antibody.pngEarlier, the Supreme Court ruled that MedImmune could sue Genentech for patent infringement even though MedImmune continued to pay licensing fees to Genentech to use disputed technology to develop the drug Synagis®.  At the same time, the U.S. Patent and Trademark Office decided to have a second review of the patents at issue, U.S. Pat. Nos. 4,816,567 and 6,331,415, which relate to antibodies and to non-specific immunoglobulins formed by recombinant techniques using host cell cultures.

The Patent Office has now finished those proceedings dealing with Genentech’s Cabilly patent under concurrent proceedings for an Inter Partes Reexamination (RE Appl. No. 90/007,542) and an Ex Parte Reexamination (RE Appl. No. 90/007,859).  While an earlier ruling by the Office declared the the claims invalid as being anticipated under various earlier patents and references, the Patent Office has now issued a Notice of Intent to Issue a Reexamination Certificate (NIRC) confirming the patentability of all claims of the Cabilly patent.  A fancy way of saying that the claims are good to go.

Note, during the reexamination process, Genentech did amend claims 21 through 32 but claims that there were amended in a way that does not affect the commercial viability of the patent. More importantly, this decision by the Patent Office is final and unappealable.

The Notice set out that the invention is for a method for producing an immunologically functional immunoglobulin molecule or an immunologically functional immunoglobulin fragment by transforming a single host cell with a first DNA sequence encoding immunoglobulin heavy chain and a second DNA sequence encoding immunoglobulin light chain and independently expressing the first DNA sequence and second DNA sequence so that said immunoglobulin heavy chain and light chain are produced as separate molecules in said transformed single host cell.

Based on the prosecution history of the patent at issue, and the interference record from Interference No. 102,572, the Examiner determined that the term “immunoglobulin molecule” in claims 1 and 33 is considered to be an immunologically functional molecule and capable of binding to a known antigen.

The following is an examiner’s statement of reasons for patentability and/or confirmation of the claims found patentable in this reexamination proceeding:

The combination of the Cabilly I patent claims and the teachings of Axel, Rice, Kaplan, Builder, Accolla, Dallas, Moore patent, Deacon and Valle and Ochi references do not suggest or contain an enabling disclosure of a method to produce an immunologically functional immunoglobulin molecule by independently expressing immunoglobulin heavy chain and light chain in a single transformed host cell.

Claims 1-20, 33-36 are confirmed and amended claims 21-32 are allowed.

Genentech’s controversial patent will not expire now until the end of 2018, an expiration date that is over 29 years after the Cabilly I patent issued.  While we don’t know the details of the final settlement, I imagine that MedImmune is probably feeling pretty good right about now that they didn’t breach their license in order to bring their earlier action contesting the patents.

See the Patent Office documents here:

Notice of Intent to Issue a Reexamination Certificate
Notice of Intent to Issue a Reexamination Certificate


MedImmune and Genentech Settle, Lawyers Look For New Topic of Discussion
USPTO Smacks Down Genentech’s Antibody Patent
Supreme Court High-Fives MedImmune

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  1. Enablement, written description, and inequitable conduct, have been raised against Cabilly II.

    None of these issues are topics of reexamination (in general), and the specific reexamination addressed only issues of obvious-type double patenting.

  2. […] The USPTO upheld the validity of Genentech’s Cabilly patent.  We covered the development here, and Patent Baristas has covered it here. […]