How far does a generic drug maker need to go to exclude liability for inducing patent infringement?

In drug patent cases the product monograph is key in assessing whether inducement exists. In the case of off-label uses, it is customary for a generic drug maker to exclude any references in the innovator’s product monograph that teach the off-label use. How far such edits must go is put in doubt by the Federal Court of Appeal decision in Apotex Inc. v. Janssen Inc., 2023 FCA 220.

The test for a finding of inducing infringement was confirmed by the Federal Court . . . [more]

A private members bill directed to a ‘right of repair’ is working its way through parliament. Bill C-244, “An Act to amend the Copyright Act (diagnosis, maintenance and repair)” is currently at third reading and may become law soon. The government included a “right of repair” in its 2023 budget documents and so far Bill C-244 has support from all parties.

The budget announcement said in part:

Budget 2023 announces that the government will work to implement a right to repair, with the aim of introducing a targeted framework for home appliances and electronics in 2024.

The government will

With OpenAI’s release of ChatGPT-3 on November 30th 2022, it very quickly became clear to people that the innocent-sounding Large Language Models (LLMs) had crossed a historic threshold when it came to the intelligence exhibited by Artificial Intelligence. Many were seeing, for the first time, a computer responding to their questions and prompts with well informed and well-formed prose that, apart from the occasional “hallucination,” spoke directly to what was asked or prompted.

The immediate legal question was whether the resulting text, while certainly exhibiting intellectual properties, constituted the sort of intellectual property that the law was intended to encourage . . . [more]

How does a Court assess a class action claim against a high-tech giant where the evidence is that the plaintiff reaffirmed the conditions of use numerous times in making her transactions in the world following the Supreme Court of Canada’s seminal case in Uber Technologies Inc. v. Heller, 2020 SCC 16, [2020] 2 S.C.R. 118.

In Heller, the Supreme Court found a compulsory arbitration clause in a contract of adhesion was unconscionable and unenforceable. The facts in that case would have required Heller to expend a year’s earnings to dispute the service agreement with Uber.

After Heller, . . . [more]

Hugh Stephens, a Canadian policy and business consultant, has a new book out In Defense of Copyright. In advance of its release, he did a column on July 15th in the Globe and Mail, “Why Canada Needs Copyright Reform Now,” calling on the government to update the Copyright Act after more than a decade of reviews and proposals. I couldn’t be more supportive of both defending and updating copyright. Now does seem to be the time, and all the more so with Prime Minister Trudeau declaring that his midsummer cabinet shake up was intended to create “the . . . [more]

In Canada (Attorney General) v. Benjamin Moore & Co., 2023 FCA 168 the Federal Court of Appeal had to assess the effort by the Federal Court to clarify the rule around subject matter objections for computer-implemented inventions. This remains a pressing issue as inventors of computerized inventions continue to seek patent protection in Canada. The Federal Court of Appeal declined to take the opportunity to clarify the rules that would be applicable because the parties and intervenors could not provide a consistent statement of the rules they thought should apply.

The background is that Benjamin Moore had been declined . . . [more]

In my last Slaw column, I dealt with the rapid responses to the “authorship” question from the leading journal Nature and the U.S. Copyright Office to the sudden arrival of large language models (LLM), such as ChatGPT. Both publisher and government agency made it clear that they will not accept such works for publication or copyright. More recently, Nature reported this June that it will now require authors to state that their submission does not use AI-generated images.

With the state and impact of LLM continuing to rapidly evolve, I want to follow with further reflections on the authorship . . . [more]

Background

By contrast with the fair dealing user’s right in Canada, the United States copyright law provides a fair use exemption. Since the reader might encounter US commentary of decisions addressing the fair use right the following comments are provided to introduce the fair use exemption.

The Canadian fair dealing user’s right has some superficial similarities to the United States fair use exemption. Under the US copyright law, “a copyright holder cannot prevent another person from making a “fair use” of copyrighted material.”^[1]

The US Supreme Court describes the fair use doctrine as “an “equitable rule of reason” that . . . [more]

Canada’s Federal Court is the go-to forum for intellectual property litigation in Canada. While provincial superior courts have concurrent jurisdiction over infringement proceedings, for several reasons, rights owners often look to the Federal Court to start their proceedings and some recent announcements have reinforced this dominance of the Federal Court for intellectual property matters.

Legislative Background

The Patent Act, Trademarks Act and Copyright Act all include provisions granting concurrent jurisdiction to the Federal Court alongside the provincial superior courts. For example, section 54(1) of the Patent Act states that infringement may be brought in superior courts which is concurrent . . . [more]

The publisher Springer Nature is issuing books with such subtitles as A Machine-Generated Literature Overview, while ChatGPT is being credited as co-author on research papers published in Elsevier journals. Yet Springer Nature’s premier journal, Nature, declared in January, that papers generated by a large language model (LLM), such as ChatGPT, will not be accepted for publication: “An attribution of authorship,” states Magdalena Skipper, editor-in-chief of Nature, “carries with it accountability for the work, which cannot be effectively applied to LLMs.” This soon became part of Nature’s authorship policy. Then on March 16th, the U.S. Copyright Office launched . . . [more]

The Federal Court has noted that the Patented Medicines (NOC) Regulations^[1] “seek to balance the patent enforcement rights of innovative drug manufacturers with the timely market entry of lower-priced generic drugs by “enabling summary legal proceedings that would address patent concerns without unduly delaying access to generic medicines”.^[2]

Before marketing a drug in Canada, manufacturers must obtain a Notice of Compliance (NOC) from Health Canada. A “first person” who obtains a NOC for an innovative drug may list any associated patent on the Patent Register. If a “second person” subsequently requests a NOC for a competing drug by . . . [more]

The Federal Court recently analyzed what portions of postal codes were personal information and how the data could be made suitably anonymous. Anonymizing data will become increasingly important under Canada’s proposed Consumer Privacy Protection Act and Artificial Intelligence and Data Act, currently at second reading as Bill C-27.

In Cain v. Canada (Health), 2023 FC 55, the Federal Court considered an application under the Access to Information Act for disclosure of postal codes and cities for licensees entitled to grow medical marijuana. The applicant sought access to the ‘Forward Sortation Area’, namely the first three digits of the . . . [more]