2,486,935 / Auto-Injection of Medication
Grammond J’s decision in Seedlings v Pfizer raises a number of issues, the most significant of which is the application of overbreadth to hold several claims invalid. This post provides an overview, and discusses Grammond J’s views on “blinding” the expert witnesses, and on the principle that claim construction should be approached “with a judicial anxiety to support a really useful invention.” Subsequent posts will deal with other aspects of the decision.
The invention at issue relates to an auto-injector, primarily intended for injecting epinephrine to treat anaphylaxis. The best known auto-injector is the EpiPen. The original EpiPen was on the market from late 1980s until 2009 [10]. Seedlings’ auto-injector, known as the LifeCard, was the inventor’s solution to problems with the original EpiPen, which he recognized both because of his work as a physician and as a result of his own experience of anaphylactic shock [13]-[14]. The original EpiPen was relatively bulky — a cylinder about 15 cm long and 2.5 cm in diameter — which made it inconvenient to carry. Also, the needle remained exposed after use, which is a particular concern in light of risk of transmission of blood-borne diseases [11]-[12]. The LifeCard is flat and much smaller than the original EpiPen — the size of a thick credit card — so it is more easily carried and used [63]. It also has a shield which moves forward once the injection is complete to protect the needle [19]. (See the video here.)
Pfizer’s allegedly infringing device, referred to as the NGA EpiPen (for “Next Generation Auto-Injector”), is an updated version of the original EpiPen (referred to as the “Legacy” EpiPen). Ultimately, when it came to infringement, Grammond J found that while Seedlings and Pfizer had addressed the same problem, they had come up with different solutions: the NGA EpiPen was oval, not flat [196], and the claims of the 935 patent were not to the concept of a needle shield, but rather a particular method of implementing that shield, and Seedlings’ implementation was different from Pfizer’s.
Blinding the experts
Seedlings “blinded” its experts and asked them to provide their opinion on various issues of claim construction, including the proper interpretation of some claim terms, with little knowledge of the actual dispute and without telling them which party was retaining them [41], [43]. Grammond J shared the skepticism regarding blinding expressed by Locke J 2016 FC 382 [42]–[48] (see here) and Phelan J 2019 FC 1355 [57]–[59], saying “[w]hen 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” [44]. With that said, one of the infringement issues was easily disposed of because Seedlings’ blinded expert had construed the term “flat” in a way that clearly supported Pfizer’s position [196].
Claim Construction
Presumption that disclosed embodiments are claimed
Grammond J noted that presumptions of interpretation are often helpful in claim construction [59]. First, he noted and applied the presumption that the inventor would have intended to claim the embodiments that are disclosed in the specification [58], [70]. “[A]n 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,” (citing 2016 FC 580 [335]). Note that Grammond J’s application of the rule made it clear that this presumption applies to any embodiment that is disclosed in the specification, not just the preferred embodiment: see also [2009] EWHC 55 (Pat) [92].
Presumption that claims should be interpreted to preserve validity?
On the other hand, Grammond J rejected Seedlings’ argument that there is a presumption “that
patents should be interpreted in a way that ensures their validity” [59]. That proposition was based
on the statement by the SCC in Consolboard [1981] 1 SCR 504, 521, quoting with apparent approval
Sir George Jessel’s statement in Hinks & Son v Safety Lighting Co (1876) 4 ChD 607, that “the
patent should be approached ‘with a judicial anxiety to support a really useful invention’.”
Grammond J noted that this statement seems to be in tension with the SCC’s statement in Whirlpool
2000 SCC 67 [49a] that “[a] patent must not of course 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.” Grammond J suggested that “the reference to ‘judicial anxiety’ appears to relate to
the idea that a patent should not be invalidated on a technicality,” [59] citing Burton Parsons [1976]
1 SCR 555, 563. While it is certainly true that a patent should not be invalidated on a technicality,
as Burton Parsons states, I doubt this is all that the SCC had in mind in Consolboard, where the
Court explained that “where the language of the specification, upon a reasonable view of it, can be
so read as to afford the inventor protection for that which he has actually in good faith invented, the
court, as a rule, will endeavour to give effect to that construction” (quoting with approval Western
Electric Co v Baldwin Int’l Radio [1934] SCR 570, 574). This seems to say something more than
merely disfavouring technical attacks.
I suggest that a way to reconcile Consolboard and Whirlpool is to consider Consolboard as stating
a presumption that the patentee intended to claim the inventive concept that was disclosed in the
specification. This is very similar to the presumption that the patentee intended to claim the specific
embodiments that were disclosed, except it looks to the inventive contribution, rather than the
embodiments. As the Supreme Court pointed out in Whirlpool [37] “the bargain between the
patentee and the public is in the interest of both sides only if the patent owner acquires real
protection in exchange for disclosure.” An inventor who has disclosed a new and useful invention
and who frames a claim that is too broad or otherwise invalid receives nothing in return for their
valuable disclosure. Conversely, a claim that is too narrow will be valid, but will deprive the inventor
of the bulk of his due reward: see Burton Parsons at 565. A presumption that the inventor intended
to claim the invention that they disclosed is no less consistent with Whirlpool, that is the
presumption that the inventor intended to claim the embodiments that were disclosed. It also seems
to be a realistic reflection of the inventor’s intent, and not a mere legal fiction. As Buckley LJ
pointed out in the EWCA in Catnic [1982] RPC 183, 227, “An applicant for a patent will want his
leading claim to be as wide as is possible consistently with its validity. He will wish to avoid any
unnecessary restriction of it.”
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