Tuesday, March 15, 2011

Patent case set for trial after rulings by Northern California Judge

A drawing from
the '522 patent.
Judge Susan Illston recently granted summary judgment on a few claims but left others for trial in a massive pharmaceutical patent case between Sanofi-Aventis Deutchland GMBH (Sanofi, plaintiff), Genentech, Inc. (Genentech, defendant) and BiogenIDEC, Inc. (Biogen, defendant).  The case involves U.S Patents 5,849,522 (shown right) and 6,218,140 (which uses the same drawings).  The patents cover a protein called an enhancer that increases the rate at which DNA is transcribed into RNA.  Sanofi argues that Genentech and Biogen infringe its patents by selling two pharmaceuticals: Rituxan (which treats non-Hodgkin's lymphoma and rheumatoid arthritis) and Avastin (which treats colon, lung and breast cancer). Interestingly, both drugs are made by Chinese hamster ovary (CHO) cell lines.

Claim 1 of the '522 patent reads:
The method to increase expression of a gene in a mammalian cell comprising inserting into a mammalian cell an isolated DNA enhancer consisting of DNA from the upstream region of the major immediate early (IE) gene of the human cytomegalovirus (HCMV) and a heterologous gene that is to be expressed, wherein the DNA from the upstream region of the IE gene of HCMV is the only HCMV material to which themammalian cell is exposed.
The underlined sections are where the fight is.

Genetech argues that it did not insert an isolated DNA enhancer into the mammalian cell because it did this years before the USPTO issued the '522 patent.  Sanofi responds that Genetech inserted the cell through mitosis by growing and replicating the enhancer-containing Rituxan cells after the initial insertion.  Or, alternately, that this process accomplishes the claim under the doctrine of equivalents.  Judge Susan wasn't buying it.
The Court concludes that Genentech does not practice the step of "inserting" and thus does notliterally infringe Claims 1 and 2 of the '522 patent [because for] DNA to be separated by human intervention, it mustactually be manipulated by a human being, not merely replicated within a hamster cell by the cell’s own natural processes.
The Court also finds that "inserting by mitosis" differs substantially from inserting by
transfection [which causes the doctrine of equivalents argument to fail as well].
With regard to the isolated DNA enhancer, Genetech argues that it uses a combined promoter/enhancer not an isolated DNA enhancer. Judge Illston agreed.
It is undisputed that promoters, from whatever source and whether altered or synthetic, are not capable of functioning independent of orientation, nor are they capable of functioning even if located long distances upstream or downstream relative to the initiation site of the linked gene. Indeed, Sanofi has admitted that the two Rituxan® fragments described [do] not have these capabilities.
Finally, with regard to the "only HCMV material to which the mammalian cell is exposed" Genetech argues that Rituxan does not infringe because it incorporates DNA that is downstream of the transcription start site.  Sanofi responds that this HCMV DNA is not "HCMV material."  Judge Illston disagreed:
Finally, the Court agrees with Genentech that if the Court were to accept Sanofi’s position that synthetic HCMV DNA is not "HCMV material," then Rituxan® does not infringe because Rituxan® does not, under Sanofi’s construction, contain "HCMV material."
She granted summary judgment on the '522 patent for the defendants. However, the '140 patent is going to trial.

No comments:

Post a Comment