Immunex Corp. v. Sandoz Inc.

964 F.3d 1049

IMMUNEX CORPORATION, Amgen Manufacturing, Limited, Plaintiffs-Appellees

Hoffmann-La Roche Inc., Plaintiff

v.SANDOZ INC., Sandoz International GmbH, Sandoz GmbH, Defendants-Appellants

2020-1037

United States Court of Appeals, Federal Circuit.

Decided: July 1, 2020

Constantine L. Trela, Jr., Sidley Austin LLP, Chicago, IL, argued for plaintiffs-appellees. Also represented by Steven J. Horowitz; Vernon M. Winters, San Francisco, CA; Joshua John Fougere, Jeffrey Paul Kushan, Washington, DC; James Asa High, Jr., Amgen Inc., South San Francisco, CA; Drew Diamond, Joseph E. Lasher, Dennis J. Smith, Wendy A. Whiteford, Thousand Oaks, CA.

William M. Jay, Goodwin Procter LLP, Washington, DC, argued for defendants-appellants. Also represented by Brian Timothy Burgess; Cindy Chang, New York, NY; Gerard Justin Cedrone, David Zimmer, Boston, MA; Dan Hoang, George C. Lombardi, Maureen L. Rurka, Julia Mano Johnson, Winston & Strawn LLP, Chicago, IL.

Matthew S. Hellman, Jenner & Block LLP, Washington, DC, for amicus curiae Association for Accessible Medicines. Also represented by Adam G. Unikowsky ; Yusuf Esat, Chicago, IL; Jeffrey Francer, The Association for Accessible Medicines, Washington, DC.

John Cameron Adkisson, Fish & Richardson PC, Minneapolis, MN, for amicus curiae Samsung Bioepis Co., Ltd. Also represented by Elizabeth M. Flanagan, Deanna Jean Reichel ; Jonathan Elliot Singer, San Diego, CA.

Before O'Malley, Reyna, and Chen, Circuit Judges.

Dissenting opinion filed by Circuit Judge Reyna.

O'Malley, Circuit Judge.

Patent owner Hoffmann-La Roche Inc. ("Roche"), its exclusive licensee Immunex Corp., and exclusive sublicensee Amgen Manufacturing, Ltd., initiated this patent infringement suit pursuant to the Biologics Price Competition and Innovation Act ("BPCIA").¹ Sandoz, Inc., Sandoz International GmbH, and Sandoz GmbH filed abbreviated Biologics License Application ("aBLA") No. 761042.² This action followed shortly thereafter. In the aBLA, Sandoz sought approval to market Erelzi, a biosimilar version of Immunex's biologic drug, Enbrel ®.

Enbrel ® is covered by the patents-in-suit: U.S. Patent Nos. 8,063,182 ("’182 patent") and 8,163,522 ("’522 patent"). Prior to trial, Sandoz stipulated to infringement of the asserted claims of the patents-in-suit. After a two-week bench trial, the United States District Court for the District of New Jersey entered final judgment for Immunex and Roche, holding that Sandoz had failed to prove that the asserted claims of the patents-in-suit were invalid.

Sandoz appeals from the district court's judgment. On appeal Sandoz argues, as it did before the district court, that the patents-in-suit are invalid for (1) obviousness-type double patenting; (2) failure to meet the written description requirement; and (3) obviousness. For the reasons discussed below, we affirm.

I. BACKGROUND

A. The Claimed Technology and Patents-in-Suit

The patents-in-suit are directed to the fusion protein etanercept and methods of making the same. Etanercept is the active ingredient in Immunex's biologic drug Enbrel ®, which is primarily 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").

IgG1 is a type of antibody. Antibodies are proteins deployed by the immune system to identify and neutralize foreign objects—such as bacteria and viruses—called antigens. Each antibody contains a region that binds to a portion of an antigen. Through this binding mechanism, an antibody can either neutralize the target antigen directly—for example, by blocking the part of a virus that is essential for the survival of the virus—or tag a microbe or an infected cell for attack by other parts of the immune system. Like all proteins, antibodies are made up of amino acids connected to form chains called polypeptides. The polypeptides fold into three-dimensional structures that impart structural and functional characteristics to the antibodies.

Structurally, each antibody (including IgG1) consists of four chains of amino acids: two identical "heavy chains" and two identical "light chains," arranged in a Y-shape. All four chains in the antibody contain two different segments: a constant region (denoted by C_H for the heavy chain constant region and C_L for the light chain constant region) and a variable region (V_H for the heavy chain variable region and V_L for the light chain variable region). The variable regions are segments of the antibody that determine whether, and how effectively, an antibody will bind to a given antigen. The constant regions, on the other hand, interact with other components of the immune system through "domains"—areas of the protein that have a specific structure and can serve a specific function. The light chain constant region consists of the CL domain. The heavy chain constant region includes the CH1, the hinge, CH2, and CH3 domains.

The human immune system also contains cytokines—cell signaling proteins that effectuate a variety of immune responses. Tumor necrosis factor ("TNF") is one type of cytokine produced in the human body. It is associated with autoimmune inflammatory diseases such as rheumatoid arthritis. TNF binds to TNF receptors ("TNFRs"), transmembrane receptors that contain three distinct regions: intracellular, transmembrane, and extracellular. There are two types of TNFRs, p55 (a 55 kDa protein) and p75 (an approximately 75 or 80 kDa protein). The extracellular region of TNFRs binds to TNF. This region can be split off to make a soluble protein that binds to TNF, allowing for removal or neutralizing of excess TNF from the body.

Etanercept—a fusion of the extracellular region of p75 and the hinge-CH2-CH3 portion of the constant region of the IgG1 heavy chain—binds to excess TNF and neutralizes it. In this way, it reduces the autoimmune inflammatory response in patients with rheumatoid arthritis.

The claims of the ’182 patent are directed to etanercept, and the claims of the ’522 patent are directed to methods of making etanercept. Both patents-in-suit claim priority to European Patent Application No. 90116707.2 ("the EP ’707 Application"), filed on August 31, 1990, and U.S. Application No. 07/580,013 ("the ’013 Application"), filed on September 10, 1990. Roche, the party that originally filed the applications in this patent family, abandoned the ’013 Application, but filed a continuation, U.S. Application No. 08/965,640 ("the ’640 Application") on July 21, 1993. This application was subject to a restriction requirement by the United States Patent and Trademark Office ("USPTO"). As a result of the restriction requirement, on May 19, 1995, Roche filed two divisional applications claiming priority to the ’640 application. These applications matured into the ’182 and ’522 patents, which issued on November 22, 2011 and April 24, 2012, respectively.

B. License Agreements Between Immunex³ and Roche

To understand the parties’ arguments on appeal, a basic understanding of the historical relationship between Immunex and Roche, as well as certain licenses between them, is necessary. By 1990, both Roche and Immunex Corp. were separately engaged in researching TNF and investigating whether targeting this molecule could provide any therapeutic benefits. In April 1990, Roche published the complete amino acid sequence of the p55 TNFR. In May 1990, Immunex Corp. published an article containing the full amino acid sequence of the p75 TNFR. And, in July 1990, Roche published the complete amino acid sequence of p75, along with part of its encoding DNA. As noted above, it was Roche that filed the priority application for the patents-in-suit in 1990, as well as the applications for the patents-in-suit in 1995.

Immunex Corp., working independently on TNFR-IgG fusion proteins, obtained FDA approval of Enbrel ® in 1998. Almost a year later, Immunex Corp. and Roche entered into a license (the "Immunex-Roche agreement"), effective as of the approval date of Enbrel ®, pursuant to which Immunex obtained a license to, inter alia , the EP ’707 Application and the ’013 Application, and all patents that issue from those applications. J.A. 25867. Immunex agreed to pay Roche royalties on the sales of Enbrel ®. J.A. 25876–80.

In 2002, non-party Amgen, Inc. acquired Immunex Corp. Subsequently, in 2004, Amgen, Inc., Immunex Corp., Roche, and non-party Wyeth entered into an "Accord & Satisfaction" agreement concerning the same patent family. J.A. 25836. The purpose of the agreement was "to eliminate the continuing obligations to pay royalties to Roche" pursuant to the Immunex-Roche agreement. Id.

Under the terms of the Accord & Satisfaction, Immunex has a paid-up, irrevocable, exclusive license to the U.S. patent family for the patents-in-suit. It has the sole right to grant sublicenses, to make, have made, use, sell, offer for sale and import products covered by the patent family. J.A. 25839. With respect to patent prosecution, Immunex has the exclusive right to prosecute patent applications in the U.S. patent family. J.A. 25840. Thus, as of 2004, Immunex controlled the prosecution of the patents-in-suit.

Under the terms of the agreement, Immunex has the first right to rectify any suspected infringement of the licensed patent family at its sole expense and under its sole control, by instituting suit or by sublicense. And, Immunex may retain the entirety of any award of damages or lost profits resulting from such an infringement suit. Roche is obligated to cooperate in any such suit, including by participating as a party to the extent required by the court in order to bring suit. Id. Immunex also has the right to an assignment of the patents-in-suit upon request and upon the payment of $50,000. Id. ("If requested ... Roche shall execute an assignment of" the patents).⁴

Under the terms of the Accord &...