McCarthy Tétrault client AbbVie wins patent infringement case against Janssen in Canada’s first antibody engineering trial

| 19 minutes

Toronto, January 22, 2014 — McCarthy Tétrault is delighted to announce that its client AbbVie has won a significant patent infringement case against Janssen Inc. related to AbbVie’s Canadian patent on anti-IL-12 antibodies.

AbbVie commenced a patent infringement action against Janssen in 2009 — the first in Canada dealing with the scope of protection for a new and significant class of drugs known as "biologics". The case involved the infringement of AbbVie’s patent for the use of a class of human anti-IL-12 antibodies to treat psoriasis, based on the fact that Janssen’s psoriasis product, Stelara, contains a human anti-IL-12 antibody.

Following a three-week trial in December 2013, the Honourable Justice Hughes of the Federal Court of Canada found AbbVie’s patent to be valid and infringed by Janssen. The full decision in AbbVie Corporation et al. v. Janssen Inc., 2014 FC 55 is found here.

The main issue in the case was whether AbbVie’s broad claims to the use of a class of antibodies were invalid because AbbVie only disclosed one antibody within the class covered by the patent. The Court concluded that the claims were not broader than AbbVie’s invention because the invention was the general discovery that an anti-IL-12 antibody would treat psoriasis, all of the antibodies covered by the claims (including Janssen’s Stelara) work to treat psoriasis, and all such antibodies were soundly predicted to do so by the AbbVie inventors.

The Court observed that Janssen’s argument about the breadth of the claims "does not come to grips with" the fact that AbbVie was the inventor of the general concept of using an antibody to IL-12 to treat psoriasis. Instead, Janssen argued that giving AbbVie broad protection for its invention was "unfair" because AbbVie’s invention was defined "functionally" instead of by specifically describing the structure of the antibodies AbbVie claimed in the patent and without specifically describing the structure of Janssen’s Stelara.

There has been a considerable amount of litigation in the United States and Europe about the validity of "functional claiming" for biologics, but there have been no cases in Canada that have considered the issue in relation to biologic drugs. This is a landmark decision, reaffirming that there is nothing inherently impermissible about functional claiming, and establishing that a class of biologics can be defined by broad functional characteristics as long as the claims are clear, do not cover non-working antibodies, and only cover antibodies that can be soundly predicted to work based on the work of the inventors. The Federal Court determined that the law in the United Kingdom regarding functional claiming is consistent with Canadian law and that the United States law had little applicability.

The Court also rejected Janssen’s allegations that the patent was invalid because the invention was "obvious". The Court determined that before AbbVie’s transformative discovery, there was only a "hope" that if an antibody were found to bind to one or more of the many potentially relevant cytokines, then some human disease might be treatable. AbbVie’s work proved that it was an anti-IL-12 antibody that would treat psoriasis and for that invention AbbVie is entitled to broad patent protection.

McCarthy Tétrault’s trial team was led by Andrew Reddon and Steven Mason. The other members of the team were Steven Tanner, Fiona Legere and Ryann Atkins.

McCarthy Tétrault’s IP Litigation Group is recognized as one of Canada’s leading practices defending patents, trademarks, trade secrets, copyright, industrial designs and other intellectual property assets. The group has expertise in a broad range of industries, including pharmaceuticals, life sciences, technology, internet, energy and communications. Its recent recognitions include being named the best patent litigation group in Canada in 2013 by Managing IP (Euromoney Legal Media Group), and being identified as one of Canada’s top patent practices in the 2013 edition of IAM Patent 1000 (Intellectual Asset Management).

About McCarthy Tétrault

McCarthy Tétrault LLP provides a broad range of legal services, advising on large and complex assignments for Canadian and international interests. The firm has substantial presence in Canada’s major commercial centres and in London, UK.

Built on an integrated approach to the practice of law and delivery of innovative client services, the firm brings its legal talent, industry insight and practice experience to help clients achieve the results that are important to them.