This is an informal case summary prepared
for the purposes of facilitating exchange during the 2024 WIPO IP
Judges Forum.
Session 6
Federal Court of Canada [2022]: Janssen Inc. v Pharmascience Inc., 2022 FC 1218
Date of judgment: August 23, 2022
Issuing authority: Federal Court
Level of the issuing authority: First instance
Type of procedure: Judicial (Administrative)
Subject matter: Patents
(Inventions); Enforcement of IP and Related Laws
Plaintiffs: Janssen Inc. and Janssen Pharmaceutica
N.V.
Defendant: Pharmascience
Inc.
Keywords: Patents, Obviousness, Lack of
patentable subject matter, Patent invalidity, Patent infringement, Injunctive
relief, Permanent Injunction, Injunctive relief
Basic facts: Janssen Inc. and Janssen
Pharmaceutica N.V. (the plaintiffs) hold Canadian Patent No. 2,655,335 (hereinafter
“the 335 Patent”), which covers a long-acting injectable formulation of
paliperidone palmitate used to treat schizophrenia. Janssen's product, INVEGA
SUSTENNA®, embodies the patented invention.
On
February 28, 2020, Pharmascience Inc. served a Notice
of Allegation and Detailed Statement in relation to its Abbreviated New Drug
Submission (ANDS) No. 236094. This submission sought approval to market and
sell a generic version of Janssen’s INVEGA SUSTENNA® in Canada, challenging the
validity of the 335 Patent.
This
action prompted Janssen to initiate a patent infringement lawsuit against Pharmascience Inc. under subsection 6(1) of the Patented
Medicines (Notice of Compliance) Regulations.
Janssen
claimed that Pharmascience’s product would infringe
on multiple claims of the 335 Patent, including the patented dosing regimen.
Pharmascience Inc. contended that the patent is
invalid, basing its claims on two main arguments: first, that the patent was
invalid due to obviousness, and second, that the claims lacked patentable
subject matter as they constituted methods of medical treatment.
Held: The court rejected both invalidity defenses raised by Pharmascience
Inc. The Court found that the claims of Canadian Patent No. 2,655,335
(the 335 patent) were not invalid for obviousness or lack of patentable subject
matter, i.e., as a method of medical treatment).
The 335 Patent had been subject to previous Federal
Court decisions:
·
Janssen Inc. v. Teva
Canada Ltd., 2020 FC 593 (hereinafter Teva
Paliperidone): In this case, the court found certain
claims of the 335 Patent valid and that Teva had infringed on those claims.
Teva’s appeal was heard September 14, 2021 and
decision is pending.
·
Janssen Inc. v. Pharmascience Inc., 2022 FC
62 and Janssen Inc. v. Apotex Inc., 2022 FC 107:
The court found on separate motions for a summary trial that Pharmascience Inc. and Apotex Inc.
would likely induce infringement of the 335 Patent. Both companies have
appealed the decisions.
The
present decision addressed Pharmascience’s patent
invalidity defenses raised in the above-noted actions.
Non-obviousness: The Court noted that the
evidence in this case aligned with the findings on non-obviousness in Teva
Paliperidone. The court found that the claims of the 335 Patent were not obvious
because the prior art did not provide information about the safety, efficacy,
pharmacokinetics, or pharmacodynamics of paliperidone palmitate. At a minimum,
pharmacokinetic data and results from clinical trials with paliperidone
palmitate would be necessary to establish a suitable dosing regimen for the
long-acting depot injection. The investor meeting transcript cited by Pharmascience Inc. (which was not at issue in Teva
Paliperidone)
was broad and did not reveal details about the 335 patent claims that would
alter the Court’s prior analysis of the prior art.
Method of medical treatment: The
court also ruled that the claims of the 335 Patent were not invalid as a method
of medical treatment (an issue not raised in Teva Paliperidone).
The court distinguished between “use” claims (which involve applying a product
for a specific purpose) and “product” claims (which include prefilled syringes,
dosage forms, and “Swiss-type” claims). The Court noted that once a
physician decides to use the products for the claimed purpose, each claim
specifies fixed dose amounts, intervals, and injection sites. While some
elements of the claims involve choice (e.g., the injection site for the
maintenance dose), the Court determined that these choices do not have clinical
implications. Therefore, implementing the claimed dosing regimens would not
require professional skill or judgment.
The
court issued a permanent injunction preventing Pharmascience
Inc. from making, using, selling, marketing, importing, exporting, or
distributing pms-PALIPERIDONE PALMITATE in Canada
until the expiry of the 335 Patent in 2028, and also
ordered Pharmascience Inc. to cover part of the
plaintiff's legal fees and disbursements.
Relevant holdings in relation
to permanent injunctions: Having found that that making, using, or
selling of the generic version (pms-PALIPERIDONE
PALMITATE) by Pharmascience Inc, as described in its
ANDS submissions Nos. 244641 and 251767, would induce infringement of the
claims of the 335 Patent, the Court issued a permanent injunction.
The
granted permanent injunction prohibited Pharmascience
Inc. from making, using, selling, marketing, importing, exporting, or
distributing pms-PALIPERIDONE PALMITATE in Canada
until the expiry of the 335 Patent in 2028, and also
ordered Pharmascience Inc. to cover part of the
plaintiff's legal fees and disbursements.
The permanent injunction aimed at protecting the
exclusive control of Janssen Inc. over the patented dosing regimen and
formulation, ensuring that no generic version of the drug can enter the market
in Canada during the patent’s remaining term.
Relevant legislation:
·
Federal Courts
Rules, SOR/98-106
·
Patented
Medicines (Notice of Compliance) Regulations, SOR/93-133