Boehringer Ingelheim (Canada) Ltd. v. Jamp Pharma Corporation

Boehringer Ingelheim (Canada) Ltd. v. Jamp Pharma Corporation
Court (s) Database
Federal Court Decisions
Date
2024-08-08
Neutral citation
2024 FC 1198
File numbers
T-1563-22
Decision Content
Date: 20240808
Docket: T-1563-22
Citation: 2024 FC 1198
Ottawa, Ontario, August 8, 2024
PRESENT: The Honourable Madam Justice Furlanetto
BETWEEN:
BOEHRINGER INGELHEIM (CANADA) LTD. AND BOEHRINGER INGELHEIM INTERNATIONAL GMBH
Plaintiffs
and
JAMP PHARMA CORPORATION
Defendant
PUBLIC JUDGMENT AND REASONS
(Confidential Judgment and Reasons issued July 26, 2024)
I. Overview [1] This judgment arises from a patent infringement action brought under subsection 6(1) of the Patented Medicines (Notice of Compliance Regulations), SOR/93-133 [PMNOC Regulations]. The patents at issue are Canadian Patent Nos. 2,591,083 [083 Patent] and 2,726,267 [267 Patent]. The innovative drug at issue is nintedanib, which is sold under the brand name OFEV®.
[2] Boehringer Ingelheim (Canada) Ltd. [BI] is the “first person” in accordance with the PMNOC Regulations. Boehringer Ingelheim International GmbH [BII] is the registered owner of the 083 Patent and the 267 Patent and is a party to the action pursuant to subsection 6(2) of the PMNOC Regulations.
[3] BI claims that the making, constructing, using and/or selling by the Defendant JAMP Pharma Corporation [JAMP] of its nintedanib capsules in a strength of 150 mg [JAMP Nintedanib] in accordance with JAMP’s Abbreviated New Drug Submission [ANDS] Control Number 262177 will infringe, and induce infringement of, at least one of claims 1-6 of the 083 Patent [083 Asserted Claims], and at least one of claims 8 (when read through claims 7, 5, 3, 2 and 1, or claims 7, 2 and 1), 22 (when read through claims 8, 7, 5, 3, 2 and 1, or claims 8, 7, 2 and 1) and 23 (when read through claims 8, 7, 5, 3, 2 and 1, or claims 8, 7, 2 and 1) of the 267 Patent [267 Asserted Claims].
[4] JAMP denies infringement of the 267 Patent and also asserts in defence that claim 8 (when read through claims 7, 2, and 1) and claims 22 and 23 (when read through claims 8, 7, 2, and 1) of the 267 Patent are invalid for obviousness and that claim 2 is invalid for overbreadth. JAMP has stipulated that it will induce infringement of the 083 Asserted Claims, but denies that it will directly infringe the claims and also asserts in defence that the 083 Patent is invalid for anticipation, double patenting, lack of sound prediction of utility, or in the alternative to lack of sound prediction, obviousness.
[5] As set out further below, I find that the action should be allowed in part as the 083 Patent is valid and infringed, but the 267 Patent is not infringed.
II. Background [6] The 083 Patent and the 267 Patent are listed on the Patent Register in association with the medicine nintedanib esylate (also spelled esilate), which is the monoethanesulfonate salt of 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone, also known as 3-Z-[1-(4-(N-((4-methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulfonate, depicted below:
[7] BI markets and sells nintedanib capsules in strengths of 100 mg and 150 mg (corresponding to 120.40 mg and 180.60 mg of nintedanib esylate, respectively) under the brand name OFEV®. A generic version of the 100 mg dosage strength of nintedanib is the subject of a separate action in this Court (T-352-24).
[8] OFEV® is indicated, inter alia, for the treatment of idiopathic pulmonary fibrosis [IPF], a rare disease of the lungs. IPF is a chronic, incurable disease that typically leads to respiratory failure and death. IPF is one of seven diseases that are classified as an idiopathic interstitial pneumonia [IIP], which is a sub-category of interstitial lung disease [ILD]. It is a progressive disease in which fibrotic material deposits and accumulates, creating scarring and distorting the interstitium (the passageway that separates the air and the blood) in ways that alters gas exchange function.
[9] Nintedanib is one of only two medicines that have been approved for the treatment of IPF in Canada. BI holds Notices of Compliance [NOC] for OFEV® and began selling OFEV® in Canada in 2014.
[10] JAMP was issued a NOC for JAMP Nintedanib on September 6, 2023. JAMP Nintedanib is approved for the treatment of IPF. However, JAMP Nintedanib has not yet been offered for sale or sold in Canada. If JAMP elects to launch JAMP Nintedanib in Canada, it will be the importer of JAMP Nintedanib into Canada, it will sell JAMP Nintedanib in Canada, and it will market JAMP Nintedanib for the indications contained in the JAMP Nintedanib product monograph.
[11] For purposes of this proceeding, the Plaintiffs have renounced the 24-month stay provided by paragraph 7(1)(d) of the PMNOC Regulations in accordance with paragraph 7(5)(b) of the PMNOC Regulations.
III. The Patents A. The 083 Patent [12] The 083 Patent is entitled “Medicaments for the Treatment or Prevention of Fibrotic Diseases” and is the national phase entry of a Patent Co-operation Treaty [PCT] patent application. The 083 Patent has a filing date of December 21, 2005 and claims priority from European Patent Application No. 04030770.4, filed on December 24, 2004. The application for the 083 Patent was published on June 29, 2006, and issued to patent on October 1, 2013. It will expire on December 21, 2025.
[13] Page 1 of the 083 Patent identifies the technical field of the invention of the 083 Patent as relating to a new use of indolinones of general formula (I) substituted in the 6 position, the tautomers, the diastereomers, the enantiomers, the mixtures thereof and the salts thereof, particularly physiologically acceptable salts thereof (083 Patent, Ex1, 1:13-21).
[14] The Background of the 083 Patent describes the compounds of general formula (I) as previously known and as having “valuable pharmacological properties” and “an inhibiting effect on various kinases, especially receptor tyrosine kinases such as VEGFR2, PDGFRα, PDGFRβ, FGFR1, FGFR3, EGFR, HER2, IGF1R and HGFR” (083 Patent, Ex1, 2:5-9).
[15] It notes that none of the compounds of general formula (I) have previously been described for their use in the treatment or prevention of fibrotic diseases (083 Patent, Ex1, 2:19-21). The 083 Patent notes that instances where fibrosis “severely compromises the normal function(s) of the organ” can lead to severe fibrotic diseases, including “idiopathic pulmonary fibrosis (IPF), liver cirrhosis, scleroderma, or renal fibrosis” (083 Patent, Ex1, 3:5-12).
[16] The 083 Patent discusses the biochemical mechanisms that underlie fibrosis and notes that “[a] large body of literature implicates the platelet-derived growth factor (PDGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), and transforming growth factor beta (TGF-β) growth factor families in the induction or persistence of fibrosis” (083 Patent, Ex1, 3:14-24). These factors bind to receptors with tyrosine kinase activity, i.e., VEGFR, for example. The 083 Patent states that experimental models reported in the literature suggest that inhibition of tyrosine kinases seems to reduce the severity of fibrosis (083 Patent, Ex1, 5: 21-23).
[17] In the Summary of the Invention, the inventors indicate that they have surprisingly found that the compounds of general formula (I) are effective in the treatment or prevention of specific fibrotic diseases (083 Patent, Ex1, 5:28-30). The Summary provides embodiments of the invention relating to nintedanib, its esylate salt and pharmaceutical compositions thereof for use in the prevention or treatment of IPF and to the use of nintedanib and its esylate salt for the prevention or treatment of IPF.
[18] In the Detailed Description [Description], the 083 Patent discloses compounds of general formula (I) and their synthesis with reference to methods described in prior patent applications. The Description provides a list of 795 compounds that it states are illustrative of the present invention (083 Patent, Ex1, 92:19-179:16). It identifies the monoethanesulfonate salt of nintedanib as a particularly preferred compound and recognizes its prior disclosure in WO 04/13099 [WO 099] (083 Patent, Ex1, 91:14-92:1).
[19] The Description provides a lengthy list of fibrotic diseases suitable for treatment with the compounds of general formula (I), highlighting that the compounds of the invention are especially suitable for the prevention or treatment of IPF as a “preferred embodiment” (083 Patent, Ex1, 180:27-31).
[20] Under the heading “Biological Activity”, the 083 Patent provides two examples evaluating compounds in a bleomycin-induced rat lung fibrosis model following a regimen known to the person skilled in the art [PSA] as the “preventative regimen”. Example B2 refers to a study involving nintedanib (compound (u)) (083 Patent, Ex1, 188:10-14). Three groups of rats were tested in the example. The first group was exposed to bleomycin sulfate (bleomycin) on day 0, followed by daily administration of nintedanib (compound (u)) for 21 days. The second group (which was the positive control) was exposed to bleomycin on day 0, followed by a saline vehicle for 21 days. The third group was treated with a saline vehicle (instead of bleomycin) between days 1 and 21, and served as the negative control.
[21] On day 21 of the study, the rats were sacrificed and their lungs surgically removed. One lung was used for histological analysis and the other lung was used to evaluate gene expression activity.
[22] From the histological analysis, the 083 Patent reported that “daily treatment of bleomycin-treated rats with 50 mg/kg of compound (u) [or nintedanib] showed a consistent, nearly complete reversal of lung fibrosis” (083 Patent, Ex1, 189:7-14, Figure 4). Similarly, the 083 Patent reported that the gene expression analysis demonstrated that nintedanib suppressed levels of fibrotic marker genes (083 Patent, Ex1, 190:6-10).
[23] The 083 Patent suggests that “[b]y reason of their biological properties” the compounds of the invention may be used as a monotherapy or in conjunction with other pharmacologically active compounds (083 Patent, Ex1, 190:13-206:25). It goes on to provide 10 exemplary formulations, including a tablet (Examples F1-F3), capsule (Examples F4 and F9), suppository (Example F5), suspension (Example F6), ampoule (Examples F7-F8), and solution for inhalation (Example 10) (083 Patent, Ex1, 207:16-214:12).
B. The 267 Patent [24] The 267 Patent is entitled “Capsule Pharmaceutical Dosage Form Comprising a Suspension Formulation of an Indolinone Derivative” and is the national phase entry of a PCT patent application. The 267 Patent has a filing date of June 4, 2009, and claims priority from European Patent Application No. 08157748.8, filed on June 6, 2008. The application for the 267 Patent was published on December 10, 2009, and issued to patent on October 31, 2017. It will expire on June 4, 2029.
[25] The 267 Patent describes the invention of the patent as relating to a suspension formulation containing the active substance nintedanib esylate, a capsule containing the formulation, a process for preparing the formulation and capsule, and packaging material for the capsule (267 Patent, Ex2, 1:4-9). More particularly, the invention is described as relating to formulations of nintedanib esylate containing lipid suspensions of the active substance in 1 to 90 wt.% medium chain triglycerides [MCT], 1 to 30 wt.% of hard fat, and 0.1 to 10 wt.% of lecithin (267 Patent, Ex2, 1:11-15).
[26] The 267 Patent describes the “aim of the …invention” as obtaining an oral pharmaceutical dosage form of the active substance that meets chemical stability and bioavailability requirements for the desired dosage range tailored to treatment and obtaining packaging suitable for the product (267 Patent, Ex2, 4:9-13).
[27] The Description refers to the surprising finding that a soft gelatin capsule including a liquid formulation comprising a viscous suspension of nintedanib esylate in MCT, hard fat and lecithin, meets the “adequate bioavailability requirements for the desired dosage range tailored to treatment” (267 Patent, Ex2, 8:31-9:5).
[28] The 267 Patent states that an advantage of such soft gelatin capsules containing a lipid suspension is that water uptake into the formulation is very unlikely and the present system is primarily in the capsule shell such that it does not further affect the chemical stability of the active substance (267 Patent, Ex2, 9:7-8, 15-16). The 267 Patent further states that there is no mass increase or sticking problem for the capsules when stored in tight packaging materials (267 Patent, Ex2, 9:23-25).
[29] The Description provides a list of at least 20 different compounds or mixtures thereof that can serve as suitable carriers or carrier components for the active substance of the preferred embodiment, while stating that the most preferred lipid carrier is MCT (267 Patent, Ex2, 11:12-13). It also goes on to identify at least eight different compounds that can serve as suitable thickeners to be used in a preferred embodiment of the invention, stating that the most preferred thickener is hard fat (267 Patent, Ex2, 11:26).
[30] The Description (267 Patent, Ex2, 12:1-7) describes lecithin as “a common excipient for carrier-systems in soft gelatin capsules” that is used “as a glidant of the highly concentrated suspension during encapsulation” and acts as a surfactant, “which may improve distribution of the formulation-droplets during in-vitro dissolution testing as well as in-vivo for drug resorption”. It may also improve wetting of the active substance crystals. It identifies the commercial product Topcithin® as a suitable lecithin to be used in the formulation of the invention.
[31] The Description states that for the present invention lecithin up to a certain content is “surprisingly” useful to improve dissolution behaviour of the finished capsules (267 Patent, Ex2, 12:9-10). The 267 Patent provides as Figure 2, a graphic representation of the effect of increasing amounts of lecithin in the formulation on the in-vitro dissolution rate.
[32] The 267 Patent describes three carrier systems (lipophilic with one surfactant, lipophilic with two surfactants, and hydrophilic) that were tested in rats for bioavailability. The 267 Patent states that all three carrier systems are suitable options for an oral dosage form of nintedanib esylate (267 Patent, Ex2, 12:33-13:4), but that “for reasons of bioavailability … [the] lipid (lipophilic) suspension formulation comprising nintedanib esilate in MCTs, hard fat and lecithin are preferred” (267 Patent, Ex2, 13:6-10).
[33] The 267 Patent provides 10 examples. Examples 1-3 disclose formulations containing nintedanib esylate in different carrier systems. Examples 4-8 disclose soft gelatin capsules having 50, 100, 125, 150 and 200 mg of nintedanib esylate. Example 9 discloses packaging materials for packaging the soft gelatin capsules of Examples 4 to 8, and Example 10 describes a manufacturing process for the preparation of a lipid formulation containing the nintedanib esylate and a process for encapsulation.
IV. Issues [34] The following issues were identified by the parties as those in dispute for this action:
083 Patent
a)The construction of the 083 Asserted Claims, and specifically the meaning to be given to “treatment or prevention of [IPF]” / “prevention or treatment of [IPF]”, and in particular the word “prevention” as used in these phrases, including, as applicable, any permitted alternative construction based on subsection 27(5) of the Patent Act, RSC, 1985, c P-4 [Patent Act];
b)Whether the making, constructing, using or selling of JAMP Nintedanib in accordance with ANDS Control Number 262177 will directly infringe claims 2, 3 and 4 of the 083 Patent?
c)Whether WO 2004/017948 A2 [WO 948] anticipates the subject-matter defined by the 083 Asserted Claims, contrary to paragraph 28.2 of the Patent Act?
d)Whether the 083 Asserted Claims are invalid for double patenting over claims 1, 2, 6 or 7 of Canadian Patent No. 2,495,350 [350 Patent];
e)Whether the use of nintedanib or nintedanib esylate in the prevention or treatment of IPF in human patients could be soundly predicted by the 083 Patent’s Canadian filing date of December 21, 2005?
f)Or, in the alternative, if a sound prediction is found, whether the subject-matter defined by the 083 Asserted Claims would have been obvious on the claim date of December 24, 2004 to a PSA, contrary to section 28.3 of the Patent Act?
g)If the 083 Asserted Claims are determined to be valid and infringed, in addition to a declaration of infringement (and scope of same), the appropriate remedies including the scope of a permanent injunction.
267 Patent
a)The construction of the 267 Asserted Claims, and specifically:
whether “lecithin” (and its amount) is a non-essential element of each of the 267 Asserted Claims; and
the extent of any permitted variability in the weight percentages relevant to claim 5.
b)Whether the making, constructing, use or sale of JAMP Nintedanib in accordance with ANDS Control Number 262177 would infringe the 267 Asserted Claims?
c)Whether claim 8 (when read through claims 7, 2, and 1) and claims 22 and 23 (when read through claims 8, 7, 2, and 1) of the 267 Patent would have been obvious on the claim date of June 6, 2008 to a PSA, contrary to section 28.3 of the Patent Act?
d)Whether claim 2 of the 267 Patent is broader than the invention made by the named inventors of the 267 Patent?
e)If the 267 Asserted Claims are determined to be valid and infringed, in addition to a declaration for infringement (and the scope of same), the appropriate remedies including the scope of a permanent injunction.
V. Witnesses [35] Seven expert witnesses gave testimony at trial: three experts were called by BI (Dr. Roland Bodmeier, Dr. Allan Myerson, and Dr. Timothy S. Blackwell), and four experts were called by JAMP (Dr. Rampurna Prasad Gullapalli, Dr. Sem Hin Phan, Dr. Robert Strieter, and Dr. Jonathan Steed). The parties agreed to stipulations as to the expertise of all expert witnesses.
A. BI’s Experts [36] Dr. Roland Bodmeier – Dr. Bodmeier obtained his Ph.D. from the University of Texas at Austin in 1986, specializing in pharmaceutics. He is currently a Professor of Pharmaceutical Technology at the College of Pharmacy Freie Universität Berlin, Germany where he has worked since 1994. Dr. Bodmeier has experience in pharmaceutical formulation, including the formulation of oral dosage forms of poorly water-soluble drugs. His research includes the solubilisation of poorly water-soluble drugs to improve the rate of dissolution and bioavailability. Dr. Bodmeier was admitted as an expert in pharmaceutical formulation, including the design, development, and testing of oral dosage forms (for example, including capsule, tablet, solution and suspension formulations, including formulations of poorly water-soluble drugs).
[37] Dr. Bodmeier provided three expert reports relating to the 267 Patent. His first report opined on claims construction and infringement. The second report opined on the validity of the 267 Patent and responded to the expert report of JAMP’s expert, Dr. Gullapalli, on that issue. The third report replied to certain comments made by Dr. Gullapalli on infringement.
[38] Dr. Bodmeier was a knowledgeable witness who provided some helpful testimony during his examination. However, his answers on cross-examination were not always direct or responsive leading to lengthy bouts of cross-examination, which at times were difficult to follow. There were also certain inconsistencies with approaches taken in this proceeding to positions taken in prior litigation in which Dr. Bodmeier was an expert. While he described the inconsistencies as a matter of context, his explanations at times fell short of providing the Court with the necessary understanding of the nuances justifying the distinct opinions given.
[39] Dr. Allan Myerson – Dr. Myerson is a Professor in the Department of Chemical Engineering at the Massachusetts Institute of Technology and a registered professional engineer in New York and Ohio. He has over forty years experience in the area of crystallization science and technology, including the study of pharmaceutical salts, crystalline solid forms (polymorphs, pseudopolymorphs), pharmaceutical manufacturing, and industrial applications of crystallization. Dr. Myerson was admitted as an expert in the area of crystallization science and technology, including the study of pharmaceutical salts (including techniques used in salt and polymorph screens), crystalline solid forms (polymorphs, pseudopolymorphs), pharmaceutical manufacturing, and industrial applications of crystallization. Dr. Myerson provided a single expert report, offering opinions on claims construction, obviousness and double patenting concerning the 083 Patent in response to the expert report of JAMP’s expert Dr. Steed and aspects of the expert report of JAMP’s expert Dr. Phan.
[40] I found Dr. Myerson to be a very knowledgeable witness who was direct and forthright in his testimony.
[41] Dr. Timothy S. Blackwell − Dr. Blackwell is the Chair of the Department of Internal Medicine at the University of Michigan. He obtained his M.D. from the University of Alabama in 1988 and completed post-graduate work in the Division of Pulmonary and Critical Care Medicine at Vanderbilt University. Dr. Blackwell has significant experience treating patients with IPF and has conducted research on pulmonary diseases, including IPF for over twenty-five years. Dr. Blackwell was admitted as an expert in the diagnosis and treatment of IPF and other pulmonary diseases with expertise in preclinical studies (including animal model studies) relating to the pathobiology and/or treatment of IPF and other pulmonary diseases. In addition, he is an expert in cell biology, cancer biology and pulmonary immunology.
[42] Dr. Blackwell provided two expert reports on the 083 Patent. In his first report, he opined on claims construction and infringement. In his second report, he opined on anticipation, obviousness, double patenting and sound prediction in response to the expert reports of JAMP’s experts Dr. Phan and Dr. Strieter.
[43] I found Dr. Blackwell to be a knowledgeable and straightforward witness who answered questions fully and fairly, readily conceding points even if against the Plaintiffs’ interests. I have relied on his testimony and the cross-examination on his evidence heavily in my decision.
B. JAMP’s Experts [44] Dr. Rampurna Prasad Gullapalli – Dr. Gullapalli obtained his Ph.D. from the University Health Sciences Centre in Memphis, Tennessee in 1993, specializing in pharmaceutics. He is currently the Vice President of the Pharmaceutical Development Department at Iambic Therapeutics, Inc. in San Diego, California. He has thirty years combined experience working in the soft gels development and manufacturing industry as well as working at various pharmaceutical and biotechnology companies particularly on capsule, tablet, solution and suspension formulation development and product manufacturing. Dr. Gullapalli was admitted as an expert in pharmaceutical formulation with expertise in the design, development, manufacturing and testing of oral dosage forms (including for poorly water-soluble drugs), including capsule, tablet, solution and suspension formulations, and specifically soft gelatin capsule formulations.
[45] Dr. Gullapalli provided two expert reports relating to the 267 Patent. His first report opined on claims construction, obviousness and overbreadth. His second report opined on JAMP Nintedanib and responded to the expert report of Dr. Bodmeier on infringement.
[46] In general, I found Dr. Gullapalli to be a helpful witness who provided useful testimony for the Court. However, there were some aspects of his opinion that appeared to evolve through testimony, particularly as it related to what he initially perceived as certain differences between lecithin and polyglyceryl-3 dioleate [PG3D], which raised some uncertainty as to the strength of those aspects of his opinion. There were also some positions on prior art which seemed to be inconsistent as between his opinions on substitutability and obviousness. However, as it is my view that the issue of infringement of the 267 Patent is dispositive of the issues on that patent, and turns largely on a reading of the 267 Patent itself, these concerns with Dr. Gullapalli’s evidence were not significant to my overall findings.
[47] Dr. Sem Hin Phan – Dr. Phan obtained a Ph.D. in Biological Chemistry and M.D. from Indiana University in 1975 and 1976, respectively. He is currently a Professor in the Department of Pathology at the University of Michigan Medical School where he has worked since 1980. He has over forty years research experience in the areas of tissue injury, repair, remodeling and fibrosis. Dr. Phan was admitted as an expert in biochemistry, pathology and immunology, including expertise in lung immunopathology, tissue injury, repair, remodeling and fibrosis (including lung/pulmonary fibrosis) and pre-clinical models of lung/pulmonary fibrosis (including animal model studies) relating to the pathobiology and/or treatment of lung/pulmonary diseases (including IPF). In addition, he is an expert in cell biology and pulmonary immunology. Dr. Phan provided a single expert report on the 083 Patent, opining on claims construction, obviousness, anticipation, and double patenting.
[48] I found Dr. Phan to be a straightforward and direct witness whose evidence on scientific matters was helpful to the Court. Dr. Phan applied his personal knowledge to the reading of the 083 Patent and the prior art, but at times seemed to not fully consider the language used in the patents in context as will be discussed further below.
[49] Dr. Robert Strieter – Dr. Strieter is a physician-scientist (pulmonary and critical care) and currently acts as a consultant to early drug development companies/organizations with a focus on therapies for pulmonary diseases. He obtained his M.D. from Michigan State University in 1983. Prior to his consulting work, Dr. Strieter was a Professor in the Department of Internal Medicine and Division of Pulmonary and Critical Care at the University of Michigan, a Professor and Chief of the Division of Pulmonary and Critical Care Medicine at the University of California-Los Angeles, a Professor and Chairman of the Department of Medicine at the University of Virginia, and the Global Head of Translational Medicine for Respiratory Diseases at Novartis. He has extensive experience researching and treating interstitial lung diseases, including IPF.
[50] Dr. Strieter was admitted as an expert in lung/pulmonary diseases (including lung/pulmonary fibrosis), including the diagnosis and treatment of IPF and other lung/pulmonary diseases. In addition, he has expertise in pre-clinical models of lung/pulmonary fibrosis (including animal model studies) relating to the pathobiology and/or treatment of lung/pulmonary diseases (including IPF), and early drug development (preclinical and translational medicine) of medicinal candidates for the treatment of lung/pulmonary diseases. He was also admitted as an expert in cell biology, cancer biology and pulmonary immunology. In his expert report, Dr. Strieter provided opinions on claims construction and the utility of the 083 Patent.
[51] There is no doubt that Dr. Strieter is a very knowledgeable witness who had valuable insights to provide to the Court arising from his clinical experience with IPF and the treatment of patients with IPF, as well as his experience working as the head of a drug development team. He provided his evidence from his personal standpoint, which in some instances imparted a perspective that went beyond that of the unimaginative skilled technician who is the PSA. I comment on those aspects further below.
[52] Dr. Jonathan Steed – Dr. Steed is a Professor of Chemistry at Durham University in the United Kingdom. Over the past thirty years, his research has focussed on crystallography, crystallization, solid-state chemistry, coordination chemistry and intermolecular interactions in solids, with a particular focus on pharmaceutical solids, co-crystals and hydrates. Dr. Steed was admitted as an expert in synthetic methods, crystallography, crystallization, solid-state chemistry, coordination chemistry and intermolecular interactions in solids, supramolecular gels and crystalline solids (including polymorphs and pseudopolymorphs), particularly pharmaceutical solids, co-crystals and hydrates and techniques used in salt and polymorph screens. Dr. Steed provided a single expert report on the 083 Patent, opining on certain mandate questions relating to claims construction, obviousness, and double patenting.
[53] I found Dr. Steed to be a forthright witness. While his direct experience with salt screens was limited, I found his knowledge of the areas within his mandate to be appropriate and his evidence helpful.
C. Fact Witnesses [54] Two fact witnesses gave evidence at trial on behalf of the Plaintiffs.
[55] The first fact witness, Dr. John Edward Park [Park], is one of the inventors of the 083 Patent. He is a “Highly Distinguished Research Fellow” in the Department of Cancer Immunology and Immune Modulation at Boehringer Ingelheim Pharma GmbH & Co. KG, a member of the Boehringer Ingelheim group of companies. Dr. Park was the former Senior Principal Scientist and Laboratory Head for the cross-therapeutic development work on nintedanib (then called BIBF1120), which compound was initially tested in the company’s Cancer Research department. Dr. Park testified on the pre-clinical development work on nintedanib for IPF.
[56] The second fact witness, Dr. Abhya Gupta [Gupta] is an “Associate Head of Medicine of Therapeutic Area Inflammation” at BII. Dr. Gupta testified on the clinical development of nintedanib for IPF, including the design of a Phase II clinical program and on external expert meetings, which took place as a means to evaluate nintedanib as a drug candidate of interest.
[57] As discussed further below, the evidence of Dr. Park and Dr. Gupta was relevant to the issue of sound prediction of utility and in particular, consideration of the factual basis and sound line of reasoning for the prediction of nintedanib’s use in the prevention or treatment of IPF.
VI. Claims Construction A. Legal Principles
[58] I recently summarized the principles of claims construction in Takeda Canada Inc v Apotex Inc, 2024 FC 106 at paragraphs 69-74 [Takeda]. These principles, which are equally applicable here, are repeated as follows.
[59] The first task for the Court in a patent infringement action is to construe the claims in issue. Claims construction is not a results-oriented exercise. Rather, the claims are to receive one and the same interpretation for all purposes: Whirlpool Corp v Camco Inc, 2000 SCC 67 [Whirlpool] at para 49(b).
[60] The focus of claims construction is on the language of the claims: Free World Trust v Électro Santé Inc, 2000 SCC 66 [Free World Trust] at para 39. The specification describes the invention so that a PSA can understand what the invention is and, when the patent expires, put it into practice, but it is the claims that carve out the boundaries of the proprietary right granted by the patent: Free World Trust at para 33; Merck & Co, Inc v Pharmascience Inc, 2010 FC 510 at para 44.
[61] Purposive construction involves the Court trying to understand the inventor’s objective intention and the particular words or phrases in the claims that describe what the inventor considered to be the essential elements of the invention: Whirlpool at para 45; Free World Trust at para 31(e); Biogen Canada Inc v Pharmascience Inc, 2022 FCA 143 [Biogen] para 74. The interpretative task of the Court is two-fold: to separate and distinguish between the essential and non-essential elements so that legal protection is given only to the essential elements of the invention claimed (Free World Trust at paras 15 and 31(e); Tearlab Corporation v I-MED Pharma Inc, 2019 FCA 179 [Tearlab] at para 31); and, to ascertain what is meant and encompassed by the essential elements so that the invention as claimed is properly characterized (Biogen at para 74).
[62] To ascertain the inventor’s objective intention, however, purposive construction involves looking at the words of the claims in context, which includes the claims individually and as a whole, and considering their purpose, as well as, the patent’s description: Biogen at paras 71-72; Whirlpool at para 49(e). Although the entire patent must be considered, the disclosure should not be used “to enlarge or contract the scope of the claims as written and … understood”: Whirlpool at para 52; Free World Trust at para 32. Adherence to the claim language allows the claims to be read in a way in which the inventor is presumed to have intended, thereby promoting fairness and predictability: Biogen at para 72; Free World Trust at paras 31(a), (b) and 41.
[63] The objective of the analysis is to interpret and respect the inventor’s objective intention as manifested in the words of the claims used, being neither benevolent nor harsh, but rather seeking a construction that is reasonable and fair to both the patentee and the public: Biogen at para 73; Consolboard Inc v MacMillan Bloedel (Sask) Ltd, [1981] 1 SCR 504 at p 520; Teva Canada Ltd v Pfizer Canada Inc, 2012 SCC 60 [Teva] at para 50; Tearlab at para 33. The words of the claims are to be read in an informed way, with a mind willing to understand, and in a way that is sympathetic to accomplishment of the inventor’s purpose, expressed or implicit in the text of the claims: Free World Trust at paras 31(c) and 44. However, as highlighted in Free World Trust at paragraph 51, “...if the inventor has misspoken or otherwise created an unnecessary or troublesome limitation in the claims, it is a self-inflicted wound. The public is entitled to rely on the words used provided the words used are interpreted fairly and knowledgeably.” [Emphasis in the original]
[64] Although the claim language must be read through the eyes of a PSA, as equipped with their common general knowledge [CGK] (Free World Trust at paras 44-45; Tearlab at para 32), a Court is entitled to differ from the construction put forward by either party in arriving at its construction as it is the task of the Court alone to construe the claims as a matter of law: Biogen at para 73; Whirlpool at para 61. The role of experts are to put the judge in the best position to do so in an informed and knowledgeable way: Biogen at para 73; Whirlpool at para 57.
[65] I will thus characterize the PSA of the 083 Patent and the PSA of the 267 Patent and their CGK before construing the claims of the patents.
B. The 083 Patent (1) PSA and CGK [66] The PSA is a hypothetical person to whom the patent is addressed. They are deemed to be unimaginative and uninventive, but at the same time to have an ordinary level of competence and knowledge, incidental to the field of the patent and to be reasonably diligent in keeping up with advances: AstraZeneca Canada Inc v Apotex Inc, 2014 FC 638 at para 51, aff’d 2015 FCA 158, rev’d on other grounds 2017 SCC 36. They have a mind willing to understand the specification put before them and is trying to achieve success, rather than look for difficulties or seek failure: Abbott Laboratories v Canada (Minister of Health), 2005 FC 1332 at para 43, aff’d 2007 FCA 153, citing to Free World Trust at para 44. This may be a single individual or a team of individuals representing different disciplines, depending on the nature of the invention. It is the person, or team of individuals, that would work the patent in a real sense: Takeda at para 76; Alcon Canada Inc v Cobalt Pharmaceuticals Company, 2014 FC 462 at para 37, aff’d 2015 FCA 191, 2015 FCA 192.
[67] The parties agree that the PSA of the 083 Patent would include a physician who treats IPF patients, such as a pulmonologist/respirologist. In addition, I agree with JAMP that the 083 Patent, which includes details on the synthesis of the compounds of the invention, their biological activity, genetic testing and analysis, formulation, pharmaceutical use and administration also includes teachings directed to other members of the drug development team, such as a chemist, biologist, molecular biologist, and formulator. Thus, although it is the perspective of the pulmonologist/respirologist on which the parties focus for the issues at play, a multi-disciplinary team would form the PSA of the 083 Patent.
[68] To properly equip myself for the claims construction exercise, I must also consider the CGK of the PSA of the 083 Patent as of June 29, 2006. CGK is the knowledge generally known by the PSA at the relevant date; however, it does not include all information in the public domain: Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 [Sanofi] at para 37; Bell Helicopter Textron Canada Limitée v Eurocopter, société par actions simplifiée, 2013 FCA 219 [Eurocopter] at paras 64-65.
[69] The evidence from the experts was consistent that the CGK of the PSA of the 083 Patent included at least the knowledge that:
a)IPF was a rare and serious disease of unknown etiology that was without an effective treatment (Blackwell XC, TT7, 1269:14-22, 1270:5-8; Strieter Ex25 para 69; Phan, XX, TT4, 810:17-811:3).
b)There were no accepted means to identify individuals with susceptibility of developing the disease and no biomarkers for the disease had been identified (Strieter, XX, TT5, 990:1-12; Phan, XX, TT4, 810:6-9, 811:21-812:4).
c)IPF was a progressive disease in which fibrosis (scarring) in the lungs worsened over time, both at existing sites in the interstitium and in additional areas of the lung parenchyma where fibrosis was not yet evident (Blackwell, Ex37, para 97; Strieter, Ex25, para 68).
d)IPF typically was not diagnosed until after onset of symptoms and the disease had progressed. In rare circumstances if an individual had a chest x-ray that showed the development of fibrosis, an IPF patient could be identified at an earlier stage (Strieter XX, TT5, 1038:17-1039:14; Blackwell, XC, TT7, 1275:21-1276:11).
e)As a practical matter, while physicians attempted to treat IPF, the treatments did not improve patient outcomes (Blackwell, XX, TT7, 1346:3-7).
f)Multiple strategies for treating IPF were under investigation with uncertain prospects of success. Those treating patients with IPF were desperate to find therapeutic solutions (Phan XX, TT4, 777:20-781:8, Ex20, para 332; Strieter XX, TT5, 973:1-12, 19-23, 974:8-12; Blackwell, Ex38, paras 228-229).
(2) Claims Construction 083 Patent [70] The 083 Asserted Claims include claims 1-6 of the 083 Patent, which read as follows:
1. Compound [nintedanib] for use in the prevention or treatment of idiopathic pulmonary fibrosis.
2. [Nintedanib esylate], for use in the prevention or treatment of idiopathic pulmonary fibrosis.
3. A pharmaceutical composition for use in the prevention or treatment of idiopathic pulmonary fibrosis, comprising [nintedanib esylate] and a pharmaceutically acceptable carrier.
4. The pharmaceutical composition according to claim 3, in the form of a capsule.
5. Use of compound [nintedanib] in the treatment or prevention of idiopathic pulmonary fibrosis.
6. Use of [nintedanib esylate] in the treatment or prevention of idiopathic pulmonary fibrosis.
[71] The parties do not dispute, and I agree, that all elements of the 083 Asserted Claims are essential. The PSA’s understanding of IPF is as set out earlier in the CGK. The only outstanding construction issue between the parties is