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`2007 07 11 Hearing Transcript.txt
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`1
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`UNITED STATES DISTRICT COURT
`
`CENTRAL DISTRICT OF CALIFORNIA
`
`HONORABLE MARIANA R. PFAELZER, JUDGE PRESIDING
`
`MEDIMMUNE, INC.,
`
`PLAINTIFF,
`
`VS.
`
`; NO. CV 03-2567-MRP
`
`GENENTECH, INC., CITY OF HOPE, :
`and CELLTECH R&D LTD.,
`
`DEFENDANTS.
`
`REPORTER'S TRANSCRIPT OF PROCEEDINGS
`
`LOS ANGELES, CALIFORNIA
`WEDNESDAY, JULY 11, 2007
`
`MARK SCHWEITZER, CSR, RPR, CRR
`OFFICIAL COURT REPORTER
`UNITED STATES DISTRICT COURT
`181-H ROYBAL FEDERAL BUILDING
`255 EAST TEMPLE STREET
`LOS ANGELES, CALIFORNIA 90012
`(213) 663-3494
`
`Page 1
`
`2
`
`Mylan v. Genentech
`IPR2016-00710
`Merck Ex. 1149, Pg. 1
`
`
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`2007 07 11 Hearing Transcript.txt
`
`1
`
`UNITED STATES DISTRICT COURT
`
`CENTRAL DISTRICT OF CALIFORNIA
`
`HONORABLE MARIANA R. PFAELZER, JUDGE PRESIDING
`
`MEDIMMUNE, INC.,
`
`PLAINTIFF,
`
`VS.
`
`; NO. CV 03-2567-MRP
`
`GENENTECH, INC., CITY OF HOPE, :
`and CELLTECH R&D LTD.,
`
`DEFENDANTS.
`
`REPORTER'S TRANSCRIPT OF PROCEEDINGS
`
`LOS ANGELES, CALIFORNIA
`WEDNESDAY, JULY 11, 2007
`
`MARK SCHWEITZER, CSR, RPR, CRR
`OFFICIAL COURT REPORTER
`UNITED STATES DISTRICT COURT
`181-H ROYBAL FEDERAL BUILDING
`255 EAST TEMPLE STREET
`LOS ANGELES, CALIFORNIA 90012
`(213) 663-3494
`
`Page 1
`
`2
`
`Mylan v. Genentech
`IPR2016-00710
`Merck Ex. 1149, Pg. 1
`
`
`
`p
`
`2007 07 11 Hearing Transcript.txt
`1 Appearances of Counsel:
`
`2 For the Plaintiff:
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`Williams & Connolly
`.
`By Gerson A. Zweifach, AAL
`Aaron P. Maurer, AAL
`Jessamyn S. Berniker, AAL
`725 Twelfth Street, N.W.
`Washington, D.C. 20005
`(202) 434-5474
`
`Munger, Tories & Olson
`By Andrea Weiss Jeffrie, AAL
`Bill ward, AAL
`355 South Grand Avenue
`35th Floor
`Los Angeles, CA 90071-1560
`(213) 683-9290
`
`Carella, Byrne, Bain, Gilfillan,
`cecchi, Stewart & olstein
`By Elliot M. olstein, AAL
`5 Becerk Farm Road
`Roseland, NJ 07068-1739
`(973) 994-1700
`
`17 For the Defendants:
`
`Keker & Van Nest
`By Daralyn J. Durie, AAL
`David 3. Silbert, AAL
`710 Sansome Street
`San Francisco, CA 94111-1704
`(415) 391-5400
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`18
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`25 [M O R E]
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`1 Appearances of Counsel (Continued):
`
`2
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`3
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`Irell & manella
`By David I. Gindler, AAL
`Joseph M. Lipner, AAL
`Page 2
`
`Merck Ex. 1149, Pg. 2
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`2007 07 11 Hearing Transcript.txt
`1800 Avenue of the Stars
`Suite 900
`Los Angeles, CA 90067-4276
`(310) 277-1010
`
`INDEX
`
`MATTER: Markman Hearing.
`
`Page 3
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`Merck Ex. 1149, Pg. 3
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`2007 07 11 Hearing Transcript.txt
`
`Los Angeles, California; wednesday, July 11, 2007
`
`10:10 A.M.
`
`WHEREUPON THE CASE HAVING BEEN CALLED AND
`
`APPEARANCES GIVEN, THE FOLLOWING PROCEEDINGS
`
`WERE HELD:
`
`THE COURT: All right. Shall we start with the
`
`7 patentee? what shall we do? what's your preference?
`
`8
`
`MR. ZWEIFACH: Well, your Honor, it's fine with us
`Page 4
`
`Merck Ex. 1149, Pg. 4
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`
`
`2007 07 11 Hearing Transcript.txt
`
`9 for you to start with the patentee, and I do have one piece
`
`10 of good news for you. You will not be disappointed to hear
`
`11 that we have resolved one of the six controversies.
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`12
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`13
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`THE COURT: No, you haven't.
`
`MR. ZWEIFACH: It's a small one, but it's better
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`14 than nothing.
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`15
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`16
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`THE COURT: Is it the "or"?
`
`MR. ZWEIFACH: No, no. It's the phrase "variable
`
`17 domain of the immunoglobulin."
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`18
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`19
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`THE COURT: what did you decide about that?
`
`MR. ZWEIFACH: we went with a phrase that was a
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`20 characterization that was in the joint statement that was
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`21 submitted to your Honor when I wasn't here. But something
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`22 tells me your Honor encouraged both sides to try to resolve
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`23 some of their differences. This has the feel of that kind of
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`24 document. Anyway, there's a characterization of what we
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`25 should agree is the variable domain of immunoglobulin. And
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`6
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`1 we agree with this. The end -- terminal end of the heavy and
`
`2 light chains up to the beginning of the content domain.
`
`3
`
`4
`
`THE COURT: All right.
`
`MR. ZWEIFACH: So that's -- we agree on that, and
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`5 so we're down to five.
`
`6
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`THE COURT: That's fine. All right. would you
`
`7 rather start with -- it doesn't make a particle of difference
`
`8 to me. If you agree to the way you're going to proceed, then
`
`9 do that. otherwise, I think we should start with you.
`
`10
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`MR. ZWEIFACH: Well, I'd be happy to start.
`
`Page 5
`
`Merck Ex. 1149, Pg. 5
`
`
`
`11
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`12
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`2007 07 11 Hearing Transcript.txt
`I don't want to trample on your feelings otherwise.
`
`MS. DURIE: we had assumed, your Honor, that as the
`
`13 patentee, we would go first since we had filed the opening
`
`14 brief and medImmune had filed a brief.
`
`15
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`16
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`17
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`THE COURT: Then let's do that.
`
`MR. ZWEIFACH: That's fine.
`
`MS. DURIE: Good morning, your Honor. we thought
`
`18 that it might be helpful to begin the proceedings this
`
`19 morning briefly by reviewing some of the technology at issue
`
`20 in the case. specifically, with respect to the invention
`
`21 that is disclosed in the Cabilly specification. This is a
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`22 brief tutorial, less than 10 minutes, and we will then
`
`23 proceed to discuss the issues raised by some of the specific
`
`24 claim terms.
`
`25
`
`THE COURT: You're going to do this on recombinant
`
`7
`
`1 technology?
`
`2
`
`mS. DURIE: Yes, specifically with respect to the
`
`3 production of recombinant antibodies. So let me begin
`
`4 briefly by reviewing the basics of antibodies.
`
`5
`
`The basic schematic of an antibody is set forth in
`
`6 figure 1 of the patent. And the actual structure of an
`
`7 antibody is more complex. It's actually a complex protein,
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`8 as you can see here. This is actually an image of a
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`9 Genentech product. But it tends to be represented more
`
`10 schematically as a simple Y shape.
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`11
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`so an antibody has four chains of protein. There
`
`12 are two chains called light chains, which are shorter, two
`
`13 chains called heavy chains, which are longer. The top
`Page 6
`
`Merck Ex. 1149, Pg. 6
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`
`
`2007 07 11 Hearing Transcript.txt
`
`14 portion of the Y is referred to as the variable domain. The
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`15 bottom portion of the Y is referred to as the constant
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`16 domain. The variable portion binds to specific antigens or
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`17 foreign substances. The constant region is what mediates an
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`18 effect with the body in order to interact with the -- the
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`19 rest of the body's immune system.
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`20
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`Now, the way that antibodies are involved in a
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`21 human immune response is that a foreign substance enters the
`
`22 body. That foreign substance activates cells within the body
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`23 known as B cells, which present antibodies on their surface.
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`24 The foreign substance, the antigen, binds to those antibodies
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`25 on the surface of the B cell, and the B cell is then
`
`8
`
`1 activated to produce multiple copies of that same antibody,
`
`2 which then bind to the antigen and cause the body's immune
`
`3 system to destroy those antibody antigen complexes, thus
`
`4 ridding the body of the foreign substance.
`
`5
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`Now, antibodies are not in nature typically
`
`6 effective as a defense against diseases that are endemic to
`
`7 the human body.
`
`8
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`9
`
`THE COURT: Wait. Say that again.
`
`MS. DURIE: Antibodies are not typically effective
`
`10 in nature as a defense to disease that arises organically
`
`11 within the human body. So in this example, if a disease
`
`12 develops naturally within the body, there is no foreign
`
`13 signal to stimulate the production of antibodies from B
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`14 cells.
`
`15
`
`And the solution that was arrived at was an effort
`
`Page 7
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`Merck Ex. 1149, Pg. 7
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`
`
`2007 07 11 Hearing Transcript.txt
`16 to try to create antibodies that would on the one hand be
`
`17 able to bind to the disease-causing substance within the
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`18 human body and at the same time mediate or interact with the
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`19 body's own immune system to create engineered or recombinant
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`20 antibodies.
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`21
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`Now, the way that these recombinant antibodies are
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`22 created typically begins with the production of mouse
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`23 antibodies. so the disease-causing agent within the human
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`24 body is taken from the person, a sample of it, and injected
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`25 into a mouse. The mouse then develops antibodies to the
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`9
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`1 substance that the mouse perceives as being foreign to it.
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`2 And those antibodies are then harvested from the mouse. The
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`3 problem is if you endeavor to inject those mouse antibodies
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`4 back into the person who has the disease, the person will
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`5
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`recognize those mouse antibodies as foreign and will develop
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`6 an immune response to the antibodies and destroy them,
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`7 typically before they can have their intended effect.
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`8
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`so the problem was you now have mouse antibodies
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`9 with the desired binding characteristics, but you need some
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`10 way in order to reduce the extent to which they will generate
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`11 an immune response.
`
`12
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`The solution to this is to create recombinantly
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`13 engineered antibodies where part of the information, the
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`14 binding region, derives from the mouse, and part of the
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`15 information, typically the constant domain, can be made to
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`16 appear human.
`
`17
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`A chimeric antibody, which is described in the
`
`18 specification, is one example of such an antibody. In a
`Page 8
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`Merck Ex. 1149, Pg. 8
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`
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`2007 07 11 Hearing Transcript.txt
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`19 chimeric antibody, the constant domain reflects a human
`
`20 constant domain, the variable domain reflects the binding
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`21 region from the mouse antibody.
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`22
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`Now, it is also possible to make what the
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`23 specification describes as altered antibodies. This is an
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`24 example of an altered antibody that is a humanized antibody
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`25 where even more of the information is replaced with human
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`10
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`1 information and just the small portions that are most
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`2 important to binding contain mouse information, in order to
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`3 minimize even further the possibility of the human generating
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`4 an immune reaction to the antibody.
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`5
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`Now, these altered antibodies are created through
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`6 genetic engineering, through recombinant technology, using
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`7 information about the DNA sequences both of human antibodies
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`8 and of the mouse antibody.
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`9
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`So very briefly, as your Honor is already aware,
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`10 DNA, a double-stranded helix, codes for messenger RNA, which
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`11 in turn codes for particular sequence of amino acids. So we
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`12 refer to the portion of the AmRNA that codes for a particular
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`13 protein as the coding region. There is a start codon that
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`14 signals the beginning of the translation process. There is a
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`15 stop codon that signals the end and through that sequence of
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`16 the start codon and the messenger RNA sequence codes for the
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`17 particular protein sequence of interest.
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`18
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`NOW, this recombinant technology -- we're now going
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`19 to illustrate how in the patent there's a description of
`
`20 using this recombinant technology to clone antibodies by
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`Page 9
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`Merck Ex. 1149, Pg. 9
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`
`
`2007 07 11 Hearing Transcript.txt
`21 creating the protein that corresponds to both the heavy and
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`22 light chains of antibodies. we start here with a host cell
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`23 which has its own DNA within it and a vector onto which
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`24 foreign DNA is going to be loaded. So we take the vector,
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`25 and the vector contains a promoter which signals to the cell
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`11
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`1 that -- to begin or to copy the DNA into protein. The vector
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`2 is cleaved, and into this vector is inserted a gene of
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`3 interest. Here we have a gene that codes for the light chain
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`4 of an antibody with a start codon and a stop codon, the green
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`5
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`and the red.
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`6
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`So now that information, that DNA, is loaded onto
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`7 the vector. And so we have, just again, a promoter, a start
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`8 codon, our gene of interest, we have the stop codon, and we
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`9 have vector DNA.
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`10
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`And that in turn then codes for the protein that is
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`11 the light chain.
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`12
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`Now, going back to our vector, in addition to
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`13 loading the light chain on, we're now going to load our heavy
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`14 chain onto the vector. So we have a heavy chain that's
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`15 longer because the protein it codes for is longer.
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`16
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`Now, that vector will be used to transform the host
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`17 cell. so it goes into the host cell and then it might --
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`18 could you stop there for a second, please. It can remain
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`19 like this as a separate DNA molecule, or in some cases it can
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`20 integrate into the host cell DNA. so in this example, it
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`21 integrates into the DNA of the host cell; and now, when
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`22 protein is created, the cell will produce protein for both
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`23 the heavy and the light chain genes.
`Page 10
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`Merck Ex. 1149, Pg. 10
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`
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`2007 07 11 Hearing Transcript.txt
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`24
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`Now, this cell will then replicate and multiple
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`25 copies of the cell will be created, each of them producing
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`12
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`1 these proteins, and these proteins can then combine in order
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`2 to form functional antibodies. And to the extent that the
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`3 amino acid sequences have been modified by nature of the DNA
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`4 being modified, we can create an altered antibody that can be
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`5
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`used as therapy.
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`6
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`Now, with that background, you will turn to a
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`7 discussion of the particular claims that are in dispute. But
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`8 I'd like to begin by noting a couple of ways in which the law
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`9 has evolved since we submitted the briefing to the court on
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`10 these issues, now several years ago.
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`11
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`As your Honor is well aware, the Federal Circuit
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`12 handed down its en banc decision in Phillips since we
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`13 completed our briefing. one of the consequences of the
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`14 Phillips decision with which your Honor is familiar is the
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`15
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`Federal circuit's reaffirmation of the importance of the
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`16 specification in the claim construction analysis.
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`17
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`One of the other important holdings of the Phillips
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`18 case is that considerations of patent validity play a
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`19 de minimis role in the claim construction analysis and that
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`20 the Court should examine the potential validity or invalidity
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`21 of the claims only in the event that the other tools of claim
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`22 construction analysis don't lead the Court to a particular
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`23 claim construction.
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`24
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`so considerations of construing the patent in order
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`25 to preserve its validity really only come into play in the
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`Page 11
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`Merck Ex. 1149, Pg. 11
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`
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`2007 07 11 Hearing Transcript.txt
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`13
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`1 event that the claim term is not otherwise susceptible to
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`2 construction, only in the event that it is ambiguous.
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`3
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`Now, turning to the first claim term that is in
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`4 dispute --
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`5
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`THE COURT: Tell me why you made that comment right
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`6 then.
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`7
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`MS. DURIE: I made that comment because it applies,
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`8 I think, to a number of medimmune's claim construction
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`9 arguments in which they are endeavoring to make claim
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`10 construction arguments that are really invalidity arguments.
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`11
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`12
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`13
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`THE COURT: Yes, they are. They are.
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`MS. DURIE: They are.
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`THE COURT: But we don't -- in this particular
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`14 proceeding, it seems to me that we are going to attempt to
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`15 construe the claims, and we are not going to be concentrating
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`16 on validity.
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`17
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`18
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`MS. DURIE: Agree completely.
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`THE COURT: Now, that is not to say that I have not
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`19 read all of this material on validity. I have. But I'm not
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`20 sitting here saying to myself, as to the claim construction,
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`21 that I should be motivated by taking into consideration all
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`22 the time the validity issue.
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`23
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`24
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`25
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`MS. DURIE: We agree completely.
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`THE COURT: It is what it is.
`
`MS. DURIE: We agree completely.
`
`Page 12
`
`Merck Ex. 1149, Pg. 12
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`
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`2007 07 11 Hearing Transcript.txt
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`14
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`1
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`THE COURT: All right. The only reason I
`
`2 interrupted you is that I just, since you brought it up, I
`
`3 want to make that clear.
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`4
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`5
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`MS. DURIE: Agreed.
`
`So the first claim term, your Honor, is
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`6 independently expressing said first DNA sequence and said
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`7 second DNA sequence so that said immunoglobulin heavy and
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`8 light chains are produced as separate molecules in said
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`9 transformed single host cell.
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`10
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`Now, the parties have agreed that the first portion
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`11 of that phrase does not need further construction by the
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`12 Court. And thus our dispute centers on the second portion of
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`13 the phrase, produced as separate molecules in said
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`14 transformed single host cell.
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`15
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`16
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`So here we have claim 1, the
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`THE COURT: Just one moment. Let's be very clear
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`17 about this. The yellow part is what you're now talking
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`18 about.
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`19
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`20
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`21
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`MS. DURIE: That is correct.
`
`THE COURT: Go on.
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`MS. DURIE: And the part that is the meaning of
`
`22 which is in dispute is the second part of that phrase after
`
`23 the "so that." The portion that reads, "said immunoglobulin
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`24 heavy and light chains are produced as separate molecules in
`
`25 said transformed" --
`
`1
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`THE COURT: In said transformed single host cell.
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`Page 13
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`15
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`Merck Ex. 1149, Pg. 13
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`
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`2
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`2007 07 11 Hearing Transcript.txt
`MS. DURIE: Correct. The parties' competing
`
`3 constructions are as follows. Our proposed construction is
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`4 that the second portion of that phrase carries its ordinary
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`5
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`meaning and does not require any further construction by the
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`6 Court. Just as we believe that the first part of that
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`7 phrase, likewise, was clear on its face.
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`8
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`MedImmune's original proposed construction of this
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`9 phrase was that the heavy and light chains are produced and
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`10 maintained in the single host cell as unreconstituted
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`11 separate molecules. when we pointed out that adding the
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`12 words "and maintained" was reading into this phrase an
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`13 additional limitation not present in the claim, MedImmune
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`14 modified the language of its proposed construction but not
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`15 its substance.
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`16
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`Medlmmune's new proposed construction is that the
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`17 heavy and light chains are separate molecules while in the
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`18 single host cell. But I believe that MedImmune agrees that
`
`19 the substance of these two proposed constructions is the same
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`20 and that Medlmmune is still arguing that the heavy and light
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`21 chains must remain as separate molecules throughout the time
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`22 that they are in the single host cell.
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`23
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`THE COURT: That's what my impression of their
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`24 argument is.
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`25
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`MS. DURIE: Okay.
`
`16
`
`1
`
`2
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`3
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`THE COURT: And if I'm wrong, you'll tell me.
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`MR. ZWEIFACH: You're right.
`
`ms. DURIE: with that, I would like to start by
`
`4 taking a look at claims 9 and 10, both of which depend from
`Page 14
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`Merck Ex. 1149, Pg. 14
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`
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`2007 07 11 Hearing Transcript.txt
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`5 independent claim 1.
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`6
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`Now, as your Honor knows, the claim construction
`
`7 analysis typically begins with looking at the language of the
`
`8 claims and the usage of the terms in the claims.
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`9
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`Claim 9 claims a process according to claim 1
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`10 wherein the immunoglobulin heavy and light chains are
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`11 expressed in the host cell and secreted therefrom as an
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`12 immunologically functional immunoglobulin molecule or
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`13 immunoglobulin fragment.
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`14
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`Claim 10 in contrast claims a process where the
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`15 heavy and light chains are produced in insoluble form and
`
`16 solubilized and allowed to re-fold to form in solution to
`
`17 form an immunologically functional immunoglobulin molecule or
`
`18 fragment.
`
`19
`
`Now, what this means is that claim 9 is claiming a
`
`20 process wherein the heavy and light chains are assembled,
`
`21 come together within the single host cell and are secreted
`
`22 from the host cell as a functional molecule or fragment.
`
`23
`
`Claim 10, on the other hand, is claiming a process
`
`24 whereby the heavy and light chains are secreted from the
`
`25 single host cell as separate molecules. They are actually in
`
`17
`
`1 this large complex and then are allowed to re-fold in order
`
`2 to form functional immunoglobulins in solution outside the
`
`3 host cell.
`
`4
`
`The first and most glaring problem with medimmune's
`
`5
`
`proposed claim construction is that it reads dependent claim
`
`6 9 out of the patent by rendering it fundamentally
`
`Page 15
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`Merck Ex. 1149, Pg. 15
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`
`
`2007 07 11 Hearing Transcript.txt
`7 inconsistent with Medlmmune's interpretation of what claim 1
`
`8 means and likewise, largely renders claim 10 redundant by
`
`9 reading that limitation back into claim 1.
`
`10
`
`Now, medimmune's only real response to this claim
`
`11 construction argument is to argue that the specification does
`
`12 not support what is claimed in claim 9, that is to say, the
`
`13 production of the immunoglobulin molecule within the single
`
`14 host cell.
`
`15
`
`I want to make two observations about that
`
`16 argument.
`
`17
`
`First, as your Honor has already, I think, noted,
`
`18 that is really a validity argument, not a claim construction
`
`19 argument. medimmune's ultimate point is that the claim
`
`20 itself, as written, does not have adequate support under
`
`21 section 112, either written description or enablement. That
`
`22 is an argument that Medlmmune certainly can make, but did
`
`23 not, I would suggest, an appropriate argument at this stage
`
`24 of the proceedings.
`
`25
`
`Second, the patent specification does exclusively
`
`18
`
`1 contemplate the possibility of the heavy and light chains
`
`2 recombining within a single host cell.
`
`3
`
`Looking here at column 12 of the patent commencing
`
`4 around line 52, you will see there's a reference to the heavy
`
`S
`
`and light chains being co-expressed in the same host, and
`
`6 then the specification reads, "This can be accomplished in
`
`7 vitro, as described below, or might be possible in vivo in a
`
`8 micro-organism which secretes the IgG chains out of the
`
`9 reducing environment of the cytoplasm."
`Page 16
`
`Merck Ex. 1149, Pg. 16
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`
`
`2007 07 11 Hearing Transcript.txt
`
`10
`
`The thing here is this is an invention that is
`
`11 directed to the heavy and light chains within a single host
`
`12 cell and not to the particular mechanism by which those heavy
`
`13 and light chains come together in order to form the
`
`14 functional antibody. That is because, as is noted in the
`
`15 immediately following paragraph, the techniques to reassemble
`
`16 isolated chains were known in the art. They were not part of
`
`17 what was inventive here.
`
`18
`
`NOW, in the case of in vitro recombination, the
`
`19 heavy and light chains coming together outside the host cell,
`
`20 the patent provides a teaching of the techniques known in the
`
`21 art in order to accomplish that result because it is
`
`22 something that the scientist has to do. It is something that
`
`23 requires the technician -- there are techniques that must be
`
`24 learned that the technician must follow.
`
`25
`
`In the case of recombination in vivo, that is
`
`19
`
`1 something that is done by the host cell itself. In the case
`
`2 of, for example, the mammalian host cells that are taught in
`
`3 the specification, the cell's own mechanism can in certain
`
`4 circumstances cause the heavy and light chain to campaign
`
`S
`
`within the cell and produce the antibody. No teaching is
`
`6 required because it's not something the scientist does. It's
`
`7 something the cell itself does.
`
`8
`
`The point is simply that the specification
`
`9 explicitly contemplates the possibility of both, and the
`
`10
`
`claims, specifically claim 9 and claim 10, are explicitly
`
`11 directed to each of those possibilities.
`
`Page 17
`
`Merck Ex. 1149, Pg. 17
`
`
`
`12
`
`2007 07 11 Hearing Transcript.txt
`unless your Honor has any questions with respect to
`
`13 this claim term, I can either proceed to the next claim term
`
`14 or allow Medlmmune to address this claim term if your Honor
`
`15 would rather proceed on a --
`
`16
`
`17
`
`18
`
`19
`
`20
`
`THE COURT: I would rather do it term by term.
`
`MS. DURIE: Very well. Thank you.
`
`THE COURT: All right.
`
`MS. DURIE: Thank you.
`
`MR. ZWEIFACH: Your Honor, I, too, have a few
`
`21 introductory remarks about why we're fighting 'about what
`
`22 we're fighting about.
`
`23
`
`THE COURT: oh, I really think I could figure out
`
`24 that. I do understand why you are.
`
`25
`
`MR. ZWEIFACH: I understand. Let me make a couple
`
`20
`
`1 of remarks by way of introduction.
`
`2
`
`The first is I'm not here to argue in asking you to
`
`3 anticipate invalidity issues. You won't hear a word from me
`
`4 on that today, but the Phillips case does instruct that one
`
`5 of the critical things for the Court to look at in construing
`
`6 claims, in construing language, is the specification, and it
`
`7 elevates that exercise, the inventor's specification, the
`
`8 description, all of the language that precedes the claim
`
`9 terms, as the first and preferred sort of touchstone of
`
`10 analysis. And it reaffirms as well that the claim terms
`
`11 should not be construed to exceed what is disclosed as the
`
`12 invention in the specification.
`
`13
`
`so it's not a matter -- I'm going to talk about the
`
`14 specification not because I'm asking you to make an early
`Page 18
`
`Merck Ex. 1149, Pg. 18
`
`
`
`2007 07 11 Hearing Transcript.txt
`
`15 judgment on validity. I'm going to talk about the
`
`16 specification because the case law teaches that the
`
`17 specification is critical to understanding the scope of the
`
`18 invention and construing the claims.
`
`19
`
`20
`
`THE COURT: You are quite right about that.
`
`MR. ZWEIFACH: So let me make one observation,
`
`21 which your Honor's made as well from an earlier visit. This
`
`22 patent has obviously an unusual history, and, as your Honor
`
`23 knows, this patent originates with a sort of copying in of
`
`24 certain claims by Dr. Boss into a Cabilly patent application
`
`25 and then a rather long process until the patent is issued.
`
`21
`
`1 And that history plays itself out in the claim construction
`
`2 controversies that are before you now.
`
`3
`
`4
`
`what do I mean by that?
`
`well, the first is that because of the patent's
`
`5
`
`rather long history, medimmune was done with this process of
`
`6 host cell transformation that Ms. Durie spoke about.
`
`7
`
`In other words, the entire body of the first -- the
`
`8 unhighlighted portion that you looked at of claim 1 about
`
`9 transforming a host cell, in other words, building that
`
`10 antibody, done five years before the patent issued, and that
`
`11 plays itself out in what is going to come out before you
`
`12 because what you will see is Genentech will be arguing to
`
`13 your Honor that various devices that are used in the host
`
`14 cell transformation process, a process we are done with, they
`
`15 will now urge your Honor to construe as if they are still
`
`16 alive in the present in the form of the altered chromosomes,
`
`Page 19
`
`Merck Ex. 1149, Pg. 19
`
`
`
`2007 07 11 Hearing Transcript.txt
`17 meaning in the form of what is currently being used.
`
`18
`
`But we're out of the host cell transformation
`
`19 business. So one entire area of controversy that is in front
`
`20 of you, all this talk about vectors and plasma as, and
`
`21 submit insertion sites, why are we fighting about that?
`
`22 We're fighting about that because we are done with host cell
`
`23 transformation, and it is now Genentech's effort to try to
`
`24 convince the court to construe the words and the terms that
`
`25 are about the mechanics of transformation, in effect to bring
`
`22
`
`1 the past into the present. So that's one entire area of
`
`2 controversy that is really a product of this sort of long
`
`3 germination of this patent, the fact that it is actually
`
`4 issued after we are out of the transformation business.
`
`5
`
`The second feature of this patent's origin -- this,
`
`6 I think, plays out here -- is that as Phillips instructs and
`
`7 as your Honor says, we're supposed to be looking at the
`
`8 specification to construe the claims, but, of course, the
`
`9 specification that you have to look at is the one, because of
`
`10 this sort of marriage of expedience, is Dr. cabilly's
`
`11 specification, and you're looking at that exclusively to
`
`12 construe Boss's claims.
`
`13
`
`why do I say that? Because the cabilly 2 patent
`
`14 has two sets of claims. It has the original cabilly claims
`
`15 or claims that Dr. cabilly drafted based on his work with
`
`16 bacteria cells, and it also has, through this copied in
`
`17 process that you know about, or. BOSS'S work, which involved
`
`18 more different kinds of cells, and those claims are broader,
`
`19 at least facially.
`
`Page 20
`
`Merck Ex. 1149, Pg. 20
`
`
`
`20
`
`21
`
`2007 07 11 Hearing Transcript.txt
`
`THE COURT: All right.
`
`MR. ZWEIFACH: So what you need to know is we are
`
`22 not alleged to be infringing any of Dr. Cabilly's own claims
`
`23 that were based on his work. The only claims we are alleged
`
`24 to be infringing are the original Boss claims, words that
`
`25 someone else wrote based on work that someone else did.
`
`23
`
`1
`
`And so why does this matter? It matters because
`
`2 there is a rather awkward but under the law critical
`
`3 relationship between Cabilly's specification and his
`
`4 description of what he did, and what he contemplated by way
`
`5 of manufacture of proteins, and what it is that MedImmune
`
`6 does.
`
`7
`
`And that's a critical driver of the fight that's in
`
`8 front of you. You are called upon by the law to pretend that
`
`9 you are construing a specification and claims together as if
`
`10 they are from one mind, and that's what we have to do here.
`
`11 But they aren't. And what you will
`
`is there is a gap, a
`
`12 particularly large gap between what Dr. Cabilly was actually
`
`13 doing and described in his specification and the operation of
`
`14 the cell, the operation of these factories that they want you
`
`15 to sort of read these claims to apply to. And that's an
`
`16 important gap, and that is really a product of the unusual
`
`17 history here.
`
`18
`
`So I think what you are going to see -- and I will
`
`19 show you a few slides to try to explain at least our
`
`20 understanding of what's going on -- is an effort by Genentech
`
`21 to effectively build a rhetorical bridge from the host cell
`
`Page 21
`
`Merck Ex. 1149, Pg. 21
`
`
`
`2007 07 11 Hearing Transcript.txt
`22 transformation process that is in our past, that we don't do
`
`23 anymore, so that vectors and plasmids and words like that are
`
`24 now still alive and applicable to things that exist in the
`
`25 present -- which are what? -- are already built factories
`
`24
`
`1 which have been generating antibodies for years.
`
`2
`
`second, you'll see an effort to try to, I think,
`
`3 walk away from much of what's in or. Cabilly's spec, but we
`
`4 can't, because this marriage of convenience between Cabilly's
`
`5 work and Boss's claims has consequences. We are obliged by
`
`6 the law to look to Cabilly's work to understand what those
`
`7 claims mean, and when you do that, you will see that his
`
`8 notion of the expression of the proteins is entirely
`
`9 different from what we do. And that's why we're fighting
`
`10 over those claim terms.
`
`11
`
`So let me show you, I think we can skip the
`
`12 antibody -- I think ms. curie has handled that. I will say
`
`13 one thing, which is it isn't correct that the only reason to
`
`14 genetically engineer antibodies is to deal with diseases that
`
`15 are -- that arise out of the --
`
`16
`
`17
`
`THE COURT: I know that.
`
`MR. ZWEIFACH: After all, my client's doing -- RSV
`
`18 is a virus. The reason we have to genetically engineer an
`
`19 antibody is because premature babies don't have the equipment
`
`20 to deal with the virus. And that's why we've created this
`
`21 drug. And I'm sure she didn't mean to suggest that was the
`
`22 only reason. But let's look at A-2, if we could. And could
`
`23 I have the book?
`
`24
`
`I have tremendous distrust of technology, and I
`Page 22
`
`Merck Ex. 1149, Pg. 22
`
`
`
`2007 07 11 Hearing Transcript.txt
`
`25
`
`have hard copies of these slides.
`
`25
`
`1
`
`2
`
`THE COURT: Thank you.
`
`MR. ZWEIFACH: This is what Dr. Cabilly described
`
`3 that he did. what did he do? He was working with bacteria.
`
`4 A bacterial host. It's a very simple cell. It doesn't even
`
`5 have a nucleus. The sort of chromosome is just floating in
`
`6 there. so what does he do? He took the code for light chain
`
`7 and heavy chain DNA. He inserted them, that code, into two
`
`8 vectors. He also described the possibility of putting it on
`
`9 one vector, but what he did was he put them into two vectors.
`
`10 The vectors which are these transforming agents in effect,
`
`11 they go into the host cell, and when you are working with a
`
`12 bacterial host cell, effectively that's the extent of
`
`13 transformation, meaning that you don't actually transform the
`
`14 chromosome, the sort of central brain doesn't get changed.
`
`15 what happens is these vectors remain in place in the
`
`16 bacterial host cell, and they actually carry out the process
`
`17 of expressing proteins.
`
`18
`
`So yes, it's a transformed host, but it's
`
`19 transformed to a limited extent because the nucleus --
`
`20 there's no nucleus. The chromosomes aren't transformed, and
`
`21 the vectors are still there. They are kind of like free
`
`22 agents. They still have the capacity to actually come out of
`
`23 there and go transform another bacterial host. So they are
`
`24 still around. so what's the next step
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