Gilead Sciences, Inc. v. Canada (Health)

Gilead Sciences, Inc. v. Canada (Health)
Court (s) Database
Federal Court Decisions
Date
2016-08-19
Neutral citation
2016 FC 856
File numbers
T-1693-14
Decision Content
Date: 20160819
Docket: T-1693-14
Citation: 2016 FC 856
Ottawa, Ontario, August 19, 2016
PRESENT: The Honourable Mr. Justice Brown
BETWEEN:
GILEAD SCIENCES, INC. AND
GILEAD SCIENCES CANADA, INC.
Applicants
and
THE MINISTER OF HEALTH AND
APOTEX INC.
Respondents
PUBLIC JUDGMENT AND REASONS
(Confidential Judgment and Reasons released July 21, 2016)
I. Nature of the Matter [1] This was originally an application for an order pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/1993-133 as amended, SOR/1998-166, SOR/1999-379, SOR/2006-242 (PM(NOC) Regulations) prohibiting the Minister of Health from issuing a Notice of Compliance (NOC) in respect of a Notice of Allegation (NOA) sent by Apotex Inc. (Apotex or the Respondent) to Gilead Sciences Canada, Inc. (Gilead or the Applicant) dated June 19, 2014 in respect of three (3) Canadian Patents: Nos 2,261,619 (619 Patent), 2,298,059 (059 Patent) and 2,512,475 (475 Patent) and tablets for oral administration containing the active pharmaceutical ingredient for the prodrug tenofovir disoproxil fumarate (TDF, marketed as VIREAD®), and the active pharmaceutical ingredient FTC (marketed as EMTRIVA® and earlier as Coviracil, or as the generic emtricitabine).
[2] The combination drug TRUVADA® is comprised of (300 mg) of TDF (VIREAD®), which is the medicine patented by the 619 Patent, and (200 mg) FTC (EMTRIVA®). TDF and FTC separately, and in the 475 Patent combination drug, are nucleoside reverse transcriptase inhibitors (NRTIs), which are useful in the treatment of human immunodeficiency virus (HIV). The combination drug covered by the 475 Patent has achieved a considerable degree of success and has become widely prescribed for the treatment of HIV.
[3] For the following reasons, only the 475 Patent is now in issue.
[4] Justice Barnes struck out Gilead’s Notice of Application regarding the validity of the 059 Patent by Order dated May 8, 2015 (Gilead Sciences, Inc v Canada (Health), 2015 FC 610), pursuant to s. 6(5)(a) of the PM(NOC) Regulations, on the basis that this patent for the particular fumarate salt used with TD had already been found invalid for obviousness in another proceeding, Gilead Sciences, Inc v Teva Canada Limited, 2013 FC 1272, and the litigation in this proceeding consisted in an abuse of process by Gilead. I will not refer further to the 059 Patent.
[5] Justice Heneghan found the 619 Patent ineligible for listing on the Patent Registry, and therefore ineligible for NOC proceedings in Gilead Sciences, Inc v Canada (Health), 2016 FC 231. As a result the 619 Patent was also struck from this proceeding. The Federal Court of Appeal dismissed an appeal from that decision: Gilead Sciences, Inc v Apotex Inc, 2016 FCA 140. The parties subsequently advised the Court that this decision of the Federal Court of Appeal means that only Apotex’s allegations regarding the 475 patent need to be adjudicated in this proceeding. Further they agreed that the Federal Court of Appeal decision has no impact on the decision I am to make in the companion Court file T-1694-14 concerning the 619 Patent, referred to in the following paragraph.
[6] Also by way of background, there is a companion case to the one at bar, namely T-1694-14, which concerns the validity of the 619 Patent for the drug TDF, i.e., VIREAD®, which I heard at the same sittings and which is decided contemporaneously with the case at bar. The companion case concerns a different but related application for prohibition brought by Gilead in respect of a Notice of Allegation sent by Apotex to Gilead (also dated June 19, 2014) in respect of the 619 Patent, the 059 Patent (in respect of which claims were struck by Barnes J: Gilead Sciences, Inc v Canada (Health), 2015 FC 610), and tablets for oral administration containing TDF (300 mg).
[7] The parties agree my decision in T-1694-14 regarding the 619 Patent will apply in relevant parts to this decision concerning the 475 Patent. The allegations and evidence regarding the 619 Patent are identical in both court files. The 619 Patent issues concern validity, and are examined on the merits in the companion case.
[8] I am granting Gilead’s application for prohibition in the companion NOC case T-1694-14 concerning the 619 Patent, having concluded that Gilead successfully established on a balance of probabilities that Apotex's allegations of invalidity are not justified. However, Gilead’s application for prohibition in the present case concerning the 475 Patent is dismissed for the reasons that follow.
[9] Because of a Protective Order dated January 22, 2016, I am issuing these confidential reasons which will become public after necessary redactions as discussed later.
II. Facts A. 475 Patent Claims [10] The 475 Patent relates to the use of combinations of TDF and FTC, in a pharmaceutical composition or formulation, for the treatment of HIV infections.
[11] In the 475 Patent, the five asserted claims state:
15. A pharmaceutical formulation comprising [2-(6-amino-purin-9-yl)-1-methyl-ethoxymethyl]-phosphonic acid diisopropoxycarbonyloxymethyl ester fumarate, hereafter called tenofovir disoproxil fumarate, and (2R, 5S, cis)-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)pyrimidin-2-one, hereinafter called emtricitabine.
16. The pharmaceutical formulation according to claim 15, further comprising one or more pharmaceutically acceptable carriers or excipients.
(…)
24. The pharmaceutical formulation according to claim 15, wherein tenofovir disoproxil fumarate and emtricitabine are present in a ratio of about 300:200 by weight.
25. The pharmaceutical formulation according to claim 24, comprising about 300 mg of tenofovir disoproxil fumarate and about 200 mg of emtricitabine.
(…)
28. The pharmaceutical formulation according to claim 15, suitable for administration once per day to an infected human.
[12] The Summary of the Invention at page 3 of the 475 Patent states:
The present invention provides combinations of antiviral compounds, in particular compositions and methods for inhibition of HIV. In an exemplary aspect, the invention includes a composition including tenofovir disoproxil fumarate and emtricitabine which has anti-HIV activity. The composition of tenofovir DF and emtricitabine is both chemically stable and either synergistic and/or reduces the side effects of one or both of tenofovir DF and emtricitabine. Increased patient compliance is likely in view of the lower pill burden and simplified dosing schedule.
The present invention relates to therapeutic combinations of [2-( 6-amino-purin-9-yl)-l-methyl-ethoxymethyl]-phosphonic acid diisopropoxycarbonyloxymethyl ester fumarate (tenofovir disoproxil fumarate, tenofovir DF, TDF, Viread®) and (2R, 5S, cis)-4-amino-5-fluoro-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(lH)-pyrimidin-2-one (emtricitabine, Emtriva™, (-)-cis FTC) and their use in the treatment of HIV infections including infections with HIV mutants bearing resistance to nucleoside and/or nonnucleoside inhibitors. The present invention is also concerned with pharmaceutical compositions and formulations of said combinations of tenofovir disoproxil fumarate and emtricitabine. Another aspect of the invention is a pharmaceutical formulation comprising a physiologically functional derivative of tenofovir disoproxil fumarate or a physiologically functional derivative of emtricitabine.
B. Witnesses (1) Experts (a) Gilead (i) Dr. Angela D.M. Kashuba [13] Dr. Kashuba is a Clinical Pharmacologist and Diplomate of the American Board of Clinical Pharmacology. Dr. Kashuba is also a Professor and Vice-Chair for Research and Graduate Education in the Eshelman School of Pharmacy at the University of North Carolina at Chapel Hill. Dr. Kashuba further is an adjunct professor of medicine at the UNC School of Medicine. Dr. Kashuba has developed an internationally recognized HIV clinical pharmacology program at UNC since joining in 1997, and has published extensively on HIV pharmacology.
[14] Apotex has challenged part of the evidence provided by Dr. Kashuba, including her opinion on chemical stability, pharmaceutical formulations, or in treatment of diseases, because of her lack of expertise in pharmaceutics and the stated fields. I agree with Apotex and accept Dr. Kashuba’s evidence only insofar as she is qualified to provide it and it lies within her field of expertise, clinical pharmacology.
(b) Apotex (i) Dr. Charles William Flexner [15] Dr. Flexner is and has been a medical doctor since 1982, specializing in clinical pharmacology and virology. Dr. Flexner is currently a Professor of Medicine (Clinical Pharmacology and Infectious Diseases) and Professor of Pharmacology and Molecular Sciences at the Johns Hopkins University School of Medicine. In addition to his teaching task, Dr. Flexner serves in various administrative roles at The Johns Hopkins University. Dr. Flexner has experience in the clinical development of new drugs for treating HIV, among other diseases, and has been an investigator for clinical trials employing many of the antiretroviral drugs currently on the market, including emtricitabine (EMTRIVA®) and tenofovir disoproxil fumarate (VIREAD®).
(ii) Professor Arthur H. Kibbe [16] Prof. Kibbe is a Professor of Pharmaceutical Sciences at the Wilkes University School of Pharmacy, Wilkes University, as well as the past Chair of the Department of Pharmaceutical Sciences in the School of Pharmacy. Prof. Kibbe has an extensive career in pharmaceutics, including in academia, industry and government. For example, Prof. Kibbe taught courses on formulation design and development, pharmacokinetics, and continuing education for pharmacists. Prof. Kibbe also chaired a special panel appointed by the Commissioner of the FDA to investigate the generic drug approval process. Prof. Kibbe’s career has focussed on pharmaceutical formulation development, pharmacokinetics, and the pharmaceutical testing, regulatory and approval processes.
(2) Fact Witnesses [17] Gilead presented affidavits from fact witnesses to provide context for the invention of TRUVADA®. The witnesses include: Dr. Michael Miller, current Senior Director of Clinical Virology, and from 2000 to 2003 the Director of Clinical Virology at Gilead; and Dr. Reza Oliyai, currently Vice-President of Product Development and Clinical Supplies, and Research Scientist from 1994 to 2004 at Gilead.
[18] Gilead acquired Triangle Pharmaceuticals (Triangle) in 2003. The evidence shows that the acquisition was entered into in large part with a view to allow the combined entity to market a combination drug that would consist of TDF, in respect of which Gilead had rights, and FTC, in respect of which Triangle had rights. Specifically, Triangle had the rights to FTC, through patent protection at one time. Gilead for its part had rights to TDF or bis(POC)PMPA, a prodrug protected by the 619 Patent.
[19] Both Triangle’s FTC and Gilead’s TDF were known to a lesser and greater extent respectively to have potential for, or to be effective as treatments for, HIV; TDF was specifically marketed for that purpose, while FTC was known to be in clinical trials for the same purpose. Both drugs are nucleoside reverse transcriptase inhibitors (NRTIs), which are compounds known to be useful in the treatment of HIV.
[20] Triangle scientists, in the months leading up to its acquisition by Gilead, prepared an internal document [“Triangle Report”] [………………………………………………………… ……………………………………………..Redacted……………………………………………………..]. Triangle provided the Triangle Report to Gilead prior to the acquisition. The Triangle Report was not made public.
[21] At the relevant time, the treatment of HIV was known to lead to resistance in mono-therapies, namely treatment regimens requiring patients to take one or, in the case of those suffering from HIV, multiple drug pills throughout the day. There was motivation for the creation of a less onerous pill-count combination therapy, such as the proposed once-daily therapy in the 475 Patent, to improve long-term viability of treatment.
III. Issues [22] By not alleging non-infringement of claims 5, 16, 24, 25 and 28, Apotex concedes that the Apotex Product infringes these claims. The parties agree that infringement is not in play, as I understand them.
[23] In my view, the issues are:
A. Whether Apotex has discharged its relatively low burden in connection with its allegations of invalidity concerning the 475 Patent relating to claims 15, 16, 24, 25 and 28 on the grounds of:
i. Anticipation, if the combination drug was disclosed in a press release or at a press conference before the relevant date;
ii. Obviousness, if the combination drug of TDF and FTC was obvious, or obvious to try, as discussed in Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61.
iii. Lack of sound prediction of or demonstrated utility as measured against the promise of the 475 Patent.
B. If any of the grounds raised by Apotex are given an air of reality, then the issue is whether Gilead has discharged its burden to establish on a balance of probabilities that such allegations are not justified.
[24] In my view, Gilead has not established on a balance of probabilities that Apotex’s allegations of anticipation and obviousness are not justified, but met its burden re demonstrated utility and sound prediction. Therefore this application must be and is dismissed.
IV. Statutory Provisions [25] The Patent Act, R.S.C., 1985, c. P-4 [Patent Act], provides at section 2 that to be patented an invention must be new and useful:
invention means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter; (invention)
invention Toute réalisation, tout procédé, toute machine, fabrication ou composition de matières, ainsi que tout perfectionnement de l’un d’eux, présentant le caractère de la nouveauté et de l’utilité. (invention)
[emphasis added]
[non souligné dans l’original]
[26] The Patent Act, provides at section 28.2 that the subject-matter defined by a claim in an application for a patent in Canada (the “pending application”) must not have been disclosed:
28.2 (1) The subject-matter defined by a claim in an application for a patent in Canada (the “pending application”) must not have been disclosed
28.2 (1) L’objet que définit la revendication d’une demande de brevet ne doit pas :
(a) more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant, in such a manner that the subject-matter became available to the public in Canada or elsewhere;
a) plus d’un an avant la date de dépôt de celle-ci, avoir fait, de la part du demandeur ou d’un tiers ayant obtenu de lui l’information à cet égard de façon directe ou autrement, l’objet d’une communication qui l’a rendu accessible au public au Canada ou ailleurs;
(b) before the claim date by a person not mentioned in paragraph (a) in such a manner that the subject-matter became available to the public in Canada or elsewhere;
b) avant la date de la revendication, avoir fait, de la part d’une autre personne, l’objet d’une communication qui l’a rendu accessible au public au Canada ou ailleurs;
(c) in an application for a patent that is filed in Canada by a person other than the applicant, and has a filing date that is before the claim date; or
c) avoir été divulgué dans une demande de brevet qui a été déposée au Canada par une personne autre que le demandeur et dont la date de dépôt est antérieure à la date de la revendication de la demande visée à l’alinéa (1)a)
[emphasis added]
[non souligné dans l’original]
[27] The Patent Act provides at section 28.3 that the subject-matter defined by a claim in an application for a patent in Canada must be subject-matter that would not have been obvious:
28.3 The subject-matter defined by a claim in an application for a patent in Canada must be subject-matter that would not have been obvious on the claim date to a person skilled in the art or science to which it pertains, having regard to
28.3 L’objet que définit la revendication d’une demande de brevet ne doit pas, à la date de la revendication, être évident pour une personne versée dans l’art ou la science dont relève l’objet, eu égard à toute communication :
(a) information disclosed more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant in such a manner that the information became available to the public in Canada or elsewhere; and
a) qui a été faite, plus d’un an avant la date de dépôt de la demande, par le demandeur ou un tiers ayant obtenu de lui l’information à cet égard de façon directe ou autrement, de manière telle qu’elle est devenue accessible au public au Canada ou ailleurs;
(b) information disclosed before the claim date by a person not mentioned in paragraph (a) in such a manner that the information became available to the public in Canada or elsewhere.
b) qui a été faite par toute autre personne avant la date de la revendication de manière telle qu’elle est devenue accessible au public au Canada ou ailleurs.
[emphasis added]
[non souligné dans l’original]
V. Analysis A. Preliminary Issues (1) Relevant Dates [28] Throughout these reasons, I note the relevant dates for the assessment of the justifiability of the various allegations of invalidity are:
i. Patent Construction – Publication Date: August 5, 2004
ii. Anticipation/Novelty: One year before Canadian Filing Date (January 13, 2004) – January 13, 2003
iii. Obviousness (State of the Art): Claim Date (Priority Date) – January 14, 2003
iv. Utility: Canadian Filing Date – January 13, 2004
[29] These relevant dates are agreed to by the parties.
(2) Expert Blinding [30] I make the same comments in this case as I make in the companion case T-1694-14, but for convenience repeat my analysis here.
[31] The parties chose different methods of gathering information from their experts for their respective opinion affidavits. While counsel for Gilead provided the legal framework to its experts early, including legal tests for anticipation, obviousness, and utility, Apotex states it did not do so before the experts had drawn their own conclusions on issues such as the promise of the patent, claim construction and the prior art.
[32] Apotex submits expert blinding has been recognized by this Court as a preferred method of gathering expert evidence and refers to: AstraZeneca Canada Inc v Apotex Inc, 2014 FC 638, per Rennie J, at para 321; Teva Canada Innovation v Apotex Inc, 2014 FC 1070, per Gleason J (as she then was), at paras 94-96; Takeda Canada Inc. v Canada (Health), 2015 FC 570, per O’Reilly J, at paras 27, 29; Allergan Inc v Apotex Inc, 2016 FC 344, per Zinn J, at para 13. For this reason, it asks the Court to assess greater weight to the opinions of its experts when addressing these issues and conclusions by the expert witnesses. In my view the blinding of a witness may be a factor, one of perhaps several, that goes to credibility and weight, but it is not a matter that goes to admissibility.
[33] Gilead, as a counter to Apotex’s allegations that Gilead’s expert evidence should be given less weight because experts were not blinded, argues that Apotex’s experts for the most part did not conduct their own research to determine the prior art, which I find was substantially the case. Instead, the Apotex experts were provided with all or virtually all of the material relevant to their opinions on prior art and skilled person in the art by counsel for Apotex. Gilead submits this diminishes the weight I should give to Apotex’s expert evidence, essentially because Apotex witnesses are not stating what the state of the prior art or skilled person was, but were in effect simply opining on what Apotex’s counsel told them was the state of the prior art and knowledge of the skilled person.
[34] The Court has to weigh the evidence before it. On the blinding issue, I agree with Justice Gleason (as she then was) in Eli Lilly Canada Inc v Apotex Inc, 2015 FC 875 at para 166:
[166] Insofar as concerns the allegation regarding lack of “blinding”, Apotex has tried to apply the decisions in Teva and AstraZeneca out of context. There, the experts whose credibility was found to be wanting based their construction of the patents in suit with a view to infringement and were able to come to their opinions based on the information in the generic company’s NOA. In Teva, this led to an especially tortured construction. In Teva and AstraZeneca, the approach taken was found to undercut the experts’ credibility as it led to an improper results-oriented opinion. Neither case can be read for the position that Apotex sought to advance here, namely, that in any case where one party blinds its experts but the other does not, the former’s evidence is to be preferred. Rather, these two decisions must be limited to the facts that arose in these cases.
And see to the same effect the approach taken by Justice Locke in Shire Canada Inc v Apotex Inc, 2016 FC 382 at paras 42-48.
[35] More generally the weighing of expert evidence is a question of fact. Having reviewed the law, and as counsel for Apotex candidly noted at the hearing, I have concluded that the blinding issue is a question of relevance, reliability and weight, and is not a doctrinal matter.
[36] For reasons set out, I prefer some experts’ evidence on certain issues, and other experts’ evidence on other matters, taking into account the arguments raised by both parties and assessing the appropriate weight to be given to the expert testimony.
(3) Claim Construction (a) Person Skilled in the Art [37] Claim construction is a question of law to be determined by the Court. Where the meaning of terms or elements of claims are not apparent from a reading of the claim itself or from reference to the specification, the experts may provide guidance on this matter. The claims are to be construed, as they would be read by a Person of Ordinary Skill in the Art (“Skilled Person”), at the relevant date, looking to the patent with a view to understand.
[38] A patent is addressed to this notional Skilled Person, who is “unimaginative and uninventive, but at the same time is understood to have an ordinary level of competence and knowledge incidental to the field to which the patent relates and to be reasonably diligent in keeping up with advances”: AstraZeneca Canada Inc v Apotex Inc, 2014 FC 638 at para 51 (citing Merck & Co v Pharmascience Inc, 2010 FC 510 at paras 34-40), aff’d 2015 FCA 158. The “unimaginative and uninventive” language is found in Beloit Canada Ltd v Valmet OY (1986), 8 C.P.R. (3d) 289 (F.C.A.) [Beloit], where the Federal Court of Appeal refers to the “unimaginative skilled technician”, and Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 at para 81, where the Supreme Court refers to inventiveness as foreign to the Skilled Person in the obviousness analysis. In my view, the Federal Court retained these concepts in its interpretation of the skilled technician in patent law: AstraZeneca Canada Inc v Apotex Inc, 2014 FC 638 at para 51 (Rennie, J as he then was) (citing Merck & Co v Pharmascience Inc, 2010 FC 510 at paras 34-40 (Hughes, J)), aff’d 2015 FCA 158 (Dawson, J.A.).
[39] The parties disagree on the abilities of the Skilled Person in relation to the 475 Patent. The 475 Patent relates to the use of combinations of TDF and FTC, in a pharmaceutical composition or formulation, for the treatment of HIV infections.
[40] In my view, the Skilled Person has education, knowledge and training in the areas of pharmaceutical formulations, treatment and prevention of HIV infection and its symptoms, and the pharmacology of antiretroviral drug therapies. The Skilled Person does not need to have clinical experience to understand the 475 Patent, though this experience would be helpful. I make this finding because the 475 Patent is for a chemically stable combination therapy useful in the treatment of HIV. These properties could only be fully assessed and understood by a person skilled in both pharmaceutical formulations (stability) and pharmacology (useful in the treatment of HIV).
(b) Claim Construction [41] Justice Kane in Alcon Canada Inc v Apotex Inc, 2014 FC 699 cited Justice Hughes on principles of claim construction:
[121] Justice Hughes provided a useful summary of the relevant principles following a review of all the jurisprudence in Pfizer Canada Inc v Pharmascience Inc, 2013 FC 120, [2013] FCJ No 111:
[64] There have been many judicial instructions as to the construction of a claim. To summarize:
• construction must be done before considering the issues of validity and infringement;
• construction is done by the Court alone, as a matter of law;
• the Court is to construe the claim through the eyes of the person skilled in the art to which the patent pertains;
• the Court may obtain the assistance of experts to explain the meaning of particular words and phrases, and as to the state of the art as of the date the claim was published;
• the Court should read the claim in the context of the patent as a whole, including the description and other claims;
• the Court should avoid importing this or that gloss from the description;
• the Court should not restrict the claim to specific examples in the patent;
• the Court should endeavour to interpret the claim in a way that gives effect to the intention of the inventor;
• the Court should endeavour to support a meritorious invention.
[42] Given I am only to consider the five asserted claims, and considering the whole of the 475 Patent, I construe the claims as comprising of a pharmaceutical formulation of FTC and TDF (Claim 15), with appropriate excipients and carriers (Claim 16), in a ratio of 200:300 by weight (Claim 24), or more specifically in formulations of 200 mg and 300 mg by weight (Claim 25), to be administered once daily to a human infected with HIV (Claim 28).
(4) Admission of Press Release and Conference Call Transcript [43] The parties disagreed on the admissibility of certain documents put forward by Apotex in its argument of invalidity on the ground of anticipation. In summary, the documents are what are alleged to be public reports relating to the merger between Gilead and Triangle, including a purported press release by Gilead dated December 4, 2002 (Press Release), and a purported transcript of a Conference Call taking the form of a Press Conference held by Gilead on December 4, 2002 (Conference Call Transcript or CCT).
[44] Also disputed were various newspaper articles and news reports covering these events dated between December 4, 2002 and January 2003. Apotex does not ask the Court to admit the newspaper articles and other news reports appended to its NOA. It asks the Court to look to those as support for the fact that the Conference Call was held on December 4, 2002. I accept the newspaper articles on this basis.
[45] The documents most relevant to this proceeding are the purported Press Release and the purported Conference Call Transcript. The alleged Press Release mentions a Conference Call to be held on December 4, 2002, and that a recording of it would be available for the public until December 7, 2002. The Press Release purports to be issued by Gilead and available on its website. It names as contact the Gilead Public Affairs Department and lists Susan Hubbard as a contact person for investors or Amy Flood for media. There is also a quote included by John C. Martin, President and CEO of Gilead then, and who remains on the Gilead executive.
[46] The Press Release was submitted as an attachment to Apotex’s NOA; it was also presented to Gilead’s witness, Dr. Miller, in his cross-examination. Apotex did not introduce the Press Release by affidavit, and was frustrated by Gilead’s counsel in its efforts to introduce it through oral testimony of Gilead’s Dr. Miller for reasons I shall come to shortly. The Press Release was not authenticated or introduced into evidence by anyone associated with its preparation, albeit for reasons outlined later, through no fault of Apotex whatsoever. Nor was there any oral or affidavit evidence that its contents were true.
[47] The Conference Call Transcript purports to have been prepared by CCBN, Inc., and to be found on a website of LexisNexis. On its face the Conference Call Transcript contains the following dates, which the parties flagged: “Copyright 2002 FDCHeMedia, Inc.”, “Copyright 2002 CCBN, Inc.”, and “LOAD DATE: January 18, 2003”. The Conference Call Transcript purports to have been transcribed from the Conference Call itself; the Conference Call allegedly took place on December 4, 2002. Arguably, if the contents of the Conference Call Transcript are admitted for the truth of what was said in such a proceeding, these dates are only relevant in my assessment of the test for anticipation, where the invention must be disclosed in a single disclosure earlier than one year before the Canadian Filing date.
[48] The Conference Call Transcript names the following as present for the Conference Call: John C. Martin (President and CEO, Gilead Sciences); John F. Milligan (Senior Vice-President and Chief Financial Officer, Gilead Sciences); Norbert Bischofberger (Executive Vice President, Research and Development, Gilead Sciences); Susan Hubbard (Associate Director of Investor Relations); Mark Perry (Executive Vice President of Operations); Margaret H. Malloy (Analyst); Elise Wang (Analyst, Salomon Smith Barney); Craig Parker (Analyst, Lehman Brothers); Michael King (Analyst, Banc of America Securities); Caroline Copithorne (Analyst, Morgan Stanley); Eric J. Ende (Analyst, Merrill Lynch); John S. Sonnier (Analyst, Prudential); Ben Pat (Analyst, RBC Capital); Jason D. Kantor (Analyst, WR Hambrecht and Co).
[49] Apotex also attached the Conference Call Transcript to its NOA. The Conference Call Transcript was not authenticated or introduced by affidavit or oral testimony of anyone associated with its preparation, nor was the truth of its contents deposed to by anyone associated with its preparation. No one from CCBN, Inc. or LexisNexis was asked to give evidence to support the veracity of the Conference Call Transcript, i.e., that it accurately sets out what was said in the Conference Call by its various alleged participants.
[50] Gilead objects to the reliance on both the Press Release and on the Conference Call Transcript on the ground they both constitute hearsay. There is no doubt both are hearsay. Both are documents introduced not to show that they were made but to establish that what is contained in them is true. The only issue is whether they are admissible into evidence. I will examine each separately.
(a) The Press Release [51] Apotex argues the Press Release is admissible on several grounds. First, the Press Release was written and released by Gilead itself, who could have but did not contest the contents or origins of the Press Release in any way, which should preclude Gilead from now arguing inadmissibility. Second, Dr. Michael Miller, Senior Director of Clinical Virology at Gilead, was served with a Direction to Attend by Apotex instructing him to produce the Press Release. Dr. Miller asked Gilead’s counsel for instructions on required steps to comply with the Direction to Attend. In his cross-examination, Dr. Miller said that Gilead’s counsel instructed him to leave this matter for counsel to address. Neither Dr. Miller nor counsel produced the Press Release as requested in the Direction to Attend. Third, Apotex argues the Press Release is both reliable and necessary, as is required by the jurisprudence setting out exceptions to the hearsay rules: R v Finta, [1994] 1 SCR 701 at 854-855 [Finta]. Fourth, Apotex submits that for anticipation, the Press Release’s contents must not be proven as true, merely that the Press Release was issued and that its contents disclosed the subject-matter of the patented claim.
[52] On the admissibility of the Press Release, of importance is the fact that Gilead’s witness, Dr. Michael Miller, was provided with a Direction to Attend that specifically identified the Press Release as a document he was required to bring to his cross-examination. Contrary to our Rules, neither Dr. Miller nor Gilead provided the Press Release. The rules of this Court governing Directions to Attend (Rules 94 and 97 of the Federal Courts Rules, (SOR/98-106)) state:
94 (1) Subject to subsection (2), a person who is to be examined on an oral examination or the party on whose behalf that person is being examined shall produce for inspection at the examination all documents and other material requested in the direction to attend that are within that person's or party's possession and control, other than any documents for which privilege has been claimed or for which relief from production has been granted under rule 230.
94 (1) Sous réserve du paragraphe (2), la personne soumise à un interrogatoire oral ou la partie pour le compte de laquelle la personne est interrogée produisent pour examen à l’interrogatoire les documents et les éléments matériels demandés dans l’assignation à comparaître qui sont en leur possession, sous leur autorité ou sous leur garde, sauf ceux pour lesquels un privilège de non-divulgation a été revendiqué ou pour lesquels une dispense de production a été accordée par la Cour en vertu de la règle 230.
(2) On motion, the Court may order that a person to be examined or the party on whose behalf that person is being examined be relieved from the requirement to produce for inspection any document or other material requested in a direction to attend, if the Court is of the opinion that the document or other material requested is irrelevant or, by reason of its nature or the number of documents or amount of material requested, it would be unduly onerous to require the person or party to produce it.
(2) La Cour peut, sur requête, ordonner que la personne ou la partie pour le compte de laquelle la personne est interrogée soient dispensées de l’obligation de produire pour examen certains des documents ou éléments matériels demandés dans l’assignation à comparaître, si elle estime que ces documents ou éléments ne sont pas pertinents ou qu’il serait trop onéreux de les produire du fait de leur nombre ou de leur nature.
97 Where a person fails to attend an oral examination or refuses to take an oath, answer a proper question, produce a document or other material required to be produced or comply with an order made under rule 96, the Court may
97 Si une personne ne se présente pas à un interrogatoire oral ou si elle refuse de prêter serment, de répondre à une question légitime, de produire un document ou un élément matériel demandés ou de se conformer à une ordonnance rendue en application de la règle 96, la Cour peut :
(a) order the person to attend or re-attend, as the case may be, at his or her own expense;
a) ordonner à cette personne de subir l’interrogatoire ou un nouvel interrogatoire oral, selon le cas, à ses frais;
(b) order the person to answer a question that was improperly objected to and any proper question arising from the answer;
b) ordonner à cette personne de répondre à toute question à l’égard de laquelle une objection a été jugée injustifiée ainsi qu’à toute question légitime découlant de sa réponse;
(c) strike all or part of the person's evidence, including an affidavit made by the person;
c) ordonner la radiation de tout ou partie de la preuve de cette personne, y compris ses affidavits;
(d) dismiss the proceeding or give judgment by default, as the case may be; or
d) ordonner que l’instance soit rejetée ou rendre jugement par défaut, selon le cas;
(e) order the person or the party on whose behalf the person is being examined to pay the costs of the examination.
e) ordonner que la personne ou la partie au nom de laquelle la personne est interrogée paie les frais de l’interrogatoire oral.
[emphasis added]
[non souligné dans l’original]
[53] Here, Gilead did not argue that the Press Release was not under its control, nor that Dr. Miller was not in a senior position at Gilead and involved in Gilead’s acquisition of Triangle. Gilead and Dr. Miller deliberately did not seek relief from production under Rule 94(2), instead, they unilaterally refused to make the required production under Rule 94(1).
[54] Gilead’s evidence was that it was instructed by its counsel not to look for the Press Release or related documents.
[55] In my view, Gilead’s non-compliance with Rule 94(1) results in the Press Release meeting the test of necessity. Necessity together with reliability are the tests to admit hearsay evidence established by the Supreme Court in Finta, R. v Khan, [1990] 2 SCR 531, R v Smith, [1992] 2 SCR 915 [Smith] , R v Blackman, 2008 SCC 37, and recently discussed by the Federal Court of Appeal in Pfizer Canada Inc v Teva Canada Limited, 2016 FCA 161. In Smith, Chief Justice Lamer confirmed that the necessity principle is engaged where the direct evidence is not available. That is the situation here: the direct evidence is not available:
The criterion of necessity, however, does not have the sense of "necessary to the prosecution's case". If this were the case, uncorroborated hearsay evidence which satisfied the criterion of reliability would be admissible if uncorroborated, but might no longer be "necessary" to the prosecution's case if corroborated by other independent evidence. Such an interpretation of the criterion of "necessity" would thus produce the illogical result that uncorroborated hearsay evidence would be admissible, but could become inadmissible if corroborated. This is not what was intended by this Court's decision in Khan.
As indicated above, the criterion of necessity must be given a flexible definition, capable of encompassing diverse situations. What these situations will have in common is that the relevant direct evidence is not, for a variety of reasons, available. Necessity of this nature may arise in a number of situations. Wigmore, while not attempting an exhaustive enumeration, suggested at §1421 the following categories:
(1) The person whose assertion is offered may now be dead, or out of the jurisdiction, or insane, or otherwise unavailable for the purpose of testing [by cross-examination]. This is the commoner and more palpable reason. . . .
(2) The assertion may be such that we cannot expect, again or at this time, to get evidence of the same value from the same or other sources . . . . The necessity is not so great; perhaps hardly a necessity, only an expediency or convenience, can be predicated. But the principle is the same.
Clearly the categories of necessity are not closed. In Khan, for instance, this Court recognized the necessity of receiving hearsay evidence of a child's statements when the child was not herself a competent witness. We also suggested that such hearsay evidence might become necessary when the emotional trauma that would result to the child if forced to give viva voce testimony would be great. Whether a necessity of this kind arises, however, is a question of law for determination by the trial judge.
[emphasis added]
[56] In my view, the Press Release is necessary as set out above. Apotex did all it could to have the Press Release produced. It called on Gilead as its alleged author. However, Gilead did not respond to the Direction to Attend or seek relief as provided by the Rules. Gilead’s counsel blocked its production; this frustrated both the authentication of the Press Release and the giving of evidence to show its contents were true. Those present still at Gilead were silent about the Press Release (and the