Obviousness-type Double Patenting Is Not So Obvious

• Jurisdiction: United States,Federal
• Citation: Vol. 45 No. 3
• Publication year: 2020
• Author: D. Benjamin Borson
• topic: Patent law,Intellectual Property

Obviousness-Type Double Patenting is Not So Obvious

D. Benjamin Borson

Borson Law Group P.C.

IMMUNEX CORPORATION, AMGEN MANUFACTURING, LIMITED, HOFFMANN-LA ROCHE INC. V. SANDOZ INC., SANDOZ INTERNATIONAL GMBH, SANDOZ GMBH, SLIP OP. 2020-1037 (FED. CIR. 1 JULY 2020)

Introduction

Obviousness-type double patenting (ODP) is a judicially created doctrine that serves two purposes: (1) to prevent an extension of the term of a commonly owned patent and a commonly owned prior patent having obvious variants of the claims, and (2) to prevent a defendant from being exposed to more than one plaintiff's infringement action based on either of the two patents.

ODP is based on comparison of the claims in two or more patents or applications. This is different from the analysis of obviousness under 35 U.S.C. § 103. Commonly, ODP is raised in patent prosecution, wherein an Examiner reviews a prior patent or application listing the same inventors or the same owner and asserts that the claims in a subsequent-filed patent application are not patentably distinct (i.e., are "obvious") from the claims of the prior patent. ODP is often raised in a Continuation application, in which the specification and figures of the prior patent and current application are identical.

If during prosecution, an Examiner believes that certain claims in an application are drawn to different inventions, the applicant must elect one set of claims for examination (Restriction), the non-elected claims are generally considered by the Examiner to be patentably distinct. If a Divisional application is filed containing the restricted claims not prosecuted in the parent patent, ODP generally cannot be raised against the Divisional application. However, this general view may not be conclusive, as patent Examiner's views may differ from those of litigants in court proceedings.

When an ODP is raised, the applicant of the second patent or application is encouraged to file a Terminal Disclaimer, in which the second patent will expire on the same date as the prior patent. A necessary requirement when filing a Terminal Disclaimer to overcome ODP, is that the two patents remain commonly owned throughout the lifetimes of the patents. In the event that the patents are sold to different entities, such that there is no common ownership, then the Terminal Disclaimer is invalid, and the subsequent patent could be invalidated.

An alternative to filing a Terminal Disclaimer is to present arguments that the two groups of claims are not obvious variants of each other. One way to do this is to present claims in the Continuation application having different limitations than the claims of the prior patent.

ODP can be analyzed using a "one-way" test, in which the claims of the pending application or later patent are found to be obvious or anticipated by the claims of the prior application or patent. Alternatively, a "two-way" test is used to analyze whether either set of claims are obvious or anticipated by the other set of claims.

Patents in Suit

In the case at issue, Immunex et al. v. Sandoz et al., Immunex holds an exclusive license from Hoffman-La Roche (Roche) for the product Enbrel^®, covered by U.S. Patent Nos. 8,063,182 (the '182 patent) and 8,163,522 (the '522 patent). The biologic product, etanercept, is indicated for reducing the signs and symptoms of moderately to severely active rheumatoid arthritis, an autoimmune disorder. Etanercept is made by combining a portion of a 75 kilodalton ("kDA") human tumor necrosis factor receptor protein with a portion of immunoglobulin G1 ("IgG1"). Slip. Op. at page 3. The '182 patent claims are drawn to etanercept, and the claims of the '522 patent are drawn to methods of manufacturing etanercept. Id. at page 5.

Both the '182 and '522 patents claim priority to European Patent Application No. 90116707.2 (the '707 application). U.S. application No. 07/580,013 (the '013 application) was filed on September 10 1990 and claimed priority to the '707 application. Roche abandoned the '013 application and filed a Continuation, U.S. application No. 08/965,640 (the '640 application). The '640 application was subject to a Restriction Requirement and Roche filed two Divisional applications claiming priority to the '640 application. These applications matured into the '182 and '522 patents. Id.

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Sandoz filed an...