Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research

Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research
Court (s) Database
Federal Court Decisions
Date
2018-03-07
Neutral citation
2018 FC 259
File numbers
T-396-13
Decision Content
Date: 20180307
Docket: T-396-13
Citation: 2018 FC 259
BETWEEN:
HOSPIRA HEALTHCARE CORPORATION
Plaintiff
and
THE KENNEDY TRUST FOR RHEUMATOLOGY RESEARCH
Defendant
AND BETWEEN:
THE KENNEDY TRUST FOR RHEUMATOLOGY RESEARCH,
JANSSEN BIOTECH, INC., JANSSEN INC. and CILAG GmbH INTERNATIONAL
Plaintiffs by Counterclaim
and
HOSPIRA HEALTHCARE CORPORATION, CELLTRION HEALTHCARE CO. LTD.
and CELLTRION, INC.
Defendants to the Counterclaim
REASONS FOR JUDGMENT
TABLE OF CONTENTS
SECTIONS:
PARAGRAPH #
I. Introduction
[1] - [5]
II. Factual Background
[6]
A. General
[6] - [17]
B. Entities
[18]
C. 630 Patent Examples
[19]
D. Witnesses
[20] - [22]
III. Issues
[23] - [25]
IV. Argument and Analysis
[26]
A. Standing Issues
[26]
(1) Issue 1: Ownership of the 630 Patent
[26] - [31]
(2) Issue 2: Standing of Janssen Canada, Janssen US, and Cilag in this action
[32] - [57]
B. Claim Construction
[58]
(1) Issue 3: Who is the POSITA?
[58] - [80]
(2) Issue 4: What was the common general knowledge at the relevant time?
[81] - [82]
(a) Re: MTX
[83] - [91]
(b) Re: Combination Therapy with MTX
[92] - [117]
(3) Issue 5: What is the proper claim construction?
[118] - [120]
(a) Infliximab
[121] - [129]
(b) Adjunctive Therapy/Despite Already Receiving MTX
[130] - [135]
C. Validity of the 630 Patent
[136]
(1) Issue 6: Is the 630 Patent invalid because it is an unpatentable method of medical treatment?
[136] - [155]
(2) Issue 7: does the 630 Patent claim improper priority?
[156] - [159]
(3) Issue 8: Novelty
[160] - [168]
(a) The Kennedy Reports
[169] - [172]
(b) T14 Patient Consent Forms
[173] - [177]
(c) Higgins, Moreland, Feldman, Elliott 1995, Elliott 1994b, and Bologna
[178] - [196]
(4) Issue 9: Obviousness
[197] - [207]
(a) POSITA and Common General Knowledge
[208]
(b) Inventive Concept
[209] - [212]
(c) State of the Art Versus Inventive Concept
[213] - [218]
(d) Differences Obvious to POSITA
[219] - [230]
(5) Issue 10: Double Patenting
[231] - [237]
(6) Issue 11: Sufficiency
[238] - [246]
(7) Issue 12: Overbreadth
[247] - [252]
(8) Issue 13: Utility/Promise of the Patent
[253] - [264]
(9) Conclusion: Validity
[265] - [267]
D. Infringement – Counterclaim
[268]
(1) Issue 14: Does Inflectra(/Remsima) infringe the Asserted Claims?
[268] - [323]
(2) Issue 15: Did Hospira induce infringement of the 630 Patent?
[324] - [328]
(a) Direct Infringement by Third Parties
[329] - [331]
(b) Influence by Hospira
[332] - [333]
(c) Hospira's Knowledge of Infringement
[334] - [335]
(3) Conclusion: Infringement
[336] - [338]
PHELAN J.
I. INTRODUCTION
[1] This trial concerned the validity of Canadian Patent No. 2,261,630 [the 630 Patent] which essentially details the adjunctive use of methotrexate [MTX] and the anti-tumour necrosis factor-α [anti-TNF-α] antibody “infliximab” for the treatment of rheumatoid arthritis [RA] and other autoimmune diseases.
This case also involved a counterclaim that the 630 Patent has been and will be infringed.
[2] RA is an autoimmune disorder that characteristically impacts the joints causing pain and disfigurement, even death.
MTX is a drug that impedes the growth of certain cells.
Infliximab is a chimeric monoclonal antibody biologic drug that prevents TNF-α from binding to TNF-α cell surface receptors. TNF-α is a cytokine (chemical messenger) that plays an important role in the autoimmune reaction.
[3] The Plaintiff in this action is Hospira Healthcare Corporation [Hospira], an interested party under s 60(1) of the Patent Act, RSC 1985, c P-4. Hospira markets, uses, and sells the biosimilar infliximab in Canada under the commercial name Inflectra as a treatment for RA.
[4] The Defendant in this action is the Kennedy Trust for Rheumatology Research [Kennedy]. Kennedy holds the 630 Patent, entitled “Anti-TNF Antibodies and Methotrexate in the Treatment of Autoimmune Disease”.
[5] In this action, the relief at issue is set out below.
The Plaintiff claimed the following against the Defendant:
(1) a declaration that Canadian Patent 2,261,630 (“the ‘630 Patent”) and each of claims 1-42 are and always have been invalid and of no force and effect, pursuant to s. 60(1) of the Patent Act R.S.C., c.P-4, as amended (the “Patent Act”);
(2) a declaration that the Plaintiff’s proposed product will not infringe claims 1-42 of the ‘630 Patent, pursuant to s. 60(2) of the Patent Act;
(3) prejudgment and post-judgment interest;
(4) its costs of this action; and
(5) such further and other relief as this Honourable Court may deem just.
The Defendant (as one of several entities that are Plaintiffs by Counterclaim) claimed the following against the Plaintiff (as one of several entities that are Defendants by Counterclaim):
(a) A declaration that the claims of Canadian Letters Patent No. 2,261,630 (the “630 Patent”) are valid and subsisting;
(b) A declaration that the defendants by counterclaim have or will infringe and induce the infringement of claims 1, 2, 3, 5, 6, 9, 10, 12, 15, 17, 18, 19, 21, 22, 25, 26, 28, 31, 33, 37, 38, 39, 40, 41 and 42 of the 630 Patent (the “Asserted Claims”) contrary to the Patent Act;
(c) An interlocutory and permanent injunction restraining the defendants by counterclaim, by their officers, directors, servants, agents, employees or otherwise, from:
(i) manufacturing, constructing, importing, exporting, selling, offering for sale or using any product that infringes or will be sold for a use that will infringe the Asserted Claims of the 630 Patent; and
(ii) otherwise infringing or inducing the infringement of the Asserted Claims of the 630 Patent;
(d) An order for the delivery-up, or destruction under oath under the supervision of this Court, of all products, in the possession or control of the defendants by counterclaim in infringement of the Asserted Claims of the 630 Patent;
(e) Damages for infringement suffered by Kennedy, Janssen Biotech, Janssen Canada and Cilag in an amount in excess of $50,000, as specified in Rule 182(b) of the Federal Courts Rules, exclusive of costs and interest, or an accounting of profits of the defendants by way of counterclaim, whichever the plaintiffs by counterclaim may elect, after due inquiry and full discovery;
(f) Pre-judgment and post-judgment interest on all monetary relief at the rate of 2% above the prevailing Bank of Canada rates;
(g) Costs of and incidental to this action on a solicitor-client basis or such other basis as this Honourable Court may order, plus GST, and including all disbursements;
(h) Such further and other relief this Honourable Court deems just and proper.
II. FACTUAL BACKGROUND
A. GENERAL
[6] The 630 Patent details the adjunctive use of MTX and infliximab for the treatment of RA and other autoimmune diseases. The history of the 630 Patent is as follows:
the patent was filed on August 1, 1997 as PCT GB1997/002058;
the patent claims priority from United States Patent Application Serial No. 08/690,775, filed on August 1, 1996;
the patent was published on February 12, 1998 as PCT Publication No. 1998/005357;
the patent entered the Canadian National Phase on January 25, 1999;
the patent was issued on December 4, 2012; and
the patent expired on August 1, 2017.
[7] In the early and mid-1990s, existing treatments for RA were sub-optimal with respect to efficacy and/or side effects. There was a pressing need for new and improved treatment options. Researchers discovered a number of pro-inflammatory cytokines in tissue samples from rheumatoid joints, such as interferon, interleukin-1, interleukin-6, TNF-α, and T-cell surface antigens such as CD4 and CD5.
It was hypothesized that the blockade of cytokines or T-cells could be an effective treatment for RA. At this time, biologic treatments were new and held the potential for danger.
[8] Biologics are genetically engineered proteins from human genes and are designed to inhibit specific components of the immune system that play a pivotal role in fueling inflammation.
[9] Researchers pursued a number of therapeutic targets. Drs. Ravinder Maini and Marc Feldmann, the named inventors of the 630 Patent, made the following discovery:
TNF-α sat at the apex of an inflammatory cascade, and that by blocking TNF-α, one could interfere with the production of other pro-inflammatory cytokines found in rheumatoid joints.
Of the pharmaceutical companies to which they proposed this idea, only Centocor Inc. [Centocor] was interested.
[10] At the time, Centocor (which has since been acquired by Johnson & Johnson) was a small biotech company. It had only one approved drug, Centoxin, a monoclonal antibody treatment for sepsis. It was in the process of developing two biologics: cA2 (infliximab), a chimeric monoclonal anti-TNF-α antibody, as a treatment for sepsis, and cM-T412, a chimeric monoclonal anti-CD4 antibody, as a treatment for RA. A chimeric antibody is one made by combining genetic material from a non-human source, such as a mouse, with genetic material from a human being.
[11] Maini and Feldmann used Centocor’s infliximab to design and conduct the T07 trial, a trial wherein ten patients with severe RA were removed from existing treatments (“washed out”) and treated with infliximab over the course of eight weeks. The results of this trial were encouraging and the trial was expanded to include a further ten patients; however, the patients all eventually relapsed. Seven patients were treated in an extension study. The results were positive, but there was concern that the duration of effect diminished with repeated infusions – likely as a result of a patient’s immune response to therapeutic antibodies through human anti-chimeric antibodies [HACA].
[12] During the T07 trial, Centoxin was withdrawn from the market. This led to Centocor suffering great financial strain as its stock fell 90%. Despite this financial pressure, Centocor supported the T09 trial – a four-week, three-arm, double-blind study.
[13] The T07 and T09 trials established that infliximab could provide patients with rapid and significant relief of RA symptoms; however, the duration of effect proved to be limited. Therefore, Maini and Feldmann designed a further trial – T14 – combining infliximab with MTX. This trial was meant to determine whether the response to infliximab could be maintained long-term and whether the combination was more effective than either infliximab or MTX alone.
[14] The T14 trial was a 26-week, seven-arm, double-blind, dose-finding study covering 101 patients, with 15 patients in each arm of the study. Three arms received infliximab at 1, 3, and 10 mg/kg.
[15] The results of the study established that the combination of MTX and infliximab exhibited enhanced efficacy over either drug alone as well as a sustained duration of effect. The T14, T15, and T17 studies (discussed further below) led to the ATTRACT trial, the Phase III trial which led to the worldwide approval of infliximab for the treatment of RA.
[16] The United States Food and Drug Administration [FDA] approved Remicade (the Defendant’s commercial infliximab product) in 1999 for the treatment of RA in combination with MTX. To this day, infliximab is only approved for the treatment of RA in Canada and the United States in combination with MTX.
[17] The allegedly infringing products, Inflectra and Remsima, are subsequent entry biologics containing CT-P13 (an infliximab biosimilar) as the active ingredient. Notices of Compliance were issued by Health Canada in January 2014, following new drug submissions first made by Celltrion Healthcare Co Ltd and Celltrion, Inc [collectively, Celltrion] in 2012. In Canada, Inflectra is imported and distributed by Hospira, following a transfer of Inflectra from Celltrion to Hospira in 2014.
Inflectra has been sold, prescribed, and administered to patients in Canada, including for the treatment of RA. Remsima is not on the market in Canada.
B. ENTITIES
[18] A number of entities were involved or implicated in this action:
Hospira is a Canadian pharmaceutical corporation and an interested party under s 60(1) of the Patent Act. Hospira manufactures and sells pharmaceutical products including Inflectra, a subsequent entry biologic of Remicade.
Celltrion is a South Korean pharmaceutical group that makes, distributes, markets, and sells biopharmaceutical products. It has a business cooperation agreement with Hospira that covers Inflectra and other biosimilar products.
The Kennedy Trust for Rheumatology Research [the Kennedy Trust] is the owner of the 630 Patent. It is a registered charity and company in the United Kingdom. It was created to serve the needs of researchers investigating the fundamental causes of rheumatic diseases. Kennedy was originally called “the Mathilda and Terence Kennedy Institute of Rheumatology”, became “the Mathilda and Terence Kennedy Institute of Rheumatology Trust” in 2000, and became the Kennedy Trust in 2012. Whether Kennedy and the Kennedy Trust are the same entity will be discussed below in Issue 1.
Janssen Biotech Inc. [Janssen US] is an American subsidiary of Johnson & Johnson. It is a biotechnology company that manufactures infliximab, which is the ingredient used by Cilag GmbH International to make the Defendant’s Remicade.
Prior to 2011, Janssen US was named Centocor Ortho Biotech Inc. This entity was formed in 2008 following the merger of Centocor and Ortho Biotech Inc. The 1992 research and licensing agreement [1992 Agreement], as amended, allows Janssen US to license the 630 Patent from the Kennedy Trust, which it in turn sub-licenses to Janssen Inc., Cilag GmbH International, and Cilag AG Schaffhausen (Cilag GmbH International’s operating company).
Janssen Inc. [Janssen Canada] is the Canadian subsidiary of Johnson & Johnson. It markets Remicade in Canada, which it buys from Cilag. It sub-licenses the 630 Patent from Janssen US.
Cilag GmbH International [Cilag] is a Swiss subsidiary of Johnson & Johnson. It purchases bulk infliximab from Janssen US, which it manufactures into Remicade through its operating company, Cilag AG Schaffhausen. It is a sub-licensee of the 630 Patent.
The Plaintiff and Defendants to the Counterclaim entities are hereafter generally collectively referred to as Hospira. The Defendant and Plaintiffs by Counterclaim will similarly be generally collectively referred to as Kennedy.
C. 630 PATENT EXAMPLES
[19] Three Examples were disclosed in the 630 Patent, all of which were the subject of considerable evidence in respect of the validity challenge. The Examples were said to support the claims of the 630 Patent.
Example 1 [the T14 Study]: A study conducted in Europe between 1994 and 1996, with results published in 1998. In this study, patients who had been using MTX and who had active disease received either MTX, infliximab, or both.
Example 2 [the T15 Study]: A study conducted in the United States between 1994 or 1995 and 1995 or 1996 that was randomized, double blinded, and placebo controlled. This study “was intended to evaluate the safety and efficiency of a chimeric monoclonal anti-tumor necrosis factor antibody (cA2) following a single infusion of 5, 10 or 20 mg/kg cA2 in combination with methotrexate”.
Example 3 [the T17 Study]: An open label study conducted in the United States between 1994 or 1995 and 1995 or 1996. This study “was intended to evaluate the effects of repeated infusions of 10 mg/kg cA2 in combination with methotrexate administered at a dose of 10 mg/week”.
D. WITNESSES
[20] Hospira called four fact witnesses and five expert witnesses:
a) Mr. Curtis Bamber provided testimony on the commercial arrangements between Hospira, Pfizer, Celltrion and other entities (such as wholesaler Innomar and the provincial formularies). In addition, Bamber testified on Inflectra's similarity to Remicade, the engagement that the Hospira sales team has with prescribing physicians, and the current use of Inflectra in Canada.
b) Ms. Alla Kron testified with respect to her engagement with prescribing physicians when promoting Inflectra. She described visits to Dr. Rubin – a later witness.
c) Dr. Gary Foster described his (partially unsuccessful) attempts to recreate the tables in the Davis Expert Report and the Pinheiro Report using the data provided in the Pinheiro Report related to data from clinical trials.
d) Dr. William Schwieterman provided testimony on his experience with the FDA in the development of drugs and, in particular, the development of biologics.
e) Dr. Vibeke Strand is a rheumatologist and a consultant in the pharmaceutical industry. She was qualified as an expert in the treatment of RA with experience in the design, conduct, and evaluation of clinical trials for RA therapies.
Strand provided testimony on the identity of the ordinary skilled worker, the prior art, and the common general knowledge, including the knowledge on treatment of RA, biologic agents, and MTX. She also testified on the design of the Example 1 study, and the insufficiencies of the data provided in support of the Claims of the 630 Patent. In addition, Strand testified that the subject matter of the Claims was previously known based on prior disclosures, and that the invention was obvious in light of the prior disclosures. She also described the promised utilities of the 630 Patent. Finally, Strand provided testimony on the biosimilarity of Remicade and Inflectra.
I found Strand to be a relatively unhelpful and untrustworthy witness. She was impeached multiple times on cross-examination by her testimony in other (related) proceedings. In addition, her close ties to the Plaintiff gave the Court cause for concern. I put little weight on her evidence of prior disclosure which was her principal focus.
f) Dr. Giovanni (John) Di Battista was qualified as an expert in antibody structure and function.
Di Battista testified on the difference between CT-P13 (Inflectra) and cA2 (Remicade) in terms of glycosylation. He also described the ordinary skilled worker and the common general knowledge (specifically with respect to glycosylation patterns) during the relevant time period. Di Battista also discussed the importance of minor variations in glycosylation, the meaning of “infliximab”, and the comparison between Remicade and Inflectra.
Di Battista was a straightforward, helpful, and credible witness. Nonetheless, I ultimately find that his evidence is insufficient to ground a finding of non-infringement.
g) Dr. Charles Goldsmith was qualified as an expert in epidemiology and biostatistics with respect to musculoskeletal diseases such as RA.
Goldsmith provided testimony on the ordinary skilled worker and the biostatistician's approach to analyzing clinical study results. Goldsmith also analyzed the data in the T14 Clinical Study Report and the T14 Maini Article, and concluded that the data was insufficient to support the conclusions drawn. Goldsmith also critiqued the Davis Expert Report.
Goldsmith was not a helpful witness. He did not review the Claims of the 630 Patent, he did not ask to review the raw data, and he did not do his own statistical calculations. There was insufficient basis for accepting his conclusions.
h) Dr. David Lloyd Scott is a medical doctor, clinical rheumatologist, researcher, and professor of clinical rheumatology. He was qualified as an expert in the treatment of rheumatology as well as the design, conduct, and evaluation of clinical trials.
Scott testified on the standard practice in the United Kingdom concerning the use of disease modifying anti-rheumatic drugs [DMARDs] as of August 1996, the identity of the ordinary skilled worker, and the use of MTX combination therapy as “the next logical step” in RA treatment. He also testified that it was self-evident that the study described in the ARC 1995 Report would be successful. Scott spoke to a number of his past publications during cross-examination.
i) Dr. Peter Tugwell is a medical doctor, clinical rheumatologist, researcher, and professor of medicine and of epidemiology and community medicine. He was qualified as an expert in the treatment of rheumatology, the design, conduct, and evaluation of clinical trials for RA therapies, and musculoskeletal research and the evaluation of evidence with respect to the effectiveness of healthcare interventions for RA.
Tugwell testified as to the next step in biologic development as of August 1, 1996, and the identity of the ordinary skilled worker and the common general knowledge. He testified that the subject matter of the Claims in the 630 Patent was previously known and obvious, and that the 630 Patent disclosed a method of medical treatment.
Tugwell was highly regarded in his field, and highly experienced. In fact, he was almost too qualified and experienced to give persuasive evidence of what the Person of Ordinary Skill in the Art [POSITA] would know, do, or conclude.
Tugwell was a straightforward witness who provided assistance to both the Plaintiff and the Defendant, in almost equal measure.
[21] Kennedy called nine fact witnesses and five expert witnesses:
a) Dr. Marc Feldmann is one of two named inventors of the 630 Patent. He testified as to the background and process leading to the invention disclosed in the 630 Patent. He described his relationship with Dr. Ravinder Maini, the other named inventor, and the relationship between Kennedy and the Kennedy Trust. He also described the novelty of the invention, as well as the trials leading to the 630 Patent.
b) Dr. Thomas Schaible is a former employee of Centocor and Janssen US. He provided evidence on the development of Remicade from the perspective of someone working at Centocor at the time.
c) Mr. Pierre Espinasse is the General Manager of Kennedy. He testified with respect to the history and structure of the Kennedy Trust, as well as the Kennedy Trust's ownership of the 630 Patent.
d) Mr. Robert Bensen is the proprietor, President, and CEO of the Charlton Health Group. He provided testimony on the use of Remicade and Inflectra in Charlton Health Group clinics, particularly with respect to MTX combination therapy.
e) Ms. Lisa Pinheiro is a vice president at the economic consulting firm Analysis Group. She described the work that she did in transferring data from the appendix of the study report into electronic form, focusing on the data underlying the tables in the 630 Patent.
f) Mr. Kevin Seeto is a finance manager at Janssen Canada and responsible for inventory management. In the 2013-2014 period, he was responsible for reporting Canadian Remicade sales to Janssen US by indication as a revenue and strategic planning finance manager. Seeto described the Remicade product and product flow between Cilag, Cilag AG Schaffhausen, Janssen US, and Janssen Canada.
g) Mr. Graeme Forster is the finance manager at Johnson & Johnson who is responsible for the calculation and payment of royalties owed under third-party licensing agreements. He testified as to the relationship between Kennedy and Janssen US, including the licences and sublicences for Remicade.
h) Mr. Jason Nitert is a business unit director for rheumatology and dermatology with Janssen Canada. He is responsible for the sales and marketing strategy for Remicade. He provided testimony on the Remicade and Inflectra products, as well as promotional efforts and commercial success.
i) Mr. Glenn Abe is the director of SEB strategy at Janssen Canada. He testified with respect to IMS data on Inflectra use in Canada, including whether these patients were receiving combination therapy with MTX.
j) Dr. Michael Schiff is a medical doctor, clinical rheumatologist, researcher, and professor of medicine and rheumatology. He was qualified as an expert in internal medicine and rheumatology, the development and science of treatments for RA.
Schiff identified the POSITA and the state of the art, construed the Claims of the 630 Patent, and provided opinions as to novelty, obviousness, utility, and whether the 630 Patent discloses a method of medical treatment.
In my view, Schiff's description of the POSITA was more realistic than those offered by the bulk of the Plaintiff's experts. His perspective and understanding of the 630 Patent and the circumstances most closely mirrored that of the POSITA identified in the evidence.
k) Dr. Jack Gauldie is a biochemist, research immunologist, and professor of immunology. He was qualified as an expert in protein and peptide structures, genetic immunotherapies, cytokines including TNF-α, and antibodies.
Gauldie described the POSITA and testified that CT-P13 is identical to cA2. Gauldie also testified that the differences in glycosylation and additional c‑terminal lysine present in CT-P13 played no role in the relevant activity of the antibody.
l) Dr. Charles Davis is a biostatistician, a consultant to the pharmaceutical industry, and a professor of biostatistics. He was qualified as an expert in the generation, monitoring, processing, analysis, and interpretation of data from all stages of clinical drug trials. Davis testified as to his analysis of the data on efficacy in the study report and the 630 Patent.
m) Dr. David Pisetsky is a medical doctor, immunologist, rheumatologist, researcher, and professor of medicine and immunology. He was qualified as an expert in immunology and rheumatology, the development and science of RA treatments, the analysis and interpretation of clinical trials in the area of rheumatology, cytokines such as TNF-α, and therapeutic antibodies.
Pisetsky provided testimony on the POSITA and the common general knowledge. He also testified that the invention disclosed in the 630 Patent had not been anticipated by any of the prior art references. Most importantly, he testified that it would not have been obvious to engage in combination therapy with MTX, and that the 630 Patent showed utility.
n) Dr. Laurence Anthony Rubin is a medical doctor and clinical rheumatologist, as well as a professor of medicine. He was qualified as an expert in rheumatology and immunology, past and present RA treatment in Canada, and the analysis and interpretation of data and the results of clinical drug trials from the perspective of a practising clinical rheumatologist.
Rubin described the POSITA and the common general knowledge. He testified with respect to Remicade and Inflectra, and his own personal practice with Remicade. He also discussed the inventive concept of the 630 Patent (the promise of the 630 Patent, a matter now disposed of by the Supreme Court, which is discussed more fully below) and the Claims of the 630 Patent.
[22] As a general matter, I found that the Defendant’s expert witnesses were more balanced, objective, and relevant than those of the Plaintiff. In so saying I want to be clear that in preferring some experts over others is not an attack on their honesty or trustworthiness. Except with some noted exceptions, these witnesses attempted to be helpful to the Court.
III. ISSUES
[23] Kennedy submitted that the issues for the Court to decide are whether or not: (1) Hospira has infringed the Asserted Claims; and (2) the Claims are invalid.
[24] Hospira, on the other hand, argued an astonishing number and veritable panoply of patent law issues, including: ownership of the 630 Patent, the proper parties to claim under the patentee, the claim date for the 630 Patent, the POSITA, the common general knowledge, claim construction, infringement, novelty, inventiveness (including the scope of the applicable prior art and inventive concept), utility (including the promise, demonstration and sound prediction), obviousness-type double patenting, claim ambiguity, whether the claims impermissibly claim a method of medical treatment, overbreadth, and insufficiency.
[25] I see the issues as follows:
Standing Issues
Is there any doubt as to the ownership of the 630 Patent?
Do Janssen Canada, Janssen US, and Cilag have standing in this action?
Claim Construction
Who is the POSITA?
What was the common general knowledge at the relevant time?
What is the proper claim construction?
Validity of the 630 Patent
Is the 630 Patent invalid because it is an unpatentable method of medical treatment?
Does the 630 Patent claim improper priority?
Is the invention disclosed by the 630 Patent novel (i.e. was the invention anticipated)?
Is the 630 Patent invalid for obviousness?
Is the 630 Patent invalid due to double patenting?
Is the 630 Patent sufficient?
Are the Claims of the 630 Patent overbroad?
Do the Claims of the 630 Patent exhibit utility?
Infringement
Does Inflectra(/Remsima) infringe the Asserted Claims?
Did Hospira induce infringement of the 630 Patent?
IV. ARGUMENT AND ANALYSIS
A. STANDING ISSUES
(1) Issue 1: Ownership of the 630 Patent
[26] Hospira submitted that the Kennedy Trust does not have standing. The evidence showed that the 630 Patent was assigned to Kennedy (“The Kennedy Institute of Rheumatology”) by the named inventors.
[27] Firstly, Hospira contended that Feldmann and Maini were not employed by the Kennedy Trust. There was contradiction between Feldman and Espinasse as to whether the inventors were employees of the Kennedy Trust.
[28] Secondly, Hospira said the evidence did not show that “The Kennedy Institute of Rheumatology” was a name used for the Kennedy Trust. In fact, the evidence showed that the Kennedy Trust and Kennedy are two separate entities: the Kennedy Trust has a mandate of support/funding, and Kennedy is a scientific institute. There is no formal relationship between the two, although the Kennedy Trust has supported Kennedy since the mid-1960s.
[29] Finally, Hospira submitted that Kennedy was transferred to Imperial College in 2000, as were the employment contracts of the named inventors. There were also agreements with respect to intellectual property. Following this, Kennedy moved to Oxford University. Kennedy has failed to put any of these transfers or agreements into evidence.
[30] However, the Kennedy Trust submitted that it has gone by a number of informal names and one such informal name was inadvertently used on the Canadian patent filing, among others. This oversight was corrected with the patent office, and subsequent name changes in 2000 and 2012 were similarly recorded. Furthermore, the licensees have been making royalty payments to Kennedy as the owner of the 630 Patent.
[31] In my view, the evidence clearly indicates that Kennedy is the owner of the 630 Patent and any mistake that was initially made on the patent filing was later rectified.
(2) Issue 2: Standing of Janssen Canada, Janssen US, and Cilag in this action
[32] Hospira argued that the burden of establishing standing is on the party claiming standing under s 55(1) of the Patent Act. This requires that one have a title or right that can be traced back to the patentee: Janssen Inc v Teva Canada Limited, 2016 FC 593 at para 43, 141 CPR (4th) 1 [Janssen v Teva] citing Signalisation de Montréal Inc v Services de Béton Universels Ltée (1992), [1993] 1 FC 341, 58 FTR 230 (CA) [Signalisation].
[33] Hospira further submitted that in this case there is no evidence as to the required title or right traced back from Janssen Canada or Cilag to the purported patentee, Kennedy. Hospira, relying on Pfizer Canada Inc v Teva Canada Ltd, 2016 FCA 161, 400 DLR (4th) 723, said that the evidence was inadmissible hearsay.
[34] Hospira further contended that a sublicence cannot exist if the patentee is not aware of the sublicence and does not consent to it, and that this was the case here.
[35] Hospira argued that the royalties are not evidence of the existence of sublicences because they do not relate to the alleged invention – the royalties are not dependant on whether a patient is receiving concomitant MTX, and royalties are also paid on sales of Remicade attributed to psoriatic arthritis, a different indication.
[36] Hospira sought to distinguish this case from Apotex Inc v Wellcome Foundation Ltd, [2001] 1 FC 495 at para 99, 186 FTR 274 (CA), aff’d 2002 SCC 77, and Jay-Lor International Inc v Penta Farm Systems Ltd, 2007 FC 358 at para 37, 313 FTR 1 [Jay-Lor], on the basis that Kennedy, Janssen US, Janssen Canada, and Cilag are not under common control.
[37] Lastly, on this issue, Hospira submitted that Janssen US and Cilag did not engage in activities for which they would require a licence as their activities do not infringe the 630 Patent. Janssen US does not manufacture or sell infliximab in Canada, nor does the infliximab it manufactures pass through Canada before being transferred to Cilag. Cilag AG Schaffhausen manufactures Remicade outside of Canada and the sale is made to Janssen Canada outside of Canada.
[38] The jurisprudence indicates the following:
a) Any party who, as a user, an assignee, a licensee, or lessee has a title or a right that can be traced back to the patentee, has standing to claim under the patentee (Signalisation at para 24).
b) A licensee – exclusive or otherwise, written or unwritten – has standing to claim under the patentee (Armstrong Cork Ltd Canada v Domco Industries Ltd, [1982] 1 SCR 907 at 917-20, 136 DLR (3d) 595; Jay-Lor at paras 32-38).
c) Where multiple parties each form an integral part of a single supply chain whereby licensed, patented products ultimately find their way to Canada, those parties have standing to claim under the patentee (Janssen v Teva at paras 60-68).
[39] In my view, Kennedy has established through admissible evidence that Janssen Canada, Janssen US, and Cilag have standing in this action.
[40] It is not disputed that a licensee has standing to claim under the patentee. The dispute is whether Janssen Canada, Janssen US, and Cilag are licensees – which can be distilled to whether Kennedy has put forward sufficient evidence to show that their titles or rights can be traced back to Kennedy, the patentee.
[41] The evidence indicates that Janssen US is a licensee of the 630 Patent under the 1992 Agreement. Janssen US then granted sublicences to Janssen Canada and Cilag. Hospira’s contention that Kennedy was unaware of the sublicences is immaterial. The 1992 Agreement clearly approves of and anticipates the granting of sublicences. It was not necessary for any of the parties to seek express approval for each individual sublicence.
[42] Licences are not required to be in writing (Janssen v Teva at para 43). Seeto’s evidence, which I accept, was that a written agreement would not be necessary or normal with respect to the related entities of Janssen US and Janssen Canada.
[43] Invoices and purchase orders were put into evidence to demonstrate the flow of infliximab through Janssen US to Cilag, and then of Remicade from Cilag to Janssen Canada. In addition, employees of Janssen Canada and Johnson & Johnson testified as to the existence of sublicences. Both Seeto and Forster indicated that their knowledge of the sublicences derived from conversations with others in the company (in Seeto’s case from Forster, and in Forster’s case from the legal department).
On this aspect, Hospira argued that it is hearsay.
[44] Recently, in R v Bradshaw, 2017 SCC 35, [2017] 1 SCR 865 [Bradshaw], the Supreme Court reviewed the rule against hearsay and the principled exceptions to the hearsay rule. Although the Supreme Court indicated that there was real danger in the acceptance of hearsay evidence, it noted that accurate fact finding may in fact be impeded in some instances by the exclusion of hearsay evidence. Under the principled approach to hearsay that has developed in the jurisprudence, hearsay may be admitted into evidence if it is both necessary and sufficiently reliable (Bradshaw at para 18).
[45] In my opinion, this evidence is not necessary. The invoices and purchase orders establish that the companies are working in concert to make Remicade available in Canada.
[46] The 1992 Agreement establishes that Janssen US has the right and ability to grant sublicences. Although they are arguably not under common control as was the case in Jay-Lor, the parties in this case have indeed “structured their affairs in a manner consistent with a licensee-licensor relationship” (Jay-Lor at para 37). In addition, no other licence has been granted to a third party.
[47] In my view, common control is not a required element for tracing interest under a patent – it is simply one factor that may be persuasive.
[48] Therefore, I find that it is a reasonable inference, based on the evidence and the facts, that Janssen US, Janssen Canada, and Cilag had licences/sublicences for the invention disclosed by the 630 Patent. As per R v Munoz (2006), 86 OR (3d) 134, 205 CCC (3d) 70 at paras 23-31 (Sup Ct J), the Court is entitled to draw reasonable inferences.
[49] Further, with respect to the royalties, Hospira may be correct that the evidence put forward fails to establish the exact amount of royalties related to the use of Remicade for concomitant treatment with MTX in MTX incomplete responders.
[50] However, in my view, the evidence is sufficient to show that some amounts of royalties were paid for this use. It is not necessary at this time to determine the precise amount of royalties paid. The evidence of payments is consistent with the other evidence of the existence of sublicences.
[51] Moreover, if the evidence of Seeto and/or Forster is necessary, then the Court must determine if it is reliable: “threshold reliability can be established by showing that (1) there are adequate substitutes for testing truth and accuracy (procedural reliability) or (2) there are sufficient circumstantial or evidentiary guarantees that the statement is inherently trustworthy (substantive reliability)” (Bradshaw at para 27).
[52] In my view, substantive reliability has greater relevance in the instant case – one must “consider the circumstances in which it was made and evidence (if any) that corroborates or conflicts with the statement” (Bradshaw at para 30). The threshold for reliability is high, but it does not require certainty.
[53] In Bradshaw, the Supreme Court considered when corroborative evidence may be relevant to a finding of substantive reliability:
[44] In my view, the rationale for the rule against hearsay and the jurisprudence of this Court make clear that not all evidence that corroborates the declarant’s credibility, the accused’s guilt, or one party’s theory of the case, is of assistance in assessing threshold reliability. A trial judge can only rely on corroborative evidence to establish threshold reliability if it shows, when considered as a whole and in the circumstances of the case, that the only likely explanation for the hearsay statement is the declarant’s truthfulness about, or the accuracy of, the material aspects of the statement. If the hearsay dangers relate to the declarant’s sincerity, truthfulness will be the issue. If the hearsay danger is memory, narration, or perception, accuracy will be the issue.
[45] First, corroborative evidence must go to the truthfulness or accuracy of the material aspects of the hearsay statement (see Couture, at paras. 83-84; Blackman, at para. 57). Hearsay is tendered for the truth of its contents and corroborative evidence must go to the truthfulness or accuracy of the content of the hearsay statement that the moving party seeks to rely on. Because threshold reliability is about admissibility of evidence, the focus must be on the aspect of the statement that is tendered for its truth. The function of corroborative evidence at the threshold reliability stage is to mitigate the need for cross-examination, not generally, but on the point that the hearsay is tendered to prove.
…
[47] Second, at the threshold reliability stage, corroborative evidence must work in conjunction with the circumstances to overcome the specific hearsay dangers raised by the tendered statement. When assessing the admissibility of hearsay evidence, “the scope of the inquiry must be tailored to t