Rob Wilson /
25 January 2016Americas

Pfizer’s plea for extra 197 days of patent life rejected

The US Court of Appeals for the Federal Circuit has rejected Pfizer’s plea to extend the term of a patent centring on cancer treatment, upholding a lower court’s ruling that cleared the US Patent and Trademark Office (USPTO) of wrongdoing.

In a 2-1 decision handed down on Friday, January 22, the federal circuit said that the USPTO did not err when it calculated the lifespan of the patent and rejected calls for 197 days to be added onto its term.

The issue centred on an ‘A-delay’, a type of patent term adjustment available when the USPTO fails to issue a first office action in a timely manner.

The case concerns US patent number 8,153,768, called “Calicheamicin derivative-carrier conjugates” and directed to cancer treatment.

Pharmaceutical company Wyeth filed a patent application in 2003 and the patent was approved in 2012. During the patent prosecution process, Wyeth was acquired by Pfizer.

The deadline for the USPTO to issue its first office action expired on July 2, 2004. On August 5, 2005, having received no office action, Pfizer wrote to the office asking when an action might be expected.

On August 10, 2005, the USPTO sent Pfizer a restriction requirement, informing the drug company that its application contained “two or more independent and distinct inventions [that] are claimed in one application” and that it should choose just one.

Pfizer responded and explained that the USPTO’s restriction requirement had omitted certain patent claims in its categorisation of the various claims.

The USPTO examiner acknowledged that the restriction requirement was not complete and agreed to withdraw it and issue a corrected version.

The corrected version was sent on February 23, 2006.

But, in the final granted patent, the USPTO did not award an A-delay for the 197 days that elapsed between the sending of the first restriction requirement and the corrected version.

Pfizer claimed that the patent’s term should have included an extra 197 days to account for the error.

The company sued the USPTO at the US District Court for the Eastern District of Virginia in 2012 seeking a summary judgment granting an extension of the patent. The USPTO also filed for a summary judgment.

In 2014 the court granted the USPTO’s motion and rejected Pfizer’s claim.

In yesterday’s ruling the federal circuit upheld the district court’s ruling.

The majority opinion was written by Judges Kathleen O’Malley and Timothy Dyk.

“The examiner’s initial restriction requirement satisfied the statutory notice requirement because it informed the applicant of ‘the broad statutory basis for [the rejection of] his claims’,” they wrote.

But Judge Pauline Newman dissented, arguing that this was a case of clear error by the examiner.

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