The largest patent infringement verdict in U.S. history did not stand the test of time at the United States Court of Appeals for the Federal Circuit, saving Abbot Laboratories the tidy sum of $1.67 billion, at least for now. With a loss such as this one can only expect the inevitable request for reconsideration, request for an en banc hearing in front of the entire Federal Circuit and an appeal to the United States Supreme Court. We haven’t heard the last of this case by a long shot, but for today Abbott has to be extremely pleased while the patent owners, Centocor Ortho Biotech and New York University, have no doubt seen better days.
The patent infringement suit involves pharmaceutical antibodies used to treat arthritis. The patent owners, Centocor Ortho Biotech, Inc. and New York University sued Abbott Laboratories, Abbott Bioresearch Center, Inc., and Abbott Biotechnology Ltd. alleging that Abbott’s Humira® antibody infringed claims 2, 3, 14, and 15 of U.S. Patent No. 7,070,775. After a five-day 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.
At the conclusion of the trial Abbott moved for judgment as a matter of law (JMOL), where the defendant essentially asks the district court judge to order that the defendant should prevail despite the jury verdict. A JMOL is not at all rare, and can sometimes be victorious. In a case as complex and time consuming it is not unheard of to have a district court judge allow a case to proceed to jury verdict even knowing that they will grant a JMOL because they believe that based on the law and the evidence the defendant should prevail. In high stakes cases everyone knows they will be appealed so better to have a jury verdict that can be reinstated rather than having to start the entire trial process from ground zero.
In this case, however, the district court did not grant all of Abbott’s JMOL requests. Abbott should a JMOL on invalidity, noninfringement, damages, and willfulness. The district court granted Abbott’s motion for JMOL of no willful infringement but denied Abbott’s other JMOL motions. Abbott appealed the district court’s denial of its JMOL motions. In ruling on the case the Federal Circuit determined that because the asserted claims of the ’775 patent lack an appropriate written description under 35 U.S.C. § 112, it was unnecessary to reach Abbott’s other invalidity arguments, its infringement arguments, or the question of damages. In its decision earlier today, the Federal Circuit (Judge Prost writing, joined by Judges Clevenger and Bryson) reversed the district court’s denial of the JMOL and held that the asserted claims were invalid for failure to meet the statutory written description requirement. This decision erases the $1.67 billion damages verdict previously achieved by Centocor/NYU.
35 U.S.C. § 112, ¶ 1 provides:
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.
To satisfy the written description requirement, set forth at the very beginning of § 112, ¶ 1, the patent applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date, he or she was in possession of the invention. One demonstrates possession of the invention through the disclosure presented in the specification of the patent. In order to assess whether the inventor possessed the invention it is necessary to engage in an objective inquiry into the four corners of the specification. Ultimately, the specification must describe an invention that is understandable to a person of ordinary skill in the art and show that the inventor actually invented the invention claimed. Merely wishing or planning in preparatory fashion for the claimed invention to later come into being does not make for an adequate written description that satisfies § 112, ¶ 1.
Essentially, this dispute boils down to whether claims filed after the earliest filing date are supported by an earlier filing date. It almost always comes as a shock to inventors, even sophisticated inventors, that claims can be added to an application after the filing date. You cannot add new matter to a patent application, but you can add new claims if those claims that are added are supported by the earlier disclosure.
In almost all situations, or at least in situations where patent attorneys are doing their job (i.e., in situations where clients are paying enough to allow for an adequate application) the disclosure filed will be far broader than the claims filed. When filing a patent application your disclosure should not be limited to what is claimed, but rather should disclose the full glory of what has been invented. A portion of what has been invented is claimed, hopefully a patent is obtained, and then you can circle back and file a continuation to attempt to get more claims allowed. In a continuation (or in the underlying original application) you can seek claims that were not previously presented and those claims will be entitled to the priority of the earlier filing date if the original filing supports the invention in the newly presented claims.
This is why patent attorneys advise clients to keep a patent application pending to which claims can be added. It is not uncommon to have a broad disclosure that will allow you to add claims, perhaps “picture claims” that specifically and unambiguously capture what a competitor is now doing but which you did not originally claim. If your disclosure supports those claims written to capture the competitor then the competitor is infringing a claimed invention that you own the rights to. If the claims added are not adequately disclosed then you might get a patent and later find out that the claims obtained are invalid because the original disclosure did not suffice to demonstrate you were in possession of the newly claimed invention as of the time of the original filing date of the priority application. That is just what happened to Centocor/NYU.
Centocor/NYU first sought claims to human variable regions and fully-human antibodies in 2002. At that time, Abbott had already discovered and patented a fully-human antibody. To ensnare Abbott with later-filed claims, Centocor needed to use a priority date from an earlier application. Because Abbott’s application was filed in 1996, Centocor relied on a priority claim dating back to applications from 1994. In order for Centocor to prevail, the asserted claims must have been supported by adequate written description in the 1994 applications. Thus, the Federal Circuit turned to the four corners of the 1994 applications to assess whether their disclosure provides adequate written description for the asserted claims.
In the crux of the ruling the Federal Circuit explained:
[W]hile 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. See Eli Lilly, 119 F.3d at 1566-69. 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-? protein, the known mouse variable region that satisfies the critical claim limitations, and potential human variable regions that will satisfy the claim limitations. See id. 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-? 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.
(internal citations omitted).
Ultimately, the Federal Circuit determined that the scope of Centocor’s right to exclude cannot overreach the scope of its contribution to the field of art as described in the patent specification. The Court concluded that the jury simply lacked the required evidence for its verdict that the asserted claims were supported by adequate written description.
We all know that there will be further filings in this case, there is simply too much money on the line. I wouldn’t be surprised if the entire Federal Circuit agreed to hear the case given the magnitude of the damages award, but this does not seem to be the type of case that would provoke interest by the Supreme Court. The Supreme Court, particularly of late, has shown great interest in patent matters, but those that broadly relate to the law. While the written description requirement is fundamentally important, I just don’t see the Supreme Court undertaking a review of a pharmaceutical case to address the written description requirement. The science will undoubtedly be complicated and any ruling would hardly change the law. It has been the case since at least the time of Samuel Morse (and before) that patent applications need to demonstrate possession of the invention. That would mean the Supreme Court would take a case not to change the law but to alter an outcome, which just doesn’t seem likely if you ask me.