Centocor v. Abbott Labs: When Is A Biotech Invention Complete And Ready For Filing?




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The following post was written by Gerald M. Murphy, Partner at Birch, Stewart, Kolasch & Birch, LLP and Practice Center Contributor.

On February 23, 2011, the Court of Appeals for the Federal Circuit in Centocor v. Abbott Labs set aside a $1.7 billion jury verdict in favor of the patentee (Centocor) and held the patent claims at issue were invalid for lack of written description.  This decision reflects a trend of the Federal Circuit in recent years to invalidate patents for lack of written description and offers little guidance as to what is necessary to actually comply with the written description requirements. This case dealt with a somewhat “unpredictable” biotech invention, where there was not an actual reduction to practice of the claimed invention.  In the pharmaceutical fields, it is very common to have method claims directed to treatment of humans and it is very unusual to have had an actual reduction to practice of the method prior to filing the patent application.  However, in this case, the claims were not directed to a method of use, but rather, a new product (antibody).  Based on this and other cases, it appears that the trend of finding lack of written description may become more common in so-called “predictable technologies.”

The Facts

A representative patent claim at issue, dependent claim 2, can be summarized by referring to the following language from claims 1 and 2:

[1.]  An isolated recombinant anti-TNFalpha antibody…comprising a human constant region, wherein said antibody…(i) competitively inhibits binding of A2 (ATCC Accession No. PTA-7045) to human TNFalpha, and (ii) binds … with an affinity of at least 1×108 liter/mole …[2.] … comprises a human constant region and a human variable region.

According to the Federal Circuit, the specification of the relevant application (a 1994 Continuation-in-Part application) indicated that the inventors had actually made a mouse antibody and a chimeric antibody having the claimed characteristics.  Therefore, there was an actual reduction to practice of claim 1 (which apparently encompassed chimeric as well as fully human antibodies).  However, there was no disclosure in the specification that the inventors actually made the narrower invention of claim 2 which was directed to a fully human antibody having the claimed characteristics.

The Testimony at Trial

Conflicting testimony on the issue of written description was offered at trial.  Centocor presented testimony of the inventor and the defendant (Abbott) offered contradictory testimony of a technical expert.

The Opinion

The court restated the basic test for written description from Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed. Cir. 2008) as follows:

[T]he 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.

The court further quoted from Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed. Cir. 1997) as follows:

[t]he 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.

So, what does “in possession” and “actually invented” mean in the context of this case?  The court attempted to explain the rationale for the decision in the following statements:

  • A “mere wish or plan” for obtaining the claimed invention is not adequate written description
  • [t]he overwhelming majority of the ‘775 patent describes the A2 mouse antibody and the single chimeric antibody that Centocor made based on A2’s mouse variable region.
  • only a few sentences sprinkled throughout the ‘775 patent [] mention human antibodies or human variable regions at all.
  • The fact that a fully-human antibody could be made does not suffice to show that the inventors of the ‘775 patent possessed such an 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.

The above quotes seem to suggest that the inventors must actually make the invention in order to have a written description.  In response to arguments made by Centocor, the Federal Circuit denied that it was imposing such a requirement in the following statement:

[W]e have repeatedly indicated that the written description requirement does not demand either examples or an actual reduction to practice. … What is does demand is that one of skill in the art can “visualize or recognize” the claimed antibodies based on the specification’s disclosure.

It is interesting to note that although this panel of the court states that it is sufficient that one skilled in the art can “visualize or recognize” the invention, the court failed to mention the 2010 Federal Circuit case of Goeddel v. Sugano, which states (in the context of a constructive reduction to practice in an interference) that “envisioning” an invention may not be sufficient (see, Goeddel v. Sugano:  What’s The Difference Between “Envisioning” An Invention And Being “In Possession” Of The Invention?)

So, What is the Law Now?

In my view, this case does very little to clarify the law of written description.  There seems to be a trend at the Federal Circuit that a patent should not be able to validly encompass significant developments which are made years after the patent application was filed.  This trend is reflected in the following statement:

The actual inventive work of producing a human variable region was left for subsequent inventors to complete.  The scope of Centocor’s rights to exclude cannot “overreach the scope of [its] contribution to the field of art as described in the patent specification”.

The Federal Circuit seems very willing to set aside jury verdicts on the issue of written description for lack of substantial evidence to support the verdict, despite the fact that conflicting testimony was submitted to the jury and the jury resolved the issue in favor of the patent owner.  How this and other written description cases will affect the treatment of patent applications at the PTO by Examiner’s remains to be seen.

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