On June 3, 2014, Chief ALJ Charles E. Bullock issued the public version of Order No. 23 (dated May 21, 2014) in Certain Antivenom Compositions and Products Containing the Same (Inv. No. 337-TA-903).  In the Order, ALJ Bullock construed various claim terms in the asserted U.S. Patent No. 8,048,414 (the ‘414 patent).

By way of background, the investigation is based on an October 20, 2013 complaint filed by BTG International Inc. (“BTG”) alleging violations of Section 337 in the importation into the U.S. and sale of certain antivenom compositions and products containing the same that infringe one or more claims of the ‘414 patent.  See our November 1, 2013 and December 2, 2013 posts for more details on the complaint and the Notice of Investigation, respectively.  The remaining Respondents are Laboratorios Silanes S.A. de C.V., Instituto Bioclon S.A. de C.V., The Silanes Group, and Rare Disease Therapeutics, Inc. (collectively, “Respondents”).  A Markman hearing was held in the investigation on April 10, 2014. 

In the Order, ALJ Bullock ruled on the level of skill of a person of ordinary skill in the art and construed the following terms in the ‘414 patent:  (1) “Fab fragments” / “F(ab)2 fragments,” (2) “bind specifically to” / “binds to,” (3) “the [or said] antivenom pharmaceutical composition neutralizes the lethality of the venom of a snake of the Crotalus genus,” and (4) “essentially free from contaminating Fc.”   

First, with respect to the level of ordinary skill, ALJ Bullock found that a person of ordinary skill in the art would possess a bachelors or equivalent degree in biology, biochemistry, or immunology with at least an additional three years of study or experience involving immunology, large-scale proteins, protein chemistry, venoms, or antivenoms.  This was similar to the proposed construction of the Commission Investigative Staff (“OUII”) and consistent with BTG’s proposal.  Respondents had argued that a person of ordinary skill would have had significantly higher qualifications.

With respect to the construction of “Fab fragments” / “F(ab)2 fragments,” ALJ Bullock adopted OUII’s proposed construction and construed “Fab fragments” as “immunoglobin fragments having a single antigen-binding site, and composed of one light chain, the variable CH1 regions of a heavy chain, and at least some portion of the hinge region of said heavy chain, wherein said light and heavy chains are covalently linked by one or more disulfide bonds” and “F(ab)2 fragments” as “immunoglobin fragments having two antigen-binding sites, and composed of two identical Fab fragments, wherein the hinge regions of the identical Fab fragments are covalently linked to each other by two or more disulfide bonds.”  The ALJ agreed with OUII’s construction after finding that it “accurately and technically describes the complex structure of Fab fragments and F(ab)2  fragments.” 

With respect to “bind specifically to” / “binds to,” and “the [or said] antivenom pharmaceutical composition neutralizes the lethality of the venom of a snake of the Crotalus genus,” the ALJ gave the terms their plain and ordinary meanings.

Lastly, with respect to “essentially free from contaminating Fc,” ALJ Bullock construed the term to mean “not more than a small, but detectable, amount of Fc, which includes Fc fragments and whole IgC molecules with Fc portions.”  The ALJ found that this construction was consistent with the specification and the knowledge of one of ordinary skill in the art.