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23 January 2024AmericasMarisa Woutersen

Federal Circuit rejects Cellect rehearing on double patenting

En banc petition concerning obviousness-type double-patenting rejected by the Court of Appeals | Decision on patent term adjustment has been closely followed by pharma companies, NYIPLA, and AIPLA.

The  US Court of Appeals for the Federal Circuit has rejected  Cellect’s petition for a panel rehearing and a rehearing en banc concerning obviousness-type double-patenting (ODP).

The case, filed January 19, concerns patent term adjustments (PTA), where certain patents had extended terms due to PTA, a benefit granted only when the  US Patent and Trademark Office (USPTO) exceeds the statutory guarantees of timely processing established by Congress.

ODP aims to prevent the unjustified extension of patent exclusivity beyond the term of a patent but has  raised pivotal questions.

Cellect initially filed a petition for a rehearing en banc, requesting a review of its case, after the  Patent Trial and Appeal Board (PTAB) stated that ODP analysis should consider the patent’s expiration date with patent term adjustment.

Cellect appealed this decision to the Court of Appeals, which found Cellect’s arguments unpersuasive and  affirmed the PTAB’s decision—leading to Cellect’s petition for a rehearing en banc.

Several organisations, including the  American Intellectual Property Law AssociationAbbViePharmaceutical Research and Manufacturers of AmericaNovartisAstraZeneca, and the  New York Intellectual Property Law Association and others  sought permission to file briefs at the Federal Circuit as amici curiae, which was granted by the court.

Case background

Cellect filed a lawsuit against  Samsung in the  US District Court for the District of Colorado, alleging infringement of four patents related to image sensor devices with a common origin from US patent number 6,275,255.

In response, Samsung initiated four ex parte reexaminations, asserting that the patents were invalid due to ODP, a point not raised during the original prosecution.

The examiner deemed the challenged claims as obvious variants of Cellect's prior-expiring reference patent claims, with the US 6,862,036 patent becoming the focus for ODP invalidation.

Cellect appealed to the PTAB, contending that ODP should not invalidate PTA based on ‘equitable principles’.

The PTAB disagreed, emphasising distinctions in the statutory language governing patent term extension (PTE) and PTA.

The board affirmed the PTAB’s decision, leading Cellect to appeal to the Court of Appeals.

In its appeal, Cellect argued that the board erred in determining patent unpatentability for ODP based on the expiration date of a patent with granted PTA, highlighting overlooked equitable concerns and challenging the legitimacy of the reexamination proceedings.

Despite Cellect's arguments, the Federal Circuit found them unpersuasive, affirming the board's decision.

Cellect’s impact

The Cellect decision  impacts relatively few patents, including pharmaceuticals, biotechnology, and medical devices, but for those it does affect, the impact is substantial.

For example,  AbbVie’s Humira, which had US sales in 2022 of more than $18.6 billion, and US revenue approaching $51 million per day,  wrote Vincent Shier for LSIPR.

AbbVie and any similarly situated company will be affected by Cellect, due to the importance of a single day of exclusivity.

AbbVie expects a 37% drop in sales of Humira, since up to ten biosimilars were expected to enter the market in mid-2023 following AbbVie’s loss of exclusivity in January 2023—making the loss of exclusivity cost AbbVie an average of about $19 million per day in revenue.

Although Humira was not a direct casualty of Cellect, there may be many drugs that are currently enjoying exclusivity due entirely to PTE, for which this decision could dramatically and unexpectedly move exclusivity expiration forward.

Cellect is represented by Paul Andre, Lisa Kobialka, James Hannah, Jonathan Caplan and Jeffrey Price from  Kramer Levin Naftalis & Frankel.

The USPTO is represented by in-house attorneys Farheena Rasheed, Amy Nelson, Kakoli Caprihan and Brian Racilla.

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