Life Sciences 2020 Year In Review

• Published date: 11 February 2021
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Bereskin & Parr LLP
• Author: Ms Melanie Szweras and Amy Dam

2020 will always be remembered as the year of COVID, and we would be remiss not to discuss the impact of COVID in the Life Sciences field. From the interest in patenting the use of remdesivir in treating COVID (see Patenting Coronavirus (COVID-19) Treatments) and finding ways to rapidly diagnose a COVID positive patient, to the race to produce a vaccine (see The Race to Produce a COVID-19 Vaccine (Part I) and The Race to Produce a COVID-19 Vaccine (Part II)), COVID has definitely brought the incredible strength of medical research to the attention of us all, while showing that scientific collaborations and acceleration to market can still occur in conjunction with intellectual property protection (see Pooling Patent Rights to Combat COVID-19 and Canadians Ramping Up COVID-19 Collaborations and IP).

Recognizing this rapid need for COVID treatment, government, including intellectual property offices and regulatory bodies, developed programs to help accelerate research, examination and approval (see Ontario Government Unveils Intellectual Property Action Plan Along with COVID-19 Research Projects and The USPTO's Fast-Track Patent Program Spurs on COVID-19 Innovations).

Although COVID has dominated most discussions, there were many other developments of note in Life Sciences IP over the last year.

Prior Art: Anticipation and Obviousness

The Federal Court of Appeal considered both anticipation and obviousness in Hospira Healthcare Corporation v. Kennedy Trust for Rheumatology Research, 2020 FCA 30 [Hospira], in a decision relating to the infliximab biosimilar. With respect to the first requirement for anticipation, Justice Locke of the Federal Court of Appeal found that the disclosure requirement "is satisfied if performing what is described in the prior art reference would necessarily result in infringement". Justice Locke could not see how the two prior art references, which disclosed the idea of co-administration of methotrexate and the antibody, did not satisfy this requirement merely because the special advantage of the adjunctive therapy was not disclosed. Justice Locke also found that "in order for any particular results from the claimed combination treatment to be a basis for distinguishing over the prior art, it would be necessary to conclude that such results constituted an essential element of the claim in question". With respect to the second requirement for anticipation, Justice Locke similarly found that what must be enabled in the prior art is the essential elements of the claims, and not the experiments that were disclosed in the patent.

Regarding obviousness, Justice Locke clarified the obvious to try test, explaining that the determinative test is whether "it was more or less self-evident to try to obtain the invention" (emphasis added). The question of "whether it was more or less self-evident that what is being tried ought to work" is not part of the determinative test, but is a factor for consideration. Justice Locke also provided certainty over what prior art is citable for obviousness, confirming that prior art should not be excluded on the basis that it could not be found using a reasonably diligent search.

In Biogen Canada Inc. v. Taro Pharmaceuticals Inc., 2020 FC 621 [Biogen], Justice Manson of the Federal Court provided a good reminder of the importance of carefully reviewing documents prior to making any disclosure, and to redact any data that may jeopardize the patentability of an invention. In this case, the claims were anticipated and found obvious in view of a single financial document. After completion of a small phase II study of fampridine SR, Acorda decided to go public in order to raise additional funds. Its registration statement included results from the first phase II trial and the design of a second phase II trial. Justice Manson found some of the claims anticipated and all the claims obvious. With respect to anticipation and relying on Hospira, he held that the disclosure requirement was satisfied because performing what was described in the second phase II trial design would necessarily result in infringement, even in the absence of results. The enablement requirement was also met. Even if the second phase II trial...