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25 January 2018Americas

Federal Circuit affirms unpatentability of Janssen patent

The US Court of Appeals for the Federal Circuit has upheld a finding that a patent which was initially applied for in 1993 is unpatentable, under double patenting rules.

The precedential judgment was handed down on Tuesday, January 23, with Chief Judge Sharon Prost speaking on behalf of the court.

Biotech company Janssen and New York University (NYU) had appealed against an ex parte reexamination decision made by the Patent Trial and Appeal Board (PTAB) on US patent number 6,284,471.

The ‘471 patent, marketed under the name Remicade, relates to anti tumour necrosis factor (TNF) antibodies and peptides, used for diagnoses and treatment of diseases related to overactive TNF such as arthritis. It was issued in 2001 to NYU.

Janssen and NYU have a research collaboration agreement to develop biologic agents, and Janssen has exclusive access to the relevant IP.

The reexamination was ordered by the US Patent and Trademark Office in 2013 on double patenting grounds, after a request was filed by a third party.

During the reexamination, Janssen cancelled two of the patent’s nine claims, requested further amendments and elected to conform the patent specifications to another earlier application.

The intended result was that the patent would be designated as a divisional of earlier applications and would be covered by the safe harbour provision.

The PTAB ruled that the amendments made during the reexamination do not classify the patent as a divisional, as the amendments were made for procedural reasons. Because the safe harbour was not applicable, the ‘471 patent was deemed unpatentable because of double patenting.

On appeal, Prost affirmed the board’s decision.

The court found that Janssen was not entitled to safe harbour as it had “deliberately” and “unnecessarily” lengthened the patent issuing process following the initial application in 1993, which allowed the biotech company to enjoy the benefits of the pending patent in the meantime.

Prost held that a company “cannot retroactively bring its challenged patent within the scope of the safe harbour provision by amendment in a reexamination proceeding”, and affirmed the PTAB’s finding that the ‘471 patent is unpatentable.

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