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Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc.

United States Court of Appeals, Federal Circuit

July 26, 2017

SOFT GEL TECHNOLOGIES, INC., Appellant
v.
JARROW FORMULAS, INC., Appellee SOFT GEL TECHNOLOGIES, INC., Appellant
v.
JARROW FORMULAS, INC., Appellee SOFT GEL TECHNOLOGIES, INC., Appellant
v.
JARROW FORMULAS, INC., Appellee

         Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. 95/002, 396, 95/002, 405, 95/002, 411.

          DEVAN V. PADMANABHAN, Winthrop & Weinstine, PA, Minneapolis, MN, argued for appellant. Also represented by Sri Sankaran, Erin Dungan, Brett Klein.

          Mark D. Giarratana, McCarter & English, LLP, Hartford, CT, argued for appellee. Also represented by Eric E. Grondahl, Charles D. Ray.

          Before Prost, Chief Judge, Bryson and HUGHES, Circuit Judges.

          Bryson, Circuit Judge.

         Soft Gel Technologies, Inc., appeals from three inter partes reexamination decisions of the Patent Trial and Appeal Board. The Board's decisions invalidated numerous claims in each of three related Soft Gel patents for obviousness. We affirm.

         I

         A

         Soft Gel is the named assignee of U.S. Patent Nos. 8, 124, 072 ("the '072 patent"), 8, 105, 583 ("the '583 patent"), and 8, 147, 826 ("the '826 patent"). The '583 patent issued from a continuation-in-part, and '826 patent issued from a continuation, of the '072 patent. The '072 patent issued on February 28, 2012; the '583 patent issued on January 31, 2012; and the '826 patent issued on April 3, 2012.

         The specifications of the three patents describe a method for dissolving a substance commonly referred to as CoQ10 in solvents known as monoterpenes. '072 patent, col. 2, 11. 46-48.[1] The patented inventions include a composition, a soft gelatin capsule, and a method of making such a soft gelatin capsule, each involving a solution of CoQ10 dissolved in a monoterpene.

         CoQ10, also known as ubiquinone, is a coenzyme, i.e., a chemical compound that is required for the biological activity of certain proteins. '072 patent, col. 1, 11. 16-25. It "affects the function of almost all cells in the body, making it essential for the health of all human tissues and organs." Id., col. 1, 11. 39-41.

         CoQ10 is necessary for certain metabolic processes and for the production of cellular energy; it has a secondary role as an antioxidant. '072 patent, col. 1, 11. 18-24, 37-38. It is particularly important in "the cells that are the most metabolically active: heart, immune system, gingiva, and gastric mucosa." Id., col. 1, 11. 22-24, 41-43. In clinical trials, CoQ10 has been shown to be effective in regulating blood pressure and cholesterol levels, improving cardiovascular health, and "thwarting various diseases such as certain types of cancers." Id., col. 1, 11. 44-49; see also id., col. 7, 11. 11-21 (noting that CoQ10 has been used in the treatment of cardiovascular conditions, periodontal diseases, mitochondrial-related diseases and disorders, and neurological disorders).

         Although CoQ10 is synthesized by the body, the body may require more than it can synthesize or obtain through normal dietary intake. '072 patent, col. 1, 11. 26-28. Oral supplementation can compensate for a CoQ10 deficiency. Id., col. 1, 11. 29-31.

         Unfortunately, CoQ10 is "sparingly soluble in hydro-philic solvents such as water." '072 patent, col. 1, 11. 51-52. According to the Soft Gel patents, at the time of the inventions most solvents that were used to administer CoQ10 in liquid form could dissolve, at most, only about 5 to 10 percent of the CoQ10. Id., col. 1, 11. 64-67; id., col. 2, 11. 59-61. For that reason, CoQ10 was generally administered in solid form, such as in a tablet or powder. Id., col. 1, U. 52-53; id., col. 2, 11. 63-64. CoQ10 could also be administered as a suspension, in which the CoQ10 is partially dissolved in a solvent. Id., col. 1, 11. 52-53; id., col. 3, 11. 21-23. But those delivery methods limited the bioavailability of the CoQ10, as only a small fraction of the CoQ10 would enter the bloodstream. Id., col. 1, 11. 53-55; id., col. 3, 11. 23-24. The Soft Gel patents state that there was "a need in the art for an improved methodology to deliver increased amount[s] of bioavailable CoQ-10 to an individual in need thereof." Id., col. 1, 11. 56-58.

         The patents describe the discovery of monoterpenes as a solvent for CoQ10. '072 patent, col. 1, 11. 62-64; id., col. 2, 11. 46-48; see also id., col. 3, 11. 24-26. Monoterpenes are a class of compounds that have a ten-carbon skeleton and consist of "two isoprene units connected in a head-to-end manner." Id., col. 3, 11. 31-34. "Suitable examples of monoterpenes include, but are not limited to, limonene, . . . carvone, . . . and derivatives thereof." Id., col. 3, 11. 49-53; see also id., col. 3, 11. 59-63 (listing, "[i]n particular, " a number of "suitable limonene derivatives").

         Unlike aqueous solvents, monoterpenes can dissolve significant amounts of CoQ10. "Generally, about 30 to about 45% of the CoQ-10 (by weight [relative to that of the monoterpene]) is solubilized [dissolved] in the monoterpene." '072 patent, col. 2, 11. 11-12; see also, e.g., id., col. 2, line 65, through col. 3, line 11 (noting that up to about 60% by weight of CoQ10 may be dissolved in monoterpene, and describing other "aspects" of the invention in which the weight of solubilized CoQ10 relative to monoterpene is "about 0.1 percent ... to about 45 percent, " "about 5 to about 50 percent, " "about 15 to about 40 percent, " and "about 20 to about 35 percent"). The solution of CoQ10 dissolved in monoterpene may then be formulated as a caplet or soft gelatin capsule containing the solution. Id., col. 3, line 64, through col. 4, line 1. Formulations of that solution of CoQ10 dissolved in a monoterpene "provid[e] increased bioavailability in delivery, " id., col. 1, 11. 10-12, because "the solvated [dissolved] coenzyme can more easily pass into cells[, ] . . . delivering increased amounts of the coenzyme into an individual's physiological makeup, " '583 patent, col. 7, 11. 4-7.

         The claims of the Soft Gel patents focus on solutions of CoQ10 and a monoterpene called limonene. Limonene is a compound that can have one of two different three-dimensional physical structures, labeled d-limonene and 1-limonene. The claims of the three Soft Gel patents were amended to cover only solutions of CoQ10 and d-limonene.

         Claim 1 of each patent is representative for purposes of ...


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