Johnson & Johnson Inc. v. Boston Scientific Ltd.

Johnson & Johnson Inc. v. Boston Scientific Ltd.
Court (s) Database
Federal Court Decisions
Date
2008-05-08
Neutral citation
2008 FC 552
File numbers
T-1822-97
Decision Content
Date: 20080508
Docket: T-1822-97
Citation: 2008 FC 552
BETWEEN:
JOHNSON & JOHNSON INC.,
EXPANDABLE GRAFTS PARTNERSHIP
and CORDIS CORPORATION Plaintiffs
and
BOSTON SCIENTIFIC LTD./
BOSTON SCIENTIFIQUE LTÉE
Defendant
REASONS FOR JUDGMENT
[Confidential Reasons for Judgment issued on April 30, 2008]
LAYDEN-STEVENSON J.
[1] The introduction of stenting revolutionized the treatment of coronary heart disease. A stent is a medical device. It is inserted through the skin, usually into an artery, and is guided to an occluded or diseased body passageway requiring repair.
[2] The plaintiffs are the alleged successive owners of two Canadian patents. Both patents claim invention over a form of balloon-expandable stent. In this action, the plaintiffs assert that the defendant manufactured and sold a device, specifically a coronary artery stent, which infringed their patents. The defendant denies the allegation and contends, among other things, that the patents in suit are invalid. I conclude that one of the patents is valid and the other is not. I also conclude that the defendant’s device does not infringe.
TABLE OF CONTENTS Paragraph
Number
Introduction 3
Background 15
The Technical Experts 31
Dr. Nigel Buller 32
Dr. Richard Stringfellow 36
Dr. David Cumberland 41
Mr. Steven Opolski 45
Dr. Patrick Prendergast 51
Stents Generally 55
The Claims in Issue 60
The '505 Patent 60
The '186 Patent 61
Reserve Ruling 63
Claim Construction 88
The Law 88
The '505 Patent 95
Expandable 99
Vascular 100
Body Passageway 101
Graft 102
First Diameter 104
Second expanded and deformed diameter 107
Radially, outwardly extending force 110
Variable and dependent 113
Intraluminal 116
First and Second Ends 128
Thin-walled 130
Substantially uniform thickness 131
Smooth 135
Dr. Buller’s “building block” 139
Contentious Terms – The Parties 140
Tubular member 148
Slots 166
Comprising 188
Analysis 198
Observations regarding experts 198
Comprising 207
Slots 215
Essential Elements 235
The '186 Patent 236
An improvement of the '505 Patent 238
The Claims 247
Estoppel 257
Validity 271
Anticipation (Novelty) 271
Boston Scientific 1980 Monograph 273
1983 Monograph 283
Johnson & Johnson 1980 Monograph 287
1983 Monograph 292
Analysis 293
1980 Monograph 296
1983 Monograph 313
Obviousness (Inventiveness) 329
Dates of Invention 330
Boston Scientific The '505 Patent 346
Johnson & Johnson The '505 Patent 356
Analysis The '505 Patent 363
Boston Scientific The '186 Patent 382
Johnson & Johnson The '186 Patent 386
Analysis The '186 Patent 393
Infringement 409
Overview 409
Analysis 420
Conclusion 445
Introduction
[3] Canadian Letters Patent No. 1,281,505 entitled “Expandable Intraluminal Graft, and Apparatus for Implanting an Expandable Intraluminal Graft” (the '505 Patent or the Palmaz Patent), naming Julio C. Palmaz as inventor, was issued to Expandable Grafts Partnership (EGP) on March 19, 1991.
[4] Canadian Letters Patent No. 1,330,186 entitled “Expandable Intraluminal Graft” (the '186 Patent or the Palmaz-Schatz Patent), naming Richard A. Schatz and Julio C. Palmaz as co-inventors, was issued to EGP on June 14, 1994.
[5] The '505 Patent generally relates to a graft or prosthesis, namely a stent, which is a device that can be used to expand and reinforce blood vessels. The stent is inserted into the lumen (channel) of a body passageway in its original diameter, delivered to an appropriate location within the body passageway, and then expanded to a larger, variable diameter controlled by the amount of force applied to the stent.
[6] The '186 Palmaz-Schatz Patent generally relates to an articulated graft or prosthesis, namely a stent, comprised of a plurality of tubular members which are connected together by one or more connector members. The Palmaz-Schatz stent is similarly inserted into the lumen of a body passageway in its original diameter, delivered to an appropriate location within the body passageway, and then expanded to a larger, variable diameter controlled by the amount of force applied to the stent.
[7] Johnson & Johnson, a United States corporation having its head office in New Brunswick, New Jersey (the parent company), is an umbrella corporation over its related and divisional companies.
[8] By a purchase agreement effective February 26, 1999, Cordis Corporation, a Florida corporation purchased by the parent company in the mid 1990s (Cordis), obtained the rights with respect to the '505 and '186 Patents from the now-defunct EGP.
[9] By assignment executed July 13, 1999, Cordis assigned its rights in the '505 and '186 Patents to Johnson & Johnson Inc., a corporation incorporated pursuant to the laws of Canada (Johnson & Johnson) and a consumer division of the parent company.
[10] Johnson & Johnson maintains that, from the date of issuance or reissuance of the noted patents until February 26, 1999, EGP had licensed Johnson & Johnson, through the source company Ethicon Inc. (Ethicon) of Somerville, New Jersey (presumably another of the parent company’s corporations) to market the patented devices. Cordis then licensed Johnson & Johnson under the '505 and '186 Patents. Relying on section 55 of the Patent Act, R.S.C. 1985, c. P-4 (the Act), Johnson & Johnson claims to be a person claiming under the patentees, EGP and Cordis, from the date of issuance of the respective patents until July 13, 1999. Thereafter, Johnson & Johnson maintains that it has been the patentee.
[11] Since 1997, Boston Scientific has sold a device in Canada known as the NIR stent. Johnson & Johnson assert that Boston Scientific, by selling the NIR stent in Canada, has infringed upon the rights of the plaintiffs, Johnson & Johnson, EGP and Cordis, without the license or consent of the plaintiffs.
[12] Boston Scientific denies the allegations of infringement and also contends that, by virtue of admissions made by the plaintiffs and their privies and findings of fact in litigation in other jurisdictions relating to patents which claim priority from the same United States applications as the patents in suit, the plaintiffs are precluded and estopped from alleging that the NIR stent infringes the patents in suit.
[13] Boston Scientific, by counterclaim, asserts that the alleged inventions described and claimed by the patents were obvious and lacked inventive ingenuity. Further, the “invention” of the '505 Patent was anticipated.
[14] The applications for the patents in suit were filed before October 1, 1989. Consequently, the provisions of the Act, as they read before that date, apply. For clarity and convenience, all references to the provisions of the Act throughout these reasons relate to, and should be taken to be, references to the Act as it read prior to October 1, 1989. There is no need to repeatedly designate the applicable provisions as “former” provisions and I do not intend to do so.
Background
[15] This non-contentious background is derived principally from the evidence of expert witnesses Doctors Buller and Cumberland. Their respective qualifications are discussed later in these reasons.
[16] Coronary heart disease is caused by narrowing or blockage of the coronary arteries which supply the heart muscle with blood. The usual cause of arterial narrowing is a gradual build up of fatty material in the arterial wall. The fatty deposits can become calcified and hardened thereby producing plaque. This process is known as atherosclerosis. The plaque can protrude into the lumen of the artery and narrow it (this is known as stenosis). As the lumen becomes progressively more narrowed, the stenosis can lead to a complete or partial blockage (occlusion). The heart muscle fed by the stenotic artery then becomes deprived of oxygenated blood. This may eventually result in chest pain (angina). If the lumen of the artery suddenly closes off, blood flow ceases and results in a heart attack (myocardial infarction) or death.
[17] Arterial disease affects other organs as well. For present purposes, we are concerned with cardiac heart disease (ischemia). Until 1977, there were only two treatments for ischemic heart disease: surgical coronary artery bypass grafting and drug therapy. Drug therapy is not relevant here.
[18] Surgery usually took (and takes) the form of open heart coronary artery bypass grafting (CABG). During this operation, a graft is sutured across the site of the occlusion, providing an alternative pathway for blood flow. The graft usually consists of a blood vessel taken from another part of the body, preferably an artery. The procedure constitutes major surgery and involves general anaesthesia and significant trauma for the patient.
[19] In 1964, Dr. Charles Dotter reported having treated arterial narrowing in the peripheral leg arteries by inserting a series of increasingly larger diameter catheters through the femoral (thigh) arteries and, using x-ray screening, pushing them through the narrowed or blocked section. This procedure was labelled “transluminal dilation”. It was performed under local anaesthetic. The label for insertion “through the skin” is percuntaneous. Dr. Dotter’s method was limited by the fact that a channel only as wide as the arterial entry site could be produced. Additionally, the technique could not be applied to any arterial territory remote from the entry site (such as a coronary artery) because it was known that flexibility would be necessary to negotiate the bends involved. Dr. Dotter’s paper entitled “Transluminal Treatment of Arteriosclerotic Obstruction” predicted eventual application of the technique to the coronary vessels.
[20] In 1977, after successful work in the peripheral arteries, Dr. Andreas Grüntzig first performed percuntaneous transluminal coronary angioplasty (angioplasty).
[21] This angioplasty procedure involves passing an outer catheter called a guide catheter through the skin (most often through the femoral artery in the groin or an artery in the arm) under x-ray control and steering it to the main coronary artery. Radio-opaque fluid, injected through the catheter, reveals the lumen of the vessels and their branches. A fine guidewire is passed through the catheter into the coronary branches and is steered, again under x-ray control, through the arteries to the diseased portion of the coronary artery. Over the guidewire, a catheter with a balloon is passed so that the balloon is placed at the site of the stenosis. Once in place, the balloon is inflated. This forces the occluded artery open, pushes back the plaque and deforms the arterial wall. The balloon is then deflated and removed. Balloons of varying inflated diameters and lengths are used, typical dimensions being 2.5 - 4 mm inflated diameter and 20mm length.
[22] Angioplasty has the advantages of low morbidity, rapid recovery time and repeatability. It gained ground rapidly in the 1980s and 1990s. However, it also has associated complications. The method can involve occlusion (due to the tearing of the vessel wall, that is, the lining of the artery, specifically the endothelium) and consequent dissection in the endothelium creating a false passage or “flap” (which can close off the true lumen). This serious complication often requires emergency surgery. Additionally, restenosis (recurrence of the narrowing) can occur during the weeks or months after the procedure.
[23] During the 1980s, as a result of the problems associated with angioplasty, researchers explored several different alternatives, including lasers, atherectomy devices and stents. Stents act as a support in the artery.
[24] Dr. Dotter had tried implanting metal spirals in animal arteries but thrombosis (blood clotting) was a problem. He turned to coiled springs initially made of stainless steel and later, nitinol (an alloy made of nickel and titanium). This alloy is described as a “memory metal”. Its physical properties are such that it can be fashioned into a particular shape at its “memory” temperature, cooled so that it then effects another shape, but when the “memory” temperature is applied to the metal, it returns to its first shape.
[25] In 1984, Maass et al. reported the use of spiral-shaped stents made of heat-treated steel alloy, configured as a double-helix spiral, torsion-reduced in diameter and transluminally inserted in the vena cava or aorta of dogs or calves. When wound tightly, the springs became narrow in diameter to allow them to be delivered into and through the lumen. Once released, they sprang back to their original size whereupon they pressed themselves against the vessel wall by elastic expansion.
[26] In 1985, Dr. Cesare Gianturco and co-workers reported their work with a stent (known as the Gianturco Z-stent), made of stainless steel wire formed in a zig-zag pattern, which they placed in major vessels of dogs. The stent features a metal wire folded numerous times such that it forms a spring-type, zig-zag pattern which springs open and expands upon being pushed from a catheter sheath. The sheath is then withdrawn. Once released from the sheath, the stent expands until the force of the stent on the walls of the vessel is in equilibrium with the force of the vessel wall on the stent. If the fully-expanded diameter is greater than that of the desired size of the lumen into which it is placed, it may cause undue injury to the vessel. This stent was not used in humans.
[27] Around 1986, the Wallstent became generally known. It is constructed of stainless steel braided wire mesh. It, too, is a self-expanding stent. It was held in a protective sheath and was implanted in dogs, mainly in the coronary arteries. The Wallstent is flexible and does provide some vessel support. However, its closed structure leads to side branch closure and the fact that it shortens on expansion (known as foreshortening) in an unpredictable fashion renders it less than ideal. Wallstent devices were also implanted in humans.
[28] During the 1980s, Dr. Julio Palmaz produced two balloon-expandable stent designs. One was made from soldered wire and another was characterized as a “slotted-tube” stent. Only the latter became commercially available. During 1986, the Palmaz stent became generally known to all those interested in interventional radiology and interventional cardiology. The Palmaz slotted-tube stent suffered from longitudinal inflexibility and the Palmaz-Schatz stent was introduced to overcome this difficulty. The Palmaz-Schatz stent consists of a series of Palmaz slotted-tube stents joined by a connector(s). In the 1990s, two major clinical trials, the Benestent and the Stress trials, were conducted in Europe and the United States at multiple centres on large numbers of patients. These trials tested the safety and efficacy of the Palmaz-Schatz stent as a treatment for coronary artery disease.
[29] Also during the mid-1980s, Dr. Roubin was working with Dr. Gianturco in the development of another stent, the Gianturco-Roubin balloon-expandable coil stent. It is a stainless steel length of wire formed into a coil. Practitioners in the field were aware of the Gianturco-Roubin stent by 1986. Although very flexible, its disadvantage is that it provides poor support and scaffolding to the vessel.
[30] Variations of coiled stent designs were subsequently developed. These were followed by a variety of stent designs typically described as second-generation and third-generation stents. The NIR stent was introduced in the late 1990s.
The Technical Experts
[31] Five technical experts provided evidence. A brief introduction to each of them is provided below.
Dr. Nigel Buller
[32] Dr. Buller, a medical doctor and cardiologist, appeared for the plaintiffs. Shortly before the trial, he returned to private practice after having been a consultant cardiologist and head of interventional cardiology at Queen Elizabeth Hospital in Birmingham, England. He continues to hold an academic appointment as senior lecturer in the cardiology department of the faculty of medicine at the University of Birmingham where he teaches general cardiology to undergraduates and interventional cardiology to postgraduates.
[33] Dr. Buller was part of the team that implanted the first coronary stent in the United Kingdom (the Wallstent). He was one of the clinical investigators in the Benestent trial in Europe and one of the first clinical investigators for the Guidant Multilink stent. On average, Dr. Buller performs approximately 200 stenting procedures each year.
[34] Dr. Buller proctored physicians in both the United Kingdom and the United States with respect to the use of balloon-expandable stents. He has served on the advisory boards of several manufacturers of coronary artery stents, has had direct involvement in research and clinical application of coronary artery stents and has had peripheral involvement in stent development.
[35] Dr. Buller has testified several times as an expert witness for Cordis and other Johnson & Johnson companies in patent trials in other jurisdictions regarding the Palmaz stent and related technology. He was declared an expert witness competent to provide opinion evidence regarding interventional cardiology, stents and stenting.
Dr. Richard Stringfellow
[36] Dr. Stringfellow, a mechanical engineer, holds an undergraduate science degree in civil engineering from Princeton University and a Master of Science and Ph.D. in mechanical engineering (with a minor in biomechanics) from the Massachusetts Institute of Technology (MIT). He completed a year of postdoctoral work at Brown University in Providence, Rhode Island. He testified for the plaintiffs.
[37] Since 2002, Dr. Stringfellow has been employed by TIAX LLC in Cambridge, Massachusetts, a firm that purchased the assets of his former employer Arthur D. Little, Inc. Throughout his employment, Dr. Stringfellow has been involved in a variety of engineering projects and has done consulting work with respect to medical devices, both surgical and implants. More particularly, he has consulted in relation to the analysis of blood processing centrifuges, suture wires, laparoscopic devices, bladder control devices, an accommodating intraocular lens, aneurism clips and stents.
[38] Dr. Stringfellow has significant expertise in Finite Element Analysis (FEA), a complicated computer analysis method used in the engineering field, which allows for the simulation and evaluation of the behaviour of complex structures.
[39] Dr. Stringfellow has previously testified as an expert witness for Johnson & Johnson, in litigation similar to this matter, in the United States. He has also performed duties, such as physical testing and FEA of various stents, to support other expert witnesses of Johnson & Johnson.
[40] Dr. Stringfellow was declared an expert witness competent to provide opinion evidence in mechanical engineering, particularly with respect to the mechanical behaviour of materials, including bending, plastic deformation, stresses and strains.
Doctor David Cumberland
[41] Although Dr. Cumberland was trained in interventional radiology, the majority of his practice has been in coronary angioplasty. He appeared as a witness for the defendant. In 1975, he was appointed consultant responsible for angiography service at Northern General Hospital in Sheffield, England. He began doing percutaneous balloon angioplasty in 1980 and began using stents in clinical practice in 1987 in collaboration with colleagues from the San Francisco Heart Institute. Dr. Cumberland began peripheral artery stent implantation in 1988 and has implanted various types of coronary stents in several thousand patients.
[42] In 1982, Dr. Cumberland founded the British Coronary Angioplasty Group (a discussion group for interventionists performing coronary angioplasty), the precursor to the present British Cardiovascular Intervention Society. Between 1983 and 1987, Dr. Cumberland founded many centres (in the technique of coronary angioplasty) in the United Kingdom, Scandinavia, India and the Middle East. He has been a lecturer and teacher of courses in coronary angioplasty in Britain, Holland, France, the United States, Argentina, Australia and India. In 1994, he was appointed professor of interventional cardiology at Sheffield University where his work involved research into stents, specifically their deployment characteristics and the consequent vascular response.
[43] Dr. Cumberland has been the recipient of invitational fellowships from the Royal College of Physicians of Edinburgh, the Royal College of Surgeons of England, the American College of Cardiology and the European Society of Cardiology. In 2000, he retired to take up posts as consultant in cardiovascular intervention at a private hospital in Kuala Lumpur and visiting professor in the cardiology department at the university hospital. In 2003, he returned to Sheffield as consultant in cardiac intervention at Sheffield Northern General Hospital. He has held a chair in interventional cardiology and considers himself to be both an interventional radiologist and an interventional cardiologist.
[44] Dr. Cumberland has provided expert evidence on behalf of Boston Scientific in litigation similar to this in various countries. He was declared an expert witness competent to provide opinion evidence regarding interventional radiology, coronary intervention and therapeutic work in relation to stents and stenting.
Mr. Steven Opolski
[45] Mr. Opolski has a B.Sc. and an M.Sc. in mechanical engineering, with a specialization in mechanical design, and has completed some doctoral work. He testified for the defendant. He has been a senior technical consultant to NMT Medical Inc. (a manufacturer of a wide range of medical devices) of Boston, Massachusetts, since 1997. His consulting includes all aspects of design and analysis of new products and enhancements to existing products and has included working with Cardio-Vascular Dynamic developing a balloon-expandable coronary stent. Mr. Opolski has designed and worked with medical devices, including stents, since 1988.
[46] Apart from two years service in the United States Army, from 1988 until 1997, Mr. Opolski was employed in various engineering and management capacities by C.R. Bard Inc. Bard (a manufacturer of medical devices) divided its products into cardiovascular, surgical and urological divisions. Mr. Opolski worked for the cardiovascular products division. In the early to mid-1990s, he worked on a nitinol self-expanding stent and was involved with the computer modeling and engineering development of various tests for pre-clinical evaluation for submission to the United States Food and Drug Administration (FDA).
[47] In the mid-1990s, Mr. Opolski was manager of a Bard “implant group” charged with the development of protocols and pre-clinical testing for a wide range of stents for the entire corporation. This included computer modeling, animal testing, fatigue testing and biocompatibility testing.
[48] Mr. Opolski is presently the president of Atlantic Engineering Inc. (Atlantic), an engineering consulting company, founded by him in 2003. He consults, through Atlantic, on engineering issues and engineering-related regulatory issues pertaining to various medical devices, particularly those that are permanently implanted in the human body. He additionally consults with companies requiring assistance in developing and applying for regulatory approval of medical devices.
[49] Mr. Opolski is a committee member of the American Society for Testing Materials (now ASTM International) initially tasked with developing standardized testing for balloon-expandable coronary stents. Its original mandate has been broadened to include stents in all areas of the body.
[50] Mr. Opolski has not performed consulting work for either Johnson & Johnson or Boston Scientific although he was an expert witness for Boston Scientific in litigation (which did not proceed to trial) involving Boston Scientific at the suit of Medtronic. He was declared an expert witness competent to give opinion evidence regarding mechanical engineering in the design, analysis and fabrication of interventional products, including stents.
Dr. Patrick Prendergast
[51] Dr. Prendergast has a Ph.D. in mechanical engineering. He is the director of the Trinity Centre for Bioengineering (TCBE) and a professor of bio-engineering at Trinity College, Dublin, Ireland. He has held post-doctoral fellowships in Italy and the Netherlands. He joined the faculty of Trinity College in 1995. He was Dean of Graduate Studies from 2003-2007 and was responsible for the admission, progression, and examination of all graduate (master and doctoral) students in the university. He was appointed director of TCBE in 2002. TCBE engages in research in the area of medical devices and medical device technologies in the schools of engineering, dentistry and medicine. It also provides master-level courses in bioengineering.
[52] Dr. Prendergast’s interest in cardiovascular devices, particularly those with a biomechanical function such as stents, was piqued during the late 1980s and early 1990s when cardiovascular device manufacturers began to locate manufacturing facilities in Ireland to take advantage of tax and other incentives offered at the time. His current responsibilities are to conduct research, develop a research strategy for TCBE, coordinate the research, and to teach and supervise graduate students.
[53] Dr. Prendergast is a prolific publisher. He is a recipient of research awards from the Europen Society of Biomechanics and the Royal Irish Academy. He is a member of the editorial board of several scientific journals including the Journal of Biomechanics and Clinical Biomechanics. He is the lead editor of “Finite Element Analysis of Medical Devices” which deals primarily with cardiovascular and orthopaedic medical devices. By invitation, he (with two colleagues) authored a paper “Stents” in the Encyclopaedia of Biomedical Engineering. He is past-president and current council member of the European Alliance of Medical and Biological Engineering and Science.
[54] Dr. Prendergast has completed research and work for Medtronic AVE (regarding its stents) through Enterprise Ireland, a state-funded initiative to encourage collaboration between local industry and research laboratories. Trinity College and Medtronic are funded by Enterprise Ireland to conduct research projects. This proceeding represents the first time that Dr. Prendergast has provided expert testimony in the litigation context. He was declared an expert witness competent to provide opinion evidence with respect to biomedical engineering with emphasis on the design, analysis and testing of implantable medical devices.
Stents Generally
[55] Strictly speaking, the general characteristics of stents constitute common general knowledge that a reader of the patents in suit would possess (in 1991) to give meaning to the words of the patent. However, there is no dispute regarding the requisite attributes that stents must possess. I think it prudent to discuss the common characteristics at this point because the information is important, non-contentious and will provide a basis upon which to move to the issue of claim construction.
[56] First, a word or two about plasticity or plastic deformation, a concept that also factors into an understanding of stents. Deform means to alter or change. When force is placed on a typical metal, the metal will displace and then recover, that is, return to its initial configuration. When sufficient force is exerted to extend the metal beyond what is known as its elastic limit, the nature of the deformation changes and the properties that would normally bring the metal back to its original configuration go away. There is a permanent set to the material, which is called plastic deformation. In a nutshell, plastic deformation means that the shape of the metal is permanently altered.
[57] With respect to characteristics, the stent must be biocompatible in the sense that it works within the surrounding tissues, avoids overstressing the surrounding vessel wall and does not harm the patient. It must be structurally stable so that it will not disengage (migrate) from its placement in the lumen. That is, the stent must provide support (to keep the lumen open).
[58] Although some recoil is inevitable, elastic recoil of an expanded stent should be minimal. The stent must have sufficient scaffolding properties, that is, there should be minimal draping of the inner lumen between the struts (the metal parts) of the expanded stent. The stenotic material should not be so stressed that it could break off and cause an obstruction elsewhere.
[59] The shearing of the metal of the stent over the vessel wall should be minimized so the endothelium is not damaged. Although the stent will shorten longitudinally during expansion, foreshortening should be minimal.
The Claims in Issue
[60] The claims in issue in relation to the '505 Patent are claims 1, 4, 11, 12, 19 and 22. They are as follows:
1. An expandable intraluminal vascular graft, comprising:
a thin walled tubular member having first and second ends and a wall surface disposed between the first and second ends, the wall surface having a substantially uniform thickness and a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axis of the tubular member;
the tubular member having a first diameter which permits intraluminal delivery of the tubular member into a body passageway having a lumen; and
the tubular member having a second, expanded and deformed diameter, upon the application from the interior of the tubular member of a radially, outwardly extending force, which second diameter is variable and dependent upon the amount of force applied to the tubular member, whereby the tubular member may be expanded and deformed to expand the lumen of the body passageway.
4. The expandable intraluminal vascular graft of claim 1, wherein the tubular member does not exert any outward, radial force while the tubular member has the first or second, expanded diameter.
11. The expandable intraluminal vascular graft of claim 1, wherein the outside of the wall surface of the tubular member is a smooth surface, when the tubular member has the first diameter.
12. An expandable prosthesis for a body passageway, comprising:
a thin-walled tubular member having first and second ends and a wall surface disposed between the first and second ends, the wall surface having a substantially uniform thickness and a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axis of the tubular member;
the tubular member having a first diameter which permits intraluminal delivery of the tubular member into a body passageway having a lumen; and
the tubular member having a second, expanded diameter, upon the application from the interior of the tubular member of a radially, outwardly extending force, which second diameter is variable and dependent upon the amount of force applied to the tubular member, whereby the tubular member may be expanded and deformed to expand the lumen of the body passageway.
19. The expandable prosthesis of claim 12, wherein the tubular member does not exert any outward, radial force while the tubular member has the first or second, expanded diameter.
22. The expandable prosthesis of claim 12, wherein the outside of the wall surface of the tubular member is a smooth surface, when the tubular member has the first diameter.
[61] The claims in issue in relation to the '186 Patent are claims 1 and 5. Those claims state:
1. An expandable intraluminal vascular graft, comprising:
A plurality of thin-walled tubular members, each having first and second ends and a wall surface disposed between the first and second ends, the wall surface having a substantially uniform thickness and a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axis of each tubular member;
at least one connector member being disposed between adjacent tubular members to flexibly connect adjacent tubular members;
each tubular member having a first diameter which permits intraluminal delivery of the tubular members into a body passageway having a lumen;
the tubular members having a second, expanded and deformed diameter, upon the application from the interior of the tubular members of a radially, outwardly extending force, which second diameter is variable and dependent upon the amount of force applied to the tubular members, whereby the tubular members may be expanded and deformed to expand the lumen of the body passageway.
5. An expandable prosthesis for a body passageway comprising:
a plurality of thin-walled tubular members, each having a first and second ends and a wall surface disposed between the first and second ends, the wall surface having a substantially uniform thickness and a plurality of slots formed therein, the slots being disposed substantially parallel to the longitudinal axis of each tubular member;
at least one connector member being disposed between adjacent tubular members to flexibly connect adjacent tubular members;
each tubular member having a first diameter which permits intraluminal delivery of the tubular members into a body passageway having a lumen; and
the tubular members having a second, expanded and deformed diameter, upon the application from the interior of the tubular members, of a radially, outwardly extending force, which second diameter is variable and dependent upon the amount of force applied to the tubular member, whereby the tubular member may be expanded and deformed to expand the lumen of the body passageway.
[62] For practical purposes, the crux of this matter turns on claim 1 of each patent. Claim 1 and claim 12 of the '505 Patent describe the same structure. The difference between them is that the structure in claim 1 is restricted to use in the vascular system while the structure in claim 12 is not limited to any specific body passageway. Claims 4 and 11 relate to claim 1 while claims 19 and 22 relate to claim 12. Claim 5 of the '186 Patent is nearly identical to claim 1 of that patent. The only distinction is the location of application. While claim 1 is directed to an intraluminal graft, claim 5 is directed to an expandable prosthesis for a body passageway. I will have more to say about this later.
Reserve Ruling
[63] Eleventh-hour pre-trial motions regarding affidavits and witness statements resulted in Prothonotary Lafrenière’s order, dated January 4, 2008, wherein he deferred objections to the admissibility of parts, or all, of various affidavits to the trial judge. I heard extensive argument in relation to the admissibility of Dr. Buller’s “Reply Witness Statement”, dated November 27, 2007. Rather than delay the witnesses and the progress of the trial, I reserved my ruling.
[64] Boston Scientific argues that the proposed testimony on construction and infringement on the “Buller Reply” does not constitute proper reply evidence. It notes that the testimony runs some 42 pages and is almost twice as long as Dr. Buller’s initial report on those issues (23 pages). Boston Scientific submits that, in seeking to “reply” on the issues of construction and infringement, Johnson & Johnson is seeking impermissibly to split its case. Accordingly, such portions of the Buller Reply, namely paragraphs 3 to 116, ought to be struck.
[65] Resolution regarding some of the impugned paragraphs was achieved following the arguments. Johnson & Johnson voluntarily struck paragraphs 4 to 6, 7 (first half of the paragraph), 9, 14 (last 2 ½ lines), 15 (second-last sentence), 19, 21 (first sentence), 22, 28, 41, 42, 44 (third sentence), 58 (last portion of second-last sentence), 63, 66 (first sentence), 69 (first sentence and last portion of second-last sentence), 83 (first sentence), 89 (last three boxes of diagram), the first sentence of paragraphs 90, 99, and 109, and all of paragraphs 115 and 116.
[66] Mr. Justice Pelletier thoroughly canvassed the issue of proper reply evidence in Halford et al. v. Seed Hawk Inc. et al. (2003), 24 C.P.R. (4th) 220 (F.C.T.D.) (Halford). I adopt his comments and his synthesis of the law, at paragraphs 12 to 15 of his reasons. These are reproduced below:
12 This leads to the question of the proper scope of reply evidence. An indirect answer to this question is provided in Allcock Laight & Westwood Ltd. v. Patten, Bernard and Dynamic Displays Ltd. [1967] 1 O.R. 18 (C.A.) where the Ontario Court of Appeal had this to say about evidence which was sought to be led by way of reply:
It is well settled that where there is a single issue only to be tried, the party beginning must exhaust his evidence in the first instance and may not split his case by first relying on prima facie proof, and when this has been shaken by his adversary, adducing confirmatory evidence: Jacobs v. Tarleton (1848), 11 Q.B. 421, 116 E.R. 534. That case was considered by this Court and the principle therein enunciated was applied in R. v. Michael, [1954] O.R. 926, 110 C.C.C. 30, 20 C.R. 18. The rule is now so well settled that it requires no further elaboration. It is important in the trial of actions, whether before a jury or a Judge alone, that this rule should be observed. A defendant is entitled to know the case which he has to meet when he presents his defence and it is not open to a plaintiff under the guise of replying to reconfirm the case which he was required to make out in the first instance or take the risk of non-persuasion.
13 The conclusion which I draw from this passage is that evidence which simply confirms or repeats evidence given in chief is not to be allowed as reply evidence. It must add something new. But since the plaintiff is not allowed to split its case, that something new must be evidence which was not part of its case in chief. That can only leave evidence relating to matters arising in defence which were not raised in the plaintiff's case in chief. But even this is subject to a limitation which is expressed in the following passage from Sopinka et al. The Law of Evidence in Canada 2nd Edition at p. 882:
Should reply evidence be excluded if the point in respect of which contradictory evidence is sought to be adduced in reply arose in cross-examination of the other parties' witness rather than their evidence in chief? In Mersey Paper Co v. Queens (County) [(1959) 18 D.L.R. (2nd) 19 (N.S.C.A.)], The Nova Scotia Court of Appeal considered this to be an unjustifiable technical distinction. It is submitted that, at least in civil cases, it would depend on whether the matter was part of the plaintiff's case and one which might have been adduced in the plaintiff's case-in-chief. A plaintiff cannot leave part of its case until cross-examination of the defendant's witnesses and then when that goes badly make up for it in reply.
Although the authorities are not entirely clear on this point, the better view is that reply evidence that conforms with the principles stated above can be adduced as of right. There is, however, a discretionary power vested in the trial judge to admit such evidence, notwithstanding that it may not be the proper subject of reply.
14 Consequently, I believe that the following principles govern the admissibility of reply evidence:
1 - Evidence which is simply confirmatory of evidence already before the court is not to be allowed.
2 - Evidence which is directed to a matter raised for the first time in cross examination and which ought to have been part of the plaintiff's case in chief is not be allowed. Any other new matter relevant to a matter in issue, and not simply for the purpose of contradicting a defence witness, may be allowed.
3 - Evidence which is simply a rebuttal of evidenc