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Rutgers v. Qiagen

Representative Claim(s)

Patent: 7,579,141
1. A method of in vitro diagnosis which discriminates between exposure of a subject to Mycobacterium tuberculosis and vaccination with the Bacille Calmette Guerin strain of Mycobacterium bovis, the method comprising testing for the presence of CD4 T lymphocytes that respond to MTBN4, wherein the presence of the CD4 T lymphocytes that respond to MTBN4 indicates that the subject has been exposed to Mycobacterium tuberculosis, and wherein CD4 T lymphocytes from a subject vaccinated with the Bacille Calmette Guerin strain of Mycobacterium bovis but not exposed to Mycobacterium tuberculosis do not respond.

Patent: 8,021,832
7. A method of in vitro diagnosis comprising:
a. contacting CD4 T lymphocytes from a subject with antigen presenting cells (APC) from the subject and an antigenic segment of MTBN4;
b. testing for the presence of CD4 T lymphocytes that respond to said antigenic segment of MTBN4;
c. discriminating between exposure of the subject to Mycobacterium tuberculosis and vaccination with the Bacille Calmette Guerin strain of Mycobacterium bovis, wherein the presence of CD4 T lymphocytes that respond to said antigenic segment of MTBN4 indicates that the subject has been exposed to Mycobacterium tuberculosis, and wherein CD4 T lymphocytes from a subject vaccinated with the Bacille Calmette Guerin strain of Mycobacterium bovis but not exposed to Mycobacterium tuberculosis do not respond.

Patent: 8,974,800
1. A diagnostic composition that discriminates between infection by Mycobacterium tuberculosis and vaccination by Bacille Calmette Guerin (BCG) strain of Mycobacterium bovis, said composition comprising antigens, all antigens in said composition consisting of at least three different polypeptides of the Mycobacterium tuberculosis complex that are not encoded by BCG, and said polypeptides including at least one isolated polypeptide from the group consisting of
(i) a first amino acid sequence consisting of the sequence of MTBN4 (SEQ ID NO:4),
(ii) a second amino acid sequence that is an antigenic segment of MTBN4 that has Mycobacterium tuberculosis specific antigenic or immunogenic properties, and
(iii) a third amino acid sequence that is identical to said first or second amino acid sequence but has conservative substitutions and has Mycobacterium tuberculosis specific antigenic or immunogenic properties.

Posture:

Motion to Dismiss

Exception Category: Natural Phenomenon

Plaintiff argued that “neither the peptide or antigenic segments or its surroundings are naturally occurring,” and that “there is no chance that any of the polypeptides or antigenic segments thereof in the compositions or methods are found in a human because a protein consists of hundreds of amino acids.” The court, acknowledging the case as a “close” one, stated that “it is at least plausible that the materials used in the inventions are not all naturally-occurring, since Plaintiff states that it highly unlikely for them to combine in this form.”

“[T]here are [also] factual questions about whether the added antigenic peptides are ‘synthetic.’”

Markedly Different?  Maybe

“It is plausible that the invention does not simply isolate or identify a material found in nature.”

“While in vitro tests had previously existed, it seems that the inventor applied that test in a new and unique way in order to significantly improve the process for detecting TB as opposed to BCG.  Also, the special characteristics of proteins as compared to those of DNA may support patent-eligibility.  Patentability is bolstered by the fact that the Patent Office applied the more stringent standards in Mayo and Myriad to the ‘800 patent and found that the invention was patent-eligible.”