Federal Circuit Overturns Novartis Gilyena’s Negative Restraint Order – Patent

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On June 21, 2022, the Federal Circuit, acting on a request for a rehearing in the Federal Circuit’s decision in
Novartis v Accord Health Care, Inc.21 F.4th 1362 (Fed. Cir. 2022), affirming the District Court’s ruling of infringement and validity of the Novartis patent on Gilenya, USP 9,187,405, granted the application and proceeded to set aside the ruling original and declared the claimed claim invalid for failing to conform to the written description of 35 USC § 112(a).

The difference between the original decision and the rehearing was a change of panel. Judge O’Malley, who wrote the original opinion joined by Judge Linn, has left the Federal Circuit. Justice O’Malley was replaced by Justice Hughes who joined Chief Justice Moore, who had dissented in the original opinion, in overturning the decision. The abrupt reversal of the federal circuit was not the result of a change in law but rather a change in the composition of the panel. This is yet another demonstration of the Federal Circuit’s failure to be consistent from panel to panel on a legal/factual issue. It is such an about-face that Judge Albright denounced in his opinion of the brief in Health Discovery Corp. against Intel Corp.. Case 6: 20-cv-0666-ADA, December 27, 2021, on motion to dismiss under 35 USC § 101. Judge Albright considered four Federal Circuit opinions on patent eligibility, two finding the eligibility and two no and could not discern the fact differences leading to opposite conclusions. Inconsistent Federal Circuit rulings lead to uncertainty in the prosecution and enforcement of patents to the detriment of the progress of the useful arts.

In Novartis, five judges considered the written description issue with 3, two Federal Circuit Judges and Third Circuit Judge Kent Jordan, sitting in District Court, finding a written description for the negative limitation of the claim to administer fingolimod “to a daily dose of 0.5 mg, in the absence of a previous loading dose regimen.” The USPTO had allowed Novartis to amend the claims to add the limitation. Only Judges Moore and Hughes found no written description. They found “palpable error” in the opinion of Circuit Judge Kent where Judges O’Malley and Linn found none and where the USPTO had considered the limitation to be justified. Thus, three judges and the USPTO had found written support, but Judges Moore and Hughes found none and reversed the decision. If there was such a clear mistake why such a split?

The facts are simple, the ‘405 patent does not describe the use of a single dose loading. He also did not describe the use of a loading dose. There was evidence, deemed persuasive by Judges Jordan, O’Malley and Linn and the USPTO, that the specification would lead to no loading dose (a higher than normal initial dose) being used. Moore and Hughes JJ. disagreed in pointing to other evidence suggesting that a loading dose could be used, which in their view precludes finding a written description of “the absence of a immediately preceding loading dose regimen”. When you have such a split, how can it be said that there is a manifest error?

A difference of opinion is not a manifest error.

This decision is an example of what is wrong with the Federal Circuit – the inability to be consistent in its decision-making and failing to give proper deference to the opinions of others.

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