While at AstraZeneca, I was involved in a wide variety of interesting projects each with its own unique challenges and learning opportunities, including projects relating to IP licensing, parallel trade, subsequent entry biologics, and product pricing. Indeed, the breadth of issues that in-house counsel face on any given day is quite impressive. Nevertheless, of all these projects one in particular stood out above them all – AstraZeneca’s appeal to the Supreme Court of Canada (SCC) on the promise doctrine. The appeal was between AstraZeneca and Apotex Inc., a generic pharmaceutical company, in relation to the Federal Court of Appeal’s decision to hold the substance patent for esomeprazole (NEXIUM) invalid for lack of utility for failing to meet the “promise of the patent”. The potential implications of this decision on the industry are profound.

By the time of my arrival, AstraZeneca, led by external counsel, were far along in their preparation for the SCC hearing having already filed their factum with the Court. As such, focus at this stage was on the rehearsal and refinement of oral submissions. To my great benefit, I was able to attend these rehearsals and participate in the process of fine-tuning arguments. It was a fantastic experience. Observing seasoned IP litigators, with the assistance of a former Supreme Court justice, carefully craft the delivery and structure of arguments and formulate persuasive responses to anticipated questions from the bench was as fascinating as it was informative.

Contemporaneous with these rehearsals was the filing of written submissions by intervening parties to the appeal. There were six interveners in total, including Innovative Medicines Canada and BIOTECanada, Intellectual Property Owners Association, Intellectual Property Institute of Canada, Centre for Intellectual Property Policy, Canadian Generic Pharmaceutical Association, and Fédération internationale des conseils en propriété intellectuelle. Together, these parties represented a broad range of stakeholders, including those from both the innovator and generic sides of the industry. Eager to learn more about the different perspectives raised by the interveners than I could glean from their respective facta, my supervisor arranged for me to sit in on meetings of the Canadian Patent Utility Coalition in which a subset of interveners elaborated on their positions. This was a great opportunity to gain a better appreciation of their main concerns and objectives, particularly in relation to issues like post-filing evidence, sound prediction and international treaties. In turn, this insight was invaluable when I was invited to review and comment on drafts of AstraZeneca’s reply factum. Having the chance to be involved in this process was a lot of fun and a real privilege.

At long last came the day of the appeal. Fortunately, I was able to make the trip up to Ottawa with my supervisor to observe the hearing in person and it was an experience I will not soon forget. Given my specific interest in IP litigation, it was terrific to watch some of the very best in their craft, employing a range of different styles, engage with what was a surprisingly active bench. I was particularly struck by the knowledge and composure demonstrated by counsel in responding to questions. In the end, it was a very exciting day all around and I, along with everyone in AstraZeneca, anxiously await the Court’s decision that is expected some time early next year.

From regulatory issues to contract drafting, I am extremely grateful to everyone in the Legal Affairs team at AstraZeneca for all the knowledge and insight they shared with me. Aside from being an impressive group of legal practitioners, they are also wonderful people. I consider myself very fortunate to have had the opportunity to learn from them and look forward to meeting again in practice.

Stephen Dalby is a JD Candidate at Osgoode Hall Law School and was enrolled in Osgoode’s Intellectual Property Law and Technology Intensive Program. As part of the program requirements, students were asked to write a reflective blog on their internship experience.

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Therapeutic use of biologics has increased considerably in recent years.[5]�� Unfortunately, due to the complexity of these molecules, development and commercial production have proven very costly.[6]�� Indeed, it is estimated that most biologics must enjoy market exclusivity for, on average, 12.9 to 16.2 years before initial research and development costs can be recovered.[7]�� Adequate IP safeguards are then vital for continued research and investment in this area.

It is axiomatic that patents play a key role in the pharmaceutical industry, but their practical value is questionable when applied to biologics in Canada. On account of the fundamental nature of biologics, it is often said that the “product is the process.”[8]�� Process patents are, therefore, of central importance. Nevertheless, pure process patents are not permitted for listing in the Patent Register for the purposes of proceedings under the Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations).[9]�� The result is a significant gap in patent protection. There remains, of course, the option to pursue an action for patent infringement against manufacturers of SEBs, but this avenue is fraught with practical difficulties. Chief among these issues are the typical length of time for a case to come to trial and be tried and how rarely preliminary injunctions are granted in Canada.[10]

Due to this gap in patent protection, data exclusivity serves as important insurance to safeguard innovator investment.[11]�� Data protection garnered considerable debate among stakeholders during CETA negotiations as innovators pressed unsuccessfully for the US standard of 12 years.[12]�� Under the current Canadian regulatory scheme, SEBs are barred from relying on reference biologic data for 8 years and will remain so should CETA be ratified.[13]�� This falls well short of the estimated market exclusivity that a biologic typically requires to be profitable. Without adequate insurance, investment in these medicines is discouraged.

Under these circumstances, reliance on trade secrets may represent a reasonable supplement or alternative to data protection and patents.[14]�� For reasons already discussed, innovators may see trade secret protection as a more attractive mechanism than process patents. Indeed, in light of patent law’s disclosure requirements, it may be worthwhile to forego patenting entirely.[15]�� Alternatively, innovators may seek to obtain substance patents that do not disclose the best mode of manufacture, although there is debate as to whether this is permissible.[16]�� As a practical consideration, innovators that opt for trade secrets over patents would also find themselves outside the jurisdiction of the Patented Medicines Price Review Board (PMPRB).[17]

For the public, the costs of a trade secret strategy are significant. Besides the obvious detriment to the pool of collective knowledge, this strategy will force prospective SEB manufacturers to reverse engineer reference biologics in order to identify the necessary manufacturing processes – an expensive and time-consuming procedure.[18] In turn, the time and cost incurred by the SEB manufacturer will delay the arrival of more affordable therapies and increase the market price of these medicines.[19]

How then can the Canadian IP regime better protect biologics? With CETA negotiations over, the opportunity to increase data protection in the near future has likely passed. Another possibility is to develop a patent-based framework specific to biologics. In Canada, such a framework could be established with a second patent register that would allow for process patents to be listed for biologics. The pharmaceutical industry`s familiarity with the PM(NOC) framework may make this an appealing option with real potential for improved enforcement of biologic-related patents. Whatever the solution, Canada must not be shortsighted in its approach to emerging medical therapies and should design balanced protections that are alive to the realities of the industry.

Stephen J. Dalby is a JD Candidate at Osgoode Hall Law School.�� Stephen is currently enrolled in Osgoode’s Intellectual Property Law Intensive Program. As part of the program requirements, students were asked to write a blog on a topic of their choice.

[1] Health Canada, “Guidance For Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs)”, (Ottawa: Health Canada, 2010), online: .

[2] Ibid.

[3] Ibid.

[4] Kristina Lybecker, “The Biologics Revolution in the Production of Drugs” in Steven Globerman, ed, Intellectual Property Rights and the Promotion of Biologics, Medical Devices, and Trade in Pharmaceuticals. (Vancouver: Fraser Institute, 2016) 9 at 12.

[5] Ibid at 16 – 20.

[6] Supra note 4 at 30.

[7] Henry Grabowski, Genia Long, and Richard Mortimer, “Data Exclusivity for Biologics” (2011) 10 Nature Reviews: Drug Discover 15 at 15.

[8] Walter Jeske et al, “Update on the safety and bioequivalence of biosimilars – focus on enoxaparin” (2013) 5 Drug, Healthcare and Patient Safety 133 at 135.

[9] Health Canada, “Guidance Document: Patented Medicines (Notice of Compliance) Regulations”, (Ottawa: Health Canada, 2015), online: .

[10] Aleksandar Nikolic, "A Comparative Study of Patent Infringement Remedies Related to Non-Practicing Entities in the Courts of Canada, the United Kingdom, and the United States" (2014). LLM Theses. Paper 4 at 73.

[11] Henry Grabowski, “Data Exclusivity for Biologics: What is the Appropriate Period of Protection?” (2009) 10 American Enterprise Institute for Public Policy Research 1 at 5; Biotechnology Industry Organization, “The Trans-Pacific Partnership and Innovation in the Bioeconomy: The Need for 12 Years of Data Protection for Biologics” (2013) at 4, online: .

[12] Biologics Price Competition and Innovation Act, 42 USC §262 (2009) s 351(k)(7)(A), online: .

[13] Canada CRC, c 870, C.08.004.1(3)(b); Comprehensive Economic and Trade Agreement, Canada and European Union, art 20.29 at s 2(b).

[14] Paul A Calvo, “Choosing Between Patent And Trade Secret Protection In A Biosimilar World” (13 January 2016), Biosimilar Development (blog), online: .

[15] Patent Act, RSC, 1985, c P-4, s 27(3).

[16] Teva Canada Ltd. v Novartis AG, 2013 FC 141 at para 376; David Vaver, "Best Mode Disclosure in Canadian Patents" (2013).��Comparative Research in Law & Political Economy.��Research Paper No. 30/2013, online: .

[17] Supra note 14 at s 80(1).

[18] W. Nicholson Price II and Arti K. Rai, “Manufacturing Barriers to Biologics Competition and Innovation” (2016) 101:3 Iowa L Rev 1023 at 1029.

[19] Ibid.

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