EXHIBIT 38

Case 3:11-cv-03788-FLW-LHG Document 112-4 Filed 12/07/12 Page 1 of 3 PageID: 2496
UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF NEW JERSEY 

OREXO AB, 

Plaintiff, 

V. 

MYLAN PHARMACEUTICALS INC. 

and MYLAN INC., 

Honorable Freda L. Wolfson, U.S.D.J. 

Honorable Lois H. Goodman, U.S.M.J. 

Civil Action No. 3:11-cv-3788 (FLW)(LHG) 

Defendants. 

DEFENDANTS/COUNTERCLAIM PLAINTIFFS MYLAN PHARMACEUTICALS 

INC. AND MYLAN INC.'S PRELIMINARY PROPOSED CLAIM CONSTRUCTIONS 

Defendants/Counterclaim Plaintiffs Mylan Pharmaceuticals Inc. and Mylan Inc. 

(collectively, "MyIan"), by their undersigned attorneys, submit the following preliminary 

proposed claim constructions for the claim terms the parties contend should be construed by the 

Court under Local Patent Rule 4.2 and the revised schedule ordered by Magistrate Judge Lois H. 

Goodman on March 28, 2012. 

MyIan has received little discovery from Plaintiff and no discovery from third 

parties. MyIan's investigation into extrinsic evidence also continues. MyIan reserves the right to 

supplement, amend, and modify its preliminary proposed constructions, and the evidence in 

support of those constructions, in light of any further discovery in this case and Mylan's 

investigation, to the extent permitted by the scheduling order or any subsequent order. 

Moreover, claims are to be construed in light of the entire patent, prosecution 

history, and body of extrinsic evidence. Phillips v. AWH Corp., 415 F.3d 1303, 1313-14, 1321 

(Fed. Cir. 2005). Indeed, the prosecution history and the patent must be read together as part of 

the complete intrinsic public record. Id. Mylan therefore generally identifies the entire '910 

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TERM IN PROPOSED SUPPORT 

CLAIM CONSTRUCTION 

(Sept. 26, 2002 Office Action, p. 4 (ORM 00000159); see also May 19, 2003 

Office Action, p. 2 (ORM_00000190).) 

"The most important aspect of the invention is the fact that the compound 

remains water-free so that the active agents do not dissolve too quickly." (Sept. 

26, 2002 Office Action, p. 5 (ORM_00000160); see also May 19, 2003 Office 

Action, p. 3 (ORM_00000191).) 

"[Alt the time the application was filed, one of ordinary skill in the art would 

have expected that an ordered mixture requires a relatively large volume of 

liquid in order to be effective. However, in the sublingual administration of an 

ordered mixture, the volume of liquid available as a solvent is limited to just a 

few millimeters." (Feb. 26, 2003 Amendment, p. 6 (ORM 00000181).) 

Testimony from experts. 

"ordered mixture 

of microparticles 

of at least one 

pharmaceutically 

active agent 

adhered to the 

surfaces of carrier 

particles" 

The result of dry mixing 

microparticles of active 

agent with carrier particles 

so that the microparticles of 

at least one 

pharmaceutically active 

agent are finely dispersed 

and cover the surface of the 

carrier particles 

Microparticles have a 

weight-based mean particle 

size of no more than 24 

microns. 

"It is preferred to formulate the composition according to the invention by use 

of the technology for formulating rapidly dissolving ordered-mixture 

compositions disclosed in European patent EP 0 324 725. In these compositions, 

the drug in a finely dispersed state covers the surface of substantially larger 

carrier particles. Such compositions disintegrate rapidly in water, thereby 

dispersing their contents of microscopic drug particles." (`910 patent, col. 3, 

lns. 26-34.) 

"It is known that ordered mixtures of a relatively coarse particulate, watersoluble, pharmaceutically acceptable carrier substance and smaller particles of 

at least one pharmaceutically active substance can be produced by means of a 

dry mixing process, in which the smaller particles adhere or bind to the surfaces 

of the larger carrier particles (C. Nystrom et al., J. Pharm. Pharmacol. 38, pages 

161-165, (1986); M. Westerberg et al, International Journal of Pharmaceutics, 

28, pages 23-31, (1986). Because of their small particle size, the therpeutically 

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