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20 July 2023Big PharmaLiz Hockley

US appeals court restores five CRISPR patents with precedential opinion on interferences

SNIPR Biome has five patents reinstated after court rules they cannot be subject to interference | Rockefeller University had challenged patents on pre-AIA, first-to-invent basis.

The US Court of Appeals for the Federal Circuit has reinstated five patents belonging to SNIPR Biome at the centre of a dispute with The Rockefeller University, in a precedential decision that clarified whether patents filed after the America Invents Act (AIA) can be subject to interferences.

In its opinion issued on Friday, July 14, the court held that the US Patent Trial and Appeal Board (PTAB) had erred when it invalidated five patents belonging to Danish biotech SNIPR covering CRISPR gene-editing technology, following a challenge from private biomedical research institute The Rockefeller University.

These patents—US patent numbers 10,463,049; 10,506,812; 10,561,148; 10,524,477; and 10,582,712—could not be cancelled by the PTAB through an interference for lack of invention priority under pre-AIA § 102(g), the court said.

‘Any unexpired patent’

The dispute dealt with patent applications filed on either side of the effective date of the AIA, on March 16, 2013. When the AIA came into force, the US’ patent system transitioned from one based on a first-to-invent system, to a first-inventor-to-file regime.

This meant the removal of so-called ‘interferences’, administrative priority contests conducted by the PTAB to determine which side could prove an earlier invention date in the case of contested inventions.

Rockefeller sought to challenge the validity of SNIPR’s patents with a pre-AIA interference proceeding, because it alleged that its own patent application predated the AIA.

SNIPR filed motions to dismiss the interference on the basis that its patents were filed after the March 16, 2013 date and therefore not subject to interference proceedings.

In 2021, the PTAB ruled in favour of Rockefeller and cancelled all five SNIPR patents. In its decision, the PTAB cited pre-AIA 35 USC § 135(a), that it could declare an interference between an application and “any unexpired patent”, and that this could be applied in this case.

‘Eliminate the spectre of interferences’

In its decision to overturn the PTAB’s ruling, the court stressed that interferences and other first-to-invent aspects of pre-AIA law do not apply to patents exclusively governed by the AIA and issued under the new first-inventor-to-file regime.

The goal of the AIA was to “eliminate the spectre of interferences”, the court said, which were lengthy, costly and placed too much burden on companies to maintain extensive documentation proving the date of their inventions.

SNIPR’s patents fell into the category of “pure AIA patents”, the judges said. The one exception to patents governed by the AIA that could be subject to interferences—‘mixed’ applications with claims filed both before and after the March 2013 date—did not apply.

Furthermore, the court held that “any unexpired patent” did not include pure AIA patents—otherwise, the judges said, “any pure AIA patent can be hauled into an interference for an invention priority contest under pre-AIA law with a pure pre-AIA or mixed application claiming the same subject matter”.

Following the ruling, SNIPR said that its five patents remained in place, none of its portfolio could again be subjected to an interference, and its patents would not be judged by the old first-to-invent standard.

Unresolved issues

Some issues, however, remain disputed between the parties, such as whether Rockefeller’s application anticipated any of SNIPR’s claims—or whether its application satisfied written description and enablement requirements.

Jasper Clube, co-founder and chief patent counsel of SNIPR Biome, commented, “SNIPR is delighted with this important decision of the Federal Circuit. We are also pleased that the Court recognised that the PTAB has never determined whether Rockefeller’s claims, which it copied from our issued patents, satisfy the patentability requirements.”

Rockefeller University attorney Salvatore Arrigo said the school disagreed with the judgment and was assessing its options, Reuters reported.

He said Rockefeller was pleased with some aspects of the decision, including the court’s finding that the university’s application is “prior art” that could potentially be used to cancel SNIPR’s patents in a different proceeding.

SNIPR Biome was represented by Morrison Foerster in the matter.

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