IP Alert: Allergan Limits Cellect, But Leaves Ambiguity in ODP Analysis

On August 13, the Federal Circuit, in Allergan USA, Inc. v. MSN Laboratories Private Ltd., held that a “first-filed, first-issued, later-expiring claim cannot be invalidated by a later-filed, later-issued, earlier-expiring reference claim having a common priority date.”

The Allergan decision clarified the same panel’s In re Cellect, LLC decision that contained language suggesting otherwise. On October 7, the U.S. Supreme Court denied Cellect’s petition for certiorari, leaving Allergan as guiding obviousness-type double patenting (ODP) challenges in the “first-filed, first issued, later-expiring” situation while leaving the door open for ODP challenges in other situations.

Background

Allergan USA, Inc. markets and sells eluxadoline tablets for irritable bowel syndrome under the brand name Viberzi. The first patent application for eluxadoline was filed in 2005 and issued as U.S. Patent No. 7,741,356 (the ’356 patent) in 2010 as shown in the figure below. Multiple continuing applications were filed from the ’356 patent. Relevant here are the ’011 and ’709 patents. Both were filed after, issued after, but will expire before the ’356 patent. This is due to the ’011 and ’709 patents not receiving any patent term adjustment (PTA), while the ’356 patent received 467 days of PTA.

Allergan sued Sun Pharmaceutical Industries Limited (Sun) on the ’356 patent (and other patents) in response to Sun seeking to introduce a generic version of Viberzi. The case went to a bench trial, where the district court decided whether claim 40 of the ’356 patent was invalid for ODP in view of claims of the ’011 and ’709 patents.

Allergan argued that the claims of the first-filed, first-issued ’356 patent were not subject to ODP over the claims of the later-filed, later-issued ’011 and ’709 patents. The district court found Allergan’s first-filed, first-issued distinction immaterial to the issue of ODP and invalidated claim 40 of the ’356 patent. Specifically, the district court interpreted the Cellect decision as rejecting the use of a case-by-case review of equitable considerations to determine if a patent owner received an unjust time extension. Instead, the district court read Cellect as requiring the consideration of expiration dates alone in the ODP analysis.

The Federal Circuit’s Decision

The same Federal Circuit panel that authored the Cellect decision took up Allergan’s appeal and reversed the district court’s invalidation of claim 40 of the ’356 patent for ODP. The panel reigned in Cellect, stating that Cellect is only controlling to the extent that it requires consideration of PTA in the ODP analysis. The panel asserted that Cellect did not specify under what circumstances can a claim properly serve as an ODP reference.

The panel concluded that the claims of the ’011 and ’709 patents “are not proper ODP references that can be used to invalidate claim 40 of the ’356 patent.” That, according to the panel, was the only conclusion consistent with the purpose of the ODP doctrine, i.e., to prevent patentees from obtaining a second patent on a patentably indistinct invention to effectively extend the life of a first patent to that subject matter.

Takeaway

Allergan holds that a claim of a later-filed, later-issued, earlier expiring patent is not a proper ODP reference to a claim of a first-filed, first-issued, later-expiring patent having a common priority date. However, the reasoning of Allergan decision is predicated on the later-filed, later-issued, earlier-expiring claim not running afoul of the purpose of the ODP doctrine. Other situations, such as a claim of a parent patent and a claim in a later-expiring continuation patent, may not be shielded from ODP by the Allergan decision.

For more information on this topic, please contact Fitch Even partner Jonathan H. Urbanek, author of this alert.

Fitch Even law clerk Christopher Paulson contributed to this alert.

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