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CAFC Weekly: Week of February 25, 2011

by Orlando Lopez

This week’s opinions range from an opinion that impacts what satisfies the written description requirement in a claim to an antibody to the relationship, or lack of relationship, between equivalence and obviousness.

In Centocor Ortho Biotech, Inc. v. Abbott Laboratories, Centocor owns a patent (the ‘775 patent) with claims to a fully human antibody useful in treating autoimmune conditions, such as various forms of arthritis.  Centocor sued Abbott claiming that Abbott’s therapeutic fully human antibody Humira®, infringed claims of the ‘775 patent.  At District Court, the jury found that Abbott willfully infringed and that the asserted claims were valid, and awarded damages to Centocor.  Abbott moved for judgment as a matter of law on the invalidity, non-infringement and non-willfulness, but was only granted judgment of non-willfulness.  Abbott appealed to the CAFC. The ‘ 775 patent is the 13th application in a line of continuations in part.  In 1991, Centocor filed an application for a mouse antibody, as well as for an antibody with a human constant region and a mouse variable region (a chimeric antibody); both antibodies aimed at treating autoimmune conditions (There are a number of reasons why mouse antibodies are not desirable. The chimeric antibody attempt to solve those problems, but the variable region is what determines the main characteristics of the antibody).  Centocor filed a series of continuation-in-part applications, aimed at antibodies with “less than an entire mouse variable region.” Those continuation-in-part applications were rejected.  In 1994, material was added to support the claim of antibodies with “less than an entire mouse variable region.” The 1994 continuation-in-part application was allowed; simultaneously, Abbott was working on a fully human antibody aimed at treating autoimmune conditions.  By 1995, Abbot had created the therapeutic fully human antibody Humira®.  In 1996, Abbott filed a patent application claiming the fully human antibody, and the application was finally allowed in 2000.  In 2002, Centocor filed the 13th continuation-in-part application that became the ‘775 patent.  The CAFC found the ‘775 patent invalid due to lack of written description.  Written description is a requirement that one skilled in the art upon reading the specification would realize, that in fact the applicant was in possession of the claimed invention.  Since the 1996 Abbott application preceded the filing of the ‘775 patent, in order to satisfy the written description requirement, the written description requirement had to be based on the 1994 CIP application.  The CAFC found that there was nothing in the 1994 CIP application that would convey to one of skill in the art, that Centocor was in possession of the fully human antibody.

Another point of interest here is a contrast between the USPTO guidelines for written description and the facts of this opinion.  The USPTO guidelines conclude that the characterization of a protein indicated that the applicant was in possession of antibodies which bind to the protein, given “well develop mature” antibody technology.  The CAFC distinguished the present situation from the USPTO guidelines example since, in the situation in the present case, an antibody with the human variable region was not available through conventional routine well developed mature technology.  This opinion clarifies the USPTO written description guidelines.

In Siemens Med. Solutions, Inc. v. Saint-Gobain Ceramics and Plastics, Inc., Siemens owns a patent covering a radiation detector including a scintillator made with a particular material. Saint- Gobain makes a scintillator material for use in radiation detectors and sells that scintillator material to a company that competes with Siemens.  The scintillator material made by Saint- Gobain differs from the Siemens scintillator material in that 10% of one of the elements in the material are substituted by another element.  The scintillator material made by Saint- Gobain is covered by another patent, to which Saint- Gobain has a license.  Siemens sued St. Gobain for contributory and induced infringement based on the doctrine of equivalents (For direct infringement, a product must have all the elements of the claim.  For infringement under the doctrine of equivalents, the product has a component that, although not exactly the same as an element of the claim, is equivalent to the element of the claim.  In one determination of equivalence, the component performs the same function, in the same way, to obtain the same result as the element of the claim).  The jury found that Saint- Gobain contributed and induced infringement, and assessed damages.  Saint- Gobain moved for judgment as a matter of law (JMOL) since, according to Saint- Gobain, infringement should have been proven by a higher standard of evidence(clear and convincing evidence) and also due to several other issues, such as jury instructions and admission of evidence.  Infringement is usually proven under the preponderance of the evidence (more likely than not) standard, but patent invalidation is judged under the clear and convincing evidence standard (The standard for patent invalidation is being challenged in Microsoft v. i4i, which will be considered by the Supreme Court).  The District Court denied the motion.  In a situation where equivalence is used against a feature of a product, where the feature is covered by another patent, the Plaintiff’s attempted to show that if the feature is insubstantially different from a limitation of the asserted claim can be alleged to be contrary to the notion that a patent is not obvious in view of the prior art.  The CAFC found that the finding of infringement was different from the finding of obviousness.  Also, in the present case, the CAFC found that infringement was related only to the conditions of the product and not to the complete coverage of the claim in the licensed patent, which had a range of concentrations of the substituted element.  The CAFC upheld the District Court decision.

In Hologic v. SenoRx, Hologic owns several patents related to balloon brachytherapy, a type of radiation therapy, and sued SenoRx for infringement of claims in those patents.  SenoRx conceded infringement of claims 1 and 8 of one of the patents, but argued that the claims were invalid.  After the District Court interpreted the claims, SenoRx moved for summary judgment of invalidity.  The District Court found claim 1 to be invalid due to anticipation; however,at trial, the jury found that claim 8 was also invalid.  Hologic appealed to the CAFC, andthe CAFC found that the claim interpretation was in error, reversed the judgment of invalidity of claim 1 and, since the jury decision was based on the erroneous claim interpretation as well, also reversed the finding of invalidity of claim 8.

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