Federal Court Holds Biologic Patent Valid and Infringed

In the first patent action involving biosimilars, the Federal Court held that the patent was valid and infringed.

The Kennedy Trust for Rheumatology Research owns Canadian Patent 2,261,630 relating to the combination of methotrexate and the anti-tumour necrosis factor-α antibody “infliximab” for the treatment of rheumatoid arthritis (RA) and other autoimmune diseases. Hospira Healthcare Corporation commenced an action seeking to invalidate the patent and Kennedy counterclaimed for infringement.

Hospira alleged the patent was invalid for claiming an unpatentable method of medical treatment, namely, that it was directed towards the “how and when” of using infliximab to treat RA. The Court ruled that the 630 Patent does not cover a method of medical treatment. It distinguished between patents for “a dosage regime leading to increased efficacy” and “a combination of elements leading to increased efficacy and duration of response.” A combination of known elements may properly be the subject of a patent and accepting Hospira’s position would mean that inventors would be unable to patent “any subsequent use for a known compound, as this would monopolize the “how and when” of using the compound for treatment.”

The Court placed no weight on the fact that Hospira’s experts were “blinded”, finding “that blinding alone is not a guarantee of reliability and it is not a sufficient reason to prefer the evidence of one witness over another”. Further, given the experts’ involvement in the development of RA treatments during the relevant period it was questionable whether “blinding holds any value” since it was “impossible to believe” they did not have knowledge of the matters at issue prior to the litigation.

Hospira asserted that the patent was anticipated by numerous prior art documents. The Court found “it would be absolutely remarkable” if the documents anticipated the patent. They did not disclose the “special advantage” of the combination and generally contained only speculation about studies that may be done in the future. Hospira also “took an improper approach” to anticipation by trying “to assemble an ‘anticipatory mosaic’” of prior art, which conflated anticipation and obviousness.

The Court reached a similar conclusion on obviousness. In relation to whether it would have been “obvious to try” the claimed invention, Justice Phelan found that “[a]lthough it may have been reasonable, based on the state of the art, to carry out the combination trials that led to this invention, it was not obvious to do so” (emphasis in original). He relied on the fact that “if this step was as clear as Hospira asserted it to be, it seems strange that it was not taken” and “despite the seemingly clear path forward, only the named inventors took this step.”

After the case was commenced, the Supreme Court, in AstraZeneca rejected the promise doctrine. Trial arguments were re-opened to allow submissions on the changed law which “has returned to the principle that utility is met if a “scintilla” of utility is demonstrated.” Hospira sought to import the discarded “promise” doctrine into allegations of insufficiency and overbreadth. The Court held that AstraZeneca did not do so and it would be inconsistent to discard the promise doctrine only to have it resurface under another principle without clear language to do so. The allegations of inutility and insufficient advanced were thus dismissed. The Court also dismissed Hospira’s allegations of overbreadth, cahracterizing is as a “hail mary”:

It is difficult to assess and accept Hospira’s position because it has failed to cite any case law or evidence in support of its conclusions. It also failed to cite any jurisprudence on the meaning of “overbreadth” in the context of patent law. Its submissions seem to have been made in the hope that something would “stick” – the patent law equivalent of the Hail Mary pass.

After upholding the validity of the Patent, Phelan J. found that it had been infringed since all essential elements of the claims were present in Hospira’s product, Inflectra/Remsima. Much of these findings were based on the product monograph, which described elements found to be essential, for example, that the product contains an infliximab biosimilar anti-TNF-α monoclonal antibody as the active ingredient and was designed to reduce or eliminate signs and symptoms of RA.

The Court also applied the three-prong test from AB Hassle v Genpharm Inc, to conclude that Hospira had induced patients to infringe. Kennedy established the three elements of the test: (i) there was direct infringement by another party, (ii) the direct infringement would not have taken place without Hospira’s influence, and (iii) Hospira knew its influence would result in infringement. Although Justice Phelan found Hospira liable for inducement, he was reluctant to do so. He noted that “if not for AB Hassle… I would be disinclined to find inducement” due to Kennedy’s inconsistent positions that, on one hand, the 630 Patent was not related to a method of medical treatment but, on the other, patients would directly infringe the patent by receiving a particular treatment method.

Kennedy’s patent was valid and infringed. The matter of damages or an accounting of profits was left for the second, bifurcated phase of the case.

A copy of the decision can be found here.