On January 17, 2014, the Federal Court rendered its decision in Abbvie Corporation et al. v. Janssen Inc., a patent infringement case involving Canadian Patent No. 2,365,281, titled “Human Antibodies that Bind Human IL-12 and Methods for Producing” (the “281 Patent”). This is the first Canadian decision to confirm the validity of functional claiming in the biologics area. The court held that the mere fact that the scope of an antibody claim is functionally defined does not automatically render the claim invalid.
The ‘281 Patent disclosed a recombinant antibody that binds to IL-12, a cytokine that plays an important role in mediating the adaptive immune response. The ‘281 Patent also disclosed the use of phage display technology to find a monoclonal antibody that would bind IL-12 with sufficient affinity. IL-12 has been linked with autoimmune disorders (where a person’s own immune system is attacking the person’s own cells and tissues), such as psoriasis. The description of the ‘281 Patent contained data from a double-blind clinical trial in which a candidate antibody, J695, was administered in healthy patients, including a person who had psoriasis. The J695 antibody was shown to reduce that person’s psoriasis symptoms.
The ‘281 Patent had 223 issued claims, but the patentee only asserted claims 143 and 222. The court construed these two claims as being directed to the use of human antibodies, however created, to treat psoriasis, which bind to IL-12 with at least a certain level of stickiness and potency.
The therapeutic agent in STELERA®, the defendant Janssen’s drug, is the antibody ustekinumab, and the drug is approved in Canada for treatment of psoriasis. This antibody was developed using transgenic mouse technology, and is structurally different from and binds to different sites than the J695 antibody described in the ‘281 Patent. However, expert evidence at trial showed that Janssen’s antibody has affinity and potency that fell within the scope of claims 143 and 222 as construed. While Janssen argued that the expert evidence is not admissible, it did not conduct its own testing, and the court found the asserted claims to be infringed by Janssen through induced infringement.
In its defence, Janssen argued that the asserted claims of the ‘281 Patent were invalid because of obviousness, covetous claiming, and insufficiency and lack of enablement. On the issue of obviousness, the court found that the claimed inventions were not self-evident having regard to the prior art. The evidence established that before the invention, there was only a hope that some human disease may be treated by an antigen binding to a cytokine like IL-12. The inventors “got lucky” and found that anti-IL-12 antibodies, with certain traits, can be used to treat psoriasis. This discovery was found by the court to be inventive, and, accordingly, the asserted claims were found to be non-obvious.
With respect to the invalidity grounds of covetous claiming, insufficiency, and lack of enablement, Justice Hughes addressed these grounds by asking a single question: Is the claim overly broad? Specifically, the court considered whether the patentee is entitled to protection over a broad class of antibodies having certain functional characteristics even though the patentee only disclosed one antibody developed using one method in the specification.
The court found that the techniques used to create these antibodies (phage display and transgenic mice) and the techniques used to measure binding and potency of the antibodies were well known in the art at the relevant time. There was no evidence that any antibody falling within the scope of either claim 143 and 222 was not useful in treating psoriasis or that a person skilled in the art, given the patent, could not have created an antibody satisfying the parameters of the asserted claims. Accordingly, claims 143 and 222 were not found to be overbroad. Justice Hughes noted that the issue of sufficiency, or overbreadth, has to be assessed on a case-by-case basis, and 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.”
This decision is notable because it is the first decision in Canada to confirm that an antibody claim is not invalid simply because it is functionally defined. This decision may also be used in overcoming Canadian patent examiner’s objections based on claim scope. In recent years, Canadian patent examiners have increased objections under section 84 of the Patent Rules, asserting that the pending claims are broader in scope than the teachings of the description and should be amended to incorporate an “essential element” identified from the disclosure. This case illustrates that a patentee is entitled to claim scope that is broader than the specific embodiments disclosed in the specification, provided there is adequate support for the claimed invention.
As the case was bifurcated, remedies and the amount of damages are to be assessed in a separate hearing. Janssen may also appeal the decision to the Federal Court of Appeal as of right. This decision, and any subsequent appeal decisions, may have significant implications for companies that are already marketing biologics in Canada or seeking to enter the Canadian market with new biologics or biosimilars/subsequent entry biologics.
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In order to ensure that your organization is complying with this legislation, it is prudent to review your current practices and list of consents, develop a plan to ensure that future CEMs are compliant and get express consent from any potential recipients.
By Vincent K.S. Yip