in this appeal, reads as follows:
1. An oral pharmaceutical preparation comprising: (a) a core region comprising an effective amount of a material selected from the group consisting of omeprazole plus an alkaline reacting compound, an alkaline omeprazole salt plus an alkaline reacting compound and an alkaline omeprazole salt alone; (b) an inert subcoating which is soluble or rapidly disintegrating in water disposed on said core region, said subcoating comprising one or more layers of materials selected from among tablet excipients and polymeric film-forming compounds; and (c) an outer layer disposed on said subcoating comprising an enteric coating.
[10] At the time the said patent was filed, it was known that omeprazole was a powerful inhibitor of gastric acid secretion and was useful to treat gastric and duodenal ulcers (Reasons at para. 5).
[11] But, as found by the Federal Court, omeprazole turned out to be a particularly difficult active pharmaceutical ingredient to formulate. It has very low solubility and is very acid and moisture sensitive. The solution found by the inventors was multifaceted in order to finely balance the incompatibility between alkalinity necessary for acceptable storage stability and the preservation of the enteric coating necessary for good gastric acid resistance (Reasons at paras. 244, 253).
[12] The skilled person to whom this patent is addressed is someone with a university degree in natural sciences and practical experience in the development of pharmaceutical dosage forms: a skilled pharmaceutical formulator (Reasons at para. 225).
[13] Astra commercialized a preparation covered by Claim 1 under the brand name LOSEC. Meanwhile, in January 2004, Apotex obtained a Notice of Compliance (NOC), allowing it to market and sell its omeprazole product (sold under the brand name Apo-Omeprazole in Canada).
[14] The 693 Patent has been the subject of much litigation in Canada and in the United States and not only between these two parties. A few of the resulting decisions were considered by the Federal Court, such as Astra Aktiebolag v. Andrx Pharmaceuticals, Inc., 222 F. Supp. 2d 423, affirmed 84 Fed. Appx. 76 (U.S. C.A. Fed. Cir. 2003) and Omeprazole Patent Litigation, Re, 490 F. Supp. 2d 381 (U.S. Dist. Ct. S.D.N.Y. 2007), affirmed 536 F. 3d 1361 (U.S. C.A. Fed. Cir. 2008), where the American courts had to determine whether various companies’ omeprazole products (including Apotex’s in the second wave of cases), infringed U.S. Patent 4,786,505, the American equivalent of the 693 Patent (Reasons at paras. 177-178). The Federal Court also referred to this Court’s decision in Apotex Inc. v. AB Hassle, 2003 FCA 409, 312 N.R. 288 [AB Hassle], where Justice Rothstein, as he then was, had to construe Claim 1 of the 693 Patent in the context of a NOC regulations proceeding (Reasons at paras. 171-176).
[15] The Federal Court stated that it had no doubt that there were ways to make useful omeprazole preparations that would not fall within Claim 1 of the 693 Patent, as this proved to be the case for some defendants in the litigation proceedings which took place in the United States (Reasons at para. 275).
[16] Apotex looked for ways to work around the 693 Patent, and thought that it had succeeded by using a different process than the one covered by Claim 17 and described in the disclosure of the 693 Patent. Since the process it used was not known when the inventors filed their patent application, it was not, and could not have been, discussed in the disclosure of the 693 Patent.
[17] As found by the Federal Court, based on tests carried out by Astra’s experts, Astra was able to ascertain the composition of Apotex’s commercial preparation of omeprazole through testing performed in 2004 and 2011. These tests established, and the Federal Court accepted this evidence, that Apotex’s product had a core containing omeprazole and an alkaline reacting compound (ARC), an outer enteric coat and a subcoat containing a methacrylic acid copolymer-povidone (MACP-PVP) complex (Reasons at paras. 303, 364).
[18] It is no longer disputed that Apotex’s omeprazole product contains a distinct structural layer of polymeric film that is present on the core between the core and the enteric coating. The Federal Court found that this layer is substantially continuous (the minor imperfections have no functional significance), and inert (Reasons at para. 364). It serves as an effective barrier between the core and the enteric coating, and in almost every instance, exceeds a thickness of 2 microns (Reasons at paras. 364-365).
[19] This layer under the enteric coating is formed by a chemical reaction between the enteric coating MACP and the core excipient PVP when the enteric coating is applied to the pellet cores during manufacture (Reasons at para. 303). This is referred to in the Reasons as an in situ subcoating as opposed to a subcoating that is sprayed, painted, compressed or otherwise applied individually during the manufacturing process. As will be further explained, a main issue before us is whether the Federal Court properly interpreted the words of Claim 1 before concluding that such a layer is a “subcoating … disposed on the core” within the ambit of the said claim.
[20] The Federal Court found that Apotex could have done testing similar to that performed by Astra’s experts before putting its omeprazole product on the market to see if its product could infringe Claim 1 of the 693 Patent because it exhibits all the essential elements of the claimed pharmaceutical preparations covered by the said patent. Instead, Apotex appeared satisfied that it would not so infringe because it had used a different process than the one described in the patent, which in its view, only covers preparations where the separating layer between the core and the enteric coat is applied during the manufacturing process before the enteric coating is applied.
[21] Both parties acknowledged before the Federal Court that there was nothing inventive about the process described in the disclosure of the 693 Patent or claimed in Claim 17 except that it had never been used to make the particular pharmaceutical preparations claimed in the 693 Patent. Indeed, the parties had agreed that the inventive concept of the claims was a formulation of omeprazole containing an alkaline core, an inert subcoating and an enteric coating which provides good long-term storage stability and gastric acid resistance (Reasons at para. 226). As mentioned at paragraph 5 above, the Federal Court’s findings that the invention was not obvious and not anticipated are not challenged in this appeal.
[22] The facts relevant to Astra’s cross appeal and its claim that Apotex should pay punitive damages can be briefly summarized as follows.
[23] Astra alleges that Apotex was deceptive in the context of a settlement obtained in an earlier NOC proceeding involving the 693 Patent (Federal Court file no.T-1446-93). Dr. Sherman, the Chairman of Apotex, testified under oath in the NOC proceeding that the Apotex omeprazole product contained dibasic sodium phosphate as an ARC, a component exemplified in the 693 Patent, whereas unbeknownst to Astra, Apotex substituted magnesium hydroxide as its ARC in its New Drug Submission to the Minister in order to avoid another patent of Astra’s that claimed dibasic sodium phosphate as a stabilizing agent (1,388,377 Patent). Apotex failed to advise Astra of this substitution when it clearly knew that its testimony on this point was inaccurate (Reasons at paras. 382-383, 386).
[24] Instead of summarizing in a distinct section, the Federal Court decision and the various findings relevant to the issues in dispute in this appeal, I will do so when reviewing each issue individually. This will avoid unnecessary repetition.
II. The issues
[25] In the appeal, the issues are:
1) Did the Federal Court err in construing the 693 Patent, and if so, then it erred in finding that Apotex’s omeprazole product infringed Astra’s 693 Patent?
2) If the Federal Court did not err in its construction, did the Federal Court err in finding:
(i) That the disclosure was sufficient?
(ii) That Claim 1 was not overbroad and not ambiguous? and,
(iii) That utility had been either demonstrated or soundly predicted?
3) Did the Federal Court err in concluding that a six-year limitation period applied to all of Apotex’ infringing activities?
[26] In the cross-appeal, the only issue is whether the Federal Court erred in declining to award punitive damages to Astra.
[27] As acknowledged by Apotex at the hearing before us, because Apotex’s argument on proper construction feeds into the validity arguments, the issue relating to the construction of the patent is the most important one.
[28] The standards of review applicable to those issues are those set out in Housen v. Nikolaisen, 2002 SCC 33, [2002] 2 S.C.R. 235. With respect to the issues set in paragraphs 25(2) and (3) above, absent an extricable error of law, Apotex must establish that the Federal Court made a palpable and overriding error.
[29] While it was argued that the standard of review for patent construction is palpable and overriding error, the Supreme Court has consistently applied correctness: Whirlpool Corp. v. Camco Inc., 2000 SCC 67 at para. 76, [2002] 2 S.C.R. 1067 [Whirlpool], and Sanofi-Aventis v. Apotex Inc., 2013 FCA 186 at paras. 32-33, 447 N.R. 313 [Plavix].
[30] However, the Federal Court is entitled to deference in respect of its appreciation of the expert evidence as to how a person of ordinary skill in the art would understand specific wording. For example, while the Federal Court noted that the expert evidence did not provide much in the way of specialized usage in respect of the words “disposed on” (Reasons at paras. 170-175), this was not so in respect of the meaning of the word “inert” (Reasons at paras. 193-194).
III. ANALYSIS
A. Construction
[31] The Federal Court summarized the applicable principles of claim construction at paragraphs 160-167 of the Reasons. Apotex does not dispute that the Federal Court correctly articulated those principles. Rather, it argues that the Federal Court adopted a fettered, results-oriented construction, by beginning its analysis by asking whether Claim 1 covered preparations having a “subcoating that forms in situ”. Apotex also submits that by focusing on whether Claim 1 as a whole related to a product on the one hand, or to a process on the other, the Federal Court improperly fettered its consideration of the wording of the claim. Thus, in Apotex’s view, although the Federal Court articulated the appropriate principles of law, it paid lip service to these principles. In other words, the Federal Court improperly applied them.
[32] Apotex also insists that the Federal Court erred by relying on this Court’s findings in AB Hassle since in that case, and the American cases cited by the Federal Court, the evidentiary record was different and in any event, those courts also erred by failing to give appropriate weight to the disclosure and the nature of the invention described therein when they construed Claim 1 of the 693 Patent or its American equivalent.
[33] Apotex argues that as a result of the above-mentioned errors in the Federal Court’s approach, specifically its failure to properly consider the disclosure in the patent and give it appropriate weight in performing its purposive analysis, the Federal Court failed to appropriately construe the words “subcoating” “disposed on”, “selected from”, and “inert”. In Apotex’s view, the Federal Court also failed to construe Claim 1 as it would have been understood by a person skilled in the art in 1991. Apotex claims that the Federal Court erred because one cannot include within the scope of the monopoly claimed that which the inventors had not disclosed to the public in the 693 Patent.
[34] Apotex raises a number of other arguments that I do not intend to discuss for they simply have no merit. I will illustrate this with two examples.
[35] Apotex says that the Federal Court replaced the words “selected from” by the word “comprising”. When one reads paragraph 284 of the Reasons on which Apotex relies for this alleged “error of law” (Apotex’s Memorandum of Law at para. 55, footnote 68), the word “comprising” is used exactly as found in Claim 1. It is not meant to replace “selected from”. The Federal Court, having reached the stage where it was in its Reasons, had looked at the composition of Apotex’s omeprazole pellets. As such, the Federal Court was not required to fully quote or give a contextual meaning to the latter part of Claim 1(b) since what was as a matter of fact before it, was a layer made of a MACP-PVP complex. Apotex also submits that the Federal Court erred in interpreting “subcoating” as not including a gelatine capsule. This is not relevant to this appeal where obviousness and anticipation are no longer in issue. Moreover, I raised this during the hearing and did not get any satisfactory answer as to why it was necessary for this Court to determine this issue in order to deal with this appeal.
[36] That said, I now turn to a few findings of the Federal Court that are at the heart of Apotex’s main argument. First, the Federal Court found that Claim 1 and its dependent claims are product claims that are not limited to preparations made by the processes expressly referred to in the disclosure (Reasons at paras. 173, 178, 179, 183).
[37] The Federal Court also held that the expression “disposed on” is not a term of art used by the skilled person to whom the patent is addressed. This expression was not given a special meaning in the disclosure where it is used only once at page 5 of the 693 Patent. Thus, there was no clear particular meaning attributed to this expression by the inventors (Reasons at paras. 170, 179-181, and 189 in fine). It found that the objective reader would understand that “the purposive use of a general term to define the product would be insufficient to import a process limitation” (Reasons at para. 179 in fine). Read in context, I understand the Federal Court to say that the expression refers to the relative position or spatial arrangement of the subcoating in the finished preparations covered by the product claims (i.e. in the completed tablets or pellets containing omeprazole).
[38] With respect to the word “inert”, the Federal Court preferred the evidence of Astra’s expert (Dr. Bodmeier) to that of Apotex’s expert (Dr. Kibbe). In the context of Claim 1, the Federal Court held that this term of art would not be understood as requiring the complete absence of any chemical reaction whatsoever, as submitted by Apotex’s expert. It would be understood by skilled formulators as meaning that the subcoating components should not interfere with the function of the enteric coating and the stability of the omeprazole core (Reasons at paras. 138, 190-195).
[39] As for the meaning of “subcoating” in the claims, the Federal Court considered the expert evidence as to how this would be understood. It noted that most of the parties’ arguments were largely matters of grammar and context where expert opinions add little, if any, interpretative value (Reasons at para. 170). The Federal Court found that the use of the term “subcoating” in Claim 1 would be understood as one or more layers that are substantially continuous with a thickness that is sufficient to achieve its purpose (Reasons at paras. 196-208).
[40] There was no real dispute before the Federal Court as to the meaning of “selected from”. This is an expression that is often used in claims and is well understood. The Federal Court considered the argument made by Apotex that the term connotes a choice (Reasons at para. 169(b)). The Federal Court did not have to comment on this further considering its overall view that, when read in context, the wording of Claim 1 does not limit it to preparations made by the process referred to in the disclosure and claimed at Claim 17.
[41] As the issue of construction of the patent is to be reviewed on the correctness standard, I have performed my own analysis of the 693 Patent. I have thus considered, as proposed by Apotex, what the invention is by reading the full specification. For the reasons that follow, I do not agree with Apotex’s suggestion that the invention is to keep the core and the enteric coating separated at all times (my emphasis), meaning from the start of the manufacturing process up until the time the products or preparations claimed are completed and ready for storage and then used to treat gastrointestinal diseases.
[42] That said, it is appropriate to first say a few words about the arguments raised by Apotex as set out in paragraphs 31 and 32 above.
[43] To argue that the Federal Court paid lip service to the principles it properly articulated because it refers to the problem confronting it (does the invention cover subcoating that forms in situ) in the construction section of its reasons shows a misunderstanding of the Federal Court’s reasons. So is the view that somehow the Federal Court failed to have regard to the actual wording of the claims simply because it viewed the 693 Patent as a product claim. This is especially so when one considers that it is Apotex itself, in its post-trial submissions, who framed the construction issue as whether or not the claims cover an in situ reaction product (Appeal Book, Vol. 5 at pages 699, 706). I am certainly not prepared to infer anything on this basis. It would be like concluding that Justice Binnie was paying lip service to a principle he enunciated in Whirlpool because he commented on the construction issues facing the Court in the section of his reasons dealing with infringement. Should we infer from this that the learned judge erred in law by ignoring that construction should be assessed first without an eye on validity and infringement? Although it may have been preferable for the Federal Court to use Apotex’s exact words, it is clear from its description of the construction issues (Reasons at paras. 163-167, 169(a) and (g)) that the Federal Court well understood the issues before it. The words used were meant to convey the main issue raised by Apotex, namely, that the wording of the claim, whether a product claim or not, does not cover a layer (under the enteric coat, i.e. subcoat) applied using a process that was unknown at the relevant time.
[44] Furthermore, identifying the type of claim one construes as a product claim (including a product by process claim) or a process claim versus a use claim or a hybrid claim, has always been part of the construction analysis in Canada as well as anywhere else in the world that I am aware of. This includes the United States, Australia, the United Kingdom and the European Union. It is a most basic principle of patent drafting that a court must consider. It has been done as a matter of course by the Supreme Court of Canada (see Whirlpool, Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34, [2004] 1 S.C.R. 902 [Monsanto], Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77, [2002] 4 S.C.R. 153 to name a few). Moreover, it is very clear from a fair reading of the Reasons that the Federal Court did not view this characterization as a final or complete answer to the construction of Claim 1. It fully considered the wording of the claim itself and the competing views offered by the parties and their experts as to how Claim 1 would be understood by a skilled person. Moreover, the Federal Court made it clear during the trial that determining whether Claim 1 was a claim for a product with 3 structural elements was not a full answer to the construction issue before it, for one still had to give meaning to the wording used such as “disposed on” (Appeal Book, Vol. 6, Trial Transcripts, Cross-Examination of Dr. Kibble at page 24224).
[45] Finally, the Federal Court properly considered this Court’s decision in AB Hassle, noting that it was not a binding precedent as it was issued in the context of a NOC proceeding and that it would not have hesitated to differ if Apotex’s position had been persuasive. The Federal Court simply found that this was not so (Reasons at paras.175-178).
[46] Returning to my analysis, the applicable principles of construction are well-established and the Federal Court properly summarized them. In both Free World Trust v. Électro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024 [Free World] and Whirlpool, the Supreme Court of Canada made it clear that patents are to be construed purposively rather than literally.
[47] The “key” to purposive construction is the identification by the court, with the assistance of the skilled reader, of the particular words and phrases in the claim that describe what the inventor considered to be “essential elements of his invention” (Whirlpool at para. 45; and Free World at para. 31). The intention of the inventor is not to be assessed subjectively (meaning that the testimony of the inventor as to what he or she had in mind is irrelevant). The intention is derived from the wording of the claims read in context harmoniously with its purpose. The Supreme Court made it abundantly clear that the objective intention of the inventor is to be found within the four corners of the patent. This means that a later patent such as Astra’s Patent No. 2,186,037 cannot be used to establish such intention or the meaning of a word. In this particular case, there was no debate that the in situ process at issue, whether or not it can be called an in situ coating process, was not part of the common general knowledge in 1991 or before. Thus, there is no need to refer to any post-art evidence in that respect.
[48] It is trite law that a court will consider the disclosure when it construes the claims. I considered the disclosure as it may help to determine if the inventor gave a particular meaning to an expression or word in the claim by adopting a special lexicon. However, the disclosure cannot be used “to enlarge or contract the scope of the claim as written and thus understood” (Whirlpool at para. 52 in fine; see also Justice Rothstein’s comment in the seminal decision of Apotex Inc. v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 at para. 77 in fine, [2008] 3 S.C.R. 265). It must be recalled that predictability (that is fairness to the public, including the competitor of the patentee), demands that primacy of the claim’s language be maintained (Free World at paras. 39-41). It is fairness to the inventor that is achieved by interpreting the claims in an informed and purposive manner. It is thus somewhat surprising that in this case, it is the competitor who insists on giving the disclosure more weight than that allegedly given to it by the Federal Court in order to restrict the scope of the claim as written at this stage when one should not be concerned with validity (i.e. for example whether the disclosure is insufficient or the claims overbroad) or infringement.
[49] Turning to the 693 Patent, the disclosure generally follows the usual pattern adopted by patent agents to describe the invention. After describing the field of the invention (page 1, at lines 3-7), it sets out the background of the invention, which, as mentioned earlier, includes that omeprazole was known for its powerful inhibitory action, and the problems encountered in formulating a pharmaceutical dosage form that will prevent degradation of the omeprazole by preventing it from coming into contact with acidic gastric juice as well as the acidic compounds of enteric coatings, which may be used to remedy the first problem. It then notes at lines 15-16 of page 2 that “in order to enhance the storage stability the cores which contain omeprazole must also contain alkaline reacting constituents” (see for example page 1 at lines 16-17, 29-32; page 2 at lines 7-13).
[50] At page 3, lines 5-6, the disclosure mentions that “under the circumstances, there has been a demand for the development of new enteric preparations of omeprazole with better stability”. The disclosure then goes on to describe various prior art, where preparations including one or several layers over the core would not solve the two problems encountered in formulating omeprazole preparations.
[51] At page 4, the inventors state: “[t]he object of the present invention is to provide an enteric coated dosage form of omeprazole, which is resistant to dissolution in acid media and which dissolves rapidly in neutral to alkaline media and which has a good stability during long-term storage”. It goes on to state the following:
[c]ores containing omeprazole mixed with alkaline compounds or an alkaline salt of omeprazole optionally mixed with an alkaline compound are coated with two or more layers, whereby the first layer/layers is/are soluble in water o (sic) rapidly disintegrating in water and consist(s) of non-acidic, otherwise inert pharmaceutically acceptable substances. This/these first layer/layers separates/separate the alkaline core material from the outer layer, which is an enteric coating. The final, enteric coated dosage form is treated in a suitable way to reduce the water content to a very low level in order to obtain a good stability of the dosage form during long-term storage.
[52] To understand the 693 Patent, it is important to take into account that, as mentioned at page 5 of the disclosure and as further confirmed by the independent Claim 1 and Claim 17, there are two aspects to the invention. The first aspect is the oral pharmaceutical preparation comprising the elements found in Claim 1. Indeed, the exact wording of that claim is found at lines 4-13 of page 5 of the disclosure. It is the only place where the expression “disposed on” is used in the disclosure.
[53] The second aspect of the invention is a process for preparing the oral preparation of the invention, which comprises coating. Again, the wording of the disclosure at lines 14-25 of page 5 is exactly the same as that of Claim 17.
[54] It is also important to mention that in the detailed description that follows from pages 5a to 9 (and most of the disclosure thereafter), the two aspects of the invention are intermingled. The second line of page 9 of the disclosure makes it clear that the drafter describes the two aspects of the invention under each of the subtitles of the detailed description and that the process used to make the core, the separating layer and the enteric coating layer (all subtitles in the disclosure) are conventional techniques. This has the advantage of also providing details that enable the public to make the oral preparation of the invention as required by law while at the same time providing support for Claim 17 (see subsection 34(1) of the old Patent Act). It also confirms the unity of the invention in that the process described in the disclosure and later claimed, in and of itself, is not inventive.
[55] To illustrate the intermingling discussed above, at pages 6 and 7 of the disclosure, one learns how the subcoating layer described on page 5 (particularly element (b)) is used to separate “the omeprazole containing alkaline reacting cores ... from the enteric coating polymer(s) containing free carboxyl groups, which otherwise causes degradation/discolouration of omeprazole during the coating process or during storage” (see page 6 at lines 3-6), and how “the separating layer(s) can be applied to cores – pellets or tablets - by conventional coating procedures” and that the material used is “chosen among the pharmaceutically acceptable, water soluble, inert compounds or polymers used for film-coating applications such as, for instance sugar, polyethylene glycol …, or the like” (see page 6 at lines 25-34). The disclosure then goes on to discuss the thickness of the separating layer, which may vary depending on the preparations (for example tablets versus pellets), and the method used to prepare them (see page 6 at lines 34-36, page 7 at lines 6-7). Another example is found at lines 16-17 of page 7, where again, when discussing the enteric coating layer, the drafter indicates that it “is applied on to the sub-coated cores by conventional coating techniques”.
[56] At page 8, lines 11-14, the disclosure makes it clear that “[w]ithout this separating layer the resistance towards gastric juice would be too short and/or the storage stability of the dosage form would be unacceptably short”.
[57] On page 9, there is a brief explanation of how one would use a preparation of the invention and administer it to treat conditions for which omeprazole is known as an active medicinal ingredient.
[58] Several examples of preparations made by known techniques, including comparative examples with preparations that do not include a subcoating layer, are found at pages 10 to 27 of the disclosure. Apotex put a lot of emphasis on these examples, going so far as to say, in answer to a question from the Bench, that were it not for these examples, there may not have been a problem construing the claims. This is followed by a discussion of the preferred embodiments of the process claimed and lessons learned from the testing. Then at page 29, there is a brief description of biopharmaceutical studies (administration of a preparation to human volunteers). As required by law, the specification ends with 19 claims. As mentioned earlier, 16 of those claims cover oral pharmaceutical preparations, while Claim 17 covers a coating process to make them. Claim 18 covers a commercial package, which includes a claimed preparation for the use covered in Claim 19.
[59] Like Justice Rothstein in AB Hassle before me, I have given much detail about the disclosure (although I could not reproduce all the passages highlighted by Apotex) rather than simply saying that I have read it carefully more than once, despite the fact that it is clearly not always essential to do so in one’s reasons.
[60] Having considered the specification as a whole, I am satisfied that the invention is a pharmaceutical preparation (such as a tablet or pellets) having a specific structure in order to provide good long-term stability and gastric acid resistance.
[61] The elements of this structure are the three elements described in Claim 1, which the inventors clearly viewed as essential.
[62] With respect to the word “subcoating”, it is defined in the claim itself as one or more layers made of one of the selected materials described in the product claims. As the word itself indicates, this or these layers are under the enteric coating (thus subcoating). The evidentiary record and the disclosure support the Federal Court’s finding that it would be understood by the skilled person that these layers are substantially continuous, with a thickness appropriate to their purpose. It is not the role of this Court to reweigh the evidence in that respect. It was also open to the Federal Court to conclude as it did with respect to the meaning of the word “inert”. Contrary to what Apotex suggested, that expression in section (b) of Claim 1 refers to the state of the layer or layers in the finished oral pharmaceutical preparation.
[63] I am satisfied that the expression “disposed on”, which expression is not a term of art, meant to describe the position or spatial arrangement in the final structure of the claimed preparations. I agree with the Federal Court that the disclosure does not attribute a particular meaning such as “coated” or “applied” to this expression. In my view, it is telling that this non-technical expression is used instead of words like “coated” or “applied” when describing this aspect of the invention at page 5. The drafter chose to use a different expression than when describing how one can make these preferred embodiments and the process claimed throughout the disclosure. This construction is perfectly in harmony with the purpose of the invention as noted by Justice Rothstein at paragraph 23 of AB Hassle referred to in the Reasons at paragraph 173. It is also in line with the inventive concept agreed upon by the parties and used by the Federal Court in its unchallenged findings that the invention was new and not obvious.
[64] There is no impermissible redundancy as suggested by Apotex. When the adjective “disposed” is used to denote a position, it must necessarily be qualified by words such as “on”, “above”, “under” or “over”. The particular position of each essential element of the structure of these new preparations is repeated not only by use of the words “disposed on” in sections (b) and (c) of Claim 1, but also by using the words “subcoating”, “outer layer… comprising an enteric coating”. This is not unusual. Patents are rarely regarded as fine examples of English writing nor are they meant to be read as such by the person skilled in the art. In my view, the language of Claim 1 as a whole makes it very clear that the position of each element of the final product is essential.
[65] Given the undisputed factual findings of the Federal Court with respect to the structure of Apotex’s omeprazole preparation and my conclusion that the Federal Court was correct in construing Claim 1 as not including a process limitation, the Federal Court’s findings in respect of infringement should stand.
IV. Validity
[66] I will thus now discuss the argument that the Federal Court erred in finding that the claims at issue were valid. As was mentioned during the hearing before us, many of the arguments raised in respect of sufficiency, overbreadth and ambiguity overlap. Thus, like the Federal Court, I will treat them under the same heading while I will treat the argument with respect to utility separately.
A. Sufficiency, overbreadth and ambiguity
[67] The Federal Court found that the 693 Patent imparts useful and sufficient information to the person of skill to craft an omeprazole formulation that would be expected to solve problems the inventors encountered. In its view, the fact that some routine stability and gastric acid resistance testing would still be required to know if a particular formulation with the structural features of Claim 1 actually worked as expected did not mean that Claim 1 was overbroad or unclear (Reasons at para. 278).
[68] The Federal Court found that by following the instructions in the specifications, and with routine testing and some adjustments if necessary, the skilled formulator is able to obtain a useful formulation (Reasons at para. 279).
[69] The Federal Court noted at paragraph 281 of the Reasons that the fact that the person skilled in the art needs to apply some basic knowledge or routine testing to work the invention is not fatal because the essential framework of the invention is provided. In that respect, the Federal Court referred to Burton Parsons Chemicals, Inc. v. Hewlett-Packard (Canada) Ltd., [1976] 1 S.C.R. 555, 54 D.L.R. (3d) 711 [Burton Parsons], which has been analyzed in a more recent decision by the same judge: Delp v. Fresh Headies Internet Sales Ltd., 2011 FC 1228, at paras. 13-19 [Delp].
[70] The Federal Court also dealt with Apotex’s argument that some materials or constituents falling within the possible selections referred to in Claim 1 could be highly reactive and would not work. The Federal Court found that the re