Seedlings Life Science Ventures, LLC v. Pfizer Canada ULC

Seedlings Life Science Ventures, LLC v. Pfizer Canada ULC
Court (s) Database
Federal Court Decisions
Date
2020-01-02
Neutral citation
2020 FC 1
File numbers
T-608-17
Decision Content
Date: 20200102
Docket: T-608-17
Citation: 2020 FC 1
Ottawa, Ontario, January 2, 2020
PRESENT: Mr. Justice Sébastien Grammond
BETWEEN:
SEEDLINGS LIFE SCIENCE VENTURES, LLC
Plaintiff/ Defendant by counterclaim
and
PFIZER CANADA ULC
Defendant/ Plaintiff by counterclaim
PUBLIC JUDGMENT AND REASONS
(Confidential Judgment and Reasons issued January 2, 2020)
TABLE OF CONTENTS
I. Background Facts 4
A. Auto-Injectors 4
B. Seedlings’s LifeCard Project 6
C. The NGA EpiPen 11
D. The Present Proceedings 13
II. Preliminary Issues 14
A. Defining the Person Skilled in the Art 15
B. Defining Common General Knowledge 16
C. Prior Art 17
D. Claims Construction 18
(1) Words and Phrases Needing Construction 21
(2) Essential Elements 34
III. Validity 34
A. Anticipation 34
(1) Legal Principles 35
(2) Application 36
B. Obviousness 44
(1) Legal Principles 44
(2) Application 45
C. Utility 47
(1) Legal Principles 47
(2) Application 49
D. Overbreadth 53
(1) A Theory of Overbreadth 54
(2) Application 57
E. Insufficient Disclosure 61
IV. Infringement 61
A. Legal Principles 61
B. Analysis 62
(1) Claim 40 62
(2) Claims 44–46 64
(3) Claim 47 67
(4) Claim 58 68
(5) Claims 59, 60 and 62 68
V. Remedies 70
A. Reasonable Royalty 71
(1) Pfizer’s Maximum Willingness to Pay 73
(2) Seedlings’s Minimum Willingness to Accept 78
(3) Division of the Gains of Trade 81
B. Accounting of Profits 82
C. Pre-judgment Interest 86
VI. Disposition 87
[1] Seedlings Life Science Ventures, LLC [Seedlings] is in the business of early-stage health-care related research and product development. It alleges that Pfizer Canada ULC [Pfizer], a major pharmaceutical company, infringes its patent by selling in Canada an auto-injector commonly known as the EpiPen. While, at first sight, the EpiPen and Seedlings’s invention do not look alike, Seedlings argues that the EpiPen infringes certain claims of its patent and seeks compensation and an accounting of profits.
[2] Pfizer denies that the EpiPen infringes upon Seedlings’s patent. Moreover, by way of counterclaim, it seeks a declaration that the claims of Seedlings’s patent asserted in this action are invalid. Pfizer argues that those claims are overly broad, obvious and anticipated by prior art. It also argues that Seedlings has never demonstrated the utility of its invention.
[3] I agree with Pfizer that the claims asserted by Seedlings are invalid, because they are all overly broad, some of them are anticipated and one of them is obvious. Moreover, had those claims been valid, I would have found that they are not infringed by the EpiPen.
[4] In so finding, I am not denying the creative value of Seedlings’s work. Indeed, I am invalidating only a subset of the claims of Seedlings’s patent. Contrary to Seedlings’s assertion, however, this is not a case of two inventors making the same invention independently, with Seedlings being the first in time to file its patent application. Rather, Seedlings’s auto-injector and the EpiPen are different inventions. The creative use of language in Seedlings’s patent cannot obscure this reality.
[5] Part I of this judgment describes the auto-injectors involved in this case. In Part II, I identify the skilled person to whom the patent is directed and I give my interpretation of certain terms of the patent, the meaning of which is in dispute. Part III is devoted to the analysis of Pfizer’s challenge to the validity of the patent’s relevant claims. I address the issues of anticipation, obviousness, utility, overbreadth and insufficiency. Even though I conclude that the relevant claims are invalid, I assess, in Part IV, whether the current version of the EpiPen infringes Seedlings’s patent. While I conclude that it does not, I also give my opinion, in Part V, as to the compensation that Pfizer would have owed to Seedlings if it had infringed valid claims of Seedlings’s patent.
I. Background Facts
[6] The legal issues arising in this case cannot be understood without a general discussion of auto-injectors and a summary of the development of the devices that are at the forefront of the case, namely, the two successive versions of the EpiPen and Seedlings’s LifeCard.
A. Auto-Injectors
[7] Syringes have been used for decades, if not centuries, to inject medication in the human body. Typically, a syringe is composed of a container to which a needle is attached, as well as a plunger that, when inserted and pushed into the container, compresses the medication and forces it through the needle.
[8] The use of a syringe to inject medication requires a certain degree of dexterity and training. Yet, in certain situations, it is desirable that patients be able to use a syringe themselves. For that reason, auto-injectors have been developed to facilitate the injection of medication in one’s own body. Broadly speaking, an auto-injector is a device that automates most, if not all steps of the injection process. Auto-injectors may be used for a variety of purposes. For example, they may allow users to inject insulin or naloxone, an antidote to opioids.
[9] Most relevant to this case is the use of auto-injectors to provide emergency treatment for anaphylaxis. Anaphylaxis is a severe condition that results from an allergic reaction, for example to certain foods or bee stings. If not treated immediately, severe cases of anaphylaxis may result in death. Thus, persons diagnosed with types of allergies that may lead to anaphylaxis are advised to carry at all times an auto-injector containing epinephrine, a medication that relieves the symptoms of anaphylaxis.
[10] The most well-known brand of epinephrine auto-injector is the EpiPen. It was developed in the 1980s by Survival Technology, Inc. [STI]. In the early 2000s, it was manufactured by Meridian Medical Technologies, Inc. [Meridian] in the United States and distributed by King Pharmaceuticals, Inc. [King], Meridian’s parent company, in that country. In Canada, beginning in 2006, the EpiPen was distributed by King Pharmaceuticals Canada Inc. [King Canada], a subsidiary of King. This product was manufactured in essentially the same form from the late 1980s until 2009. As it is no longer on the market, the parties have referred to it as the “EpiPen Legacy,” and I will adopt that term in these reasons.
[11] The EpiPen Legacy has a generally cylindrical form, measuring approximately 15 centimeters in length and 2.5 centimeters in diameter. After taking it out of its carrying case and removing a safety pin, the user activates the EpiPen Legacy by pressing its front end against the injection site. A needle then sticks out of the front end and injects the medication. A picture of the EpiPen Legacy is reproduced below.
[12] There were several concerns with the EpiPen Legacy. After operation, the needle remained exposed. This created a safety concern, especially as people became more aware of the risk of transmission of blood-borne diseases, in particular HIV/AIDS and hepatitis C. The EpiPen Legacy was also considered to be somewhat bulky, which discouraged users from carrying it at all times. Moreover, the instructions printed on the cylinder were not easy to read.
B. Seedlings’s LifeCard Project
[13] Dr. Keith Rubin is the founder and CEO of Seedlings. He is a medical doctor by training. In the 1990s, he was practicing in New York City. A significant portion of his patients were diagnosed with HIV/AIDS or hepatitis C. As a result, Dr. Rubin was acutely aware of the risks associated with the handling of needles.
[14] One day, Dr. Rubin had a traumatic experience. As a result of eating nougat that, unbeknownst to him, contained hazelnuts, he had an anaphylactic shock. He had to be transported to the emergency room. The treatment he received saved his life.
[15] Dr. Rubin thus began to carry an EpiPen Legacy. While recognizing that the device could save his life, or that of other persons subject to the same condition, he became conscious of its shortcomings. Given the nature of his medical practice, he was keenly aware of the risks associated with the exposed needle. He also thought that people would be more inclined to carry an auto-injector if it were smaller. Thus, he decided that he could make a contribution to public health by designing a new auto-injector that would overcome those limitations.
[16] Dr. Rubin knew that this endeavour would require teamwork. He enlisted the help of Eclipse Product Development Corp. [Eclipse], a company specializing in the design and testing of medical devices. He explained his idea to Mr. Jim Sellers, Eclipse’s CEO, and Mr. Haydn Taylor, its senior designer. He founded Seedlings in February 2002. Soon afterwards, Seedlings and Eclipse signed a product design agreement. A schedule to that agreement contained the ideal specification for the auto-injector, including maximal dimensions, ease of use and needle protection. Under that agreement, any intellectual property deriving from the project would belong to Seedlings. The project became known as the LifeCard.
[17] The development of the LifeCard began in earnest in early 2002. Eclipse proposed a number of potential concepts. It was eventually decided that the needle shield would also serve as the actuator. Thus, the user would not need to press any button to operate the device. Eclipse designed an actuator assembly that included a needle shield that, after triggering the injection of medication, would automatically deploy over the needle and then lock in that position. At that stage, the LifeCard was designed with computer-assisted design [CAD] software that allowed, among other things, simulation of the movement of the components of the device.
[18] The following view of the device with the upper portion of the cover removed gives a general idea of the arrangement of the internal components.
[19] The following video, created by Mr. Taylor in March 2002 using CAD software, illustrates the intended functioning of the LifeCard. It highlights a latch mechanism, located towards the rear end of the device, by which pressure on the needle shield unlocks the power source – a spring – and triggers the injection process. It also shows the double-latch mechanism – also called shield latch – that permits the needle shield to move forward once the injection is complete and then locks it in its extended position. [See Video 1 (2657)]
[20] It will be noted that, in this video, the medication is contained in a collapsible bellows, made of plastic. Seedlings and Eclipse realized that epinephrine could only be kept in a glass container, which, obviously, cannot be collapsible. Thus, Eclipse designed what the parties referred to as a flat “reverse syringe,” that is, a syringe in which the needle is attached to the plunger. To operate it, one must press the container against the plunger and needle. The container (or vial) of the syringe is made of glass instead of plastic. The following video shows the intended operation of this version of the LifeCard. [See Video 2 (2684)].
[21] On May 23, 2002, Seedlings filed US patent application no. 10/154,202.
[22] Eclipse then proceeded to make prototypes of the LifeCard. The first prototypes were “look-like” prototypes, intended to show the proposed shape and visual appearance of the device. It then designed “works-like” prototypes, that is, prototypes that would simulate the actual operation of the device. The “works-like” prototype was designed in the fall of 2002 and its components were made over the winter of 2003.
[23] The LifeCard prototype was first successfully fired on April 1, 2003. It was fired again a few days later, but on the third attempt, the glass of the syringe vial broke. There is an issue as to the evidence of the dates of those tests. I will address it when I discuss the utility of the patent.
[24] On May 9, 2003, Seedlings filed a Canadian patent application, claiming priority to the US application filed in May 2002. It was laid open for public inspection on December 4, 2003.
[25] Eclipse continued testing the LifeCard prototype. It was able to successfully inject ink into a chicken breast, as shown on a video that was played at trial. The testing program, however, was not free from difficulties. The mechanism often suffered from “racking,” and there were many instances where the glass vial broke when the device was triggered. I will return to the testing program later in these reasons, when I discuss the utility of the patent.
[26] Seedlings then sought to find partners for the commercialization of the LifeCard. Dr. Rubin realized that the commercial success of the LifeCard would depend on a larger organization that would provide, among other things, the requisite manufacturing, distribution and marketing capacities, which Seedlings did not possess. He thus sought meetings with various pharmaceutical companies. While some of them were impressed with the concept and initially showed interest, ultimately no one pursued the matter. In particular, Dr. Rubin had discussions with Pfizer, Inc. [Pfizer US], which was not involved in making or marketing the EpiPen at that time, and Meridian. Pfizer US was initially interested in testing prototypes of the LifeCard, but its interest dwindled after an internal reorganization. With respect to Meridian, Dr. Rubin testified that he had a single meeting with Mr. Steven Natsch, Meridian’s director of operations, in May 2004. On that occasion, he informed Mr. Natsch of the development of the LifeCard and Seedlings’s patent application. He described the conversation as “high-level” (October 22, 2019, pp. 31-32). There were no further discussions with Meridian.
[27] Seedlings was granted US patent no. 6,979,316 on December 27, 2005.
[28] In 2007, Seedlings entered into a licence agreement with |||||||||||||||||||||||||||||||||||||||||||||||||||||| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||. Pursuant to this agreement, |||||||||||||||||| was granted a non-exclusive licence to use Seedlings’s US and Canadian patents. Subsequently, |||||||||||||||||| concluded an agreement with |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||| for the commercialization of epinephrine auto-injectors known as ||||||||||||||||||||||||||||||||||||||||. The internal functioning of those devices has not been put in evidence before me. The extent to which they use the technology developed by Seedlings remains unclear.
[29] The processing of Seedlings’s Canadian patent application took some time. In 2011 and 2012, there were discussions between the Patent Office and Seedlings’s Canadian patent agents, which resulted in certain claims being withdrawn, certain claims being amended and new claims being added. I will return to those interactions when discussing claims construction. On March 18, 2014, Seedlings was granted patent no. 2,486,935, which I will call “the ‘935 patent” or “Seedlings’s patent.”
C. The NGA EpiPen
[30] In the early 2000s, Meridian decided to enhance its EpiPen. Mr. John Wilmot, who testified at trial, led this project on behalf of Meridian. He explained that Meridian embarked upon that project for a number of reasons. It was aware of the possibility that the regulations concerning sharps protection for products used in hospitals or by medical personnel could one day be extended to consumer products such as auto-injectors. It also wanted to improve usability of the device, in light of the potential entry of competitors on the market.
[31] During the year 2002, various concepts were assessed, including a push-button-activated device and several forms of sharps protection. It is only toward the end of that year that a new way of locking the needle shield after activation was found. The development process continued in 2003 and a substantially final design was achieved in early 2004. Starting in August 2004, Meridian filed patent applications that led to the granting of US patent no. 7,794,394 in September 2010. The device became known as the “Next Generation Auto-Injector” or “NGA.” I will use that acronym to describe this new version of the EpiPen, in contrast to the EpiPen Legacy.
[32] Mr. Wilmot testified that, while designing the NGA EpiPen, he was not aware of Seedlings’s patent application and did not rely in any way on Seedlings’s design (October 29, 2019, pp. 34–35).
[33] The dimensions of the NGA EpiPen are similar to those of the EpiPen Legacy. However, while the Legacy is cylindrical, the NGA has an oval shape. This facilitates its handling and the reading of the instructions label and prevents it from rolling if it is left on a slightly inclined surface. A picture of an NGA EpiPen is reproduced below.
[34] The user of the NGA EpiPen must first remove the device from its carrying case and remove the blue safety pin found on the top of the device. The orange end of the device must then be firmly pressed on the injection site. A needle will then extend outside of the orange part and inject the medication. Once the injection is completed, the device may be pulled from the injection site. The orange cover will then extend and cover the needle, thus ensuring protection from needlestick.
[35] To illustrate the internal functioning of the NGA EpiPen, I have reproduced, in Schedule A to this judgment, diagrams prepared by Meridian in 2004 showing the main steps of the operation of the device.
[36] Meridian began manufacturing the NGA EpiPen in 2009. The first shipments to Canada were in February 2010 and the first Canadian sales were made in the first quarter of 2010.
[37] In 2011, Pfizer US acquired King. Because of the ensuing corporate reorganization, Pfizer Canada Inc., now known as Pfizer Canada ULC, the defendant in this case [Pfizer or Pfizer Canada], continued the business of King Canada, in particular with respect to the distribution of the NGA EpiPen in Canada. Pfizer Canada is a subsidiary of Pfizer US. At the same time, Meridian also became a subsidiary of Pfizer US.
D. The Present Proceedings
[38] When Dr. Rubin first became aware of the NGA EpiPen, in late 2009 or early 2010, he quickly formed the opinion that it incorporated two of the important features of the LifeCard, namely, a flatter housing and a needle shield that is the actuator and that locks in place to protect the needle after the device has been used. As he said, “they LifeCarded the EpiPen.”
[39] Seedlings then investigated enforcement options. In June 2012, Seedlings wrote a letter to Pfizer US to inform it that the NGA EpiPen was infringing Seedlings’s patent. Dr. Rubin testified that he asked Seedlings’s attorneys to send the letter to Pfizer US. Although a copy of the letter was filed in evidence, there is no direct evidence that it was sent to Pfizer US and no evidence that Pfizer US received it. Pfizer Canada, the defendant in this action, says that it has no knowledge of what its parent company may have received. In any event, there was no follow-up by either Seedlings or Pfizer US.
[40] Seedlings began this action against Pfizer Canada in April 2017.
II. Preliminary Issues
[41] Before analyzing the issues of invalidity and infringement that are at the heart of this case, it is necessary to address certain preliminary issues: the identity of the “skilled person” to whom the patent is addressed, the definition of the “common general knowledge” possessed by the skilled person, the proper construction (or interpretation) of certain expressions found in the asserted claims of Seedlings’s patent and the identification of the essential elements of those claims.
[42] Dealing with those issues at the outset, as is customary in patent infringement cases, affords certain benefits. It ensures consistency in the analysis. For example, one should not construe a claim in one way for the purposes of validity, and in a different way for the purposes of infringement: Whirlpool Corp v Camco Inc, 2000 SCC 67 at paragraph 49(b), [2000] 2 SCR 1067 [Whirlpool]. Identifying the skilled person and common general knowledge at an early stage of the analysis also provides a basis for determining what, in the relevant field of activity, will be considered as inventive. Moreover, addressing issues of claim construction before analyzing validity or infringement prevents claims construction from becoming a “results-oriented” exercise: Whirlpool, at paragraph 49(a).
[43] This is not to say that these preliminary issues must be determined in total isolation from the actual issues in dispute. It would be impossible to identify the skilled person without knowing the subject matter of the relevant patent. It would be highly impractical to construe the claims without knowing what specific terms or phrases give rise to interpretive difficulties. In this case, these difficulties were brought to the forefront because Seedlings “blinded” its experts and asked them to provide their opinion on those preliminary issues with little knowledge of the actual dispute and without telling them which party was retaining them. Whatever the merits of blinding in other respects, I must say that it is not particularly helpful with respect to the skilled person, common general knowledge and claims construction.
[44] More generally, I do not agree that Seedlings’s experts’ opinions must be preferred because they were blinded. Most of what is called “expert opinion” is in fact argument, and often argument about the interpretation of legal documents. When courts assess arguments, they focus on the validity of the reasoning, not on the credibility of the person who puts the argument forward. Thus, when assessing expert testimony, the logical character of their reasoning is much more important than the fact that some of them were blinded. Moreover, I did not find that experts who were blinded in the early phases of the preparation of their reports were more neutral or more objective in later phases of the preparation of their reports or when testifying at trial. I thus share the skepticism of certain of my colleagues with respect to blinding: Shire Canada Inc v Apotex Inc, 2016 FC 382 at paragraphs 42–48; Janssen Inc v Apotex Inc, 2019 FC 1355 at paragraphs 57–59.
A. Defining the Person Skilled in the Art
[45] It is generally accepted that patents are not meant to be read by ordinary persons, but rather a “person skilled in the art or science to which it pertains” (see sections 27(3)(b) and 28.3 of the Patent Act, RSC 1985, c P-4) or, in short, the skilled person: Burton Parsons Chemicals, Inc v Hewlett-Packard (Canada) Ltd, [1976] 1 SCR 555 at 563 [Burton Parsons].
[46] In this case, the parties agree that the skilled person would be a person holding a degree in biomedical or mechanical engineering. They disagree, however, as to that person’s practical experience. Seedlings argues that three years’ experience would be sufficient, while Pfizer says that five to ten years would be more appropriate. Moreover, Mr. Sheehan, Pfizer’s expert, says that this experience must pertain to medical devices, while Mr. DiGasbarro, one of Seedlings’s experts, would consider any kind of mechanical design experience.
[47] I am unsure about the usefulness of setting out a precise number of years of experience in the job description of the fictional skilled person. The real concern is that the skilled person must not be inventive. In this regard, Seedlings points to the fact that several of the expert witnesses in this case filed their first patent applications within a few years of graduating. The best answer to that concern is to keep front of mind the fact that the skilled person must not show inventiveness. In any event, if a precise number of years is needed, I would hold that five years is appropriate, as this is the point where the ranges proposed by both parties’ experts meet. I would also hold that this experience must pertain to medical devices, given the highly specialized nature of this field.
B. Defining Common General Knowledge
[48] The next preliminary issue is the definition of common general knowledge, which is defined as “knowledge generally known by persons skilled in the relevant art at the relevant time:” Apotex Inc v Sanofi-Synthelabo Canada Inc, 2008 SCC 61 at paragraph 37, [2008] 3 SCR 265 [Sanofi]; see also Bell Helicopter Textron Canada Limitée v Eurocopter, société par actions simplifiée, 2013 FCA 219 at paragraph 65 [Eurocopter]; Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc, 2016 FCA 119 at paragraph 25, [2017] 2 FCR 280. It is what the skilled person would know without doing research. It must be distinguished from publicly accessible knowledge: not all public knowledge is commonly known. In this case, the relevant time is the date Seedlings’s patent was laid open for public inspection, which is December 4, 2003.
[49] Seedlings does not dispute the identification of common general knowledge proposed by Mr. Sheehan, Pfizer’s expert. Mr. Sheehan said that this would comprise knowledge of existing auto-injectors and their internal mechanisms, knowledge of the various manners in which an auto-injector may be activated, as well as common components of those devices, such as housing, syringes, needles, springs, latches and so forth.
C. Prior Art
[50] Auto-injectors are not new and many patents have been granted for such devices. In his report, Mr. Sheehan, Pfizer’s expert, traces the history of auto-injectors and describes several patented devices.
[51] Two such patents are the focus of arguments regarding anticipation and obviousness. In both cases, Mr. Wilmot is among the named inventors.
[52] The first one, US patent no. 5,295,965 [the ‘965 patent], was issued in 1994 and describes an auto-injector with a needle shield that deploys automatically after injection. Several embodiments of the device are shown in the drawings. Most of them are push-button-actuated. However, one figure shows how the device can be modified to make it front-actuated.
[53] The second one, US patent no. 6,210,369 [the ‘369 patent], was issued in 2001 and describes an auto-injector that is push-button-actuated and that has a needle shield that deploys automatically after injection.
D. Claims Construction
[54] It is now well accepted that patent claims should be interpreted according to the modern method of legal interpretation. According to that method, one should give meaning to legal language based on all relevant clues or guides – what Lord Hoffmann once famously called the “factual matrix” in which words are employed: Investors Compensation Scheme v West Bromwich Building Society, [1997] UKHL 28, [1998] 1 All ER 98; see also Sattva Capital Corp v Creston Moly Corp, 2014 SCC 53 at paragraphs 46–48, [2014] 2 SCR 633.
[55] The Supreme Court of Canada confirmed the application of that method to patent claims in two judgments issued twenty years ago: Whirlpool; Free World Trust v Électro Santé Inc, 2000 SCC 66, [2000] 2 SCR 1024 [Free World Trust], although it labelled it as the “purposive method.” Thus, a claim may be interpreted based on other information found in the patent, whether in the disclosure or in other claims: Consolboard Inc v MacMillan Bloedel (Sask) Ltd, [1981] 1 SCR 504 at 520 [Consolboard]. Expert evidence may assist the interpretive exercise, although the court is never bound by the experts’ opinions: Whirlpool, at paragraphs 61–62; Eurocopter, at paragraph 74. In this process, the court should strive to understand and give effect to the inventor’s intention, rather than subvert it through an overly technical analysis of language.
[56] These broad principles are not different from those applicable to the interpretation of legal documents generally. Patents, however, have special characteristics that need to be taken into account in their interpretation. A patent defines a monopoly granted to an inventor in consideration of the disclosure of the invention to the public. It is often described as a bargain, or quid pro quo, between the inventor and the public: Free World Trust, at paragraph 13; Apotex Inc v Wellcome Foundation Ltd, 2002 SCC 77 at paragraph 37, [2002] 4 SCR 153 [Wellcome Foundation]; AstraZeneca Canada Inc v Apotex Inc, 2017 SCC 36 at paragraph 39, [2017] 1 SCR 943 [AstraZeneca]. Thus, the language of the claims perform a notice function: they warn potential infringers of what they must not do. For that reason, courts have typically been loath to resort to extrinsic evidence in the interpretation of patent claims. A third party could not be presumed to know of such evidence and should be entitled to rely on the language of the claims: Free World Trust, at paragraphs 33–43. Moreover, it has often been said that patents must be interpreted in a balanced manner, that gives equal consideration to the interests of the inventors and those of the public or, in other words, that is “fair to both patentee and public:” Consolboard, at 520.
[57] The interpretation of patent claims must also take into account the structure that the Patent Act imposes on patent applications. Section 27 states that an application must contain a specification, which includes a full description of the invention, its method of constructing and, in the case of a machine, its principle and its “best mode” in which the principle is applied. The specification must end with “a claim or claims defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege or property is claimed.” Section 37 also requires the inventor to provide drawings, whenever the invention can be represented in this manner.
[58] Thus, even though the invention must be described in the specification and drawings, the scope of the monopoly is defined by the claims. The claims are not limited to the “best mode,” often called the “preferred embodiment,” described in the specification or illustrated in the drawings: Bombardier Recreational Products Inc v Arctic Cat, Inc, 2018 FCA 172 at paragraph 54. Conversely, an interpretation of the claims that would exclude the embodiment shown in the drawings or described in the specification is suspect, as it is unlikely to reflect the inventor’s intention: Bristol-Myers Squibb Canada Co v Teva Canada Limited, 2016 FC 580 at paragraph 335.
[59] When the modern method leaves the court undecided as between two potential interpretations, presumptions of interpretation are often used to settle the issue. Seedlings argues that one such presumption is that patents should be interpreted in a way that ensures their validity. That presumption was colourfully described as a “judicial anxiety to support a really useful invention” in a 19th-century English case quoted in Consolboard, at 520. In my view, there cannot be such a presumption. It would go against the principle that patents should not be construed “with an eye on the allegedly infringing device in respect of infringement or with an eye to the prior art in respect of validity to avoid its effect:” Whirlpool, at paragraph 49(a). The Federal Court of Appeal has rejected such a presumption in ABB Technology AG v Hyundai Heavy Industries Co, Ltd, 2015 FCA 181 at paragraph 45. Upon closer inspection, the reference to “judicial anxiety” appears to relate to the idea that a patent should not be invalidated on a technicality (see, in this regard, Burton Parsons, at 563), not a more general presumption of interpretation in favour of the inventor.
(1) Words and Phrases Needing Construction
[60] The parties have identified six phrases or expressions found in the claims of Seedlings’s patent that they do not construe in the same manner. I will review each of them and provide my interpretation.
(a) “flat housing”
[61] Claim 40, through its dependence on claim 2, describes a device with a “flat housing.” The claims, however, do not define “flat.” Defining flatness was the subject of lengthy discussion at trial. Broadly speaking, two options are available. First, one may stipulate a bright-line test based on a mathematical comparison between the dimensions of the device along the three axes. That approach, however, bears an arbitrary dimension, as do all exercises of line-drawing. A second option is to adopt a purposive interpretation. Under that approach, one inquires into what the inventors were trying to accomplish by requiring a flat housing. This, of course, results in a less precise definition, which requires the exercise of judgment when deciding whether the patent has been infringed. Yet, this approach is preferable, as it is better aligned with Free World Trust and the rejection of literalism in claims construction and legal interpretation more generally.
[62] The purpose of the flatness requirement is revealed by certain passages of the specification. Paragraph 3 describes the EpiPen Legacy as “relatively bulky.” Paragraphs 5 and 8 describe the patented device as “more compact, low-profile.” Paragraph 6 explains that this is intended to “facilitate the ease and convenience of carrying, handling and using the device.” In this regard, both allergists who testified at trial, Dr. Greenwald and Dr. Upton, agreed that patients are more likely to carry a compact, flat device at all times on their person (see, in particular, Dr. Greenwald’s report, paragraphs 89, 97 and 105; Dr. Upton’s report, paragraphs 47–48).
[63] Paragraph 42 of the specification then provides the most relevant indication of what the inventors had in mind when they used the word “flat:”
42. The device preferably is dimensioned to be held in one’s palm and may have peripheral dimensions approximating those of a conventional credit card. […] The thickness of the device is substantially less than either of the length or width and, in the preferred illustrative example, may be in the order of 0.25 inch thick. The device, so dimensioned, has a generally flat appearance. It is carried easily in ones [sic] pocket or purse without feeling bulky or uncomfortable thereby increasing the likelihood of it being carried on one’s person and being available, if needed. […]
[64] Similar language is found in paragraph 43:
The term “flat” when used in this specification to describe the housing of the device is intended to mean a configuration that can be confined in a virtual three dimensional envelope having a length, a width, and a thickness, and in which the thickness is substantially less than each of the length and width, with each of the length, width and thickness being measured along orthogonal directions.
[65] Thus, I consider that when the inventors used the adjective “flat,” they meant that the object so described has a thickness that is substantially less than its length or width. In addition, when the adjective “flat” in used in conjunction with the noun “housing,” the inventors meant that the device itself would be of such dimensions that it can easily be carried in one’s pocket.
[66] Of course, the dimensions of the preferred embodiment should not be considered as an outer limit of what is acceptable or “flat.” Nevertheless, the specification makes it clear that “flat” means an object that can be easily carried in one’s pocket. Moreover, the inventors intended “flat” to refer to an object that would be significantly different in shape from the EpiPen Legacy. Indeed, Mr. DiGasbarro agreed that, from a common-sense perspective, the intent was to make the device smaller than the EpiPen Legacy (October 24, 2019, p. 115).
[67] If the above approach is found to be inadequate and a bright-line test is necessary, I would adopt the test proposed by Mr. Sheehan: the thickness of the device must be substantially less than both its length and width, and substantially less means less than 50%. This, I believe, accords with conceptions of flatness in everyday language. A book is flat, but a brick is not. A requirement that the thickness be less than 50% of the other two dimensions is also compatible with the specifications and drawings. No object described as being flat in the patent has a thickness that is more than half of its other dimensions. Moreover, such a requirement provides a substantial margin of manoeuvre for creating embodiments of the invention. In any event, as we will see later in these reasons, nothing turns on the choice between these two approaches.
(b) “within the housing”
[68] Claim 2 states: “both of the syringe body and the needle being disposed and maintained within the housing.” Claim 40 incorporates that language from claim 2. Claims 44 and 47 and, through their dependence on claim 48, claims 58, 59, 60 and 62 include similar language.
[69] Pfizer’s expert, Mr. Sheehan, asserts that “within the housing” means “entirely within the housing.” To Mr. Sheehan, that means that where the device includes a needle shield that partially extends outside of the housing before activation, the needle must not extend outside of the housing, even if it is entirely contained within the needle shield.
[70] I reject that submission. It is obvious from the specification and drawings that, in the embodiments of the invention that include a needle shield, “within the housing” really means “within the housing or needle shield.” A purposive interpretation focuses on what the inventors intended to accomplish. In this case, they wanted to ensure that the needle would be invisible before the device is activated. Moreover, as Mr. Sheehan recognized in cross-examination (October 28, 2019, pp 105–113), all the drawings show a needle that extends somewhat outside of the housing, but remains within the needle shield. If his proposed construction were to prevail, this would mean that the embodiments disclosed in the patent are not covered by the patent’s claims. This would be absurd. Pfizer’s position is simply a literal meaning argument that disregards both purpose and context.
[71] Pfizer nevertheless submits that, as claim 2 does not include a needle shield, “within the housing” must mean “entirely within the housing,” at least with respect to claim 40, which depends on claim 2. I disagree. When a claim is dependent on another claim, the dependent claim must be assessed separately from the independent claim: Zero Spill Systems (Int’l) Inc v Heide, 2015 FCA 115 at paragraphs 83­–94. Thus, when construing claim 40, the elements of claim 2 that are incorporated must be read together with the elements added by claim 19 (on which claim 40 depends) and claim 40 itself. This includes a needle shield.
(c) “retracted storage position” / “disposed and maintained rearwardly”
[72] All the relevant independent claims, namely, claims 2, 44, 47 and 48, describe the syringe container or the needle as having a “retracted, storage position.” Mr. Sheehan asserts that this means that, in the storage position, the syringe must be closer to the rear end of the device than to its forward end.
[73] I reject that submission. The more logical interpretation of “retracted” is that it refers to the position of the syringe or needle before the device is activated, in contradistinction to its position after activation. This is borne out by the context in which the phrase is found in the various claims. Claim 2, for example, includes the following language:
… both of the syringe body and the needle being disposed and maintained within the housing in a retracted, storage position, the syringe being movable longitudinally as a unit within the housing from the retracted storage position to an injection position in which the needle extends longitudinally beyond the forward end of the housing to penetrate tissue;
[74] Here, the “retracted storage position” is contrasted to the injection position. For this device to function, it is obvious that the syringe and needle must move from one position to the other. Nothing in the above-quoted language suggests, however, that the syringe and needle mus