Source: http://www.lexvivo.com/2017/06/
Timestamp: 2019-04-22 02:34:49+00:00

Document:
The Supreme Court of Canada/La Cour Suprême du Canada ("La Cour Suprême") rarely decides patent cases. However, when it does, it really decides them. On June 30, 2017, La Cour Suprême handed down a decision in AstraZeneca Canada v. Apotex. At issue was the "promise of the patent" doctrine, which the Canadian Federal Court of Appeal, and the Federal Court of Canada below, have long upheld and elaborated. To satisfy the utility requirement, the disclosure of a patent must, for each claim, either demonstrate or soundly predict utility. But the utility analysis does not end there; in addition, the disclosure must also fulfill any specific promise of utility by demonstrating or soundly predicting it.
This doctrine, however, is unsound. It is an interpretation of the utility requirement that is incongruent with both the words and the scheme of the Patent Act.
ultimately, every invention pertains to a single subject-matter, and any single use of that subject-matter that is demonstrated or soundly predicted by the filing date is sufficient to make an invention useful for the purposes of [Section 2].
is unsound. It is an interpretation of the utility requirement that is incongruent with both the words and the scheme of the Patent Act.
In decisive fashion, La Cour Suprême extinguished the promise of patent doctrine with the words "it is not good law".
This judicial decision has implications well beyond the immediate parties in the case. By relaxing the criteria for meeting the utility requirement, more inventions should be patentable. Applicants for biopharmaceutical patents, in which demonstrating details of efficacy tends to be more challenging than in other arts, may particularly benefit from the demise of promise doctrine.
The effects of the AstraZeneca Canada v. Apotex may be especially inflammatory to the parties involved in the Eli Lilly and Company v. Canada trade dispute, which largely focused on whether or not promise of the patent doctrine was good Canadian law. Now that the doctrine has gone up in smoke, it make spark a new fire under Eli Lilly and other patent applicants previously burned by what they view as broken promises.
Is an Applicant [generic biosimilar company] required by 42 U.S.C. § 262(l)(2)(A) to provide the Sponsor [reference biologic drug company] with a copy of its biologics license application and related manufacturing information, which the statute says the Applicant "shall provide," and, where an Applicant fails to provide that required information, is the Sponsor's sole recourse to commence a declaratory-judgment action under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii)?
If a subsection (k) applicant fails to provide the application and information required under paragraph (2)(A), the reference product sponsor, but not the subsection (k) applicant, may bring an action under section 2201 of Title 28, for a declaration of infringement, validity, or enforceability of any patent that claims the biological product or a use of the biological product.
Under this rule, a reference biologic drug company whose FDA-licensed biologic drug entered the market first may seek declaratory judgment for infringement of its patent(s) by any would-be competitor generic biosimilar company failing to provide "its biologics license application and related manufacturing information", but may not seek federal injunctive relief to obtain that application and related information. Nevertheless, opting out of the patent dance does narrow the options available to a generic biologics company, largely letting the research biologic company decide when and how to initiate litigation.
The Court also addressed two other important issues. It left undecided questions about whether Amgen might be able to obtain injunctive relief under California state unfair competition law, though such availability might be federally preëmpted. However, contrary to Amgen's assertion that a generic biosimilar company must provide notice to a relevant research biologics company only after its product has been licensed by the FDA, the Court instead decided that "[a biosimilar drug] applicant may provide notice either before or after receiving FDA approval", suggesting that biosimilar drugs could reach market earlier than six months after licensure.
Perhaps the most important result of the Sandoz v. Amgen decision is clarification about the patent dance. Just as the whip and nae-nae is decidedly optional, so too, the Supremes have decided, is the patent dance.

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