intellectual property
| By Noel Courage and Phil Goldbach
IP for Ig: Protection for Antibody-based Assets in the Canadian Market and Beyond
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ntibodies (immunoglobulins) and other antibody-derived biologics have become a mainstay of the biotechnology industry, both here in Canada and around the world. Novel antibodies are continuously being designed, modified, expressed and purified for a number of uses, including as therapeutics, diagnostics, or research tools. As is the case with other types of life science technologies, intellectual property (IP) rights must be a key consideration for anyone creating new and innovative antibodies or antibody-based applications. This article provides a brief overview of IP issues and considerations for those engaged in antibody technologies.
20 BIOTECHNOLOGY FOCUS April/May 2018
Understanding IP Rights Surrounding Antibodies As is often the case when discussing IP for technologies, the focus here will be on patents and patent protection. However, it is important to note that patents are not and should not be the only type of IP right considered. Trade secrets can be used to protect certain aspects of antibody manufacturing and production particular to an organization. Trademarks, copyright, and industrial designs can all apply to the marketing, branding and selling of products and/or services in the antibody space. For innovative antibody-based therapeutics, a particular type of IP right called data protection can provide an extra layer of protection (beyond the scope of discussion in this article).
Patents are a powerful tool for maximizing value in an innovative technology. An issued patent gives the patent holder a monopoly over the claimed invention for a period of twenty years (plus some extension time in certain jurisdictions) from the patent application filing date. As antibody-based technologies have increased dramatically, so has the number of corresponding patent filings. As of the writing of this article, the total number of published patent documents (i.e., patent applications plus issued patents) with claims to antibodies or antibody-based products is around 300,000 globally, and 20,000 in Canada. The number of patent documents published by the Canadian Intellectual Property Office (CIPO) has increased almost every year, with more than 100 per year since 1990 and more than 1,000 since 2012. Out of the total 20,000 or so total patent documents, the vast majority (>95%) originated, and are owned, by organizations based outside of Canada. With regard to regulatory approvals, monoclonal antibodies now comprise a large proportion of Health Canada-approved innovative drugs each year â specifically: 8/36 in 2015, 7/35 in 2016, and 10/35 in 2017. To our knowledge, most or all of these drugs originated from outside Canada. Many of the up-and-coming Canadian companies profiled in the feature article in this edition of Biotechnology Focus follow the types of IP strategies outlined below. Generally speaking, the strongest patent claims (protection) will focus on the antibody itself, a chemical compound. The claim wording reflects the type of invention, such as an antibody directed against a novel antigen versus against a known antigen. In terms of claiming a novel antibody, functional claims may be available in some patent offices (i.e., claims primarily based on antibody binding properties). Applicants may also claim by reference to the minimally required DNA/ protein sequence needed to maintain a desired function. In most cases, this means claiming a specific set of CDR sequences. This provides protection not only for the full-length
