Abbot Wins Federal Circuit Reversal of $1.67B Patent Verdict

By Gene Quinn
February 23, 2011

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.

[Bio-Pharma]

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.

The Author

Gene Quinn

Gene Quinn is a Patent Attorney and Editor and President & CEO ofIPWatchdog, Inc.. Gene founded IPWatchdog.com in 1999. Gene is also a principal lecturer in the PLI Patent Bar Review Course and Of Counsel to the law firm of Berenato & White, LLC. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 6 Comments comments.

  1. Anon February 24, 2011 7:58 am

    This leaves me wondering about the difference between actual reduction and constructive reduction.

    Is all constructive reduction now merely “a plan” that will be hammered? Will all patent applications, by default, have to have actual “models” complete at the time of filing? Should the Office require that these models be submitted as evidence of “possession” since constructive reduction is seemingly dead?

  2. Gene Quinn February 24, 2011 8:37 am

    Everyone-

    In the original article I failed to provide a link to the actual decision. I just updated the article with this line: “In its decision earlier today, the Federal Circuit (Judge Prost writing, joined by Judges Clevenger and Bryson) reversed…”

    Anon-

    I understand why you are asking those questions. I really don’t know the answer because the science is not in my wheelhouse so to speak. I will try and find someone who can write about the science involved and whether the CAFC actually got it right. The legal analysis looks good to me, don’t you think?

    -Gene

  3. Anon February 24, 2011 9:01 am

    Gene,

    In my mind, this is not a surprise per se – A trend towards the use of 112 as a “weapon” to deny patents seems to have been building as the demise of the 101 arguments appeared more and more inevitable.

    I will freely admit to a pro-patent bias, and do believe that “possession” as read fairly in the 112 requirement is good law. But “possession” as read in this decision no longer encompasses a constructive reduction. This will not be the last seismic shift in this area of law, and it appears that a return to providing working models in order to prove “possession” may be an end result. Will, or can, the Office handle applicants behavior if this road is followed?

    One would think that patent law is full of examples of “the law of unintended consequences” , and perhaps some of the consequences – the desire to return to an earlier day – drives some of these decisions. To me, innovation means moving forward – and sometimes that moving forward meets a subtle (and perhaps too subtle to be noticed) inclination to fight that forward movement. This decision particularly screams to me a necessity now of “prove to me” that, as I mentioned, may lead to applicant behavior that the Office will be ill-equipped to handle.

    Slightly off-topic, but to me this notion of shepherding innovation merely by what the Office can handle is most noticeable in the shift of inventive activity in the computer arts. The record is clear that the Office first fought these types of innovation, not on the principle that they were not innovations, but rather, that the Office lacked the ability to judge these innovations. The influence of this type of thinking can be insidious. Those who cry out “not in my backyard’ may realize too late that the law applies across all arts – and such decisions as here will have wide ranging effects.

    I am interested in what preparation for these effects others are contemplating.

  4. EG February 24, 2011 1:39 pm

    Gene,

    I’ve had a chance to go through the case. I’m not a molecular biologist, but I do understand the science involved (at least with regard to the “written description” issue:

    1. The therapeutic TNF-a antibodies involved in this suit had to satisfy 3 criteria: (a) high affinity in binding to TNF-a so that antibody would “stick” to TNF-a (“high affinity”); (b) the ability to function as an antibody for TNF-a (“neutralizing activity”); and (c) doesn’t trigger immune responses (“reduced immunogenicity”). Criteria (a) and (b) are usually in the “variable” region of the antibody, while criteria (c) is usually in the “constant” region of the antibody.

    2. Centocor, the patentees, approach to these antibodies was to use the corresponding “variable” region of the mouse TNF-a (which is the most sensitive to changes) antibody, but to then insert the corresponding “constant” region of the human TNF-a (which is less sensitive to changes) antibody. This sort of combo is called a “chimeric antibody.” That’s what was described at least in the initial Centocor applications.

    3. Abbott, one of the alleged infringers, took a different approach. Instead of forming a chimeric antibody, Abbott was able to create a human TNF-a antibody that used the “variable” region and “constant” region of a human TNF-a antibody. In fact, Abbott was able to obtain a patent on this “fully human” TNF-a antibody.

    4. Only after Abbotts’s patent was granted and after regulatory approval of Abbotts’ “fully human” TNF-a antibody (Humira) did Centrocor file a patent application to add claims to such a “fully human” TNF-a antibody. But because Abbotts filing date was earlier than this later filed Centrocor application, Centrocor had go back to its earlier applications to, in essence, “swear behind” Abbott’s patent as prior art. But Centrocor only exemplified in these earlier applications “chimeric” and not “fully human” TNF-a antibodies, and thus didn’t evidence “possession” of the “fully human” TNF-a antibody. That’s why the “written description” requirement proved fatal to Centrocor’s allegedly infringed patent.

    Hope that explanation helps on understanding the “science’ involved in the “written description” issue. If the facts are as laid out by the Federal Circuit panel, in my opinion, Centrocor’s patent is likely dead, even if the case is considered by the en banc Federal Circuit. The “lack of possession” of “fully human” TNF-a antibodies in the earlier applications is completely fatal on the “written description” requirement.

  5. Anon February 24, 2011 2:05 pm

    I am less alarmed after additional reading including EG’s piece (thanks EG).

  6. Gene Quinn February 24, 2011 3:33 pm

    Anon-

    I asked EG to write something up for us given that he is a “chem/pharma guy.” I figured he would be able to translate the science for us to understand. It looks like the CAFC did get this one correct. Straight forward, basic written description law. It just seems that Centocor got caught doing what the giants always do, adding after the fact picture claims to a long pending patent application. I have a feeling this practice will start to get vetted in more cases that reach the CAFC given how widespread the practice is. Not that there is anything wrong with the practice, I think companies, including small businesses, should employ the tactic. It just helps to actually have a specification that supports the after filed claims.

    -Gene