- Health Canada and Federal Court Make Important Biologic Decisions
- January 21, 2014 | Author: Urszula Wojtyra
- Law Firm: Smart & Biggar/Fetherstonhaugh - Toronto Office
Last week was a landmark for biologics in Canada: Health Canada approved two antibody subsequent entry biologics (SEBs) and the Federal Court issued a decision finding a patent directed at a therapeutic use of an antibody to be valid and infringed.
Health Canada approves first antibody SEBs
On January 15, 2014, Health Canada issued notices of compliance (NOCs) to Celltrion Healthcare Co. Ltd. for REMSIMA and INFLECTRA, which both contain a monoclonal antibody, infliximab, as the medicinal ingredient. Janssen Inc. markets REMICADE, containing infliximab, for a number of indications, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis and psoriasis. It is not clear at this time for which indications REMSIMA and INFLECTRA were approved.
Both INFLECTRA and REMSIMA were granted marketing approval in the European Union in September 2013. The approvals were granted to Celltrion Healthcare Hungary Kft. (INFLECTRA) and Hospira UK Limited (REMSIMA). Both were approved as “biosimilars” to REMICADE, and have been approved in all the same therapeutic areas as REMICADE.
These approvals bring the total number of SEBs approved in Canada to date to three, including Sandoz’s OMNITROPE, which contains somatotropin.
Federal Court issues decision in biologic patent infringement action: patent valid and infringed
On January 17, 2014, Justice Hughes of the Federal Court rendered a decision in a biologic patent infringement action, finding AbbVie Corporation (Abbvie)’s patent valid and infringed by Janssen Inc. (Janssen)’s antibody drug STELARA (ustekinumab) used in the treatment of psoriasis: AbbVie Corporation v Janssen Inc, 2014 FC 55. AbbVie does not market and does not have an NOC for a drug containing ustekinumab for treatment of psoriasis.
The patent at issue:
AbbVie, formerly Abbott, owns the patent at issue, Canadian Patent No. 2,365,281, titled “Human Antibodies that Bind Human IL-12 and Methods for Producing.”
The patent relates to isolated human antibodies that bind IL-12, one of many cytokines that function to mediate and regulate immune reactions in the body. The binding of the antibody to IL-12 prevents receptor binding, thereby making the antibody useful in the treatment of diseases, including psoriasis. The patent describes the use of a particular method, phage display, to make monoclonal antibodies.
Example 9 contained the sole clinical data in the patent, describing a double-blind clinical trial of the administration of a particular antibody, J695, or placebo to healthy subjects. One of the subjects was suffering from psoriasis at the beginning of the study, happened to receive the antibody treatment, and reported an improvement in his psoriasis symptoms.
Of the 226 claims in the patent, only two were at issue in the case. Justice Hughes construed the two claims as being directed to the use of an isolated human antibody, however created, that binds IL-12 with a minimum specified affinity and has a minimum specified potency in particular in vitro assays as set out in the claims, for the treatment of psoriasis.
The medicinal ingredient in Janssen’s STELARA product is a human antibody derived using transgenic mouse technology, as opposed to phage display used to derive J695, the antibody described in the patent. However, given the construction that the claims were not limited to human antibodies created by a particular method, this was found insufficient to take STELARA outside the scope of the claims. Furthermore, AbbVie had conducted testing of the STELARA antibody, which the Court accepted as establishing that the antibody met the affinity and potency required by the claims. As such, Justice Hughes found that STELARA infringed the claims.
Janssen submitted that the patent was invalid on the basis of, inter alia, obviousness and overbreadth.
Obviousness. Justice Hughes emphasized that that the claims are the appropriate focus for identifying the inventive concept of the claims at issue, as opposed to “some generalized concept of invention as expressed in the patent as a whole.” For the claims at issue, he held the inventive concept was that “psoriasis may be treated by the use of human antibodies that bind to human IL-12, which antibodies have a stickiness of at least the claimed amount and a potency of at least the claimed amount.” The difference between the prior art and the invention as claimed “is that between hope and certainty.” He explained, at paragraph 133:
...before the invention was made, there was a hope that, among the “soup” of cytokines in the human body, if an [antibody] was found to bind to one or more of them, then certain human diseases might be treatable. The invention here was that it was found that a particular cytokine should be bound by an [antibody] having certain properties, and then psoriasis would be treatable. [Emphases in original]
Distinguishing between the “worth a try” approach and the “more or less self-evident” approach, holding the latter to be the law in Canada, he found that AbbVie’s researchers “got lucky,” and that the invention was not self-evident having regard to the prior art.
Overbreadth. Justice Hughes framed the question as follows:
...Having claimed the invention without reference to the specific antibody described in the patent, or even the specific method by which it was described to be made in the patent, can the claim be so broad as to cover whatever antibody falls within the constraints as [construed above] and still be valid?
On the particular facts of this case and in light of the evidence, the answer was yes.
The evidence showed that techniques used to create antibodies were well known, as were the methods for measuring affinity and potency. Furthermore, there was no evidence that there was anything falling within the scope of the asserted claims that was not useful for the treatment of psoriasis, or that a skilled person could not have created an antibody that met the parameters of the two asserted claims. Justice Hughes found that the claims were not merely functionally claiming a desired result, particularly given the fact that it was AbbVie who first confirmed that if an antibody did bind to IL-12, psoriasis could be treated. Before this confirmation, there was only a hope or speculation. Furthermore, the claims included certain criteria for the antibody, namely specified minimum affinity and potency:
...AbbVie was the first to confirm that, if you want to treat psoriasis, you must get an antibody that binds to IL-12 and it must have at least a certain level of stickiness and potency. That is very different from saying - we have a particular antibody (J695), and we put it into people, and it treats their psoriasis; therefore, we want a patent claiming any antibody that does that. There may be many ways to treat psoriasis, but AbbVie’s way is to have an antibody that does so by binding to IL-12 with at least a certain level of stickiness and potency.
Justice Hughes concluded that “there is no simple principle that can be universally applied that would say, for example, that you have shown only one or two antibodies in your disclosure; you cannot claim all that will do the particular trick you have in mind.”
Remedy. Justice Hughes declared, as between the parties, the claims valid and infringed. Pursuant to a bifurcation order, the trial dealt only with infringement and invalidity. Issues relating to remedy, including entitlement to an injunction, and quantum, were deferred to a subsequent trial.
Janssen may appeal to the Federal Court of Appeal, as of right.
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