The Product Monograph
In the pharmaceutical industry, the issue of copyright can arise in the context of product monographs. Once approved by Health Canada, product monographs are publicly available documents and contain the information for safe and effective use of a drug. It is drafted and redrafted as Health Canada and the drug manufacturer discuss the product and exchange information. A final approved product monograph may not include all of the information exchanged between the parties, but is the result of discussions and compromise between them. It is published as part of the Notice of Compliance ("NOC") issued by Health Canada and without it, the drug product cannot be sold.
A claim in copyright infringement for substantial reproduction of a product monograph remains an available avenue for an innovator seeking to enforce its intellectual property in Canada. After all, it can be argued that a product monograph is a "literary work" within the meaning of the Copyright Act. The most recent (and possibly first) attempt by an innovator to initiate an action for infringement of copyright in a product monograph unfortunately provided no clarity on this issue. AstraZeneca started the infringement action and Apotex responded by seeking to expunge the copyright registrations held by AstraZeneca. However, the infringement action was discontinued. The issue has been raised as part of other actions, for example, as part of motions for interlocutory injunctions.1 Canadian Courts have not yet decided the issue, but have indicated that the arguments (for either view) are "arguable" at least. The Court has hinted that it would require detailed evidence concerning the 'degree of direction and control' exercised by or under Her Majesty, since section 12 of the Copyright Act provides that any work prepared under the direction and control of Her Majesty (or "any government department") belongs to Her Majesty.
So while the outcome remains far from settled, it is easy to understand the dilemma that would ultimately test the Court: weighing public disclosure and access to pharmaceutical information on one hand, and the rights of authors, which encourages the creation of works, on the other. Making pharmaceutical information available to the public (physicians, pharmacists, and patients) is a major objective to be achieved by the product monograph. The Court has signaled that there exists a challenge in attempting to balance public policy with the rights afforded by copyright law. While an incredible amount of work is put into the innovator company's monograph, the Court has said it can be difficult for a generic to produce its version of a monograph that does not substantially reproduce the standard information found in the innovator's (i.e.information as to the action of the drug, its indications of clinical use, precautions to be taken, dosage and administration, etc.). Therefore, the challenge facing the generic manufacturer, from the Court's point of view, is for it to produce a monograph which will be approved, and contain much of the essential information found in the innovator's monograph, but to obtain it from independent and public sources and thus avoid infringement.2 This seems unlikely, so it remains to be seen how the Court will ultimately side in this seemingly unstable intersection of copyright and patent law.
Working with Copyright-Protected Publications
It is also important to consider the effect of working with or sharing copyright-protected publications. For example, while collaboration and knowledge-sharing are vital to those in the pharmaceutical industry, it is important for employees to read and be aware of the Terms and Conditions of a content-provider's website to determine if "sharing" of content (without permission) is prohibited. While "sharing" may be expressly prohibited, it could nevertheless be excepted from copyright infringement if it is a "fair dealing" pursuant to section 29 of the Copyright Act (i.e. if for "research", "private study" or "education" purposes). So while the act of sharing may ultimately qualify as an exception to "copyright infringement" in Canada, it may still be a breach of the company's Terms and Conditions.
It is therefore incumbent on companies to ensure that they have the appropriate licenses to cover the types of uses they require. Corporate responsibility and adherence to copyright law is vital in this regard, since information sharing is key to growth in the pharmaceutical field.
Footnotes
1 See Pfizer Canada Inc. v. Canada (Attorney General) (1986), 10 C.P.R. (3d) 268 (F.C.T.D.); Proctor & Gamble Pharmaceuticals Canada Inc. v. Novopharm Ltd. (1996), 68 C.P.R. (3d) 461 (F.C.T.D.) at para. 33; Upjohn Co. v. Apotex Inc. (1993), 51 C.P.R. (3d) 292 at para. 19 (F.C.T.D.).
2 See Smith, Kline & French Canada Ltd. v. Frank W. Horner Inc. (1982), 68 C.P.R. (2d) 42 (F.C.T.D.).
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
