GILEAD SCIENCES, INC. v. GILEAD SCIENCES, 2016 FC 856

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: N os 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); SusanHubbard (Associate Director of Investor Relations); Mark Perry (Executive Vice President of Operations); Margaret H.

Malloy (Analyst); Elise Wang (Analyst, Salomon SmithBarney); 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 ofanyone 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 askedto 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 arehearsay. 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 admissibleinto 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 notcontest 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 ofClinical 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 onrequired 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 isrequired by the jurisprudence setting out exceptions to the hearsay rules: R v Finta, (SCC), [1994] 1 SCR 701 at 854-855 [Finta].

Fourth, Apotex submits thatfor 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 thepatented 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 specificallyidentified 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 beexamined on an oral examination or the party on whosebehalf that person is being examined shall produce forinspection at the examination all documents and othermaterial requested in the direction to attend that are withinthat person's or party's possession and control, other thanany documents for which privilege has been claimed or forwhich relief from production has been granted under rule230. 94

(1) Sous réserve du paragraphe (2), la personne soumiseà un interrogatoire oral ou la

partie pour le compte delaquelle la personne est interrogée produisent pour examenà l’interrogatoire les documents et les éléments matérielsdemandés dans l’assignation à comparaître qui sont en leurpossession, sous leur autorité ou sous leur garde, sauf ceuxpour lesquels un privilège de non-divulgation a étérevendiqué ou pour lesquels une dispense de production aété accordée par la Cour en vertu de la règle 230.

(2) On motion, the Court may order that a person to beexamined or the party on whose behalf that person is beingexamined be relieved from the requirement to produce forinspection any document or other material requested in adirection to attend, if the Court is of the opinion that thedocument or other material requested is irrelevant or, byreason of its nature or the number of documents or amountof material requested, it would be unduly onerous torequire the person or party to produce it.

(2) La Cour peut, sur requête, ordonner que la personne oula

partie pour le compte de laquelle la personne estinterrogée soient dispensées de l’obligation de produirepour examen certains des documents ou éléments matérielsdemandés dans l’assignation à comparaître, si elle estimeque ces documents ou éléments ne sont pas pertinents ouqu’il serait trop onéreux de les produire du fait de leurnombre ou de leur nature. 97 Where a person fails to attend an oral examination orrefuses to take an oath, answer a proper question, producea document or other material required to be produced orcomply with an order made under rule 96, the Court may 97 Si une personne ne se présente pas à un interrogatoireoral ou si elle refuse de prêter serment, de répondre à unequestion légitime, de produire un document ou un élémentmatériel demandés ou de se conformer à une ordonnancerendue en application de la règle 96, la Cour peut :(

a) order the person to attend or re-attend, as the case maybe, at his or her own expense;

a) ordonner à cette personne de subir l’interrogatoire ou unnouvel interrogatoire oral, selon le cas, à ses frais;(

b) order the person to answer a question that wasimproperly objected to and any proper question arisingfrom the answer;

b) ordonner à cette personne de répondre à toute question àl’égard de laquelle une objection a été jugée injustifiéeainsi qu’à toute question légitime découlant de sa réponse;(

c) strike all or part of the person's evidence, including anaffidavit made by the person;

c) ordonner la radiation de tout ou

partie de la preuve decette personne, y compris ses affidavits;(

d) dismiss the proceeding or give judgment by default, asthe case may be; or

d) ordonner que l’instance soit rejetée ou rendre jugementpar défaut, selon le cas;(

e) order the person or the party on whose behalf theperson is being examined to pay the costs of theexamination.

e) ordonner que la personne ou la

partie au nom de laquellela personne est interrogée paie les frais de l’interrogatoireoral.[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’sacquisition 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 productionunder 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 toadmit hearsay evidence established by the Supreme Court in Finta, R. v Khan, (SCC), [1990] 2 SCR 531, R v Smith, (SCC), [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, ChiefJustice 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 thecriterion of reliability would be admissible if uncorroborated, but might no longer be "necessary" to the prosecution's case if corroborated by other independent evidence. Suchan

interpretation of the criterion of "necessity" would thus produce the illogical result that uncorroborated hearsay evidence would be admissible, but could become inadmissibleif 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 thatthe 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 exhaustiveenumeration, 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]. Thisis 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 childwas 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 Conference Call Transcript) – nothing prevented their giving evidence to this Court. This conduct made it necessary for Apotex to produce the Press Release. [ 57 ] I also find the Press Release to be reliable: it purports to have been taken from Gilead’s website and published before the start of litigation.

Gilead’s silence on the veracity and reliability of the document constituted non-compliance with the Rules, and again leads me to draw an inference in support of the reliability of the Press Release: Eli Lilly & Co v Nu-Pharm Inc (1996), 69 C.P.R. (3d) 1 at 18-19 (FCA) . Gilead had ample opportunity to challenge the reliability of the document or to bring a witness forward if the document contained inaccuracies. Gilead failed to do so. [ 58 ] Given it is both necessary and reliable, I therefore admit the Press Release. I find it is a copy of an actual Press Release issued by Gilead dated December 4, 2002.

That said, as noted below, the Press Release does not advance the position taken by Apotex except to lend credence to the fact of the public access to the Conference Call at the relevant time for anticipation. (

b) The Conference Call Transcript [ 59 ] I agree with Gilead that the Conference Call Transcript would ordinarily constitute inadmissible hearsay. I note the importance of the Conference Call Transcript to establish the breadth of the public disclosure during the Conference Call on December 4, 2002.

I also note the document itself says that before relying on the transcript, the transcript from the company itself should be reviewed: “THE INFORMATION CONTAINED IN EVENT TRANSCRIPTS IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY’S CONFERENCE CALL AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE CONFERENCE CALLS. (…).

USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY’S CONFERENCE CALL ITSELF AND THE APPLICABLE COMPANY’S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.” (Emphasis added.) In this case, the company in whose possession a transcript could arguably be found is Gilead. [ 60 ] However, I agree with Apotex that the Conference Call Transcript should be admitted as an exception to the hearsay rule, and do so for the same reasons that led me to admit the Press Release: the exception based on necessity and reliability.

Again, Apotex did all it could to prove the Conference Call Transcript including serving a Direction to Attend on Dr. Miller, the only witness in this proceeding who presumably had access to it. Despite being obliged to produce the Conference Call Transcript in full under Rule 94(1) of the Federal Courts Rules or to seek relief under Rule 94(2), Gilead complied with neither component of Rule 94. Gilead’s evidence was that it was instructed by counsel not to look for this or related documents.

Perhaps Gilead’s witnesses or employees kept notes, or their own copies of the Conference Call; perhaps they could recall what words were spoken; perhaps they had their own recording. The Court does not know. This state of affairs is brought about because of Gilead’s unilateral conduct. Gilead made it unavailable; the Conference Call Transcript meets the test of necessity. [ 61 ] I also agree the Conference Call Transcript is reliable; the Conference Call was contemporaneously transcribed in 2002. In this connection I note copyright on the transcript is dated 2002.

The transcript was published by LexisNexis, a well-known legal publisher and content provider, and was published well before the present litigation arose. I also Note that the Conference Call Transcript’s content was not contested by Gilead, whose principals participated in it. I note also that Gilead is the only party with actual knowledge and possession of these relevant facts. Moreover, two persons identified on the Conference Call Transcript, Dr. Norbert Bischofberger and Dr.

John Martin, remain in leadership positions at Gilead, and would have been able to produce evidence supporting any inaccuracy in the Conference Call Transcript had there been any such inaccuracies. However, Gilead chose not to provide any evidence from these witnesses under its control. Its counsel instructed the Gilead witness not to search for either the Press Release or the Conference Call Transcript. B.

Anticipation or Novelty [ 62 ] The Patent Act provides that a patent may not be granted for an invention which was previously disclosed or which was not novel, where the content of the disclosure would be available to the public in Canada. The relevant time to determine whether the 475 Patent was anticipated was January 13, 2003, or one year before the 475 Patent’s Canadian Filing Date of January 13, 2004. The Patent Act states in relevant part: 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; … […] [emphasis added] [non souligné dans l’original] [ 63 ] The Supreme Court of Canada in Apotex Inc v Sanofi-Synthelabo Canada Inc , 2008 SCC 61 at paras 18-37 [ Sanofi ] prescribes that anticipation consists in one publicly available document disclosing the content of the patent at issue, such that the patent would infringe the prior disclosure when made, and that this prior disclosure enable the “skilled person” to make the invention as claimed.

Justice Rothstein (for the Court) stated: [20] In his reasons after referring to s. 27(1) of the Act, the applications judge defined anticipation as meaning “that the exact invention had already been made and publicly disclosed” (para. 55). Shore J. cited this Court’s decision in Free World Trust v. ̟lectro Santé Inc. , [2000] 2 S.C.R. 1024, 2000 SCC 66 , at para. 26 , which approved of the test for anticipation described in Beloit Canada Ltd. v.

Valmet OY (1986), 8 C.P.R. (3d) 289 (F.C.A.), at p. 297 : One must, in effect, be able to look at a prior, single publication and find in it all the information which, for practical purposes, is needed to produce the claimed invention without the exercise of any inventive skill. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and without possibility of error be led to the claimed invention. [Emphasis added by the applications judge.] [21] The applications judge noted that the English Court of Appeal stated in General Tire & Rubber Co. v.

Firestone Tyre & Rubber Co. , [1972] R.P.C. 457, at p. 486: If, on the other hand, the prior publication contains a direction which is capable of being carried out in a manner which would infringe the patentee’s claim, but would be at least as likely to be carried out in a way which would not do so, the patentee’s claim will not have been anticipated, although it may fail on the ground of obviousness .

To anticipate the patentee’s claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented . . . . [Emphasis added by the applications judge.] He then noted that in Free World , at para. 26, this Court approved the following statement from General Tire : A signpost, however clear, upon the road to the patentee’s invention will not suffice.

The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentee. [p. 486] [22] The law of anticipation as explained in Beloit and General Tire has been accepted in Canada without reservation: see Free World , at para. 26.

In his application of the law to the facts, there is no doubt that Shore J. was using the test as set out in Beloit when he stated, at para. 57: Based on the law, the question before the Court is whether a person skilled in the art was given such a clear direction that, by reading and following the ’875 patent (or its U.S. or French equivalents) would in every case and without possibility of error make a compound or pharmaceutical composition within the claims of the ’777 patent (e.g. the bisulfate salt of clopidogrel).

(

c) Recent United Kingdom Jurisprudence [23] For the reasons that follow, and in light of recent jurisprudence, I am of the respectful opinion that the applications judge overstated the stringency of the test for anticipation that the “exact invention” has already been made and publicly disclosed. [24] In the 2005 decision of the House of Lords in Synthon , Lord Hoffmann has brought some further clarity to the law of anticipation as understood since General Tire . His reference at para. 20 to the “unquestionable authority” of Lord Westbury in Hills v. Evans (1862), 31 L.J.

Ch. (N.S.) 457, at p. 463, makes it plain that his analysis does not depend on any change on English law flowing from the enactment of the Patents Act 1977 (U.K.), 1977, c. 37, or the U.K.’s adoption of the Convention on the Grant of European Patents , 1065 U.N.T.S. 199 (entered into force October 7, 1977).

He distinguishes between two requirements for anticipation that were not theretofore expressly considered separately, prior disclosure and enablement. [25] He explains that the requirement of prior disclosure means that the prior patent must disclose subject matter which, if performed, would necessarily result in infringement of that patent, and states, at para. 22: If I may summarise the effect of these two well-known statements [from General Tire and Hills v.

Evans ], the matter relied upon as prior art must disclose subject matter which, if performed, would necessarily result in an infringement of the patent. . . . It follows that, whether or not it would be apparent to anyone at the time, whenever subject matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied.

When considering the role of the person skilled in the art in respect of disclosure, the skilled person is “taken to be trying to understand what the author of the description [in the prior patent] meant” (para. 32). At this stage, there is no room for trial and error or experimentation by the skilled person.

He is simply reading the prior patent for the purposes of understanding it. [26] If the disclosure requirement is satisfied, the second requirement to prove anticipation is “enablement” which means that the person skilled in the art would have been able to perform the invention (para. 26). [ 64 ] In this connection I note the test laid out in Sanofi was based on different statutory language from that in effect in this application. At the time Sanofi was decided, the law specifically stated that disclosure had to be in a patent or in a publication form: 27.

(1) Subject to this section, any inventor or legal representative of an inventor of an invention that was (

a) not known or used by any other person before he invented it, (

b) not described in any patent or in any publication printed in Canada or in any other country more than two years before presentation of the petition hereunder mentioned, and (

c) not in public use or on sale in Canada for more than two years prior to his application in Canada, may, on presentation to the Commissioner of a petition setting out the facts, in this Act termed the filing in the application, and on compliance with all other requirements of this Act, obtain a patent granting to him an exclusive property in the invention. [ 65 ] The current provision does not specify the form of disclosure, which now may be written or oral. Both parties relied on the current provision: 28.2

(1) The subject-matter defined by a claim in an application for a patent in Canada (the “pending application”) must not have been disclosed (

a) more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant, in such a manner that the subject-matter became available to the public in Canada or elsewhere; (

b) before the claim date by a person not mentioned in paragraph (

a) in such a manner that the subject-matter became available to the public in Canada or elsewhere; (

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 (

d) in an application (the “co-pending application”) for a patent that is filed in Canada by a person other than the applicant and has a filing date that is on or after the claim date if (…). [ 66 ] In Stratton: Annotated Patent Act , s. 28.2 Commentary, the form of disclosure is explained: Regarding availability to the public, in contrast to previous

definitions of novelty, and to

definitions in other jurisdictions, the current Act does not define separate categories for different means of disclosure to the public. For example, there is no special category for anticipation by publication, nor for anticipation by offering for sale or selling products embodying the subject-matter of a claim. [ 67 ] Apotex noted the public nature of the Conference Call, which I accept. The Press Release stated there would be a conference call. The Conference Call Transcript itself confirms the Conference Call took place. The key date for anticipation is January 13, 2003.

While the call took place December 4, 2002, it appears the Conference Call Transcript was loaded or published on January 18, 2003. The Conference Call was open to the public; it could be heard live and for three days after it was held. The Conference Call Transcript is the transcript of the public call.

If the Patent was anticipated by the Conference Call, in my view such anticipation took place on December 4, 2002, before the relevant date for anticipation. [ 68 ] In AstraZeneca Canada Inc v Apotex Inc , 2014 FC 638 , Justice Rennie (as he then was) summarized anticipation as follows: [223] Apotex asserts that the ‘653 patent is invalid because what the patent claims was not new, or rephrased in positive terms, because it was “anticipated.” Novelty is a requirement for a valid patent under sections 2 and 28.2 of the Patent Act .

In essence, an alleged patent is anticipated if the skilled person, before the patent claim date (May 28, 1993), and with reference to a single prior art reference, could have performed the patent without “undue burden.” [224] The Supreme Court of Canada established a refined two-part test for anticipation in Sanofi-Synthelabo Plavix , at paras 30-33. For a patent to be anticipated there must be, from the perspective of the skilled person: (1) prior disclosure and (2) enablement from that prior disclosure. [ 69 ] I will now analyze the two parts of the anticipation doctrine: prior disclosure and enablement.

(1) Disclosure [ 70 ] As discussed above, for there to be disclosure of the 475 Patent by either the Press Release or Conference Call or the Conference Call Transcript, I am required to find that the Press Release and/or the Conference Call Transcript, being a record of the Conference Call itself, disclose all the information needed for the Skilled Person, who is unimaginative and without inventive skill, to make subject matter that would necessarily result in infringement of the 475 Patent. [ 71 ] I agree with Gilead that the Beloit test set out in J.M.

Voith v Beloit (1991), 36 CPR (3d) 322 (FCA) [ Beloit ] continues to be the law after Sanofi . Beloit is a decision of the Federal Court of Appeal. Beloit explains disclosure as one disclosure, which contains so clear a direction that the Skilled Person reading and following it would in every case and without possibility of error be led to the claimed invention: One must, in effect, be able to look at a prior, single publication and find in it all the information which, for practical purposes, is needed to produce the claimed invention without the exercise of any inventive skill.

The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and without possibility of error be led to the claimed invention.

Where, as here, the invention consists of a combination of several known elements, any publication which does not teach the combination of all the elements claimed cannot possibly be anticipatory. [emphasis added] [ 72 ] Gilead argues and I agree that the Beloit test was reaffirmed when it was quoted by the Federal Court of Appeal post- Sanofi in Bell Helicopter Textron Canada Limitée v Eurocopter, société par actions simplifiée , 2013 FCA 219 [ Eurocopter ]:

[109] Anticipation may occur by prior publication, oral communication, or use. In this case, Bell Helicopter only raises anticipation by prior publication. Anticipation by prior publication requires that the invention be in fact disclosed in written documentation made available to the public, such as patents, journal articles, and trade literature, including instruction and repair manuals and brochures. The objective test for disclosure by prior publication is set out as follows in Beloit Canada Ltée/Ltd. v.

Valmet Oy (1986), 8 C.P.R. (3d) 289, 64 N.R. 287, at para. 30 of the N.R. ed.: One must, in effect, be able to look at a prior, single publication and find in it all the information which, for practical purposes, is needed to produce the claimed invention without the exercise of any inventive skill. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and without possibility of error be led to the claimed invention.

Where, as here, the invention consists of a combination of several known elements, any publication which does not teach the combination of all the elements claimed cannot possibly be anticipatory. [110] This test for anticipation was cited with approval in Free World Trust at para. 26 , where it was further noted that it was a difficult test to meet. Subject to the distinction between disclosure and enablement, this test for anticipation by publication still applies: Sanofi at para. 28. [emphasis added] [ 73 ] In construing the asserted claims of the 475 Patent, I may be guided by the experts.

On the one hand, Gilead’s expert Dr. Kashuba, without any experience in pharmaceutics, considers the alleged claimed invention to be the combination of at least TDF and FTC in a pharmaceutical formulation that has antiviral activity, and that is chemically stable or synergistic, or both chemically stable and synergistic. [ 74 ] On the other hand, Apotex’s witness Dr. Kibbe stated that the invention is the co-formulation of TDF and FTC for use in the treatment of HIV. [ 75 ] Dr.

Flexner for Apotex explains in his opinion the invention is the single dose co-formulation of FTC and TDF for the treatment of HIV infection. [ 76 ] In this case, I am not satisfied that the Press Release, on its own, discloses the claimed invention, that is, the combination of TDF and FTC in a once-daily co- formulation pill, which necessarily must exhibit a certain chemical stability and effectiveness in order to be of any use in the treatment of HIV infection.

In my respectful opinion, the overall purpose and tone of the Press Release is to address the commercial and business synergies between Gilead and Triangle.

The only relevant evidence for drug or pharmaceutical disclosure in the Press Release is the following: In addition to pursuing the commercialization of Coviracil [FTC] as a single agent, Gilead plans to immediately initiate development of a co-formulation of Viread and Coviracil as a potential fixed-dose combination treatment for patients with HIV. [ 77 ] As Gilead explains, at the time, FTC (or Coviracil) was not fully developed and available for distribution as a single formulation; it was only in the clinical trial phase.

Moreover, there is no indication in the Press Release that any testing was done showing the co-formulation was a sound option for development, or that the co-formulation would prove chemically stable. While TDF and FTC and their respective dosage forms would have been known to the Skilled Person, in my view the Press Release does not contain so clear a direction that the Skilled Person reading and following it would in every case and without possibility of error be led to the claimed invention.

The Press Release does not demonstrate to me that a Skilled Person would be lead to the 300 mg and 200 mg co-formulation immediately and without possibility of error. [ 78 ] Therefore, I am not prepared to find the Press Release taken alone discloses the invention of TRUVADA®, which comprises a once-daily chemically stable co- formulation of TDF and FTC in a 300 mg and 200 mg combination to treat HIV. [ 79 ] On the other hand, the Conference Call itself, reflected in the Conference Call Transcript, discloses far more than the Press Release.

In my view, the Conference Call discloses information on which a Skilled Person would be lead to the claimed once-daily 300 mg and 200 mg co-formulation of TDF and FTC to treat HIV immediately and without possibility of error. The Conference Call Transcript (which I find accurately reports the Conference Call itself) quotes Gilead’s Dr. Bischofberger as stating: The co-formulation work is currently ongoing, but based on the physical chemical properties of both components we don’t anticipate that there will any big challenges in doing that.

With regards to regulatory pathway it’s pretty clear all we would really need is a CMC package. So, you need the chemistry manufacturing information plus bio-equivalent study, so to show that the co-formulated tablet gives you the same exposure to the individual components as the individual components do.

But in addition to that, we are initiating and we actually have ongoing studies already to look at the combination of FTC of our Coviracil and Viread in HIV infected patients. [ 80 ] In my view, this statement discloses to the Skilled Person with a view to understand that the co-formulation only requires a CMC package, which to a Skilled Person would mean that the doses in the co-formulation are the same as the doses in the individual tablets. This statement also discloses the use of the co-formulation for HIV infected patients. [ 81 ] Later in the Conference Call, Gilead’s John F.

Milligan states: The pathway for co-formulated products is very straight forward. It is limited by stability studies. So, it’s limited not by clinical data, but by stability to have a shelf life, (…). This statement further explains that the co-formulation must be chemically stable for purposes of its shelf-life. [ 82 ] Given the invention claims a once-daily chemically stable co-formulation of TDF and FTC in doses of 300 mg and 200 mg, which I note are identical to the doses in their individual tablets, for the treatment of HIV, the claim was in fact disclosed during the Conference Call.

Therefore, I find the Conference Call discloses subject matter which, if performed, would necessarily result in infringement of the patent, which comprises a once-daily chemically stable co-formulation of TDF and FTC in a 300 mg and 200 mg combination to treat HIV. Taken together and read as a whole, I find there was sufficient disclosure in the Conference Call and/or the Conference Call Transcript to establish anticipation.

(2) Enablement [ 83 ] Because the invention was disclosed in the Conference Call as reported in the Conference Call Transcript, I must now consider enablement. At the enablement phase routine trial and error is permitted by the Skilled Person, who however could not take any inventive steps or undergo undue burden to arrive at the claimed invention: [27] Once the subject matter of the invention is disclosed by the prior patent, the person skilled in the art is assumed to be willing to make trial and error experiments to get it to work.

While trial and error experimentation is permitted at the enablement stage, it is not at the disclosure stage. For purposes of enablement, the question is no longer what the skilled person would think the disclosure of the prior patent meant, but whether he or she would be able to work the invention. Sanofi at para 27. [ 84 ] Sanofi discussed the following factors to be considered when determining whether the disclosure also enabled the claimed invention: [37] Drawing from this jurisprudence, I am of the opinion that the following factors should normally be considered. The list is not exhaustive.

The factors will apply in accordance with the evidence in each case. 1. Enablement is to be assessed having regard to the prior patent as a whole including the specification and the claims. There is no reason to limit what the skilled person may consider in the prior patent in order to discover how to perform or make the invention of the subsequent patent. The entire prior patent constitutes prior art. 2. The skilled person may use his or her common general knowledge to supplement information contained in the prior patent.

Common general knowledge means knowledge generally known by persons skilled in the relevant art at the relevant time. 3. The prior patent must provide enough information to allow the subsequently claimed invention to be performed without undue burden. When considering whether there is undue burden, the nature of the invention must be taken into account. For example, if the invention takes place in a field of technology in which trials and experiments are generally carried out, the threshold for undue burden will tend to be higher than in circumstances in which less effort is normal.

If inventive steps are required, the prior art will not be considered as enabling. However, routine trials are acceptable and would not be considered undue burden. But experiments or trials and errors are not to be prolonged even in fields of technology in which trials and experiments are generally carried out. No time limits on exercises of energy can be laid down; however, prolonged or arduous trial and error would not be considered routine. 4.

Obvious errors or omissions in the prior patent will not prevent enablement if reasonable skill and knowledge in the art could readily correct the error or find what was omitted.

[ 85 ] In Eurocopter , the Federal Court of Appeal wrote, citing Sanofi : [108] The second requirement, enablement, is assessed once it has been determined, on an objective basis, that the subject matter of the invention has indeed been disclosed. For the purposes of enablement, the question is no longer what the skilled person understands from the disclosure, but whether that person would be able to work the invention without undue burden: Sanofi at paras. 26 and 37. When considering whether there is undue burden, the nature of the invention must be taken into account.

Some trials and experiments are allowed at this stage. But these are not to be prolonged, even in the fields of technology in which trials and experiments are generally carried out: Sanofi at paras. 27 and 33 to 37. [ 86 ] In

summary, Sanofi says the following are to be considered when determining whether there was enablement: 1. The entire disclosure; 2. Common general knowledge of the Skilled Person; 3. Whether the trials are routine or long and arduous; and 4. Whether reasonable skill and knowledge in the art could readily correct obvious errors or find what was omitted in the disclosure. [ 87 ] These factors have been followed in later judgments. I will now consider each. 1. The Disclosure [ 88 ] In the present application, the disclosure in the Press Release falls short of meeting the requirements for enablement.

However the disclosure in the Conference Call is another matter. It contains the following elements: i. Coviracil (FTC or EMTRIVA®) was “highly complementary” to VIREAD®, i.e., TDF, for HIV (page 2); ii. FTC is a once-daily pill that has a safety profile similar to a placebo (page 2); iii. FTC and TDF have “no overlapping resistance mutations. This would suggest that they would be highly compatible when used in combination” (page 2); iv. Gilead’s John Milligan: “there is an obvious need for new once daily therapies…Viread and Coviracil have a very strong complementarity to them. They are both once daily.

They are both potent. There are no overlapping [irritations]. They are both very well tolerated products and so there is an obvious synergy there.” (page 4); v. Gilead’s Norbert Bischofberger: “The co-formulation work is currently ongoing, but based on the physical chemical properties of both components we don’t anticipate that there will be any big challenges in doing that.” (page 5); vi. TDF (sold as VIREAD®) was already being combined with 3TC (lamivudine) (another NRTI drug useful in the treatment of HIV) in 50% of the patients taking VIREAD®; vii.

The drug to be made by the merged company would be a co-formulation; viii. The co-formulation would comprise VIREAD® and Coviracil (FTC); ix. Gilead was to initiate development of the co-formulation of VIREAD® and Coviracil as a potential fixed combination treatment for patients with HIV. This could result in the first combination product dose that is one pill once daily; and x. Gilead did not “anticipate that there will be any big challenges in [co-formulating VIREAD® and Coviracil]” . (page 5) 2. Common General Knowledge of the Skilled Person [ 89 ] Dr.

Kibbe for Apotex provided helpful expert evidence on the common general knowledge of the Skilled Person. Here I note that while Gilead’s Dr. Kashuba is a pharmacology expert, she has admitted to having no expertise in pharmaceutical chemistry or formulation, which is the determined field for this disclosure. Because Gilead did not provide the Court with expert evidence on this topic, and because of Dr. Kibbe’s excellent credentials in this field, I prefer Dr.

Kibbe’s evidence on the common general knowledge of the pharmaceutical formulator. [ 90 ] In the prior art, Coviracil and VIREAD® would have active pharmaceutical ingredients with known dosage and whose preparation methods were known, though perhaps covered by patents. [ 91 ] I therefore find that the Skilled Person who is a chemical formulator would know that Coviracil’s dosage was 200 mg, and that VIREAD®’s dosage was 300 mg. 3. Type of Testing [ 92 ] For the reasons explained above, here again I prefer Dr. Kibbe’s opinion. Dr.

Kibbe provides evidence describing the nature of the work of a Skilled Person who is a pharmaceutical formulator. In his affidavit, Dr. Kibbe states a formulator would readily perform routine tests for chemical stability to ensure the two active pharmaceutical ingredients are compatible for co-formulation. Once these routine tests are completed, the skilled pharmaceutical formulator would readily prepare appropriate excipients and manufacture the co-formulation into a one-dose pill form medicament, as is claimed by the invention. 4.

Obvious Errors or Omissions [ 93 ] The disclosure obviously does not disclose the method of preparation for Coviracil, VIREAD®, or its co-formulation.

However, the Skilled Person may look to the prior art or elsewhere to supply this omission at the enablement stage. [ 94 ] Here, I note Coviracil and VIREAD®’s active pharmaceutical ingredient preparation was known and disclosed in prior patents, thus readily available to the Skilled Person. [ 95 ] With this additional knowledge, in my respectful view, the routine tests described earlier become even more straightforward. [ 96 ] The invention was to combine two drugs with known dosage for once-daily oral administration to create a once-daily, one-pill co-formulation.

I find the invention was enabled by the Conference Call such that looking at its disclosure, and looking to the prior art and common general knowledge as would a skilled pharmaceutical formulator, the Skilled Person would only have to conduct routine tests to arrive at the claimed invention in the 475 Patent. [ 97 ] In this manner, the Conference Call disclosed and enabled the invention claimed in the 475 Patent. Therefore I must conclude Gilead has failed to establish on a balance of probabilities that Apotex’s allegations of anticipation were not justified.

On this ground I would dismiss Gilead’s application for prohibition. C. Obviousness

(1) Obvious and obvious to try [ 98 ] Apotex alleges the combination of TDF and FTC was obvious in light of the state of the art and the treatments offered at the relevant time. Gilead disagrees. Given my finding on anticipation I need not address this issue, but will do so because it was fully argued. [ 99 ] The Supreme Court of Canada in Sanofi established the following framework for the obviousness inquiry:

[67] It will be useful in an obviousness inquiry to follow the four-step approach first outlined by Oliver L.J. in Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd ., [1985] R.P.C. 59 (C.A.). This approach should bring better structure to the obviousness inquiry and more objectivity and clarity to the analysis. The Windsurfing approach was recently updated by Jacob L.J. in Pozzoli SPA v. BDMO SA , [2007] F.S.R. 37 (p. 872), [2007] EWCA Civ 588, at para. 23: In the result I would restate the Windsurfing questions thus: (1) (

a) Identify the notional “person skilled in the art”; (

b) Identify the relevant common general knowledge of that person;

(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;

(3) Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed; (4)Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention? [Emphasis added.] It will be at the fourth step of the Windsurfing/Pozzoli approach to obviousness that the issue of “obvious to try” will arise. [ 100 ] According to the Supreme Court of Canada in Sanofi , the “obvious to try” test may also be applied to assess obviousness, although it is not the sole factor in the obviousness inquiry: [66] For a finding that an invention was “obvious to try”, there must be evidence to convince a judge on a balance of probabilities that it was more or less self-evident to try to obtain the invention.

Mere possibility that something might turn up is not enough. (…) i. When Is the “Obvious to Try” Test Appropriate? [68] In areas of endeavour where advances are often won by experimentation, an “obvious to try” test might be appropriate. In such areas, there may be numerous interrelated variables with which to experiment.

For example, some inventions in the pharmaceutical industry might warrant an “obvious to try” test since there may be many chemically similar structures that can elicit different biological responses and offer the potential for significant therapeutic advances. ii. “Obvious to Try” Considerations [69] If an “obvious to try” test is warranted, the following factors should be taken into consideration at the fourth step of the obviousness inquiry. As with anticipation, this list is not exhaustive. The factors will apply in accordance with the evidence in each case. 1.

Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified predictable solutions known to persons skilled in the art? 2. What is the extent, nature and amount of effort required to achieve the invention? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine? 3. Is there a motive provided in the prior art to find the solution the patent addresses? [70] Another important factor may arise from considering the actual course of conduct which culminated in the making of the invention.

It is true that obviousness is largely concerned with how a skilled worker would have acted in the light of the prior art.

But this is no reason to exclude evidence of the history of the invention, particularly where the knowledge of those involved in finding the invention is no lower than what would be expected of the skilled person. [ 101 ] I will now review these factors. (a) “Person skilled in the art” [ 102 ] I previously described the Skilled Person as a person or a team of persons with an advanced degree in pharmaceutical formulation, and with 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. (

b) Relevant common general knowledge of the Skilled Person [ 103 ] I previously described the common general knowledge of the Skilled Person in the anticipation analysis: the Skilled Person would know of VIREAD® and Coviracil and their active pharmaceutical formulations and individual dosage as disclosed in publications and in the testing conducted. The Skilled Person would have known both were administered once-daily. The experts agree that the standard of care for the treatment of HIV infection by January 2003 was the chronic use of a combination of drugs.

The Skilled Person would also have known from the Conference Call and or the Conference Call Transcript that the co-formulation of Viread ® and Coviracil was not expected by Gilead to present any particular challenges. [ 104 ] The skilled chemical formulator would also know how to conduct chemical stability tests and otherwise choose appropriate filler and excipients in the formulation of a drug.

(2) Inventive concept of the claim [ 105 ] The claims before me are claims 15, 16, 24, 25 and 28 of the 475 Patent.

These claims provide that the co-formulation is of TDF and FTC (Claim 15), with carriers and excipients (Claim 16), in 300 mg and 200 mg dosage (Claims 24 and 25), and in a pharmaceutical formulation which can be administered once daily to a human infected with HIV (Claim 28). [ 106 ] The inventive concept is the chemically stable co-formulation of FTC and TDF for a once-daily oral pill with anti-HIV activity. [ 107 ] Although Gilead argues the synergy of FTC and TDF is part of the inventive concept, I am not satisfied that this is an essential element of the claimed invention. First I note the co-formulation h

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