Update: The litigation between Janssen and Hospira relating to the biosimilar INFLECTRA, including the appeal of the reconsideration decision, was discontinued in July 2021.
As reported previously here, the Federal Court had found that Kennedy’s patent for infliximab (Janssen’s REMICADE) was valid and infringed by Hospira’s biosimilar INFLECTRA (“Trial Decision”). As reported here, the Federal Court of Appeal remitted issues of anticipation and obviousness for reconsideration to the trial judge.
In broad terms, the 630 patent claims use of the combination of infliximab with methotrexate (MTX) for the treatment of rheumatoid arthritis (RA) in patients whose disease was not controlled by previous MTX treatment alone.
The Court identified three specific matters to be reconsidered, based on the Court of Appeal decision:
- Anticipation: how two pieces of prior art did not satisfy the disclosure and enablement requirements;
- Obviousness: to consider obviousness in light of two pieces of prior art which should not have been excluded as they were publicly available, even if they would not have been located by the skilled person on a reasonable and diligent search; and
- Obvious to try: as certain pieces of prior art appear to suggest that it was more or less self-evident to try the invention, to provide a clearer analysis of all of the obvious to try factors.
The Court of Appeal had raised two concerns regarding the Trial Decision analysis of anticipation: (1) the rejection of the two prior art references as speculative did not focus on the essential elements of the claims and (2) the analysis did not address disclosure and enablement distinctly.
On reconsideration, the Court held that neither piece of prior art disclosed certain essential elements of certain claims. For example, one piece of prior art, the 94 Kennedy Report, referred to “patients”, but did not disclose the patient group as MTX incomplete responders, nor did it disclose that the combination of infliximab and MTX works, i.e. reduces RA symptoms. While the second piece of prior art, Higgins, mentioned the possibility of combining another antibody with MTX, it did not disclose the combination of infliximab and MTX or the specific dose or dosing schedules.
Regarding enablement, the Federal Court stated that the Court of Appeal held “no specific result had to be obtained, [but] it did not hold that no result would be satisfactory.” The Federal Court held that arriving at the claims was not routine: a clinical trial would be necessary to administer infliximab and MTX, and “combining MTX with a biologic was risky and something not done” by the skilled person.
Taking into account the two previously excluded prior art documents in assessing obviousness, the Court arrived at the same conclusion. Higgins was held as advancing “the idea of a trial without assurance of a result.” Further, as Higgins was located by lawyers and provided to the expert, it “runs counter to an obviousness argument if virtually no one knew of the document.”
The other prior art, an FDA Workshop, was a meeting attended by expert rheumatologists, including the skilled person, and was an “informed high-level discussion and professional “brain storming”, much of it speculative.” The Court found that there is no evidence that the skilled person would take from “comments laced through the [Workshop] transcript” that the way forward was obvious. Rather, Hospira had created a “tapestry of obviousness” filling in the gaps between the state of the art and the invention with impermissible hindsight.
The Court concluded that the prior art, including Higgins and the FDA Workshop, did not render the invention obvious.
3. Obvious to Try
As directed by the Court of Appeal, the Court assessed each factor of the obvious to try test.
As part of the first factor, the Court took into account the two additional pieces of prior art and concluded again that it would not be self-evident to try to obtain the invention, particularly against a backdrop of multiple failures.
With regard to the second factor, the nature, extent and amount of effort required to achieve the invention, the Court found that the effort to achieve the invention would not be simple and routine, but rather prolonged and difficult as well as uncertain. “The design and running of clinical trials to establish the efficacy of the combination would likely have been prolonged and difficult. This is not a case where there is an established, simple test or a surrogate measurement criteria…” Further, testing in a single person would be insufficient.
While the third factor, motivation to find the solution, supported an obvious to try conclusion, when weighed with the above factors as well as the fourth factor, the actual course of conduct, the Court concluded that Hospira had not shown that the invention was obvious to try.
For the above reasons, the Court upheld and reinstated the Trial Decision, apart from the few original findings (claims asserted and infringement by Celltrion) reversed by the Court of Appeal.
Hospira has appealed the reconsideration decision. The trial to determine the quantification of Janssen’s damages resumed on February 1, 2021.
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