In an order construing the terms of a patent related to the substance mannitol, the Court defined the following terms:
- “pulverulent mannitol”
- “according to a Test I of between about 40% and about 80%”
- “mechanical action in a ERWEKA TAP friabilimeter”
- “the test on a sieve with mesh size of 100 microns”
- “a rate of dissolution according to a Test II of between about 0 and 30 seconds”
- “introducing into about 150 g of demineralized and degassed water maintained at about 20 degrees C and subjected to stirring at 200 rpm in a 250 ml low form beaker, exactly 5 g of a particle size cut, within the range of about 100 and 200 microns, of the powder to be tested”
- “perfect visual clarity of the suspension thus prepared”
- “comprising a mannitol richness… greater than approximately 90%
- “granulating by a wet route”
Roquette Freres v. SPI Pharma, Inc., C.A. No. 06-540-GMS, Order Construing the Terms of U.S. Patent No. 5,573,777 (D. Del. June 11, 2010).
Of note, the court gave a narrow definition of the term “pulverulent mannitol” based on the patent’s written description which referred to “relatively pure pulverulent mannitol” as “the present invention” or the “invention” throughout the specification and did not “indicate that ‘relatively pure pulverulent mannitol’ is merely a preferred embodiment.” Id. at 1-2 n. 1.