Free Order - District Court of Delaware - Delaware

Case 1:07-cv-00156-JJF Document 149 Filed 07/29/2008 Page 1 of 4
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
PDL BIOPHARMA, INC., :
Plaintiff, E
v. E Civil Action No. 07-156-JJF
ALEXION PHARMACEUTICALS, INC., i
Defendant. i
O R D E R
At Wilmington, this<2;l day of July 2008, for the reasons
discussed in the Memorandum Opinion issued this date;
IT IS HEREBY ORDERED that the following terms and/or phrases
in U.S. Patent Nos. 5,693,761 (“the ‘761 patent"), 5,693,762
(“the ‘762 patent") and 6,180,370 (“the ‘370 patent") are
assigned the following meanings:
1. The term ““humanized immunoglobulin" means an
“immunoglobulin comprising a human framework region and one or
more CDR’s from a non—human (usually a mouse or rat)
immunoglobulin." Framework amino acid substitutions are optional.
2. The terms “c0mplementary determining region," or
“CDR," means “amino acid sequence in the variable region, the
boundaries of which are defined by the Kabat methodology.”
3. The terms “framew0rk,” “framework region" and
“variab1e framework regions" mean “those portions of the variable
region of an immunoglobulin that are not a CDR (where the term
‘CDR' means ‘amino acid sequence in the variable region, the

Case 1:07-cv-00156-JJF Document 149 Filed 07/29/2008 Page 2 of 4
boundaries of which are defined by the Kabat methodology’)."
4. The terms “heavy and light chain variable region
frameworks” and “heavy and light chain frameworks” mean “those
portions of the heavy chain and light chain variable regions of
an immunoglobulin that are not a CDR (where ‘CDR’ means ‘amino
acid sequence in the variable region, the boundaries of which are
defined by the Kabat methodology’)."
5. The term “donor immunoglobulin" is construed to
mean “the non—human immunoglobulin providing the CDRs." Framework
amino acid substitutions are optional.
6. The terms “human acceptor immunoglobulin" and
“acceptor human immunoglobulin" mean “the human immunoglobulin
providing the framework for the CDRs." Framework amino acid
substitutions are optional.
7. The term “humanized immunoglobulin light chain
variable region framework" means “the light chain variable region
framework (defined as ‘portions of the [light] chain variable
region of an immunoglobulin that are not a CDR (where the term
‘CDR’ means ‘amino acid sequence in the variable region, the
boundaries of which are defined by the Kabat methodology’) of a
humanized immunoglobulin (defined as ‘an immunoglobulin
comprising a human framework region and one or more CDR’s from a
non—human (usually a mouse or rat) immunoglobulin)'."
8. The term “humanized immunoglobulin heavy chain variable
region framework" means “the heavy chain variable region

Case 1:07-cv-00156-JJF Document 149 Filed 07/29/2008 Page 3 of 4
framework (defined as ‘portions of the [heavy] chain variable
region of an immunoglobulin that are not a CDR (where the term
‘CDR’ means ‘amino acid sequence in the variable region, the
boundaries of which are defined by the Kabat methodology’)of a
humanized immunoglobulin (defined as ‘an immunoglobulin
comprising a human framework region and one or more CDR’s from a
non—human (usually a mouse or rat) immunoglobulin)’."
9. The phrases “DNA segment encoding a humanized
heavy chain variable region"/”DNA segment encoding the humanized
immunoglobulin heavy chain variable region" mean “the
polynucleotide segment which codes for the humanized heavy chain
variable region (as defined above). The segment may either be
joined or separate from the segment encoding the light chain."
10. The phrases “DNA segment encoding a humanized
light chain variable region"/”DNA segment encoding the humanized
immunoglobulin light chain variable region" mean “the
polynucleotide segment which codes for the humanized light chain
variable region (as defined above). The segment may either be
joined or separate from the segment encoding the heavy chain."
11. The phrase “DNA segments encoding the humanized
heavy and light chains" means “the polynucleotide segments which
code for the humanized light and heavy chains (as defined above).
The segments may be either joined or separate.”
12. The phrases “DNA segments encoding humanized light
and heavy chain variable regions”/”DNA segments encoding heavy

Case 1:07-cv-00156-JJF Document 149 Filed 07/29/2008 Page 4 of 4
and light chain variable regions of a humanized immunoglobulin"
mean “the polynucleotide segments which code for the humanized
light and heavy chains (as defined above). The segments may be
either joined or separate."
l3. The phrase “synthesizing a [the] DNA segment
encoding a humanized heavy chain variable region" means
“producing a [the] polynucleotide segment that codes for the
humanized heavy [light] chain variable region (as defined
above)."
14. The phrase “is at least 65% identical" is
construed according to its plain meaning when read in the context
of the claim, and further construction by the Court is not
required.