Seedlings Clarifies Key Patent Litigation Issues

On January 2, 2020, the Federal Court delivered its judgement in Seedlings Life Science Ventures, LLC v. Pfizer Canada ULC, 2020 FC 1. The Federal Court dismissed Seedlings’ claim for patent infringement covering an auto-injector medical device, and allowed Pfizer’s counterclaim, declaring the patent’s claims invalid on various grounds, including overbreadth, anticipation, and obviousness.

The plaintiff, Seedlings Life Science Ventures, LLC (“Seedlings”), developed an auto-injector device—a syringe dubbed LifeCard—which: (1) minimized the risks from the exposed needle; and (2) was easily portable. The LifeCard featured a “flat housing” shape like a credit card, and a physical shield that moved forward and locked in the position following injection to protect against further contact with the needle, called “needlestick”.

Pfizer sells its own auto-injector, commonly known as EpiPen. While Pfizer’s EpiPen also protected against the needlestick, the Court considered the LifeCard and the EpiPen to be different inventions.[1]

Below, we summarize some of the key issues considered by the Court.

  1. Blinded Experts Not Always Helpful

As has become commonplace in Canadian patent litigation, Seedlings asked the Court to prefer its experts’ opinions because they were “blinded”, a practice of shielding the experts from various information about the parties and their positions. The Court rejected Seedlings’ argument, holding that preliminary issues, such as the identity of the skilled person and her or his common general knowledge, need not be determined in total isolation from the actual issues in dispute. The Court held that “[i]t would be impossible to identify the skilled person without knowing the subject matter of the relevant patent [and that i]t would be highly impractical to construe the claims without knowing what specific terms or phrases give rise to interpretive difficulties”.[2] In fact, the Court held that Seedlings’ decision to shield its experts from these important issues meant that Pfizer’s experts were to be preferred.

The Court echoed the skepticism expressed by other judges of the Court with respect to blinding, holding that “[w]hatever 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”.[3]

  1. The “Judicial Anxiety To Support A Really Useful Invention” Discounted

In several foundational cases, Canadian Courts have held that patents should be construed “with a judicial anxiety to support a really useful invention”.[4] For some time, it has been unclear how that presumption of interpretation squared with the Supreme Court’s holding in Whirlpool v. Camco that “[c]laims construction is antecedent to consideration of both validity and infringement issues.”[5] The Court rejected the “judicial anxiety to support a really useful invention” holding that…

…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’. The Federal Court of Appeal has rejected such a presumption. Upon closer inspection, the reference to ‘judicial anxiety’ appears to relate to the idea that a patent should not be invalidated on a technicality, not a more general presumption of interpretation in favour of the inventor. [Citations omitted]

  1. Federal Court Considers File Wrapper Estoppel for the Second Time

Under newly-enacted section 53.1 of the Patent Act, file wrappers are admissible in evidence to rebut the patentee’s arguments about the construction of the patent. Up until Seedlings, the provision has been considered and applied only once, in Canmar Foods Ltd. and TA Foods Ltd., Re, 2019 FC 1233.

In Seedlings, the parties disagreed over the construction of phrase “retracted storage position” in all of the asserted independent claims.[6] Pfizer raised section 53.1 of the Act and argued that the representations made during prosecution meant that the claims had a specific meaning contrary to its most logical interpretation. While the file wrapper revealed that the examiner had initially rejected the claims as anticipated by an earlier patent, and that the claims had been amended to overcome the prior art, the Court held that it was difficult to draw firm conclusions from the exchange between Seedlings and the Patent Office. The representations made to the Patent Office did not clearly rebut the construction urged by Seedlings. Rather, the Court interpreted the claim based on its most logical interpretation and did not apply section 53.1.

  1. Overbreadth Doctrine Has a Statutory Basis

Although Seedlings conceded that Claims 48-54, and 56 were invalid for anticipation, Pfizer sought a declaration that all those claims are invalid for overbreadth. In response, Seedlings argued that the: (a) the overbreadth doctrine has no statutory basis;[7] and (b) that it has recently been subject to criticism amongst legal commentators.[8] The Federal Court disagreed, holding that overbreadth had a statutory basis, stemming “by implication, from the scheme of the Patent Act, and in particular section 27(4), which requires ‘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.’” According to the Court, “[i]f the subject-matter of the invention must be defined, it must be defined accurately and not in an overly broad manner.”

The Court noted that, although the case law does not set out a specific test or method for assessing overbreadth, typically a finding of overbreadth hinges upon the fact that essential elements of the invention are missing from the claims.[9]

Ultimately, the Court held that all of the claims were overbroad, and therefore invalid, because they omitted essential features of the invention, namely, “a syringe carrier, a flat reverse syringe or collapsible bellows and a shared latch locking mechanism”.[10]

  1. Remedies

Having invalidated all of the claims, the Court assessed remedies in obiter.  The Court held that he would not have allowed Seedlings to elect an accounting of Pfizer’s profits because Seedlings was a non-practicing entity.[11] The Court held that “if the patentee made its profits by selling licenses, it should not be entitled to compensation beyond a reasonable royalty”. While this holding was expressly obiter, the Court’s holding was based on numerous Federal Court, Federal Court of Appeal, and Supreme Court authorities.[12]

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[1] At para. 4.

[2] At para. 43.

[3] At para. 43.

[4] See, e.g., Minerals Separation North American Corp. v. Noranda Mines Ltd., [1950] S.C.R. 36 at 65 and Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504 at 521, both citing Hinks & Son v. Safety Lighting Company (1876), 4 Ch. D. 607.

[5] Whirlpool Corp. v. Camco Inc., 2000 SCC 67 at para. 43.

[6] At para. 60.

[7] At para. 169.

[8][8] At para. 168.

[9] At para. 173, citing Aux Sable Liquid Products LP v. JL Energy Transportation Inc., 2019 FC 581 at paras. 56–74, and Les Laboratoires Servier v. Apotex Inc., 2019 FC 616 at paras. 205–242.

[10] At para 174.

[11] At para 253.

[12] At para. 252, citing Colonial Fastener Co v Lightning Fastener Co1936 CanLII 26 (SCC), [1937] SCR 36 at 45; Lubrizol Corp v Imperial Oil Ltd (1992), 1992 CanLII 8530 (FCA), 45 CPR (3d) 449 at 474 (FCA); Unilever PLC v Proctor & Gamble Inc (1993), 47 CPR (3d) 479 at 525 (FCTD), aff’d (1995), 61 CPR (3d) 499 (FCA); Alliedsignal Inc v du Pont Canada Inc1998 CanLII 7464 at paragraphs 21–22 (FCTD), aff’d 1999 CanLII 7409 (FCA)Jay-Lor, at paragraph 119Frac Shack Inc v AFD Petroleum Ltd2017 FC 104 at paragraph 283, reversed on other grounds, 2018 FCA 140Human Care Canada Inc v Evolution Technologies Inc2018 FC 130 at paragraph 437, reversed on other grounds, 2019 FCA 209

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