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Federal Circuit Reverses $1.67 Billion Damages Award Against Abbott Labs, Finding Asserted Patent Invalid for Weak Written Description

February 23, 2011

Overturning the largest patent infringement verdict ever in a suit against Abbott Laboratories’ Humira antibodies to treat arthritis, the U.S. Court of Appeals for the Federal Circuit Feb. 23 ruled that the plaintiff’s asserted patent is invalid under the written description requirement of the Patent Act at 35 U.S.C. § 112, ¶ 1 because it fails to adequately “describe a single antibody that satisfies the claim limitations” (Centocor Ortho Biotech Inc. v. Abbott Laboratories, Fed. Cir., No. 2010-1144, 2/23/11).

In reversing the award and judgment against Abbott, the court said that Centocor’s patent specification expressed a “mere wish or plan” for obtaining the claimed invention, which is not sufficient for purposes of § 112, ¶ 1.

Abbott’s Humira Antibodies Found Infringing.

In this suit, Centocor Ortho Biotech Inc. and New York University (Centocor)  had sued  Abbott Laboratories, alleging that Abbott’s Humira® antibody infringes claims of a patent (7,070,775) covering tumor necrosis factor alpha (“TNF-α”) antibodies used to treat arthritis. After a trial, the jury found Abbott liable for willful infringement. The jury rejected Abbott’s argument that the asserted claims were invalid, and awarded Centocor over $1.67 billion in damages--the largest patent infringement verdict ever.

Overproduction of TNF-α can lead to various autoimmune conditions, including arthritis, but the human body does not typically make TNF-α antibodies. As a result, pharmaceutical companies have competed to engineer antibodies that can “neutralize” human TNF-α for use as a drug. Many of the antibodies typically produced in this field by researchers were mice antibodies that lacked the desired neutralizing activity and sufficient binding affinity to stick to human TNF-α. Moreover, as human patients frequently have immunological reactions when treated with antibodies produced in mice or other nonhuman species, reduced immunogenicity became another important quality sought by researchers. Prior to the ‘775 patent, Abbott had obtained its own patent (6,090,382) covering a fully-human antibody to TNF-α that had high affinity and neutralizing activity.

Centocor Disclosed a ‘Mere Wish or Plan’ for Obtaining Claimed Invention.

On appeal, Abbott argued that the asserted claims were invalid under the Patent Act’s written description requirement at 35 U.S.C. § 112, ¶ 1, which states:

The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

Noting that Centocor’s later-filed claims assert priority dating to continuation-in-part (CIP) applications filed in 1994, the Federal Circuit said that the key issue here is whether the ’775 patent provides adequate written description for the claimed human variable regions—portions that determine what the antibody is and where on TNF-α the antibody will bind. “One of skill in the art cannot look at a mouse variable region and know how to turn it into a human variable region with the same affinity and activity as the mouse antibody,” Judge Sharon Prost clarified.

To satisfy the written description requirement, “the applicant must ‘convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention,’ and demonstrate that by disclosure in the specification of the patent,” Prost continued, quoting Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115 (Fed. Cir. 2008) and Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991). Ultimately, “the specification must describe an invention understandable to [a person of ordinary skill in the art] and show that the inventor actually invented the invention claimed,” she said, quoting the en banc ruling in Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010).

While Centocor insisted that the asserted claims are adequately described, Abbott argued under Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), that the 1994 CIP applications fail the written description test by expressing a “mere wish or plan” for how one might obtain the claimed invention.

The Federal Circuit agreed with Abbott, stating:

Thus, while the patent broadly claims a class of antibodies that contain human variable regions, the specification does not describe a single antibody that satisfies the claim limitations. … It  does not disclose any relevant identifying characteristics for such fully-human antibodies or even a single human variable region. See id. Nor does it disclose any relationship between the human TNF-α protein, the known mouse variable region that satisfies the critical claim limitations, and potential human variable regions that will satisfy the claim limitations. … There is nothing in the specification that conveys to one of skill in the art that Centocor possessed fully-human antibodies or human variable regions that fall within the boundaries of the asserted claims.

At bottom, the asserted claims constitute a wish list of properties that a fully-human, therapeutic TNF-α antibody should have: high affinity, neutralizing activity, and the ability to bind in the same place as the mouse A2 antibody. The specification at best describes a plan for making fully-human antibodies and then identifying those that satisfy the claim limitations. But a “mere wish or plan” for obtaining the claimed invention is not sufficient. … At the time the 1994 CIP applications were filed, it was entirely possible that that no fully-human antibody existed that satisfied the claims. Because Centocor had not invented a fully-human, high affinity, neutralizing, A2 specific antibody in 1994, a reasonable jury could not conclude that it possessed one.

Merely Disclosing Protein Not Sufficient in This Case.

Still, Centocor insisted that the Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004), and the Patent and Trademark Office’s revised written description guidelines of March 25, 2008 support the view that fully disclosing the human TNF-α protein provides adequate written description for any antibody that binds to human TNF-α.

The Federal Circuit disagreed, saying that Centocor had made “an unduly broad characterization of the guidelines and our precedent.” Prost noted that the antibody example in the PTO guidelines shows that an applicant can claim an antibody to novel protein X without describing the antibody when (1) the applicant fully discloses the novel protein and (2) generating the claimed antibody is so routine that possessing the protein places the applicant in possession of an antibody. However, generating fully-human antibodies with the claimed properties was not possible in 1994 using “conventional,” “routine,” “well developed and mature” technology, Prost stressed. In Noelle, she noted, the claims broadly covered an antibody that specifically binds human CD40CR protein but the specification only disclosed the mouse CD40CR protein and an antibody to that protein. Drawing support from that case, Prost said that the court there found that Noelle’s specification did not provide adequate written description for such broad claims.

Prost continued:

While our precedent suggests that written description for certain antibody claims can be satisfied by disclosing a well-characterized antigen, that reasoning applies to disclosure of newly characterized antigens where creation of the claimed antibodies is routine. Here, both the human TNF-α protein and antibodies to that protein were known in the literature. The claimed “invention” is a class of antibodies containing a human variable region that have particularly desirable therapeutic properties: high affinity, neutralizing activity, and A2 specificity.

Claiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described.

Here, Prost noted that Centocor placed great weight on the remark of an expert (Salfeld) that the antibody-antigen relationship is like “a key in a lock.” In doing so, she said, Centocor ignored the expert’s point about the challenge of finding an appropriate antibody on “a ring with a million keys on it.” Prost was not persuaded that generating fully-human antibodies with the claimed properties would be straightforward to a skilled artisan “given the state of human antibody technology in 1994. Unlike the antibody example cited in the PTO guidelines, therefore, simple possession of the known TNF-α protein did not place Centocor in possession of the claimed antibodies.”

Constructive Possession of the Invention Was Never Shown.

In closing, the court acknowledged Centocor’s point that the written description requirement does not demand an inventor to make an invention, and does not require examples or an actual reduction to practice. What it does require is that a skilled artisan can “visualize or recognize” the claimed antibodies based on the specification’s disclosure, the court said, quoting Eli Lilly.

Quoting Ariad, the Federal Circuit concluded as follows:

In other words, the specification must demonstrate constructive possession, and the ’775 patent’s specification fails to do so. … Centocor’s asserted claims to fully-human antibodies “merely recite a description of the problem to be solved while claiming all solutions to it.” … The actual inventive work of producing a human variable region was left for subsequent inventors to complete.

The opinion was joined by Senior Judge Raymond Clevenger and Judge William C. Bryson.

Centocor was represented by Dianne B. Elderkin of Akin Gump Strauss Hauer & Feld, Philadelphia. Abbott was represented by William F. Lee of Wilmer Cutler Pickering Hale and Dorr, Boston.

Amicus curiae Professor Oskar Liivak of Cornell Law School, Ithaca, New York, appeared on his own behalf.

Read Professor Liivak’s amicus brief.

Mary J. Stewart of Eli Lilly and Co., Indianapolis, appeared for amicus curiae Eli Lilly.

Read Eli Lilly’s amicus brief.

 


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