On 21 January 2021 and following appeal, the US Federal Court again found that the patent held by The Kennedy Trust for Rheumatology Research regarding the use of infliximab (Janssen’s Renicade) is valid and infringed by Hospira’s biosimilar, Inflectra.
The UK’s Kennedy Trust holds a patent for the combined use of infliximab with methotrexate (MTX) for the treatment of rheumatoid arthritis in patients whose disease was not previously controlled by methotrexate treatment alone. In a litigation that concluded in 2018, the US Federal Court found that Kennedy’s patent was valid and infringed by Hospira Healthcare Corporation’s biosimilar, Inflectra. Following this, the Federal Court of Appeal remitted issues of anticipation and obviousness for reconsideration to the trial judge. However, following this reconsideration, the Federal Court has again found that Kennedy’s infliximab Canadian 630 patent is valid.
During the reconsideration, the Federal Court re-examined three specific matters identified by the Court of Appeal. These related to Anticipation, Obviousness and Obvious to try.
Anticipation
The Court of Appeal raised two concerns regarding the analysis of anticipation in the initial trial. These included the rejection of two prior art references (referred to as ‘the 94 Kennedy Report’ and ‘Higgins’) which were said to be speculative and not focusing on the essential elements of the claims and, the fact that analysis did not address disclosure and enablement distinctly. However, on reconsideration, the Court held that neither piece of prior art disclosed certain essential elements of certain claims. Regarding enablement, the Federal Court held that arriving at the claims was not routine and it would be necessary to undertake a clinical trial to administer infliximab and MTX, and ‘combining MTX with a biologic was risky and something not done’.
Obviousness
The court of Appeal raised concerns over the obviousness of the invention due to the existence of two excluded pieces of prior art – Higgins and an FDA Workshop. However, the Court concluded that the prior art did not render the invention obvious.
Obvious to try
The Court of Appeal highlighted that certain pieces of prior art appeared to suggest that it was an obvious decision to try the invention. However, the Federal Court concluded that Hospira had not shown that the invention was obvious to try.
Despite the negative outcome of the reconsideration, Hospira has appealed the decision and the trial recommenced on 1 February 2021.
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