ViiV Healthcare Company v. Gilead Sciences Canada, Inc.

ViiV Healthcare Company v. Gilead Sciences Canada, Inc.
Court (s) Database
Federal Court Decisions
Date
2020-04-06
Neutral citation
2020 FC 486
File numbers
T-226-18
Decision Content
Date: 20200406
Docket: T-226-18
Citation: 2020 FC 486
Ottawa, Ontario, April 6, 2020
PRESENT: The Honourable Mr. Justice Manson
BETWEEN:
VIIV HEALTHCARE COMPANY,
SHIONOGI & CO., LTD. AND
VIIV HEALTHCARE ULC
Plaintiffs/
Defendants by Counterclaim
and
GILEAD SCIENCES CANADA, INC.
Defendant/
Plaintiff by Counterclaim
JUDGMENT AND REASONS
I. Introduction
[1] This is a motion for summary trial in a patent action. Given the narrow and well-defined issues before the Court, this is an appropriate proceeding to advance the litigation and narrow the issues in dispute.
II. Background
[2] The Defendant, Gilead Sciences Canada, Inc [Gilead] brought this motion for summary trial in the context of an action brought by the Plaintiffs, ViiV Healthcare Company, Shionogi & Co Ltd, and ViiV Healthcare ULC [collectively “ViiV”], alleging that Gilead has infringed Canadian Patent No. 2,606,282 [the 282 Patent] by making, using, selling, or offering to sell bictegravir as a component in its BIKTARVY product. Gilead denies all allegations of infringement, and counterclaims alleging that the 282 Patent is invalid.
[3] The motion is limited to two issues:
The proper construction of Ring A as defined in claims 1, 11, and 16 of the 282 Patent; and
Whether, based on that construction, bictegravir falls within the scope of claims 1, 11, and 16 of the 282 Patent.
[4] At the outset of the trial, ViiV admitted that Ring A is an essential element of the claims, so the only issue in dispute with respect to claim construction is whether any of claims 1, 11, and 16 cover bridged bicyclic Ring A structures.
A. The 282 Patent
[5] The 282 Patent is titled “Polycyclic Carbamoylpyridone Derivatives Having HIV Integrase Inhibitory Activity.” The patent is co-owned by ViiV Healthcare Company [ViiV USA] and Shionogi & Co, Ltd [Shionogi]. ViiV Healthcare ULC, a Canadian entity, is licensed indirectly by ViiV USA and Shionogi, and as such is a person claiming under the patentees.
[6] The 282 Patent is 315 pages long. It contains 437 claims and covers a multitude of compounds. However, as stated above, only claims 1, 11, and 16 are at issue in this summary trial. Each of these claims refers to a genus of compounds and their pharmaceutically acceptable salts or solvates. Claims 1 and 11 are the only asserted independent claims. The parties and their experts focused substantially all of their interpretive efforts on pages 39-42, 47-54, and 241-245 of the disclosure – less than 20 pages of the 245 page disclosure.
[7] As stated in the “Technical Field” section of the disclosure, the 282 Patent discloses novel compounds possessing inhibitory activity against human immunodeficiency virus [HIV] integrase and pharmaceutical compositions containing said compounds. The general structure of the claimed compounds, depicting Ring A on the right, is first used on page 4 of the patent:
B. Bictegravir
[8] Bictegravir sodium is one of three medicinal components in Gilead’s BIKTARVY product. As depicted in the BIKTARVY product monograph, bictegravir sodium has the following structural formula:
[9] This structural formula is in reverse orientation to the structural formulas in the 282 Patent. When rotated 180 degrees to be consistent with the formulas in the patent, the structure of bictegravir sodium is:
[10] At issue is the purposive construction of Ring A in claims 1, 11, and 16, and whether bictegravir’s bridged ring, circled in the images above, falls within the scope of the claims.
III. Summary Trial
[11] The factors to be considered on a motion for summary trial include:
• The amount involved;
• The complexity of the matter;
• The urgency of the matter;
• Any prejudice likely to arise by reason of delay;
• The cost of taking the case forward to a conventional trial in relation to the amount involved;
• The course of the proceedings;
• Whether the litigation is extensive and the summary trial will take considerable time;
• Whether credibility is a crucial factor and the deponents of the conflicting affidavits been cross examined;
• Whether the summary trial involves a substantial risk of wasting time and effort, and producing unnecessary complexity;
• Whether the motion results in litigating in slices; and
• Any other matters which arise for consideration.
Wenzel Downhole Tools v National-Oilwell Canada Ltd, 2010 FC 966, at paras 36-37 [Wenzel]
[12] If the Court is satisfied that there is sufficient evidence for adjudication, regardless of the amounts involved, the complexities of the issues and the existence of conflicting evidence, the Court may grant judgment, either generally or on an issue, unless it would be unjust to do so (Federal Courts Rules, SOR-98/106, r 216(6)).
[13] Summary trial need not be reserved for cases where the summary trial will result in determination of every issue. The Court has discretion to look at one or more issues and determine whether it is appropriate to deal with those issues by way of summary trial (Federal Courts Rules, r 213(1); Teva Canada Limited v Wyeth and Pfizer Canada Inc, 2011 FC 1169 (rev’d on other grounds 2012 FCA 141), at para 32 [Teva Canada]).
[14] ViiV submits that lack of expert opinion evidence is a factor that weighs against the appropriateness of a summary trial (Wenzel, above, at para 38). However, the facts of that case were markedly different from the present case. In Wenzel, there was no expert evidence before the Court. In this case, the parties put forward five expert witnesses, who were all cross-examined on their reports during the summary trial. The Court has all of the necessary expert evidence in addition to the 282 Patent specification to construe Ring A of claims 1, 11 and 16 and determine whether Gilead has made out its case of non-infringement.
[15] ViiV further submits that summary trial is inappropriate because it will result in litigating in slices. In Wenzel, Justice Snider noted that severing off the issue of anticipation would not conclusively dispose of the trial if the Court made a determination against the defendants. In that event, the Court would still need to consider obviousness, an issue based on much of the same evidence, at trial (Wenzel at para 38).
[16] The motion before this Court is distinguishable from the cases cited by ViiV. The issue for summary trial turns on the construction of only one claim element: Ring A in each of claims 1, 11, and 16 and whether based on that construction, Gilead may infringe one or more of these claims and claims dependent thereon. As discussed further below with respect to the burden of proof, claim construction is a question of law, and the only factual determination necessary to dispose of the summary trial has already been determined.
[17] The motion before the Court may be dispositive of ViiV’s claim, and in any event, will result in the following efficiencies:
(1) If the Court finds that bictegravir does not fall within the scope of claims 1, 11, or 16 of the 282 Patent, none of these claims and their dependant claims can be or will be infringed by Gilead, and ViiV’s action will be dismissed in its entirety.
(2) If the Court finds that bictegravir does fall within the scope of any of claims 1, 11, or 16 of the 282 Patent, disposition of the claim construction issue will provide greater certainty and clarity for a trial of the remaining issues, including validity. The construction of Ring A in the asserted claims is a necessary first step in determining the scope of the asserted claims in this action for both infringement and validity.
[18] As noted by Justice Hughes, “[t]hese Rules are intended to be used, not avoided or distinguished” (Teva Canada, above, at para 33). Despite ViiV’s continued attempts to derail the summary trial, I find that Gilead’s motion is both appropriate and timely.
A. Burden of Proof
[19] Gilead, as the party seeking summary trial, bears the burden of demonstrating that summary trial is appropriate (Teva Canada at para 35). For the reasons given above, Gilead has met this burden.
[20] On the merits of the summary trial issue, the usual burden in a civil trial applies, that is, the “party making an assertion must prove it by relevant evidence and the application of appropriate law” (Teva Canada at para 36). In this case, Gilead asserts that bictegravir does not fall within the scope of claims 1, 11, and 16 of the 282 Patent, and thus bears the burden of proving non-infringement.
[21] That said, claim construction is a question of law for the Court (Whirlpool Corp v Camco Inc, 2000 SCC 67 at paras 61 & 76 [Whirlpool]). While the issue of infringement is a question of mixed fact and law, the only fact required to determine whether there is infringement of claims 1, 11, and 16 is the structure of bictegravir. The admissibility of evidence establishing bictegravir’s structure was the subject of great debate prior to the summary trial, despite the parties’ general agreement on the actual structure. The Court found Gilead’s BIKTARVY product monograph admissible, so this fact has been established. Therefore, Gilead’s assertions of non-infringement will simply flow from the Court’s construction of Ring A in the three claims at issue.
[22] To the extent ViiV asserts that any aspect of Ring A is non-essential, it bears the burden on this issue (Free World Trust v Électro Santé Inc, 2000 SCC 66 at para 57 [Free World Trust]).
IV. The Experts
A. Gilead’s Experts
(1) Mark Lautens, PhD
[23] Dr. Lautens is a Professor of Chemistry at the University of Toronto. He obtained his PhD in synthetic reactions and metal catalysis from the University of Wisconsin-Madison in 1985, and completed postdoctoral studies in the field of bioactive natural product synthesis at Harvard University between 1985 and 1987.
[24] Dr. Lautens’ areas of research include new and improved chemical reactions for biologically or medicinally interesting compounds, and his laboratory focuses on designing streamlined syntheses for pharmaceuticals. He has published extensively in the field of synthetic chemistry, and acts as a consultant to the pharmaceutical industry.
[25] Dr. Lautens was qualified as an expert in organic chemistry and synthetic organic chemistry, including how to characterize molecules for pharmaceutical applications.
[26] Dr. Lautens was a credible witness. His evidence was clear and direct, and he remained consistent during cross-examination. Dr. Lautens did concede that he is not a medicinal chemist and he was giving his opinion on the claims strictly from the perspective of a synthetic organic chemist. His interpretation of claims 1, 11, and 16 involves a starting position that Ring A as defined in the claims is ambiguous, and therefore he looks to the disclosure to see how the skilled person would understand the claims, based on their common general knowledge [CGK] at the relevant date.
(2) Brent Stranix, PhD
[27] Dr. Stranix is a Medicinal Chemistry Consultant at the Montreal Heart Institute. He obtained his PhD in organic chemistry from McGill University in 1997. Following his PhD, he completed postdoctoral studies at McGill in the field of bio-inorganic chemistry.
[28] Dr. Stranix has worked as a medicinal chemist on drug design and development for over 20 years, with a focus on compounds with anti-HIV activity including inhibitors of the HIV-1 integrase enzyme.
[29] Dr. Stranix was qualified an expert in organic chemistry, medicinal chemistry, and HIV integrase inhibitor drug design and discovery. At trial, Dr. Stranix’s evidence was weakened by challenges to his credibility, and he was evasive on cross-examination.
[30] Gilead did not ask Dr. Stranix to interpret claim language. As further set out below, the key evidence for understanding the scope of the claims in issue is provided by Dr. Lautens, Dr. Winkler, and to the extent Dr. Winkler relied on a medicinal chemist’s knowledge, Dr. Williams.
[31] Further, despite opining on how the skilled person would understand certain aspects of the asserted claims in light of their CGK, Dr. Stranix admitted on cross-examination that “didn't really look at the whole disclosure of the 282 Patent” and he did not consider the definitions of “heterocycle” contained in the disclosure. Dr. Stranix did not opine on matters relating only to biology or virology, as this was outside his expertise.
[32] In light of these admissions, Dr. Stranix’s evidence is of limited value in construing the claims in issue.
B. ViiV’s Experts
(1) Jeffrey D. Winkler, PhD
[33] Dr. Winkler is a Professor of Chemistry at the University of Pennsylvania. He obtained his PhD in chemistry from Columbia University in 1981 and completed postdoctoral studies in the chemistry department at Columbia University between 1981 and 1983.
[34] Dr. Winkler’s research areas include the design and synthesis of both natural and unnatural products with important structural and/or biological properties. Dr. Winkler has published extensively in peer-reviewed scholarly journals, is a named inventor on numerous patents, and acts as a consultant to the pharmaceutical industry.
[35] Dr. Winkler was qualified as an expert in the field of organic chemistry, particularly synthetic organic chemistry.
[36] Dr. Winkler was a credible witness. He answered questions clearly and his evidence was consistent both in chief and during cross-examination. However, Dr. Winkler’s claim construction opinion was weakened by his admission that he used infringement-centric hindsight in construing the claims.
(2) Peter Williams, PhD
[37] Dr. Williams obtained his PhD in organic chemistry from Michigan State University in 1982 and completed postdoctoral studies in total synthesis of natural products at Stanford University between 1982 and 1985.
[38] Dr. Williams worked as a medicinal chemist at Merck from 1985 to 2013. During this time, he worked in drug discovery and was involved in multiple projects aimed at creating new anti-HIV drugs. Dr. Williams is listed as a co-inventor on several issued patents and has authored or co-authored several scientific papers in the area of HIV integrase inhibitors.
[39] Dr. Williams was qualified as an expert in the fields of medicinal chemistry and HIV integrase inhibitor drug design and discovery. Dr. Williams relied on Dr. Winkler’s claim construction in providing his opinion, stating that the medicinal chemist Person of Ordinary Skill in the Art [POSITA] would understand the terms in the same way. Dr. Williams was a credible witness.
(3) Mamuka Kvaratskhelia, PhD
[40] Dr. Kvaratskhelia is a Professor of Medicine in the Infectious Diseases Division at the University of Colorado School of Medicine. He obtained his PhD in Biotechnology and Biochemistry at the Georgian Institute of Agriculture and Biotechnology Center at Moscow State University in 1991.
[41] Dr. Kvaratskhelia’s research focuses on HIV integrase inhibitors, specifically the investigation of the structure and function of HIV integrase as a therapeutic target. He was qualified by the Court as an expert in biochemistry and molecular virology relating to HIV.
[42] Dr. Kvaratskhelia admitted on cross-examination that the claims at issue are not directed towards a skilled biologist or virologist. He stated that he did not consider the meaning of Ring A as defined in claims 1, 11, and 16, and consideration of the types of compounds that fall within the scope of these claims is not within his expertise.
[43] While Dr. Kvaratskhelia gave evidence as to how the claimed compounds work based on the skilled biologist/virologist POSITA’s reading of the Experimental Examples in the 282 Patent, given that Ring A is admitted to be an essential element, his evidence is not relevant to determining the scope of Ring A in claims 1, 11, and 16.
[44] As such, I find that his evidence is of limited weight in respect of the issues on this motion.
V. Claim Construction
[45] The principles of claim construction were recently summarized by the Federal Court of Appeal in Tearlab Corporation v I-Med Pharma Inc, 2019 FCA 179 at paragraphs 30-34:
[30] The general principles of claim construction are now well established and were set out by the Supreme Court in three cases (Whirlpool at paras. 49-55; Free World Trust v. Électro Santé Inc., 2000 SCC 66, [2000] 2 S.C.R. 1024 at paras. 31-67 [Free World Trust]; Consolboard Inc. v. MacMillan Bloedel (Sask.) Ltd., 1981 CanLII 15 (SCC), [1981] 1 S.C.R. 504 at p. 520 [Consolboard]). These principles can be summarized as follows.
[31] The Patent Act promotes adherence to the language of the claims, which in turn promotes fairness and predictability (Free World Trust at paras. 31(a), (b) and 41). The words of the claims must, however, be read in an informed and purposive way (at para. 31(c)), with a mind willing to understand (at para. 44). On a purposive construction, it will be apparent that some elements of the claimed invention are essential while others are non-essential (at para. 31(e)). The interpretative task of the court, in claim construction, is to separate and distinguish between the essential and the non-essential elements, and to give the legal protection to which the holder of a valid patent is entitled only to the essential elements (at para. 15).
[32] To identify these elements, the claim language must be read through the eyes of a POSITA, in light of the latter’s common general knowledge (Free World Trust at paras. 44-45; see also Frac Shack at para. 60; Whirlpool at para. 53). As noted in Free World Trust:
[51] …The words chosen by the inventor will be read in the sense the inventor is presumed to have intended, and in a way that is sympathetic to accomplishment of the inventor’s purpose expressed or implicit in the text of the claims. However, if the inventor has misspoken or otherwise created an unnecessary or troublesome limitation in the claims, it is a self-inflicted wound. The public is entitled to rely on the words used provided the words used are interpreted fairly and knowledgeably. [Emphasis in the original.]
[33] Claim construction requires that the disclosure and the claims be looked at as a whole “to ascertain the nature of the invention and methods of its performance, … being neither benevolent nor harsh, but rather seeking a construction which is reasonable and fair to both patentee and public” (Consolboard at p. 520; see also Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60, [2012] 3 S.C.R. 625 at para. 50). Consideration can thus be given to the patent specifications to understand what was meant by the words in the claims. One must be wary, however, not to use these so as “to enlarge or contract the scope of the claim as written and … understood” (Whirlpool at para. 52; see also Free World Trust at para. 32). The Supreme Court recently emphasized that the focus of the validity analysis will be on the claims; specifications will be relevant where there is ambiguity in the claims (AstraZeneca Canada Inc. v. Apotex Inc., 2017 SCC 36, [2017] 1 S.C.R. 943 at para. 31; see also Ciba at paras. 74-75).
[34] Finally, it is important to stress that claim construction must be the same for the purpose of validity and for the purpose of infringement (Whirlpool at para. 49(b)).
[46] The relevant date for construing the claims is the publication date: November 2, 2006.
[47] Counsel for ViiV acknowledged that Ring A is an essential element of claims 1, 11, and 16. As argued by Gilead, I find that ViiV’s evidence in support of its “variant theory” is irrelevant, based on its admission that Ring A is an essential feature of the asserted claims.
[48] Accordingly, the crux of the claim construction issue is whether Ring A in claims 1, 11, and 16 includes bridged rings, or is limited to spiro and fused rings. ViiV encourages the Court to adopt a broader interpretation, that based on the claims and disclosure of the 282 Patent, Ring A purposively construed includes bridged rings, whereas Gilead puts forward a narrower interpretation of Ring A that excludes bridged rings. Where the parties’ expert evidence diverges, the Court must focus carefully on which interpretation adheres more closely to the established principles of purposive claim construction.
[49] The nub of Gilead’s argument is that the 282 Patent disclosure makes specific reference to spiro and fused Ring A structures, but at no point are bridged bicyclic compounds disclosed, either by name or concept. Therefore, in Gilead’s submission, Ring A as depicted in claims 1, 11, and 16 must be limited to spiro and fused bicyclic structures. The parties cited several cases where the Court either construed claim terms narrowly in accordance with examples disclosed in the patent, or construed claim terms more broadly in accordance with the plain meaning of the term.
[50] In Dableh, Justice Muldoon made recourse to the disclosure of the patent, specifically the preferred embodiment depicted in a diagram, in construing the terms "varying electric current" and "electromagnetic coil." He found that “varying electric current” was not broad enough to embrace an AC current and, therefore, must be limited to a DC current. Similarly, he construed “electromagnetic coil” to be limited to a sturdy, heavy coil akin to the coil the patentee used in his actual device (as summarized by the Court of Appeal in Dableh v Ontario Hydro, (1996) 68 CPR (3d) 129 (FCA) at 144 [Dableh]).
[51] The Federal Court of Appeal reversed, finding that the evidence clearly established that no ambiguity existed in these claim terms. Accordingly, the claim at issue was worded broadly enough to cover an AC source of electricity and coils other than those used by the patentee in his device. In coming to this decision, the Federal Court of Appeal noted the judge had accepted the respondent’s expert evidence, and none of the respondent’s expert witnesses saw any ambiguity in the meaning and scope of the claim terms in question. Therefore, the trial judge erred in construing the meaning of the claim terms by reference to the disclosure, as the terms were not ambiguous (Dableh, above, at 147).
[52] In Whirlpool, the claims at issue used the term “vanes” and the parties disagreed on whether this term encompassed both rigid and flexible vanes, or rigid vanes only. At trial, Justice Cullen concluded that flexible vanes, while not explicitly excluded from the patent, were nevertheless not included. This finding was based on the expert evidence that while flexible vanes for use with unitary action agitation machines were known to the skilled person, “it was out of the question to consider flex vanes on a dual action agitator at the material time” (Whirlpool Corporation v Camco Inc, (1997) 76 CPR (3d) 150 (FCTD) at 195 [Whirlpool FC]).
[53] Dual action agitation was such a new thing that it was considered an entirely different category from unitary action agitation. Justice Cullen concluded that only using hindsight would one interpret the patent at issue as including both rigid and flex vanes. Absent this hindsight analysis, he concluded that the claims only included rigid vanes (Whirlpool FC, above, at 171).
[54] The Supreme Court of Canada ultimately upheld this finding, stating that because none of the experts interpreted the patent as teaching the use of flex vanes, it was open to the trial judge to conclude that the patent specification taught rigid vanes only (Whirlpool, at para 60).
[55] In Bridgeview, the claim term at issue was “manipulator” as used in a patent for a hay bale processor. The expert evidence was that at the relevant time, three types of “manipulators” were known. However, only one of these types of manipulators—“roller” type—was described in the patent disclosure. Justice Campbell accepted expert evidence that the POSITA at the relevant time would have understood “manipulator” to be limited to “roller” type manipulators based on the context of the entire specification (Bridgeview Manufacturing Inc v 931409 Alberta Ltd (Central Alberta Hay Centre), 2009 FC 50 at para 31 [Bridgeview]).
[56] On appeal, the patentee argued that the trial judge used the specification to improperly narrow the scope of the claim. The Federal Court of Appeal rejected this argument, upholding the trial judge’s construction despite the fact that it tended to make a later claim redundant. Claim redundancy by itself was not sufficient to overcome a purposive interpretation of the patent specification (Bridgeview Manufacturing Inc v 931409 Alberta Ltd (Central Alberta Hay Centre), 2010 FCA 188 at para 33).
[57] In ABB Technology, the claims at issue referred to a “moveable switch-contact element.” One controversy that arose was whether this term was limited to a “sliding contact switch” or would be understood to also include a “knife blade switch” (ABB Technology AG v Hyundai Heavy Industries Co, Ltd, 2013 FC 947 at para 37 [ABB Technology]). The patentee’s expert opined that the skilled person would not understand the reference to a “moveable switch-contact element” to include a knife blade switch, based on the “exemplary embodiment” of a sliding contact switch in figures used in the disclosure. Justice Barnes rejected this argument, noting that the figures were merely labelled “exemplary” and a skilled reader could just as easily infer from this language that the claims were not limited, but rather included both types of switches.
[58] The defendant’s expert opined that the phrase “moveable switch-contact element” was a generic term that includes knife switches and sliding contact switches. Justice Barnes accepted this position, and had no difficulty concluding that the claim language “comfortably describes both switch types” (ABB Technology, above, at para 45).
[59] The Federal Court of Appeal affirmed, finding no reason to interfere with Justice Barnes’ finding on the construction issue (ABB Technology AG v Hyundai Heavy Industries Co, Ltd, 2015 FCA 181 at para 57 [ABB Technology FCA]). Justice Stratas noted that the figures relied on by the patentee’s expert were merely referred to as “exemplary,” not even “preferred.”
[60] In dismissing the patentee’s arguments, Justice Stratas concisely summarized Justice Barnes’ finding on the key claim term: “In this case, viewing the words of Claim 1 and the context of those words through the goggles supplied by the experts it preferred, the Federal Court did not find ambiguity in those words. It found that the words, ‘a moveable switch contact element,’ covered both knife blade switches and sliding contact switches” (ABB Technology FCA, above, at para 51).
[61] In Bombardier, the claim term at issue was “engine cradle” and the dispute between the parties was whether the engine cradle as claimed required solid walls, or could be an open structure. At trial, Justice Roy construed “engine cradle” to be limited to walled engine cradles, finding there was no evidence to the contrary (Bombardier Recreational Products Inc v Arctic Cat Inc, 2017 FC 207 at para 347). Based on his reading of the patent, he found there was simply no embodiment where walls were eliminated from the engine cradle, and the evidence appeared clear that the inventors meant for their invention to have a walled engine cradle in which the engine could be disposed.
[62] The Federal Court of Appeal reversed, finding that on the proper evidence of the POSITA’s CGK and how they would understand the claim term “engine cradle,” the only conclusion available to the trial judge was that the term would refer to any rigid structure which acts as a receptacle or compartment to receive the engine. Accordingly, the “engine cradle” could be a structure with solid walls, or alternatively an open structure (Bombardier Recreational Products Inc v Arctic Cat, Inc, 2018 FCA 172 at para 34 [Bombardier FCA]).
[63] Justice Gauthier for the Federal Court of Appeal noted that the trial judge appeared to accept expert evidence that the “cradle could be a structure delimited by solid walls, or alternatively an open structure” but nevertheless went on to limit the claim term to walled structures only (Bombardier FCA, above, at para 38). Justice Gauthier found that the trial judge put undue weight on figures included in the preferred embodiments section, ultimately relying on the figures over expert evidence to the contrary. Further, there was no definition in the patent that limited the ordinary meaning of “engine cradle” and the disclosure made clear that the preferred embodiments did not exhaust the claimed invention (Bombardier FCA at para 43).
[64] Ultimately, Justice Gauthier concluded that on a proper construction of the claims, read in the context of the disclosure, informed by the evidence of the CGK of the POSITA, the engine cradle was not limited to a variety that included walls (Bombardier FCA at para 57).
[65] As evidenced by these examples, in some circumstances the proper construction will limit a claim term to specific embodiments disclosed in the patent specification. In other cases, the basic principle that the description of the preferred embodiments is not meant to include all the possible embodiments of the invention claimed will govern (Bombardier FCA at para 54).
[66] The common thread in all of these cases is that the court is to construe the claims through the eyes of the POSITA in light of their CGK at the relevant date. Apart from the patent specification, the only evidence the Court should consider to inform its analysis of the claims is evidence of how the POSITA would understand the claims in light of his or her relevant CGK in the context of the specification as a whole (Bombardier FCA at para 24).
[67] The sole issue in this case boils down to whether the POSITA, in reading the claims and disclosure in light of their CGK at the relevant time, would have understood Ring A, as an “optionally substituted heterocycle,” to include bridged bicyclic rings.
[68] One distinguishing factor between this case and all of the above cited cases, is that here we are dealing with a chemical patent. All of the contentious claim terms above arose in the context of mechanical patents. The construction exercise in the present case is not as simple as considering two or three known types of a mechanical component. The main contentious claim term here is “heterocycle” but the list of so-called variants that the parties are concerned about are fused, spiro, and bridged bicyclic ring structures. Before considering the parties’ arguments on bridged bicyclic structures, the Court must consider whether, in the context of the invention of compounds with HIV integrase inhibitory activity, the POSITA would understand the term “heterocycle” to refer to bicyclic or polycyclic Ring A structures.
[69] Gilead submits that the focus in construing the claims should be on what the patentee actually invented, and Bridgeview and Whirlpool support its position that the claims at issue should be construed to encompass only spiro and fused rings as disclosed in the 282 Patent.
[70] Conversely, ViiV submits that the claim terms are unambiguous, and in any event, the disclosure is not to be used to expand or contract the scope of the claims.
A. Person of Ordinary Skill in the Art [POSITA]
[71] The experts generally agreed that the 282 Patent is directed towards a team of scientists including a synthetic organic chemist, a medicinal chemist, and a biologist/virologist. The POSITA team would have knowledge of HIV, HIV integrase, and HIV integrase inhibitors.
[72] Dr. Winkler and Dr. Lautens agree that the chemistry-related aspects of the patent are directed towards someone with a PhD in organic chemistry or synthetic organic chemistry, and one to three years of practical laboratory experience. Alternatively, the chemist could have a Master’s degree in organic chemistry or synthetic organic chemistry with commensurate additional practical experience in synthetic organic chemistry. The POSITA would have experience synthesizing and characterizing organic compounds, and would be familiar with common chemistry nomenclature.
[73] The medicinal chemist POSITA would preferably have a PhD in organic chemistry and several years of industry experience in HIV integrase drug discovery. Alternatively, the medicinal chemist POSITA could have a Bachelor of Science degree and proportionally more industry experience.
[74] Claims 1, 11 and 16 all relate to classes of chemical compounds and their structures; chemistry matters within both Dr. Winkler and Dr. Lautens’ expertise as of November 2006.
[75] Dr. Williams and Dr. Stranix have the education and experience of the medicinal chemist POSITA, and would have understood the medicinal chemistry aspects of the 282 Patent as of November 2006. They provided their opinions from this perspective.
[76] While Dr. Kvaratskhelia provided his opinion from the perspective of the virologist POSITA, as stated above, I find that his evidence is of very limited value and not helpful in construing the scope of Ring A in claims 1, 11, and 16.
[77] Further to this point, ViiV’s criticism that Gilead did not provide evidence from a biologist or virologist despite its own definition of the POSITA is misguided, given that the sole issue on this motion is the construction of Ring A in claims 1, 11, and 16. ViiV’s position is that by limiting its expert evidence to that of an organic chemist and a medicinal chemist, Gilead has only provided a partial interpretation of the patent, leaving the Court with an incomplete view.
[78] To support this position, ViiV relies on Justice Barnes’ comments in Janssen Inc v Teva Canada Limited, 2015 FC 184 at paragraphs 92-93 and Justice Locke’s comments in Teva Canada Limited v Janssen Inc, 2018 FC 754 at paragraph 236. In both cases, the parties disagreed on the characteristics of the skilled person. In resolving the issue, Justice Barnes held that in order to construe the claims, the notional skilled person must be capable of understanding the entirety of the patent in issue. Similarly, Justice Locke held that the skilled person is not defined claim-by-claim, and there cannot be different skilled persons for different claims.
[79] I agree with these findings related to the POSITA, however they do not apply in this case. The parties agree on the composition of the POSITA team. Where, as in this case, the sole construction issue is outside the expertise of certain members of the skilled team, a party cannot be faulted for failing to lead evidence from the perspective of those members. Dr. Kvaratskhelia acknowledged that claims 1, 11, and 16 are not directed to a skilled biologist or virologist, and the scope of these claims is not within his expertise. Evidence from additional virologists would not have helped the Court.
B. Common General Knowledge [CGK]
[80] The only CGK relevant for determining the scope of Ring A as set out in claims 1, 11 and 16 is that of the organic chemist and the medicinal chemist POSITA, as part of the composite POSITA, at the relevant date. Dr. Lautens’ chemistry primer, as annotated by Dr. Winkler where relevant, provides the necessary chemistry CGK for the POSITA to interpret the claims.
[81] The POSITA would have understood that a heterocycle is a cyclic structure that includes one or more non-carbon atoms, also known as heteroatoms, as part of the ring. Heterocycles can be of any ring size, and can vary in terms of the number, type, and position of heteroatoms.
[82] The POSITA would have further understood that hydrogen atoms can be replaced by non-hydrogen atoms or molecular groups, and that in such circumstances the replacing atom or group would be called a substituent or a substitution.
[83] Rings can be joined together to form bicyclic or polycyclic ring structures, and there are only three ways in which rings can be joined. The POSITA would have known that the three categories of bicyclic compounds are spiro, fused, and bridged:
[84] As seen in the above image, the two rings in the spiro structure share a single atom. In the fused system, the two rings share two adjacent atoms, and in the bridged system, the rings share two non-adjacent atoms.
[85] In addition to the knowledge of general chemistry set out in Dr. Lautens’ chemistry primer, the POSITA team would have been monitoring the development of HIV integrase inhibitors, and would have been aware of publications and other public documents.
[86] In light of monitoring the development of HIV integrase inhibitors, the POSITA team would have been aware that several “integrase strand transfer inhibitors” [INSTIs] had been reported and three such compounds had reached clinical trials. The pharmacophore—the portion of the molecular structure that binds to the biological target—of many of these compounds was understood to have two common elements: a triad of electronegative atoms (O/O/N or O/O/O), and a hydrophobic group, which was often a fluorobenzyl or similar group.
[87] As submitted by Gilead, while members of the skilled team would have knowledge of the HIV integrase enzyme and its inhibitors, knowledge of HIV integrase inhibitors does not necessarily assist in determining the scope of Ring A of the compound claims at issue. In fact, Dr. Stranix—Gilead’s medicinal chemistry expert—opines that the skilled person with knowledge of HIV integrase would be in no better position than an organic chemist without such background to review the claims and disclosure to determine the meaning of Ring A. Similarly, Dr. Williams—ViiV’s medicinal chemistry expert—opines that the medicinal chemistry POSITA would have understood the claim terms in the same way that an organic chemist would have at the relevant date of November 2, 2006.
C. Scope of the Claims in Issue
(1) Ring A
[88] In the structures shown in the 282 Patent, Ring A is depicted as the rightmost ring defined by the curved line or semicircular arc. The arc shape can be used for structural formulas to imply a ring without defining any other parameters such as ring size, bond characteristics, and the presence, number, type, or position of additional heteroatoms. As depicted throughout the patent, Ring A shares a nitrogen atom with the middle ring and is therefore by definition a heterocycle. The structure depicted in claim 1 is exemplary:
[89] Ring A is included as an element of each of claims 1, 11, and 16. The specific claim language for each individual claim will be detailed below.
[90] While the arc appears to only depict a single ring in the structure, the parties’ experts agree that the POSITA, based on their CGK, would understand that additional rings are possible beyond a monocyclic Ring A. Reading the patent as a whole, the POSITA would see written references to tricylic and tetracylic compounds, and chemical structures of tricyclic, tetracyclic, and pentacyclic compounds, indicating that one or two additional rings are possible beyond the tricyclic core as depicted in the structures in the claims.
[91] As highlighted by ViiV, and relied on by Dr. Winkler, one such reference to tetracyclic compounds is found in the abstract. However, the abstract must not be taken into account for the purpose of interpreting the scope of protection sought or obtained (Patent Rules, SOR/2019-251, s 55(8); Laboratoires Servier v Apotex Inc, 2009 FCA 222 at para 105 [Laboratoires Servier]).
[92] In closing arguments, ViiV suggested this is not a hard and fast rule, as the Supreme Court of Canada has previously held that the disclosure of a patent includes the abstract (Monsanto Canada Inc v Schmeiser, 2004 SCC 34 at para 18). The Federal Court of Appeal has previously rejected this argument in the context of using the abstract to ascertain the promise of the patent under the now defunct Promise Doctrine (Laboratoires Servier, above, at para 104). I reject th