SCOTUS refuses to hear Eli Lilly patent win

The US Supreme Court has declined to review  Eli Lilly’s patent infringement victory against  Dr Reddy’s and  Hospira.

Yesterday, June 15, the court refused to grant certiorari in two petitions, upholding an August 2019 decision from the US Court of Appeals for the Federal Circuit.

Last year, the Federal Circuit  affirmed two findings that Dr Reddy’s and Hospira (now owned by Pfizer) had infringed Eli Lilly’s cancer drug Alimta (pemetrexed).

In a precedential decision, handed down in August 2019, the Federal Circuit ruled that Dr Reddy’s and Hospira’s proposed drugs infringed Eli Lilly’s patent-protected treatment under the doctrine of equivalents.

Dr Reddy’s and Hospira, in petitions filed in February, argued that the Federal Circuit had misapplied the Supreme Court’s ruling in Festo Corp v Shoketsu Kinzoku Kogyo Kabushiki Co, in which the Supreme Court held that courts should presume estoppel based upon a narrowing amendment.

However, the patentee may avoid the estoppel by providing evidence that the “rationale underlying the [narrowing] amendment … bear[s] no more than a tangential relation to the equivalent in question”.

“The Federal Circuit’s confusion over the meaning of Festo’s “tangential” exception warrants this court’s review. It is a recurring question whose answer this court should not leave in its current panel-dependent state. Both of the Federal Circuit’s approaches cannot be right, and the approach taken here and in other cases is wrong,” said Dr Reddy’s.

Hospira added that “relying on isolated words in Festo, the Federal Circuit has constructed a doctrinal framework governing prosecution history estoppel that is untethered from Festo’s reasoning and will lead to abuse of the patent prosecution process”.

The patent at issue, US number 7,772,209, covers a method of administering the chemotherapy drug pemetrexed disodium with folic acid and vitamin B12 to reduce the incidence of patient toxicity caused by Alimta. It expires in May 2022.

Before the Federal Circuit, Dr Reddy’s and Hospira had argued that the district court had erred by refusing to apply prosecution history estoppel to bar Lilly’s doctrine of equivalents claim.

Eli Lilly had originally sought broad claims to methods of “administering an antifolate in conjunction with a methylmalonic acid lowering agent, with or without folic acid” but, following examination, the company amended its claims to narrow “antifolate” to “pemetrexed disodium” and cancelled its dependent claim limited to pemetrexed disodium.

Finding Dr Reddy’s and Hospira’s view of prosecution history estoppel, and the tangential exception in particular, was “too rigid”, the Federal Circuit sided with Eli Lilly.

Both of the companies’ petitions have been rejected.

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