Eli Lilly Canada Inc. v. Apotex Inc

Eli Lilly Canada Inc. v. Apotex Inc
Court (s) Database
Federal Court Decisions
Date
2015-07-20
Neutral citation
2015 FC 875
File numbers
T-1598-13
Decision Content
Date: 20150720
Docket: T-1598-13
Citation: 2015 FC 875
Ottawa, Ontario, July 20, 2015
PRESENT: The Honourable Madam Justice Gleason
BETWEEN:
ELI LILLY CANADA INC.
Applicant
and
APOTEX INC. AND
THE MINISTER OF HEALTH
Respondents
and
ICOS CORPORATION
Respondent Patentee
JUDGMENT AND REASONS
[1] In this application, Eli Lilly Canada Inc. [Lilly] seeks an order under section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 [the PMNOC Regulations] to prohibit the Minister of Health [the Minister] from issuing a Notice of Compliance [NOC] to the respondent, Apotex Inc. [Apotex], for approval to sell its generic version of tadalafil [APO-Tadalafil] until after the expiry of the Canadian Patent 2,226,784 [the 784 Patent] on July 11, 2016.
[2] Tadalafil is used, among other things, to treat male erectile dysfunction (or ED), a condition that affects a substantial number of men. Lilly markets tadalafil under the brand name CIALIS. The 784 Patent is listed against CIALIS on the Patent Register maintained by the Minister under sections 3 and 4 of the PMNOC Regulations.
[3] Apotex sought an NOC from the Minister for approval to sell its Apo-Tadalafil product and, by virtue of section 5 of the PMNOC Regulations, was required to address the 784 Patent. It did so in a Notice of Allegation [NOA] that it served on Lilly on August 16, 2013. In its NOA, Apotex raised several grounds that it did not pursue during the hearing of this matter.
[4] Following receipt of Apotex’ NOA, on September 27, 2013, Lilly filed the present application to prohibit the Minister from issuing an NOC to Apotex for Apo-Tadalafil.
[5] Apotex does not contest that its Apo-Tadalafil product would infringe Claims 1, 2, 4, 9, 12, 14, 15 and 18 of the 784 Patent. Thus, infringement is not in issue in this application. Validity of the 784 Patent, however, is in issue.
[6] By the time of the hearing, Apotex had narrowed the grounds in support of its invalidity claim to two. It first asserts in this regard that the 784 Patent is invalid because it is an impermissible double patenting of the invention claimed in the earlier 2,181,377 Canadian Patent [the 377 Patent] that Lilly is similarly licensed to use and which likewise pertains to tadalafil. Second, Apotex says that the 784 Patent is invalid for insufficiency because it fails to provide guidance on how to produce hydrate forms of the compounds claimed in the 784 Patent. In addition to these invalidity arguments, Apotex also asserts that Lilly lacks standing under the PMNOC Regulations to bring this application as it has failed to show that there is a proper chain of title to the 784 Patent in its favour.
[7] This is the second PMNOC case involving the 784 Patent. On January 7, 2015, my colleague, Justice Yves de Montigny, issued reasons in Eli Lilly Canada v Mylan Pharmaceuticals ULC, 2015 FC 17, 249 ACWS (3d) 191 [Mylan Tadalafil] in which he dismissed Mylan’s prohibition application because he found Mylan’s allegations of invalidity to be unjustified. Some of the arguments advanced by Apotex in this case are similar to those advanced by Mylan in Mylan Tadalafil and some of the evidence in the two cases is similar.
[8] For the reasons set out below, I have reached the same conclusion as Justice de Montigny and have determined that Apotex’ allegations of invalidity are unjustified. I have also found its other argument regarding Eli Lilly’s alleged lack of standing to be without merit and have accordingly concluded that an order prohibiting the Minister from issuing an NOC to Apotex for its tadalafil product should issue.
I. Background [9] To put the issues in this case into context, it is necessary to briefly review some of the science behind the 748 Patent.
[10] ED is defined as the inability to sustain an erection sufficient to allow for penetration of a man’s partner. An erection occurs when blood flows to and remains in the penis, causing it to become rigid. The penis contains two compartments on either side of the urethra, called the corpora cavernosa, which are comprised of blood vessels and smooth muscle tissue. Smooth muscle is also found in other locations throughout the body, including in the lungs, the tissue surrounding the vasculature and in the gastro-intestinal tract. Smooth muscle tissue can relax and contract; however, this occurs involuntarily as smooth muscles are controlled by the body’s autonomic nervous system.
[11] In the penis, in its flaccid state, the smooth muscle in the corpora cavernosa is contracted, which allows blood to flow into and out of the corpora cavernosa at approximately the same rate. When an erection occurs, the smooth muscle in the corpora cavernosa relaxes, which restricts the veins flowing out of the penis and causes the corpora cavernosa to fill with blood and become engorged. Thus, contrary to what one might expect, it is the relaxation of the smooth muscle corpora cavernosa that enables an erection.
[12] Smooth muscle relaxation results from a series of complex biochemical reactions that occur along intercellular communication systems, termed “pathways”. One pathway involved in the erectile process is the NO/cGMP pathway. The 784 Patent is directed to this pathway.
[13] In the NO/cGMP pathway, two different processes occur. In the first, nitric oxide or NO is released principally by the non-adrenergic non-cholinergic [NANC] nerves in the penis following sexual stimulation. NO is termed a “first messenger”, and it enters the smooth muscle cells or interacts with receptors on the cell surface, causing an intercellular reaction. Inside the smooth muscle cells of the corpora cavernosa, this reaction eventually results in the production of a “second messenger” called cyclic guanosine-3′, 5′-monophosphate (or cGMP). cGMP causes the smooth muscle in the corpora cavernosa to relax, which enables an erection.
[14] The second process in the NO/cGMP pathway involves the breakdown of cGMP by a class of enzymes called phosphodiesterases or PDEs, which convert cGMP into its non-cyclic form called guanosine-3′, 5′-monophosphate or GMP. In contrast to cGMP, GMP does not cause smooth muscle relaxation. Thus, when cGMP converts to GMP in the cells of the corpora cavernosa, an erection is lost and the penis returns to its resting state.
[15] There are several types of PDEs present in the body. It is now known that the primary one that acts to convert cGMP to GMP in the corpora cavernosa is called PDE V.
[16] Tadalafil operates so as to restrict the production of PDE V. When this isozyme is suppressed, cGMP is not converted to GMP in the corpora cavernosa (or the conversion is slowed). When sexual stimulation occurs and the NANC nerves in the penis release NO, an erection will tend to be maintained if there is insufficient GMP in the corpora cavernosa to cause the smooth muscles to contract. Thus, through suppression of PDE V, which acts to create GMP, tadalafil helps to maintain an erection.
[17] Tadalafil was first developed for use in the treatment of hypertension and cardiac disorders. It is a derivative of tetracycline and was first synthesized in laboratories of Laboratoire Glaxo, a predecessor to GlaxoSmithKline [GSK France], in France in 1993.
[18] Tadalafil was first claimed in the British Patent GB No. 9401090.7, the international precursor to the 377 Patent, which was filed on January 21, 1994. The 377 Patent was filed in Canada on January 19, 1995 and claims a priority date of January 21, 1994, the date of filing of the British Patent. The 377 Patent was published on July 27, 1995. The 377 Patent claims several compounds, including tadalafil, pharmaceutical compositions and use of these compounds in the treatment of disorders where the inhibition of PDE V is thought to be beneficial. The 377 Patent does not name ED as one of these disorders or discuss ED in any way.
II. The 784 Patent [19] The 784 Patent was filed in Canada on July 11, 1996, claims a priority date of July 14, 1995 and was published on February 6, 1997. It is entitled “Use of cGMP-Phosphodiesterase Inhibitors to Treat Impotence”. It relates to the use in the treatment of ED of some of the compounds claimed in the 377 Patent. Dr. Daugan, an employee of GSK France, the successor to Laboratoire Glaxo, is the inventor of the 784 Patent (and was also the inventor of the 377 Patent). The 784 Patent discloses the same in vitro tests that were disclosed in the 377 Patent.
[20] Justice Yves de Montigny aptly summarized the import of the 784 Patent in Mylan Tadalafil in the following terms:
[12] According to the specification part of the disclosure, many different drugs have been shown to induce penile erection but are only effective after direct injection into the penis, and are not approved for ED. […]
[13] The specification goes on to describe the compounds of the invention (tadalafil and 3-methyl tadalafil), and states that these compounds, “unexpectedly”, have been found to be useful in the treatment of ED. “Furthermore the compounds may be administered orally, thereby obviating the disadvantages associated with i.c. administration” (pp 3-4 of the Patent).
[14] The gist of the invention is described in the following way:
It has been shown that compounds of the present invention are potent and selective inhibitors of cGMP specific PDE [i.e. PDE V]. It has now been surprisingly found that human corpus cavernosum contains three distinct PDE enzymes. The predominant PDE has further surprisingly been found to be cGMP PDE [i.e. PDE V]. As a consequence of the selective PDE V inhibition exhibited by compounds of the present invention, the subject compounds can elevate cGMP levels, which in turn can mediate relaxation of the corpus cavernosum tissue and consequent penile erection.
(‘784 Patent, p 4)
[15] Oral administration is said to be the “preferred route”, because it is the most convenient and avoids the disadvantages associated with intracavernosal (i.c.) administration, but the drug can also be administered sublingually or buccally. Oral dosages of the compound for curative or prophylactic treatment of ED are said to be in the range of from 0.5 to 800 mg daily, the actual dosing regimen being determined by a physician. For human use, the compounds will be administered in admixture with a pharmaceutical carrier selected with regard to the intended route of administration: “For example, the compound may be administered orally, buccally or sublingually, in the form of tablets containing excipients such as starch or lactose, or in capsules or ovules either alone or in admixture with excipients, or in the form of elixirs or suspensions containing flavouring or colouring agents” (‘784 Patent, p 5).
[16] The ‘784 Patent includes data from two in vitro tests on tadalafil and 3-methyl tadalafil. The first test shows that, when in proximity to the PDE V enzyme, the compounds inhibit its activity. The second test shows that the compounds can penetrate and prolong the cGMP response in rat aortic smooth muscle cells. Taken together, these data indicate that the compounds are potent inhibitors of PDE V in vitro. The Patent also states that the compounds were shown to be highly selective inhibitors of PDE V over other PDE enzymes, but does not provide these data. The ‘784 Patent contains no in vivo testing or clinical studies of any of its compounds.
[21] The 784 Patent has 28 claims; those in issue are reproduced in the Appendix to these Reasons. There is no dispute between Apotex and Lilly on the construction of these claims.
[22] Claim 1 claims the compounds to which the Patent is directed and sets out their chemical formulae. It includes physiologically acceptable salts or solvates of the claimed compounds. It claims a pharmaceutical composition comprised of these compounds for the curative or prophylactic treatment of ED in a male animal.
[23] Claim 2 claims a pharmaceutical composition comprising two of the compounds falling within Claim 1, namely, tadalafil and 3-methyl tadalafil or a physiologically acceptable salt or solvate of the two compounds for the treatment of ED in a male animal. Claims 3 and 13 claim these compounds where the solvates are hydrates. The parties concur that the term “solvates” as used in Claim 2 (and subsequent claims) includes hydrates. A solvate is a physical form of a chemical compound that is a crystalline solid containing a solvent incorporated within the crystal structure. A hydrate is a solvate in which the incorporated solvent is water.
[24] Claim 4 claims the compositions of Claim 2 for use in human males.
[25] Claim 9 claims the use of tadalafil for manufacturing a medicament for the curative or prophylactic treatment of ED in a male animal.
[26] Claim 12 claims the use of tadalafil, 3-methyl tadalafil or a physiologically acceptable salt or solvate of the two compounds for the treatment of ED in a male animal. Unlike Claims 2, 4, 9 and 15, Claim 12 is not limited to a particular pharmaceutical composition but rather more broadly claims the use of the compounds or their physiologically acceptable salts or solvates for the prophylactic or curative treatment of ED in a male animal.
[27] Claim 14 adds to Claims 9 through 13 that the male animal is human.
[28] Claim 15 claims the use of the compositions of Claims 1, 2 and 4 for the treatment of ED in a male animal.
[29] Claim 18 is dependent on Claims 9 to 17 and claims compounds, medicaments, compositions and combinations of formulations that are used or adapted to be used orally. When one combines Claim 18 with Claims 12 and 14, the claim is made to the use of tadalafil, 3‑methyl tadalafil or a physiologically acceptable salt or solvate of the two compounds in treating ED in human males upon oral administration. This is the narrowest of the Claims at issue in this application.
III. The Issues [30] As noted, three issues arise in this application, namely:
1. Is the 784 Patent invalid for double patenting over the 377 Patent?
2. Is the 784 Patent invalid for insufficiency?
3. Does Lilly lack standing to bring this application due to a defect in the chain of title?
IV. The Witnesses [31] Lilly filed affidavits from six fact witnesses and five experts. Apotex filed evidence from two fact witnesses and four experts.
[32] More specifically, Lilly filed the affidavit of a law clerk (to adduce relevant documents) and of Drs. Daugan, Grondin, Martins and Kral as well as from Jennifer Smith and Patrick Desbiens as fact witnesses and of Laëtitia Bénard and Drs. Goldstein, Kennedy, Wuest and Brock as expert witnesses. Dr. Kennedy’s evidence is no longer relevant as it relates solely to the issue of sound prediction, which Apotex raised in its NOA but dropped in its Memorandum and is no longer in play.
[33] As noted, Doctor Daugan is the inventor of the 377 and 784 Patents and is a French pharmaceutical researcher employed by GSK France. In his affidavit, he describes his involvement in the development of tadalafil as part of a research project to identify PDE V inhibitors for the treatment of hypertension and congestive heart failure. He recounts that a patent was filed when tadalafil was first developed (GB Patent No. 9401090.7, the international version of the 377 Patent). After this patent was filed, and after seeing literature on the use of PDE V inhibitors in treating ED, discussions with colleagues at Laboratoire Glaxo and early clinical trials of tadalafil, he says he began to consider that tadalafil could be used to treat ED. He says that at this point the second patent – the international version of the 784 Patent – was filed.
[34] Dr. Grondin is employed as a researcher by GSK France. His affidavit describes his role in supervising the early in vitro experiments on tadalafil. Like Dr. Daugan, he describes the decision to file the international version of the 784 Patent after researchers predicted that tadalafil – initially developed to treat hypertension and congestive heart failure – could also be used to treat ED. He says this decision was based in part on the review of the patent application relating to sildenafil, which is better known under its brand name, VIAGRA.
[35] Pfizer filed a patent application for sildenafil that was published before the priority date of the 784 Patent. More specifically, PCT Application No. WO 94/28902 [the 902 Application] has a publication date of December 22, 1994. The Canadian version of this Patent, CA 2,163,446, was filed May 13, 1994. Sildenafil is chemically distinct from tadalafil, but like tadalafil, is a potent and selective PDE V inhibitor and is used to treat ED. As is more fully discussed below, in Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60, [2012] 3 SCR 625 [Sildenafil SCC], the Supreme Court of Canada held that an NOC should issue for a generic version of sildenafil because the allegations of insufficiency made with respect to the Canadian version of the 902 Application were justified, since the Patent failed to disclose that sildenafil was the compound claimed in the patent that was effective to treat ED.
[36] The next Lilly witness, Dr. Martins, is a pharmacologist and a specialist in cGMP and PDE enzymes. In his affidavit he describes his experience in the preparation of the recombinant PDE V enzymes for the research leading up to the 784 Patent. His evidence is not central to the issues that remain in play in this application.
[37] Jennifer Smith is counsel at Eli Lilly Canada and appends to her affidavit the 1997 Amendment to the Collaboration Agreement between Glaxo Group Limited, Glaxo Wellcome Inc. [Glaxo U.S.] and ICOS Corporation [the 1997 Amendment] that Lilly claims is the document pursuant to which rights in the 784 Patent were assigned from Glaxo Group Limited and its affiliates to ICOS.
[38] Patrick Desbiens is the President of GSK France. In his affidavit he states that in 1997 Laboratoire Glaxo was an affiliate of Glaxo Group Limited within the meaning of the 1991 Collaboration Agreement by and among Glaxo Group Limited, Glaxo U.S. and ICOS [the 1991 Collaboration Agreement] that was amended by the 1997 Amendment.
[39] Dr. Kral is the co-inventor of another patent pertaining to tadalafil, Canadian Patent No. 2,379,948 [the 948 Patent], which is a formulation patent. In her affidavit she describes her involvement in the research and introduces two early research reports that she reviewed in the context of her work leading up to the 948 Patent.
[40] In terms of Lilly’s experts, Laëtitia Bénard is a French lawyer and offers the opinion that, under French law, the rights to an invention made “during the course of a mission” by an employee hired to invent under an employment agreement belong to the employer. The implication is that the rights to the tadalafil patents, for which Dr. Daugan is the named inventor, automatically transferred to his employer, Laboratoire Glaxo.
[41] Dr. Brock is a urologist, specializing in ED. He teaches at and is the Program Director for the Urology Residency Training Program at the University of Western Ontario. He is currently the Secretary of the Sexual Medicine Society of North America, the Vice-President of the Canadian Urology Association and the Scientific Chair of the Society for the Study of the Aging Male. He is the author of over 150 publications, 25 book chapters, numerous abstracts and the recipient of more than 20 research awards from national and international research organizations. He has spoken widely, and his work in urology and erectile dysfunction has been acknowledged through his role as section editor of the Canadian Urology Association Journal, as well as through his participation as an editorial board member of numerous other scientific journals. Dr. Brock was accepted as an expert in respect of issues similar to those that arise in this case in Mylan Tadalafil and in two sildenafil cases: Pfizer Canada v Novopharm, 2009 FC 638, 76 CPR (4th) 83 (Kelen J), rev’d on other grounds in Sildenafil SCC, and Pfizer Canada v Apotex, 2007 FC 971, 61 CPR (4th) 305 (Mosley J), aff’d 2009 FCA 8, 72 CPR (4th) 141 [Sildenafil NOC].
[42] Dr. Brock consults for many pharmaceutical companies, including Lilly. He was involved in the clinical trials of sildenafil and was also the lead investigator for several Phase II clinical studies undertaken by Lilly in conjunction with tadalafil. He sits on the advisory board of Lilly. He also participated in the press briefings when tadalafil was revealed by Lilly and, during the course of these briefings, sat alongside the senior executives of Lilly as part of the company’s team.
[43] In his affidavit, Dr. Brock offers opinions on the issues of double patenting, sound prediction and insufficiency. In terms of double patenting, he opines that the 784 Patent is not invalid for double patenting over the 377 Patent. Regarding same invention-type double patenting, he believes that the two patents do not claim the same invention. Regarding obviousness-type double patenting, he believes that the person skilled in the art would not consider the inventive concept of the 784 Patent to be obvious. The other issues discussed in his affidavit are no longer in play as Apotex dropped its allegations related to sound prediction and to the particular argument regarding insufficiency that Dr. Brock references in his affidavit.
[44] Dr. Goldstein is also a urologist, specializing in sexual dysfunction. He was the co-Director of the Laboratory for Sexual Medicine Research at the Boston University School of Medicine from 1981 to 2005 and the editor-in-chief of the International Journal of Impotence Research from 2001 to 2004. From 2004 to 2014 he was the editor-in-chief of the Journal of Sexual Medicine and is currently the editor-in-chief of the Journal of Sexual Medicine Reviews. He is currently a consultant and is also the Director of Sexual Medicine and a Clinical Professor of Surgery at the Alvarado Hospital and the University of California, San Diego. Like Dr. Brock, he has belonged to numerous professional organizations and has written broadly in areas associated with sexual dysfunction, with nearly 300 peer-reviewed papers, multiple book chapters and research awards from national and international organizations. Like Dr. Brock, he was accepted by this Court as an expert in respect of issues similar to those that arise in this case in Mylan Tadalafil.
[45] In his affidavit, Dr. Goldstein offers opinions on the issues of double patenting, sound prediction and insufficiency. In terms of double patenting, he opines that the 784 Patent is not invalid for double patenting over the 377 Patent as he believes the claims of the 784 Patent are novel and inventive over the claims of the 377 Patent. The other issues discussed in his affidavit are no longer in play as Apotex has dropped them.
[46] Dr. Wuest is a Professor of Chemistry at the Université de Montréal and possesses a Ph.D. in chemistry from Harvard University. His research focuses on design, synthesis, structure and properties of molecular materials. He is a member of several advisory boards and selection committees associated with the award of prizes in chemistry, has published and delivered a myriad of peer-reviewed papers and has received several research grants.
[47] In his affidavit, Dr. Wuest provides an opinion on insufficiency and expresses the view that once a person skilled in the art had made the compounds to which the 784 Patent pertains, that person could solubize them, attempt to crystallize them in the presence of water under a variety of conditions and carry out routine variations of these conditions to form hydrates. He thus expresses the view that the 784 Patent is not invalid for insufficiency for lack of directions regarding the production of hydrates of tadalafil and 3-methyl tadalafil.
[48] As for Apotex’ witnesses, the fact witnesses include a law clerk, who merely appends documentation to her affidavit, and Duane Terrill, the Associate Director, Regulatory Affairs at Apotex, who explains in his affidavit the somewhat circuitous route by which this application came to be. His evidence is not relevant to the issues that remain to be decided in this application.
[49] Apotex’ expert witnesses are Dr. Corbin, Dr. Burnett and Dr. Warrington, who speak to the issue of double patenting, Mark Eisen, a patent agent who opines on the chain of title issue, and Dr. Trout, who opines on the insufficiency issue.
[50] Dr. Corbin is a biochemist and is currently a Professor Emeritus in the Department of Molecular Physiology and Biophysics at the Vanderbilt University School of Medicine in Nashville, Tennessee. Previously, he was a Professor and Assistant Professor at the same university. Over the course of his career, Dr. Corbin has sat on various editorial boards and editorial advisory boards, including for the Journal of Biological Chemistry, received multiple research grants and has published widely in various peer-reviewed journals and presented numerous papers at conferences. He discovered PDE V and has studied the effects of sildenafil, vardenafil and tadalafil on PDE V.
[51] The portions of his affidavit that are relevant in this application deal with the issue of double patenting. He offers the opinion that the 784 Patent is invalid for obviousness-type double patenting, taking the view that a person skilled in the art with the common general knowledge (at July 11, 1996 or July 14, 1995) would not have required inventive ingenuity to bridge the gap between the subject matter disclosed and claimed in the claims of the 784 and 377 Patents.
[52] Dr. Burnett is a urologist specializing in sexual medicine. He is currently the Patrick C. Walsh Distinguished Professor at the Department of Urology at Johns Hopkins University School of Medicine in Baltimore, Maryland. He is also the Director, Basic Science Laboratory in Neurology, Sexual Medicine Fellowship Program and the Sexual Medicine Division in the Department of Urology at John Hopkins Hospital. He has published nearly 200 peer-reviewed articles, several non-scientific articles and editorials, two books and 42 book chapters and has served in an editorial capacity for numerous journals and reviews. He is a member of several professional organizations, advisory committees and review groups.
[53] In his affidavit, Dr. Burnett opines on the double patenting issue and offers the opinion that a person skilled in the art with the common general knowledge at the date(s) he was asked to consider (July 14, 1995 and July 11, 1996) would not have required inventive ingenuity to arrive at the subject matter disclosed and claimed in the claims of the 784 Patent in light of the subject matter claimed in the 377 Patent.
[54] Dr. Warrington is a medicinal chemist with a Ph.D. in pharmaceutical chemistry from the University of London. He worked from 1965 to 2005 for Smith Kline & French Laboratories Ltd. and successor companies, SmithKline Beecham Pharmaceuticals and GlaxoSmithKline R&D Ltd. [collectively, SmithKline]. From 1986 to 1992, he led SmithKline’s research program on PDE enzyme inhibitors. Following his retirement from SmithKline, Dr. Warrington held the positions of visiting professor in the Chemistry Department at the University of Durham and member of the steering committee of that university’s Biological Sciences Institute. He also sits on the advisory panel and the commercialization advisory panel of the University of Strathclyde and has chaired special committees associated with micro- and nanotechnologies, proteomics and high throughput technologies. In addition, he has served as a consultant to a range of pharmaceutical companies and has co-authored approximately 40 scientific publications dealing predominantly with medicinal chemistry.
[55] In his affidavits, Dr. Warrington opined on construction of the 377 and 784 Patents, double patenting, utility and sound prediction. In terms of double patenting, Dr. Warrington offers the view that the skilled person would not have required inventive ingenuity to arrive at the subject matter of Claims 1, 2, 4, 9-12, 14, 15 and 18 of the 784 Patent in light of the subject matter of Claims 10, 13 and 19 of the 377 Patent and the common general knowledge assessed as of the dates he was given (July 14, 1995 and July 11, 1996). His opinions on utility and sound prediction are not relevant in this application as Apotex has not pursued these allegations.
[56] Dr. Trout is a Professor of chemical engineering at the Massachusetts Institute of Technology and holds a Ph.D. from the University of California at Berkeley in chemical engineering. He has frequently spoken on pharmaceuticals and pharmaceutical processing and regularly teaches a course on pharmaceutical crystallization to industry. He has published over 135 papers in refereed journals and has served as reviewer for several journals. His research is related to pharmaceutical development and manufacturing, with particular emphasis on pharmaceutical crystallization and nucleation (or the first step in crystallization).
[57] In his affidavit, Dr. Trout opines that the 784 Patent does not teach how to prepare hydrates of tadalafil or 3-methyl tadalafil and that a skilled person would not be able to prepare hydrates of these substances having regard to the common general knowledge. He thus offers the view that the 784 Patent is invalid for insufficiency.
[58] Finally, Mark Eisen is a patent agent who provides evidence on the chain of title issue. He deposes that Dr. Daugan signed an assignment of his rights in the 784 Patent to ICOS Corporation, effective January 19, 1998, and that this assignment was registered by the Canadian Intellectual Property Office [CIPO] on April 6, 1998. He also deposes that no other assignment of rights in respect of the 784 Patent was filed with CIPO.
V. Is the 784 Patent Invalid for Double Patenting over the 377 Patent? [59] I turn now to assessment of the first ground of invalidity asserted by Apotex, namely, that the 784 Patent is invalid for double patenting over the 377 Patent.
A. General Principles Applicable to Double Patenting [60] The doctrine of double patenting, as developed by Canadian courts, prevents a patent holder from “evergreening” its patent by obtaining a second patent for the same invention for which a patent has already been granted. Typically, double patenting is asserted as a ground of invalidity where, like here, the first patent is not yet published at the priority date of the second patent and therefore cannot be considered in an obviousness analysis. Under section 28.3 of the Patent Act, RSC 1985, c P-4, the obviousness analysis is temporally limited to the claim date, i.e. the priority date of the patent in issue – where there is an international filing under the Patent Cooperation Treaty – or to one year prior to the Canadian filing date, where there is no priority claim made in the patent. Section 28.3 of the Patent Act provides in this regard:
Invention must not be obvious
Objet non evident
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.
[61] In the leading case dealing with double patenting, Whirlpool Corp v Camco Inc, 2000 SCC 67, [2000] 2 SCR 1067 [Whirlpool], Justice Binnie described the policy behind the doctrine of double patenting in the following terms at para 63:
The prohibition against double patenting relates … to the “evergreen” problem … The inventor is only entitled to “a” patent for each invention: Patent Act, s. 36(1). If a subsequent patent issues with identical claims, there is an improper extension of the monopoly.
[62] In Whirlpool, the Supreme Court held that double patenting requires comparison of the claims in the two patents of the patent holder and that there are two sorts of double patenting: same invention-type double patenting and obviousness-type double patenting.
[63] In same invention-type double patenting, the claims in the subsequent patent are identical to or coterminous with the claims in the earlier patent. As Justice Roger Hughes noted in Merck & Co v Pharmascience, 2010 FC 510 at paras 117-124, 85 CPR (4th) 179 [Finasteride] and Bristol-Myers Squibb Canada Co v Apotex, 2009 FC 137 at paras 173-175, 74 CPR (4th) 85, the inquiry in this type of double patenting is akin to the anticipation inquiry and involves asking whether the patent holder has claimed the same invention as claimed in the earlier patent.
[64] Obviousness-type double patenting is a broader concept and involves determining whether the claims in the subsequent patent are patentably distinct from those in the first patent or, in other words, involve a non-obvious invention over and above that claimed in the first patent. As Justice Binnie noted in Whirlpool, above, obviousness-type double patenting “is a more flexible and less literal test that prohibits the issuance of a second patent with claims that are not ‘patentably distinct’ from those of the first patent” (at para 66).
[65] A classic case of this sort of double patenting arose in Commissioner of Patents v Farbwerke Hoechst Aktiengesellschaft Vormals Meister Lucius & Bruning, [1964] SCR 49, 41 CPR 9 [Farbwerke] where the subsequent patent claimed a diluted form of the medicine identified in the earlier patent. There, Justice Judson held at page 53 that the claims of the second patent were not patentably distinct from those in the earlier patent because the addition of a common excipient to increase bulk did “not result in a further invention over and above that of the medicinal itself”.
[66] Conversely, in Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 at paras 112-115, [2008] 3 SCR 265, selection of one of the compounds that was particularly efficacious from among hundreds of thousands falling within the scope of an earlier genus patent was found not to constitute obviousness-type double patenting because the second compound was patentably distinct from the larger genus claimed in the original patent as it possessed advantages that were not claimed in the earlier patent.
[67] In Whirlpool, in addition to delineating the bounds of the doctrine of double patenting, the Supreme Court also underscored that a purposive approach to claims construction is required when construing patent claims. This requires identification by the court, with the assistance of expert evidence, of the essential elements of the claims as they would be understood by a person skilled in the art to which the patent is addressed. Thus, the words used in the claims are not to be read merely in a grammatical sense but, rather, must be interpreted knowledgeably through the eyes of a skilled reader and in the context of the specification as a whole so as to arrive at an interpretation that is, according to the Supreme Court, neither too benevolent nor too harsh and that is thus fair to both the patentee and the public. Therefore, while the specification cannot be used to expand or contract the claims, it may, where necessary, be used to construe the claims of a patent (Whirlpool, above, at para 49; Consolboard Inc v MacMillan Bloedel (Sask) Ltd, [1981] 1 SCR 504 at 520, 122 DLR (3d) 203 [Consolboard]).
[68] Thus, to recap, in order to assess a claim of double patenting, the court must undertake the following three-step inquiry:
• First, it must set out what is claimed in each of the patents, construing the claims, if necessary;
• Second, the court must determine if the claims in the two patents are identical. If they are and the same invention is claimed, the second patent will be void for same invention or coterminous double patenting; and
• Finally, if the inventions claimed in the two patents are not identical, the court must then go on to determine if the invention claimed in the later patent is inventive or patentably distinct from the invention claimed in the earlier patent. If not, then the second patent will be void for obviousness-type double patenting.
B. Disputes Between Lilly and Apotex in Respect of Double Patenting [69] In the present case, application of the foregoing analytical framework gives rise to three principal points of dispute between Apotex and Lilly.
[70] First, they disagree on how the claims in the 377 Patent are to be construed, with Lilly arguing they should be construed narrowly and Apotex arguing they should be construed more broadly.
[71] Second, they disagree as to the date at which the obviousness-type double patenting inquiry is to be conducted. Lilly says it should be undertaken at January 21, 1994, the priority date of the 377 Patent, the earlier of the two relevant patents in this case. Apotex, on the other hand, argues that it should be undertaken at February 6, 1997, the publication date of the 784 Patent, the later of the two relevant patents in this case. They, however, agree as to the outcome of the analysis undertaken at each of these dates.
[72] More specifically, if the relevant date for purposes of the inquiry is the earliest possible one, i.e. January 21, 1994, the priority date of the 377 Patent, Apotex conceded in oral argument that the claims of the 784 Patent would not be obvious over the claims of the 377 Patent because the common general knowledge of the skilled person – through whose eyes the Patents are to be construed – had not advanced enough to render the claims of the 784 Patent obvious by January 21, 1994.
[73] On the other hand, if the relevant date for assessing obviousness-type double patenting is the latest possible one posited, i.e. February 6, 1997, the publication date of the 784 Patent, Lilly does not contest that the claims in the 784 Patent would be void for obviousness-type double patenting and, indeed, called no evidence to counter Apotex’ expert evidence that the common general knowledge of the skilled person to whom the 784 Patent is addressed had advanced to such a degree by February 1997 so as to render the claims of the 784 Patent obvious.
[74] Thus, if obviousness-type double patenting is assessed at January 21, 1994, the parties concur that the 784 Patent is not void for obviousness-type double patenting. Conversely, if the analysis is undertaken as of February 6, 1997, they agree that it would be void for obviousness-type double patenting.
[75] The parties, however, diverge as to the outcome of the obviousness-type double patenting inquiry if the relevant date for assessing the issue falls somewhere between January 21, 1994 and February 6, 1997. This is their third area of disagreement.
[76] Lilly says that if th