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Federal Court of Appeal Examines the Scope of the Implied License to Use a Patented Article

The Federal Court of Appeal had the opportunity to examine the implied license to use a patented article upon its unrestricted sale in Pharmascience Inc. v. Janssen Inc., 2024 FCA 10.

The issue arose since Pharmascience’s proposed paliperidone palmitate for the treatment of schizophrenia and related disorders did not offer the 75 mg-eq. dosage form which would be available from the Patentee Janssen. Janssen brought action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations[1]. In that action, the respondents, Janssen sought a declaration that Pharmascience would infringe Canadian Patent No. 2,655,3.

Pharmascience defence was that an essential element of each claim was a 75 mg-eq. dose and Pharmascience would not produce this dose. It would be available from Janssen hence they argued no infringement would occur since there is an implied license to use the 75 mg-eq. dose.

Pharmascience relied on the well-established jurisprudence that it is clear that the sale of a patented article without restriction includes the right to use that article as the purchaser pleases.[2]

Janssen argued that this principle does not apply in this case. It notes that the article it would sell (the 75 mg-eq. dose) is not itself a patented article, but merely a component of a patented invention that includes several different doses. Janssen argued that the jurisprudence concerning implied license is limited to the patented article itself, and therefore the purchase from Janssen of only the 75 mg-eq. dose would not carry with it an implied license to combine that dose with other doses obtained from Pharmascience to practise the patented invention.[3]

The Federal Court of Appeal examined the prior cases on implied license and agreed that the principle of implied license is limited to the patented article itself and does not extend to a component of the invention.

As a result, the Federal Court of Appeal found that there would be direct infringement and in these facts that would amount to inducing infringement.

The case casts light on the scope of the implied license by a purchaser of a patented article.

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[1] S.O.R./93-133.

[2] See Pharmascience Inc. v. Janssen Inc., 2024 FCA 10 at para 16 citing Thomas v. Hunt (1864), 17 C.B.N.S. 183, 144 E.R. 74 at 76; Betts v. Willmott (1871), L.R. 6 Ch. App. 239, 19 W.R. 369 at 245; Badische Anilin und Soda Fabrik v. Isler (1906), 1 Ch. 605, 75 L.J. Ch. 411 at 610, aff’d [1906] 2 Ch. 443, 23 R.P.C. 633 (C.A.); Hatton v. Copeland-Chatterson Co. (1906), 37 S.C.R. 651 at 653; Gillette v. Rea, [1910] O.J. No. 587, 15 O.W.R. 345 at para. 2; National Phonograph Company of Australia Ld. v. Menck, [1911] A.C. 336, 28 R.P.C. 229 at 234, 238, 246, 248 (U.K.P.C.); Signalisation de Montréal Inc. v. Services de Béton Universels Ltée, [1993] 1 F.C. 341, [1992] F.C.J. No. 1151 at paras. 17, 20 (C.A.), Eli Lilly & Co. v. Novopharm Ltd., [1998] 2 S.C.R. 129, 161 DLR (4th) 1, Apotex Inc. v. Merck & Co., 2002 FCA 210, [2002] F.C.J. No. 811 at para. 39; Distrimedic Inc. v. Dispill Inc., 2013 FC 1043, [2013] F.C.J. No. 1093 at para. 226; Angelcare Canada Inc. v. Munchkin, Inc., 2022 FC 507, [2022] F.C.J. No. 480 at para. 276.

[3] See Pharmascience Inc. v. Janssen Inc., 2024 FCA 10 at para 17.

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